Rosuvastatin Tarbis Farma 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rosuvastatin Tarbis Farma 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Rosuvastatin Tarbis Farma is and what it is used for
2. What you need to know before taking Rosuvastatin Tarbis Farma
3. How to take Rosuvastatin Tarbis Farma
4. Possible side effects
5. How to store Rosuvastatin Tarbis Farma
6. Contents of the pack and other information

1. What Rosuvastatina Tarbis Farma is and what it is used for

Rosuvastatina Tarbis Farma contains the active substance rosuvastatin. It belongs to a group of medicines known as statins.

Your doctor has prescribed Rosuvastatina Tarbis Farma because:

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

Rosuvastatina Tarbis Farma is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.

You have been prescribed a statin because changes in your diet and increased physical activity have not been sufficient to correct your cholesterol levels. You must continue to follow a cholesterol-lowering diet and maintain regular physical exercise while taking Rosuvastatina Tarbis Farma.

Or

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

Heart attacks, strokes, and other related health problems may be caused by a condition called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why is it important that you continue taking Rosuvastatina Tarbis Farma?

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

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

• Rosuvastatin lowers the amount of "bad" cholesterol and increases "good" cholesterol.
• It works by blocking the production of "bad" cholesterol and improves the body's ability to remove it from the blood.

In most people, high cholesterol levels do not affect how they feel, as they produce no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed vessels can become blocked, cutting off blood supply to the heart or brain, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of heart attack, stroke, or other related health problems.

You need to continue taking Rosuvastatina Tarbis Farma, even after your cholesterol levels have returned to normal, because it prevents cholesterol levels from rising again and stops the formation of fatty deposits. However, you should stop treatment if your doctor advises you to do so, or if you become pregnant.

2. What you need to know before taking Rosuvastatina Tarbis Farma

Do not take Rosuvastatina Tarbis Farma:

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

• If you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with Rosuvastatina by using an appropriate contraceptive method.

• If you have liver disease.

• If you have severe kidney problems.

• If you experience repeated or unexplained 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 cyclosporine (used, for example, after an organ transplant).

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

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

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 gland is not functioning properly.
• If you have repeated or unexplained 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 (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines called fibrates to lower cholesterol.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Rosuvastatina

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained 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 experience unexplained muscle pain or cramps, especially if you also have general malaise 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 gland is not functioning properly.
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken cholesterol-lowering medicines.
• If you are taking medicines to treat HIV infection (AIDS 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), taken orally or by injection. The combination of fusidic acid and rosuvastatin can cause serious muscle problems (rhabdomyolysis); see “Other medicines and Rosuvastatina Tarbis Farma”.
  • If you are over 70 years old, as your doctor must determine the appropriate starting dose of rosuvastatin for you.
  • If you have severe respiratory failure.
  • If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate starting dose of Rosuvastatina Tarbis Farma for you.
  • If you have or have had myasthenia (a disease causing generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

If you are in any of the 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 any dose of Rosuvastatina Tarbis Farma.

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Rosuvastatina Tarbis Farma. Stop using Rosuvastatina Tarbis Farma and seek immediate medical attention if you notice any of the symptoms described in section 4.

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing increased levels of liver enzymes (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) before and during treatment with Rosuvastatina Tarbis Farma.

While taking this medicine, your doctor will monitor you closely 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: Rosuvastatin must not be given to children under 6 years of age.

• If the patient is under 18 years of age: Rosuvastatin 40 mg tablets must not be given to children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Tarbis Farma

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

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

• cyclosporine (used after organ transplant),

• regorafenib (used to treat cancer),

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

• fibrates (such as gemfibrozil, fenofibrate),

• any other medicine used to lower cholesterol (such as ezetimibe),

• treatments for indigestion (used to neutralize stomach acid),

• erythromycin (an antibiotic),

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

• oral contraceptives (the pill),

  • 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines may be altered by rosuvastatin or may change the effect of rosuvastatin.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart rosuvastatin. Rarely, taking rosuvastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about rhabdomyolysis in Section 4.

Pregnancy and breastfeeding

Do not take Rosuvastatina Tarbis Farma if you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatin by using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive and operate machinery while being treated with Rosuvastatina Tarbis Farma, as it will not affect their ability. However, some people may feel dizzy during treatment with rosuvastatin. If you feel dizzy, consult your doctor before attempting to drive or use machinery.

This medicine contains lactose.

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

Rosuvastatin contains sodium:

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

For the full list of excipients, see section Contents of the pack and other information.

3. How to take Rosuvastatina Tarbis Farma

Follow exactly the administration instructions for this medicine 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 be initiated with a dose of 5 mg or 10 mg, even if you have previously taken a higher dose of another statin.

The choice of starting dose will depend on:

• Your cholesterol levels.
• Your risk level of having a heart attack or stroke.
• Whether you have any factors that make you more susceptible to possible adverse effects.

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

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

• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are over 70 years old.
• If you have moderate kidney problems.
• If you are at risk of muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is so you receive the appropriate rosuvastatin dose for your condition. If you started with a 5 mg dose, 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 10 mg dose, 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 rosuvastatin is 40 mg. This dose is only for patients with high cholesterol and a high risk of heart attack or stroke whose cholesterol levels do not decrease sufficiently with 20 mg.

If you are taking rosuvastatin to reduce the risk of heart attack, stroke, or related health problems:

The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the previously mentioned factors.

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 rosuvastatin dose appropriate for treating your condition. The recommended maximum daily dose of rosuvastatin is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take the dose prescribed by your doctor once daily. Rosuvastatin 40 mg tablets must not be administered to children and adolescents.

How to take the tablets

Swallow each tablet whole with water.

Take rosuvastatin once daily. You may 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 monitoring of cholesterol levels

It is important to visit your doctor regularly for cholesterol 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 rosuvastatin dose appropriate 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you are admitted to a hospital or receive treatment for another condition, 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 usual time. Do not take a double dose to make up for a missed dose.

If you stop taking rosuvastatin

Consult your doctor if you wish to discontinue treatment with rosuvastatin. Your cholesterol levels may rise again if you stop taking rosuvastatin.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time.

Stop taking rosuvastatin and seek immediate medical attention if 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.

• Severe skin itching (with hives).

  • Reddish, flat lesions on the trunk, often circular or target-shaped, sometimes with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).

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

Also stop taking rosuvastatin and consult your doctor immediately:

• If you experience unexplained muscle pain and cramps lasting 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 experienced unpleasant muscle effects, which very rarely have resulted in a potentially life-threatening muscle injury called rhabdomyolysis.
• If you experience muscle breakdown.
• If you develop a syndrome presenting symptoms similar to lupus (including hives, 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.
• Increased levels of protein in the urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (common adverse effect only with the daily 40 mg dose of rosuvastatin).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, are overweight, and have high blood pressure. Your doctor will monitor you closely while you are taking this medicine.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Hives, itching, and other skin reactions.
• Increased levels of protein in the urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (only for rosuvastatin 5 mg, 10 mg, and 20 mg).

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, and severe skin itching (with hives). If you think you are having an allergic reaction, stop taking Rosuvastatin Hetero and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Rosuvastatin Hetero and consult your doctor immediately if you have unexplained muscle pain or cramps lasting longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increased liver enzymes in blood.
• Bleeding or bruising more easily than normal due to low platelet count in the blood.
• Syndrome presenting symptoms similar to lupus (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 arms and legs (with numbness or tingling),
• joint pain,
• memory loss,
• enlargement of the breasts in men (gynecomastia).

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• 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,
• persistent muscle weakness,
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing),
• Ocular myasthenia (a disease causing weakness of the eye muscles),
• Consult your doctor if you experience weakness in arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

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

5. Storage of Rosuvastatin Tarbis Farma

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiry date stated on the packaging/blister/after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin Tarbis Farma

The active substance in Rosuvastatin Tarbis Farma is rosuvastatin.

The film-coated tablets of Rosuvastatin Tarbis Farma contain calcium rosuvastatin equivalent to 5 mg of rosuvastatin.

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

Appearance of the product and contents of the pack

Rosuvastatin Tarbis Farma is marketed in 4 strengths:

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

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

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

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.U.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer:

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola, PLA 3000;

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

NL Rosuvastatine Hetero 5 mg filmomhulde tabletten

DE Rosuvastatin Amarox 5 mg Filmtabletten

ES Rosuvastatina Tarbis Farma 5 mg comprimidos recubiertos con película EFG

Date of the most recent revision of this leaflet: 01/2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/