Sibutramine, the active substance of Lindaksa belongs to a group of medicines for the treatment of obesity, reinforcing the feeling of satiety and at the same time increases the release of energy from the body. He, along with diet and exercise reduces body teglo.Lindaksa created to influence obesity.
LINDAXA 15mg. 30 caps
LINDAXA WHAT IS AND WHAT IT IS USED
Sibutramine, the active substance of Lindaksa belongs to a group of medicines for the treatment of obesity, reinforcing the feeling of satiety and at the same time increases the release of energy from the body. He, along with diet and exercise reduces body teglo.Lindaksa created to influence obesity. It should be administered in conjunction with a reduced calorie diet and increased physical activity as part of a comprehensive program of weight reduction when you change modes (regulation of food and physical activity) did not produce a significant result.
Treatment should be part of a program to reduce body weight:
- Obese overfeeding (body mass index of (BMI) 30 kg / m or more),
- Overweight patients overfeeding (body mass index (BMI) 27 kg/m2 or more) and associated risk factors such as diabetes mellitus, type II or disturbances in the composition of fat in the blood (dyslipidemia).
Treatment should be initiated under medical supervision of a physician experienced in the treatment of obesity.
The amount of weight must be coupled with a change the composition of food and diet, and increase physical activity. Lindaksa should be administered only to patients who did not respond adequately to the desired weight thereof lowering mode, i.e. in patients who have difficulties to reach or retain more than 5% decrease in body weight for 3 months .
(BMI = body mass index is calculated by dividing weight in kilograms by height in meters squared) Lindaksa is the treatment of adults under 65 years of age.
BEFORE YOU USE LINDAXA
Do not take LINDAXA if:
you are allergic to the active ingredient sibutramine or any of the excipients;
have congenital motor tics (involuntary muscle spasms) or verbal tics (stuttering), called syndrome of Gilles de la Tourette;
have severely impaired nutrition (anorexia - anorexia or bulimia, eating);
suffer from obesity caused by reasons other than overeating (Organ reasons);
have a mental illness;
are taking or have (in the last 2 weeks) medicines for depression (MAOIs) or other acting on central nervous system drugs cause mental illness, medications for sleep disorders (tryptophan) or other medicines for weight reduction;
have a disease of the heart and blood vessels (coronary artery disease, congestive heart failure, increased heart rate, irregular heartbeat, clogged arteries in the extremities), cerebral vascular accident or transient disorders of cerebral circulation adequately controlled blood pressure (> 145 / 90 mmHg);
you have an overactive thyroid gland (hyperthyroidism);
you have severe hepatic dysfunction;
you have severe renal impairment;
you have an enlarged prostate with urinary retention;
have a tumor of the adrenal glands, which produce hormones (pheochromocytoma);
have increased intraocular pressure (glaucoma);
you have an addiction to drugs, medication or alcohol;
you are pregnant or breastfeeding.
Due to lack of sufficient data, the drug not be used in children, adolescents under 18 and adults over 65 years of age.
Be especially careful with LINDAXA:
You can use this product only if there are good reasons for this:
if you suffer from epilepsy;
If you have mild to moderate and severe diseases of the liver and kidneys;
if you have anorexia nervosa or bulimia as a prequel;
if you suffer from open-angle glaucoma and the risk of increased intraocular pressure;
if you suffer from depression;
if you have a family history of motor or verbal tics;
If you use drugs affecting coagulation or platelet function, or a tendency to bleed;
if you are a woman of childbearing age should use effective contraception when taking product Lindaksa.
if you are taking sibutramine concomitantly with medications that change the heart rate (ECG changes), this applies to certain medications used to treat allergy (astemizole, terfenadine), drugs that affect the heart rhythm (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol) , drugs for treating digestive disorders (cisapride), drugs for the treatment of certain psychiatric disorders (pimozide, sertindole, and tricyclic antidepressants), and drugs that affect the blood levels of potassium and magnesium;
Blood pressure and heart rate will be monitored by your doctor at least every two weeks during the first 3 months of treatment. Between 4 and 6 months, this monitoring should be once a month, and then at regular intervals no greater than 3 mesetsa.Patsienti with elevated blood pressure and adequate medicated control (<145/90 mmHg) blood pressure monitoring may be at shorter intervals. In patients with blood pressure higher than 145/90 mmHg, found in two consecutive measurements, treatment should be discontinued by the physician. Treatment should also be stopped if the heart rate is accelerated by> 10 beats / minute at rest or there is an increase of> 10 mmHg in systolic / diastolic blood pressure at two consecutive visits lekar.S particular attention should be monitored for blood pressure patients with signs of sleep apnea (breathing stops briefly during sleep).
Taking other medicines
Please tell your doctor if you are taking shi recently taken any other medicines, even those sold without a prescription
Co-administration of all dosage forms of drugs for the treatment of fungal diseases (ketoconazole, itraconazole), a medicament for the treatment of infections (erythromycin klaritomitsin, troleandomycin), and drugs that are applied, for example in organ transplants, for inhibition of immune responses (cyclosporine) degradation of sibutramine in the body and its elimination is delayed altering its effect and can lead to increased occurrence of adverse drug reactions;
rapid elimination of sibutramine and reducing its effects were reported with the concomitant administration of drugs for treating tuberculosis (rifampicin), drugs for the treatment of epilepsy (phenytoin, carbamazepine or phenobarbital), and medicaments for the treatment of inflammatory reactions (dexamethasone);
serious interactions may be prepared by co-administration of sibutramine and drugs which increase the level of serotonin in the blood (substances normally found in human beings and are relevant to the activity of the nervous system.) This phenomenon is called serotonin syndrome (which is manifested by tremor, increase in blood pressure, rapid heart rate, confusion and loss of consciousness). It was reported in conjunction with the simultaneous reception of a group of drugs for the treatment of depression - selective inhibitors of serotonin reuptake (SSRI - substances which increase the concentration of serotonin in the blood), with a medicament for the treatment of migraine (such as sumatriptan, dihydroergotamine) or opioids (strong remedies for pain relief - pentazocine, pethidine, fentanyl, dextromethorphan).
Co-administration of the drug Lindaksa with drugs that increase blood pressure or heart rate (eg sympathomimetic) have not been subject to systematic studies. Medicaments of this type are some that interfere with cough, cold and allergy (such as ephedrine, pseudoephedrine), and certain drugs that reduce hyperaemia eg. xylometazoline. Patients taking these drugs should be treated with Lindaksa very carefully.
Effect of oral contraceptive agents is not affected by the medicament Lindaksa.
Alcohol consumption does not correspond to the recommended dietary rules. However, a single concomitant use of sibutramine and alcohol did not alter the responses.
LINDAXA intake of food and fluids
The medicament should be administered in the morning with and without food. The capsule should be swallowed whole, followed by adequate fluid intake (eg a glass of water). Generally, the alcohol is compatible with the recommended dietary rules.
Pregnancy and lactation
Seek the advice of your doctor or pharmacist before using any medications.
Pregnant and breastfeeding women should not be using Lindaksa. Women of childbearing age should use effective contraception while taking Lindaksa
Driving and using machines
The drug may inhibit your ability to drive, operate machinery, or in high-risk environments. These activities can be carried out with the prior permission of a doctor.
Important information about some of the ingredients of Lindaksa
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Lindaksa.Lekarstveniyat product contains sunset yellow FCF, which rarely can cause allergic reactions.
HOW TO USE LINDAXA
Always take Lindaksa exactly as prescribed by your doctor. If you are unsure, ask your doctor or pharmacist.
Treatment should be part of a comprehensive program for weight loss, held under medical supervision. To achieve the expected effect of treatment, follow strictly the prescribed dosage.
The initial dose is 1 capsule Lindaksa 10 once daily in the morning with or without food. The capsule should be swallowed whole with some water (a cup of water).
In patients not adequately respond to treatment (weight reduction of less than 2 kg for 4 weeks), but better tolerated dose of 10 mg dose may be increased to a capsule Lindaksa 15 once daily. Treatment should be stopped by a doctor in patients who have not achieved adequate response Lindaksa 15 (weight loss less than 2 kg for 4 weeks).
Duration of treatment:
Lindaksa treatment must be discontinued after three months in patients who have reduced their body weight in less than 5% in comparison with its weight prior to that period.Lechenieto Lindaksa should not be continued in patients whose body weight is increased by 3 or more pounds despite initial weight loss. In patients with comorbidities is recommended that continuing treatment with Lindaksa only when losing weight is associated with other clinical benefits such as improved blood lipid profile in patients with altered one (dyslipidemia), or to help control blood glucose in patients with diabetes type II.
Treatment with Lindaksa can not last more than one year.
If you think the effect of Lindaksa is very strong or very weak inform accordingly your doctor or pharmacist.
If you take more than necessary LINDAXA:
Do not take more medicine than prescribed by your doctor.
There is only little experience of overdose with sibutramine. No known symptoms of overdose, although this has been reported to increase the incidence of adverse drug reactions. In case of overdose or accidental ingestion of drugs by children, seek medical advice.
If you forget to take LINDAXA
In case you forget to take medication, continue the next day with the usual daily dose. Do not take a double dose to make up.
If you stop taking LINDAXA
Do not stop treatment early without consulting your doctor.
POSSIBLE SIDE EFFECTS
As with all medications, LINDAKSA can cause side effects, although not all of them suffer.
Undesirable effects occur mainly in the initiation of treatment (during the first 4 weeks). Severity and frequency decreases with time. As a rule, they are not serious and do not lead to discontinuation.
Adverse reactions are presented in the table are sorted according to their frequency of occurrence: very common (> 1/10), common (> 1/100 to <1/10), uncommon (> 1/1, 000 to <1 / 100), rare (> 1/10, 000 to <1/1000), very rare (<1/10, 000), not known (can not be estimated from available data).
Heart and blood vessels
Common tachycardia (increased heart rate) Palpitations (rapid heart beat) Hypertension (increase in blood pressure) Vasodilatation (redness of the face and neck)
Very common Constipation Dry mouth
Common Nausea exacerbation of hemorrhoids
Common Dizziness Paraesthesia (sensation of tingling in the extremities) Headache Anxiety
Skin and subcutaneous tissue
Frequent change of taste
Than those observed following side effects with the use of Lindaksa: blurred vision, diarrhea and vomiting, hypersensitivity reactions from mild skin rash and hives to swelling in the pharynx, larynx or tongue (angioedema) and shock, mood swings (depression), anxiety, seizures, serotonin syndrome (see paragraph Taking other medicines), hair loss, manifestations of kidney, urinary incontinence, sexual dysfunction and menstrual cycle, transient increases in liver enzymes, decreased platelet bleeding, headache and increased appetite.
Headache and increased appetite have been reported very rarely in discontinuation of the drug.
Although unrelated treatment with sibutramine include increased blood pressure in the pulmonary artery, seek immediate medical help in case of shortness of breath, chest pain and swelling of the extremities.
If any of the side effects gets serious, or if you notice any side effects not specified in this leaflet, please ask your doctor or pharmacist
HOW TO STORE LINDAXA
Keep out of reach of children.
Do not use LINDAXA after the expiry date printed on the box / blister. Expiry date refers to the last day of the indicated month.
Do not store above 30 ° in the original package to protect from moisture.
Medicines should not be disposed of via waste water or household waste. Ask your doctor or pharmacist how to dispose of medication that you no longer need. These measures will help to protect the environment.
What does LINDAXA?
The active ingredient is sibutramine. Each capsule contains 10 mg or 15 mg of sibutramine hydrochloride monohydrate, equivalent to 8.37 mg or 12.55 mg of sibutramine.
Excipients: Capsule contents: lactose monohydrate, microcrystalline cellulose, silica, colloidal anhydrous, magnesium stearate.
Capsule 10 mg: gelatin, quinoline yellow (E104), sunset yellow FCF (E 110), titanium dioxide (E171), black iron oxide (E172), red iron oxide (E 172), black ink.
Capsule 15 mg: gelatin, quinoline yellow (E104), sunset yellow FCF (E110), indigo carmine (E 132), titanium dioxide (E 171), black ink..