ROSUVASTATIN TARBIS FARMA 5 mg FILM-COATED TABLETS

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 rosuvastatina or any of its components.
• If you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina, stop 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 and unexplained muscle pain or 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 medication called ciclosporin (used, for example, after an organ transplant).
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking Rosuvastatina Tarbis Farma or other related medications

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

Additionally, 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 does not function properly.
• If you have repeated and unexplained muscle pain or cramps, a personal or family history of muscle problems, or a 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 (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medications called fibrates to lower cholesterol.

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

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 and unexplained muscle pain or cramps, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unexplained muscle pain or cramps, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have constant muscle weakness.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland does not function properly.
• If you are taking other medications called fibrates to lower cholesterol. Read this package leaflet carefully, even if you have taken cholesterol-lowering medications before.
• If you are taking medications to treat HIV infection (such as ritonavir with lopinavir and/or atazanavir). See "Other medications and Rosuvastatina Tarbis Farma".
• If you are taking or have taken in the last 7 days a medication called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. The combination of fusidic acid and rosuvastatina can cause serious muscle problems (rhabdomyolysis); see "Other medications and Rosuvastatina Tarbis Farma".
  • If you are over 70 years old, as your doctor will need to determine the appropriate starting dose of rosuvastatina 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 will need to determine the appropriate starting dose of Rosuvastatina Tarbis Farma for you.
  • If you have or have had myasthenia (a disease that causes generalized 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 are in any of the above situations (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. 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 blood test that checks for increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function tests) before and after treatment with Rosuvastatina Tarbis Farma.

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 old: Rosuvastatina should not be administered to children under 6 years old.
• If the patient is under 18 years old: The 40 mg rosuvastatina tablets should not be administered to children and adolescents under 18 years old.

.

Other medications and Rosuvastatina Tarbis Farma

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

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

• ciclosporin (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 medication), ticagrelor, or clopidogrel.
• fibrates (such as gemfibrozil, fenofibrate),
• any other medication 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 uric acid levels in the blood),
• teriflunomide (used to treat multiple sclerosis)
  • 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, pibrentasvir.

The effects of these medications may be altered 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 medication. Your doctor will tell you when it is safe to restart rosuvastatina. In rare cases, taking rosuvastatina with fusidic acid can cause serious muscle problems (rhabdomyolysis). See Section 4 for more information on rhabdomyolysis.

Pregnancy and breastfeeding

Do not take Rosuvastatina Tarbis Farmaif you are pregnant or breastfeeding. 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 using any medication.

Driving and using machines

Most 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 medication contains lactose.

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

Rosuvastatina contains sodium:

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

For the complete list of excipients, see the section Package contents and additional information.

3. How to take Rosuvastatina Tarbis Farma

Follow the instructions for administration of this medication indicated by your doctor. If 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 degree of risk you have of having a heart attack or stroke.
• If you have any factors that make you more vulnerable to possible side effects.

Check with your doctor or pharmacist what the best starting dose of rosuvastatina is for you.

Your doctor may decide to start treatment with the smallest 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 having muscle pain or cramps (myopathy).

Dose increase and maximum daily dose

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

If you are taking rosuvastatina to reduce the risk of having a heart attack, 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 above 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 achieve the appropriate dose of rosuvastatina to treat your condition. The maximum recommended daily dose of rosuvastatina is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take the dose indicated by your doctor once a day. Do notadminister the 40 mg rosuvastatina tablets to children and adolescents.

Taking the tablets

Swallow each tablet whole with water.

Take rosuvastatina 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 to visit your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and are being maintained at appropriate levels.

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

If you take more Rosuvastatina 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, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take Rosuvastatina

Do not worry, simply take the next scheduled dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Rosuvastatina

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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine 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 rosuvastatin 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).
  • Reddish patches, not elevated, in a target or circular shape on the trunk, 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 skin rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking rosuvastatin and consult your doctor immediately:

• if you experience unjustified muscle pain and cramps that 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 that, very rarely, have resulted in a potentially fatal muscle injury called rhabdomyolysis,
• if you experience muscle rupture,
• if you present with a syndrome that has similar symptoms 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.
• An increase in the amount of protein in the urine – this usually reverses on its own without the need to interrupt treatment with rosuvastatin tablets (common adverse 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, are overweight, and have high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

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 reverses on its own without the need to interrupt 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, 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 unjustified muscle pain or cramps that 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 a low platelet count in the blood.
• Syndrome that has similar symptoms 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 the legs and arms (with numbness or tingling),
• joint pain,
• memory loss,
• increase in breast size in men (gynecomastia).

Adverse Effects of 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,
• constant muscle weakness,
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing),
• Myasthenic 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 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 Medicines Vigilance System for Human Use: https://wwwnotificaram.es. By reporting adverse effects, you can contribute to providing 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 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 away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosuvastatin Tarbis Farma

The active ingredient of Rosuvastatin Tarbis Farma is rosuvastatin.

The film-coated tablets of Rosuvastatin Tarbis Farma contain rosuvastatin calcium 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, yellow iron oxide (E172) (only for 5 mg), red iron oxide (E172).

Appearance of the Product and Package Contents

Rosuvastatin Tarbis Farma is marketed in 4 doses:

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

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

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

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

This medicine is presented in packaging with blisters 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 a silica gel desiccant, which contain 90 tablets. Each bottle contains a silica gel desiccant that should 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 package sizes are 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

Netherlands

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

NL Rosuvastatine Hetero 5 mg film-coated tablets

DE Rosuvastatin Amarox 5 mg film-coated tablets

ES Rosuvastatina Tarbis Farma 5 mg film-coated tablets EFG

Date of the last revision of this prospectus: 01/2024

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