FLUVASTATIN TEVA-RATIOPHARM 80 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Fluvastatin Teva-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 get 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 pack

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

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

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

Fluvastatin Teva-ratiopharm 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 or 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 fat) in the blood.

Your doctor may also prescribe Fluvastatin Teva-ratiopharm to prevent other serious heart problems (e.g. a heart attack) in patients after they have undergone heart catheterization through an intervention in the heart vessels.

If you have any doubts about how this medicine works or why it has been prescribed for you, ask your doctor.

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

Follow carefully all the instructions given to you by your doctor, they may be different from those contained in this leaflet.

Read the following explanations before taking Fluvastatin Teva-ratiopharm.

Do not takeFluvastatin Teva-ratiopharm

• if you are allergic (hypersensitive) to fluvastatin or any of the other ingredients of Fluvastatin Teva-ratiopharm listed in section 6.
• if you have liver problems, or have a persistent increase in certain liver enzymes (transaminases) of unknown cause
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatin Teva-ratiopharm.

• if you are or have taken in the last 7 days a medicine that contains fusidic acid, (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Fluvastatin Teva-ratiopharm can cause serious muscle problems (rhabdomyolysis).
• if you have previously suffered from liver disease. Normally, you will have blood tests to check your liver function before starting treatment with Fluvastatin Teva-ratiopharm, when increasing the dose and at different time intervals during treatment to monitor the appearance of possible side effects.
• if you have kidney disease.
• if you have thyroid disease (hypothyroidism).
• if you have a personal or family history of muscle diseases.
• 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 low blood pressure (these signs may include dizziness, feeling of vertigo)
• if you engage in excessive controlled or uncontrolled muscle exercise
• if you are going to have surgery
• if you have had severe metabolic, endocrine or electrolyte disorders such as uncontrolled diabetes and low potassium levels in the blood.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects 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 to appear (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 high blood pressure.

Check with your doctor or pharmacist before taking Fluvastatin Teva-ratiopharm

• if you have severe respiratory failure

If you are in any of these situations, tell your doctor before takingFluvastatin Teva-ratiopharm. Your doctor will perform a blood test before prescribing Fluvastatin Teva-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 Fluvastatin Teva-ratiopharm, you develop symptoms or signs such as nausea, vomiting, loss of appetite, yellow eyes or skin, confusion, euphoria, depression, mental slowness, slurred speech, sleep disturbances, tremors, bruising or bleeding, these may be signs of liver failure. In this case, contact your doctor immediately.

Fluvastatin Teva-ratiopharm and people over 70 years old

If you are over 70 years old, your doctor may want to check if you have risk factors for muscle diseases. You may need specific blood tests.

Children/adolescents

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

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

Other medicines and Fluvastatin Teva-ratiopharm

Tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines or if you might take/use any other medicines, even those obtained without a prescription.

• If you need to take oral fusidic acid to treat a bacterial infection, you will have 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 Teva-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 Teva-ratiopharm.

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

• Cyclosporin (a medicine used to suppress the immune system)
• Fibrates (e.g. gemfibrozil), nicotinic acid or bile acid sequestrants (medicines used to lower "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 Teva-ratiopharm with food and drinks

You can take Fluvastatin Teva-ratiopharm with or without food.

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, 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 precautions to avoid becoming pregnant while receiving treatment with Fluvastatin Teva-ratiopharm.

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

Your doctor will discuss with you the potential risks of taking Fluvastatin Teva-ratiopharm during pregnancy.

Driving and using machines

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

Fluvastatin Teva-ratiopharm contains sodium

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

3. How to take Fluvastatin Teva-ratiopharm

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Do not take a higher dose than indicated.

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

How much Fluvastatin Teva-ratiopharm should you take

Usual doses in adults

The dose range of fluvastatin for adults is 20 mg to 80 mg per day and depends on the reduction of cholesterol levels that is necessary. Your doctor may adjust your dose at intervals of 4 weeks or more.

Use in children and adolescents

In children (9 years of age and older) the initial dose is usually 20 mg 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.

Fluvastatin Teva-ratiopharm is only available in 80 mg prolonged-release tablets. For lower doses (20 mg and 40 mg), your doctor will prescribe other fluvastatin medicines.

When to take Fluvastatin Teva-ratiopharm

If you are taking Fluvastatin Teva-ratiopharm 80 mg prolonged-release tablets EFG, you can take your dose at any time of the day.

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

If you take more Fluvastatin Teva-ratiopharm than you should

If you have accidentally taken too much Fluvastatin Teva-ratiopharm, inform your doctor immediately or call the Toxicology Information Service telephone 91 562 04 20, indicating the medicine and the amount ingested. You may need medical attention.

If you forget to take Fluvastatin Teva-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 Teva-ratiopharm

To maintain the benefits of your treatment, do not stop taking Fluvastatin Teva-ratiopharm unless your doctor tells you to. You should continue taking Fluvastatin Teva-ratiopharm as prescribed to keep your "bad" cholesterol levels low. Fluvastatin Teva-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 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: seek medical attention immediately.

• if you suffer from unexplained muscle pain, sensitivity or weakness. These can be the first signs of a potentially serious muscle breakdown. This can be avoided if your doctor stops your treatment with fluvastatin as soon as possible. These side effects have also been described with other medicines of the same family (statins).
• if you suffer from 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 - anaphylactic reaction).
• if you have bleeding or bruising more easily than normal (signs of a decrease in the number of platelets)
• if you have red or purple skin lesions (signs of inflammation of the blood vessels - vasculitis). This side effect is very rare
• if you have a skin rash with red spots mainly on the face that may 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 - inflammation of the pancreas).

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

Other side effects: inform your doctor if you are concerned

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 of hands or feet, altered or decreased sensitivity.

Frequency not known (frequency 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, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

Consult 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 difficulty 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 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.

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluvastatin Teva-ratiopharm

Keep out of the sight and reach of children.

Do not store above 30°C.

Blisters:

Store in the original packaging to protect from light.

Bottle (glass and HDPE bottle):

Keep the container tightly closed to protect from moisture and light.

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

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

6. Container Content and Additional Information

Composition of Fluvastatina Teva-ratiopharm

The active ingredient is fluvastatina sodium, equivalent to 80 mg of fluvastatina.

The other components are:

Core of the tablet:

Povidone, microcrystalline cellulose, hydroxyethylcellulose, magnesium stearate manitol (E421), magnesium stearate,

Coating of the tablet:

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

Appearance of the Product and Container Content

Fluvastatina Teva-ratiopharm 80 mg are prolonged-release biconvex, round, yellow tablets.

Container sizes:

Blister (OPA/Aluminum/PVC-Aluminum): 10, 20, 28,30, 50, 60 and 100 prolonged-release tablets.

Not all container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid

Manufacturer:

Actavis Ltd.

BLB015-016, Belebel Industrial Estate,

Zejtun ZTN 3000

Malta

Date of the Last Revision of this Prospectus: March 2023

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