PINMACTIL 80 MG PROLONGED-RELEASE FILM-COATED TABLETS - patient leaflet, side effects, dosage

Package leaflet: Information for the patient

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. See section 4.

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. Contents of the pack and other information

1. what pinmactil is and what it is used for

Pinmactil 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.

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 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 levels of certain

liver enzymes (transaminases).

• – if you are pregnant or breast-feeding (see ‘Pregnancy, breast-feeding and fertility’).

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 are taking or have taken in the last 7 days a medicine called fusidic acid (to treat bacterial

infections), orally or by injection. The combination of fusidic acid and fluvastatin can lead to serious muscle problems (rhabdomyolysis)

• 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 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.

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

Your doctor will take a blood test before prescribing Pinmactil.

If during treatment with Pinmactil, you develop symptoms or signs such as nausea, vomiting, loss of appetite, yellow eyes 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.

If you develop breathing problems including persistent cough and/or shortness of breath or fever, contact your doctor.

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.

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.

Children and 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

Tell your doctor or pharmacist if you are taking, or 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 fluvastatin. Your doctor will tell you when it is safe to restart fluvastatin. Taking fluvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See section 4 for more information regarding rhabdomyolysis.

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 or pharmacist if you are taking any of the following:

• Medicines used to suppress the immune system (e.g. ciclopsorin
• 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 or erythromycin (medicines used to treat bacterial infections)
• 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, breast-feeding and fertility

Do not take Pinmactil if you are pregnant or breastfeeding 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, 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.

Take adequate precaution (e.g. use reliable contraception) 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.

Fertility

In animal studies no effects on male or female fertility were observed.

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

Always take this medicine exactly as your doctor or pharmacist 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 Pinmactil.

How much Pinmactil to take

• – The recommended 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.

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.

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.

Use in children and adolescents

For children (aged 9 years and older) the recommended starting dose is 20 mg fluvastatin per day. The maximum daily dose if 80 mg. Dose adjustments may be made by your doctor at 6-week intervals.

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 a forgotten dose.

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 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 side effects could be serious. If you think you have any of the following side effects, stop taking this medicine and contact your doctor or go to your nearest hospital emergency department immediately.

Rare (may affect up to 1 in 1,000 people):

• If you have unexplained muscle pain, tenderness or weakness (rhabdomyolysis),, 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).

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

• If you have unusual tiredness or fever, yellowing of the skin and eyes, dark coloured urine (signs of hepatitis).
• If you bleed or bruise more easily than normal (signs of decreased number of blood platelets, which help the blood to clot).
• 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 have skin swelling, difficulty in breathing, dizziness (signs of severe allergic reaction).
• If you have signs of skin reactions such as skin rash, hives, redness, itching, swelling of the face,

eyelids and lips.

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

• If you have signs of inflammation, swelling and irritation of a tendon. In some case this can lead to tendon rupture.
• Breathing problems including persistent cough and/or shortness of breath or fever
• Diabetes – you may feel hungry, very thirsty and pass large volumes of urine. 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 experience any of these, tell your doctor straight away.

Other possible side effects:

Common (may affect up to 1 in 10 people):

Difficulty in sleeping, headache, stomach discomfort e.g. indigestion, abdominal pain, nausea (feeling sick), 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.
• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual difficulties
• Depression.

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 viaBy reporting side effects you can help provide more information on the safety of this medicine.

5. how to store pinmactil

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

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

Tablet bottle (glass and plastic bottles): 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.

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- the active substance is: fluvastatin. each prolonged-release tablet contains 80 mg fluvastatin (as

fluvastatin sodium).

• – The other ingredients are:

What Pinmactil looks like and contents of the pack

Pinmactil are yellow, round, biconvex prolonged-release tablets and are available in pack sizes of:

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

HDPE bottle with desiccant (Do not eat the desiccant) and snap-on cap (LDPE) with a tamper evident ring. Pack sizes of 250 prolonged-release tablets.

Glass bottle with desiccant (Do not eat the desiccant) and HDPE cap: 28, 98, 100, 250 or 500 prolonged release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan

Potters Bar,

Hertfordshire,

EN6 1TL

United Kingdom

Manufacturer(s):

Actavis hf.

Reykjavikurvegi 78,

IS-222 Hafnarfjordur

Iceland

Actavis Ltd.

BLB016, Bulebel Industrial Estate,

Zejtun ZTN 3000

Malta

McDermott Laboratories t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate,

Grange Road,

Dublin 13,

Ireland

Mylan Hungary Kft

H-2900 Komarom,

Mylan utca 1,

Hungary

This medicinal product is authorised in the Member States of the EEA under the following names:

Finland France Italy The Netherlands Portugal Spain UK

Fluvastatin Mylan 80 mg depottabletti Fluvastatine Mylan L.P. 80 mg, comprime pellicule a liberation prolongee Fluvastatina Mylan Generics Fluvastatine Retard Mylan 80 mg, tabletten met verlengde afgifte Fluvastatina Mylan Fluvastatina MYLAN 80 mg comprimidos de liberacion prolongada EFG Pinmactil 80mg prolonged release tablet

This leaflet was last revised in 10/2017

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