Acomplia

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

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1. NAME OF THE MEDICINAL PRODUCT 
 
ACOMPLIA 20 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 20 mg rimonabant. 
Excipients: 
The tablets contain approx. 115 mg lactose. 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet 
Biconvex, teardrop-shaped, white tablets debossed with “20” on one side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
As an adjunct to diet and exercise for the treatment of obese patients (BMI ≥ 30 kg/m2), or overweight 
patients (BMI > 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see 
section 5.1). 
 
4.2 Posology and method of administration 
 
In adults, the recommended dosage is one 20 mg tablet daily to be taken in the morning before 
breakfast. 
 
The treatment should be introduced with a mildly reduced calorie diet. 
 
The safety and efficacy of rimonabant have not been evaluated beyond 2 years.  
 
• Special Populations 
 
Elderly: 
No dosage adjustment is required in elderly (see section 5.2). ACOMPLIA should be used with 
caution in patients over 75 years of age (see section 4.4). 
 
Patients with hepatic insufficiency: 
No dosage adjustment is required for patients with mild or moderate hepatic impairment. ACOMPLIA 
should be used with caution in patients with moderate hepatic impairment. ACOMPLIA should not be 
used in patients with severe hepatic impairment (see section 4.4 and 5.2). 
 
Patients with renal impairment: 
No dosage adjustment is required for patients with mild and moderate renal impairment (see section 
5.2). ACOMPLIA should not be used in patients with severe renal impairment (see section 4.4 and 
5.2). 
 
Paediatrics: 
ACOMPLIA is not recommended for use in children below age 18 due to a lack of data on efficacy 
and safety. 
 

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4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients 
Lactation. 
Ongoing major depressive illness and/or ongoing antidepressive treatment (see section 4.4) 
 
4.4 Special warnings and precautions for use 
 
• Depressive disorders 
Depressive disorders or mood alterations with depressive symptoms have been reported in up to 10%, 
and suicidal ideation in up to 1%, of patients receiving rimonabant (see section 4.8). In patients with 
current suicidal ideations and/or with a history of suicidal ideation and depressive disorder rimonabant 
should not be used unless the benefits of treatment are considered to outweigh these risks in an 
individual patient. (See section 4.3 and 4.8). Obesity is a condition that can be associated with 
depressive disorders. Depressive disorders can be associated with an increased risk of suicidal 
thoughts, self harm and suicide.  
 
The prescriber should carefully investigate if the patient has had a depressive disorder in the past in 
order to evaluate the potential risks with rimonabant treatment.  
 
Depressive reactions may occur in patients who have no obvious risk factors, apart from obesity itself. 
In postmarketing experience, more than half of the patients who develop such reactions appear to do 
so within 1 month of starting treatment, approximately 80% appear to do so within 3 months.  
Patients should be actively monitored for signs and symptoms of psychiatric disorders, particularly 
depression following the start of treatment. If depression is diagnosed during rimonabant therapy, 
rimonabant treatment must be stopped. The patient should be monitored and treated appropriately. 
 
Patients, especially those with a history of depressive disorders/mood alterations, (and relatives or 
other relevant persons) should be alerted about the need to monitor for the emergence of such 
symptoms and to seek medical advice immediately if these occur.  
 
• Other psychiatric conditions 
Therapy with rimonabant is not recommended in patients with uncontrolled psychiatric illness.  
If psychiatric illness is diagnosed during rimonabant therapy, treatment must be stopped.  
 
• Seizures 
Rimonabant has not been studied in patients being treated for epilepsy. In clinical trials no difference 
in the incidence of seizures was seen in patients receiving rimonabant or placebo. Rimonabant, 
however, should be used with caution in these patients, see also section 5.3. 
 
• Hepatic impairment 
Rimonabant is metabolised by the liver, thus caution is advised in patients with moderate hepatic 
impairment. The pharmacokinetics and safety of rimonabant have not been studied in patients with 
severe hepatic impairment; its use in these patients is not recommended. 
 
• Renal impairment 
There are limited data in patients with moderate renal impairment and no data in patients with severe 
renal impairment. Rimonabant should not be used in patients with severe renal impairment (see section 
4.2 and 5.2). 
 
• Elderly 
The efficacy and safety of rimonabant treatment in patients over 75 years of age has not sufficiently 
been established. Rimonabant should be used with caution in this population (see section 5.2). 
 

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• Race 
The clinical effect (weight loss) of rimonabant in Black patients was lower than in Caucasians. This 
could be caused by a higher rimonabant clearance than in Caucasians resulting in a lower exposure 
(see section 5.2). 
 
• Diabetic patients 
 
Due to the effect of rimonabant on the blood glucose level, when rimonabant is administered in 
diabetic patients, hypoglyceamia can occur (see section 4.8). Monitoring of blood glucose level is 
recommended in these patients. 
 
• Drug Interaction 
Rimonabant should be used with caution in combination with potent CYP3A4 inhibitors (e.g. 
ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)(see section 4.5). 
 
• Lactose 
Since ACOMPLIA tablets contain lactose, patients with rare hereditary problems of galactose 
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this 
medicine. 
 
Patients should be instructed not to increase their dose of ACOMPLIA. 
 
Patients who had a cardiovascular event (myocardial infarction, stroke, etc.) less than 6 months ago 
were excluded in the studies for rimonabant. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Rimonabant is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in 
vitro. Concomitant administration of CYP3A4 inhibitors will lead to increased exposure of 
rimonabant. Concomitant administration of CYP3A4 inducers is expected to reduce the exposure of 
rimonabant. 
 
Potential for other medicinal products to affect rimonabant:  
Concomitant administration of ketoconazole (a potent CYP3A4 inhibitor) increased rimonabant AUC 
by 104% (95% prediction interval: 40% - 197%). A similar increase in exposure is expected with other 
potent CYP3A4 inhibitors. Caution is advised during concomitant use of ACOMPLIA and potent 
CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, 
nefazodone). 
Although concomitant administration of CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, 
carbamazepine, St John’s wort) has not been studied, it is expected that concomitant administration of 
potent CYP3A4 inducers may reduce the plasma concentration of rimonabant and may result in loss of 
efficacy. 
 
Concomitant administration of orlistat, ethanol or lorazepam had no significant effect on the plasma 
levels of rimonabant.  
 
Potential for rimonabant to affect other medicinal products:  
The in vivo inhibitory effect on CYP2C8 has not been studied. However, in vitro, rimonabant had a 
mild inhibitory effect on CYP2C8. The potential for inhibition of CYP2C8 in vivo appears to be low. 
Rimonabant does not inhibit or induce other CYP enzymes or P-glycoprotein (P-gp) in vitro. This was 
confirmed clinically with specific probe studies using midazolam (CYP 3A4 substrate) and warfarin 
(CYP 2C9 substrate) and digoxin (a P-gp substrate). 
 
The steady-state pharmacokinetics of an ethinyl estradiol/levonorgestrel combination oral 
contraceptive were not significantly altered by concomitant administration of rimonabant. 
 

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4.6 Pregnancy and lactation 
 
There are no adequate or well-controlled studies in pregnant women. Animal data are inconclusive but 
suggest possible deleterious effects on embryonal/foetal development (see section 5.3). The potential 
risk for humans is unknown. Use in pregnancy is, therefore, not recommended. Patients should notify 
their physician if they become pregnant during treatment with ACOMPLIA. 
 
Rimonabant has been detected in the milk of lactating rats and rimonabant may inhibit the suckling 
reflex. It is not known if rimonabant is excreted in human milk. ACOMPLIA is contraindicated during 
breast-feeding (see section 4.3). 
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effects on the ability to drive and use machines have been performed.  
Cognitive investigations in clinical pharmacology studies demonstrated that rimonabant is devoid of 
any significant cognitive or sedative effect. 
 
4.8 Undesirable effects 
 
ACOMPLIA 20 mg has been evaluated for safety in approximately 2500 patients enrolled in studies 
that examined the metabolic and weight loss effects in overweight and obese patients and in 
approximately 3800 patients in other indications. In placebo-controlled studies, the discontinuation 
rate due to adverse reactions was 15.7% for patients receiving rimonabant. The most common adverse 
reactions resulting in discontinuation were: nausea, mood alteration with depressive symptoms, 
depressive disorders, anxiety and dizziness. 
 
Depressive disorders were reported in 3.2% of obese patients, or overweight patients with associated 
risk factor(s) treated with rimonabant 20 mg. These were usually mild or moderate in severity and 
resulted in recovery in all cases either after corrective treatment or discontinuation of rimonabant and 
did not exhibit any differentiating characteristics compared to cases reported in the control groups. 
 
The following table (table 1) shows all treatment-emergent adverse reactions from placebo-controlled 
studies in patients treated for weight loss and related metabolic disorders when these incidences were 
statistically significantly greater than the corresponding placebo rate (for events ≥ 1%) or considered 
clinically relevant (for events < 1%). 
 
Classification of expected frequencies of undesirable effects: 
Very common (≥10%); Common (≥1, <10%); Uncommon (≥0.1, <1%); Rare (≥0.01, <0.1%); Very 
rare (<0.01%), Not known (cannot be estimated from the available data). 
 

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Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
 
Table 1: 
System Organ 
Class 

Very common 
 
 

Common  
 

Uncommon  Rare  

Infections and 
infestations 

Upper respiratory 
tract infection 

Gastroenteritis 
 

  

Metabolism and 
nutrition disorders 

  Hypoglycaemia*  

Psychiatric 
disorders 

 Depressive 
disorders 
Mood alterations 
with depressive 
symptoms 
Anxiety 
Irritability 
Nervousness 
Sleep disorders 
Insomnia 
Parasomnias 

Panic symptoms 
Anger 
Dysphoria 
Emotional 
disorder 
Suicidal ideation 
Aggressiveness 
Aggressive 
behaviour 

Hallucinations 

Nervous system 
disorders 

 Memory loss 
Dizziness 
Hypoaesthesia 
Sciatica  
Paresthesia 

Lethargy 
Tremor 

 

Vascular disorders  Hot flush   
Respiratory, 
thoracic and 
mediastinal 
disorders 

  Hiccups  

Gastrointestinal 
disorders 

Nausea Diarrhoea 
Vomiting 

  

Skin and 
subcutaneous tissue 
disorders 

 Pruritus 
Hyperhidrosis  
 

Night sweats  

Musculoskeletal 
and 
connective 
tissue disorders 

 Tendonitis 
Muscle cramp 
Muscle spasms 

  

General disorders  Asthenia/fatigue 
Influenza 

  

Injury, Poisoning 
and procedural 
complications 

 Fall 
Contusion 
Joint sprain 

  

*frequency is based only on reports in obese or overweight diabetic patients. 
 
In clinical studies for other indications, the following additional adverse reactions were commonly 
reported: 
− infections and infestations: sinusitis 
− metabolism and nutrition disorders: anorexia, decreased appetite,  
− gastrointestinal disorders: stomach discomfort, dry mouth. 
 

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Post-Marketing 
In addition the following adverse reactions were reported during postmarketing (frequency not 
known): 
− Psychiatric disorder: psychotic disorders including hallucinations, delusion and paranoia. 
− Skin and subcutaneous tissue disorders: rash. 
− Nervous disorders: convulsions, disturbance in attention, headache. 
− gastrointestinal disorders: abdominal pain. 
 
Laboratory adverse events 
ACOMPLIA has not been shown to alter laboratory test values. 
 
4.9 Overdose 
 
Experience with rimonabant in overdosage is limited. In a single-dose tolerability study, doses up to 
300 mg were administered to a limited number of subjects with only minor symptoms reported. These 
included headache, euphoria, fatigue and insomnia. The pharmacokinetic profile demonstrates that a 
plateau in exposures is reached at 180 mg. There is no specific antidote for rimonabant; therefore, 
appropriate supportive measures should be initiated in case of overdose. Treatment should consist of 
the general measures employed in the management of overdoses, such as keeping airways 
unobstructed, monitoring cardiovascular function and general symptomatic and supportive measures. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmaco-therapeutic group: Anti obesity agent 
ATC code: A08AX01  
 
Rimonabant is a selective cannabinoid-1 receptor (CB1) antagonist that inhibits the pharmacological 
effects of cannabinoid agonists in vitro and in vivo. 
The endocannabinoid system is a physiological system present in brain and peripheral tissues 
(including adipocytes) that affects energy balance, glucose and lipid metabolism and body weight, and 
in neurons of the mesolimbic system modulates the intake of highly palatable, sweet or fatty foods. 
 
Clinical study results 
 
Weight Management 
 
In total more than 6800 patients were included in the Phase 2 and Phase 3 clinical studies. The patients 
included in the phase 3 trials followed a restrictive diet during the trial prescribed by a dietician and 
they were advised to increase their physical activity. Patients had a BMI ≥ 30 kg/m² or BMI 
> 27 kg/m² with hypertension and/or dyslipidemia at inclusion. Approximately 80% of the population 
were women, 87% Caucasian and 9% Black. Experience in patients over 75 years and 
Orientals/Asians was limited. 
 
Significant mean weight reductions from baseline to one year for ACOMPLIA 20 mg versus placebo 
were demonstrated in three studies conducted in non-diabetic patients. A mean weight loss of 6.5 kg 
from baseline to one year was shown for ACOMPLIA 20 mg versus a mean weight loss of 1.6 kg for 
placebo (Difference -4.9 kg CI95% -5.3;-4.4, p< 0.001).  
The percentage of patients who lost 5% and 10% of their baseline body weight after 1 year of 
treatment are given in table 2: 
 

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Table 2: 
 Non-diabetic studies Diabetic study 

 Placebo  
ACOMPLIA  
20 mg 

Placebo 
 

ACOMPLIA 
20 mg 

nITT 1254 2164 348 339 
 

Weight at baseline 
(kg)  

101 101 96 95 
 

Subjects with a 5% 
weight reduction  

19.7% 50.8% 14.5% 49.4% 

     
Difference (CI 95%) 31.1% (28%; 34%) 34.9% (28%; 41%) 

 
Subjects with a 10% 
weight reduction  

7.8% 27.0% 2.0% 16.2% 

Difference (CI 95%) 19.2%  (17%; 22%) 14.2%  (10%; 19%) 
 

 
Most of the observed weight reduction was obtained within the first nine months of treatment. 
ACOMPLIA 20 mg was effective in maintaining weight loss up to two years. Weight loss at two years 
was 5.1 kg for patients who received ACOMPLIA 20 mg and 1.2 kg for placebo (Difference -3.8 kg; 
CI95% -4.4, -3.3; p< 0.001). 
 
Rimonabant 20 mg reduced the risk of weight regain. Patients who received ACOMPLIA 20 mg for 
one year were re-randomized to ACOMPLIA 20 mg or placebo. At two years, patients continuing on 
rimonabant had  a mean  total weight loss of 7.5 kg over 2 years whereas patients re-randomized to 
placebo group during the second year had a mean total weight loss of 3.1 kg over 2 years. At two 
years, the difference in total weight loss between ACOMPLIA and placebo was -4.2 kg (CI95% -5.0;-
3.4, p< 0.001). 
 
Treatment with rimonabant was associated with significant reductions in waist circumference, a 
known marker of intra-abdominal fat. 
 
The effects on body weight appeared to be consistent among men and women. In the limited number 
of Black patients weight loss was less pronounced (mean difference to placebo -2.9 kg). No 
conclusions can be drawn with regard to effects in patients over 75 years or in Asian/Oriental patients 
due to the low number of patients. 
 
Weight management and additional risk factors 
In the non-diabetic studies including a mixed population of subjects with/without (treated) 
dyslipidemia, an increase in HDL-C and decrease in triglycerides (at one year) was observed. For 
HDL-C an average increase of 16.4% was seen under rimonabant 20 mg (baseline HDL-C 
1.24 mmol/l) compared to an increase of 8.9% for placebo (baseline HDL-C 1.21 mmol/l). The 
difference was statistically significant (Difference 7.9% CI95% 6.6%; 9.2%, p< 0.001). For the 
triglycerides an average decrease of 6.9% was seen under rimonabant 20 mg (baseline TG 
1.62 mmol/l) compared to an increase of 5.8% for placebo (baseline TG 1.65 mmol/l). The difference 
was statistically significant (Difference -13.3% CI95% -16.5; -10.2% p< 0.001). It is estimated that 
approximately half of the observed improvement in HDL-C and triglycerides in patients who received 
rimonabant 20 mg was beyond that expected from weight loss alone. 
Generally ACOMPLIA 20 mg had no significant effect on Total-C or LDL-C levels. 
 
In the trial in type 2 diabetic patients (RIO-Diabetes) who were overweight or obese treated with 
metformin or sulfonylurea improvements in HbA1c and body weight were observed. The absolute 
change in HbA1c at one year was -0.6 for rimonabant 20 mg (baseline 7.3%) and +0.1 on placebo 
(baseline 7.2%). Differences were statistically significant (Difference -0.7%, CI95% -0.80;-0.5, 
p<0.001).  

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At one year a mean weight loss of 5.3 kg was shown for ACOMPLIA 20 mg versus a loss on placebo 
of 1.4 kg (Difference –3.9 kg CI95% -4.6;-3.3 p<0.001). The percentage of patients who lost 5% and 
10% of their baseline body weight after 1 year of treatment are given in the table 2. 
In a second trial in treatment naïve type 2 diabetic obese patients (Serenade), the absolute change in 
HbA1c (with a baseline of 7.9% for both groups) at six months was -0.8 for rimonabant 20 mg and      
-0.3 under placebo (Difference -0.51 CI95% -0.78, -0.24 p< 0.001). The percentage of patients reaching 
HbA1c < 7% was 51% in the rimonabant group and 35% in the placebo group. The difference in mean 
body weight change between the 20 mg and placebo groups was 3.8 kg (CI95% -5.0, -2.6 p< 0.001). 
Changes in HDL-C and TG in this population were similar to that of the non-diabetic population. It is 
estimated that approximately half of the mean improvement in HbA1c in patients receiving 
rimonabant 20 mg was beyond that expected from weight loss alone. 
 
5.2 Pharmacokinetic properties 
 
Rimonabant pharmacokinetics are fairly dose proportional up to about 20 mg. AUC increased less than 
in proportion to dose above 20 mg. 
 
Absorption: 
Rimonabant displays high in vitro permeability and is not a substrate of P-glycoprotein. The absolute 
bioavailability of rimonabant has not been determined. Following multiple once-daily doses of 20 mg 
to healthy subjects in the fasted state, maximum plasma concentrations of rimonabant are achieved in 
approximately 2 hours with steady state plasma levels achieved within 13 days (Cmax = 196 ± 
28.1 ng/ml; Ctrough = 91.6 ± 14.1 ng/ml; AUC0-24 = 2960 ± 268 ng.h/ml). Steady state rimonabant 
exposures are 3.3-fold higher than those observed after the first dose. Population pharmacokinetic 
analysis demonstrated less fluctuation in peak to trough plasma concentration but no differences in 
steady state AUC as weight increases. As weight increases from 65 to 200 kg, Cmax is expected to 
decrease 24% and Ctrough is expected to increase by 5%. Time to steady state is longer in obese patients 
(25 days) as a consequence of the higher volume of distribution in these patients. Population 
pharmacokinetic analysis indicated that rimonabant pharmacokinetics are similar between healthy 
non-smoking subjects and patients who smoke. 
 
Effect of food: 
Administration of rimonabant to healthy subjects in the fasted state or with a high fat meal 
demonstrated that Cmax and AUC were increased 67% and 48% respectively, under fed conditions. In 
clinical studies, ACOMPLIA 20 mg was taken in the morning usually before breakfast.  
 
Distribution: 
The in vitro human plasma protein binding of rimonabant is high (> 99.9%) and non-saturable over a 
wide concentration range. The apparent peripheral volume of distribution of rimonabant appears to be 
related to body weight, with obese patients having a higher volume of distribution than normal-weight 
subjects. 
 
Biotransformation: 
Rimonabant is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in 
vitro. Circulating metabolites do not contribute to its pharmacologic activity. 
 
Elimination: 
Rimonabant is mainly eliminated by metabolism and subsequent biliary excretion of metabolites. Only 
an approximate 3% of the dose of rimonabant is eliminated in the urine, while approximately 86% of 
the dose is excreted in the faeces as unchanged drug and metabolites. In obese patients, the elimination 
half-life is longer (about 16 days) than in non-obese patients (about 9 days) due to a larger volume of 
distribution. 
 

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Special Populations 
Race: 
In single- and repeat-dose studies, the Cmax and AUC of rimonabant were similar in healthy Japanese 
and Caucasian subjects, whereas elimination half-life was shorter in Japanese subjects (3-4 days) 
compared to Caucasian subjects (about 9 days). The difference in half-life was due to differences in 
peripheral volume of distribution as a consequence of lower weight in Japanese subjects. 
Black patients may have up to a 31% lower Cmax and a 43% lower AUC than patients of other races.  
 
Gender: 
The pharmacokinetics of rimonabant are similar in female and male patients.  
 
Elderly: 
Elderly patients have slightly higher exposure than young patients. Based on a population 
pharmacokinetic analysis (age range 18 - 81 years) a 75 year old patient is estimated to have a 21% 
higher Cmax and a 27% higher AUC than a 40 year old patient. 
 
Patients with hepatic insufficiency: 
Mild hepatic impairment does not alter rimonabant exposure. Data are insufficient to draw conclusions 
regarding pharmacokinetics in moderate hepatic impairment. Patients with severe hepatic impairment 
were not evaluated. 
 
Patients with renal impairment: 
The effect of renal function on the pharmacokinetics of rimonabant has not been studied specifically. 
Based on data from population pharmacokinetic studies, mild renal impairment do not seem to affect 
the pharmacokinetics of rimonabant. Limited data suggest an increased exposure in patients with 
moderate renal impairment (40% increase in AUC). There are no data in severe renal impairment. 
 
5.3 Preclinical safety data 
 
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to 
clinical exposure levels and with possible relevance to clinical use were as follows: 
Convulsions were observed sporadically in studies in rodents and macaques. No convulsions were 
observed in dogs during a 3 month study. In some, but not all cases, initiation of convulsions appeared 
to be associated with procedural stress such as handling of the animals. A proconvulsant activity of 
rimonabant was found in one of two safety pharmacology studies. No adverse effect of rimonabant 
treatment was observed on EEG patterns in rats. 
 
Increased incidence and/or severity of clinical signs suggestive of increased tactile hyperesthesia were 
observed in rodent studies. A direct effect of rimonabant cannot be ruled out. 
 
Liver steatosis and a dose-related increase in centrilobular necrosis were observed in long-term studies 
in the rat. A direct effect of rimonabant cannot be ruled out. 
 
In standard fertility studies in female rats (dosing for 2 weeks prior to mating) there was abnormal 
oestrous cyclicity and a decrease in corpora lutea and fertility index at doses of rimonabant that 
induced maternal toxicity (30 and 60 mg/kg/day). Following dosing for a longer treatment duration 
prior to mating (9 weeks) that permitted recovery from the initial effects of rimonabant, no adverse 
effects were seen on fertility or oestrous cyclicity. Regarding reproductive parameters, at 30 mg/kg no 
differences were observed between treated animals and controls, at 60 mg/kg effects were still 
observed (decreased number of corpora lutea, implantations, total and viable fetuses). 
 
Sporadic malformations (anencephaly, micro-ophthalmia, widened brain ventricles and omphalocele) 
were observed in the rabbit embryofetal toxicity studies at doses resulting in exposures comparable 
with the clinical exposures. Although maternal toxicity was observed at these doses, a relation to 
treatment cannot be excluded. No treatment-related malformations were seen in the rat. 
 

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Effects of rimonabant on pre- and post-natal development were assessed in the rat at doses up to 
10 mg/kg/day. There was a treatment related increase in pup mortality in the pre-weaning period. The 
increased pup mortality might be attributable to a failure of the dam to nurse or ingestion of 
rimonabant in milk and/or inhibition of the suckling reflex that is reported in the literature to be 
initiated in neonatal mice by endocannabinoid signalling via CB1 receptors. There are reports in the 
literature that, in both rodents and humans, the spatial distribution and density of CB1 receptors in the 
brain changes during development. The potential relevance of this to administration of a CB1 
antagonist is unknown. In the pre- and post-natal development study in rats, exposure to rimonabant in 
utero and via lactation produced no alterations on learning or memory, but equivocal effects on motor 
activity and auditory startle response were observed in the pups as a result of rimonabant exposure. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core:  
maize starch,  
lactose monohydrate,  
povidone K 30 (E1201),  
croscarmellose sodium (E468),  
sodium laurilsulfate (E487),  
microcrystalline cellulose (E460),  
magnesium stearate 
 
Tablet coating:  
lactose monohydrate,  
hypromellose 15 mPa.s (E464),  
titanium dioxide (E171),  
macrogol 3000 
 
Tablet polishing:  
carnauba wax (E903) 
 
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 storage conditions.  
 
6.5 Nature and contents of container 
 
PVC-aluminium blister packs containing 14, 28, 30, 56, 84, 90 and 98 film-coated tablets. 
70 x 1 film-coated tablets in PVC-aluminium perforated unit dose blister packs. 
Opaque white HDPE bottles containing 28, 98 and 500 film-coated tablets. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements 
 

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7. MARKETING AUTHORIZATION HOLDER
 
sanofi-aventis. 
174 Avenue de France 
F-75013 Paris  
France 
 
8. MARKETING AUTHORIZATION NUMBER 
 
EU/1/06/344/001-011 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 
19 June 2006 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this product is available on the website of the European Medicines Agency 
(EMEA) http://www.emea.europa.eu. 

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http://www.emea.europa.eu/


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ANNEX II 
 

A. MANUFACTURING AUTHORISATION HOLDERS 
RESPONSIBLE FOR BATCH RELEASE 

 
B. CONDITIONS OF THE MARKETING AUTHORISATION 

 

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A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH 
RELEASE 

 
 
Name and address of the manufacturers responsible for batch release
 
Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, France 
 
sanofi-aventis S.p.A., Strada Statale 17, Km 22 , 67019 Scoppito (AQ), Italy 
 
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 OF THE MARKETING AUTHORISATION 
 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 

THE MARKETING AUTHORISATION HOLDER 
 
Medicinal product subject to medical prescription. 
 
 
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable. 
 
 
• OTHER CONDITIONS 
 
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the 
product is placed on the market. 
 
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in 
the Pharmacovigilance Plan. 
 
An updated risk management plan should be provided as per the CHMP guideline on risk management 
systems for medicinal products for human use. 

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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 

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A. LABELLING 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
Carton for the presentations of 14, 28, 30 56, 70, 84, 90 and 98 film-coated tablets in blisters 

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ACOMPLIA 20 mg film-coated tablets  
rimonabant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg of rimonabant. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
56 film-coated tablets 
70x1 film coated-tablets 
84 film-coated tablets 
90 film-coated tablets 
98 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 

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8. EXPIRY DATE 
 
EXP {MM/YYYY} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
 
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 
 
sanofi-aventis 
174 avenue de France 
F-75013 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/06/344/001  
EU/1/06/344/002  
EU/1/06/344/003  
EU/1/06/344/004  
EU/1/06/344/005  
EU/1/06/344/006  
EU/1/06/344/010 
EU/1/06/344/011 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
ACOMPLIA 

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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blisters of the presentations of 14, 28, 56, 84 and 98 film-coated tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ACOMPLIA 20 mg film-coated tablets  
rimonabant 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis 
 
 
3. EXPIRY DATE 
 
EXP {MM/YYYY} 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Monday 
Tuesday 
Wednesday 
Thursday 
Friday 
Saturday 
Sunday 
 
 

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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blisters of the presentations of 30, 70 x 1 and 90 film-coated tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ACOMPLIA 20 mg film-coated tablets  
rimonabant 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis 
 
 
3. EXPIRY DATE 
 
EXP {MM/YYYY} 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE 
PACKAGING 
 
Carton of the presentations of 28, 98 and 500 film-coated tablets in HDPE bottles / HDPE bottle 
label for the presentations of 28, 98 and 500 film-coated tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ACOMPLIA 20 mg film-coated tablets  
rimonabant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg of rimonabant. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains lactose monohydrate. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 film-coated tablets 
98 film-coated tablets 
500 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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

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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 
 
sanofi-aventis 
174 avenue de France 
F-75013 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/06/344/007  
EU/1/06/344/008  
EU/1/06/344/009  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
ACOMPLIA 
 

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B. PACKAGE LEAFLET 

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PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

ACOMPLIA 20 mg film-coated tablets 
(rimonabant) 

 
Read all of this leaflet carefully before you start taking this medicine. 
- 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. Do not pass it on to others. It may harm them, even if 

their symptoms are the same as yours. 
- If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please 

tell your doctor or pharmacist. 
- You are advised to share the information in this leaflet with relatives or other relevant persons. 
 
In this leaflet:  
 
1. What ACOMPLIA is and what it is used for 
2. Before you take ACOMPLIA 
3. How to take ACOMPLIA 
4. Possible side effects 
5 How to store ACOMPLIA 
6. Further information 
 
 
1. WHAT ACOMPLIA IS AND WHAT IT IS USED FOR 
 
The active ingredient of ACOMPLIA is rimonabant. It works by blocking specific receptors in the 
brain and fat tissues called CB1 receptors. ACOMPLIA is indicated in the treatment of obese or 
overweight patients with additional risk factors such as diabetes or high levels of fatty substances in 
the blood called lipids (dyslipidaemia; mainly cholesterol and triglycerides) as adjunct to diet and 
exercise. 
 
 
2. BEFORE YOU TAKE ACOMPLIA 
 
Do not take ACOMPLIA 
− if you currently suffer from depression 
− if you are currently being treated for depression 
− if you are allergic (hypersensitive) to rimonabant, or any of the other ingredients of ACOMPLIA 
− if you are breast-feeding 
. 
Take special care with ACOMPLIA 
Tell your doctor before you start to take this medicine 
− if you have previously suffered from depression or have had suicidal thoughts 
− if you have impaired liver function 
− if you have severely impaired renal function 
− if you have diabetes (see section 4) 
− if you are currently being treated for epilepsy 
− if you are less than 18 years of age. There is no information available on the use of ACOMPLIA 

in people under 18 years of age.  
 
Serious psychiatric events including depression or mood changes have been reported in patients taking 
ACOMPLIA (see section POSSIBLE SIDE EFFECTS).  
 
If you experience symptoms of depression (see below) during treatment with ACOMPLIA you should 
contact your doctor and stop the treatment. 

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Signs and symptoms associated with depression could be: 
Sadness, depressed mood; loss of interest in previously pleasurable activities; agitation; irritability; 
slowed, inhibited actions; poor concentration; anxiety; difficulty in sleeping (insomnia); thoughts or 
words about death or suicide. 
You should inform your doctor if any of the symptoms listed above develop or worsen after treatment 
has begun. 
 
Taking other medicines 
The activity of ACOMPLIA is increased by simultaneous use of some drugs (so-called CYP3A4 
inhibitors) such as: 
− itraconazole (antifungal medicine) 
− ketoconazole (antifungal medicine) 
− ritonavir (medicine for the treatment of HIV infections) 
− telithromycin (antibiotic) 
− clarithromycin (antibiotic) 
− nefazodone (anti-depressor) 
Please inform your doctor or pharmacist if you are taking or have recently taken the above mentioned 
medicines or any other medicines, including those obtained without a prescription such as St John’s 
wort, rifampicin (antibiotic), medicines for weight loss, medicines to improve blood lipids (fats), 
antidiabetes medicines and medicines to treat epilepsy (e.g. phenytoin, phenobarbital, carbamazepine) 
or depression. 
 
Pregnancy and breast-feeding 
ACOMPLIA should not be taken during pregnancy. 
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning 
to become pregnant while taking ACOMPLIA.  
 
Do not take this medicine when breast-feeding. Tell your doctor if you are breast-feeding or if you are 
planning to breast-feed your baby.  
 
Driving and using machines 
At the recommended dose, ACOMPLIA is not expected to reduce your ability to drive and use 
machines. 
 
Important information about some of the ingredients of ACOMPLIA 
ACOMPLIA tablets include lactose. If you are intolerant to some sugars, contact your doctor before 
taking this medicine. 
 
 
3. HOW TO TAKE ACOMPLIA 
 
Always take ACOMPLIA exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are not sure. The usual dose is one 20 mg tablet to be taken once daily in the 
morning before breakfast. Swallow the tablet whole.  
 
You need to start and continue a reduced calorie diet and a physical activity program to get best 
results. Your doctor should recommend the type of diet and the level of physical activity required, that 
suits your specific condition and overall health. 
 
Taking ACOMPLIA with food and drink 
ACOMPLIA should be taken once daily in the morning before breakfast. 
 
If you take more ACOMPLIA than you should 
If you take more ACOMPLIA than you should tell a doctor or pharmacist. 
 

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If you forget to take ACOMPLIA 
Take it as soon as you remember but do not take a double dose to make up for any forgotten dose.  
 
If you have any further questions on the use of this product ask your doctor or your pharmacist. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, ACOMPLIA can cause side effects, although not everybody gets them 
Very common side effects, that affect more than 1 per 10, that have occurred in patients on 
ACOMPLIA include: 
nausea and upper respiratory tract infection. 
 
Common side effects, that affect more than 1 per 100 but less than1 per 10, that have occurred in 
patients on ACOMPLIA include: 
upset stomach, vomiting, trouble with sleeping, nervousness, depression, irritability, dizziness, 
diarrhoea, anxiety, itching, excessive sweating, muscle cramps or spasm, fatigue, bruising, tendon pain 
and inflammation (tendonitis), memory loss, back pain (sciatica), altered sensitivity (less sensitivity or 
abnormal burning or prickling sensation) of the hands and feet, hot flush, fall, influenza, and joint 
sprain. 
 
Uncommon side effects, that affect less than 1 per 100 but more than1 per 1000, that have occurred in 
patients on ACOMPLIA include: 
Sleepiness (lethargy), tremor, night sweats, panic symptoms, hiccups, anger, restlessness (dysphoria), 
emotional disorder, suicidal thoughts, aggressiveness or aggressive behaviour, hypoglycaemia (low 
blood sugar). 
 
Rare side effects, that affect less than 1 per 1000, that have occurred in patients on ACOMPLIA 
include: hallucinations. 
 
During post-marketing experience the following side effects have also been reported (frequency not 
known): 
Convulsion, disturbance in attention, delusion (false belief), paranoia, rash, headache and stomach 
pain. 
 
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 
tell your doctor or pharmacist. 
 
 
5. HOW TO STORE ACOMPLIA 
 
Keep out of the reach and sight of children. 
 
Do not use ACOMPLIA after the expiry date which is stated on the outer packaging after EXP. The 
expiry date refers to the last day of that month. 
 
This medicinal product does not require any special storage conditions  
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 

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6. FURTHER INFORMATION 
 
What ACOMPLIA contains 
The active substance is rimonabant. One film-coated tablet contains 20 mg rimonabant. 
The other ingredients are:  
Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium 
(E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate 
Tablet coating: lactose monohydrate, hypromellose 15 mPa.s (E464), titanium dioxide (E171), 
macrogol 3000 
Tablet polishing: carnauba wax (E903) 
 
What ACOMPLIA looks like and contents of the pack 
ACOMPLIA 20 mg is supplied as teardrop-shaped, white film-coated tablets debossed with “20”on 
one side. 
 
ACOMPLIA is available in blister packs of 14, 28, 30, 56, 84, 90 and 98 tablets, in perforated unit 
dose blister packs containing 70 x 1 tablets, and in white plastic bottles containing 28, 98 and 500 
tablets.  
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
sanofi-aventis 
174, avenue de France 
F-75013 Paris 
France 
 
 
Manufacturers 
Sanofi Winthrop Industrie 
30-36, avenue Gustave Eiffel – BP 27166 
F-37071 Tours Cedex 2 
France 
 
sanofi-aventis S.p.A. 
Strada Statale 17, Km 22 
67019 Scoppito (AQ) 
Italy 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder:  
 

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België/ Belgique/ Belgien 
sanofi-aventis Belgium 
Tél/Tel: +32 (0)2 710 54 00 
 

Luxembourg/Luxemburg 
sanofi-aventis Belgium  
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) 
 

България 
sanofi-aventis Bulgaria EOOD 
Тел.: +359 (0)2 970 53 00 
 

Magyarország 
sanofi-aventis zrt., Magyarország 
Tel.: +36 1 505 0050 
 

Česká republika 
sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Malta 
sanofi-aventis Malta Ltd. 
Tel: +356 21493022 
 

Danmark 
sanofi-aventis Denmark A/S 
Tlf: +45 45 16 70 00 
 

Nederland 
sanofi-aventis Netherlands B.V. 
Tel: +31 (0)182 557 755 
 

Deutschland 
Sanofi-Aventis Deutschland GmbH 
Tel: +49 (0)180 2 222010 
 

Norge 
sanofi-aventis Norge AS 
Tlf: +47 67 10 71 00 
 

Eesti 
sanofi-aventis Estonia OÜ 
Tel: +372 627 34 88 
 

Österreich 
sanofi-aventis GmbH 
Tel: +43 1 80 185 – 0 
 

Ελλάδα 
sanofi-aventis AEBE 
Τηλ: +30 210 900 16 00 
 

Polska 
sanofi-aventis Sp. z o.o. 
Tel.: +48 22 541 46 00 
 

España 
sanofi-aventis, S.A. 
Tel: +34 93 485 94 00 
 

Portugal 
sanofi-aventis - Produtos Farmacêuticos, S.A. 
Tel: +351 21 35 89 400 
 

France 
sanofi-aventis France 
Tél: 0 800 222 555 
Appel depuis l’étranger : +33 1 57 63 23 23 
 

România 
sanofi-aventis România S.R.L. 
Tel: +40 (0) 21 317 31 36 
 

Ireland 
sanofi-aventis Ireland Ltd. 
Tel: +353 (0) 1 403 56 00 
 

Slovenija 
sanofi-aventis d.o.o. 
Tel: +386 1 560 48 00 
 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
sanofi-aventis Pharma Slovakia s.r.o. 
Tel: +421 2 57 103 777 
 

Italia 
sanofi-aventis S.p.A. 
Tel: +39 02 393 91 
 

Suomi/Finland 
sanofi-aventis Oy 
Puh/Tel: +358 (0) 201 200 300 
 

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 
 

Sverige 
sanofi-aventis AB 
Tel: +46 (0)8 634 50 00 
 

Latvija 
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 
 

United Kingdom 
sanofi-aventis 
Tel: +44 (0) 1483 505 515 
 

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Lietuva 
UAB sanofi-aventis Lietuva 
Tel: +370 5 2755224 
 

 

 
 
This leaflet was last approved in  
 
 
 
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web 
site: http://www.emea.europa.eu.  

29 

http://www.emea.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
	CONDITIONS OF THE MARKETING AUTHORISATION
	LABELLING
	PACKAGE LEAFLET