Dorisin Xl 80mg Prolonged Release Tablets
Package leaflet: Information for the user
Dorisin XL 80mg prolonged release tablets 80mg 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Dorisin XL 80mg prolonged release tablets is and what it is used for
2. What you need to know before you take Dorisin XL 80mg prolonged release tablets
3. How to take Dorisin XL 80mg prolonged release tablets
4. Possible side effects
5. How to store Dorisin XL 80mg prolonged release tablets
6. Contents of the pack and other information
1. What Dorisin XL 80mg prolonged release tablets is and what it is used for
Dorisin XL 80mg prolonged release tablets contains the active 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.
• Dorisin XL 80mg prolonged release tablets 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.
• i n adult patients with high blood levels of cholesterol
• i n adult patients with high blood levels of both cholesterol and triglycerides (another sort of blood lipid)
• Your doctor can also prescribe Dorisin XL 80mg prolonged release tablets 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 Dorisin XL 80mg prolonged release tablets
Do not take Dorisin XL 80mg prolonged release tablets
• 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 Dorisin XL 80mg prolonged release tablets and tell your doctor.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Dorisin XL 80mg prolonged release tablets
• i f you previously had a liver disease. Liver function tests will normally be done before you start Dorisin XL 80mg prolonged release tablets, 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).
• i f you have a medical history of muscle diseases yourself or in your family.
• i f you had muscle problems with another lipidlowering medicine.
• if you regularly drink large amounts of alcohol.
• 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 Dorisin XL 80mg prolonged release tablets can lead to serious muscle problems (rhabdomyolysis).
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.
Check with your doctor or pharmacist before taking Dorisin XL 80mg prolonged release tablets:
• if you have severe respiratory failure
If any of these apply to you, tell your doctor before you take Dorisin XL 80mg prolonged release tablets. Your doctor will take a blood test before prescribing Dorisin XL 80mg prolonged release tablets.
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.
People over 70 years of age
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
Dorisin XL 80mg prolonged release tabletshas 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 Dorisin XL 80mg prolonged release tablets in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.
Other medicines and Dorisin XL 80mg prolonged release tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription.
• 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 Dorisin XL 80mg prolonged release tablets. Taking Dorisin XL 80mg prolonged release tablets with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
Dorisin XL 80mg prolonged release tablets 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 Dorisin XL 80mg prolonged release tablets.
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).
Dorisin XL 80mg prolonged release tablets with food and drink
You can take Dorisin XL 80mg prolonged release tablets 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 Dorisin XL 80mg prolonged release tablets 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. If you are pregnant, consult your doctor or pharmacist before taking Dorisin XL 80mg prolonged release tablets. Use reliable contraception for the whole time that you are taking Dorisin XL 80mg prolonged release tablets.
If you become pregnant while taking this medicine, stop taking Dorisin XL 80mg prolonged release tablets and see your doctor.
Driving and using machines
There is no information on the effects of Dorisin XL
80mg prolonged release tablets on your ability to drive and use machines.
3. How to take Dorisin XL 80mg prolonged release tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor 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 Dorisin XL 80mg prolonged release tablets.
How much Dorisin XL 80mg prolonged release tablets to take
• The 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 capsules or tablets of Dorisin XL 80mg prolonged release tablets to take.
Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
When to take Dorisin XL 80mg prolonged release tablets
If you are taking Dorisin XL 80mg prolonged release tablets tablets you can take your dose at any time of the day.
Dorisin XL 80mg prolonged release tablets can be taken with or without meals. Swallow whole with a glass of water.
If you take more Dorisin XL 80mg prolonged release tablets than you should
If you have accidentally taken too much Dorisin XL 80mg prolonged release tablets, talk to your doctor straight away. You may need medical attention.
If you forget to take Dorisin XL 80mg prolonged release tablets
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 Dorisin XL 80mg prolonged release tablets
To maintain the benefits of your treatment, do not stop taking Dorisin XL 80mg prolonged release tablets unless your doctor tells you to. You must continue to take Dorisin XL 80mg prolonged release tablets as directed to keep the levels of your 'bad' cholesterol down. Dorisin XL 80mg prolonged release tablets 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.
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 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 drugs 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 have skin swelling, difficulty in breathing, dizziness (signs of severe allergic reaction).
• If you bleed or bruise more easily than normal (signs
of decreased number of platelets).
• If you have red or purple skin lesions (signs of blood vessel inflammation).
• If you have red blotchy rash mainly on the face which may be accompanied by fatigue, fever, nausea, loss of appetite (signs of lupus erythematous-like reaction).
• If you have severe upper stomach pain (signs of 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 nigh blood pressure. Your doctor will monitor you while you are taking this medicine.
Not known
• Muscle weakness that is constant
Reporting of side effects
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. ov.uk/yellowcard. By reporting side effects you can elp provide more information on the safety of this medicine."
5. How to store Dorisin XL 80mg prolonged release tablets
Do not store above 30°C.
Store in the original package in order to protect from moisture.
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 carton and blister.
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 Dorisin XL 80mg prolonged release tablets contains
The active substance is: fluvastatin sodium.
Each Dorisin XL 80mg prolonged release tablets tablet contains 84.2mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid.
The other ingredients of Dorisin XL 80mg prolonged release tablets are:
Tablet core: Carrageenan, Magnesium stearate Film-coating: Hydroxypropyl cellulose, Hypromellose 6cP, Iron oxide yellow, Titanium dioxide, Macrogol 8000, Iron oxide red
What Dorisin XL 80mg prolonged release tablets looks like and contents of the pack
Dorisin XL 80mg prolonged release tablets are dark yellow, round, biconvex tablets and are packed in Aluminium/Aluminium blisters strips.
Each pack of Dorisin XL 80mg prolonged release tablets contains 7 or 28 or 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmathen International SA, 4 Dervenakion str., 153 51 Pallini, Hellas
Manufacturer
Pharmathen SA, 6 Dervenakion str., 153 51 Pallini, Hellas