Fluvastatin STADA 80 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fluvastatina STADA 80 mg prolonged-release tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Fluvastatina STADA is and what it is used for
2. What you need to know before taking Fluvastatina STADA
3. How to take Fluvastatina STADA
4. Possible side effects
5. How to store Fluvastatina STADA
6. Contents of the pack and other information

1. What Fluvastatina STADA is and what it is used for

Fluvastatina STADA contains the active substance fluvastatina sódica, which belongs to a group of medicines known as statins, used to lower lipids (fats) in the blood. These medicines are used in patients whose condition cannot be controlled by diet and exercise alone.

• Fluvastatina STADA is a medicine used to treat elevated levels of fats in the blood of adults, particularly total cholesterol and so-called "bad" cholesterol or LDL-cholesterol, which is associated with an increased risk of heart disease and stroke:

  • in adult patients with high blood cholesterol levels.
  • in adult patients with high levels of both cholesterol and triglycerides (another type of lipid) in the blood.

• Your doctor may also prescribe Fluvastatina STADA to help prevent serious heart problems (e.g. a heart attack) in patients who have undergone heart catheterization or procedures on the heart's blood vessels.

2. What you need to know before taking Fluvastatin STADA

Carefully follow all instructions given to you by your doctor. These may differ from the general information contained in this leaflet.

Before taking Fluvastatin STADA, read the following information:

DO NOT take Fluvastatin STADA:

• 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, or have a persistent and unexplained increase in levels of certain liver enzymes (transaminases).
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

If you are in any of these situations, do not take Fluvastatin STADA and consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Fluvastatin STADA.

• if you have previously had liver disease. You will usually have liver function tests before starting treatment with Fluvastatin STADA, when your dose is increased, and at regular intervals during treatment to monitor for adverse effects.
• if you have kidney disease.
• if you have a thyroid gland disorder (hypothyroidism).
• if you or a family member has a history of muscle disorders.
• if you have experienced 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 (symptoms may include dizziness, lightheadedness).
• if you engage in excessive physical exercise, controlled or uncontrolled.
• if you are about to undergo surgery.
• if you have severe metabolic, endocrine, or electrolyte disorders such as uncontrolled diabetes or low potassium levels in the blood.
• if you are taking or have taken, within the last 7 days, an oral or injectable medicine called fusidic acid (a medicine for bacterial infection). The combination of fusidic acid and Fluvastatin STADA may cause serious muscle problems (rhabdomyolysis).

While you are taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Talk to your doctor or pharmacist before taking Fluvastatin STADA if you:

• have severe respiratory insufficiency.

If you are in any of these situations, inform your doctor before taking Fluvastatin STADA. Your doctor will perform a blood test before prescribing Fluvastatin STADA to you.

If during treatment with Fluvastatin STADA you experience symptoms or signs such as nausea, vomiting, loss of appetite, yellowing of the eyes or skin, confusion, euphoria or depression, mental slowness, difficulty speaking, sleep disturbances, tremors, or easy bruising or bleeding, these may be signs of liver dysfunction. In this case, contact your doctor immediately.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and treat muscle weakness.

Fluvastatin STADA and people over 70 years of age

If you are over 70 years old, your doctor may want to assess whether you have risk factors for muscle disorders. You may require specific blood tests.

Fluvastatin STADA and children/adolescents

Fluvastatin has not been studied and is not indicated in children under 9 years of age. For information on dosing in children over 9 years of age and adolescents, see section 3.

There is no experience with the use of fluvastatin in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Other medicines and Fluvastatin STADA

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• If you need to take oral fusidic acid for the treatment of a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Fluvastatin STADA. Taking Fluvastatin STADA with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See section 4 for further information on rhabdomyolysis.

Fluvastatin STADA may be taken alone or with other cholesterol-lowering medicines prescribed by your doctor.

After taking a resin, e.g. cholestyramine (used mainly to treat high cholesterol), wait at least 4 hours before taking Fluvastatin STADA.

Inform your doctor and pharmacist if you are taking any of the following medicines:

• Cyclosporine (a medicine used to suppress the immune system).
• Fibrates (e.g. gemfibrozil), nicotinic acid, or bile acid sequestrants (medicines used to lower levels of bad cholesterol).
• Fluconazole (a medicine used to treat fungal infections).
• Rifampicin (an antibiotic).
• Phenytoin (a medicine used to treat epilepsy).
• Oral anticoagulants such as warfarin (medicines used to reduce blood clots).
• Glibenclamide (a medicine used to treat diabetes).
• Colchicine (used to treat gout).

Taking Fluvastatin STADA with food and drink

You may take Fluvastatin STADA with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatin STADA if you are pregnant or breastfeeding, as the active substance may cause harm to the fetus and it is unknown whether it is excreted in breast milk. If you are pregnant, consult your doctor or pharmacist before taking Fluvastatin STADA.

You must take appropriate precautions to avoid becoming pregnant while receiving treatment with Fluvastatin STADA.

If you become pregnant while taking this medicine, you must stop taking Fluvastatin STADA and consult your doctor.

Your doctor will discuss with you the potential risks of taking Fluvastatin STADA during pregnancy.

Driving and using machines

There is no information available on the effects of Fluvastatin STADA on the ability to drive or use machines.

Fluvastatin STADA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Fluvastatina STADA

Follow exactly the instructions for use of this medicine as given by your doctor. Do not take a higher dose than indicated.

Your doctor will recommend that you follow a low-cholesterol diet. Continue this diet while taking Fluvastatina STADA.

How much Fluvastatina STADA you should take

• The dosage range for adults is 20 mg to 80 mg daily and depends on the required reduction in cholesterol levels. Your doctor may adjust your dose at intervals of 4 weeks or longer.
• In children (9 years of age and older), the usual initial dose is 20 mg daily. The maximum daily dose is 80 mg. Your doctor may adjust your dose at intervals of 6 weeks.

Your doctor will inform you exactly how many tablets of Fluvastatina STADA you should take.

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

Please note that you cannot use Fluvastatina STADA 80 mg prolonged-release tablets for all the dosage strengths described above. Fluvastatina STADA 80 mg prolonged-release tablets must not be divided. For lower doses (20 mg and 40 mg), your doctor will prescribe other medicines containing fluvastatin.

When to take Fluvastatina STADA

You may take your dose of Fluvastatina STADA at any time of day.

Fluvastatina STADA may be taken with or without food. Swallow the tablet whole with a glass of water.

If you take more Fluvastatina STADA than you should

If you have accidentally taken too much Fluvastatina STADA, inform your doctor immediately. You may require medical attention.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Fluvastatina STADA

Take the missed dose as soon as you remember. However, do not take it if less than 4 hours remain before your next scheduled dose. In this case, take the next dose at the usual time.

Do not take a double dose to make up for a missed dose.

If you stop taking Fluvastatina STADA

To maintain the benefits of your treatment, you should not stop taking Fluvastatina STADA unless your doctor tells you to. You should continue taking Fluvastatina STADA as prescribed to maintain low levels of your "bad" cholesterol. Fluvastatina STADA will not cure your condition but will help you control it. It is necessary to check your cholesterol levels regularly to monitor your progress.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) adverse effects could be serious: seek immediate medical help if:

• You experience unexplained muscle pain, tenderness or weakness. These may be early signs of potentially serious muscle breakdown. This can be prevented if your doctor stops your treatment with fluvastatin as soon as possible. These adverse effects have also been observed with similar medicines in this class (statins).
• You experience unusual tiredness or fever, yellowing of the skin or eyes, or dark-coloured urine (signs of hepatitis).
• You develop signs of skin reactions such as rash, blisters, redness, itching, swelling of the face, eyelids or lips.
• You have skin swelling, difficulty breathing, or dizziness (signs of a severe allergic reaction).
• You experience bleeding or bruising more easily than normal (signs of a reduced number of blood platelets).
• You develop red or purple skin lesions (signs of blood vessel inflammation).
• You develop a skin rash with red spots, mainly on the face, possibly accompanied by fatigue, fever, nausea, or loss of appetite (signs of a lupus-like reaction).
• You have severe pain in the upper abdomen (signs of inflammation of the pancreas).

If you experience any of these adverse effects, inform your doctor immediately.

Other adverse effects: inform your doctor if you are concerned.

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

Difficulty sleeping, headache, stomach discomfort, abdominal pain, nausea, abnormal test results in blood parameters related to muscle and liver.

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

Tingling or numbness in the hands or feet, altered or reduced sensation.

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

• Impotence.
• Persistent muscle weakness.
• Breathing problems including persistent cough and/or difficulty breathing or fever.
• Diarrhoea.

Other possible adverse effects:

• Sleep disorders, including insomnia and nightmares.
• Memory loss.
• Sexual dysfunction.
• Depression.
• Diabetes. This is more likely if you have high levels of sugars and fats in the blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Tendon problems, sometimes complicated by tendon rupture.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluvastatin STADA

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

• Do not use this medicine after the expiry date stated on the blister pack and container after EXP. The expiry date refers to the last day of the month indicated.

• Do not store above 30°C.

• Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Fluvastatin STADA

• The active substance is fluvastatin.

Each prolonged-release tablet contains 80 mg of fluvastatin (as fluvastatin sodium).

• The other components are:

• Tablet core: povidone, microcrystalline cellulose, hydroxyethylcellulose, mannitol, magnesium stearate.

• Tablet coating: hypromellose 50, macrogol 6000, yellow iron oxide (E172), titanium dioxide (E171).

Appearance of the product and contents of the pack

Fluvastatin STADA prolonged-release tablets are biconvex, round and yellow.

Pack sizes:

Blister (OPA/Al/PVC-Al): 7, 20, 28, 30, 50, 56, 98, 100 and 120 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Manufacturer:

Actavis Ltd.

BLB016, Belebel Industrial Estate,

Zejtun ZTN 3000

Malta

or

Actavis ehf.

Reykjavikurvegi 78,

IS-222 Hafnarfjordur

Iceland

or

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel

Germany

Date of the most recent review of this leaflet: October 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/