Meridia 15 mg is indicated for the treatment of obesity. It should be used in conjunction with a reduced energy diet and increased physical activity, as part of a comprehensive weight loss programme, when regimen measures alone (i.e. diet and physical activity modification) have been insufficiently effective.
Treatment should be part of the weight reduction programme.
Active pharmaceutical ingredient
Sibutramine hydrochloridum monohydricum 15 mg in 1 capsule.
Lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, dimethicone, shellac, soya lecithin, indigo carmine, titanium dioxide, gelatin, sodium lauryl sulphate, black iron oxide, quinoline yellow (Meridia 15 mg).
Centrally acting preparation for the treatment of obesity.
Characteristics of the drug:
Sibutramine, the active substance of Meridia, belongs to the group of preparations for the treatment of obesity that increase the feeling of satiety and at the same time increase the energy expenditure of the body. This helps, along with diet and exercise, to reduce the patient’s body weight.
Use of the drug:
Meridia is indicated for the treatment of obesity. It should be used in conjunction with a reduced-energy diet and increased physical activity as part of a comprehensive weight reduction programme when dietary measures alone (i.e. diet and physical activity modification) have been insufficiently effective.
The product should not be used in:
– Hypersensitivity to sibutramine or any other component of the product;
– serious eating disorders (anorexia or bulimia);
– obesity due to causes other than overeating (organic causes);
– certain mental or nervous disorders (Gilles de la Tourette syndrome, manic episode cannot be excluded in patients with bipolar affective disorder);
– concomitant use (or use in the past 2 weeks) of drugs to treat depression (MAO inhibitors) or other centrally acting drugs to treat mental illness (antidepressants, antipsychotics), drugs to treat sleep disorders (tryptophan) or weight loss drugs;
– cardiovascular disease (ischaemic heart disease, congestive heart failure, rapid heart rate, irregular heart rhythm, occlusion of the arteries of the extremities), stroke or transient cerebrovascular accident, inadequately controlled high blood pressure (> 145/90 mm Hg);
– increased thyroid activity (hyperthyroidism);
– severe hepatic impairment;
– severe renal impairment;
– prostate enlargement with urinary retention;
– tumour of the adrenal medulla (pheochromocytoma);
– glaucoma (glaucoma);
– drug, medicine or alcohol addiction;
– pregnancy and breastfeeding.
Due to lack of experience, the product should not be administered to children, adolescents and patients over 65 years of age.
Only for particularly serious reasons should patients with epilepsy, patients with mild to moderate liver or kidney damage, and patients who have congenital motor tics (spontaneous muscle twitching) or verbal tics (speech slurring) take the medicine.
Only for particularly serious reasons should patients take sibutramine at the same time as medicines that can cause changes in heart rate (changes on an ECG). These include some medicines to treat hypersensitivity (astemizole, terfenadine), medicines to treat heart rhythm disorders (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol), products for the treatment of digestive disorders (cisapride), products for the treatment of certain mental disorders (pimozide, sertindole and tricyclic antidepressants) and products that may affect potassium and magnesium levels in the blood.
Side effects of the medicine:
Side effects occur mainly at the beginning of treatment (during the first 4 weeks). They decrease in severity and frequency over time. They are generally not severe and do not lead to discontinuation of treatment.
Adverse reactions are listed in the table according to frequency of occurrence (very common > 1/10, common <= 1/10 and > 1/100):
|Body system||Occurrence||Side effects|
|heart and blood vessels||frequent||tachycardia (rapid heart rate)|
|palpitations (heart palpitations)|
|hypertension (increase in blood pressure)|
|vasodilation (flushing of the face, neck with hot flashes)|
|digestive system||very common||constipation|
|frequent||feeling like vomiting|
|aggravation of hemorrhoids|
|central nervous system||very common||dry mouth, insomnia|
|paresthesia (tingling in the limbs, tingling), headache|
|sensory functions||frequent||change of taste|
In addition, the following side effects may occur after taking Meridia: blurred vision, diarrhea and vomiting, hypersensitivity symptoms ranging from mild skin rashes and hives to swelling in the larynx, pharynx or tongue (angioedema) and shock, mood changes (depression), agitation, epileptic seizures, transient short-term memory impairment, serotonin syndrome (see Interactions section), hair loss, kidney disease, urinary retention, sexual and menstrual disturbances, transient rise in liver enzymes and decrease in platelets.
Headaches and increased appetite have very rarely been observed after omission of the drug.
Although treatment with sibutramine has not been associated with the occurrence of a rise in pulmonary blood pressure, immediate medical attention should be sought if there is a feeling of shortness of breath, chest pain, and rotation of the extremities.
Consult a physician immediately if any side effects or other unusual reactions occur.
Interactions with other drugs:
The effects of Meridia and the effects of other medicines taken at the same time may interact with each other. Your doctor should be informed of all medications you are currently taking or will begin taking, both prescription and over-the-counter. Consult your doctor before taking any other medicine, even over-the-counter, at the same time as Meridia and do not take it without consulting your doctor.
Slowing down the breakdown of sibutramine in the body and its excretion, and thus increasing its effect and side effects, may occur with concomitant administration of a medicine for the treatment of fungal diseases (ketoconazole, itraconazole), medicines for the treatment of infections (erythromycin, clarithromycin, troleandomycin) and a medicine used, for example, in organ transplants to suppress immune reactions (cyclosporine).
Accelerated excretion of sibutramine, and hence a reduction in its effect, may occur with concomitant administration of a medicine for the treatment of tuberculosis (rifampicin), a medicine for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital) and a medicine for the treatment of inflammatory reactions (dexamethasone).
Serious interactions may be caused by the concomitant administration of sibutramine and medicines that increase the level of serotonin in the blood (substances that occur naturally in the body and are involved in the functioning of the nervous system). This phenomenon is called serotonin syndrome (manifested by tremors, rising blood pressure, increased heart rate, confusion and unconsciousness). Rarely, it may occur in association with the co-administration of selective serotonin reuptake inhibitors (SSRIs – substances that increase the concentration of serotonin in the blood) together with anti-migraine drugs (such as sumatriptan, dihydroergotamine) or in association with opiates (strong pain medications – pentazocine, pethidine, fentanyl, dextromethorphan).
The concomitant use of Medria with drugs that may increase blood pressure or heart rate (e.g. sympathomimetics) has not been systematically evaluated. Medications of this type include some cough, cold and allergy medicines (e.g. ephedrine, pseudoephedrine) and some decongestants (e.g. xylometazoline). Patients taking these medications should be given Meridia only with caution.
Meridia does not affect the effect of oral contraceptives.
Alcohol consumption is not compatible with the recommended dietary precautions. However, it has been shown that a single administration of sibutramine together with alcohol has not yet resulted in further effects on reactivity.
Guidance for pregnant and lactating women
Women of childbearing potential should be protected by effective contraception while being treated with Meridia.
Treatment should be part of a weight reduction regimen . The prescribed dosage should be carefully followed to achieve the correct effect of the product.
Adults: the initial dose is 1 capsule of Meridia 15 mg once a day.
In case you forget to take the medicine, continue the next day with the normal dose, never take two capsules at the same time.
Duration of treatment :
Patients whose weight loss was less than 5% of their original weight 3 months after starting treatment will have their treatment stopped by their doctor.
Patients who, after initial weight loss, have gained more than 3 kg during subsequent treatment will also have their treatment discontinued by the physician.
Treatment is long-term, but as there are no data on the safety and efficacy of the product when given for more than one year, treatment should not exceed this period.
Patients should be informed of the need for lifestyle changes as part of sibutramine treatment and the need to adhere to these changes to maintain reduced weight in the long term. If the patient stops adhering to the lifestyle changes, they may regain weight. Even after discontinuation of Meridia, the patient should continue to follow good lifestyle principles.
How to use the drug:
The product is administered in the morning with or without food, the capsule is swallowed whole and washed down with a sufficient amount of liquid (e.g. a glass of water).
There is very little experience with sibutramine overdose. There are no known symptoms of overdose, but there may be an increased incidence of side effects. Consult a physician in the event of an overdose or accidental ingestion by a child.
Blood pressure must be checked very carefully in patients with symptoms of sleep apnoea (brief stoppages of breathing in sleep).
Meridia may reduce the ability to drive, operate machinery, or work in hazardous conditions.
Storing the medicine
Store the product at a temperature below 25 °C. C in the original inner container to protect it from moisture in the air.
The product must not be used after the expiry date stated on the packaging.
Keep the product out of the reach and sight of children.
Package contains 30 tablets