Sibunta 10 (Weight Loss)

Sibunta 10 Weight Loss Capsules (Sibutramine 10mg)

Expiry date: July 2011

Generic version of Reductil (tm) and Meridial (tm)

30 Capsules (one month) - £24.99

90 Capsules (three months) £64.99 - cost per month £21.66

180 Capsules (six months) £114.99 - cost per month £19.16

360 Capsules (twelve months) £215.99 - cost per month £17.99

Manufactured by Ajanta Pharma

WHAT SIBUNTA 10 IS AND WHAT IT IS USED FOR

Sibunta 10, which contains sibutramine is a medicine to help you lose weight if your doctor has determined you are obese, or over- weight with additional risk factors for obesity such as diabetes and/or elevated lipids. Your doctor may start you on Sibunta 10 if diet and exercise for three months didn't help you lose enough weight. This medicine makes you feel full sooner so you eat less food. By eating less you should be able to lose and control your weight. This medicine is part of your weight loss plan you set up with your doctor.

This medicine should be used together with a low calorie diet and an increase in your physical activity. The combination will also help you lose weight. Your doctor will guide you with your weight loss program and will give you regular check-ups.

BEFORE YOU TAKE SIBUNTA 10

Do Not Take SIBUNTA 10

• if you have obesity that is not related to overeating
• if your blood pressure is above 145/90 mmHg whether or not you take blood pressure medicines
• if you have, or have had in the past, an eating disorder, such as anorexia or bulimia
• if you are allergic to sibutramine or any of the other ingredients of Sibunta 10 (please refer to Section 6 or the list of ingredients for this medicine)
• if you have a mental illness such as manic depression (bipolar disorder)
• if you are currently using or have used in the past 2 weeks MAOI medicines (to treat depression or Parkinson's disease) or you have used other medicines to treat depression, psychosis or weight loss or tryptophan to treat sleep disorders. These medicines can affect the amount of the chemical called serotonin in your brain. This can be a problem if you also use Sibunta 10 at the same time
• if you have Tourette's syndrome
• if you have or have ever had heart problems, a raised heart rate, an uneven heart beat, heart failure, hardening of the arteries or strokes
• if you have an overactive thyroid gland
• if you have severe kidney disease, are on dialysis or have severe liver disease
• if you are a male patient and you notice problems with your prostate. An enlarged prostate may make it hard to empty your bladder even if you feel an urge to urinate
• if you have a certain kind of tumours on the adrenal glands (phaeochromocytoma)
• if you have an eye problem called narrow angle glaucoma
• if you abuse drugs, medicines or alcohol or have done so in the past
• if you are pregnant or planning to become pregnant or if you are breastfeeding.
• if you are under 18 or over 65 years old.

Take Special Care with SIBUNTA 10

Your doctor will check your progress regularly, measuring your weight, blood pressure and pulse rate to be sure that this medicine is the right treatment for you.

Talk to your doctor:

• if your blood pressure or heart rate goes up or gets too high. It is very important to have your blood pressure checked if you have a sleeping problem called sleep apnoea
• if you experience symptoms such as shortness of breath, chest pain and swollen ankles due to pulmonary hypertension
• if you have epilepsy (seizures)
• if you have kidney or liver problems
• if you have a family history of tics.
• if you have depression
• if you have a condition that makes you prone to bleeding or if you are taking any medicines that may thin your blood or may increase bleeding
• if you have an eye problem called wide angle glaucoma (increase of pressure in your eyes) or if you are at risk because you have a relative who has had this condition

Your doctor will decide if you should continue taking this medicine.

Important information about some of the ingredients of SIBUNTA 10

Sibunta 10 contains lactose. If you have been told by your doctor that you are have an intolerance to some sugars, tell your doctor taking this medicinal product.

Using Other Medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

Several medicines can cause unwanted reactions if used with Sibunta 10. Ask your doctor or pharmacist for advice before taking this medicine. In particular tell your doctor if you are using any of the following medicines:

• if you are currently using or have used in the past 2 weeks MAOI medicines (to treat depression or Parkinson's disease) or you have used other medicines to treat depression, psychosis or weight loss or tryptophan to treat sleep disorders (see Do Not Take SIBUNTA 10)
• medicines to treat migraine headaches e.g. sumatriptan, ergot (dihydroergotamine)
• some kinds of strong pain-killers: for example, fentanyl and pethidine, pentazocine
• certain medicines that can increase blood pressure, such as cold or allergy medications e.g. dextromethorphan, ephedrine, pseudoephedrine
• cimetidine (a medicine used to treat ulcers)
• some medicines to treat infections including antibiotics, such as rifampicin, erythromycin, troleandomycin and clarithromycin, or antifungal medicines, such as itraconazole and ketoconazole. Talk to your doctor if you are using any medicine to treat an infection
• some epilepsy (seizure) medicines: carbamazepine, phenobarbitone and phenytoin
• some medicines called steroids and medicines that affect your body's ability to fight disease: such as dexamethasone and cyclosporin

Taking SIBUNTA 10 with Food and Drink

• It doesn't matter if you have eaten or not when you take this medicine
• This medicine should be swallowed whole with a full glass of water

Pregnancy and Breast-feeding

You shouldn't use Sibunta 10 if you are pregnant or planning to become pregnant. Take measures to avoid becoming pregnant while using this medicine. Do not breast-feed if you are taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and Using Machines

If you find that this medicine affects your judgment, your thinking or your coordination, you should not drive or use tools or machinery.

HOW TO TAKE SIBUNTA 10

Always take this medicine exactly as your doctor has told you. If you are not sure, you should check with your doctor.

The starting dose is one 10mg capsule of Sibunta 10 every morning, swallowed whole with a glass of water. Do not chew or break open the capsule. It doesn't matter if you have eaten or not when you take this medicine.

If you haven't lost about four pounds (two kilograms) of weight during the first four weeks you take Sibunta 10, your doctor may want to increase your dose of this medicine to one 15 mg capsule taken once a day. Sibunta 10 must be taken as prescribed by your doctor.

If you take more SIBUNTA 10 than you should

If you took more Sibunta 10 than you should, immediately tell your doctor or pharmacist. Taking too much Sibunta 10 may make you feel dizzy. Your heart may beat faster and your blood pressure may increase. You may also get a headache.

If you forget to take SIBUNTA 10

If you do forget to take a dose, just skip it. Do not take a double dose to make up for the one you have missed. Talk to your doctor or pharmacist if you have any questions about how to take this medicine.

If you stop taking SIBUNTA 10

If you stop taking this medicine, you might get a headache or want to eat more. If this happens, talk to your doctor.

POSSIBLE SIDE EFFECTS

Like all medicines, Sibunta 10 can cause side effects, although not everyone gets them. Most side effects occur during the first four weeks of treatment. Most of these are not serious, occur less often and became less marked over time or go away when this medicine is stopped.

The following side effects have been seen with Sibunta 10. Some of these may become serious. You should talk to your doctor and/or pharmacist if you notice any of the following.

• An increase in blood pressure or heart rate
• An irregular heart beat such as a fluttering of the heart
• A rare but serious problem called serotonin syndrome. This is a combination of symptoms that can include feeling confused, sweating, shaking, nausea, hallucinations, sudden jerking of the muscles or a fast heart beat. This may occur when people take other medicines that affect a brain chemical called serotonin along with this medicine
• If you get breathing problems, chest pains or swollen ankles
• Unusual bleeding or unusual bruising, or if it takes you longer than usual to stop bleeding
• If you get a rash or hives, trouble breathing, fainting and swelling of the face and throat. You may be having an allergic reaction which may need emergency treatment. If you get any of these symptoms, stop taking this medicine and talk to your doctor right away

Very common side effects (in more than 1 in 10 patients taking this medicine in clinical trials) include:

• trouble sleeping
• constipation
• dry mouth

Common side effects (in less than 1 in 10 patients taking this medicine in clinical trials) include:

• a fast heart beat
• increased blood pressure
• awareness of the heartbeat (palpitations)
• nausea
• headache
• anxiety
• a "pins-and-needles" feeling
• dizziness
• hot flushes or sweating
• If you have haemorrhoids (piles), they could become worse

Foods and drinks may taste different than they used to or you may have a different taste in your mouth.

Other side effects include (less common or with an unknown frequency): seizures, trouble remembering things, blurred vision, diarrhoea, vomiting, thinning hair, erectile dysfunction/abnormal orgasms, menstrual disorders, bleeding into the skin with joint pain, feeling agitated or depressed, bleeding in the stomach, kidney problems, inability to empty the bladder and increases in certain liver tests.

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.

HOW TO STORE SIBUNTA 10

Keep out of the reach and sight of children.

Do not store above 25c. Store in the original package in order to protect from moisture.

Do not use this medicine if you notice the capsules are damaged or don't look right in some other way.

Do not use this medicine after the expiry date which is stated on the blister strip and the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or with household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

FURTHER INFORMATION

What SIBUNTA 10 Contains

The active substance is sibutramine, as sibutramine hydrochloride monohydrate.

Sibunta 10 Capsules also contain the following non active ingredients: Lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica. Capsule shell and markings contain: Indigo carmine (E132), titanium dioxide (E171), gelatin, sodium lauryl sulphate, dimethicone, propylene glycol, iron oxide black (E172), shellac glaze, lecithin (E322).

Sibunta 10 10 mg capsules also contain quinilone yellow (E104).

What SIBUNTA 10 looks like and contents of the pack

Sibunta 10 10mg Capsules are immediate release hard gelatin capsules with a blue cap and yellow body.