Sibutramine-40mg
Sibutramine - 40 mg
Sibutramine 40mg is indicated for the treatment of obesity. It should be used in conjunction with a reduced-calorie diet and increased physical activity as part of a comprehensive weight-loss program if lifestyle measures alone (i.e., dietary and physical activity changes) have been insufficiently effective.
Treatment should be part of a weight loss program.
Indications
A centrally acting agent for the treatment of obesity.
Characteristics of the drug:
Sibutramine, the active ingredient in Sibutramine 40 mg, belongs to a group of medications for the treatment of obesity that increase the feeling of satiety while simultaneously increasing the body’s energy expenditure. In this way, together with diet and exercise, they help reduce the patient’s body weight.
Use of the medication:
This product is intended for the treatment of obesity. It should be used in conjunction with a reduced-calorie diet and increased physical activity as part of a comprehensive weight-loss program if lifestyle measures alone (i.e., dietary changes and physical activity) have been insufficiently effective.
Contraindications:
The product must not be used in cases of:
- hypersensitivity to sibutramine or any other component of the product;
- serious eating disorders (anorexia or bulimia);
- obesity caused by factors other than overeating (organic causes);
- certain mental or neurological disorders (Gilles de la Tourette syndrome; a manic episode cannot be ruled out in patients with bipolar affective disorder);
- concurrent use (or use within the past 2 weeks) of medications for treating depression (MAO inhibitors) or other centrally acting medications for treating mental disorders (antidepressants, antipsychotics), medications for treating sleep disorders (tryptophan), or weight-loss medications;
- heart and vascular diseases (ischemic heart disease, congestive heart failure, rapid heart rate, irregular heart rhythm, peripheral arterial occlusion), stroke or transient ischemic attack, poorly controlled high blood pressure (>
145/90 mm Hg);- overactive thyroid (hyperthyroidism);
- severe liver dysfunction;
- severe kidney dysfunction;
- enlarged prostate with urinary retention;
- adrenal medullary tumor (pheochromocytoma);
- glaucoma;
- drug, medication, or alcohol dependence;
- pregnancy and breastfeeding.
Due to a lack of experience, the product must not be administered to children, adolescents, or patients over 65 years of age.
Patients with epilepsy, patients with mild to moderate liver or kidney impairment, and patients with a congenital motor tic (involuntary muscle twitching) or verbal tic (stuttering) should use this product only for particularly serious reasons.
Only for particularly serious reasons should patients take sibutramine concurrently with medications that may cause changes in heart rate (ECG changes). These include certain medications for treating hypersensitivity (astemizole, terfenadine), medications for treating heart rhythm disorders (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol), medications for treating digestive disorders (cisapride), medications for certain mental disorders (pimozide, sertindole, and tricyclic antidepressants), and medications that may affect potassium and magnesium levels in the blood.
Side effects of the medication:
Side effects occur mainly at the start of treatment (during the first 4 weeks). Their severity and frequency decrease over time. Generally, they are not serious and do not lead to discontinuation of treatment.
Side effects are listed in the table according to frequency of occurrence (very common >
1/10, common <= 1/10, and > 1/100):The following side effects may also occur after taking this medicine: blurred vision, diarrhea and vomiting, hypersensitivity reactions ranging from mild skin rashes and hives to swelling of the larynx, pharynx, or tongue (angioedema) and shock, mood changes (depression), agitation, seizures, transient short-term memory impairment, serotonin syndrome (see Interactions section), hair loss, kidney disease, urinary retention, sexual dysfunction and menstrual cycle disturbances, transient elevation of liver enzymes, and decreased platelet count.
Headaches and increased appetite have been observed very rarely after missing a dose. Although no link has been established between sibutramine treatment and the occurrence of elevated pulmonary artery pressure, you should seek immediate medical attention if you experience shortness of breath, chest pain, or swelling of the limbs. If you experience any side effects or other unusual reactions, consult your doctor immediately.
Interactions with other medications:
The effects of Sibutramine 40 mg and the effects of other medications taken at the same time may influence each other. Your doctor should be informed of all medications you are currently taking or plan to start taking, whether prescribed or over-the-counter. Before taking any other medication, including over-the-counter drugs, at the same time as Sibutramine 40mg, consult your doctor and do not take it without consulting them. The breakdown and excretion of sibutramine in the body may be slowed down, thereby increasing its effects and side effects, when taken concurrently with medications for treating fungal infections (ketoconazole, itraconazole), medications used to treat infections (erythromycin, clarithromycin, troleandomycin), and medications used, for example, in organ transplants to suppress immune responses (cyclosporine). Accelerated elimination of sibutramine, and thus a reduction in its effect, may occur when the product is administered concurrently with medications for the treatment of tuberculosis (rifampicin), medications for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital), and medications for the treatment of inflammatory reactions (dexamethasone). Serious interactions may occur with the concurrent administration of sibutramine and medications that increase serotonin levels in the blood (substances that occur naturally in the body and are involved in nervous system function). This condition is called serotonin syndrome (manifested by tremors, increased blood pressure, rapid heart rate, confusion, and loss of consciousness). It may rarely occur in connection with the concurrent administration of selective serotonin reuptake inhibitors (SSRIs—substances that increase serotonin levels in the blood) together with migraine medications (such as sumatriptan, dihydroergotamine), or in combination with opioids (strong pain medications—pentazocine, pethidine, fentanyl, dextromethorphan). The concurrent use of Sibutramine 40 mg with medications that may increase blood pressure or heart rate (e.g., sympathomimetics) has not been systematically evaluated. Medications of this type include certain cough, cold, and allergy medications (e.g., ephedrine, pseudoephedrine) and certain decongestants (e.g., xylometazoline). Sibutramine 40 mg should be administered with caution to patients taking these medications. Sibutramine 40 mg does not affect the efficacy of oral contraceptives. Alcohol consumption is not compatible with the recommended dietary measures. However, it has been demonstrated that a single dose of sibutramine taken together with alcohol did not further impair reaction times.
Instructions for pregnant and breastfeeding women
Women of childbearing age should use effective contraception while taking Sibutramine 40mg.
Dosage:
Treatment should be part of a weight-loss regimen. To achieve the desired effect of the product, the prescribed dosage must be strictly followed.
Adults:The initial dose is 1 capsule of Sibutramine 40mg once daily. If you forget to take the medication, continue with the normal dose the next day; never take two capsules at once.
Duration of treatment:
The doctor will discontinue treatment for patients whose weight loss is less than 5% of their original weight 3 months after starting treatment. The doctor will also discontinue treatment for patients who, after initial weight loss, gain more than 3 kg during further treatment. Treatment is long-term; however, since data on the safety and efficacy of the product when administered for longer than one year are not yet available, treatment should not exceed this period. Patients should be informed of the need to make lifestyle changes as part of treatment with sibutramine and of the necessity to adhere to these changes to maintain weight loss long-term. If the patient stops adhering to lifestyle changes, they may regain weight. Even after discontinuing treatment with Sibutramine 40 mg, the patient should continue to follow the principles of a healthy lifestyle.
How to use the medication:
The medication is taken in the morning with or without food; the capsule should be swallowed whole with a sufficient amount of liquid (e.g., a glass of water).
Overdose:
There is very little experience with sibutramine overdose. Symptoms of overdose are unknown, but an increased incidence of side effects may occur. In case of overdose or accidental ingestion by a child, consult a doctor.
WarningsBlood pressure must be monitored very carefully in patients with symptoms of sleep apnea (brief pauses in breathing during sleep). Sibutramine 40 mg may impair the ability to drive, operate machinery, or work in hazardous conditions.
Storage of the MedicationStore the medication at a temperature not exceeding 25°C in the original inner packaging to protect it from moisture.
WarningsDo not use this medicine after the expiration date printed on the package. Keep this medicine out of the reach and sight of children.