ROSUVASTATIN TEVA-RATIOPHARM 10 mg FILM-COATED TABLETS

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

Do not take Rosuvastatina Teva-ratiopharm

• If you are allergicto the active substance rosuvastatinaor to any of the other components of this medication (see section 6).
• If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatina, stop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatina Teva-ratiopharm 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 weakness.
• If you are taking a combination of medications sofosbuvir/velpatasvir/voxilaprevir(used to treat a viral liver infection called hepatitis C).
• If you are taking a medication called ciclosporin(used, for example, after an organ transplant).

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

Additionally, do not takethe highest dose (40 mg)

• If you have moderate kidney problems(if you are unsure, consult your doctor).
• If your thyroid glandis not working correctly.
• If you have repeated or unexplained muscle pain or weakness, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications.
• 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 to appear (see section 4).
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medications called fibratesto lower cholesterol.

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

Warnings and precautions

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

kidney problemsliver problemsrepeated or unexplained muscle pain or weakness, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unexplained muscle pain or weakness, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have constant muscle weakness.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 to appear (see section 4).severe skin rash or skin peeling, blisters, and/or mouth sores after taking rosuvastatina or other related medications.large amounts of alcohol.thyroid glandis not working correctly.other medicationscalled fibratesto lower cholesterol.medicationsto treat HIV infection(such as ritonavir with lopinavir and/or atazanavir), see Using Rosuvastatina Teva-ratiopharm with other medications.fusidic acid(an antibiotic), orally or by injection. The combination of fusidic acid and rosuvastatina can rarely cause serious muscle problems (rhabdomyolysis); please see "Other medications and rosuvastatina" for more information. If you are over 70 years old, (as your doctor will determine the appropriate starting dose of rosuvastatina for you).severe respiratory insufficiency.of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will determine the appropriate starting dose of rosuvastatina for you.

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

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

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

In a small number of people, statins can affect the liver. This is detected by a simple blood test that checks for increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function tests) before and after treatment with rosuvastatina.

While taking this medication, your doctor should monitor you if you have diabetes or are at risk of developing 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: Rosuvastatina should notbe administered to children under 6 years of age.
• If the patient is under 18 years of age: It is not recommendedto administer Rosuvastatina Teva-ratiopharm 40 mg tablets to children and adolescents under 18 years of age.

Using Rosuvastatina Teva-ratiopharm with other medications

Tell your doctor or pharmacist if you are using, have recently used, or might use other medications, including those obtained without a prescription.

Tell your doctor if you are using any of the following medications:

• ciclosporin (used after an organ transplant),
• warfarin, ticagrelor, or clopidogrel (or any other blood thinner),
• fibrates (such as gemfibrozil, fenofibrate) or any other medication used to lower cholesterol (such as ezetimibe),
• indigestion treatments (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 uric acid levels in the blood),
• teriflunomide (used to treat multiple sclerosis),
• any of the following medications 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 medications can be altered by Rosuvastatina or can change the effect of Rosuvastatina.

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

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and using machines

Most patients can drive vehicles and use machines during treatment with rosuvastatina, as it will not affect their ability. However, some people may feel dizzy during treatment with rosuvastatina. 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 told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to take Rosuvastatina Teva-ratiopharm

Follow the administration instructions for this medication exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Usual dose in adults

If you are taking rosuvastatina for high cholesterol:

Starting dose

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

• Your cholesterol levels.
• The degree of risk you have of having a heart attack or stroke.
• If you have factors that make you more vulnerable to possible side effects.

Consult your doctor or pharmacist to determine the best starting dose of Rosuvastatina for you.

Your doctor may decide to start treatment with the smallest 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 having muscle pain or weakness (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is to ensure you are taking the correct dose of Rosuvastatina for you. If you started with a dose of 5 mg, 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 dose of 10 mg, 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 Rosuvastatina is 40 mg. This dose is only for patients with high cholesterol and a high risk of having a heart attack or stroke, whose cholesterol levels do not decrease sufficiently with 20 mg.

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

The recommended dose is 20 mg per day. 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 in children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The recommended starting dose is 5 mg. Your doctor may gradually increase your dose to the dose of Rosuvastatina Teva-ratiopharm that is suitable for you. The maximum recommended daily dose is 10 or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take the dose indicated by your doctor once daily. Do notadminister Rosuvastatina Teva-ratiopharm 40 mgtablets to children.

Taking the tablets

Swallow each tablet with a glass of water.

Take Rosuvastatina Teva-ratiopharm once a day. You can 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 cholesterol level checks

It is essential to visit your doctor regularly for cholesterol checks to ensure your cholesterol levels have normalized and are maintained at appropriate levels.

Your doctor may decide to increase your dose to ensure you are taking the correct dose of Rosuvastatina for you.

If you take more Rosuvastatina Teva-ratiopharm than you should

Contact your doctor or the nearest hospital for advice.

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 medication and the amount ingested.

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

If you forget to take Rosuvastatina Teva-ratiopharm

Do not worry, simply take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Rosuvastatina Teva-ratiopharm

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

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

4. Possible Adverse Effects

Like all medicines, Rosuvastatin may cause adverse effects, although not all people suffer from them.

It is essential that you know what these adverse effects may be. They are usually mild and disappear in a short period.

Stop taking Rosuvastatin Teva-ratiopharm and seek immediate medical attentionif 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 can cause difficulty swallowing.
• Intense itching of the skin (with hives).
• Red spots on the torso, not elevated, in a target or circular shape, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking Rosuvastatin and consult your doctor immediately

• unjustified muscle pain and crampsthat last longer than expected. Muscle symptoms are more frequent in children and adolescents than in adults. As with other statins, a very small number of people have suffered unpleasant muscle effects that, very rarely, have resulted in a potentially fatal muscle injury called rhabdomyolysis.
• (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 It is more frequent if you have high sugar and fat levels in your blood, are overweight, or have high blood pressure. Your doctor will monitor you while you take this medication
• An increase in the amount of protein in the urine – this usually returns to normal on its own without the need to interrupt treatment with Rosuvastatina (only with Rosuvastatina Teva-ratiopharm 40 mg film-coated tablets EFG).

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Urticaria, itching, and other skin reactions.
• An increase in the amount of protein in the urine – this usually returns to normal on its own without the need to interrupt treatment with Rosuvastatina tablets (uncommon adverse effect with daily doses of 5 mg, 10 mg, and 20 mg of Rosuvastatina).

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, intense itching of the skin (with hives). If you think you are having an allergic reaction, stop taking Rosuvastatina and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Rosuvastatina and consult your doctor immediately if you have unjustified muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in blood.
• Bleeding or bruising more easily than normal due to a low platelet count in the blood
• Syndrome that has similar symptoms to lupus (including urticaria, 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 the urine.
• Nerve damage in the legs and arms (with numbness or tingling).
• Joint pain.
• Memory loss.
• Enlargement of the breast in men (gynecomastia)

Adverse Effects of Unknown Frequency that may include:

• Diarrhea (loose stools).
• Cough
• Shortness of breath
• Edema (swelling)

• Sleep disturbances including insomnia and nightmares

• Sexual difficulties
• Depression
• Respiratory problems including persistent cough and/or shortness of breath or fever.
• Tendon injuries
• Constant muscle weakness
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenic ocular (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 breathing.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines Website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rosuvastatina Teva-ratiopharm

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

For blisters:

Do not store at a temperature above 30 ºC.

For bottles:

This medication does not require special storage conditions.

Expiration after opening the bottle 6 months.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosuvastatina Teva-ratiopharm 10 mg

• The active ingredient is rosuvastatin.

Rosuvastatina Teva-ratiopharm 10 mg film-coated tablets contain rosuvastatin calcium equivalent to 10 mg of rosuvastatin.

• The other components (excipients) are:

Core of the tablet: 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, and iron oxide red (E172)

Appearance of the Product and Package Contents

Rosuvastatina Teva-ratiopharm 10 mg film-coated tablets are pink, round, biconvex tablets, marked with “10” on one face and with a score line on the other, approximately 7 mm in diameter.

The tablets can be divided into two equal halves.

Rosuvastatina Teva-ratiopharm 10 mg film-coated tablets are presented in blister packs of 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, and 100 tablets, and bottles of 28, 30, and 100 tablets.

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

Only some package sizes may be marketed.

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-Strassee 3,

D-89143 Blaubeuren (Germany)

O

Pliva Croatia, Ltd.

Prilaz baruna Filipovica 25

10.000 Zagreb

Croatia

O

Teva Pharma, S.L.U.

Polígono Industrial Malpica, c/C, nº 4,

50016 Zaragoza

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Austria: Rosuvastatin ratiopharm 10 mg Filmtabletten

Bulgaria: ???????????? ???? 10 mg ????????? ????????

Czech Republic: Rosuvastatin-Teva Pharma 10 mg

Finland: Rosuvastatin ratiopharm 10 mg tabletti, kalvopäällysteinen

Iceland: Rosuvastatin Teva

Norway: Rosuvastatin Teva

Portugal: Rosuvastatina ratiopharm

Romania: Rosuvastatina ratiopharm 10 mg comprimate filmate

Spain: Rosuvastatina Teva-ratiopharm 10 mg comprimidos recubiertos con película EFG

Date of the last revision of this prospectus:February 2024

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

You can access detailed information about this medication by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74734/P_74734.html