Zyflutin Xl 80mg Prolonged Release Tablets
Package leaflet: Information for the user
Zyflutin XL 80 mg prolonged-release tablets Fluvastatin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Zyflutin XL is and what it is used for
2. What you need to know before you take Zyflutin XL
3. How to take Zyflutin XL
4. Possible side effects
5. How to store Zyflutin XL
6. Contents of the pack and other information
1. What Zyflutin XL is and what it is used for
Zyflutin XL contains the active substance fluvastatin sodium which belongs to a group of medicines known as statins, which are lipid-lowering medicines: they lower the fat (lipids) in your blood. They are used in patients whose conditions cannot be controlled by diet and exercise alone.
Zyflutin XL is a medicine used to treat raised levels of fats in the blood in adults, in particular total cholesterol and so called “bad” or LDL cholesterol, which is associated with an increased risk of heart disease and stroke.
- in adult patients with high blood levels of cholesterol
- in adult patients with high blood levels of both cholesterol and triglycerides (another sort of blood lipid)
Your doctor can also prescribe Zyflutin XL to prevent further serious cardiac events (e.g. heart attack) in patients after they already went through a heart catheterisation, with an intervention in the heart vessel.
2. What you need to know before you take Zyflutin XL
Follow all instructions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
Read the following explanations before you take Zyflutin XL.
Do not take Zyflutin XL
- if you are allergic to fluvastatin or any of the other ingredients of this medicine (listed in section 6).
- if you currently have liver problems, or if you have unexplained, persistently high level of certain liver enzymes (transaminases).
- if you are pregnant or breast-feeding (see “pregnany and breast-feeding”).
If any of these apply to you, do not take Zyflutin XL and tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zyflutin XL
- if you previously had a liver disease. Liver function tests will normally be done before you start Zyflutin XL, when your dose is increased and at various intervals during treatment to check for side effects.
- if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Zyflutin XL name can lead to serious muscle problems (rhabdomyolysis).
- if you have a kidney disease.
- if you have a thyroid disease (hypothyroidism).
- if you have a medical history of muscle diseases yourself or in your family.
- if you had muscle problems with another lipid-lowering medicine.
- if you regularly drink large amounts of alcohol.
Check with your doctor or pharmacist before taking Zyflutin XL
- if you have a lung disorder presenting with breathing discomfort, non productive cough and deterioration in general health (tiredness, weight loss and fever), which might be signs of a so-called interstitial lung disease. Treatment with Zyflutin XL must not be started in case of (suspected) interstitial lung disease
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
If any of these apply to you, tell your doctor before you take Zyflutin XL. Your doctor will take a blood test before prescribing Zyflutin XL.
Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.
People over 70 years
If you are over 70 years your doctor may want to check if you have risk factors for muscular diseases. You may need specific blood tests.
Children and adolescents
Zyflutin XL has not been investigated and is not intended for the use in children below 9 years. For dose information in children and adolescents over 9 years, see section 3.
There is no experience with the use of fluvastatin in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.
Other medicines and Zyflutin XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Zyflutin XL. Taking Zyflutin XL with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
Zyflutin XL can be taken on its own or with other cholesterol-lowering medicines prescribed by your doctor.
After intake of a resin, e.g. cholestyramine (primarily used to treat high cholesterol) wait at least 4 hours before taking Zyflutin XL.
Tell your doctor or pharmacist if you are taking any of the following:
- Ciclosporin (a medicine used to suppress the immune system).
- Fibrates (e.g. gemfibrozil), nicotinic acid or bile acid sequestrants (medicines used to lower bad cholesterol levels).
- Fluconazole (a medicine used to treat fungal infections).
- Rifampicin (an antibiotic).
- Phenytoin (a medicine used to treat epilepsy).
- Phenprocoumon or Warfarin (medicines used to reduce blood clotting).
- Glibenclamide (a medicine used to treat diabetes).
- Colchicine (used to treat gout).
Zyflutin XL with food and drink
You can take Zyflutin XL with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Zyflutin XL if you are pregnant or breast-feeding as the active ingredient may lead to harm to your unborn child, and it is not known whether the active ingredient is excreted in human breast milk. Use reliable contraception for the whole time that you are taking Zyflutin XL.
If you become pregnant while taking this medicine, stop taking Zyflutin XL and see your doctor.
Driving and using machines
There is no information on the effects of Zyflutin XL on your ability to drive and use machines.
3. How to take Zyflutin XL
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure. Do not exceed the recommended dose.
Your doctor will recommend you to follow a low-cholesterol diet. Stay on this diet while
taking Zyflutin XL.
How much fluvastatin to take
- The recommended dose range for adults for treatment of raised levels of fats in the blood is 20 to 80 mg per day and depends on the extent of cholesterol lowering which needs to be achieved. Dose adjustments may be made by your doctor at 4-week or longer intervals.
- The recommended dose for adults for prevention of further serious heart-related events is 80 mg per day.
- For children with familial hypercholesterolaemia (genetic disorder characterized by high cholesterol levels) aged 9 years and older the recommended starting dose is 20 mg per day. The maximum daily dose is 80 mg. Dose adjustments may be made by your doctor at 6-week intervals.
Your doctor will tell you exactly how much fluvastatin to take.
Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
For lower dosages other dosage forms are available
When to take Zyflutin XL
You can take Zyflutin XL at any time of the day.
Zyflutin XL can be taken with or without meals. Swallow whole with a glass of water.
If you take more Zyflutin XL than you should
If you have accidentally taken too much Zyflutin XL, talk to your doctor straight away. You may need medical attention.
If you forget to take Zyflutin XL
Take one dose as soon as you remember. However, do not take it if there is less than 4 hours before your next dose. In this case take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Zyflutin XL
To maintain the benefits of your treatment, do not stop taking Zyflutin XL unless your doctor tells you to. You must continue to take Zyflutin XL as directed to keep the levels of your ‘bad’ cholesterol down. Zyflutin XL will not cure your condition but it does help control it. Your cholesterol levels need to be checked regularly to monitor your progress.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following serious side effects, stop taking Zyflutin XL and go to your
doctor or to the nearest hospital straight away.
Rare (may affect up to 1 in 1,000 people):
- unexplained muscle pain, tenderness or weakness. These might be early signs of a potentially severe muscle degradation. This can be avoided if your doctor stops your treatment with fluvastatin as quickly as possible. These side effects have also been found with similar medicines of this class (statins).- signs of skin reactions such as skin rash or hives.
Very rare (may affect up to 1 in 10,000 people):
- severe muscle degradation called rhabdomyolysis
- unusual tiredness or fever, yellowing of the skin and eyes, dark coloured urine (signs of hepatitis)
- skin swelling, difficulty in breathing, dizziness (signs of severe allergic reaction).
- bleeding or bruising more easily than normal (signs of decreased number of blood platelets).
- red or purple skin lesions (signs of blood vessel inflammation).
- red blotchy rash mainly on the face which may be accompanied by fatigue, fever, nausea, loss of appetite (signs of lupus erythematous-like reaction).
- severe upper stomach pain (signs of inflamed pancreas).
signs of skin reactions such as redness, itching, swelling of the face, eyelids, and lips
Other side effects: tell vour doctor if they worry you.
Common (may affect up to 1 in 10 people):
Difficulty in sleeping, headache, stomach discomfort, abdominal pain, nausea.
Very rare (may affect up to 1 in 10,000 people):
Tingling or numbness of the hands or feet, disturbed or decreased sensibility.
Not known (frequency cannot be estimated from the available data):
Muscle weakness that is constant.
Other possible side effects:
- Sleep disturbances, including nightmares
- Memory loss
- Sexual difficulties
- Depression
- Breathing problems including persistent cough and/or shortness of breath or fever
- Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
Children and adolescents
Fluvastatin has only been investigated in children of 9 years and older with heterozygous familial hypercholesterolaemia, a genetic disorder characterized by high cholesterol levels. The safety profile of fluvastatin in children and adolescents with familial hypercholesterolaemia seems to be similar to the one observed in adults.
Laboratory investigations
Elevated level of liver enzymes (marker of liver damage) and elevated level of creatine kinase (marker of muscular damage) in the blood can be found in patients treated with Zyflutin XL.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zyflutin XL
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP:.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Zyflutin XL contains:
- The active substance is: fluvastatin. Each tablet contains 80 mg of fluvastatin as fluvastatin sodium.
- The other ingredients are:
Tablet core: Carageenan, Magnesium stearate
Film-coating: Hydroxypropyl cellulose, Hypromellose 6cP, Iron oxide yellow, Titanium dioxide, Macrogol 8000, Iron oxide red
What Zyflutin XL looks like and contents of the pack
Zyflutin XL are dark yellow, round, biconvex tablets and are packed in Aluminium/Aluminium blisters strips.
Each pack of Zyflutin XL contains 20, 28, 30, 50, 56, 60, 90, 98, 100, 490 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ratiopharm GmbH, Graf-Arco-Str.3, 89079 Ulm, Germany.
Manufacturer:
Pharmathen S.A., 6 Dervenakion str, 153 51, Pallini, Attiki, Greece. or
Merckle GmbH, Ludwig-Merckle-StraBe 3, 89143 Blaubeuren, Germany.