Package Insert: Information for the Patient

Rosuvastatina Combix 10 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, becauseit containsimportant 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 to you alone, and you should not give it to others who may 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.

6. Contents of the pack and additional information

Rosuvastatin Combix belongs to a group of medications called statins.

You have been prescribed Rosuvastatin Combix because:

• You have high cholesterol levels. This means you are at risk of suffering a heart attack or a cerebral infarction.

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

You have been instructed 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 reduce cholesterol and continue to perform physical exercise while undergoing treatment with Rosuvastatin Combix.

Or

• You present other factors that increase the risk of suffering a heart attack, cerebral infarction, or other health-related problems.

A heart attack, cerebral infarction, and other health-related problems may 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 Combix?

Rosuvastatin Combix 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 Combix 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 cerebral infarction. By reducing your cholesterol levels, you can reduce the risk of suffering a heart attack, cerebral infarction, or other health-related problems.

You needto continue taking Rosuvastatin Combix, even if you have already achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing again and causing the formation of fatty deposits.However, you should interrupt treatment if your doctor instructs you to do so or if you become pregnant.

Do not take Rosuvastatina Combix

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina Combixstop 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 unjustified muscle pain and cramps.
• If you are taking a medicine called ciclosporin(used for example, after an organ transplant).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking rosuvastatina or other related medicines.

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

Also, do not take the highest dose of Rosuvastatina 40 mg

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid glanddoes not work 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 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 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 work correctly.
• If you are taking other medicines called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines previously.
• If you are taking medicines to treat HIV (AIDS virus) or hepatitis C infectionsuch as ritonavir with lopinavir and/or atazanavir or simeprevir, seeOther medicines and Rosuvastatina Combix.
• If you are taking or have takenin the last 7daysa medicine that contains fusidic acidwhich is used to treat bacterial infections.

• If you are over 70 years old, as your doctor must establish 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 must establish the appropriate starting dose of rosuvastatina for you.
• If you have or have had myasthenia(a disease that is characterized by 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 may 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 find yourself in any of these situations mentioned above (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 test that detects increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will usually perform blood tests (liver function test) before and after treatment with Rosuvastatina Combix.

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 Combix

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:

• ciclosporin (used after an organ transplant),
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate) or
• any other medicine used to lower cholesterol (such as ezetimibe),
• medicines for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• oral contraceptives (the pill),
• hormone replacement therapy or
• antiviral medicines such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections including HIV, that is, AIDS virus or hepatitis C – see Warnings and precautions).
• regorafenib (used to treat cancer),
• 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 modified by Rosuvastatina Combix or may 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 taking rosuvastatina. Your doctor will tell you when to restart your treatment with this medicine. Taking rosuvastatina with fusidic acid rarely may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

Taking Rosuvastatina with food and drinks

You can take this medicine with or without food.

Pregnancy and breastfeeding

Do not take Rosuvastatina Combixif you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina Combixstop 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 medicine.

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, yellow iron oxide, and red iron oxide:

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

This medicine may cause allergic reactions because it containsyellow iron oxideand red iron oxide. It may cause asthma, especially in patients allergic to aspirin.

The complete list of components is found inContents of the pack and additional information.

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 Rosuvastatina Combix for high cholesterol levels:

Starting dose

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

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

Your doctor may decide to start treatment with the lowest 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 take 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 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.

Use 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 to treat your condition. The maximum recommended daily 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 notadminister the 40 mg tablets of rosuvastatin to children.

Swallowing the tablets

Swallow each tablet whole with water.

Take Rosuvastatina Combix 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 checks

It is essential that you attend your doctor regularly for cholesterol checks, to ensure that 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 Rosuvastatina Combix 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 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 compensate for a missed dose.

If you interrupt treatment with Rosuvastatina Combix

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 Combix 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.
• Rash on the trunk, red, non-elevated, in the shape of a target or circles, 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 rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing.
• Intense itching of the skin (with rashes).

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 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 fatal muscle injury calledrabdomiolysis.
• Lupus-like syndrome (including rashes, joint disorders, and blood cell effects).
• Muscle rupture

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 interrupt treatment with rosuvastatina tablets (frequent side effect only with a daily dose of 40 mg of rosuvastatina).
• 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.
• An increase in the amount of protein in urine – this usually reverts to normal on its own without the need to interrupt treatment with rosuvastatina tablets (rare side effect with daily doses of 5 mg, 10 mg, and 20 mg of rosuvastatina).

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

• Jaundice (yellowing of the skin and eyes).
• Hepatitis (inflamed liver).
• Traces of blood in 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 (cannot be estimated from available data) that may include

• 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 damage.
• 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).
• Peripheral neuropathy (a disorder of the functioning of the nerves surrounding the spinal cord)

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 of 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 the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Do not store above 86°F (30°C). Store in the original packaging.
• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date shown on the packaging 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 unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Rosuvastatina Combix

• The active ingredient is rosuvastatina. Each film-coated tablet contains rosuvastatina calcium equivalent to 10 mg of rosuvastatina.
• The other components are:

Core of the tablet: 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 indigo carmine aluminum lake (E132).

Appearance of the product and content of the container

Pink film-coated tablets, round, biconvex, with smooth beveled edges on both faces.

Aluminum/Aluminum blisters with desiccant.

Packaging of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Combix Laboratories, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: April 2023

The detailed and 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 .