ROSUVASTATIN TEVA 40 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 rosuvastatinaor any of the other ingredients of this medicine (see section 6).
• 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 are pregnantor breast-feeding. If you become pregnant while taking rosuvastatina, stop taking it immediatelyand inform your doctor. Women must 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 haverepeated 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 calledciclosporin(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 takethe highest dose (40 mg) of Rosuvastatina

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid glandis not working correctly.
• If you have repeated or unexplained muscle pains, a personal or family history of muscle problems, or a previous 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(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines calledfibratesto 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

• if you have kidney problems
• if you have liver problems
• If you have repeated or unexplained muscle pains, 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 have unexplained muscle pain, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you have 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 make the disease worse or trigger the onset of myasthenia (see section 4).
• If you regularly drink large amounts of alcohol.
• If your thyroid glandis not working correctly.
• If you are taking other medicines calledfibratesto lower cholesterol.
• If you are taking medicines forHIV infection(such as ritonavir with lopinavir and/or atazanavir), see Using Rosuvastatina Teva with other medicines.
• If you are taking or have taken in the last 7 days a medicine calledfusidic acid(an antibiotic), orally or by injection. The combination of fusidic acid and rosuvastatina can cause serious muscle problems (rhabdomyolysis), please see “Other medicines and rosuvastatina”.
• 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(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 40 mg (the highest dose of this medicine) and consult your doctor or pharmacist before starting to take any dose of rosuvastatina.

In a small number of people, statins can affect the liver. This is identified by a simple test that looks for high levels of liver enzymes in the blood. For this reason, your doctor will normally carry out this blood test (liver function test) before and during treatment with 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.

While you are on 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 and fats in your blood, are overweight, and 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:The 40 mg tablet of rosuvastatina is not recommended for use in 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, including those obtained without a prescription.

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

• ciclosporin (used after an organ transplant),
• warfarin, clopidogrel, 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) If you need to take fusidic acid by mouth to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart rosuvastatina tablets. Taking rosuvastatina with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.
• 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 can be altered by rosuvastatina or can change the effect of Rosuvastatina.

Pregnancy and breast-feeding

Do not takeRosuvastatinaif you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatina, stop taking it immediatelyand inform your doctor. Women must 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 tablet; this is essentially “sodium-free”.

3. How to take Rosuvastatina Teva

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are in doubt, consult your doctor or pharmacist again.

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 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).

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 very high cholesterol levels 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 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 mg to 20 mg once daily. The recommended starting dose for treatment is 5 mg. Your doctor may gradually increase your dose to the dose of rosuvastatina that is right for you. The maximum recommended daily dose is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take the dose prescribed by your doctor once daily. Do notgive rosuvastatina 40 mgtablets to children.

Taking the tablets

Swallow each tablet with a glass of water.

Take Rosuvastatina once a day. You can take it at any time of the 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 your cholesterol levels

It is important that you regularly visit your doctor to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and remain 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 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 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, not raised, 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, which have very rarely 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
• 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 the 40 mg dose).
• 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 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 with the 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 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 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.
• Increased breast tissue 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).
• Myasthenia of the eye (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 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 Rosuvastatin Teva

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.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of 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 Rosuvastatin Teva 40 mg film-coated tablets EFG

• The active ingredient is rosuvastatin.

Rosuvastatin Teva 40 mg film-coated tablets EFG contain rosuvastatin calcium equivalent to 40 mg of rosuvastatin.

• The other components (excipients) are:

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

Tablet coating: lactose monohydrate, hypromellose 6 Cp, titanium dioxide (E171), triacetin, and iron oxide red (E172)

Appearance of the Product and Package Contents

Rosuvastatin Teva 40 mg film-coated tablets are oval, biconvex, pink, engraved with "40" on one side and with a score line on the other side, dimensions: 11.5 x 7 mm

The tablets can be divided into two equal halves.

Rosuvastatin Teva 40 mg film-coated tablets are available in blister packs of 7, 14, 15, 20, 28, 28 (calendar pack), 30, 30 (unit-dose blister), 42, 50, 50 (unit-dose blister), 56, 60, 84, 90, 90 (unit-dose blister), 98, 100, and 100 (unit-dose blister) tablets, and bottles of 28, 30, 100, and 250 tablets.

Only some pack 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)

Or

HBM Pharma s.r.o.

Sklabinská 30, 036 80 Martin

Slovak Republic

Or

PLIVA Krvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz Baruna Filipovica, 25

Zagreb 10000 Croatia

Or

Teva Pharma, S.L.U.

Polígono Industrial Malpica, c/C, nº 4,

50016 Zaragoza

Spain

Date of the last revision of this prospectus: April 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/