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Package leaflet: Information for the user

PINMACTIL® 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 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 Pinmactil is and what it is used for

2.    What you need to know before you take Pinmactil

3.    How to take Pinmactil

4.    Possible side effects

5.    How to store Pinmactil

6.    Content of the pack and further information

1.    What Pinmactil is and what it is used for

Pinmactil 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.

Pinmactil 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 Pinmactil 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 Pinmactil

Follow all the doctor's instructions carefully. They may differ from the general information contained in this leaflet.

Read the following explanations before you take Pinmactil. Do not take Pinmactil:

•    if you are allergic (hypersensitive) to fluvastatin or any of the other ingredients of Pinmactil listed in section 6 of this leaflet.

•    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 Pinmactil and tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Pinmactil.

•    If you previously had a liver disease. Liver function tests will normally be done before you start Pinmactil, when the 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 disease yourself or in your family.

•    If you have 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.

If during treatment with Pinmactil, 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.

Also tell your doctor or pharmacist if you have 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 Pinmactil:

•    if you have severe respiratory failure

If any of these apply to you, tell your doctor before taking Pinmactil.

Your doctor will take a blood test before prescribing Pinmactil.

Pinmactil 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.

Pinmactil and children/adolescents Pinmactil 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 Pinmactil in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.

Other medicines and Pinmactil Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pinmactil 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 Pinmactil.

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).

Pinmactil with food and drink

You can take Pinmactil with or without food.

Pregnancy and breast-feeding Do not take Pinmactil 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 Pinmactil.

Take adequate precaution against pregnancy while taking Pinmactil.

If you become pregnant while taking this medicine, stop taking Pinmactil and see your doctor.

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

Driving and using machines

There is no information on the effects of Pinmactil on

your ability to drive and use machines.

3. How to take Pinmactil

Follow your doctor's instructions carefully. Do not exceed the recommended dose.

Your doctor will recommend you to follow a low-cholesterol diet. Stay on this diet while taking Pinmactil. How much Pinmactil to take

•    The dose range for adults is 20 to 80 mg fluvastatin 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 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 many tablets of Pinmactil to take.

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

Please note that you cannot use Pinmactil 80 mg prolonged-release tablets for all the above dosages. Pinmactil is only available as 80 mg prolonged-release tablets. For lower doses (20 mg and 40 mg), your doctor will prescribe other fluvastatin medicines.

Date: 06 MAR 2015

When to take Pinmactil

If you are taking Pinmactil you can take your dose at any time of the day.

Pinmactil can be taken with or without meals. Swallow whole with a glass of water; do not divide, chew or crush the tablet.

If you take more Pinmactil than you should

If you have accidentally taken too muchPinmactil, talk to your doctor straight way. You may need medical attention.

If you forget to take Pinmactil

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 the one that you missed.

If you stop taking Pinmactil

To maintain the benefits of your treatment, do not stop taking Pinmactil unless your doctor tells you to. You must continue to take Pinmactil as directed to keep the levels of your 'bad' cholesterol down. Pinmactil 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 product, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, Pinmactil can cause side effects, although not everybody gets them.

Very common: affects more than 1 user in 10

Common: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1,000

Rare: affects 1 to 10 users in 10,000

Very rare: affects less than 1 user in 10,000

Not known: frequency cannot be estimated from the

available data.

Some rare or very rare side effects could be serious: get medical help immediately.

•    If you have unexplained muscle pain, tenderness or weakness, especially if this is constant. 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).

•    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 blood 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 erythematosus-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, abnormal blood test values for muscle and liver.

Very rare:

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

Not known:

Impotence.

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 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.

5. How to store Pinmactil

Keep this medicine out of the sight and reach of children.

Blisters: Keep the blisters in the outer carton in order to protect from light.

Tablet bottle (glass and HDPE bottle): Keep the container tightly closed in order to protect from moisture and light.

Do not store above 30 °C Do not use Pinmactil after the expiry date, which is stated on the blister, carton and tablet bottle, respectively, after 'EXP'. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Pinmactil contains:

•    The active substance is: Fluvastatin. Each prolonged-release tablet contains 80 mg fluvastatin (as fluvastatin sodium).

•    The other ingredients are:

Tablet core:

Povidone, microcrystalline cellulose, hydroxyethyl cellulose mannitol, magnesium stearate

Film-coating:

Hypromellose 50, macrogol 6000, iron oxide yellow (E172), titanium dioxide (E171).

What Pinmactil looks like and contents of the pack

Pinmactil are yellow, round, biconvex prolonged-release tablets

Pack sizes:

Blister (OPA/Alu/PVC-Alu): 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 490 prolonged-release tablets.

HDPE bottle with desiccant and snap-on cap (LDPE) with a tamper evident ring. Pack sizes of 250 prolonged-release tablets.

Glass bottle with desiccant and HDPE cap: 28, 98, 100, 250 and 500 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Mylan Potters Bar,

Hertfordshire,

EN6 1TL

United Kingdom

Manufacturer:

Actavis hf.

Reykjavikurvegi 78,

IS-222 Hafnarfjordur Iceland

Actavis Ltd.

BLB016, Bulebel Industrial Estate,

Zejtun ZTN 3000

Malta

This medicinal product is authorised in the Member States of the EEA under the following names: 'Fluvastatine Retard Mylan 80mg tabletten met verlengde afgifte' 'Fluvastatin Mylan 80 mg' 'Fluvastatin Mylan 80mg depottabletter'

'Fluvastatin Mylan 80 mg depottabletti'

'Fluvastatine Mylan L.P. 80 mg, comprime pellicule a liberation prolongee'

'Fluvastatin-Generics [UK] 80 mg retard tabletta'

'Statease XL 80mg prolonged-release tablets'

'Fluvastatina Mylan Generics' 'Fluvastatine Retard Mylan 80 mg, tabletten met verlengde afgifte' 'Fluvagen'

'Fluvastatina Mylan 80 mg comprimidos de libertagao prolongada'

'Fluvastatin Mylan 80 mg' 'Fluvastatina MYLAN 80 mg comprimidos de liberacion prolongada EFG'

'Pinmactil 80 mg prolonged-release tablet'