Sinfatix 80mg Xl Prolonged Release Tablets
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Sinfatix 80mg XL and children/adolescents
Package leaflet: information for the user
Sinfatix 80mg XL 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
What is in this leaflet
1. What Sinfatix 80mg XL is and what it is used for
2. What you need to know before you take Sinfatix 80mg XL
3. How to take Sinfatix 80mg XL
4. Possible side effects
5. How to store Sinfatix 80mg XL
6. Contents of the pack and other information
1. What Sinfatix 80mg XL is and what it is used for
• Sinfatix 80mg XL contains the active substance fluvastatin sodium which belongs to a group of medicines known as statins, which are lipid-lowering medicines: they reduce the fat (lipids) level in your blood. They are used in patients whose conditions cannot be controlled by diet and exercise alone.
• Sinfatix 80mg XL is a medicine used to treat raised levels of fat 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 Sinfatix 80mg 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.
• You must talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before you take Sinfatix 80mg 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 Sinfatix 80mg XL.
Do not take Sinfatix 80mg XL
• if you are allergic to Fluvastatin or to any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems currently, or if you have unexplained, persistently high levels of certain liver enzymes (transaminases),
• if you are pregnant or breast-feeding (see “Pregnancy and breast-feeding”).
If any of these apply to you, do not take Sinfatix
80mg XL and tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Sinfatix 80mg XL
• If you previously had a liver disease. Liver function tests will normally be done before you start Sinfatix 80mg XL, when your dose is increased and at various intervals during treatment to check for side effects.
• 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.
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.
Check with your doctor or pharmacist before taking Sinfatix 80mg XL:
• If you have severe respiratory failure.
If any of these apply to you, tell your doctor before you take Sinfatix 80mg XL. Your doctor will take a blood test before prescribing Sinfatix 80mg XL.
Sinfatix 80mg XL and 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.
Sinfatix 80mg XL has not been investigated and is not intended for 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 Sinfatix 80mg XL in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.
Other medicines and Sinfatix 80mg XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Sinfatix 80mg 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 Sinfatix 80mg XL.
Tell your doctor and 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)
• Oral anticoagulants like warfarin (medicines used to reduce blood clotting)
• Glibenclamide (a medicine used to treat diabetes)
• Colchicines (used to treat gout)
Sinfatix 80mg XL with food and drink
You can take Sinfatix 80mg XL with or without food.
Pregnancy, breast-feeding and fertility
Do not take Sinfatix 80mg 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 Sinfatix 80mg XL.
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.
Driving and using machines
There is no information on the effects of Sinfatix 80mg XL on your ability to drive and use machines.
3. How to take Sinfatix 80mg XL
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Follow your doctor's instructions carefully. Do not exceed the recommended dose.
Your doctor will recommend you follow a low-cholesterol diet. Stay on this diet while taking this medicine.
How much to take
The recommended dose range for adults 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.
For children (aged 9 years and older), the usual 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 many tablets to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
When to take Sinfatix 80mg XL
• If you are taking Sinfatix 80mg XL, you can take your dose at any time of the day.
• Sinfatix 80mg XL can be taken with or without meals. Swallow whole with a glass of water.
If you take more Sinfatix 80mg XL than you should
If you have accidentally taken too much Sinfatix 80mg XL, talk to your doctor straight away. You may need medical attention.
If you forget to take Sinfatix 80mg 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 Sinfatix 80mg XL
To maintain the benefits of your treatment, do not stop taking Sinfatix 80mg XL unless your doctor tells you to. You must continue to take Sinfatix 80mg XL as directed to keep the levels of your 'bad' cholesterol down. Sinfatix 80mg XL will not cure your condition but it does help control it. Your cholesterol levels need to be checked regularly to monitor your progress.
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If you have any further questions on the use of this Marketing Authorisation holder
medicine, ask your doctor or pharmacist. Manufacturer
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Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Rare: may affect up to 1 in 1,000 people Very rare: may affect up to 1 in 10,000 people Not known: frequency cannot be estimated from the available data
Some rare or very rare effects could be serious: get medical help immediately.
• If you have unexplained muscle pain, tenderness or weakness. These might be early signs of 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).
• If you have unusual tiredness or fever, yellowing of the skin and eyes, dark-coloured urine (signs of hepatitis).
• If you have signs of skin reactions such as skin rash, hives, redness, itching, swelling of the face, eyelids, and lips.
• If you bleed or bruise more easily than normal (signs of decreased number of blood platelets).
• If you have red or purple skin lesions (signs of blood vessel inflammation).
• If you have a red blotchy rash mainly on the face which may be accompanied by fatigue, fever, nausea, loss of appetite (signs of lupus erythematosus-like reaction).
• If you have severe upper stomach pain (sign of an inflamed pancreas).
If you experience any of these, tell your doctor straight away.
Other side effects: tell your doctor if they worry you.
Common:
Difficulty in sleeping, headache, stomach discomfort, abdominal pain, nausea.
Very rare:
Tingling or numbness of the hands or feet, disturbed or decreased sensibility.
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
• 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.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Accord Healthcare Limited Sage House,
319, Pinner Road North Harrow Middlesex HA1 4 HF United Kingdom
This leaflet was last revised in 06/2012
5. How to store Sinfatix 80mg XL
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label and carton after 'EXP'. The expiry date refers to the last day of that month.
• Store below 30°C in the original container in order to protect from light and moisture.
• 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 Sinfatix 80mg XL contains
The active substance is fluvastatin sodium.
Each prolonged release tablet contains 84.280 mg of Fluvastatin sodium equivalent to 80 mg Fluvastatin.
The other ingredients are:
Tablet core:
Cellulose microcrystalline, Potassium hydrogen carbonate, Povidone K-30, Hydroxy propyl cellulose, Hypromellose K 100, Hypromellose K 4M, Magnesium stearate
Film coat:
Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc, Iron oxide yellow (E172)
What Sinfatix 80mg XL looks like and contents of the pack
Yellow colored, round, biconvex, beveled edged film coated tablets, debossed with “F80” on one side and plain on other side.
Sinfatix 80mg XL is available in OPA-Al-PVC/Al blisters packs containing 7, 14,28,30,56,70,84,90 and 98 tablets.
Not all pack sizes may be marketed.