Package Insert: Information for the Patient

Rosuvastatina MABO-FARMA 5 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they 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.

1. What isRosuvastatina MABO-FARMAand what is it used for

2. What you need to know before starting to takeRosuvastatina MABO-FARMA

3. How to takeRosuvastatina MABO-FARMA

4. Possible side effects

5. Storage ofRosuvastatina MABO-FARMA

6. Contents of the pack and additional information

Rosuvastatin MABO-FARMA belongs to a group of medications called statins.

You have been prescribed Rosuvastatin because:

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

Rosuvastatin 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.

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?

Rosuvastatin 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 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 and prevent 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, even if you have already achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing again and forming fatty deposits. However, you should interrupt treatment if your doctor instructs you to do so or if you become pregnant.

Do not take Rosuvastatina MABO-FARMA

• If you are allergic (hypersensitive) to rosuvastatina or to any of the other components of this medication (listed in section 6).
• If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatinastop taking it immediately and inform your doctor.Women should avoid becoming pregnant during treatment with Rosuvastatina using an appropriate contraceptive method.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking rosuvastatina or other related medications.
• 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 combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C).
• If you are taking a medication called ciclosporina(used, for example, after an organ transplant).

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

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 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 medications to lower cholesterol levels. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you experience general discomfort 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 glanddoes not function correctly.
• If you are taking other medications called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken medications to lower cholesterol previously.
• If you are taking medications to treat HIV (HIV virus) or hepatitis C infection,such as ritonavir with lopinavir and/or atazanavir or simeprevir, seeOther medications and Rosuvastatina.
• If you are taking or have taken in the last 7 days a medication calledacid fusidic(an antibiotic), orally or injectable. The combination of acid fusidic and Rosuvastatina may cause severe muscle problems (rhabdomyolysis),see Other medications and Rosuvastatina.
• If you have severe respiratory insufficiency.
• 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 are over 70 years old(since your doctor must establish the appropriate starting dose of rosuvastatina for you).
• If you have or have had myasthenia(a disease that causes 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).

If you find yourself in any of these situations mentioned above (or are unsure):

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

In a reduced 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.

While taking this medication, 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.

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

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 medications and Rosuvastatina

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• ciclosporina (used after an organ transplant),
• anticoagulants, p. Ej. 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 ezetimiba),
• medications for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• acid fusidic (an antibiotic, see more Advertencias and precautions)
• oral contraceptives,
• hormone replacement therapy,
• regorafenib (used to treat cancer)
• darolutamida (used to treat cancer)
• any of the following medications used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Advertencias and Precautions): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medications may be modified by rosuvastatina or may change the effect of rosuvastatina.

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

Pregnancy and breastfeeding

Do not take rosuvastatinaif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatinastop 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 operating machinery

Most patients can drive vehicles and use machines during treatment with rosuvastatina 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.

Rosuvastatina MABO-FARMA contains lactose

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of 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 start withthe dose of 5 mg or 10 mg, even if you have taken a higher dose of another statin previously.

The choice of the starting dose will depend on:

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

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

•If you are ofAsian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).

•If you are over70 years old.

•If you have moderate kidney problems.

•If you have a risk of developing muscle pain and cramps (myopathy).

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 later 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 cerebral infarction, 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 cerebral infarction 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.

Recommended doses in children and adolescents aged 6-17 years

The dose range in children and adolescents aged 6 to 17years is 5mg to 20mg once a day. The usual starting dose for treatment is 5mg per day and your doctor may increase your dose gradually to reach the right dose of rosuvastatin for you. The maximum recommended daily dose of rosuvastatin is 10mg or 20mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once a day.Do notadminister rosuvastatin40 mgtablets to children.

Tablet intake

Swallow each tablet whole with water.

Take rosuvastatin 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 level checks

It is essential that you visit your doctor regularly for cholesterol level checks, to ensure your cholesterol levels have normalized and remain at appropriate levels.

Your doctor may decide to increase your dose to ensure you are taking the right dose of rosuvastatin 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, 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 illness, 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 scheduled time. Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Rosuvastatina

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 may cause side effects, although not everyone will experience them.

It is important that you know which side effects may occur. They are usually mild and disappear within a short period of time.

Stop taking rosuvastatin and seek medical attention immediatelyif you experience any of the following allergic reactions:

Also, stop taking rosuvastatin and consult your doctor immediately:

• If you experience unexplained 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 calledrabdomyolysis.
• If you experience muscle rupture.

• If you experience a syndrome with symptoms similar to lupus (including rash, joint disorders, and effects on blood cells).

Frequent side effects (may affect up to 1 in 10 people)

Rare side effects (may affect up to 1 in 100 people)

Very rare side 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 rashes). If you think you are having an allergic reaction, stop taking rosuvastatinand seek medical attention immediately.
• Muscle injury in adults – as a precaution,stop taking rosuvastatin and consult your doctor immediately if you experience unexplained muscle pain and crampsthat last longer than expected.
• Intense stomach pain (possible sign of pancreatitis).
• Increased liver enzymes in the blood.
• Reduced platelets in the blood.
• Bleeding or bruising more easily than normal due to low platelet count in the blood.
• Syndrome with symptoms similar to lupus (including rash, joint disorders, and effects on blood cells).

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

Side effects of unknown frequency (frequency cannot be estimated from available data):

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting 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 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.

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

Do not use this medication after the expiration date that appears on the packaging/blister/label after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rosuvastatina MABO-FARMA

• The active ingredient of Rosuvastatina MABO-FARMA is rosuvastatina. Each film-coated tablet contains 5 mg of rosuvastatina, as rosuvastatina calcium.
• The other components are: Nucleus: Microcrystalline cellulose PH-101, anhydrous colloidal silica, crospovidone type A, microcrystalline cellulose PH-102, lactose monohydrate, and magnesium stearate. Coating: Opadry II yellow 33K12488 containing: hypromellose, titanium dioxide (E-171), lactose monohydrate, triacetin, and iron oxide red (E-172)

Appearance of the product and contents of the packaging

Yellow film-coated tablets, round, biconvex, marked with "ROS" over "5" on one face and smooth on the other; with a diameter of 7 mm.

The tablets are presented in OPA-AL-PVC/Al blisters.

They are presented in packaging of 14, 20, 28, 30, 56, 60, 84, 90, and 100 film-coated tablets.

Only some sizes of packaging may be commercially marketed.

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Rejas 2, planta 1.

28821, Coslada. Madrid-España

Responsible for Manufacturing

Medochemie Ltd (Central Factory)

1-10 Constantinoupoleos Street,

Limassol, 3011, Cyprus

or

Medochemie LTD (Factory AZ)

2 Michael Erakleous Street, Agios Athanassios Industrial Area,

Agios Athanassios, Limassol, 4101,

Cyprus

Last review date of this leaflet: April 2023

Detailed and updated information on this medicine is available on the website of the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) http://www.aemps.gob.es/