Lescol XL 80 mg Prolonged Release Tablets


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Lescol XL 80 mg Prolonged Release Tablets


LESCOL XL 80 mg Prolonged Release Tablets


This leaflet tells you about Lescol XL Prolonged Release Tablets. They will be referred to simply as Lescol in this leaflet.

What you need to know about Lescol

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.

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.

In this leaflet: 1. What Lescol is, and what it’s used for 2. Things to consider before you start to take Lescol 3. How to take Lescol 4. Possible side effects 5. How to store Lescol 6. Further information What Lescol is and what it’s used for

Lescol XL Tablets contain 80 mg of the active ingredient fluvastatin (as fluvastatin sodium). The ‘prolonged release’ formulation means that the active ingredient is released slowly and evenly throughout the day. Fluvastatin is one of a group of drugs called statins.

Why does your doctor want you to take Lescol?

Your blood tests have shown that you have too much of certain types of fats such as cholesterol and triglycerides in your blood. Although these are vital to health, high blood levels are one of the important causes of heart disease.

Your doctor has decided to treat you with Lescol, together with a low fat diet, to help reduce the levels of cholesterol and triglycerides. This will lower your risk of heart problems and slow down any hardening of the arteries or rate of heart disease.

Lescol can also be used to reduce the risk of a heart attack after some types of surgery.

Things to consider before you start to take Lescol Some people MUST NOT take Lescol. Talk to your doctor if: You think you may be allergic to fluvastatin or other statins, or to any of the other ingredients of Lescol. (These are listed at the end of the leaflet.) You have liver problems, or you have had any disease which may have affected your liver. You are pregnant or breast-feeding. You are aged under 9. You should also ask yourself these questions before taking Lescol: Have you ever had any liver disease? Are you a heavy drinker (of alcohol)? Do you have any kidney problems? Do you have an underactive thyroid gland (hypothyroidism)? Do you, or any member of your family, have a history of any muscle disorders? Have you previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g. other “statin” or “fibrate” medicines)? Check with your doctor or pharmacist before taking Lescol: if you have severe respiratory failure.

If the answer to any of these questions is YES, tell your doctor or pharmacist. Your doctor will need to carry out a blood test before, and possibly during, your Lescol treatment to see whether you are at risk of muscle-related side effects. Your doctor may also decide to give you a blood test if you are older than 70 years.

Are you taking other medicines?

Some medicines can interfere with your treatment or alter blood levels of those drugs you are currently taking.

Tell your doctor if you are taking any of the following drugs because there is a higher risk of developing muscle problems when they are taken with Lescol:

other cholesterol lowering drugs such as fibric acid derivatives (e.g. gemfibrozil) or nicotinic acid, erythromycin (an antibiotic), ciclosporin (an immunosuppressive drug), colchicines for gout.

Also make sure your doctor knows if you are taking any of the following:

Rifampicin, an antituberculosis drug. (The effects of Lescol might be reduced.) Phenytoin, an antiepileptic medicine. (Blood levels of phenytoin and Lescol might be raised.) Drugs to prevent blood clotting (e.g. coumarin derivatives such as warfarin). You may notice that you bleed more easily. Glibenclamide, an antidiabetic drug. These are not usually given at the same time. Your doctor may want you to take them together although there is an increased risk hypoglycaemia (low blood sugar). Itraconazole or fluconazole which are antifungal medicines. cholestyramine, another drug to help lower blood cholesterol.

Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.

Will there be any problems with driving or using machinery?

There is no information available to suggest that Lescol will affect your ability to drive or to operate machinery.

How to take Lescol

The doctor will decide what dose of Lescol you should take. Always take the medicine exactly as your doctor has told you to. The dose will be on the pharmacist’s label. Check the label carefully. It should tell you how much to take, and how often. If you are not sure, ask your doctor or pharmacist. Keep taking Lescol for as long as you have been told unless you have any problems. In that case, check with your doctor.

Remember you must stay on your low fat diet.

Swallow the tablets whole with a glass of water. They should not be broken or chewed. If you need a dose less than 80 mg the doctor will prescribe Lescol Capsules.

To reduce the blood level of cholesterol and other fats: The usual starting dose is 20 or 40 mg a day, usually taken in the evening. The doctor will periodically check your cholesterol levels and may adjust your dose, up to a maximum of 80 mg a day, depending on what the levels are. To help slow down hardening of the arteries or the rate of heart disease: The usual dose is 40 mg daily. To reduce the risk of heart attack after certain types of surgery: The usual dose is 80 mg daily.

Follow your doctor’s instructions exactly and never change the dose yourself.

If you are also taking cholestyramine you should take Lescol at least four hours after taking the resin because it can interfere with the way the fluvastatin is taken up in the body.

What if you forget to take a dose?

If you forget to take a dose, take it as soon as you remember. Then go on as before.

What if you take too much?

If you accidentally take too much, tell your doctor at once or contact your nearest hospital casualty department. Take your medicine with you so that people can see what you have taken.

Possible side effects

Lescol is suitable for most people, but, like all medicines, it can sometimes cause side effects.

Some side effects can be serious

Stop taking Lescol and tell your doctor straight away if you notice:

Your muscles feel weak, painful or tender, particularly if, at the same time, you feel unwell or have a high temperature, or if you start to get cramp. In very rare cases (likely to affect fewer than 1 in 10,000 patients), this has progressed to become a serious and potentially life-threatening condition called rhabdomyolysis. Bronchospasm with wheezing or coughing and difficulty in breathing, or if you feel faint (you might have low blood pressure), have a rash, or experience itching or facial swelling. These symptoms might be the result of an allergic reaction which is very rare. The side-effects listed below have also been reported.

Up to 1 in 10 people have experienced:

Sleeplessness Headache Stomach ache Indigestion Nausea.

Up to 1 in 1,000 people have experienced:

Skin rash, itching and other skin reactions.

Up to 1 in 10,000 people have experienced:

Changes in blood cell counts Pins and needles or changes in touch sensations (this may indicate injury or damage to nerve endings) Inflamed blood vessels Hepatitis (liver disease) Lupus-type reactions such as rash, joint pains and general malaise Severe pain in the upper abdomen (stomach).

In a small number of patients slight increases in liver enzymes have occurred but most patients did not develop any symptoms. Enzyme levels returned to normal or became more normal when therapy was stopped. Your doctor will usually carry out liver function tests before you start therapy and periodically thereafter.

Very rarely, Lescol has caused inflammation of the liver. If you experience yellowing of the skin and eyes and dark coloured urine, tell your doctor immediately.

Other possible side effects

Sleep disturbances, including insomnia and nightmares Memory loss Sexual difficulties Depression Breathing problems including persistent cough and/or shortness of breath or fever

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.

How to store Lescol

Keep the tablets in the original pack.

Do not store the tablets above 30?C.

Keep all medicines out of the reach and sight of children.

Do not take the medicine after the expiry date which is printed on the outside of the pack.

If your doctor tells you to stop taking Lescol, please take any unused tablets back to your pharmacist to be destroyed. Only keep them if the doctor tells you to. Do not throw them away with your normal household water or waste. This will help to protect the environment.

Further information

Lescol XL 80 mg Prolonged Release Tablets are round, yellow tablets marked ‘Lescol XL’ on one side and ‘80’ on the other. They contain 84.24 mg of fluvastatin sodium which provides 80 mg of the active ingredient, fluvastatin.

The tablets also contain the inactive ingredients microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, potassium hydrogen carbonate, povidone, magnesium stearate, yellow iron oxide (E172), titanium dioxide (E171) and macrogol 8000.

The tablets come in packs of 28 tablets.

The product licence holder is

Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR England

Lescol is made by

Novartis Farmaceutica S.A. Ronda Santa Maria 158, Barbera Del Valles (Barcelona) Spain

This leaflet was revised in December 2009.

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.

LESCOL is a registered Trademark

Copyright Novartis Pharmaceuticals UK Limited

Lescol XL 80 mg Prolonged Release Tablets

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