Product Information for the Patient

Rosuvastatina Tarbis Farma 20 mg Film-Coated Tablets

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, 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 product information. See section 4.

1. What isRosuvastatina Tarbis Farmaand for what it is used

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

3. How to takeRosuvastatina Tarbis Farma

4. Possible adverse effects

5. Storage ofRosuvastatina Tarbis Farma

6. Contents of the package and additional information

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

You have been prescribed Rosuvastatina Tarbis Farma because:

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

Rosuvastatina Tarbis Farma 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 changes made to your diet and increased physical exercise have not been sufficient to correct your cholesterol levels. You must maintain a diet that helps to lower cholesterol and continue exercising while taking Rosuvastatina Tarbis Farma.

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 related 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 Rosuvastatina Tarbis Farma?

Rosuvastatina Tarbis Farma 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).

•Rosuvastatina 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, preventing blood supply to the heart or brain, causing 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 needto continue taking Rosuvastatina Tarbis Farma, 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 Farma:

•If you have ever had an allergic reaction to rosuvastatinaor to any of its components.

•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 combination of sofosbuvir/velpatasvir/voxilaprevir(used to treat a viral liver infection called hepatitis C)

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

•If you have ever developed a severe skin rash or peeling, blisters, and/or mouth sores after taking Rosuvastatina Tarbis Farma or other related medicines.

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

Also, do not take Rosuvastatina Tarbis Farma 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 medicines.

•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 medicines called fibratesto lower cholesterol.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rosuvastatina

•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 medicines. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you have general discomfort or fever. Also inform your doctor or pharmacist if you have persistent muscle weakness.

•If you regularly consume large amounts of alcohol.

•If your thyroid glanddoes not function 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 (HIV virus, such as ritonavir with lopinavir and/or atazanavir. . See “Other medicines and Rosuvastatina Tarbis Farma”.

•If you are taking or have taken within the last 7 days a medicine called fusidic acid(a medicine for bacterial infection), orally or by injection. The combination of fusidic acid and rosuvastatina may cause severe muscle problems (rhabdomyolysis); see “Other medicines and Rosuvastatina Tarbis Farma”.

• If you are over 70 years old, as your doctor must establish the starting dose of rosuvastatina suitable for you.
• 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 starting dose of Rosuvastatina Tarbis Farma suitable for you.
• If you have or have had myasthenia (a disease that involves generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins sometimes can worsen the disease or cause myasthenia (see section 4).

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

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

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Rosuvastatina Tarbis Farma treatment. Stop using Rosuvastatina Tarbis Farma 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 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 Tarbis Farma.

While taking this medicine, your doctor will closely 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 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.

.

Other medicines and Rosuvastatina Tarbis Farma

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

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

-ciclosporina (used after an organ transplant),

-regorafenib (used to treat cancer)

-anticoagulants, e.g. warfarin, acenocoumarol or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken with this medicine), ticagrelor or clopidogrel.

-fibrates (such as gemfibrozil, fenofibrate),

-any other medicine used to lower cholesterol (such as ezetimiba),

-medicines for indigestion (used to neutralize stomach acid),

-erythromycin (an antibiotic),

-fusidic acid (an antibiotic – please see Warnings and precautions)

-oral contraceptives (the pill),

• darolutamida (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),

- teriflunomida (used to treat multiple sclerosis)

• certain medicines 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, pibrentasvir.

The effects of these medicines may be modified by rosuvastatina or may change the effect of rosuvastatina.

If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart rosuvastatina. In rare cases, taking rosuvastatina with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information about rhabdomyolysis in Section 4.

Pregnancy and breastfeeding

Do not take Rosuvastatina Tarbis Farmaif 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 medicine.

Driving and using machines

The majority of patients can drive vehicles and use machines during treatment with Rosuvastatina Tarbis Farma 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.

This medicine contains lactose.

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

Rosuvastatina contains sodium:

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, that is, essentially "sodium-free".

For the complete list of excipients, see the sectionContents of the pack and additional information.

Follow exactly the administration instructions of this medication as indicated by your doctor. If in 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 potential 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 lower dose (5 mg):

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

•If you areover 70 years old.

•If you have moderate kidney problems.

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

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 then 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 earlier.

Recommended doses in children and adolescents aged 6-17 years

The usual recommended starting dose is 5 mg. Your doctor may increase your dose to reach the right dose of rosuvastatin for your condition. The maximum daily recommended dose of rosuvastatin is 10 mg for children aged 6-9 years and 20 mg for children aged 10-17 years. Take the dose indicated by your doctor once a day.Do not administer rosuvastatin 40 mg tablets to children and adolescents.

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 visit 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 so that 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

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 can 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 rosuvastatina 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 skin itching (with rashes).

• Reddish patches, not elevated, in the shape of a bull's-eye or circles on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).

• Generalized skin rash, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking rosuvastatina and consult your doctor immediately:

•if you experience unexplained muscle pain and crampsthat last longer than expected. 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 side effects, which, very rarely, have resulted in a potentially fatal muscle injury calledrabdomiolysis,

•if you experience muscle rupture,

•if you experience a syndrome with symptoms similar to lupus(including urticaria, joint disorders, and blood cell effects).

Frequent side 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 urine – this usually reverts to normal on its own without the need to stop taking rosuvastatina tablets (frequent side effect only with the daily dose of 40 mg of rosuvastatina).

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

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

•Urticaria, itching, and other skin reactions.

•An increase in the amount of protein in urine – this usually reverts to normal on its own without the need to stop taking rosuvastatina tablets (only for rosuvastatina 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 skin itching (with rashes). If you think you are having an allergic reaction, stop taking Rosuvastatina Hetero and seek medical attention immediately.

•Adult muscle injury – as a precaution, stop taking Rosuvastatina Hetero and consult your doctor immediately if you experience unexplained muscle pain and crampsthat last longer than expected.

•Severe stomach pain (possible sign of pancreatitis).

•Increased liver enzymes in the blood.

•Bleeding or bruising more easily than normal due to low platelet count in the blood.

•Syndrome with symptoms similar to lupus (including urticaria, joint disorders, and blood cell effects).

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

•Icterus (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 breasts in men (gynecomastia).

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

•Diarrhea (loose stools),

•Cough,

•Shortness of breath,

•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,

•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 the arms or legs that worsens after periods of activity, double vision, 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 medication does not require special storage 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 disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Rosuvastatina Tarbis Farma Composition

The active ingredient of Rosuvastatina Tarbis Farma is rosuvastatina.

The film-coated tablets of Rosuvastatina Tarbis Farma contain rosuvastatina calcium equivalent to 5 mg of rosuvastatina.

The other components of the tablets are: lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, sodium hydrogen carbonate, talc, magnesium stearate, hypromellose, titanium dioxide, triacetin, yellow iron oxide (E172) (only for 5 mg), red iron oxide (E172).

Product Appearance and Packaging Contents

Rosuvastatina Tarbis Farma is marketed in 4 doses:

Rosuvastatina Tarbis Farma 5 mg film-coated tablets are yellowish to yellow, round, biconvex, film-coated tablets, with the imprint “H” on one side and “R3” on the other side.

Rosuvastatina Tarbis Farma 10 mg film-coated tablets are pale pink to pink, round, biconvex, film-coated tablets, with the imprint “H” on one side and “R4” on the other side.

Rosuvastatina Tarbis Farma 20 mg film-coated tablets are pale pink to pink, round, biconvex, film-coated tablets, with the imprint “H” on one side and “R5” on the other side.

Rosuvastatina Tarbis Farma 40 mg film-coated tablets are pale pink to pink, oval, biconvex, film-coated tablets, with the imprint “H” on one side and “R6” on the other side.

This medication is presented in blister packs of 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, 100, and 140 tablets and plastic bottles with a child-resistant polypropylene closure and silica gel desiccant, containing 90 tablets. Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect the tablets. The silica gel desiccant is located inside a small cylinder and should not be swallowed.

It is possible that not all packaging sizes are marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.U.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible Manufacturer:

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola, PLA 3000;

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

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

NLRosuvastatine Hetero 5 mg filmomhulde tabletten

DERosuvastatin Amarox 5 mg Filmtabletten

ESRosuvastatina Tarbis Farma 5 mg comprimidos recubiertos con película EFG

Last review date of this leaflet: 01/2024

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