Patient Information Leaflet: Package Insert

Alzil 20 mg Film-Coated Tablets EFG

Rosuvastatin

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

• Keep this leaflet, as 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. Do 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 isAlziland what it is used for

2. What you need to know before starting to takeAlzil

3. How to takeAlzil

4. Possible side effects

5. Storage ofAlzil

6. Contents of the pack and additional information

Rosuvastatin contains the active ingredient rosuvastatin and belongs to a group of medications called statins.

You have been prescribed rosuvastatin because:

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

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

You have been advised to take a statin because changes made to your diet and increased physical exercise have not been sufficient to correct your cholesterol levels. You must maintain a diet that helps to lower cholesterol and continue exercising while on treatment with rosuvastatin.

Or

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

A heart attack, stroke, and other related health problems can 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 remove 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 lowering your cholesterol levels, you can reduce your risk of having a heart attack, stroke, or related health problems.

You needto continue taking rosuvastatin, even if you have achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing again and forming fatty deposits. However, you should stop treatment if your doctor advises you to or if you become pregnant.

DO NOT TAKE rosuvastatin OR INFORM YOUR DOCTOR BEFORE TAKING ALZIL

•If you are allergic (hypersensitive) to rosuvastatin or to any of the other ingredients of this medicine (listed in section 6).

•If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatinstop taking it immediately and inform your doctor.Women should avoid becoming pregnant during treatment with rosuvastatin 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 rosuvastatin or other related medicines.

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

Also, do not take rosuvastatin 40 mg (the highest 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 previously.

•If you are taking medicines to treat HIV (AIDS virus) or hepatitis C infection,such as ritonavir with lopinavir and/or atazanavir or simeprevir, seeOther medicines and Alzil.

•If you are taking or have taken in the last 7 days a medicine calledacid fusidic(a medicine to treat bacterial infections), by oral or injectable route. The combination of acid fusidic and rosuvastatin may cause severe muscle problems (rhabdomyolysis),please see Other medicines and Alzil.

•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 are over 70 years old(since 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 that, in some cases, affects the muscles used for breathing) or myasthenic eye (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) associated with rosuvastatin treatment have been reported. 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 the highest dose of 40 mg and consult your doctor or pharmacist before starting to take any dose of rosuvastatin.

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 should not be administered to children and adolescents under 18 years of age.

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 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.

Other medicines and Alzil

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),

-any other medicine used to lower cholesterol (such as ezetimiba),

-medicines for indigestion (used to neutralise stomach acid),

-erythromycin (an antibiotic),

-acid fusidic (an antibiotic - please see below and in Warnings and precautions)

-oral contraceptives (the pill),

-hormone replacement therapy

-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 rosuvastatin or may change the effect of rosuvastatin.

If you must take acid fusidic by oral route for the treatment of a bacterial infection, you should temporarily stop taking rosuvastatin. Your doctor will indicate when you should restart your treatment with this medicine. Taking rosuvastatin 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 rosuvastatinif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatinstop taking it immediatelyand 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 him before taking this medicine.

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

Follow exactly the 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 taking rosuvastatin for high cholesterol levels:

Starting dose

Your rosuvastatin treatment 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 any factor that makes you more vulnerable to potential side effects.

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

Swallowing the tablets

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 attend 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 so that 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 Toxicological 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 rosuvastatin

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 rosuvastatin treatment

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 rosuvastatin and seek medical attention immediatelyif you notice any of the following symptoms:

•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).

•Syndrome similar to lupus (which includes skin rash, joint disorders, and effects on blood cells).

•Muscle rupture.

• Reddish patches on the trunk, flat, 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 syndrome or drug hypersensitivity syndrome).

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.

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

•Headache.

•Stomach pain.

•Constipation.

•Nausea.

•Muscle pain.

•Weakness.

•Dizziness.

•Increased protein levels in urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (frequent side effect only with the daily dose of 40 mg of rosuvastatin).

•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.

•Increased protein levels in urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (only for rosuvastatin 5 mg, 10 mg, and 20 mg).

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.

•Severe stomach pain (possible sign of pancreatitis).

•Increased liver enzymes in the blood.

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 the 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 (frequency cannot be estimated from available data):

•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).

•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 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://wwwnotificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This product does not require special storage conditions.

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/container/label 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 medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

The active principle of Alzil is rosuvastatina. The film-coated tablets of Alzil contain rosuvastatina calcium equivalent to 20 mg of rosuvastatina. The other components of the tablet core are: lactose monohydrate, microcrystalline cellulose, crospovidone, sodium bicarbonate, anhydrous colloidal silica, and magnesium stearate. The film coating contains: hypromellose, titanium dioxide (E171), macrogol 6000, talc, and iron oxide red (E172).

Appearance of the product and content of the packaging

Alzil is presented in packaging with blisters of 28 tablets.

Alzil 20 mg film-coated tablets are round, biconvex, pink tablets with marking 20.

Marketing authorization holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona (Spain)

Responsible for manufacturing

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Last review date of this leaflet: May 2023

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