Rosuvastatin Combix 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rosuvastatina Combix 5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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 must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Rosuvastatina Combix is and what it is used for

2. What you need to know before taking Rosuvastatina Combix

3. How to take Rosuvastatina Combix

4. Possible side effects

5. How to store Rosuvastatina Combix

6. Contents of the pack and other information

1. What Rosuvastatina Combix is and what it is used for

Rosuvastatina Combix belongs to a group of medicines called statins.

You have been prescribed Rosuvastatina Combix because:

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

Rosuvastatina Combix 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 maintain a cholesterol-lowering diet and continue regular physical exercise while taking Rosuvastatina Combix.

Or

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

Heart attack, stroke, 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 Combix?

Rosuvastatina Combix 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).

• Rosuvastatina Combix reduces the amount of "bad" cholesterol and increases "good" cholesterol.
• It works by blocking the production of "bad" cholesterol and improving 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, preventing blood flow 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 related health problems.

You need to continue taking Rosuvastatina Combix, even after your cholesterol levels have reached the desired target, because it prevents cholesterol levels from rising again and stops the formation of fatty deposits. However, you should stop treatment if your doctor instructs you to do so, or if you become pregnant.

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 to any of the other ingredients of this medicine (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 must avoid becoming pregnant during treatment with Rosuvastatina Combix by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain and cramps.
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).
• If you have ever developed a severe skin rash or skin peeling, blisters and/or mouth sores after taking rosuvastatin or other related medicines.

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

In addition, do not take the 40 mg dose of Rosuvastatina (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 to take Rosuvastatina Combix:

• 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 accompanied by 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 or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by mouth or injection. The combination of fusidic acid and rosuvastatin may cause serious muscle problems (rhabdomyolysis).
• 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 rosuvastatin for you.
• If you have or have had myasthenia (a disease characterized by 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).

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

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

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

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 after starting treatment with Rosuvastatina Combix.

While taking this medicine, your doctor will monitor you closely 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: Rosuvastatin must not be given to children under 6 years of age.
• If the patient is under 18 years of age: The 40 mg tablets of rosuvastatin are not recommended for children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Combix

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

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

• cyclosporine (used after organ transplantation),
• 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),
• treatments 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, i.e., 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 altered by Rosuvastatina Combix, or they may change the effect of Rosuvastatina Combix.

If you need to take fusidic acid orally to treat a bacterial infection, you must temporarily stop treatment with rosuvastatin. Your doctor will advise you when to restart treatment with this medicine. Taking rosuvastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Rosuvastatina with food and drink

You may take this medicine with or without food.

Pregnancy and breastfeeding

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

Rosuvastatina Combix contains lactose, tartrazine, and Allura Red AC:

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

This medicine may cause allergic reactions because it contains tartrazine and Allura Red AC. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

The complete list of ingredients can be found in Contents of the pack and other information.

3. How to take Rosuvastatina Combix

Follow exactly the instructions for using this medicine as given by your doctor. If in 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 be initiated with the 5 mg or 10 mg dose, 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 of having a heart attack or stroke.
• Whether you have factors that make you more susceptible to potential adverse 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 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 a specific genetic variation (known as genetic polymorphism) that may cause increased levels of rosuvastatin.
• If you have moderate kidney problems.
• If you are at risk of muscle pain and cramps (myopathy).
• If you are taking rosuvastatin together with other medicines that may increase rosuvastatin levels 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 rosuvastatin dose appropriate for you. 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 per day. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

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 rosuvastatin dose appropriate for treating your condition. The maximum recommended 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. The 40 mg tablets are not recommended for use in children.

How to take the tablets

Swallow each tablet whole with water.

Take Rosuvastatina Combix 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 that you 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 Rosuvastatina Combix 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 91 562 04 20, stating the medicine and the amount ingested.

If you are admitted to hospital or receive treatment for another condition, inform 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 usual time.

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

If you stop taking Rosuvastatina Combix

Consult your doctor if you wish to stop 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 Rosuvastatina Combix 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.
• Red, flat spots on the trunk, target-shaped or circular, often 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 rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Swelling of the face, lips, tongue and/or throat, which may cause difficulty swallowing.

Severe skin itching (with hives). You should also stop taking this medicine and consult your doctor immediately if you experience

• Unexplained muscle pain and cramps lasting longer than expected. Muscle symptoms are more common 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 fatal muscle injury called rhabdomyolysis.
• Lupus-like syndrome (including rashes, joint disorders, and effects on blood cells).
• Muscle rupture.

Frequent 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 urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin tablets (frequent adverse effect only with the 40 mg daily dose of rosuvastatin).
• Diabetes. This is more likely if you have high levels of sugar and lipids in your blood, 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.
• An increase in the amount of protein in urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin tablets (uncommon adverse effect with the daily doses of 5 mg, 10 mg, and 20 mg of rosuvastatin).

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 this medicine and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking this medicine 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).
• Increase in liver enzymes (transaminases) in blood.
• Reduction in platelets in 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).
• Blood traces in urine.
• Nerve damage in arms and legs (with numbness or tingling).
• Joint pain.
• Memory loss.
• Enlargement of breasts in men (gynecomastia).

Adverse effects with unknown frequency (cannot be estimated from available data), which may include

• Diarrhea (loose stools).
• Cough.
• Shortness of breath.
• Edema (swelling).
• Sleep disturbances, including insomnia and nightmares.
• Sexual difficulties.
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Tendon injuries.
• Constant muscle weakness.
• Myasthenia gravis (a condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a condition causing weakness of the eye muscles).
• Peripheral neuropathy (a disorder affecting the function of 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 of adverse effects:

If you experience any 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rosuvastatina Combix

• Do not store above 30°C. Keep in the original container.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and containers. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatina Combix

• The active substance is rosuvastatin. Each film-coated tablet contains calcium rosuvastatinate equivalent to 5 mg of rosuvastatin.
• The other components are:

Tablet core: Monohydrate lactose, microcrystalline cellulose (E460i), crospovidone, meglumine, magnesium stearate (E470b).

Coating: Opadry II 33K520023 yellow: Hypromellose (E464), monohydrate lactose, titanium dioxide (E171), triacetin, yellow tartrazine aluminum lake (E102), red allura AC aluminum lake (E129), and indigo carmine aluminum lake (E132).

Appearance of the product and contents of the pack

Film-coated tablets, yellow in colour, round, biconvex, with smooth beveled edges on both sides.

Aluminum/Aluminum blisters with desiccant.

Packs containing 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 latest revision of this package leaflet: April 2023

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