ROSUVASTATIN TEVA 15 mg FILM-COATED TABLETS

2. What you need to know before you take Rosuvastatina Teva

Do not take Rosuvastatina Teva

• If you are allergicto the active substance rosuvastatina or any of the other ingredients of this medicine (see section 6).
• If you are pregnantor breast-feeding. 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.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pains.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir(used to treat a viral liver infection called hepatitis C).
• If you are taking a medicine 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.

Also, do not take Rosuvastatina 30 mg or a higher dose:

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid gland does not work correctly.
• If you have repeated or unexplained muscle pains, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines 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 treatment with rosuvastatina.

• If you have repeated or unexplained muscle pains, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you have unexplained muscle pain, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you experience persistent muscle weakness.
• If you have or have had myasthenia(a disease that causes general muscle weakness, which 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 (see section 4).
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking rosuvastatina or other related medicines.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland does not work correctly.
• If you are taking other medicines called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines before.
• If you are taking medicines to treat HIV infection(such as ritonavir with lopinavir and/or atazanavir), see "Other medicines and Rosuvastatina Teva".
• If you are taking or have taken in the last 7 days a medicine called fusidic acid(an antibiotic), orally or by injection. The combination of fusidic acid and rosuvastatina can cause serious muscle problems (rhabdomyolysis), see "Other medicines and Rosuvastatina Teva".
• If you are over 70 years old(as your doctor will need to choose the right starting dose of rosuvastatina for you).
• If you have severe respiratory problems.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will need to choose the right starting dose of rosuvastatina for you.

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

• Do not take Rosuvastatina Teva 30 mg or a higher dose 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 rosuvastatina. Stop taking 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 carry out blood tests (liver function tests) before and after starting treatment with rosuvastatina.

While you are on this medicine, your doctor will need to 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 levels of sugar or fat in your blood, are overweight, or have high blood pressure.

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatina should not be given to children under 6 years of age.
• If the patient is under 18 years of age: It is not recommended to give Rosuvastatina 30 mg or higher doses to children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Teva

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

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

• ciclosporin (used after an organ transplant),
• warfarin, clopidogrel, or ticagrelor (or any other blood thinner),
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
• indigestion treatments (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic – see "Warnings and precautions"),
• oral contraceptives (the pill),
• 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 the 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 fusidic acid by mouth to treat a bacterial infection, you must stop taking this medicine temporarily. Your doctor will tell you when it is safe to start taking rosuvastatina again. Taking rosuvastatina with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Pregnancy and breast-feeding

Do not take rosuvastatinaif you are pregnant or breast-feeding. 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 taking any medicine.

Driving and using machines

Most patients can drive and use machines while taking 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 contains lactose and sodium.

Lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Sodium

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

3. How to take Rosuvastatina Teva

Follow the instructions for administration of this medicine exactly as told by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual doses 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 before. The choice of starting dose will depend on:

• Your cholesterol levels.
• The level 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 muscle pains (myopathy).

For doses not covered by this medicine, other presentations are available on the market.

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the right 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 enough with 20 mg.

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

The recommended dose is 20 mg once 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 in children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg once daily, and your doctor may gradually increase the dose to find the right amount of rosuvastatina film-coated tablets for you. The maximum daily dose of rosuvastatina is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take your dose once daily. Children should not use Rosuvastatina 30 mgor higher doses.

Taking the tablets

Swallow each tablet whole with a glass of water.

Take Rosuvastatina Teva 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 checks of cholesterol levels

It is important that you see your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and are being maintained at the right levels.

Your doctor may decide to increase your dose so that you are taking the right dose of rosuvastatina for you.

If you take more Rosuvastatina Teva 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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take Rosuvastatina Teva

Do not worry, just 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

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

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

4. Possible Adverse Effects

Like all medicines, rosuvastatin can cause adverse effects, although not all people suffer from them.

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

Stop taking Rosuvastatina Teva 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.
• Severe skin itching (with hives).
• Red spots on the torso, often with blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking rosuvastatina and consult your doctor immediately

• unjustified muscle pain and crampsthat last 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 suffered unpleasant muscle effects, which have very rarely resulted in a potentially life-threatening 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
• 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 the 40 mg dose).
• Diabetes mellitus It is more common 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 are taking this medication.

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

• Hives, 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 (only 5 mg, 10 mg, and 20 mg doses).

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 rosuvastatinaand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking rosuvastatina and consult your doctor immediatelyif you have unjustified muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in the blood.
• Bleeding or bruising more easily than usual due to a low platelet count in the blood.
• Lupus or similar disease (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 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, which can affect the muscles used for breathing in some cases).
• Myasthenia gravis (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.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that are not listed in this leaflet. 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

Keep out of sight and reach of children.

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

For blisters:

Do not store above 30 ºC.

For bottles:

This medication does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosuvastatina Teva

• The active ingredient is rosuvastatin.

Rosuvastatina Teva 15 mg: each film-coated tablet contains 15 mg of rosuvastatin (as rosuvastatin calcium).

Rosuvastatina Teva 30 mg: each film-coated tablet contains 30 mg of rosuvastatin (as rosuvastatin calcium).

• The other components (excipients) are:

Core of the tablet:

microcrystalline cellulose,

lactose monohydrate,

crospovidone (type B),

hydroxypropylcellulose,

sodium hydrogen carbonate,

magnesium stearate.

Coating of the tablet:

lactose monohydrate,

hypromellose 6 Cp,

titanium dioxide (E171),

triacetin,

yellow iron oxide (E172).

Appearance of the Product and Package Contents

Rosuvastatina Teva 15 mg film-coated tablets are yellow, round, biconvex, marked with “15” on one side and flat on the other.

Rosuvastatina Teva 30 mg film-coated tablets are yellow, round, biconvex, marked with “30” on one side and flat on the other.

Rosuvastatina Teva is available in blister packs of 28, 30, 56, 90, 98, and 100 tablets, and bottles of 30 and 100 tablets.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva B.V.

Swensweg 5, 2031GA Haarlem

Netherlands

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strassee 3,

D-89143 Blaubeuren (Germany)

Or

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

Prilaz Baruna Filipovica, 25

Zagreb 1000 Croatia

Or

Teva Pharma, S.L.U.

Polígono Industrial Malpica, c/C, nº 4,

50016 Zaragoza

Spain

Or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80.

31-546 Krakow

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas – Madrid (Spain)

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

Austria: Rosuvastatin ratiopharm 15 / 30 mg Filmtabletten

Belgium: Rosuvastatine Teva 15 / 30 mg filmomhulde tabletten/comprimés pelliculés/ Filmtabletten

Finland: Rosuvastatin Actavis 15 / 30 mg tabletti, kalvopäällysteinen

Croatia: Epri 15 / 30 mg filmom obložene tablete

Hungary: Rozuva-Teva 15 / 30 mg filmtabletta

Portugal: Rosuvastatina Ratiopharm

Date of the last revision of this leaflet:August 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 and updated information about this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89822/P_89822.html

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