Patient Information Leaflet: Package Insert

Alzil 15 mg Film-Coated Tablets

rosuvastatina

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Alzil is and what it is used for

2. What you need to know before you start taking Alzil

3. How to take Alzil

4. Possible side effects

5. Storage of Alzil

6. Contents of the pack and additional information

Rosuvastatin belongs to a group of medications called statins.

They have prescribed rosuvastatin because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or a stroke. Rosuvastatin is used in adults, adolescents, and children 6 years of age or older to treat high cholesterol.
• They have indicated that you should 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 exercising while on treatment with rosuvastatin.
• You have other factors that increase your risk of suffering a heart attack, stroke, or other health problems.

A heart attack, stroke, and other related health problems may be caused by a disease called atherosclerosis. Atherosclerosis is caused by the formation of fatty deposits in your arteries.

Why it is 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 decreases 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 stroke. By reducing your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or related health problems.

You needto continue takingrosuvastatin, even if you have achieved the correct cholesterol levels,since it prevents cholesterol levels from increasing againand causing the formation of fatty deposits. However, you should stop treatment if your doctor instructs you to or if you become pregnant.

Do not take Alzil

• If you are allergic to rosuvastatinor to any of the other ingredients of this medicine (listed in

section 6).

• If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor.
• 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 are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medicines(used to treat a viral liver infection called hepatitis C).
• 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 find yourself in any of the above situations (or are unsure),please consult your doctor.

Do not take rosuvastatin 30 mg or 40 mg (the higher dose)

-If you have moderate kidney problems(if in doubt, consult your doctor).

-If your thyroid glanddoes not function 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.

Warnings and precautions

• Consult your doctor or pharmacist before starting to take rosuvastatin: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 function correctly.
• If you are taking other medicines called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines before.
• If you are taking medicines to treat HIV (AIDS virus) infection, such as ritonavir with lopinavir and/or atazanavir, see“Other medicines and rosuvastatin”.
• If you are taking or have taken within the last 7 days a medicine containing fusidic acid(used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and rosuvastatin may cause severe muscle problems (rhabdomyolysis), please see“Other medicines androsuvastatin””.
• If you are over 70 years old,as your doctor must establish the appropriate starting dose of rosuvastatin 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 rosuvastatin for you.
• If you have or have had myasthenia(a disease that causes generalised muscle weakness, which in some cases affects the muscles used for breathing) or myasthenic eye disease (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 with rosuvastatin treatment. Stop using rosuvastatin 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 Rosuvastatin 30 mg and 40 mg (the higher dose) and consult your doctor or pharmacist before starting to take any dose of rosuvastatin.

In a small number of people, statins can affect the liver. This is detected by a simple test that measures increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function test) before and after treatment with rosuvastatin.

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: Rosuvastatin should not be administered to children under 6 years of age.
• If the patient is under 18 years of age: Rosuvastatin 40 mg tablets should not be administered to children and adolescents under 18 years of age.

Other medicines and rosuvastatin

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:

The effects of these medicines may be modified by rosuvastatin or may change the effect of rosuvastatin.

If you need to take fusidic acid orally to treat a bacterial infection, you should stop taking rosuvastatin temporarily. Your doctor will tell you when it is safe to start taking rosuvastatin again. Taking rosuvastatin with fusidic acid may rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Do not takerosuvastatinif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatin using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

The majority of patients can drive vehicles and use machines during treatment with rosuvastatin as it will not affect their ability. However, some people may feel dizzy during treatment with rosuvastatin. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Alzil contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1mmol) pertablet; this is essentially “sodium-free”.

Follow the exact administration instructions of this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual doses in adults

If you are takingrosuvastatinafor high cholesterol levels:

Starting dose

Your treatment with rosuvastatina 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:

• Your cholesterol levels.
• The degree of risk you have of suffering a heart attack or cerebral infarction.
• If you have factors that make you more vulnerable to possible adverse effects.

Check with your doctor or pharmacist which is the best starting dose of rosuvastatina 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 areover 70 years old.
• If you have moderate kidney problems.
• If you have a risk of suffering 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 rosuvastatina for you. If you started with a dose of 5 mg, your doctor may decide to double the dose to 10 mg, then 15 mg or 20 mg and later to 30-40 mg, if necessary. If you started with a dose of 10 mg, your doctor may decide to increase the dose to 15-20 mg and later to 30-40 mg, if necessary. There will be a four-week interval between each dose adjustment.

The maximum daily dose of rosuvastatina is 40 mg. This dose is only for patients with high cholesterol levels and a high risk of suffering a heart attack or cerebral infarction, whose cholesterol levels do not decrease enough with 20 mg.

If you are taking rosuvastatina to reduce the risk of suffering 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.

Use in children and adolescents aged 6-17 years

The dose range in children and adolescents aged 6 to 17 years is 5 mg to 20 mg once a day. The usual starting dose is 5 mg per day and your doctor may increase your dose gradually to reach the right dose of rosuvastatina for you. The recommended maximum daily dose of rosuvastatina is 10-20 mg for children aged 6-17 years, depending on the underlying disease being treated. Take your dose once a day.Do not administer the30 mg and 40 mg rosuvastatina tabletsto children.

Swallowing the tablets

Swallow each tablet whole with water.

Takerosuvastatinaonce 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 rosuvastatina for you.

If you take more rosuvastatina 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 rosuvastatina. Your cholesterol levels may increase again if you stop taking rosuvastatina.

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 takingrosuvastatinaand 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.
• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing.
• Intense itching of the skin (with rashes).
• Reddish patches on the trunk, 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 symptoms similar to the flu (Stevens-Johnson syndrome).
• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking rosuvastatina 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 calledrabdomiólisis.

• If you experience muscle rupture.

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

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 returns 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 returns 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, and20 mg of rosuvastatina).

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 takingrosuvastatinaand seek medical attention immediately.
• Adult muscle injury – as a precaution,stop takingrosuvastatinaand consult your doctor immediately if you experience unexplained muscle pain or cramps that last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) 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)

• Jaundice (yellowing of the skin and eyes), hepatitis (inflamed liver), blood in the urine, nerve damage in the legs and arms (with numbness or tingling), joint pain, memory loss, and increased breast size in men (gynecomastia).

Side 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, and 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). Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, or 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttps://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.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Alzil

• The active principle is rosuvastatina. The film-coated rosuvastatina tablets contain rosuvastatina calcium equivalent to 15 mg of rosuvastatina.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, crospovidone, magnesium stearate, sodium hydrogen carbonate, anhydrous colloidal silica, hypromellose, titanium dioxide (E171), macrogol, and talc.

Appearance of the product and contents of the packaging

Alzil 15 mg are film-coated white tablets, round, biconvex, approximately 8.4 mm in diameter, and marked “15” on one side.

Alzil 15 mg is presented in Aluminio/Poliamida-Aluminio-PVC blisters.

Packaging sizes:

Alzil 15 mg film-coated tablets : 28 tablets.

Marketing authorization holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona

Spain

Responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos (Madrid)

Spain

Last review date of this leaflet: March 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .