Neofordex

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Neofordex 40 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains dexamethasone acetate equivalent to 40 mg dexamethasone. 
 
Excipient with known effect 
 
Each tablet contains 98.1 mg lactose. 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet 
White, oblong (11 mm × 5.5 mm) tablet with a score-line on one face. 
The tablet can be divided for administration of a 20 mg dose (see section 4.2). 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Neofordex is indicated in adults for the treatment of symptomatic multiple myeloma in combination with 
other medicinal products. 
 
4.2 Posology and method of administration 
 
Treatment must be initiated and monitored under the supervision of physicians experienced in the 
management of multiple myeloma. 
 
Posology 
 
The dose and administration frequency varies with the therapeutic protocol and the associated treatment(s). 
Neofordex administration should follow instructions for dexamethasone administration when described in 
the Summary of Product Characteristics of the associated treatment(s). If this is not the case, local or 
international treatment protocols and guidelines should be followed. Prescribing physicians should carefully 
evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the 
patient. 
 
The usual posology of dexamethasone is 40 mg once per day of administration. 
 
At the end of dexamethasone treatment, the dose should be tapered in a stepwise fashion until a complete 
stop. 
 
Missed dose 
The tablet should be taken immediately if the dose was missed for less than 12 hours. 
The next tablet should be taken at the usual time, if the dose was missed for more than 12 hours. 
In case of a missed dose, a double dose must not be taken. 
 
Special population 
 
Elderly  



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In elderly and/or frail patients, the daily dose may be reduced to 20 mg of dexamethasone, according to the 
appropriate treatment regimen. 
 
Hepatic impairment  
Patients with hepatic impairment require appropriate monitoring and should be dosed with caution as there 
are no data for this patient population (see sections 4.4 and 5.2). 
 
Renal impairment 
Patients with renal impairment require appropriate monitoring (see section4.4). 
 
Paediatric population 
There is no relevant use of Neofordex in the paediatric population for the indication of multiple myeloma. 
 
Method of administration  
 
Oral use.  
 
In order to minimise insomnia, the tablet should preferably be taken in the morning. 
 
Tablets should be kept in the blister package until administration. Individual tablets in intact packaging 
should be separated from the blister using the perforation, e.g. for use in multi-compartment compliance aids. 
 
Tablets may be broken in two equal halves using the score line to provide the 20mg dose. Due to possible 
stability issues affecting half tablets stored after division, half-tablets that are not taken immediately 
should be discarded in agreement with local precautions for environmental protection (see also 6.4).  
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Active viral disease (especially viral hepatitis, herpes, varicella, shingles). 
 
Uncontrolled psychoses. 
 
When dexamethasone is given in combination with other medicinal products, refer to their Summaries of 
Product Characteristics for additional contraindications. 
 
4.4 Special warnings and precautions for use 
 
Dexamethasone is a high-dose glucocorticoid. This should be taken into consideration in the surveillance of 
the patient. The benefit from dexamethasone treatment should be carefully and continuously weighed against 
actual and potential risks. 
 
Risk of infection 
 
Treatment with high-dose dexamethasone increases the risk of developing serious infections, in particular 
due to bacteria, yeasts and/or parasites. Such infections can also be caused by microorganisms that rarely 
cause disease under normal circumstances (opportunistic infections). Signs of a developing infection may be 
masked by dexamethasone therapy.  
 
Before the start of treatment, any source of infection, especially tuberculosis, should be removed. During 
treatment, patients should be closely monitored for the appearance of infections. In particular, pneumonia 
occurs commonly. Patients should be informed of the signs and symptoms of pneumonia and be advised to 
seek medical attention in case of their appearance. In case of active infectious disease, appropriate 
anti-infective treatment must be added to the treatment with dexamethasone. 
 



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In cases of prior tuberculosis with major radiological sequelae or if it is not certain that a full 6-month 
rifampicin treatment course has been followed, a prophylactic anti-tuberculosis treatment is required. 
 
There is a risk of severe strongyloidiasis. Patients from endemic areas (tropical and sub-tropical regions, 
southern Europe) should have a stool examination and if required an eradication of the parasite before 
initiating dexamethasone treatment. 
 
Certain viral diseases (varicella, measles) can be aggravated in patients receiving glucocorticoid treatment or 
who have received glucocorticoid treatment within the previous 3 months. Patients must avoid contact with 
subjects with chickenpox or measles. Immunocompromised patients who have not previously had 
chickenpox or measles are particularly at risk. If such patients have been in contact with people with 
chickenpox or measles, a preventive treatment with intravenous normal immunoglobulin or passive 
immunisation with varicella zoster immunoglobulin (VZIG) must be started as appropriate. Exposed patients 
should be advised to seek medical attention without delay. 
 
Vaccinations 
 
Dexamethasone should not be used with live attenuated vaccines (see section 4.5). Vaccinations with 
inactivated vaccines are usually possible. However, the immune response and hence the effect of the 
vaccination can be diminished by high glucocorticoid doses. 
 
Interference with laboratory tests 
 
Dexamethasone can suppress skin reaction to allergy testing. It can also affect the nitro blue tetrazolium 
(NBT) test for bacterial infections and cause false-negative results.   
 
Psychiatric disorders 
 
Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with 
systemic steroids (see section 4.8). Symptoms typically emerge within a few days or weeks of starting the 
treatment. Risks may be higher with high doses (see also section 4.5 for pharmacokinetic interactions that 
can increase the risk of adverse reactions), although dose levels do not allow prediction of the onset, type 
severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although 
specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if 
worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. 
Patients/carers should also be alert to possible psychiatric disturbances that may occur either during, or 
immediately after, dose tapering/withdrawal of systemic steroids, although such reactions have been reported 
infrequently.  
 
Particular care is required when considering the use of systemic corticosteroids in patients with existing or 
previous history of severe affective disorders in themselves or in their first degree relatives. These would 
include depressive or manic-depressive illness and previous steroid psychoses.  
 
Insomnia may be minimised by administering Neofordex in the morning. 
 
Tumour lysis syndrome 
 
In post marketing experience tumour lysis syndrome (TLS) has been reported in patients with 
haematological malignancies following the use of dexamethasone alone or in combination with other 
chemotherapeutic agents. Patient at high risk of TLS, such as patients with high proliferative rate, high 
tumour burden, and high sensitivity to cytotoxic agents, should be monitored closely and appropriate 
precaution taken. 
 
Gastrointestinal disorders 
 
Treatment for active gastric or duodenal ulceration should be commenced prior to initiation of 
corticosteroids. Appropriate prophylaxis should be considered for patients with a previous history of, or risk 



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factors for, gastric or duodenal ulceration, haemorrhage or perforation. Patients should be monitored 
clinically, including by endoscopy. 
 
Eye disorders 
 
Systemic treatment with glucocorticoids can induce chorioretinopathy which may result in impaired vision 
including loss of vision. 
 
Prolonged use of corticosteroids may produce subcapsular cataracts, glaucoma with possible damage to the 
optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. 
Particular care is needed when treating patients with glaucoma (or family history of glaucoma) as well as 
when treating patients with ocular herpes simplex, because of possible corneal perforation. 
 
Tendonitis  
 
Corticosteroids can favour the development of tendonitis and, in exceptional cases, rupture of the affected 
tendon. This risk is increased by concomitant use of fluoroquinolones and in patients undergoing dialysis 
with secondary hyperparathyroidism or after renal transplantation. 
 
Pheochromocytoma crisis  
 
Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic 
corticosteroids. Corticosteroids should only be administered to patients with suspected or identified 
pheochromocytoma after an appropriate risk/benefit evaluation. 
 
Elderly 
 
The common adverse reactions to systemic corticosteroids may be associated with more serious 
consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to 
infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions. 
 
Monitoring 
 
Use of corticosteroids requires appropriate monitoring in patients with ulcerative colitis (due to perforation 
risk), recent intestinal anastomoses, diverticulitis, recent myocardial infarction (risk of left ventricular free 
wall rupture), diabetes mellitus (or family history), renal insufficiency, hepatic impairment, osteoporosis and 
myasthenia gravis. 
 
Long-term treatment 
 
During treatment, a diet low in simple sugars and high in protein should be followed due to the 
hyperglycaemic effect of corticosteroids and their stimulation of protein catabolism with a negative nitrogen 
balance. 
 
Water and sodium retention is common and can lead to hypertension. Sodium intake should be reduced and 
blood pressure should be monitored. Particular care is needed when treating patients with renal impairment, 
hypertension or congestive heart failure. 
 
Potassium levels should be monitored during treatment. Potassium supplementation should be given 
particularly if there is a risk of cardiac arrhythmia or concurrent hypokalaemic medicinal products. 
 
Glucocorticoid therapy may reduce the effect of anti-diabetic and antihypertensive treatment. The dose of 
insulin, oral anti-diabetics and anti-hypertensive medicinal products may have to be increased. 
 
Depending on the duration of treatment, calcium metabolism may be impaired. Calcium and vitamin D levels 
should be monitored. In patients not already prescribed bisphosphonates for multiple myeloma related bone 
disease, bisphosphonates should be considered, particularly if risk factors for osteoporosis are present. 



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Use in combination with other multiple myeloma treatment(s) 
 
When Neofordex is given in combination with other medicinal products, the Summary of Product 
Characteristics of these other medicinal products must be consulted prior to initiation of treatment 
with Neofordex.  
 
When Neofordex is used in combination with known teratogens (e.g. thalidomide, lenalidomide, 
pomalidomide, plerixafor), particular attention to pregnancy testing and prevention requirements is 
needed (see section 4.6). 
 
Venous and arterial thromboembolic events 
In patients with multiple myeloma, the combination of dexamethasone with thalidomide and its analogues is 
associated with an increased risk of venous thromboembolism (predominantly deep vein thrombosis and 
pulmonary embolism) and arterial thromboembolism (predominantly myocardial infarction and 
cerebrovascular event) (see sections 4.5 and 4.8). 
 
Consequently, patients with known risk factors for thromboembolism (including prior thrombosis) should be 
closely monitored. Action should be taken to try to minimise all modifiable risk factors (e.g. smoking, 
hypertension, and hyperlipidaemia). Concomitant administration of erythropoietic medicinal products may 
also increase thrombotic risk in these patients. Therefore, erythropoietic medicinal products, or other 
medicinal products that may increase the risk of thrombosis, such as hormone replacement therapy, should 
be used with caution in multiple myeloma patients receiving dexamethasone with thalidomide and its 
analogues. A haemoglobin concentration above 12 g/dl should lead to discontinuation of erythropoietic 
medicinal products. 
 
Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. 
Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, 
chest pain, arm or leg swelling. Prophylactic antithrombotic treatment should be recommended, especially in 
patients with additional thrombotic risk factors. The decision to take antithrombotic prophylactic measures 
should be made after careful assessment of an individual patient’s underlying risk factors. 
 
If the patient experiences any thromboembolic events, treatment must be discontinued and standard 
anticoagulation therapy started. Once the patient has been stabilised on the anticoagulation treatment and any 
complications of the thromboembolic event have been managed, the treatment with dexamethasone and 
thalidomide or its analogues may be restarted at the original dose dependent upon a benefit risk assessment. 
The patient should continue anticoagulation therapy during the course of treatment with dexamethasone and 
thalidomide or its analogues.  
 
Neutropenia and thrombocytopenia 
The combination of dexamethasone with lenalidomide in multiple myeloma patients is associated with a 
higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients compared 
with 0.6% in placebo/dexamethasone-treated patients; see section 4.8). Grade 4 febrile neutropenia episodes 
were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 0.0% in 
placebo/dexamethasone treated patients; see section 4.8). Neutropenia was the most frequently reported 
Grade 3 or 4 haematological adverse reaction in patients with relapsed/refractory multiple myeloma treated 
with the combination of dexamethasone with pomalidomide. Patients should be monitored for 
haematological adverse reactions, especially neutropenia. Patients should be advised to promptly report 
febrile episodes. A dose reduction of lenalidomide or pomalidomide may be required. In case of neutropenia, 
the physician should consider the use of growth factors in patient management. 
 
The combination of dexamethasone with lenalidomide in multiple myeloma patients is associated with a 
higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in 
lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated 
patients) (see section 4.8). Thrombocytopenia was also reported very commonly by patients with 



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relapsed/refractory multiple myeloma treated with the combination of dexamethasone with pomalidomide. 
Patients and physicians are advised to be observant for signs and symptoms of bleeding, including petechiae 
and epistaxes, especially in case of concomitant treatment susceptible to induce bleeding. A dose reduction 
of lenalidomide or pomalidomide may be required. 
 
A complete blood cell count, including white blood cell count with differential count, platelet count, 
haemoglobin, and haematocrit should be performed at baseline, every week for the first 8 weeks of 
dexamethasone/lenalidomide treatment and monthly thereafter to monitor for cytopenias. 
 
Lactose intolerance 
 
Neofordex contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase 
deficiency or glucose-galactose malabsorption should not take this medicinal product. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Prior to the use of Neofordex in combination with any other medicinal product, reference should be 
made to the Summary of Product Characteristics of that product. 
 
Pharmacodynamic interactions 
 
The following combinations should be avoided due to safety concerns 
• With acetylsalicylic acid, at doses ≥ 1 g per dose or 3 g per day, due to an increased risk of bleeding. 

At doses ≥ 500 mg per dose or < 3 g per day, precautions are required due to increased risk of 
haemorrhage, ulcerations and gastro-intestinal perforation. However, antithrombotic prophylaxis with 
low-dose acetylsalicylic acid is possible;  

• With live attenuated vaccines, due to risk of vaccine-related illness with risk of death (see section 4.4). 
 
The following combinations require precautions due to safety concerns 
• With hypokalaemic medicinal products: hypokalemic diuretics, single or in combination, laxatives, 

tetracosactide, intravenous amphotericin B, due to increased risk of hypokalaemia. Potassium levels 
should be monitored and corrected as necessary. In addition, amphotericin B carries a risk of cardiac 
enlargement and cardiac failure with concurrent use. 

• With digitalis, as hypokalaemia enhances the toxic effects of digitalis. Any hypokalaemia should be 
corrected and patients should be monitored clinically, for electrolytes and by electrocardiograpy. 

• With medicinal products that carry a risk of Torsades de Pointes, due to increased risk of ventricular 
arrhythmia. Any hypokalaemia should be corrected and patients should be monitored clinically, for 
electrolytes and by electrocardiography. 

• With erythropoietic medicinal products or other medicinal products that may increase the risk of 
thrombosis, such as hormone replacement therapy, in patients receiving thalidomide or its analogues 
with Neofordex (see sections 4.4 and 4.8). 

• With non-steroidal anti-inflammatory drugs (NSAIDs), due to an increased risk of gastrointestinal 
ulceration. 

• With hypoglycaemic medicinal products, as dexamethasone can raise glycaemic levels and diminish 
glucose tolerance, with a possibility of ketoacidosis. Patients should be made aware of this risk and 
self-monitoring of blood and urine should be reinforced, especially during the initiation of treatment. 
The posology of anti-diabetic medicinal products may have to be adjusted during and after the 
treatment with dexamethasone. 

• With anti-hypertensive medicinal products, due to a reduction of their effect (water and sodium 
retention). The dose of the anti-hypertensive treatment may have to be adjusted during the treatment 
with dexamethasone. 

• With fluoroquinolones, due to possibly increased risk of tendonitis and, in exceptional cases, rupture 
of the affected tendon, particularly after long-term treatment. 

• With methotrexate, due to an increased risk of haematological toxicity. 
 



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Pharmacokinetic interactions 
 
Effects of other medicinal products on dexamethasone 
Dexamethasone is metabolized via cytochrome P450 3A4 (CYP3A4), and transported by the P-glycoprotein 
(P-gp, also known as MDR1). Concomitant administration of dexamethasone with inducers or inhibitors of 
CYP3A4 or P-gp may lead to decreased or increased plasma concentrations of dexamethasone, respectively. 
 
The following combinations require precautions due to changes in dexamethasone pharmacokinetics 
 
− Medicinal products that may reduce dexamethasone plasma concentration: 
• Aminogluthetimide, due to a reduction of the efficacy of dexamethasone through an increase of its 

hepatic metabolism.  
• Anticonvulsants that are hepatic enzyme inducers: carbamazepine, fosphenytoin, phenobarbital, 

phenytoin, primidone, due to the reduction of dexamethasone plasma levels and hence its efficacy.  
• With rifampicin, due to reduction of dexamethasone plasma concentrations and efficacy by an increase 

of its hepatic metabolism.  
• Topical gastro-intestinal medicinal products, antacids and activated carbon, as well as colestyramine, 

due to reduction of the intestinal absorption of dexamethasone. The administration of such medicinal 
products and Neofordex should be separated by at least two hours. 

• Ephedrine, due to a reduction in dexamethasone plasma levels by increased metabolic clearance. 
− Medicinal products that may increase dexamethasone plasma concentration: 
• Aprepitant and fosaprepitant, due to an increase of dexamethasone plasma concentrations by a 

reduction of its hepatic metabolism.  
• Clarithromycin, erythromycin, telithromycin, itraconazole, ketoconazole, posaconazole, voriconazole, 

nelfinavir, ritonavir: Increased dexamethasone plasma concentration due to reduction of its hepatic 
metabolism by these enzyme inhibitors. 

 
Effects of dexamethasone on other medicinal products 
Dexamethasone is a moderate inducer of CYP3A4 and of P-gp. Concomitant administration of 
dexamethasone with substances that are metabolised via CYP3A4 or transported by P-gp could lead to 
increased clearance and decreased plasma concentrations of these substances:  
 
• Oral contraceptives, as it cannot be excluded that the efficacy of oral contraceptives may be reduced 

during treatment. No interaction study has been performed with oral contraceptives. Effective 
measures to avoid pregnancy must be taken (see section 4.6). Efficacy of hormone replacement 
therapy may also be reduced. 

• Oral anticoagulants, due to a possible impact of corticosteroids on the metabolism of the oral 
anticoagulant and on coagulation factors, as well as the haemorrhagic risk (mucosa of the digestive 
tract, vascular fragility) of dexamethasone therapy itself at high doses or treatment periods above 
10 days. It the combination is required, monitoring should be reinforced and coagulation parameters 
controlled after one week and then every other week of treatment as well as after the end of treatment. 

• Docetaxel and cyclophosphamide, due to reduction of their plasma levels by induction of CYP3A and 
P-gp.  

• Lapatinib, due to increased hepatotoxicity of lapatinib likely due to induction of CYP3A4 metabolism. 
• Ciclosporin, due to a reduction of ciclosporin bioavailability and plasma levels. Ciclosporin may also 

increase the intracellular uptake of dexamethasone. In addition, convulsions have been reported with 
concurrent use of dexamethasone and ciclosporin. Concomitant use of dexamethasone and 
ciclosporine should be avoided. 

• Midazolam, due a reduction in midazolam plasma levels by CYP3A4 induction. The efficacy of 
midazolam may be reduced. 

• Ivermectin, due to a reduction of ivermectin plasma levels. Parasite eradication must be successfully 
terminated before dexamethasone use (see section 4.4). 

• Rifabutin, due to reduced rifabutin plasma levels by induction of intestinal and hepatic CYP3A4.  
• Indinavir, due to a strong reduction of indinavir plasma levels by intestinal CYP3A4 induction. 
• Erythromycin, due to increased metabolism of erythromycin in non-carriers of the CYP3A5*1 allele 

after dexamethasone treatment. 



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• Isoniazid, as glucocorticoids may decrease isoniazid plasma concentrations, probably due to a 
stimulation of hepatic metabolism of isoniazid and a reduction of glucocorticoid metabolism. 

• Praziquantel, due to the reduction of praziquantel plasma concentrations due to an increase of its 
hepatic metabolism by dexamethasone, with a risk of failure of treatment. The treatments with the two 
medicinal products should be separated by at least one week. 

 
Repeated, daily administration of dexamethasone also leads to reduced dexamethasone plasma levels due to 
the induction of CYP3A4 and P-gp. No dose adjustment is needed in the treatment of multiple myeloma. 
 
Dexamethasone has no clinically significant pharmacokinetic interaction with thalidomide, lenalidomide, 
pomalidomide, bortezomib, vincristine or doxorubicin. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential 
 
Women should avoid pregnancy during Neofordex treatment. Dexamethasone may cause congenital 
malformations (see section 5.3). Dexamethasone may be used with known teratogens (e.g. thalidomide, 
lenalidomide, pomalidomide, plerixafor), or with cytotoxic substances which are contraindicated in 
pregnancy. Patients receiving Neofordex in combination with products containing thalidomide, lenalidomide 
or pomalidomide should adhere to the pregnancy prevention programmes of those products. Reference 
should be made to all the relevant Summary of Product Characteristics prior to the commencement of any 
combination treatment for additional information.  
 
Contraception in males and females 
 
Women of childbearing potential and their male partners should take appropriate contraceptive measures. In 
particular, the requirements of the pregnancy prevention programme for combination treatment with 
thalidomide or its analogues must be followed. The efficacy of oral contraceptives may be reduced during 
dexamethasone treatment (see section 4.5). 
 
Pregnancy 
 
Based on human experience, dexamethasone is suggested to cause congenital malformations, particularly 
intra-uterine growth retardation and rarely neonatal adrenal insufficiency, when administered during 
pregnancy.  
Studies in animals have shown reproductive toxicity (see section 5.3). 
 
Neofordex should not be used during pregnancy unless the clinical condition of the woman requires 
treatment with dexamethasone. 
 
Breast-feeding 
 
Glucocorticoids are excreted in human milk and effects have been shown in breastfed newborns/infants of 
treated women. 
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Neofordex 
therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the 
woman. 
 
Fertility 
 
Studies in animals have shown reductions in female fertility (see Section 5.3). No data on male fertility are 
available. 
 
4.7 Effects on ability to drive and use machines 
 



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Neofordex has moderate influence on the ability to drive and use machines. 
Dexamethasone may cause confusional state, hallucinations, dizziness, somnolence, fatigue, syncope and 
blurred vision (see section 4.8). If affected, patients should be instructed not to drive, use machines or 
perform hazardous tasks while being treated with dexamethasone.  
 
4.8 Undesirable effects 
 
Summary of the safety profile  
 
Adverse reactions to Neofordex correspond to the predictable safety profile of glucocorticoids. 
Hyperglycaemia, insomnia, muscle pain and weakness, asthenia, fatigue, oedema and weight increase occur 
very commonly. Less common but serious adverse reactions include: pneumonia and other infections and 
psychiatric disorders (see section 4.4). In combination with thalidomide or its analogues the most serious 
adverse reactions were venous thromboembolic events, predominantly deep vein thrombosis and pulmonary 
embolism, and myelosuppression, particularly neutropenia and thrombocytopenia (see section 4.4). 
 
The incidence of predictable adverse reactions, including adrenal atrophy, correlates with dose, timing of 
administration and the duration of treatment (see section 4.4). 
 
Tabulated list of adverse reactions 
 
The adverse reactions observed in patients treated with dexamethasone are listed below by system organ 
class and frequency. Frequencies are defined as: 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 including isolated 
reports), not known (cannot be estimated from the available data). 
 

System organ class  Adverse reactions 
Infections and infestations Common: Pneumonia, herpes zoster, upper respiratory tract 

infection, lower respiratory tract infection, oral candidiasis, oral 
fungal infection, urinary tract infection, herpes simplex, candida 
infection; 
Not known: Infection, sepsis. 

Blood and the lymphatic system 
disorders 

Common: Neutropenia, anaemia, thrombocytopenia, lymphopenia, 
leukopenia, leukocytosis; 
Uncommon: Febrile neutropenia, pancytopenia, coagulopathy. 

Endocrine disorders Common: Cushing’s syndrome; 
Uncommon: Hypothyroidism; 
Not known: Adrenal atrophy, steroid withdrawal syndrome, adrenal 
insufficiency, hirsutism, menstrual irregularity.  

Metabolism and nutrition 
disorders 

Very common: Hyperglycaemia; 
Common: Hypokalaemia, diabetes mellitus, anorexia, increased or 
decreased appetite, hypoalbuminaemia, fluid retention, 
hyperuricaemia; 
Uncommon: Dehydration, hypocalcaemia, hypomagnesemia; 
Not known: Glucose tolerance impaired, sodium retention, 
metabolic alkalosis. 

Psychiatric disorders Very common: Insomnia; 
Common: Depression, anxiety, aggression, confusional state, 
irritability, nervousness, mood alteration, agitation, euphoric mood; 
Uncommon: Mood swings, hallucinations; 
Not known: Mania, psychosis, behavioural disturbance. 



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Nervous system disorders Common: Peripheral neuropathy, dizziness, psychomotor 
hyperactivity, disturbance in attention, memory impairment, 
tremor, paraesthesia, headache, ageusia, dysgeusia, somnolence, 
lethargy, balance impaired, dysphonia; 
Uncommon: Cerebrovascular accident, transient ischaemic attack, 
amnesia, coordination abnormal, ataxia, syncope; 
Not known: Convulsions. 

Eye disorders Common: Vision blurred, cataract; 
Uncommon: Conjunctivitis, increased lacrimation; 
Not known: Chorioretinopathy, glaucoma. 

Ear and labyrinth disorders Common: Vertigo. 
Cardiac disorders Common: Atrial fibrillation, supraventricular extrasystoles, 

tachycardia, palpitations; 
Uncommon: Myocardial ischaemia, bradycardia; 
Not known: Congestive heart failure. 

Vascular disorders Common: Venous thromboembolic reactions, predominantly deep 
vein thrombosis and pulmonary embolism, hypertension, 
hypotension, flushing, blood pressure increased, diastolic blood 
pressure decreased; 
Not known: Purpura, bruising. 

Respiratory, thoracic, or 
mediastinal disorders 

Common: Bronchitis, cough, dyspnoea, pharyngolaryngeal pain, 
hoarseness, hiccough.  

Gastrointestinal disorders Very Common: Constipation; 
Common: Vomiting, diarrhoea, nausea, dyspepsia, stomatitis, 
gastritis, abdominal pain, dry mouth, abdominal distension, 
flatulence; 
Not known: Pancreatitis, gastrointestinal perforation, 
gastrointestinal haemorrhage, gastrointestinal ulcer. 

Hepatobiliary disorders Common: Liver function tests abnormal, alanine aminotransferase 
increased. 

Skin and subcutaneous tissue 
disorders 

Common: Rash, erythema, hyperhidrosis, pruritus, dry skin, 
alopecia; 
Uncommon: Urticaria; 
Not known: Skin atrophy, acne. 

Musculoskeletal and connective 
tissue disorders 

Very common: Muscular weakness, muscle cramps; 
Common: Myopathy, musculoskeletal pain, arthralgia, pain in 
extremity; 
Not known: Pathological fracture, osteonecrosis, osteoporosis, 
tendon rupture. 

Renal and urinary disorders Common: Pollakiuria; 
Uncommon: Renal failure. 

General disorders and 
administration site conditions 

Very common: Fatigue, asthenia, oedema (including peripheral and 
facial oedema); 
Common: Pain, mucosal inflammation, pyrexia, chills, malaise; 
Not known: Impaired healing. 

Investigations Common: Weight decreased, weight increased. 
 
Description of selected adverse reactions 
 
Prior to the use of Neofordex in combination with any other medicinal product, reference should be 
made to the Summary of Product Characteristics of that product.  
 
The incidence rate of certain adverse reactions varies depending on the combination treatment used.  
 
The combination of lenalidomide with dexamethasone in relapsed or refractory multiple myeloma patients is 
associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated 



12 

patients compared with 0.6% in placebo/dexamethasone-treated patients). Grade 4 febrile neutropenia 
episodes were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 
0.0% in placebo/dexamethasone treated patients). A similar incidence of high-grade neutropenia was 
reported in newly diagnosed patients treated with the combination of lenalidomide and dexamethasone. 
 
Neutropenia occurred in 45.3% of relapsed and refractory multiple myeloma patients who received low dose 
dexamethasone plus pomalidomide (Pom + LD-Dex), and in 19.5% of patients who received high dose 
dexamethasone (HD-Dex). Neutropenia was Grade 3 or 4 in 41.7% of patients who received Pom + LD-Dex, 
compared with 14.8% who received HD-Dex. In Pom + LD-Dex treated patients neutropenia was 
infrequently serious (2.0% of patients), did not lead to treatment discontinuation, and was associated with 
treatment interruption in 21.0% of patients, and with dose reduction in 7.7% of patients. Febrile neutropenia 
(FN) was experienced in 6.7% of patients who received Pom + LD-Dex, and in no patients who received 
HD-Dex. All were reported to be Grade 3 or 4. FN was reported to be serious in 4.0% of patients. FN was 
associated with dose interruption in 3.7% of patients, and with dose reduction in 1.3% of patients, and with 
no treatment discontinuations. 
 
The combination of lenalidomide with dexamethasone in relapsed or refractory multiple myeloma patients is 
associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in 
lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated 
patients). A similar incidence of high-grade thrombocytopenia was reported in newly diagnosed patients 
treated with the combination of lenalidomide and dexamethasone. Thrombocytopenia occurred in 27.0% of 
relapsed and refractory multiple myeloma patients who received Pom + LD-Dex, and 26.8% of patients who 
received HD-Dex. Thrombocytopenia was Grade 3 or 4 in 20.7% of patients who received Pom + LD-Dex 
and in 24.2% who received HD-Dex. In Pom + LD-Dex treated patients, thrombocytopenia was serious in 
1.7% of patients, led to dose reduction in 6.3% of patients, to dose interruption in 8% of patients and to 
treatment discontinuation in 0.7% of patients. 
 
The combination of lenalidomide, thalidomide or pomalidomide with dexamethasone is associated with an 
increased risk of deep vein thrombosis and pulmonary embolism in patients with multiple myeloma (see 
section 4.5). Concomitant administration of erythropoietic medicinal products or previous history of deep 
vein thrombosis may also increase thrombotic risk in these patients. 
 
Low-grade peripheral neuropathic reactions, predominantly grade 1 paraesthesia, may be observed with 
dexamethasone alone in up to 34% of newly diagnosed multiple myeloma patients. However, both incidence 
and severity of peripheral neuropathy increase with concomitant bortezomib or thalidomide administration. 
In one study, 10.7% of patients treated with thalidomide and dexamethasone experienced grade 3/4 
neuropathic reactions, compared to 0.9% of patients treated with dexamethasone alone. 
 
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 
 
Acute toxicity of dexamethasone is weak and toxic effects have rarely been observed after an acute overdose. 
No antidote exists and treatment is symptomatic. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Corticosteroids for systemic use, glucocorticoids, ATC code: H02AB02 
 

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


13 

Mechanism of action 
 
Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low 
mineralocorticoid activity. At high doses (e.g. 40mg), it reduces the immune response. 
 
Dexamethasone has been shown to induce multiple myeloma cell death (apoptosis) via a down-regulation of 
Nuclear Factor-κB activity and an activation of caspase-9 through second mitochondria-derived activator of 
caspase (Smac; an apoptosis promoting factor) release. Prolonged exposure was required to achieve 
maximum levels of apoptotic markers along with increased caspase-3 activation and DNA fragmentation. 
Dexamethasone also down-regulated anti apoptotic genes and increased IκB-α protein levels.  
 
Dexamethasone apoptotic activity is enhanced by the combination with thalidomide or its analogues and 
with proteasome inhibitor (e.g. bortezomib).  
 
Multiple myeloma is a progressive rare haematologic disease. It is characterized by excessive numbers of 
abnormal plasma cells in the bone marrow and overproduction of intact monoclonal immunoglobulin (IgG, 
IgA, IgD, or IgE) or Bence-Jones protein only (free immunoglobulin monoclonal κ and λ light chains). 
 
Clinical efficacy and safety 
 
No clinical efficacy and safety studies have been conducted using Neofordex in the treatment of multiple 
myeloma. 
 
The efficacy and safety of dexamethasone combination treatment in multiple myeloma has been confirmed 
in numerous clinical studies in newly diagnosed patients and in patients with relapsed or refractory disease. 
The patient populations studied included a wide range of ages, as well as patients considered eligible or 
ineligible for autologous stem cell transplantation. High-dose (40mg or 20mg) oral dexamethasone has been 
studied in the therapy of multiple myeloma in combination with chemotherapy in the VAD regimen 
(vincristine, adriamycin/doxorubicin and dexamethasone) or in association with novel agents, including 
thalidomide and its analogues as well as proteasome inhibitors. In controlled studies, combination treatment 
with dexamethasone consistently showed better outcomes in terms of survival and response than single-agent 
dexamethasone. 
 
Paediatric population 
 
The European Medicines Agency has waived the obligation to submit the results of studies with Neofordex 
in all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric 
use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
After oral administration of Neofordex, dexamethasone peak plasma levels are reached at a median of three 
hours. Bioavailability of dexamethasone is approximately 80%. There is a linear relationship between 
administered and bioavailable doses.   
Dexamethasone is transported by the P-glycoprotein (also known as MDR1). Other MDR transporters may 
also have a role in dexamethasone transport. 
 
Distribution 
 
Dexamethasone is bound by plasma proteins, principally albumin, up to about 80%, depending on the 
administered dose. At very high doses the majority of dexamethasone circulates unbound in the blood. The 
volume of distribution is approximately 1 l/kg. Dexamethasone crosses the blood-brain barrier and the 
placental barrier and passes into breast milk. 
 
Biotransformation 



14 

 
A minor part of administered dexamethasone is excreted unchanged by the kidney. The major part is 
hydrogenated or hydroxylated in humans, the major metabolites being hydroxy-6-dexamethasone and 
dihydro-20-dexamethasone. 30 to 40% are conjugated to glucuronic acid or sulphated in the human liver and 
excreted in this form in the urine. Dexamethasone is metabolized via cytochrome P450 3A4 (CYP3A4). 
Other cytochrome P450 isoenzymes may also play a role in dexamethasone biotransformation. 
 
Elimination 
 
The plasma half-life of dexamethasone is approximately 250 minutes.  
 
Specific groups of patients 
 
No data are available on the biotransformation of dexamethasone in hepatically impaired patients. 
 
Smoking has no influence on dexamethasone pharmacokinetics. No differences were found in 
dexamethasone pharmacokinetics between subjects of European and Asian (Indonesian and Japanese) 
descent. 
 
5.3 Preclinical safety data 
 
Glucocorticoids have only weak acute toxicity. No chronic toxicity and carcinogenicity data are available. 
Genotoxicity findings have been shown to be artefactual. In reproductive toxicity studies in mice, rats, 
hamsters, rabbits and dogs, dexamethasone has led to embryo-fetal malformations such as increase in cleft 
palate and skeletal defects; decreases in thymus, spleen and adrenal weight; lung, liver, and kidney 
abnormalities; and inhibition of growth. Post-natal development assessment of animals treated prenatally 
presented decreased glucose tolerance and insulin sensitivity, behavioural alterations and decrease in brain 
and body weight. In males, fertility may be decreased through germ cell apoptosis and spermatogenic 
defects. Data on female fertility are contradictory. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Lactose monohydrate 
Microcrystalline cellulose 
Magnesium stearate 
Colloidal anhydrous silica 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special temperature storage conditions. 
 
Tablets should be kept in the blister package until administration. Individual tablets in intact packaging 
should be separated from the blister using the perforation, e.g. for use in multi-compartment compliance aids. 
Halved tablets that are not taken immediately should be disposed of (see section 6.6).  
 



15 

6.5 Nature and contents of container  
 
10 x 1 tablets in OPA/Aluminium /PVC-Aluminium perforated unit dose blister.  
 
Pack size of 10 tablets. 
 
6.6 Special precautions for disposal  
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. Advise patients to not dispose of unused tablets through household waste or wastewater. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Laboratoires CTRS 
63, rue de l’Est 
92100 Boulogne-Billancourt 
France 
Email: ctrs@ctrs.fr 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1053/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 March 2016 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 
  

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


16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 

ANNEX II 
 

A. MANUFACTURER 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 



17 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Laboratoires CTRS 
63, rue de l’Est 
92100 Boulogne-Billancourt 
France 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
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.  

  



18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



20 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Neofordex 40 mg tablets  
dexamethasone 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains dexamethasone acetate equivalent to 40 mg dexamethasone. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
10 x 1 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral 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 
 
 



21 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Laboratoires CTRS 
63, rue de l’Est 
92100 Boulogne-Billancourt 
France 
Email: ctrs@ctrs.fr 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1053/001  
 
 
13. BATCH NUMBER 
 
LOT 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
neofordex 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 
 
  



22 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Neofordex 40 mg tablet  
dexamethasone 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Laboratoires CTRS 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



24 

Package leaflet: Information for the patient 
 

Neofordex 40 mg tablet 
dexamethasone 

 
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 or pharmacist. 
- 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 or pharmacist. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Neofordex is and what it is used for  
2. What you need to know before you take Neofordex 
3. How to take Neofordex 
4. Possible side effects  
5. How to store Neofordex 
6. Contents of the pack and other information 
 
 
1. What Neofordex is and what it is used for 
 
Neofordex is a medicine that contains the active substance dexamethasone. Dexamethasone is a type of 
hormone called a glucocorticoid, sometimes called a corticoid or corticosteroid, with various actions 
including effects on white blood cells, which form part of the immune system (the body’s natural defences). 
Dexamethasone is similar to glucocorticoids which are naturally produced in the body. 
 
Neofordex is used to treat adult patients with multiple myeloma, a cancer of the blood affecting the white 
blood cells that produce antibodies. Neofordex will be given in combination with other medicines for 
multiple myeloma. They act together by killing cancerous white blood cells. 
 
 
2. What you need to know before you take Neofordex 
 
Do not take Neofordex 
− if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6); 
− if you have a viral infection, especially viral hepatitis, herpes, chickenpox or shingles; 
− if you have an untreated psychiatric illness. 
 
Warnings and precautions  
Talk to your doctor, pharmacist, nurse, before taking Neofordex especially if given with other medicinal 
products. 
 
Risk of infection 
Treatment with Neofordex (a high-dose corticosteroid) may reduce your body’s ability to fight infection (in 
particular due to bacteria, yeasts and/or parasites). This can sometimes lead to infections caused by germs 
that rarely cause infection under normal circumstances (called opportunistic infections). If you get an 
infection of any kind during treatment with this medicine, contact your doctor immediately. This is 
particularly important if you notice signs of pneumonia: cough, fever, shortness of breath and chest pain. 
You may also feel confused, particularly if you are elderly. You should also tell your doctor if you have had 
tuberculosis or if you have stayed in regions where roundworm infections are common.  
 



25 

Note: It is important that while you are taking Neofordex you avoid contact with anyone who is suffering 
from chickenpox, measles or shingles. If you think you may have had contact with anyone with these 
conditions, you should inform your doctor immediately.  
 
Psychiatric disorders 
High-dose corticosteroids, including dexamethasone, can cause psychological problems that may sometimes 
be serious. Talk to your doctor before taking Neofordex if you or a member of your immediate family have 
suffered, or currently suffer from severe depression or manic attacks. This is especially important if you feel 
depressed or might be thinking about suicide. Insomnia may be minimised by administering Neofordex in 
the morning. 
 
Tumour lysis syndrome 
You should tell your doctor if you have symptoms of tumour lysis syndrome such as muscle cramping, 
muscle weakness, confusion, visual loss or disturbances and shortness of breath 
 
Long-term treatment 
During treatment with this medicine it is important to maintain a balanced diet (low in sugar and sodium, 
high in protein). Water and sodium retention is common and can lead to hypertension.  
Your doctor will advise on an appropriate diet, and may prescribe potassium, calcium or vitamin D 
supplements. 
 
Glucocorticoid therapy like dexamethasone may reduce the effect of medicines to treat diabetes or 
hypertension. The dose of these medicines may have to be increased by your doctor. 
 
Haematology  
If you have had blood clots in the past you should inform your doctor before taking Neofordex. The 
combination of dexamethasone with thalidomide, lenalidomide or pomalidomide (medicines to treat multiple 
myeloma) increases the risk of blood clots in the veins and arteries. You must tell your doctor immediately if 
you experience shortness of breath, chest pain or swelling in the arms or legs. 
 
The combination of dexamethasone with lenalidomide or pomalidomide may cause a decrease in normal 
white blood cells (blood cells that help fight infection) and/or blood platelets (which help prevent bleeding). 
Your doctor will arrange appropriate blood tests before and during treatment.  
 
Pheochromocytoma crisis  
Treatment with this medicine may cause pheochromocytoma crisis, which can be fatal. Pheochromocytoma 
is a rare tumor of the adrenal glands Crisis can occur with the following symptoms: headaches, sweating, 
palpitations, and hypertension. Contact your doctor immediately if you experience any of these signs. 
 
Eye disorders 
Treatment with this medicine may cause central serous chorioretinopathy, an eye disease that leads to blurred 
or distorted vision. This happens usually in one of the eyes. If you notice blurring or distorted vision that 
lasts for several days, please contact your doctor. 
 
Tendonitis  
Treatment with this medicine may cause tendon inflammation. In extremely rare cases, a tendon may 
rupture. This risk is increased by treatment with certain antibiotics and by kidney problems. Contact your 
doctor if you notice painful, stiff or swollen joints or tendons. 
 
Please inform any doctor, dentist or person who may prescribe a treatment for you that you are currently 
taking or have recently taken dexamethasone (see section “Other medicines and Neofordex”). 
 
If you become ill or are involved in an accident, or if you need surgery (even at the dentist) or require a 
vaccination (high dose of glucocorticoid may diminish the effect of “live virus” vaccines) you should inform 
the doctor treating you that you are taking or have recently taken high-dose corticosteroids. 
 



26 

If you need tests (in particular for infections) you should inform the person performing the tests as 
dexamethasone may interfere with the results. 
 
Talk to your doctor before taking Neofordex 
- if you have liver or kidney disease, 
- if you have heart disease or you have recently had a heart attack, 
- if you have high blood pressure, high cholesterol or you are a smoker, 
- if you have diabetes or if there is a history of diabetes in your family, 
- if you have osteoporosis, especially if you are a woman who has been through the menopause, 
- if you have glaucoma (increased eye pressure) or if there is a history of glaucoma in your family, 
- if you have myasthenia gravis (a disease affecting the muscles), inflammation of a tendon (tendonitis), 
- if you have a peptic ulcer (ulcer in your stomach or duodenum), or a history of peptic ulcers, stomach 

bleeding or perforation, 
- if you have inflammation of the colon, diverticulitis, or have recently had surgery on the intestine,  
- if you have or are suspected of having pheochromocytoma (a tumor of the adrenal glands). 
 
You doctor will observe you more closely if you have any of the listed diseases. 
 
Elderly 
If you are elderly, some of the side effects of Neofordex may be more serious, especially thinning of the 
bones (osteoporosis), high blood pressure, low potassium levels, diabetes, susceptibility to infection and 
thinning of the skin. Your doctor will monitor you more closely. 
 
Children and adolescents 
Children do not develop multiple myeloma. This medicine should not be given to children (i.e. anyone below 
the age of 18 years). 
 
Other medicines and Neofordex 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
 
You must read the package leaflets of all medicines to be taken in combination with Neofordex for 
information related to these medicines before starting treatment with Neofordex. When thalidomide, 
lenalidomide or pomalidomide is used, particular attention to pregnancy testing and prevention requirements 
is needed. 
 
If you are taking any of the following medicines, you should consult your doctor before taking Neofordex: 
 
The following combinations should be avoided 
- Acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever (may 

increase the risk of bleeding);  
- You should also tell your doctor if you have recently received a vaccination or are planning to be 

vaccinated (please see section “Warnings and precautions”). 
 
The following combinations require precautions  
- Medicines that reduce blood potassium levels: for example, some diuretics or laxatives, amphotericin B 

injection, tetracosactide, due to the risk of decreased potassium levels. Your doctor may need to monitor 
the level of potassium; 

- Medicines that can increase the risk of abnormal heart rhythm (e.g. some medicines for treatment 
of heart disease, as digitalis), since low levels of potassium increase the risk of abnormal heart beats; 

- Medicines to treat hypertension, since their effect can be reduced. Your doctor may need to adjust the 
dose of anti-hypertensive treatment; 

- Medicines to treat anaemia such as Erythropoietin (EPO) or other medicines such as hormone 
replacement therapy, may increase the risk of formation of blood clots (please see sections “Warnings 
and precautions” and “Possible side effects”); 

- Medicines to treat pain, inflammation and fever (non-steroidal anti-inflammatory drugs) e.g. ibuprofen, 
naproxen, diclofenac, meloxicam and others may increase the risk of bleeding or open sores in the 
stomach; 



27 

- Medicines for treatment of diabetes, as Neofordex can modify glucose level. It is important to self-
monitor blood glucose levels, especially during the initiation of treatment. Your doctor may need to 
adjust the dose of anti-diabetic medicines; 

- Some antibiotics (such as fluoroquinolones) may increase the risk of tendonitis and, in exceptional cases, 
rupture of the affected tendon, particularly after long-term treatment; 

- Certain medicines to treat cancer (such as methotrexate) may increase the risk of infection, bleeding or 
anaemia. 

 
The following medicines may influence the effect of Neofordex  
These medicines may reduce the effect of Neofordex:  
- Aminogluthetimide (medicine to treat Cushing’s syndrome or breast cancer); 
- Anticonvulsants (for the treatment of epilepsy) such as carbamazepine, fosphenytoin, phenobarbital, 

phenytoin, primidone; 
- Rifampicin (used to treat tuberculosis); 
- Medicines for an upset stomach (for example antacids) as well as colestyramine (to lower cholesterol); 

The administration of such medicines with Neofordex should be separated by at least two hours; 
- Ephedrine (to treat asthma attacks or relieve nasal congestion). 
These medicines may increase the effect of Neofordex: 
- Aprepitant or fosaprepitant (for the treatment of nausea and vomiting after surgery or caused 

by chemotherapy [cancer treatment]); 
- Antibiotics, with active substance names ending in –mycin and antifungals (to treat fungal infections) 

with active substance names ending in –conazole; and anti-HIV medicines with active substance 
names ending in –navir.  

 
Neofordex may influence the effect of these medicines 
- The effect of oral contraceptives and hormone replacement therapy (HRT) may be reduced. Effective 

measures to avoid pregnancy must be taken (see section “Pregnancy, breast-feeding and fertility”); 
- The effect of oral anticoagulants may be increased, leading to increased bleeding risk. Your doctor may 

need to monitor closely your blood coagulation parameters; 
- The effect of certain medicines to treat cancer (such as docetaxel and cyclophosphamide) may be 

reduced; 
- The liver effects of lapatinib (used to treat cancer) may be increased; 
- The effect of ciclosporin (a medicine used to suppress immune reactions) may be reduced. In addition, 

convulsions have been reported with concurrent use of dexamethasone and ciclosporin. Concomitant use 
of Neofordex and ciclosporine should be avoided; 

- The effect of midazolam (used as sleeping pill and for the treatment of epilepsy) may be reduced; 
- The effect of ivermectin (for certain worm infections) may be reduced, therefore the treatment with 

ivermectin must be successfully terminated before Neofordex administration (see section “Warnings and 
precautions”); 

- The effect of rifabutin or isoniazid (used to treat tuberculosis) may be reduced; 
- The effect of indinavir (used in the treatment of HIV) may be reduced;  
- The effect of erythromycin may be reduced; 
- The effect of praziquantel (for certain worm infections) may be reduced with a risk of failure 

of treatment, therefore treatment with praziquantel and Neofordex should be separated by at least one 
week. 

 
Pregnancy, breast-feeding and fertility 
If you are pregnant or breast-feeding, you think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
You must avoid getting pregnant during treatment with Neofordex which may cause congenital 
malformations. You and your partner must use appropriate contraception.  
You should not use Neofordex during pregnancy unless your clinical condition requires treatment with 
dexamethasone. Inform your doctor immediately if you are pregnant or if you become pregnant during 
treatment.  
 



28 

Glucocorticoids are excreted in human milk, therefore, a risk to the newborns/infants cannot be excluded. 
Tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether 
to stop breast-feeding, or whether to stop taking Neofordex, considering the benefit of breast-feeding to the 
baby and the benefit of Neofordex to the mother.  
 
Driving and using machines 
Neofordex has moderate influence on the ability to drive and use machines. Do not drive, use any tools or 
machines or carry out any hazardous tasks if you experience side effects, such as confusion, hallucinations, 
dizziness, tiredness, sleepiness, fainting or blurred vision.   
 
Neofordex contains lactose 
Neofordex contains lactose, a sugar. If you have been told by your doctor that you have intolerance to some 
sugars, contact your doctor before taking this medicine. 
 
 
3. How to take Neofordex 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.  
 
Your doctor will decide the dose and how often you should take Neofordex. This can vary according to your 
condition and to other associated treatment(s). The recommended dose is one tablet each time. If you are 
over 65 years old and/or frail, your doctor may prescribe a half tablet each time. Do not exceed or take less 
than the prescribed dose. You must take this medicine on the appropriate days, exactly as your doctor 
prescribed. 
 
Your doctor may change the dose and frequency of administration based on certain parameters including 
your blood analyses, your general condition, other medicines prescribed to you and your response to the 
treatment.  
 
Swallow the prescribed dose of one tablet (40 mg) or half a tablet (20 mg) in the morning with a glass of 
water.  
 
If your dose is half a tablet (20 mg), the tablet should be divided into two equal halves using the score line. 
Take one half tablet straightaway. Do not save the spare half tablet to take on another day as this 
medicine may deteriorate once divided and taken out of its packaging. Then, keep the spare half tablet 
in a safe place, out of the sight and reach of children, until you can throw it away properly, as you should not 
throw away any medicines in wastewater or household waste. Ask your pharmacist how to throw them away. 
If you have difficulties taking the tablet out of the blister or breaking the tablet, ask somebody for help.  
Insomnia may be minimised by administering Neofordex in the morning. 
 
If you take more Neofordex than you should 
If you take too much Neofordex contact your doctor or hospital immediately. 
 
If you forget to take Neofordex 
If you forget to take Neofordex at the usual time and 

– if you are less than 12 hours late: take the tablet immediately. 
– if you are more than 12 hours late: do not take the tablet but take the next tablet at the usual time.  

 
Do not take a double dose to make up for a forgotten tablet. 
 
If you stop taking Neofordex 
You may experience serious side effects if you stop taking this medicine suddenly. If you stop taking this 
medicine too quickly, you may have low blood pressure. You may also feel a ‘withdrawal symptom’. This 
may include headache, problems with your vision (including pain or swelling in the eye), feeling or being 
sick, fever, pain in your muscles and joints, swelling in the inside of your nose, weight loss, itchy skin and 
conjunctivitis. If your treatment is to be stopped follow your doctor’s advice.  
 



29 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.  
 
The side effects listed below were seen when dexamethasone was taken for the treatment of multiple 
myeloma and for the treatment of other diseases. In some cases, the combination of several medicines can 
increase the side effects of one or the other of these medicines taken separately.  
 
Neofordex may cause serious mental health problems. These are common (may affect up to 1 in 10 people) 
and may include: 

- feeling depressed (including thinking about suicide) 
- feeling high (mania), very happy (euphoria) or moods that go up and down, 
- feeling anxious, having difficulty in concentrating and memory loss, 
- feeling, seeing or hearing things that do not exist or believing in things that are not real, having 

gloomy thoughts, changing how you act. 
If you notice any of these symptoms talk to a doctor straight away. 
 
Other possible side effects may be: 
Very common: may affect more than 1 in 10 people 
− Increased blood sugar levels (hyperglycaemia); 
− Constipation; 
− Having trouble sleeping (insomnia); 
− Muscle cramps, muscle weakness; 
− Tiredness, weakness, swelling of the body and face. 
Common: may affect up to 1 in 10 people 
− Bacterial, viral or fungal infections, including pneumonia, shingles, infections of the nose, mouth, tonsils 

or throat, bronchitis, herpes, bladder infection, candida infection; 
− Reduction in the number of red or white blood cells and/or platelets, or increased number of white blood 

cells, decreased levels of potassium or of albumin (a protein) in the blood, increased levels of uric acid in 
the blood, changes in liver function tests;  

− Cushing’s syndrome, i.e. weight gain of the trunk and face, excessive sweating, stretch marks, visible 
swollen capillaries (small blood vessels) and dryness of the skin, growth of extra facial hair (especially 
in women) and thinning of the hair;  

− Development of diabetes, loss or increase of appetite, weight gain or weight loss, water retention;  
− Aggression, confusion, irritability, nervousness, restlessness, altered mood; 
− Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet due to nerve 

damage, dizziness, trembling, headache, loss of or change in the sense of taste;  
− Cataract, blurred vision; 
− Fast or irregular heart rhythm, too high or too low blood pressure, formation of blood clots that may clog 

blood vessels (for example in legs or lungs), swelling of arms or legs, reddening of the skin of the face or 
body;  

− Cough, breathing difficulties, difficulties speaking, sore throat or mouth, hoarseness, dry mouth, 
hiccough, inflammation of the mucous membranes; 

− Vomiting, nausea, diarrhoea, indigestion, bloating, swollen and/or painful stomach; 
− Rash, itching, reddened skin, excessive sweating (hyperhidrosis), dry skin, hair loss (alopecia); 
− Muscle wasting, pain of the muscles, joints, bones or limbs; 
− Frequent urination; 
− Pain, fever, chills, fainting, vertigo, exhaustion, drowsiness, impaired sense of balance.  
Uncommon: may affect up to 1 in 100 people 
− Fever due to a lack of certain white blood cells, lack of all types of blood cells, diminished blood 

clotting,; 



30 

− Failure of the thyroid gland to produce normal amounts of hormones (hypothyroidism);  
− Lack of body water (dehydration) with thirst or headache, decreased magnesium or calcium levels in the 

blood; 
− Mood swings, hallucinations; 
− Stroke, difficulties in coordination or movement, fainting; 
− Inflammation of the eye and/or eyelids, increased tearing; 
− Heart attack, abnormally slow heartbeat; 
− Hives; 
− Failure of the kidneys. 
Not known: frequency cannot be estimated from the available data 
− Infection, inflammation of the whole body due to infection (sepsis); 
− Inability of the body to respond normally to severe stress such as accidents, surgery or illness due to 

insufficient function of the adrenal glands, severe unusual headache with visual disturbances linked to 
the withdrawal of treatment, irregularity of menstrual cycles in women, excessive hair growth 
(hirsutism); 

− Increased need for diabetes medicine, salt imbalance, potassium loss due to low carbon dioxide levels (a 
condition called metabolic alkalosis); 

− Epileptic fits;  
− Increased pressure in the eye including glaucoma, choroid and retinal disorders (chorioretinopathy); 
− Inability of the heart to pump enough blood round the body (heart failure); 
− Ulcers, perforations and/or bleeding in the oesophagus (gullet), stomach or intestine, inflamed pancreas 

(which may show as pain in the back and abdomen); 
− Slow wound healing, acne, thinning of the skin, bruising, red or purple discolorations on the skin 

(purpura); 
− Thinning of the bones with increased risk of fracture, bone disease, ruptured tendon. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed 
in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 
V. By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5. How to store Neofordex 
 
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 if you notice any defects, or any signs of deterioration of the tablets or packaging. 
 
This medicine does not require any special temperature storage conditions. Keep tablets in the blister 
packaging until you take them. If you are using a pill organiser box, use the perforation to separate individual 
tablets from the blister without opening the packaging. 
 
Throw away half tablets that you have not taken. 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 Neofordex contains  
- The active substance is dexamethasone. Each tablet contains dexamethasone acetate equivalent to 

40 mg dexamethasone. 

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


31 

- The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate and 
colloidal anhydrous silica (see section 2).  

 
What Neofordex looks like and contents of the pack 
Each tablet is white, oblong in shape, with a score line on one face. The tablet can be divided into two equal 
halves.  
 
Each carton contains 10 x 1 tablets in OPA/Aluminium /PVC-Aluminium perforated unit dose blister.  
 
Marketing Authorisation Holder and Manufacturer 
 
 
Laboratoires CTRS 
63, rue de l’Est  
92100 Boulogne-Billancourt 
France 
 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Laboratoires CTRS 
Tél/Tel: +32 (0)2 40 11 442 
ctrs@ctrs.fr  
 

Lietuva 
Immedica Pharma AB  
Tel/Puh: +46 (0)8 533 39 500  
info@immedica.com  

България 
Laboratoires CTRS 
Teл.: + 33 (0)1 70 76 06 37 
ctrs@ctrs.fr  
 

Luxembourg/Luxemburg 
Laboratoires CTRS 
Tél/Tel: +352 278 62 329 
ctrs@ctrs.fr  
 

Česká republika 
Laboratoires CTRS 
Teл.: + 33 (0)1 70 76 06 37 
ctrs@ctrs.fr  
 

Magyarország 
Laboratoires CTRS 
Teл.: + 33 (0)1 70 76 06 37 
ctrs@ctrs.fr  

Danmark 
Immedica Pharma AB  
Tlf: +46 (0)8 533 39 500  
info@immedica.com  

Malta 
Laboratoires CTRS 
Tel: +356 2776 1358 
ctrs@ctrs.fr  
 

Deutschland 
Laboratoires CTRS 
Tel: +49 (0)3022153008 
ctrs@ctrs.fr  
 

Nederland 
Laboratoires CTRS 
Tel: +31 (0)2 070 38 155 
ctrs@ctrs.fr  
 

Eesti 
Immedica Pharma AB  
Tel/Puh: +46 (0)8 533 39 500  
info@immedica.com  

Norge 
Immedica Pharma AB  
Tel/Puh: +46 (0)8 533 39 500  
info@immedica.com  
 

Ελλάδα 
RAFARM AEBE 
Τηλ: + 302 106776550 
  

Österreich 
Laboratoires CTRS 
Tel: +43 (0)7 208 16 847 
ctrs@ctrs.fr  
 

mailto:ctrs@ctrs.fr
mailto:info@immedica.com
mailto:ctrs@ctrs.fr
mailto:ctrs@ctrs.fr
mailto:ctrs@ctrs.fr
mailto:ctrs@ctrs.fr
mailto:info@immedica.com
mailto:ctrs@ctrs.fr
mailto:ctrs@ctrs.fr
mailto:ctrs@ctrs.fr
mailto:info@immedica.com
mailto:info@immedica.com
mailto:ctrs@ctrs.fr


32 

España 
Laboratoires CTRS 
Tel: + 34 914 146 613 
ctrs@ctrs.fr  
 

Polska 
Laboratoires CTRS 
Tel.: + 33 (0)1 70 76 06 37 
ctrs@ctrs.fr  
 

France 
Laboratoires CTRS 
Tél: + 33 (0)1 70 76 06 37 
ctrs@ctrs.fr  
 

Portugal 
Laboratoires CTRS 
Tel: + 33 (0)1 70 76 06 37 
ctrs@ctrs.fr  
 

Hrvatska 
Laboratoires CTRS 
Tel: + 33 (0)1 70 76 06 37 
ctrs@ctrs.fr  
 
Ireland 
Aspire Pharma Ltd 
Tel: +44(0)1730 231148  

România 
Laboratoires CTRS 
Tel: + 33 (0)1 70 76 06 37 
ctrs@ctrs.fr  
 
Slovenija 
Laboratoires CTRS 
Tel: + 33 (0)1 70 76 06 37 
ctrs@ctrs.fr  
 

Ísland 
Immedica Pharma AB  
Sími: + 46 (0)8 533 39 500 
info@immedica.com  

Slovenská republika 
Laboratoires CTRS 
Teл.: + 33 (0)1 70 76 06 37 
ctrs@ctrs.fr 
   

 
Italia 
Laboratoires CTRS 
Tel: + 39 (0)687 501302 
ctrs@ctrs.fr  

 
Suomi/Finland 
Immedica Pharma AB  
Tel/Puh: +46 (0)8 533 39 500  
info@immedica.com  

 
Κύπρος 
RAFARM AEBE 
Τηλ: + 302 106776550 

 
Sverige 
Immedica Pharma AB  
Tel: +46 (0)8 533 39 500  
info@immedica.com  

 
Latvija 
Immedica Pharma AB  
Tel: +46 (0)8 533 39 500  
info@immedica.com 
   

 
United Kingdom 
Aspire Pharma Ltd 
Tel: +44(0)1730 231148 
 

  
 
This leaflet was last revised in 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  
 
 
 
 

mailto:ctrs@ctrs.fr
mailto:ctrs@ctrs.fr
mailto:ctrs@ctrs.fr
mailto:ctrs@ctrs.fr
mailto:ctrs@ctrs.fr
mailto:ctrs@ctrs.fr
mailto:ctrs@ctrs.fr
mailto:info@immedica.com
mailto:ctrs@ctrs.fr
mailto:ctrs@ctrs.fr
mailto:info@immedica.com
mailto:info@immedica.com
mailto:info@immedica.com
http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER 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
	A. LABELLING
	B. PACKAGE LEAFLET