The package insert of the medicine Slenfig

the package insert of the medicine Slenfig. Active principles Sibutramine Hydrochloride Monoidratado.

what For?

Slenfig capsule is indicated as adjunctive therapy as part of a program of weight management recommended for patients with a body mass index (BMI) greater than or equal to 30 kg/m2.

adult Use – oral Use

Contraindications

When should I not use?

Slenfig is contraindicated in patients with a history of type 2 diabetes mellitus with at least 1 other risk factor or hypertension controlled by medication, dyslipidemia, current practice of smoking to diabetic nephropathy with evidence of microalbuminúria.

Slenfig is contraindicated in patients with a history of coronary artery disease (angina, history of myocardial infarction), congestive heart failure, tachycardia, arterial disease obstructive peripheral, arrhythmia or cerebrovascular disease (stroke or transient ischemic attack).

Slenfig is contraindicated in patients with hypertension controlled inadequately, > 145/90 mm hg (see Warnings and Precautions).

Slenfig is contraindicated in patients above the age of 65 years.

Slenfig is contraindicated to patients with history or presence of eating disorders such as bulimia and anorexia.

Slenfig is contraindicated to patients with known hypersensitivity to sibutramine or any of the other ingredients of the formula.

Slenfig is contraindicated to patients receiving inhibitors of the monoaminooxidase. It is recommended an interval of at least two weeks after discontinuation of mao inhibitors before starting treatment with sibutramine (see Drug Interactions).

Slenfig is contraindicated to patients receiving other drugs action on the central for weight reduction or treatment of psychiatric disorders.

Slenfig is contraindicated for patients with a body mass index (BMI) less than 30 kg/m2.

Dosage

How to use?

Slenfig should only be used under medical or dietetic supervision.

The recommended initial dose is 1 capsule of 10 mg per day, administered orally, ingested in the morning, with a little liquid, before or after food.

If you do not lose at least 2kg in the first 4 weeks of treatment, the doctor should reevaluate the treatment, which may include a dose increase to 15 mg or cessation of treatment with sibutramine.

treatment should be suspended in patients who have not experienced the loss of at least 2 kg after 4 weeks of treatment with the dose of 15 mg/day.

Whenever there is a change in the dose proposed for the treatment, you must-if you have to pay attention to the control of heart rate and blood pressure. (see Warnings and Precautions).

Doses above 15 mg daily are not recommended.

Sibutramine must be administered for a period of up to 2 years.

treatment should be suspended in patients who do not achieve the weight loss suitable, for example, those whose weight loss stabilizes at less than 5% of the initial weight or whose weight loss after 3 months of initiation of therapy is less than 5% of the initial weight.

treatment should be discontinued in patients who readquirirem 3 kg or more after weight loss obtained previously (see Warnings and Precautions).

In patients with obesity-related diseases, it is recommended that treatment with sibutramine will only be maintained if the weight loss generated by the medicine is associated with other clinical benefits.

Follow the guidance of your doctor, always respecting the schedules, doses and duration of treatment.

do Not stop treatment without the knowledge of your doctor.

This medicine should not be broken, opened or chewed.

Side Effects

What are the evils that can cause me?

During clinical studies most of the reported adverse reactions occurred at the beginning of treatment with sibutramine (during the first four weeks).

Their severity and frequency diminished over time and the effects, in general, were not serious, did not lead to discontinuation of treatment and were reversible.

In the case of allergic reactions, stop treatment with Slenfig and promptly report the incident to your doctor.

Reaction very common (occurs in 10% of patients using this drug): Constipation, dry mouth and insomnia.

Reaction common (occurs in between 1% and 10% of the patients using this drug): Tachycardia (increased heart rate), palpitations, increased blood pressure/hypertension, vasodilation (redness, heat waves), nausea, worsening of the hemorrhoid, delirium, paresthesia (sensations on the skin such as cold, heat, tingling, pressure), headache, anxiety, sweating (sweat intense) and taste changes.

Warnings and Precautions

what should I know before using?

Tell your doctor specifically if you are taking or if you are taking the drugs as reducing agents of the weight, nasal decongestants, antidepressants, antitussígenos, drugs for migraine or other medications that do not require a prescription to be purchased.

If there is history of anorexia nervosa (eating disorder), bulimia nervosa (self-induced vomiting after eating), or other eating disorders, and the knowledge, intention, or suspicion of pregnancy and breastfeeding, the doctor should be informed for guidance carefully.

in addition, epilepsy or seizures prior, glaucoma (eye disease) and other diseases should also be informed.

organic Causes of obesity (such as hypothyroidism not treated) should be excluded before prescribing Slenfig.

Slenfig substantially increases blood pressure and/or heart rate in some patients.

The monitoring of blood pressure and heart rate is required during treatment with sibutramine.

In the first 3 months of treatment, these parameters should be checked every 2 weeks.

Between 4 and 6 months these parameters should be checked once per month and then periodically, at maximum intervals of 3 months.

treatment should be discontinued in patients who have an increase, after two consecutive measurements, resting heart rate of ≥ 10 bpm or systolic blood pressure/diastolic ≥ 10 mmHg.

In hypertensive patients well controlled if blood pressure exceeds 145/90 mmHg at two readings in a row, the treatment should be discontinued (see Adverse Reactions).

In patients with the syndrome of sleep apnea special care should be taken in monitoring blood pressure.

Cases of psychosis, mania, suicidal thoughts and suicide have been reported in patients taking sibutramine. If these events occur, treatment with sibutramine should be discontinued.

Cases of depression have been reported in patients taking sibutramine. If this event occurs during treatment with sibutramine, discontinuation should be considered.

Slenfig should be used with caution in patients with hepatic impairment mild to moderate. Sibutramine should not be used in patients with severe hepatic impairment. Slenfig should be used with caution in patients with predisposition to bleeding and those taking concomitant medications known to affect hemostasis and function of the platelet.

pulmonary Hypertension: although sibutramine has not been associated with pulmonary hypertension and certain weight reducing agents of action central that cause the release of serotonin in the nerve endings (the mechanism of different action of sibutramine) were associated to pulmonary hypertension.

bleeding Disorders: in common with other agents that inhibit serotonin reuptake, there is a potential risk of increased bleeding in patients taking sibutramine. During the treatment, the patient should not drive vehicles or operate machinery, as your skill and attention may be harmed.

Cautions and warnings for special populations:
Sex: the data relatively limited available so far provide no evidence of a difference in clinically relevant effects of sibutramine in men and women.

renal Insufficiency: Slenfig should be used with caution in patients with renal insufficiency mild to moderate, and should not be used in patients with severe renal insufficiency, including patients in advanced stage and perform dialysis.

hepatic Insufficiency: Slenfig should be used with caution in patients with hepatic impairment mild to moderate, and should not be administered in patients with liver failure.

Use in children: Slenfig should not be used in children and adolescents.

Slenfig in pregnancy and lactation: although studies in animals have shown that sibutramine is not teratogênica, the safety of the use of sibutramine during human gestation has not been established and, for this reason, the employment deSlenfig during pregnancy is not recommended. Women with the potential to become pregnant should employ measures of contraception are suitable during the treatment with Slenfig. Tell your doctor if you become pregnant or if you plan to become pregnant during treatment.

the Period of breast-feeding: it is not known whether sibutramine or its metabolites are excreted in the bed mother, therefore, the employment of Slenfig is not recommended during lactation. Tell your doctor if you are breast-feeding.

This medicine should not be usefullarge computerized data set for pregnant women without medical or dental surgeon.

Drug Interactions

it is recommended the use of alcoholic beverages along with Slenfig because it may cause additional changes of psychomotor performance or cognitive functions.

it is recommended to use Slenfig together with inhibitors of the monoaminooxidase inhibitors (Maois), medicines action central, inhibitors of the reuptake of serotonin, migraine medicines, decongestants, antitussígenos, antigripais, antiallergic, containing ephedrine or pseudoephedrine, inhibitors of cytochrome P450 (ketoconazole, erythromycin and cimetidine).

reversible Changes of liver enzymes have been observed in the laboratory tests in clinical studies.

The presence of food in the digestive tube does not change the action of the drug.

Overdose

what to do if someone use a larger amount than is recommended?

The experience of overdose with sibutramine hydrochloride monoidratado is limited.

adverse effects commonly associated with overdose are tachycardia, hypertension, headache, and dizziness.

The treatment should consist in the employment of general measures for the handling of the overdose: monitoring respiratory, should the need arise; monitoring cardiac and vital signs, in addition to the general measures of support.

In the case of use of large amount of this medicine, look for fast medical help and take the packaging or package insert for the drug, if possible.