What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL35533/0151 .


Dorisin XL 80mg Prolonged Release Tablets

Package leaflet: Information for the user

Dorisin XL 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Dorisin XL is and what it is used for
2. Before you take Dorisin XL
3. How to take Dorisin XL
4. Possible side effects
5. How to store Dorisin XL
6. Contents of the pack and other information

1. What Dorisin XL is and what it is used for

Dorisin 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.

  • Dorisin 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 Dorisin XL to prevent further serious cardiac events (e.g. heart attack) in patients who have already had a heart catheterisation, with an intervention in the heart vessel.

2. What you need to know before you take Dorisin XL

Do not take Dorisin 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 “pregnancy and breast-feeding”).

If any of these apply to you, do not take Dorisin XL and tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dorisin XL

  • 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 can lead to serious muscle problems (rhabdomyolysis).
  • if you previously had a liver disease. Liver function tests will normally be done before you start Dorisin 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.
  • if you have a serious infection.
  • if you have very low blood pressure (signs may include dizziness, light-headedness).
  • if you have controlled or uncontrolled excessive muscle exercise.
  • if you are about to have an operation.
  • if you have severe metabolic, endocrine or electrolyte disorders such as decompensated diabetes and low blood potassium.

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 Dorisin XL:

  • if you have severe respiratory failure

If any of these apply to you, tell your doctor before taking Dorisin XL. Your doctor will take a blood test before prescribing Dorisin 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.

If during treatment with Dorisin XL, you develop symptoms or signs such as nausea, vomiting, loss of appetite, yellow eye or skin, confusion, euphoria or depression, mental slowing, slurred speech, sleep disturbance, tremors or easy bruising or bleeding, these may be signs of liver failure. In such case contact a doctor immediately.

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 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 Dorisin XL in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.

Other medicines and Dorisin XL

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. Taking Dorisin XL with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

Dorisin 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 Dorisin 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).

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 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.

Take adequate precaution against pregnancy while taking Dorisin XL. If you become pregnant while taking this medicine, stop taking Dorisin XL and see your doctor.

Your doctor will discuss with you the potential risk of taking Dorisin XL during pregnancy.

Driving and using machines

There is no information on the effects of Dorisin XL on your ability to drive and use machines.

Dorisin XL contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Dorisin XL

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist or 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.

How much Dorisin XL to take

Recommended doses in adults

  • The dose range of Fluvastatin 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.

Use in children and adolescents

  • For children (aged 9 years and older) the usual starting dose is 20 mg of fluvastatin 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 Dorisin XL to take.

Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

When to take Dorisin XL

If you are taking Dorisin XL tablets you can take your dose at any time of the day.

Dorisin XL can be taken with or without meals. Swallow whole with a glass of water.

If you take more Dorisin XL than you should

If you have accidentally taken many tablets of Dorisin XL, talk to your doctor straight away. You may need medical attention.

If you forget to take Dorisin 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 Dorisin XL

To maintain the benefits of your treatment, do not stop taking Dorisin XL unless your doctor tells you to. You must continue to take Dorisin XL as directed to keep the levels of your ‘bad’ cholesterol down. Dorisin 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.

Some rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) side 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 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 (may affect up to 1 in 10 people):

Difficulty in sleeping, headache, stomach discomfort, abdominal pain, nausea. Abnormal blood test values for muscle and liver.

Very rare (may affect up to 1 in 10,000 people):

Tingling or numbness of the hands or feet, disturbed or decreased sensitivity.

Not known (frequency cannot be estimated from the available data):

Impotence, muscle weakness that is constant, breathing problems including persistent cough and/or shortness of breath or fever, diarrhoea.

Other possible side effects

  • Sleep disturbances, including insomnia and nightmares
  • Memory loss
  • Sexual difficulties
  • Depression
  • 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.
  • Inflammation, swelling, and irritation of a tendon

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 (Website: www.mhra. gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dorisin 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 carton and blister after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package in order to protect from 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 to protect the environment.

6. Contents of the pack and other information

What Dorisin XL contains

The active substance is: fluvastatin sodium.

Each Dorisin XL tablet contains 84.2mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid.

The other ingredients of Dorisin XL are:

Tablet core: Carrageenan, Magnesium stearate.

Film-coating: Hydroxypropyl cellulose, Hypromellose 6cP, Iron oxide yellow (E172), Titanium dioxide (E171), Macrogol 8000, Iron oxide red (E172).

What Dorisin XL looks like and contents of the pack

Dorisin XL tablets are dark yellow, round, biconvex tablets and are packed in Aluminium/Aluminium blisters strips.

Each pack of Dorisin XL contains 7 or 28 or 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aspire Pharma Ltd
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom

Manufacturer

Pharmathen SA
6 Dervenakion str.
153 51 Pallini
Hellas

Date of last revision: 12/2018

1010066-P2.2