Rosuvastatin Teva-Ratiopharm 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Rosuvastatin Teva-ratiopharm 5 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medicine because 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 must not be given to other people, even if they have the same symptoms, as it may 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 Rosuvastatin Teva-ratiopharm is and what it is used for
2. What you need to know before taking Rosuvastatin Teva-ratiopharm
3. How to take Rosuvastatin Teva-ratiopharm
4. Possible adverse effects
5. How to store Rosuvastatin Teva-ratiopharm
6. Contents of the pack and other information

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

Rosuvastatin belongs to a group of medicines called statins.

Your doctor has prescribed rosuvastatin because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or stroke.

Rosuvastatina Teva-ratiopharm is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.

You have been prescribed a statin because changes in your diet and increased physical exercise have not been sufficient to correct your cholesterol levels. You must continue with a cholesterol-lowering diet and maintain regular physical activity while taking Rosuvastatina Teva-ratiopharm.

Or

• You have other risk factors that increase your chance of having a heart attack, stroke, or other related health problems.

Heart attack, stroke, and other related health problems may be caused by a condition called atherosclerosis. Atherosclerosis occurs due to the buildup of fatty deposits in your arteries.

Why it is important that you continue taking Rosuvastatina Teva-ratiopharm

Rosuvastatin is used to correct levels of fatty substances in the blood called lipids, the most well-known being cholesterol.

There are different types of cholesterol in the blood: "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Rosuvastatin lowers the amount of "bad" cholesterol and increases "good" cholesterol.
• It works by blocking the production of "bad" cholesterol and improves the body's ability to remove it from the blood.

In most people, high cholesterol levels do not affect how you feel, as they produce no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed vessels can become blocked, preventing blood supply to the heart or brain, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or related health problems.

You need to continue taking rosuvastatin even after your cholesterol levels have returned to normal, because it prevents cholesterol levels from rising again and stops the formation of fatty deposits. However, you must stop treatment if your doctor advises you to do so, or if you become pregnant.

2. What you need to know before taking Rosuvastatina Teva-ratiopharm

Do not take Rosuvastatina Teva-ratiopharm

• If you are allergic to the active substance rosuvastatin or to any of the other ingredients of this medicine (see section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatina Teva-ratiopharm by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain or cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C).
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

If you are in any of the situations listed above (or are unsure), please consult your doctor again.

Also, do not take the highest dose (40 mg)

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not functioning properly.
• If you have repeated or unexplained muscle pain or cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines.
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines called fibrates to lower cholesterol.

If you are in any of the situations listed above (or are unsure), please consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rosuvastatina Teva-ratiopharm if:

• you have kidney problems.
• you have liver problems.
• you have repeated or unexplained muscle pain or cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if accompanied by general malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.
• you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking rosuvastatin or other related medicines.
• you regularly consume large amounts of alcohol.
• your thyroid gland is not functioning properly.
• you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken cholesterol-lowering medicines.
• you are taking medicines to treat HIV infection (AIDS virus), such as ritonavir with lopinavir and/or atazanavir; see Use of Rosuvastatina Teva-ratiopharm with other medicines.
• you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infection), taken orally or by injection. The combination of fusidic acid and rosuvastatin may cause serious muscle problems (rhabdomyolysis); please see “Other medicines and rosuvastatin”. If you are over 70 years of age, (as your doctor must determine the appropriate starting dose of rosuvastatin for you).
• you have severe respiratory failure.
• you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate starting dose of rosuvastatin for you.

If you are in any of the above-mentioned situations (or are unsure):

• Do not take Rosuvastatina Teva-ratiopharm 40 mg (the highest dose of this medicine) and consult your doctor or pharmacist before starting any dose of Rosuvastatina.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop using rosuvastatin and seek immediate medical attention if you notice any of the symptoms described in section 4.

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing increased levels of liver enzymes (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) before and during treatment with rosuvastatin.

While taking this medicine, your doctor should monitor you for diabetes or risk factors for diabetes. You may be at risk of developing diabetes if you have high blood sugar or fat levels, are overweight, or have high blood pressure.

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatin should not be given to children under 6 years of age.
• If the patient is under 18 years of age: Rosuvastatin 40 mg tablets are not recommended for children and adolescents under 18 years of age.

Use of Rosuvastatina Teva-ratiopharm with other medicines

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

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

• cyclosporine (used after organ transplantation),
• warfarin, ticagrelor, or clopidogrel (or any other blood thinners),
• fibrates (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine (such as ezetimibe),
• treatments for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic – please see “Warnings and precautions”), oral contraceptives (the pill), hormone replacement therapy,
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• capmatinib (used to treat cancer),
• hormone replacement therapy,
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high levels of uric acid in blood),
• teriflunomide (used to treat multiple sclerosis),
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines may be altered by Rosuvastatina or may change the effect of Rosuvastatina.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart rosuvastatin. Taking rosuvastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take Rosuvastatina if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatin by using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive and operate machinery while being treated with rosuvastatin, as it will not affect their ability. However, some people may experience dizziness during treatment with rosuvastatin. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatina Teva-ratiopharm contains lactose and sodium.

Lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Sodium

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

3. How to take Rosuvastatine Teva-ratiopharm

Follow exactly the instructions for the use of this medicine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Usual doses in adults

If you are taking rosuvastatin for high cholesterol levels:

Starting dose

Your treatment with Rosuvastatin should begin with a dose of 5 mg or 10 mg, even if you have previously taken a higher dose of another statin. The choice of starting dose will depend on:

• Your cholesterol levels.
• Your risk of having a heart attack or stroke.
• Whether you have factors that make you more susceptible to possible side effects.

Consult your doctor or pharmacist to determine the most appropriate starting dose of Rosuvastatin for you.

Your doctor may decide to start treatment with the lowest dose (5 mg) if:

• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
• you are over 70 years old.
• you have moderate kidney problems.
• you are at risk of muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you receive the dose of Rosuvastatin appropriate for you. If you started with a 5 mg dose, your doctor may decide to double the dose to 10 mg, then to 20 mg, and later to 40 mg if necessary. If you started with a 10 mg dose, your doctor may decide to double the dose to 20 mg and then to 40 mg, if necessary. There will be an interval of four weeks between each dose adjustment.

The maximum daily dose of Rosuvastatin is 40 mg. This dose is only for patients with high cholesterol and a high risk of heart attack or stroke whose cholesterol levels do not decrease sufficiently with 20 mg.

If you are taking Rosuvastatine Teva-ratiopharm to reduce the risk of heart attack, stroke or related health problems:

The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

Use in children and adolescents aged 6–17 years

The dose range for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual recommended starting dose is 5 mg daily, and your doctor may gradually increase the dose until reaching the dose of Rosuvastatine Teva-ratiopharm appropriate for you. The maximum recommended daily dose is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take the dose prescribed by your doctor once daily. Rosuvastatine Teva-ratiopharm 40 mg tablets must not be administered to children.

How to take the tablets

Swallow each tablet with a glass of water.

Take Rosuvastatine Teva-ratiopharm once daily. You may take it at any time of day, with or without food.

Try to take the tablets at the same time each day. This will help you remember to take them.

Regular monitoring of cholesterol levels

It is important that you visit your doctor regularly for cholesterol checks to ensure your cholesterol levels have normalized and remain at appropriate levels.

Your doctor may decide to increase your dose so that you receive the dose of Rosuvastatin appropriate for you.

If you take more Rosuvastatine Teva-ratiopharm than you should

Contact your doctor or nearest hospital for advice.

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

If you are admitted to hospital or receive treatment for another condition, inform the healthcare staff that you are taking Rosuvastatin.

If you forget to take Rosuvastatine Teva-ratiopharm

Do not worry; simply 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 Rosuvastatine Teva-ratiopharm

Consult your doctor if you wish to stop treatment with Rosuvastatin. Your cholesterol levels may rise again if you stop taking Rosuvastatin.

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

4. Possible adverse effects

Like all medicines, Rosuvastatin may cause adverse effects, although not everyone experiences them.

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time.

Stop taking Rosuvastatin Teva-ratiopharm and seek immediate medical attention if you experience any of the following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue and/or throat.
• Swelling of the face, lips, tongue and/or throat, which may cause difficulty swallowing.
• Severe skin itching (with hives).
• Red, flat, non-elevated spots on the trunk, often circular or target-shaped, sometimes with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also stop taking Rosuvastatin and consult your doctor immediately

• if you experience unexplained muscle pain and cramps lasting longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects, which very rarely have led to a potentially fatal muscle injury called rhabdomyolysis.
• if you experience muscle rupture
• if you develop a syndrome with symptoms resembling lupus (including rash, joint disorders, and effects on blood cells)

Common adverse effects (may affect up to 1 in 10 people)

• Headache
• Stomach pain
• Constipation
• Nausea
• Muscle pain
• Weakness
• Dizziness
• Diabetes mellitus. This is more likely to occur if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Increase in the amount of protein in urine – this usually returns to normal on its own without needing to stop treatment with Rosuvastatin (only with Rosuvastatin Teva-ratiopharm 40 mg film-coated tablets EFG).

Uncommon adverse effects (may affect up to 1 in 100 people)

• Hives, itching, and other skin reactions.
• Increase in the amount of protein in urine – this usually returns to normal on its own without needing to stop treatment with Rosuvastatin tablets (uncommon adverse effect with daily doses of 5 mg, 10 mg, and 20 mg of Rosuvastatin).

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

• Severe allergic reaction – symptoms include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe skin itching (with hives). If you think you are having an allergic reaction, stop taking Rosuvastatin and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Rosuvastatin and consult your doctor immediately if you have unexplained muscle pain or cramps lasting longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increase in liver enzymes (transaminases) in blood.
• Bleeding or bruising more easily than normal due to low platelet levels in the blood.
• Syndrome with symptoms resembling lupus (including hives, joint disorders, and effects on blood cells).

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

• Jaundice (yellowing of the skin and eyes).
• Hepatitis (inflamed liver).
• Traces of blood in urine.
• Nerve damage in arms and legs (with numbness or tingling).
• Joint pain.
• Memory loss.
• Breast enlargement in men (gynecomastia).

Adverse effects with unknown frequency that may include:

• Diarrhea (loose stools).

• Cough

• Shortness of breath

• Edema (swelling)

• Sleep disturbances including insomnia and nightmares

• Sexual difficulties

• Respiratory problems including persistent cough and/or breathlessness or fever.

• Tendon injuries

• Persistent muscle weakness

• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).

• Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rosuvastatin Teva-ratiopharm

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation CAD. The expiry date refers to the last day of the month indicated.

For blisters:

Do not store above 30 °C.

For bottles:

This medicine does not require any special storage conditions.

Shelf-life after first opening of the bottle: 6 months.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin Teva-ratiopharm 5 mg

• The active substance is rosuvastatin.

Rosuvastatin Teva-ratiopharm 5 mg film-coated tablets contain rosuvastatin calcium equivalent to 5 mg of rosuvastatin.

• The other components (excipients) are:

Tablet core: microcrystalline cellulose, lactose monohydrate, crospovidone (type B), hypromellose 6 Cp, sodium hydrogen carbonate, magnesium stearate.

Coating: lactose monohydrate, hypromellose 6 Cp, titanium dioxide (E171), triacetin, yellow iron oxide (E172).

Appearance of the product and contents of the pack

Rosuvastatin Teva-ratiopharm 5 mg film-coated tablets are yellow, round, biconvex tablets marked with "5" on one side, with a diameter of 5.5 mm.

Rosuvastatin Teva-ratiopharm 5 mg film-coated tablets are available in blister packs containing 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98 and 100 tablets, and in bottles containing 28, 30 and 100 tablets.

The bottle contains a separate compartment with a desiccant containing silica gel. DO NOT remove it from the bottle. DO NOT ingest the desiccant containing silica gel.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3,

D-89143 Blaubeuren (Germany)

Or

PLIVA CROATIA LIMITED (PLIVA HRVATSKA D.O.O.)

Prilaz Baruna Filipovica, 25

Zagreb 1000 Croatia

Or

Teva Pharma, S.L.U.

Polígono Industrial Malpica, c/C, nº 4,

50016 Zaragoza

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria: Rosuvastatin ratiopharm 5 mg Filmtabletten

Bulgaria: Rosuvastatin ratiopharm 5 mg film-coated tablets

Finland: Rosuvastatin ratiopharm 5 mg tabletti, kalvopäällysteinen

Iceland: Rosuvastatin Teva

Norway: Rosuvastatin Teva

Portugal: Rosuvastatina ratiopharm

Spain: Rosuvastatina Teva-ratiopharm 5 mg comprimidos recubiertos con película EFG

Date of the most recent revision of this leaflet: February 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74731/P_74731.html