ROSUVASTATIN COMBIX 20 mg FILM-COATED TABLETS

2. What you need to know before taking Rosuvastatina Combix

Do not take Rosuvastatina Combix

• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medication (listed in section 6).
• If you are pregnant or breastfeeding.If you become pregnant while taking Rosuvastatina Combix, stop taking it immediately and inform your doctor.Women should avoid becoming pregnant during treatment with Rosuvastatina Combix using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain or cramps.
• 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, blisters, and/or sores in the mouthafter taking rosuvastatina 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 the 40 mg dose of Rosuvastatina

• If you have moderate kidney problems(if you are unsure, consult your doctor).
• If your thyroid glandis not working correctly.
• If you have repeated or 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 drink large amounts of alcohol.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medications called fibratesto 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 Combix:

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or 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 drink large amounts of alcohol.
• If your thyroid glandis not working correctly.
• If you are taking other medications called fibratesto lower cholesterol. Read this summary carefully, even if you have taken cholesterol-lowering medications before.
• If you are taking medications to treat HIV infection (AIDS virus) or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir, see Other medications and Rosuvastatina Combix.
• If you are taking or have taken in the last 7 days a medication that contains fusidic acid(used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Rosuvastatina Combix can cause serious muscle problems (rhabdomyolysis).

• 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(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will need to determine the appropriate starting dose of rosuvastatina 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).

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.

If you are in any of the above situations (or are unsure):

• Do not take the highest dose (40 mg) 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 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 Combix.

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

Other medications and Rosuvastatina Combix

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),
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant medication, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate), or
• any other medication used to lower cholesterol (such as ezetimibe),
• treatments for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• oral contraceptives (the pill),
• hormone replacement therapy, or
• antiviral medications such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections, including HIV, i.e., AIDS, or hepatitis C – see Warnings and precautions).
• regorafenib (used to treat cancer),
• 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 can be altered by Rosuvastatina Combix or can change the effect of Rosuvastatina Combix.

If you need to take fusidic acid orally for the treatment of a bacterial infection, you should temporarily stop treatment with rosuvastatina. Your doctor will tell you when to restart treatment with this medication. Taking rosuvastatina with fusidic acid can rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Rosuvastatina Combix with food and drinks

You can take this medication with or without food.

Pregnancy and breastfeeding

Do not take Rosuvastatina Combixif you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina Combix, stop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatina Combix 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 Combix, as it will not affect their ability. However, some people may feel dizzy during treatment with Rosuvastatina Combix. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatina Combix contains lactose, orange yellow S, and allura red AC

If your doctor has told you that you have an intolerance to certain sugars (lactose or milk sugar), consult with them before taking this medication.

This medication may cause allergic reactions because it contains orange yellow S and allura red AC. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

The complete list of ingredients is found in Package contents and additional information.

3. How to take Rosuvastatina Combix

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Usual dose in adults

If you are taking Rosuvastatina Combix for high cholesterol:

Starting dose

Your treatment with Rosuvastatina Combix 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 factors that make you more vulnerable to possible side effects.

Check with your doctor or pharmacist what the best starting dose of Rosuvastatina Combix is 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 genetic polymorphism), which can cause an increase in rosuvastatina levels.
• If you have moderate kidney problems.
• If you are at risk of having muscle pain or cramps (myopathy).
• If you are taking rosuvastatina with other medications that can increase rosuvastatina levels in the blood.

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 enough 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.

Use in children and adolescents aged 6-17 years

The 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 40 mg rosuvastatina tablets to children.

Taking the tablets

Swallow each tablet whole with water.

Take Rosuvastatina Combix 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 cholesterol level checks

It is essential that you visit your doctor regularly for cholesterol checks to ensure that your cholesterol levels have normalized 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 Combix 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 Combix.

If you forget to take Rosuvastatina Combix

Do not worry, simply take the next scheduled dose at the planned time.

Do not take a double dose to make up for a forgotten dose.

If you stop treatment with Rosuvastatina Combix

Consult your doctor if you want to stop treatment with 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 Rosuvastatina Combix 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.
• Red, non-raised spots on the torso, target-shaped or circular, 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).
• Swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing.
• Intense itching of the skin (with hives).

Also, stop taking this medicine and consult your doctor immediately if you experience:

• 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 life-threatening muscle injury called rhabdomyolysis.
• Lupus-like syndrome (including rashes, joint disorders, and effects on blood cells).
• Muscle rupture.

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 rosuvastatina tablets (common adverse effect only with the daily dose of 40 mg of rosuvastatina).
• Diabetes. This is more likely if you have high sugar and lipid levels in your blood, 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 rosuvastatina tablets (uncommon adverse effect with daily doses of 5 mg, 10 mg, and 20 mg of rosuvastatina).

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, intense itching of the skin (with hives). If you think you are having an allergic reaction, stop taking this medicineand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking this medicine 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.
• Reduced platelet count in the blood.
• Lupus-like syndrome (including rashes, joint disorders, and effects on blood cells).
• Muscle rupture.

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 size in men (gynecomastia).

Adverse Effects of Unknown Frequency (cannot be estimated from available data) 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, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).
• Peripheral neuropathy (a disorder of the functioning of the nerves surrounding the spinal cord).

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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rosuvastatina Combix

• Do not store above 30°C. Store in the original package.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosuvastatina Combix

• The active ingredient is rosuvastatina. Each film-coated tablet contains rosuvastatina calcium equivalent to 20 mg of rosuvastatina.
• The other ingredients are:

Tablet core: Lactose monohydrate, microcrystalline cellulose (E460i), crospovidone, meglumine, magnesium stearate (E470b).

Coating: Opadry II 33K540005 pink: Hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin, yellow-orange aluminum lake S (E110), red allura AC aluminum lake (E129), and carmine indigo aluminum lake (E132).

Appearance of the Product and Package Contents

Film-coated tablets, pink, round, biconvex, with the engraving "20" on one side and smooth on the other.

Aluminum/Aluminum blisters with desiccant.

Packages of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of the Last Revision of this Leaflet: April 2023

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.