Cinacalcet Accordpharma

ANNEX I 

 
SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 30 mg film-coated tablets  
Cinacalcet Accordpharma 60 mg film-coated tablets  
Cinacalcet Accordpharma 90 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 30 mg, 60 mg or 90 mg cinacalcet (as hydrochloride).  
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
Cinacalcet Accordpharma 30 mg film-coated tablets 
 
Light green coloured, oval shaped (approximately 9.65 mm long and 6.00 mm wide), biconvex, film-
coated tablets debossed with "HB1" on one side and plain on other side. 
 
Cinacalcet Accordpharma 60 mg film-coated tablets 
 
Light green coloured, oval shaped (approximately 12.20 mm long and 7.60 mm wide), biconvex, film-
coated tablets debossed with "HB2" on one side and plain on other side. 
 
Cinacalcet Accordpharma 90 mg film-coated tablets 
 
Light green coloured, oval shaped (approximately 14.00 mm long and 8.70 mm wide), biconvex, film-
coated tablets debossed with "HB3" on one side and plain on other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Secondary hyperparathyroidism 
 
Adults 
Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease 
(ESRD) on maintenance dialysis therapy. 
 
Paediatric population 
Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage 
renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately 
controlled with standard of care therapy (see section 4.4). 
 
Cinacalcet Accordpharma may be used as part of a therapeutic regimen including phosphate binders 
and/or Vitamin D sterols, as appropriate (see section 5.1). 
 



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Parathyroid carcinoma and primary hyperparathyroidism in adults 
 
Reduction of hypercalcaemia in adult patients with: 

• parathyroid carcinoma. 
• primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium 

levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not 
clinically appropriate or is contraindicated. 

 
4.2 Posology and method of administration 
 
Secondary hyperparathyroidism 
 
Adults and elderly (> 65 years) 
The recommended starting dose for adults is 30 mg once per day. Cinacalcet should be titrated every 2 
to 4 weeks to a maximum dose of 180 mg once daily to achieve a target parathyroid hormone (PTH) in 
dialysis patients of between 150-300 pg/mL (15.9-31.8 pmol/L) in the intact PTH (iPTH) assay. PTH 
levels should be assessed at least 12 hours after dosing with cinacalcet. Reference should be made to 
current treatment guidelines. 
 
PTH should be measured 1 to 4 weeks after initiation or dose adjustment of cinacalcet. PTH should be 
monitored approximately every 1-3 months during maintenance. Either the intact PTH (iPTH) or 
bio-intact PTH (biPTH) may be used to measure PTH levels; treatment with cinacalcet does not alter 
the relationship between iPTH and biPTH. 
 
Dose adjustment based on serum calcium levels 
Corrected serum calcium should be measured and monitored and should be at or above the lower limit 
of the normal range prior to administration of first dose of cinacalcet (see section 4.4). The normal 
calcium range may differ depending on the methods used by your local laboratory. 
 
During dose titration, serum calcium levels should be monitored frequently, and within 1 week of 
initiation or dose adjustment of cinacalcet. Once the maintenance dose has been established, serum 
calcium should be measured approximately monthly. In the event that corrected serum calcium levels 
fall below 8.4 mg/dL (2.1 mmol/L) and/or symptoms of hypocalcaemia occur the following 
management is recommended: 
 

Corrected Serum calcium level or clinical 
symptoms of hypocalcaemia 

Recommendations 

< 8.4 mg/dL (2.1 mmol/L) and > 7.5 mg/dL 
(1.9 mmol/L), or in the presence of clinical 
symptoms of hypocalcaemia 

Calcium-containing phosphate binders, vitamin D 
sterols and/or adjustment of dialysis fluid calcium 
concentrations can be used to raise serum calcium 
according to clinical judgment. 

< 8.4 mg/dL (2.1 mmol/L) and > 7.5 mg/dL 
(1.9 mmol/L) or persistent symptoms of 
hypocalcaemia despite attempts to increase 
serum calcium 

Reduce or withhold dose of cinacalcet. 

≤ 7.5 mg/dL (1.9 mmol/L) or persistent 
symptoms of hypocalcaemia and Vitamin D 
cannot be increased 

Withhold administration of cinacalcet until serum 
calcium levels reach 8.0 mg/dL (2.0 mmol/L) 
and/or 
symptoms of hypocalcaemia have resolved. 
Treatment should be reinitiated using the next 

     
Paediatric population 
 
Corrected serum calcium should be in the upper range of, or above, the age-specified reference 
interval prior to administration of first dose of cinacalcet, and closely monitored (see section 4.4). The 



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normal calcium range differs depending on the methods used by your local laboratory and the age of 
the child/patient. 
 
The recommended starting dose for children aged ≥ 3 years to < 18 years is ≤ 0.20 mg/kg once daily 
based on the patient’s dry weight (see table 1). 
 
The dose can be increased to achieve a desired target iPTH range. The dose should be increased 
sequentially through available dose levels (see table 1) no more frequently than every 4 weeks. The 
dose can be increased up to a maximum dose of 2.5 mg/kg/day, not to exceed a total daily dose of 180 
mg. 

Table 1. Cinacalcet daily dose in paediatric patients 
 

 
Patient dry weight (kg) 

 
Starting dose (mg) 

Available sequential dose 
levels (mg) 

10 to < 12.5 1 1, 2.5, 5, 7.5, 10 and 15 
≥ 12.5 to < 25 2.5 2.5, 5, 7.5, 10, 15, and 30 
≥ 25 to < 36  

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5, 10, 15, 30, and 60 

≥ 36 to < 50 5, 10, 15, 30, 60, and 90 
≥ 50 to < 75 10 10, 15, 30, 60, 90, and 120 
≥ 75 15 15, 30, 60, 90, 120, and 180 

 
Cinacalcet Accordpharma is only available as film-coated tablet. Thus, it is not possible to administer 
cinacalcet Accordpharma to paediatric patients that require less than a full 30 mg dose. If an alternate 
dose is required, other cinacalcet products offering such an option should be used. 
 
Dose adjustment based on PTH levels 
PTH levels should be assessed at least 12 hours after dosing with cinacalcet and iPTH should be 
measured 1 to 4 weeks after initiation or dose adjustment of cinacalcet. 
 
The dose should be adjusted based on iPTH as shown below: 

• If iPTH is < 150 pg/mL (15.9 pmol/L) and ≥ 100 pg/mL (10.6 pmol/L), decrease the dose of 
cinacalcet to the next lower dose. 

• If iPTH < 100 pg/mL (10.6 pmol/L), stop cinacalcet treatment, restart cinacalcet at the next 
lower dose once the iPTH is > 150 pg/mL (15.9 pmol/L). If cinacalcet treatment has been 
stopped for more than 14 days, restart at the recommended starting dose. 

 
Dose adjustment based on serum calcium levels 
Serum calcium should be measured within 1 week after initiation or dose adjustment of cinacalcet. 
 
Once the maintenance dose has been established, weekly measurement of serum calcium is 
recommended. Serum calcium levels in paediatric patients should be maintained within the normal 
range. If serum calcium levels decrease below the normal range or symptoms of hypocalcaemia occur, 
appropriate dose adjustment steps should be taken as shown in table 2 below: 
 

Table 2. Dose adjustment in paediatric patients ≥ 3 to < 18 years of age 
 

Corrected Serum calcium value or 
clinical symptoms of hypocalcaemia 

Dosing recommendations 

Corrected serum calcium is at or below 
age-specified lower limit of normal or 
if symptoms of hypocalcaemia occur, 
regardless of calcium level. 

Stop treatment with cinacalcet.* 
 
Administer calcium supplements, calcium-containing 
phosphate binders and/or vitamin D sterols, as clinically 
indicated. 



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Corrected Serum calcium value or 
clinical symptoms of hypocalcaemia 

Dosing recommendations 

Corrected total serum calcium is above 
age-specified lower limit of normal, and 
 
Symptoms of hypocalcaemia have 
resolved. 

Restart at the next lower dose. If cinacalcet treatment has 
been stopped for more than 14 days, restart at the 
recommended starting dose. 
 
If patient was receiving the lowest dose (1 mg/day) prior 
to discontinuation, restart at the same dose (1 mg/day). 

*If the dose has been stopped, corrected serum calcium should be measured within 5 to 7 days 
 
The safety and efficacy of cinacalcet in children aged less than 3 years for the treatment of secondary 
hyperparathyroidism have not been established. Insufficient data are available. 
 
Switch from etelcalcetide to Cinacalcet Accordpharma 
 
The switch from etelcalcetide to Cinacalcet Accordpharma and the appropriate wash out period has 
not been studied in patients. In patients who have discontinued etelcalcetide, Cinacalcet 
Accordpharma should not be initiated until at least three subsequent haemodialysis sessions have been 
completed, at which time serum calcium should be measured. Ensure serum calcium levels are within 
the normal range before Cinacalcet Accordpharma is initiated (see sections 4.4 and 4.8). 
 
Parathyroid carcinoma and primary hyperparathyroidism 
 
Adults and elderly (> 65 years) 
The recommended starting dose of cinacalcet for adults is 30 mg twice per day. The dose of cinacalcet 
should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice 
daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to reduce serum calcium 
concentration to or below the upper limit of normal. The maximum dose used in clinical trials was 
90 mg four times daily. 
 
Serum calcium should be measured within 1 week after initiation or dose adjustment of cinacalcet. 
Once maintenance dose levels have been established, serum calcium should be measured every 
2 to 3 months. After titration to the maximum dose of cinacalcet, serum calcium should be periodically 
monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of 
cinacalcet therapy should be considered (see section 5.1). 
 
Paediatric population 
The safety and efficacy of cinacalcet in children for the treatment of parathyroid carcinoma and 
primary hyperparathyroidism have not been established. No data are available. 
 
Hepatic impairment 
 
No change in starting dose is necessary. Cinacalcet should be used with caution in patients with 
moderate to severe hepatic impairment and treatment should be closely monitored during dose titration 
and continued treatment (see sections 4.4 and 5.2). 
 
Method of administration 
 
For oral use. 
Tablets should be taken whole and should not be chewed, crushed or divided. 
 
It is recommended that cinacalcet be taken with food or shortly after a meal, as studies have shown 
that bioavailability of cinacalcet is increased when taken with food (see section 5.2). 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  



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Hypocalcaemia (see sections 4.2 and 4.4). 
 
4.4 Special warnings and precautions for use 
 
Serum calcium 
 
Life threatening events and fatal outcomes associated with hypocalcaemia have been reported in adult 
and paediatric patients treated with cinacalcet. Manifestations of hypocalcaemia may include 
paraesthesias, myalgias, cramping, tetany and convulsions. Decreases in serum calcium can also 
prolong the QT interval, potentially resulting in ventricular arrhythmia secondary to hypocalcaemia. 
Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with 
cinacalcet (see section 4.8). Caution is advised in patients with other risk factors for QT prolongation 
such as patients with known congenital long QT syndrome or patients receiving medicinal products 
known to cause QT prolongation. 
 
Since cinacalcet lowers serum calcium, patients should be monitored carefully for the occurrence of 
hypocalcaemia (see section 4.2). Serum calcium should be measured within 1 week after initiation or 
dose adjustment of cinacalcet. 
 
Adults 
Cinacalcet treatment should not be initiated in patients with a serum calcium (corrected for albumin) 
below the lower limit of the normal range. 
 
In CKD patients receiving dialysis who were administered cinacalcet, approximately 30% of patients 
had at least one serum calcium value less than 7.5 mg/dL (1.9 mmol/L). 
 
Paediatric population 
 
Cinacalcet should only be initiated for the treatment of secondary HPT in children ≥ 3 years old with 
ESRD on maintenance dialysis therapy, in whom secondary HPT is not adequately controlled with 
standard of care therapy, where serum calcium is in the upper range of, or above, the age-specified 
reference interval. 
 
Closely monitor serum calcium levels (see section 4.2) and patient compliance during treatment with 
cinacalcet. Do not initiate cinacalcet or increase the dose if non-compliance is suspected. 
 
Prior to initiating cinacalcet and during treatment, consider the risks and benefits of treatment and the 
ability of the patient to comply with the recommendations to monitor and manage the risk of 
hypocalcaemia. 
 
Inform paediatric patients and/or their caregivers about the symptoms of hypocalcaemia and about the 
importance of adherence to instructions about serum calcium monitoring, and posology and method of 
administration. 
 
CKD patients not on dialysis 
Cinacalcet is not indicated for CKD patients not on dialysis. Investigational studies have shown that 
adult CKD patients not on dialysis treated with cinacalcet have an increased risk for hypocalcaemia 
(serum calcium levels < 8.4 mg/dL [2.1 mmol/L]) compared with cinacalcet-treated CKD patients on 
dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney 
function. 
 
Seizures 
 
Cases of seizures have been reported in patients treated with cinacalcet (see section 4.8). The threshold 
for seizures is lowered by significant reductions in serum calcium levels. Therefore, serum calcium 
levels should be closely monitored in patients receiving cinacalcet, particularly in patients with a 
history of a seizure disorder. 



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Hypotension and/or worsening heart failure 
 
Cases of hypotension and/or worsening heart failure have been reported in patients with impaired 
cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and 
may be mediated by reductions in serum calcium levels (see section 4.8). 
 
Co-administration with other medicinal products 
 
Administer cinacalcet with caution in patients receiving any other medicinal products known to lower 
serum calcium. Closely monitor serum calcium (see section 4.5). 
 
Patients receiving cinacalcet should not be given etelcalcetide. Concurrent administration may result 
in severe hypocalcaemia. 
 
General 
 
Adynamic bone disease may develop if PTH levels are chronically suppressed below approximately 
1.5 times the upper limit of normal with the iPTH assay. If PTH levels decrease below the 
recommended target range in patients treated with cinacalcet, the dose of cinacalcet and/or vitamin D 
sterols should be reduced or therapy discontinued. 
 
Testosterone levels 
 
Testosterone levels are often below the normal range in patients with end-stage renal disease. In a 
clinical study of adult ESRD patients on dialysis, free testosterone levels decreased by a median of 
31.3% in the cinacalcet-treated patients and by 16.3% in the placebo-treated patients after 6 months of 
treatment. An open-label extension of this study showed no further reductions in free and total 
testosterone concentrations over a period of 3 years in cinacalcet-treated patients. The clinical 
significance of these reductions in serum testosterone is unknown. 
 
Hepatic impairment 
 
Due to the potential for 2 to 4 fold higher plasma levels of cinacalcet in patients with moderate to 
severe hepatic impairment (Child-Pugh classification), cinacalcet should be used with caution in these 
patients and treatment should be closely monitored (see sections 4.2 and 5.2). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Medicinal products known to reduce serum calcium 
 
Concurrent administration of other medicinal products known to reduce serum calcium and cinacalcet 
may result in an increased risk of hypocalcaemia (see section 4.4). Patients receiving cinacalcet should 
not be given etelcalcetide (see section 4.4). 
 
Effect of other medications on cinacalcet 
 
Cinacalcet is metabolised in part by the enzyme CYP3A4. Co-administration of 200 mg bid 
ketoconazole, a strong inhibitor of CYP3A4, caused an approximate 2-fold increase in cinacalcet 
levels. Dose adjustment of cinacalcet may be required if a patient receiving cinacalcet initiates or 
discontinues therapy with a strong inhibitor (e.g. ketoconazole, itraconazole, telithromycin, 
voriconazole, ritonavir) or inducer (e.g. rifampicin) of this enzyme. 
 
In vitro data indicate that cinacalcet is in part metabolised by CYP1A2. Smoking induces CYP1A2; 
the clearance of cinacalcet was observed to be 36-38% higher in smokers than non-smokers. The 
effect of CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) on cinacalcet plasma levels has not 



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been studied. Dose adjustment may be necessary if a patient starts or stops smoking or when 
concomitant treatment with strong CYP1A2 inhibitors is initiated or discontinued. 
 
Calcium carbonate: Co-administration of calcium carbonate (single 1,500 mg dose) did not alter the 
pharmacokinetics of cinacalcet. 
 
Sevelamer: Co-administration of sevelamer (2,400 mg tid) did not affect the pharmacokinetics of 
cinacalcet. 
 
Pantoprazole: Co-administration of pantoprazole (80 mg od) did not alter the pharmacokinetics of 
cinacalcet. 
 
Effect of cinacalcet on other medications 
 
Medicinal products metabolised by the enzyme P450 2D6 (CYP2D6): Cinacalcet is a strong inhibitor 
of CYP2D6. Dose adjustments of concomitant medicinal products may be required when cinacalcet is 
administered with individually titrated, narrow therapeutic index substances that are predominantly 
metabolised by CYP2D6 (e.g. flecainide, propafenone, metoprolol, desipramine, nortriptyline, 
clomipramine). 
 
Desipramine: Concurrent administration of 90 mg cinacalcet once daily with 50 mg desipramine, a 
tricyclic antidepressant metabolised primarily by CYP2D6, significantly increased desipramine 
exposure 3.6-fold (90% CI 3.0, 4.4) in CYP2D6 extensive metabolisers. 
 
Dextromethorphan: Multiple doses of 50 mg cinacalcet increased the AUC of 30 mg 
dextromethorphan (metabolised primarily by CYP2D6) by 11-fold in CYP2D6 extensive metabolisers. 
 
Warfarin: Multiple oral doses of cinacalcet did not affect the pharmacokinetics or pharmacodynamics 
(as measured by prothrombin time and clotting factor VII) of warfarin. 
 
The lack of effect of cinacalcet on the pharmacokinetics of R-and S-warfarin and the absence of auto-
induction upon multiple dosing in patients indicates that cinacalcet is not an inducer of CYP3A4, 
CYP1A2 or CYP2C9 in humans. 
 
Midazolam: Co-administration of cinacalcet (90 mg) with orally administered midazolam (2 mg), a 
CYP3A4 and CYP3A5 substrate, did not alter the pharmacokinetics of midazolam. These data suggest 
that cinacalcet would not affect the pharmacokinetics of those classes of medicines that are 
metabolised by CYP3A4 and CYP3A5, such as certain immunosuppressants, including cyclosporine 
and tacrolimus. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no clinical data from the use of cinacalcet in pregnant women. Animal studies do not 
indicate direct harmful effects with respect to pregnancy, parturition or postnatal development. No 
embryonal/foetal toxicities were seen in studies in pregnant rats and rabbits with the exception of 
decreased foetal body weights in rats at doses associated with maternal toxicities (see section 5.3). 
Cinacalcet should be used during pregnancy only if the potential benefit justifies the potential risk to 
the foetus. 
 
Breast-feeding 
 
It is not known whether cinacalcet is excreted in human milk. Cinacalcet is excreted in the milk of 
lactating rats with a high milk to plasma ratio. Following careful benefit/risk assessment, a decision 
should be made to discontinue either breast-feeding or treatment with cinacalcet. 
 



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Fertility 
 
There are no clinical data relating to the effect of cinacalcet on fertility. There were no effects on 
fertility in animal studies. 
 
4.7 Effects on ability to drive and use machines 
 
Dizziness and seizures, which may have major influence on the ability to drive and use machines, have 
been reported by patients taking cinacalcet (see section 4.4). 
 
4.8 Undesirable effects 
 
a) Summary of the safety profile 
 
Secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism 
 
Based on available data from patients receiving cinacalcet in placebo-controlled studies and single-
arm studies the most commonly reported adverse reactions were nausea and vomiting. Nausea and 
vomiting were mild to moderate in severity and transient in nature in the majority of patients. 
Discontinuation of therapy as a result of undesirable effects was mainly due to nausea and vomiting. 
 
b) Tabulated list of adverse reactions 
 
Adverse reactions, considered at least possibly attributable to cinacalcet treatment in the placebo-
controlled studies and single-arm studies based on best-evidence assessment of causality are listed 
below using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); 
uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). 

 
Incidence of adverse reactions from controlled clinical studies and post-marketing experience are: 
 

MedDRA system organ class Subject incidence Adverse reaction 
Immune system disorders Common* Hypersensitivity reactions 
Metabolism and nutrition disorders Common Anorexia Decreased appetite 
Nervous system disorders Common Seizures† Dizziness 

Paraesthesia 
Headache 

Cardiac disorders Not known* Worsening heart failure† 
QT prolongation and 
ventricular arrhythmia 
secondary to hypocalcaemia† 

Vascular disorders Common Hypotension 
Respiratory, thoracic and mediastinal 
disorders 

Common Upper respiratory infection 
Dyspnoea Cough 

Gastrointestinal disorders Very common Nausea Vomiting 
Common Dyspepsia Diarrhoea 

Abdominal pain Abdominal 
pain – upper Constipation 

Skin and subcutaneous tissue disorders Common Rash 
Musculoskeletal and connective tissue 
disorders 

Common Myalgia Muscle spasms Back 
pain 

General disorders and administration 
site conditions 

Common Asthenia 

Investigations Common Hypocalcaemia† 
Hyperkalaemia 
Reduced testosterone levels† 

†see section 4.4 



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*see section c 
 
c) Description of selected adverse reactions 
 
Hypersensitivity reactions 
Hypersensitivity reactions including angioedema and urticaria have been identified during post-
marketing use of cinacalcet. The frequencies of the individual preferred terms including angioedema 
and urticaria cannot be estimated from available data. 
 
Hypotension and/or worsening heart failure 
There have been reports of idiosyncratic cases of hypotension and/or worsening heart failure in 
cinacalcet-treated patients with impaired cardiac function in post-marketing safety surveillance, the 
frequencies of which cannot be estimated from available data. 
 
QT prolongation and ventricular arrhythmia secondary to hypocalcaemia 
QT prolongation and ventricular arrhythmia secondary to hypocalcaemia have been identified during 
post-marketing use of cinacalcet, the frequencies of which cannot be estimated from available data 
(see section 4.4). 
 
d) Paediatric population 
 
The safety of cinacalcet for the treatment of secondary HPT in paediatric patients with ESRD 
receiving dialysis was evaluated in two randomised controlled studies and one single-arm study 
(see section 5.1). Among all paediatric subjects exposed to cinacalcet in clinical studies a total of 
19 subjects (24.1%; 64.5 per 100 subject years) had at least one adverse event of hypocalcaemia. A 
fatal outcome was reported in a paediatric clinical trial patient with severe hypocalcaemia (see section 
4.4). 
 
Cinacalcet should be used in paediatric patients only if the potential benefit justifies the potential risk.  
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Doses titrated up to 300 mg once daily have been administered to adult patients receiving dialysis 
without adverse outcome. A daily dose of 3.9 mg/kg was prescribed to a paediatric patient receiving 
dialysis in a clinical study with subsequent mild stomach ache, nausea and vomiting.  
 
Overdose of cinacalcet may lead to hypocalcaemia. In the event of overdose, patients should be 
monitored for signs and symptoms of hypocalcaemia, and treatment should be symptomatic and 
supportive. Since cinacalcet is highly protein-bound, haemodialysis is not an effective treatment for 
overdose. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents, ATC code: H05BX01.  
 
Mechanism of action 
 

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The calcium sensing receptor on the surface of the chief cell of the parathyroid gland is the principal 
regulator of PTH secretion. Cinacalcet is a calcimimetic agent which directly lowers PTH levels by 
increasing the sensitivity of the calcium sensing receptor to extracellular calcium. The reduction in 
PTH is associated with a concomitant decrease in serum calcium levels. 
 
Reductions in PTH levels correlate with cinacalcet concentration. 
 
After steady state is reached, serum calcium concentrations remain constant over the dosing interval.  
 
Secondary hyperparathyroidism 
 
Adults 
Three, 6-month, double-blind, placebo-controlled clinical studies were conducted in ESRD patients 
with uncontrolled secondary HPT receiving dialysis (n = 1,136). Demographic and baseline 
characteristics were representative of the dialysis patient population with secondary HPT. Mean 
baseline iPTH concentrations across the 3 studies were 733 and 683 pg/mL (77.8 and 72.4 pmol/L) for 
the cinacalcet and placebo groups, respectively. 66% of patients were receiving vitamin D sterols at 
study entry, and > 90% were receiving phosphate binders. Significant reductions in iPTH, serum 
calcium-phosphorus product (Ca x P), calcium, and phosphorus were observed in the cinacalcet-
treated patients compared with placebo-treated patients receiving standard of care, and the results were 
consistent across the 3 studies. In each of the studies, the primary endpoint (proportion of patients with 
an iPTH ≤ 250 pg/mL (≤ 26.5 pmol/L)) was achieved by 41%, 46%, and 35% of patients receiving 
cinacalcet, compared with 4%, 7%, and 6% of patients receiving placebo. Approximately 60% of 
cinacalcet-treated patients achieved a ≥ 30% reduction in iPTH levels, and this effect was consistent 
across the spectrum of baseline iPTH levels. The mean reductions in serum Ca x P, calcium, and 
phosphorus were 14%, 7% and 8%, respectively. 
 
Reductions in iPTH and Ca x P were maintained for up to 12 months of treatment. Cinacalcet 
decreased iPTH and Ca x P, calcium and phosphorus levels regardless of baseline iPTH or Ca x P 
level, dialysis modality (PD versus HD), duration of dialysis, and whether or not vitamin D sterols 
were administered. 
 
Reductions in PTH were associated with non-significant reductions of bone metabolism markers (bone 
specific alkaline phosphatase, N-telopeptide, bone turnover and bone fibrosis). In post-hoc analyses of 
pooled data from 6 and 12 months clinical studies, Kaplan-Meier estimates of bone fracture and 
parathyroidectomy were lower in the cinacalcet group compared with the control group. 
 
Investigational studies in patients with CKD and secondary HPT not undergoing dialysis indicated that 
cinacalcet reduced PTH levels to a similar extent as in patients with ESRD and secondary HPT 
receiving dialysis. However, efficacy, safety, optimal doses and treatment targets have not been 
established in treatment of predialytic renal failure patients. These studies show that CKD patients not 
undergoing dialysis treated with cinacalcet have an increased risk for hypocalcaemia compared with 
cinacalcet-treated ESRD patients receiving dialysis, which may be due to lower baseline calcium  
levels and/or the presence of residual kidney function. 
 
EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events) was a randomised, 
double-blind clinical study evaluating cinacalcet versus placebo for the reduction of the risk of all-
cause mortality and cardiovascular events in 3,883 patients with secondary HPT and CKD receiving 
dialysis. The study did not meet its primary objective of demonstrating a reduction in risk of all-cause 
mortality or cardiovascular events including myocardial infarction, hospitalisation for unstable angina, 
heart failure or peripheral vascular event (HR 0.93; 95% CI: 0.85, 1.02; p = 0.112). After adjusting for 
baseline characteristics in a secondary analysis, the HR for the primary composite endpoint was 0.88; 
95% CI: 0.79, 0.97. 
 
Paediatric population 



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The efficacy and safety of cinacalcet for the treatment of secondary HPT in paediatric patients with 
ESRD receiving dialysis was evaluated in two randomised controlled studies and one single-arm 
study. 
 
Study 1 was a double-blind, placebo-controlled study in which 43 patients aged 6 to < 18 years were 
randomised to receive either cinacalcet (n = 22) or placebo (n = 21). The study consisted of a 24-week 
dose titration period followed by a 6-week efficacy assessment phase (EAP), and a 30-week 
open-label extension. The mean age at baseline was 13 (range 6 to 18) years. The majority of patients 
(91%) were using vitamin D sterols at baseline. The mean (SD) iPTH concentrations at baseline were 
757.1 (440.1) pg/mL for the cinacalcet group and 795.8 (537.9) pg/mL for the placebo group. The 
mean  (SD) corrected total serum calcium concentrations at baseline were 9.9 (0.5) mg/dL for the 
cinacalcet group and 9.9 (0.6) mg/dL for the placebo group. The mean maximum daily dose of 
cinacalcet was 1.0 mg/kg/day. 
 
The percentage of patients who achieved the primary endpoint (≥ 30% reduction from baseline in 
mean plasma iPTH during the EAP; weeks 25 to 30) was 55% in the cinacalcet group and 19.0% in 
the placebo group (p = 0.02). The mean serum calcium levels during the EAP were within the normal 
range for the cinacalcet treatment group. This study was terminated early due to a fatality with severe 
hypocalcaemia in the cinacalcet group (see section 4.8). 
 
Study 2 was an open-label study in which 55 patients aged 6 to < 18 years (mean 13 years) were 
randomised to receive either cinacalcet in addition to standard of care (SOC, n = 27) or SOC alone 
(n = 28). The majority of patients (75%) were using vitamin D sterols at baseline. The mean (SD) 
iPTH concentrations at baseline were 946 (635) pg/mL for the cinacalcet + SOC group and 
1228 (732) pg/mL for the SOC group. The mean (SD) corrected total serum calcium concentrations at 
baseline were 9.8 (0.6) mg/dL for the cinacalcet + SOC group and 9.8 (0.6) mg/dL for the SOC group. 
25 subjects received at least one dose of cinacalcet and the mean maximum daily dose of cinacalcet 
was 0.55 mg/kg/day. The study did not meet its primary endpoint (≥ 30% reduction from baseline in 
mean plasma iPTH during the EAP; weeks 17 to 20). Reduction of ≥ 30% from baseline in mean 
plasma iPTH during the EAP was achieved by 22% of patients in the cinacalcet + SOC group and 32% 
of patients in the SOC group. 
 
Study 3 was a 26-week, open-label, single-arm safety study in patients aged 8 months to < 6 years 
(mean age 3 years). Patients receiving concomitant medications known to prolong the corrected QT 
interval were excluded from the study. The mean dry weight at baseline was 12 kg. The starting dose 
of cinacalcet was 0.20 mg/kg. The majority of patients (89%) were using vitamin D sterols at baseline. 
 
Seventeen patients received at least one dose of cinacalcet and 11 completed at least 12 weeks of 
treatment. None had corrected serum calcium < 8.4 mg/dL (2.1 mmol/L) for ages 2-5 years. iPTH 
concentrations from baseline were reduced by ≥ 30% in 71% (12 out of 17) of patients in the study. 
 
Parathyroid carcinoma and primary hyperparathyroidism 
 
In one study, 46 adult patients (29 with parathyroid carcinoma and 17 with primary HPT and severe 
hypercalcaemia who had failed or had contraindications to parathyroidectomy) received cinacalcet for 
up to 3 years (mean of 328 days for patients with parathyroid carcinoma and mean of 347 days for 
patients with primary HPT). Cinacalcet was administered at doses ranging from 30 mg twice daily to 
90 mg four times daily. The primary endpoint of the study was a reduction of serum calcium of 
≥ 1 mg/dL (≥ 0.25 mmol/L). In patients with parathyroid carcinoma, mean serum calcium declined 
from 14.1 mg/dL to 12.4 mg/dL (3.5 mmol/L to 3.1 mmol/L), while in patients with primary HPT, 
serum calcium levels declined from 12.7 mg/dL to 10.4 mg/dL (3.2 mmol/L to 2.6 mmol/L). 
Eighteen (18) of 29 patients (62%) with parathyroid carcinoma and 15 of 17 subjects (88%) with 
primary HPT achieved a reduction in serum calcium of ≥ 1 mg/dL (≥ 0.25 mmol/L). 
 
In a 28 week placebo-controlled study, 67 adult patients with primary HPT who met criteria for 
parathyroidectomy on the basis of corrected total serum calcium (> 11.3 mg/dL (2.82 mmol/L) but 
≤ 12.5 mg/dL (3.12 mmol/L), but who were unable to undergo parathyroidectomy were included. 



13 
 

Cinacalcet was initiated at a dose of 30 mg twice daily and titrated to maintain a corrected total serum 
calcium concentration within the normal range. A significantly higher percentage of cinacalcet-treated 
patients achieved mean corrected total serum calcium concentration ≤ 10.3 mg/dL (2.57 mmol/L) and 
≥ 1 mg/dL (0.25 mmol/L) decrease from baseline in mean corrected total serum calcium 
concentration, when compared with the placebo-treated patients (75.8% versus 0% and 84.8% versus 
5.9% respectively). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
After oral administration of cinacalcet, maximum plasma cinacalcet concentration is achieved in 
approximately 2 to 6 hours. Based on between-study comparisons, the absolute bioavailability of 
cinacalcet in fasted subjects has been estimated to be about 20-25%. Administration of cinacalcet with 
food results in an approximate 50–80% increase in cinacalcet bioavailability. Increases in plasma 
cinacalcet concentration are similar, regardless of the fat content of the meal. 
 
At doses above 200 mg, the absorption was saturated probably due to poor solubility.  
 
Distribution 
 
The volume of distribution is high (approximately 1,000 litres), indicating extensive distribution. 
Cinacalcet is approximately 97% bound to plasma proteins and distributes minimally into red blood 
cells. 
 
After absorption, cinacalcet concentrations decline in a biphasic fashion with an initial half-life of 
approximately 6 hours and a terminal half-life of 30 to 40 hours. Steady state levels of cinacalcet are 
achieved within 7 days with minimal accumulation. The pharmacokinetics of cinacalcet does not 
change over time. 
 
Biotransformation 
 
Cinacalcet is metabolised by multiple enzymes, predominantly CYP3A4 and CYP1A2 (the 
contribution of CYP1A2 has not been characterised clinically). The major circulating metabolites are 
inactive. 
 
Based on in vitro data, cinacalcet is a strong inhibitor of CYP2D6, but is neither an inhibitor of other 
CYP enzymes at concentrations achieved clinically, including CYP1A2, CYP2C8, CYP2C9, 
CYP2C19, and CYP3A4 nor an inducer of CYP1A2, CYP2C19 and CYP3A4. 
 
Elimination 
 
After administration of a 75 mg radiolabelled dose to healthy volunteers, cinacalcet was rapidly and 
extensively metabolised by oxidation followed by conjugation. Renal excretion of metabolites was the 
prevalent route of elimination of radioactivity. Approximately 80% of the dose was recovered in the 
urine and 15% in the faeces. 
 
Linearity/non-linearity 
 
The AUC and Cmax of cinacalcet increase approximately linearly over the dose range of 30 to 180 mg 
once daily. 
 
Pharmacokinetic/pharmacodynamic relationship(s) 
 
Soon after dosing, PTH begins to decrease until a nadir at approximately 2 to 6 hours post-dose, 
corresponding with cinacalcet Cmax. Thereafter, as cinacalcet levels begin to decline, PTH levels 
increase until 12 hours post-dose, and then PTH suppression remains approximately constant to the 



14 
 

end of the once daily dosing interval. PTH levels in cinacalcet clinical trials were measured at the end 
of the dosing interval. 
 
Elderly 
There are no clinically relevant differences due to age in the pharmacokinetics of cinacalcet. 
 
Renal insufficiency 
The pharmacokinetic profile of cinacalcet in patients with mild, moderate, and severe renal 
insufficiency, and those on haemodialysis or peritoneal dialysis is comparable to that in healthy 
volunteers. 
 
Hepatic insufficiency  
Mild hepatic impairment did not notably affect the pharmacokinetics of cinacalcet. Compared to 
subjects with normal liver function, average AUC of cinacalcet was approximately 2-fold higher in 
subjects with moderate impairment and approximately 4-fold higher in subjects with severe 
impairment. The mean half-life of cinacalcet is prolonged by 33% and 70% in patients with moderate 
and severe hepatic impairment, respectively. Protein binding of cinacalcet is not affected by impaired 
hepatic function. Because doses are titrated for each subject based on safety and efficacy parameters, 
no additional dose adjustment is necessary for subjects with hepatic impairment (see sections 4.2 and 
4.4). 
 
Gender 
Clearance of cinacalcet may be lower in women than in men. Because doses are titrated for each 
subject, no additional dose adjustment is necessary based on gender. 
 
Paediatric population 
The pharmacokinetics of cinacalcet was studied in paediatric patients with ESRD receiving dialysis 
aged 3 to 17 years of age. After single and multiple once daily oral doses of cinacalcet, plasma 
cinacalcet concentrations (Cmax and AUC values after normalisation by dose and weight) were similar 
to those observed in adult patients. 
 
A population pharmacokinetic analysis was performed to evaluate the effects of demographic 
characteristics. This analysis showed no significant impact of age, sex, race, body surface area, and 
body weight on cinacalcet pharmacokinetics. 
 
Smoking 
Clearance of cinacalcet is higher in smokers than in non-smokers, likely due to induction of CYP1A2-
mediated metabolism. If a patient stops or starts smoking, cinacalcet plasma levels may change and 
dose adjustment may be necessary. 
 
5.3 Preclinical safety data 
 
Cinacalcet was not teratogenic in rabbits when given at a dose of 0.4 times, on an AUC basis, the 
maximum human dose for secondary HPT (180 mg daily). The non-teratogenic dose in rats was 4.4 
times, on an AUC basis, the maximum dose for secondary HPT. There were no effects on fertility in 
males or females at exposures up to 4 times a human dose of 180 mg/day (safety margins in the small 
population of patients administered a maximum clinical dose of 360 mg daily would be approximately 
half those given above). 
 
In pregnant rats, there were slight decreases in body weight and food consumption at the highest dose. 
Decreased foetal weights were seen in rats at doses where dams had severe hypocalcaemia. Cinacalcet 
has been shown to cross the placental barrier in rabbits. 
 
Cinacalcet did not show any genotoxic or carcinogenic potential. Safety margins from the toxicology 
studies are small due to the dose-limiting hypocalcaemia observed in the animal models. Cataracts and 
lens opacities were observed in the repeat dose rodent toxicology and carcinogenicity studies, but were 



15 
 

not observed in dogs or monkeys or in clinical studies where cataract formation was monitored. 
Cataracts are known to occur in rodents as a result of hypocalcaemia. 
 
In in vitro studies, IC50 values for the serotonin transporter and KATP channels were found to be 7 and 
12-fold greater, respectively, than the EC50 for the calcium-sensing receptor obtained under the same 
experimental conditions. The clinical relevance is unknown, however, the potential for cinacalcet to 
act on these secondary targets cannot be fully excluded. 
 
In toxicity studies in juvenile dogs, tremors secondary to decreased serum calcium, emesis, decreased 
body weight and body weight gain, decreased red cell mass, slight decreases in bone densitometry 
parameters, reversible widening of the growth plates of long bones, and histological lymphoid changes 
(restricted to the thoracic cavity and attributed to chronic emesis) were observed. All of these effects 
were seen at a systemic exposure, on an AUC basis, approximately equivalent to the exposure in 
patients at the maximum dose for secondary HPT. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core 
 
Cellulose, microcrystalline 
Crospovidone  
Magnesium stearate 
 
Tablet coat 
 
Hypromellose (E464)  
Titanium dioxide (E171)  
Triacetin  
Indigo carmine aluminum lake (E132)  
Iron oxide yellow (E172) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
Blister 
 
36 months. 
 
Bottle 
 
36 months. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 



16 
 

6.5 Nature and contents of container  
 
Blister 
 
Clear PVC/ Aluminium blister. Pack sizes of 14, 28 or 84 tablets and unit dose blister containing 14 x 
1, 28 x 1 or 84 x 1 tablet. 
 
Bottle 
 
High Density Polyethylene (HDPE) bottle with a child-resistant polypropylene cap. Pack size of 30 
tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal  
 
No special requirements for disposal. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a planta, 
08039 Barcelona, Spain 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1429/001 – 30 mg carton with 14 tablets 
EU/1/20/1429/002 – 30 mg carton with 28 tablets 
EU/1/20/1429/003 – 30 mg carton with 84 tablets 
EU/1/20/1429/004 – 30 mg bottle with 30 tablets 
EU/1/20/1429/005 – 60 mg carton with 14 tablets 
EU/1/20/1429/006 – 60 mg carton with 28 tablets 
EU/1/20/1429/007 – 60 mg carton with 84 tablets 
EU/1/20/1429/008 – 60 mg bottle with 30 tablets 
EU/1/20/1429/009 – 90 mg carton with 14 tablets 
EU/1/20/1429/010 – 90 mg carton with 28 tablets 
EU/1/20/1429/011 – 90 mg carton with 84 tablets 
EU/1/20/1429/012 – 90 mg bottle with 30 tablets 
EU/1/20/1429/013 - 30 mg carton with 14 x 1 tablet 
EU/1/20/1429/014 - 30 mg carton with 28 x 1 tablet 
EU/1/20/1429/015 - 30 mg carton with 84 x 1 tablet 
EU/1/20/1429/016 - 60 mg carton with 14 x 1 tablet 
EU/1/20/1429/017 - 60 mg carton with 28 x 1 tablet 
EU/1/20/1429/018- 60 mg carton with 84 x 1 tablet 
EU/1/20/1429/019 - 90 mg carton with 14 x 1 tablet 
EU/1/20/1429/020 - 90 mg carton with 28 x 1 tablet 
EU/1/20/1429/021 - 90 mg carton with 84 x 1 tablet 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 3rd April 2020 
 
 



17 
 

10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this product is available on the website of the European Medicines Agency 
http://www.ema.europa.eu  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

ANNEX II 
 
 A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
 B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
 C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

http://www.ema.europa.eu/


18 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Accord Healthcare Limited 
Ground floor, Sage House, 319 Pinner Road 
Harrow, HA1 4HF 
United Kingdom 
 
LABORATORI FUNDACIÓ DAU 
C/ C, 12-14 Pol. Ind. Zona Franca, 
Barcelona, 08040, Spain 
 
Pharmadox Healthcare Ltd. 
KW20A Kordin Industrial Park 
Paola, PLA 3000 
Malta 
 
Accord Healthcare Polska Sp. z o.o., 
ul. Lutomierska 50, Pabianice, 
95-200, Poland 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription.  
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
● Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
● Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 
marketing authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
 ● At the request of the European Medicines Agency; 
 ● Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile 
or as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  



19 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



20 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



21 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON FOR BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 30 mg film-coated tablets 
cinacalcet 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 30 mg of cinacalcet (as hydrochloride) 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
14 film-coated tablets 
28 film-coated tablets 
84 film-coated tablets 
14 x 1 film-coated tablet 
28 x 1 film-coated tablet 
84 x 1 film-coated tablet 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



22 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a planta,  
08039 Barcelona, Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1429/001 – 30 mg carton with 14 tablets 
EU/1/20/1429/002 – 30 mg carton with 28 tablets 
EU/1/20/1429/003 – 30 mg carton with 84 tablets 
EU/1/20/1429/013 - 30 mg carton with 14 x 1 tablet 
EU/1/20/1429/014 - 30 mg carton with 28 x 1 tablet 
EU/1/20/1429/015 - 30 mg carton with 84 x 1 tablet 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Cinacalcet Accordpharma 30 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



23 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 30 mg film-coated tablets  
cinacalcet 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



24 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
UNIT DOSE BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 30 mg Tablets  
cinacalcet 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



25 
 

 
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON FOR BOTTLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 30 mg film-coated tablets 
cinacalcet 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 30 mg of cinacalcet (as hydrochloride) 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
30 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



26 
 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a planta,  
08039 Barcelona, Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1429/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Cinacalcet Accordpharma 30 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



27 
 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BOTTLE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 30 mg film-coated tablets  
cinacalcet 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 30 mg of cinacalcet (as hydrochloride). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



28 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a planta,  
08039 Barcelona, Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1429/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  



29 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON FOR BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 60 mg film-coated tablets 
cinacalcet 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 60 mg of cinacalcet (as hydrochloride) 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
14 film-coated tablets 
28 film-coated tablets 
84 film-coated tablets 
14 x 1 film-coated tablet 
28 x 1 film-coated tablet 
84 x 1 film-coated tablet 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



30 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a planta,  
08039 Barcelona, Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1429/005 – 60 mg carton with 14 tablets 
EU/1/20/1429/006 – 60 mg carton with 28 tablets 
EU/1/20/1429/007 – 60 mg carton with 84 tablets 
EU/1/20/1429/016 - 60 mg carton with 14 x 1 tablet 
EU/1/20/1429/017 - 60 mg carton with 28 x 1 tablet 
EU/1/20/1429/018- 60 mg carton with 84 x 1 tablet 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Cinacalcet Accordpharma 60 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



31 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 60 mg film-coated tablets  
cinacalcet 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
  



32 
 

 
 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
UNIT DOSE BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 60 mg Tablets  
cinacalcet 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
  



33 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON FOR BOTTLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 60 mg film-coated tablets 
cinacalcet 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 60 mg of cinacalcet (as hydrochloride) 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
30 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



34 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a planta,  
08039 Barcelona, Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1429/008 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Cinacalcet Accordpharma 60 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



35 
 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BOTTLE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 60 mg film-coated tablets  
cinacalcet 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 60 mg of cinacalcet (as hydrochloride). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



36 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a planta,  
08039 Barcelona, Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1429/008 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  



37 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON FOR BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 90 mg film-coated tablets 
cinacalcet 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 90 mg of cinacalcet (as hydrochloride) 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
14 film-coated tablets 
28 film-coated tablets 
84 film-coated tablets 
14 x 1 film-coated tablet 
28 x 1 film-coated tablet 
84 x 1 film-coated tablet 
 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



38 
 

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a planta,  
08039 Barcelona, Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1429/009 – 90 mg carton with 14 tablets 
EU/1/20/1429/010 – 90 mg carton with 28 tablets 
EU/1/20/1429/011 – 90 mg carton with 84 tablets 
EU/1/20/1429/019 - 90 mg carton with 14 x 1 tablet 
EU/1/20/1429/020 - 90 mg carton with 28 x 1 tablet 
EU/1/20/1429/021 - 90 mg carton with 84 x 1 tablet 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Cinacalcet Accordpharma 90 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



39 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 90 mg film-coated tablets  
cinacalcet 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



40 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
UNIT DOSE BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 90 mg Tablets  
cinacalcet 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
  



41 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON FOR BOTTLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 90 mg film-coated tablets 
cinacalcet 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 90 mg of cinacalcet (as hydrochloride) 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
30 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



42 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a planta,  
08039 Barcelona, Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1429/012 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Cinacalcet Accordpharma 90 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



43 
 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BOTTLE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cinacalcet Accordpharma 90 mg film-coated tablets  
cinacalcet 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 90 mg of cinacalcet (as hydrochloride). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



44 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a planta,  
08039 Barcelona, Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1429/012 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
 
  



45 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



46 
 

Package leaflet: Information for the patient 
 

Cinacalcet Accordpharma 30 mg film-coated tablets  
Cinacalcet Accordpharma 60 mg film-coated tablets  
Cinacalcet Accordpharma 90 mg film-coated tablets 

cinacalcet 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor, pharmacist or nurse. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Cinacalcet Accordpharma is and what it is used for 
2. What you need to know before you take Cinacalcet Accordpharma 
3. How to take Cinacalcet Accordpharma 
4. Possible side effects 
5. How to store Cinacalcet Accordpharma 
6. Contents of the pack and other information 
 
 
1. What Cinacalcet Accordpharma is and what it is used for 
 
Cinacalcet Accordpharma contains the active ingredient cinacalcet, which works by controlling the 
levels of parathyroid hormone (PTH), calcium and phosphorous in your body. It is used to treat 
problems with organs called parathyroid glands. The parathyroids are four small glands in the neck, 
near the thyroid gland, that produce parathyroid hormone (PTH). 
 
Cinacalcet Accordpharma is used in adults: 
- to treat secondary hyperparathyroidism in adults with serious kidney disease who need dialysis 

to clear their blood of waste products. 
- to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with parathyroid 

cancer. 
- to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with primary 

hyperparathyroidism when removal of the gland is not possible. 
 
Cinacalcet Accordpharma is used in children aged 3 years to less than 18 years of age to treat 
secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their 
blood of waste products, whose condition is not controlled with other treatments. 
 
In primary and secondary hyperparathyroidism too much PTH is produced by the parathyroid glands. 
“Primary” means that the hyperparathyroidism is not caused by any other condition and “secondary” 
means that the hyperparathyroidism is caused by another condition, e.g. kidney disease. Both primary 
and secondary hyperparathyroidism can cause the loss of calcium in the bones, which can lead to bone 
pain and fractures, problems with blood and heart vessels, kidney stones, mental illness and coma. 
 
 
2. What you need to know before you take Cinacalcet Accordpharma 
 
Do not take Cinacalcet Accordpharma:  
- if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in 

section 6). 



47 
 

 
- if you have low levels of calcium in your blood. Your doctor will monitor your blood calcium 

levels. 
 
Warnings and precautions 
Talk to your doctor, pharmacist or nurse before taking Cinacalcet Accordpharma. 
 
Before you start taking Cinacalcet Accordpharma, tell your doctor if you have or have ever had: 
- seizures (fits or convulsions). The risk of having seizures is higher if you have had them before; 
- liver problems; 
- heart failure. 
 
Cinacalcet Accordpharma reduces calcium levels. Life threatening events and fatal outcomes 
associated with low calcium levels (hypocalcaemia) have been reported in adults and children treated 
with Cinacalcet Accordpharma. 
 
Please tell your doctor if you experience any of the following which may be signs of low calcium 
levels: spasms, twitches, or cramps in your muscles, or numbness or tingling in your fingers, toes or 
around your mouth or seizures, confusion or loss of consciousness while being treated with Cinacalcet 
Accordpharma. 
 
Low calcium levels can have an effect on your heart rhythm. Tell your doctor if you experience an 
unusually fast or pounding heartbeat, if you have heart rhythm problems, or if you take medicines 
known to cause heart rhythm problems, while taking Cinacalcet Accordpharma. 
 
For additional information see section 4. 
 
During treatment with Cinacalcet Accordpharma, tell your doctor: 
- if you start or stop smoking, as this may affect the way Cinacalcet Accordpharma works. 
 
Children and adolescents 
Children under the age of 18 with parathyroid cancer or primary hyperparathyroidism must not take 
Cinacalcet Accordpharma. 
 
If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium 
levels before starting treatment with Cinacalcet Accordpharma and during treatment with Cinacalcet 
Accordpharma. You should inform your doctor if you experience any of the signs of low calcium 
levels as described above. 
 
Cinacalcet Accordpharma is only available as film-coated tablet. Thus, it is not possible to administer 
Cinacalcet Accordpharma to paediatric patients that require less than a full 30 mg dose. If an alternate 
dose is required, other cinacalcet medicines offering such an option should be used. 
 
It is important that you take your dose of Cinacalcet Accordpharma as advised by your doctor. 
 
Other medicines and Cinacalcet Accordpharma 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines 
particularly etelcalcetide or any other medicines that lower the level of calcium in your blood. 
 
You should not receive Cinacalcet Accordpharma together with etelcalcetide. 
 
Tell your doctor if you are taking the following medicines 
 
Medicines such as these can affect how Cinacalcet Accordpharma works: 
- medicines used to treat skin and fungal infections (ketoconazole, itraconazole and 

voriconazole); 
- medicines used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin); 



48 
 

- a medicine used to treat HIV infection and AIDS (ritonavir); 
- a medicine used to treat depression (fluvoxamine). 
 
Cinacalcet Accordpharma may affect how medicines such as the following work: 
- medicines used to treat depression (amitriptyline, desipramine, nortriptyline and 

clomipramine); 
- a medicine used to relieve cough (dextromethorphan); 
- medicines used to treat changes in heart rate (flecainide and propafenone); 
- a medicine used to treat high blood pressure (metoprolol). 
 
Pregnancy, breast-feeding and fertility 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Cinacalcet Accordpharma has not been tested in pregnant women. In case of pregnancy, your doctor 
may decide to modify your treatment, as Cinacalcet Accordpharma might harm the unborn baby. 
 
It is not known whether Cinacalcet Accordpharma is excreted in human milk. Your doctor will discuss 
with you if you should discontinue either breast-feeding or treatment with Cinacalcet Accordpharma. 
 
Driving and using machines 
Dizziness and seizures have been reported by patients taking Cinacalcet Accordpharma. If you 
experience these side effects, do not drive or operate machines. 
 
 
3. How to take Cinacalcet Accordpharma 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are unsure. Your doctor will tell you how much Cinacalcet Accordpharma you 
must take. 
 
Cinacalcet Accordpharma must be taken orally, with or shortly after food. The tablets must be taken 
whole and are not to be chewed, crushed or divided. 
 
Your doctor will take regular blood samples during treatment to monitor your progress and will adjust 
your dose if necessary. 
 
If you are being treated for secondary hyperparathyroidism 
The usual starting dose for Cinacalcet Accordpharma in adults is 30 mg (one tablet) once per day. 
 
The usual starting dose of Cinacalcet Accordpharma for children aged 3 years to less than 18 years of 
age is no more than 0.20 mg/kg of body weight daily. 
 
Cinacalcet Accordpharma is only available as film-coated tablet. Thus, it is not possible to administer 
Cinacalcet Accordpharma to paediatric patients who require doses lower than 30 mg, or who are 
unable to swallow tablets. If an alternate dose or form of this medicine is required, other cinacalcet 
medicines offering such an option should be used; ask your doctor or pharmacist. 
 
If you are being treated for parathyroid cancer or primary hyperparathyroidism 
The usual starting dose for Cinacalcet Accordpharma in adults is 30 mg (one tablet) twice per day. 
 
If you take more Cinacalcet Accordpharma than you should 
If you took more Cinacalcet Accordpharma than you should you must contact your doctor 
immediately. Possible signs of overdose include numbness or tingling around the mouth, muscle aches 
or cramps and seizures. 
 
If you forget to take Cinacalcet Accordpharma 



49 
 

Do not take a double dose to make up for a forgotten dose. 
If you have forgotten a dose of Cinacalcet Accordpharma, you should take your next dose as normal. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Please tell your doctor immediately: 
- If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures 

These may be signs that your calcium levels are too low (hypocalcaemia). 
- If you experience swelling of the face, lips, mouth, tongue or throat which may cause difficulty 

in swallowing or breathing (angioedema). 
 
Very common: may affect more than 1 in 10 people 
- nausea and vomiting, these side effects are normally quite mild and do not last for long. 
 
Common: may affect up to 1 in 10 people 
- dizziness 
- numbness or tingling sensation (paraesthesia) 
- loss (anorexia) or decrease of appetite 
- muscle pain (myalgia) 
- weakness (asthenia) 
- rash 
- reduced testosterone levels 
- high potassium levels in the blood (hyperkalaemia) 
- allergic reactions (hypersensitivity) 
- headache 
- seizures (convulsions or fits) 
- low blood pressure (hypotension) 
- upper respiratory infection 
- breathing difficulties (dyspnoea) 
- cough 
- indigestion (dyspepsia) 
- diarrhoea 
- abdominal pain, abdominal pain – upper 
- constipation 
- muscle spasms 
- back pain 
- low calcium levels in the blood (hypocalcaemia). 
 
Not known: frequency cannot be estimated from available data 
- Hives (urticaria) 
- Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or 

breathing (angioedema) 
- Unusually fast or pounding heart beat which may be associated with low levels of calcium in 

your blood (QT prolongation and ventricular arrhythmia secondary to hypocalcaemia). 
 
After taking Cinacalcet Accordpharma a very small number of patients with heart failure had 
worsening of their condition and/or low blood pressure (hypotension). 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist or. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 



50 
 

listed in Appendix V By reporting side effects you can help provide more information on the safety of 
this medicine.  
 
 
5. How to store Cinacalcet Accordpharma 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The 
expiry date refers to the last day of that month. 
 
Do not use this medicine after the expiry date which is stated on the carton and bottle. The expiry date 
refers to the last day of that month. 
 
This medicinal product does not require any special storage conditions. 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Cinacalcet Accordpharma contains 
- The active substance is cinacalcet. Each film-coated tablet contains 30 mg, 60 mg or 90 mg of 

cinacalcet (as hydrochloride). 
- The other ingredients are:  

- Cellulose, microcrystalline 
- Crospovidone 
- Magnesium stearate 

- The tablets are coated with:  
- Hypromellose (E464),  
- Titanium dioxide (E171),  
- Triacetin,  
- Indigo carmine aluminum lake (E132),  
- Iron oxide yellow (E172) 

 
What Cinacalcet Accordpharma looks like and contents of the pack 
 
Cinacalcet Accordpharma 30 mg film-coated tablets (tablet) 
 
Light green colored, oval shaped (approximately 9.65 mm long and 6.00 mm wide), biconvex, film-
coated tablets debossed with "HB1" on one side and plain on other side. 
 
Cinacalcet Accordpharma 60 mg film-coated tablets (tablet) 
 
Light green colored, oval shaped (approximately 12.20 mm long and 7.60 mm wide), biconvex, film-
coated tablets debossed with "HB2" on one side and plain on other side. 
 
Cinacalcet Accordpharma 90 mg film-coated tablets (tablet) 
 
Light green colored, oval shaped (approximately 14.00 mm long and 8.70 mm wide), biconvex, film-
coated tablets debossed with "HB3" on one side and plain on other side. 
 
Cinacalcet Accordpharma is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets. 
Cinacalcet Accordpharma is provided in PVC/Alu blister packs containing 14, 28 or 84 tablets and 
unit dose blister containing 14 x 1, 28 x 1 or 84 x 1 tablet. 
Cinacalcet Accordpharma is available in bottles of 30 mg, 60 mg or 90 mg film-coated tablets. Each 
bottle holds 30 film-coated tablets. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


51 
 

 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Accord Healthcare S.L.U 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a planta,  
08039 Barcelona, Spain 
 
Manufacturer 
Accord Healthcare Limited 
Ground floor, Sage House, 319 Pinner Road 
Harrow, HA1 4HF 
United Kingdom 
 
LABORATORI FUNDACIÓ DAU 
C/ C, 12-14 Pol. Ind. Zona Franca, 
Barcelona, 08040, Spain 
 
Pharmadox Healthcare Ltd. 
KW20A Kordin Industrial Park 
Paola, PLA 3000 
Malta 
 
Accord Healthcare Polska Sp. z o.o., 
ul. Lutomierska 50, Pabianice, 
95-200, Poland 
 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu   
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET