FLUVASTATIN RATIOPHARM 80 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Fluvastatin ratiopharm 80 mg prolonged-release tablets EFG

fluvastatin sodium

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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Fluvastatin ratiopharm and what is it used for

Fluvastatin ratiopharm contains the active substance fluvastatin sodium, which belongs to a group of medicines called statins, which are lipid-lowering medicines. They reduce the amount of fat (lipids) in the blood. They are used in patients whose condition cannot be controlled by diet and exercise alone.

Fluvastatin is a medicine used to treat high levels of fat in the blood in adults, in particular total cholesterol and the so-called "bad" cholesterol (LDL-cholesterol), which is associated with a high 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 Fluvastatin ratiopharm to prevent other serious heart problems (e.g. a heart attack) in patients who have already undergone a heart catheterization procedure.

If you have any questions about how Fluvastatin ratiopharm works or why it has been prescribed for you, ask your doctor.

2. What you need to know before you take Fluvastatin ratiopharm

Follow carefully all instructions given to you by your doctor, even if they differ from the general information contained in this leaflet.

Read the following explanations before taking Fluvastatin ratiopharm.

Do not takeFluvastatin ratiopharm

• if you are allergic to fluvastatin or any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems or have elevated liver enzymes (transaminases) of unknown cause and persist.
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Fluvastatin ratiopharm

• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Fluvastatina ratiopharm can cause serious muscle problems (rhabdomyolysis)
• if you have had liver disease before. Normally, your doctor will perform liver function tests before starting treatment with Fluvastatina ratiopharm, when the dose is increased, and at different time intervals during treatment to check for adverse effects.
• if you have kidney disease
• if you have thyroid disease (hypothyroidism)
• if you have a personal or family history of muscle disease
• 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, vertigo)
• If you engage in excessive controlled or uncontrolled muscle exercise
• If you are going to undergo surgery soon
• If you have severe metabolic, endocrine, or electrolyte disorders, such as uncompensated diabetes and low potassium levels in the blood
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4)

While taking this medicine, your doctor will closely monitor you 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 sugar or fat in your blood, are overweight, or have had high blood pressure.

Talk to your doctor or pharmacist before taking Fluvastatin ratiopharm

• if you have severe respiratory failure

If you are in any of these situations, tell your doctor before takingFluvastatin ratiopharm. Your doctor will perform a blood test before prescribing Fluvastatin ratiopharm.

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

If during treatment with Fluvastatina ratiopharm 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 failure. In this case, contact your doctor immediately.

Fluvastatin ratiopharm in people over 70 years of age

• if you are over 70 years old, your doctor may want to clarify if you are at risk of suffering from muscle disorders. You may need additional blood tests.

Children and adolescents

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

There is no experience with the use of Fluvastatin ratiopharm in combination with nicotinic acid, colestyramine, or fibrates in children and adolescents.

Other medicines and Fluvastatin ratiopharm

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Fluvastatin ratiopharm. The use of Fluvastatin ratiopharm with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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

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

Tell 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 "bad" cholesterol levels)
• 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 clotting)
• Glibenclamide (a medicine used to treat diabetes)
• Colchicine (used to treat gout)

Fluvastatin ratiopharm with food and drinks

You can take Fluvastatin ratiopharm with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatin ratiopharm if you are pregnant or breastfeeding, as the active substance may harm the fetus and it is not known if it is excreted in breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking any other medicine.

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

You should take adequate precautions to avoid becoming pregnant while receiving treatment with Fluvastatin ratiopharm.

Driving and using machines

No information is available on the effects of Fluvastatin ratiopharm on the ability to drive and use machines.

Fluvastatin ratiopharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per prolonged-release tablet; it is essentially "sodium-free".

3. How to take Fluvastatin ratiopharm

Follow exactly the administration instructions of Fluvastatin ratiopharm given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Do not exceed the recommended dose.

Your doctor will recommend that you follow a low-cholesterol diet. Continue with this diet while taking Fluvastatin ratiopharm.

How much Fluvastatin Teva should you take

Usual doses in adults

The recommended dose range of fluvastatin for adults with high levels of fat in the blood is 20 mg to 80 mg per day and depends on the reduction of cholesterol levels needed. Your doctor may adjust your dose at intervals of 4 weeks or more.

Dose in children and adolescents

In children (9 years of age and older), the initial dose is usually 20 mg of fluvastatin per day. 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 much fluvastatin you should take.

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

When to take Fluvastatin ratiopharm

If you are taking Fluvastatin ratiopharm, take your dose at any time of the day.

Fluvastatin ratiopharm can be taken with or without food. Swallow it whole with a glass of water.

If you take more Fluvastatin ratiopharm than you should

If you have accidentally taken too many Fluvastatin ratiopharm tablets, inform your doctor immediately. You may need medical attention.

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

If you forget to take Fluvastatin ratiopharm

Take a dose as soon as you remember. However, do not take it if it is less than 4 hours before the next dose. In this case, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Fluvastatin ratiopharm

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

If you have any other questions about the use of this product, 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 may be serious; seek medical attention immediately.

• If you experience unexplained muscle pain, sensitivity, or weakness. These can be early signs of a potentially serious muscle disorder (rhabdomyolysis). This can be avoided if your doctor stops your treatment with fluvastatin as soon as possible. These side effects have also been observed with similar medicines in this class (statins).

• if you experience unusual tiredness or fever, yellowing of the skin and eyes, dark-colored urine (signs of hepatitis)
• if you have signs of skin reactions such as rash, blisters, redness, itching, swelling of the face, eyelids, and lips.
• if you have swelling of the skin, difficulty breathing, dizziness (signs of a severe allergic reaction).

• if you have bleeding or bruising more easily than normal (signs of a decrease in the number of blood platelets)
• if you have red or purple skin lesions (signs of inflammation of blood vessels)
• if you have a skin rash with red spots, mainly on the face, which can be accompanied by fatigue, fever, nausea, loss of appetite (signs of a systemic lupus erythematosus-like reaction),
• if you have severe pain in the upper abdomen (signs of pancreatitis).

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

Other side effects: discuss them with your doctor if they worry you

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

Difficulty sleeping, headache, stomach upset, abdominal pain, nausea, altered values in muscle and liver parameters in blood tests.

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

Numbness or tingling in hands or feet, altered or decreased sensitivity.

Frequency not known (cannot be estimated from the available data):

• Impotence, constant muscle weakness, respiratory problems including persistent cough and/or difficulty breathing or fever
• Diarrhea.
• Severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

Talk to your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or breathing.

Other possible side effects:

• sleep disturbances, including insomnia and nightmares
• memory loss
• sexual difficulties
• depression

• Diabetes. This is more likely if you have had high levels of sugar and fat in the 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

If you think any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience 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 through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluvastatin ratiopharm

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

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the carton and on the blister after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the blisters and any unused medicinal products in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the blisters and any unused medicinal products. This will help protect the environment.

6. Further information

Composition of Fluvastatin ratiopharm

The active substance is fluvastatin sodium, equivalent to 80 mg of fluvastatin.

The other ingredients are: Tablet core: carrageenan, magnesium stearate.

Tablet coating: hydroxypropyl cellulose, hypromellose 6cP, macrogol 8000, yellow iron oxide (E-172), red iron oxide.

Appearance of the product and pack contents

Fluvastatin ratiopharm 80 mg are prolonged-release tablets of dark yellow color, round, biconvex in aluminum/aluminum blisters.

Pack sizes:

Blisters containing 20, 28, 30, 50, 56, 60, 90, 98, 100, and 490 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B 1ª planta

28108 Alcobendas Madrid

Manufacturer:

Pharmathen S.A.,

6 Dervenakion Str,

153 51 Pallini, Attiki (Greece)

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Pharmathen International S.A.

Sapes Industrial Park

Block 5 Rodopi

69300 Greece

Date of last revision of this leaflet: April 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http: //www.aemps.gob.es/