Package Insert: Information for the Patient

Rosuvastatina Tarbis 5 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isRosuvastatina Tarbisand for what it is used

2. What you need to know before starting to takeRosuvastatina Tarbis

3. How to takeRosuvastatina Tarbis

4. Possible adverse effects

5. Storage ofRosuvastatina Tarbis

6. Contents of the package and additional information

Rosuvastatin Tarbis contains the active ingredient rosuvastatin, which belongs to a group of medicines called statins.

You have been prescribed Rosuvastatin because:

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

Rosuvastatin is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.

You have been advised to take a statin because the changes made to your diet and the increase in physical exercise have not been sufficient to correct your cholesterol levels. You must maintain a diet that helps to lower cholesterol and continue to exercise while on treatment with Rosuvastatin.

Or

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

A heart attack, stroke, and other health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the formation of fatty deposits in your arteries.

Why is it important to continue taking Rosuvastatin?

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

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

•Rosuvastatin reduces the amount of bad cholesterol and increases good cholesterol.

•It acts by blocking the production of bad cholesterol and improving the body's ability to eliminate it from the blood.

In most people, high cholesterol levels do not affect how they feel since they do not produce any symptoms. However, if left untreated, fatty deposits can form in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed vessels can become blocked and prevent blood supply to the heart or brain, causing a heart attack or stroke. By reducing your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other health problems.

You needto continue taking rosuvastatin, even if you have achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing again and forming fatty deposits. However, you should stop treatment if your doctor advises you to or if you become pregnant.

Do not take Rosuvastatina Tarbis

•If you are allergic (hypersensitive) to rosuvastatina or to any of the other components of this medication (listed in section 6).

•If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatinastop taking it immediately and 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 unjustified muscle pain and cramps.

•If you are taking a medication called ciclosporina(used, for example, after an organ transplant).

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

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

•If you have moderate kidney problems(if in doubt, consult your doctor).

•If your thyroid glanddoes not function correctly.

•If you have repeated or unjustified muscle pain and cramps, a personal or family history of muscle problems or a previous history of muscle problems during treatment with other cholesterol-lowering medications.

•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 take other medications called fibratesto lower cholesterol.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rosuvastatina

•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 myasthenia gravis (a disease that causes weakness of the eye muscles), as statins sometimes can worsen the disease or cause myasthenia (see section 4).

• If you have kidney problems.

•If you have liver problems.

•If you have repeated or unjustified muscle pain and cramps, a personal or family history of muscle problems or a previous history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you experience general discomfort or fever. Also, inform your doctor or pharmacist if you experience persistent muscle weakness.

•If you regularly consume large amounts of alcohol.

•If your thyroid glanddoes not function correctly.

•If you take other medications called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medications previously.

•If you take medications to treat HIV (HIV virus) or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir, seeOther medications and Rosuvastatina

•If you take or have taken in the last 7 days a medication calledacid fusidic(a medication to treat bacterial infections), by oral or injectable route. The combination of acid fusidic and Rosuvastatina may cause severe muscle problems (rhabdomyolysis).

•If you have severe respiratory failure,

•If you are of Asian origin, for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian. Your doctor must establish the appropriate starting dose of rosuvastatina for you.

•If you are over 70 years old(since your doctor must establish the appropriate starting dose of rosuvastatina for you).

If you find yourself in any of these situations mentioned above (or are unsure):

•Do not take the highest dose of 40 mg and consult your doctor or pharmacist before starting to take any dose of Rosuvastatina.

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

While taking this medication, 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 blood sugar levels, are overweight and have high blood pressure.

Children and adolescents

•If the patient is under 6 years of age: Rosuvastatina should not be administered to children under 6 years of age.

•If the patient is under 18 years of age:Rosuvastatina 40 mg tablets should not be administered to children and adolescents under 18 years of age.

Use of Rosuvastatina Tarbis with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Inform your doctor if you are using any of the following medications: ciclosporina (used after an organ transplant), warfarin or clopidogrel (or any other anticoagulant, such as acenocoumarol), fibrates (such as gemfibrozil, fenofibrate) or any other medication used to lower cholesterol (such as ezetimiba), treatments for indigestion (used to neutralize stomach acid), erythromycin (an antibiotic), acid fusidic (an antibiotic - please see below and in Warnings and precautions) oral contraceptives (the pill), hormone replacement therapy, regorafenib (used to treat cancer) or 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvirntasvir.The effects of these medications may be modified by rosuvastatina or may change the effect of rosuvastatina.

If you need to take acid fusidic by oral route for the treatment of a bacterial infection, you should temporarily suspend the treatment with rosuvastatina. Your doctor will indicate when you should restart your treatment with this medication. The combination of rosuvastatina and acid fusidic may rarely cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Rosuvastatina Tarbis with food and drinks

You can take this medication with or without food.

Pregnancy, breastfeeding and fertility

Do not take rosuvastatinaif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatinastop 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 Tarbiscontains lactose.

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

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

Usual doses in adults

If you are taking rosuvastatin for high cholesterol levels:

Starting dose

Your treatment with rosuvastatin should start witha 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 any factor that makes you more vulnerable to possible side effects.

Check with your doctor or pharmacist which is the best starting dose of rosuvastatin for you.

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

•If you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).

•If you are over 70 years old.

•If you have a specific genetic variation (known as a genetic polymorphism), which may cause an increase in rosuvastatin levels.

•If you have moderate kidney problems.

•If you have a risk of developing muscle pain and cramps (myopathy).

•If you are taking rosuvastatin with other medications that may increase the level of rosuvastatin in the blood.

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is to ensure you are taking the right dose of rosuvastatin 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 later to 40 mg, if necessary. There will be a four-week interval between each dose adjustment.

The maximum daily dose of rosuvastatin is 40 mg. This dose is only for patients with high cholesterol levels 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 rosuvastatin to reduce the risk of having a heart attack, a 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 a day. The usual starting dose for treatment is 5 mg per day, and your doctor may increase your dose gradually to reach the right dose of rosuvastatin for you. The maximum recommended daily dose of rosuvastatin is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once a day.Do not administer rosuvastatin 40 mg tablets to children.

Tablet intake

Swallow each tablet whole with water.

Take rosuvastatin 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 every day. This will help you remember to take them.

Regular cholesterol level checks

It is essential that you attend your doctor regularly for cholesterol level checks, to ensure your cholesterol levels have normalized and remain at appropriate levels.

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

If you take more Rosuvastatin than you should

Contact your doctor or nearest hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you enter a hospital or receive treatment for another illness, inform the healthcare staff that you are taking Rosuvastatin.

If you forget to take Rosuvastatin

Do not worry, simply take the next scheduled dose at the planned time. Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Rosuvastatin

Consult your doctor if you want to stop taking rosuvastatin. Your cholesterol levels may increase again if you stop taking rosuvastatin.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

It is essential that you know which side effects may occur. They are usually mild and disappear within a short period of time.

Stop taking rosuvastatin and seek medical attention immediatelyif 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.

•Intense itching of the skin (with rashes).

• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).
• Muscle rupture.

Also, stop taking rosuvastatin and consult your doctor immediately if you experience unexplained and prolonged muscle pain and cramps.Muscle symptoms are more common in children and adolescents than in adults. Like other statins, a very small number of people have experienced unpleasant muscle effects, which, very rarely, have resulted in a potentially life-threatening muscle injury calledrabdomyolysis.

Frequent side effects (may affect up to 1 in 10 people)

•Headache, stomach pain, constipation, nausea, muscle pain, weakness, dizziness.

•Increased protein levels in urine – this usually returns to normal on its own without the need to discontinue rosuvastatin treatment (frequent side effect only with the daily dose of 40 mg of rosuvastatin).

•Diabetes. This is more likely if you have high blood sugar and lipid levels, obesity, and high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Rare side effects (may affect up to 1 in 100 people)

•Urticaria, itching, and other skin reactions.

•Increased protein levels in urine – this usually returns to normal on its own without the need to discontinue rosuvastatin treatment (only for rosuvastatin 5 mg, 10 mg, and 20 mg).

Very rare side 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 rashes).If you think you are having an allergic reaction, stop taking rosuvastatinand seek medical attention immediately.

•Muscle injury in adults – as a precaution,stop taking rosuvastatin and consult your doctor immediately if you experience unexplained and prolonged muscle pain and cramps.

•Severe stomach pain (possible sign of pancreatitis).

•Increased liver enzymes (transaminases) in blood.

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

J jaundice (yellowing of the skin and eyes), hepatitis (inflamed liver), blood in urine, nerve damage in legs and arms (with numbness or tingling), joint pain, memory loss, and increased breast size in men (gynecomastia).

Side effects of unknown frequency (frequency cannot be estimated from available data):

Diarrhea (loose stools), Stevens-Johnson syndrome (severe skin rash in the form of blisters on the skin, mouth, eyes, and genitals), 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, persistent muscle weakness, Myasthenia gravis (a disease that causes generalized muscle weakness, which, in some cases, affects the muscles used for breathing), Myasthenia 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 eyelid drooping, difficulty swallowing or difficulty breathing.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://wwwnotificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medicationdoes not require special conservation conditions.

Keep this medication out of the sight and reach of children.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Rosuvastatina Tarbis

•The active ingredient is rosuvastatin (as rosuvastatin calcium). Each tablet contains 5 mg of rosuvastatin.

•The other components are: lactose monohydrate, microcrystalline cellulose (E-460), sodium citrate, crospovidone type B, anhydrous colloidal silica, magnesium stearate,

hypromellose 2910 (6 cP), macrogol 3350, triacetin, and titanium dioxide (E-171)

Appearance of the product and content of the packaging

Rosuvastatina Tarbis 5 mg film-coated tablets are white or almost white, round, and biconvex with the engraving “5” on one face.

They are presented in packs of 28 tablets and in clinical packs of 100 tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible for manufacturing

Zaklady Farmaceutyczne Polpharma SA

(Pharmaceutical Works Polpharma SA)

19 Pelplinska Street,

83-200 Starogard Gdanski,

Poland

Last review date of this leaflet:April 2023

The detailed updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/