ALZIL 30 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Alzil 30 mg film-coated tablets

rosuvastatin

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Alzil and what is it used for
2. What you need to know before you take Alzil
3. How to take Alzil
4. Possible side effects
5. Storing Alzil
6. Contents of the pack and other information

1. What is Alzil and what is it used for

Alzil belongs to a group of medicines called statins.

You have been prescribed rosuvastatin because:

• You have high levels of cholesterol. This means you are at risk of having a heart attack or stroke. Rosuvastatin is used in adults, adolescents, and children over 6 years to treat high cholesterol.

You have been told to take a statin because changes to your diet and increasing exercise have not been enough to correct your cholesterol levels. You should maintain a diet that helps lower your cholesterol and continue to exercise while you are taking rosuvastatin.

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

Heart attack, stroke, and other related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the build-up of fatty deposits in your arteries.

Why it is important to keep taking rosuvastatin

Rosuvastatin is used to correct the levels of fatty substances in the blood called lipids, the most well-known of which is cholesterol.

There are different types of cholesterol in the blood, the "bad" cholesterol (LDL-C) and the "good" cholesterol (HDL-C).

• Rosuvastatin lowers the amount of "bad" cholesterol and increases the "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 because they do not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed blood vessels can become blocked, cutting off the 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 need to keep takingrosuvastatin, even if you have already achieved the correct cholesterol levels, as it prevents your cholesterol levels from rising againand causing the build-up of fatty deposits. However, you should stop taking it if your doctor tells you to or if you become pregnant.

2. What you need to know before you take Alzil

Do not take rosuvastatin

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

If you are pregnantor breast-feeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women must 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 unexplained muscle pains.
• If you are taking a medicine called ciclosporin(e.g., after an organ transplant).
• If you are taking a combination of medicines called sofosbuvir/velpatasvir/voxilaprevir(used to treat hepatitis C infection).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking rosuvastatin or other related medicines.

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

Also, do not take rosuvastatin 30 mg or 40 mg (the highest dose)

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid gland does not work properly.
• If you have repeated or unexplained muscle pains, 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 drink 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 fibratesto lower your cholesterol.

If you are 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 rosuvastatin:

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained muscle pains, 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 unexplained muscle pain, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland does not work properly.
• If you are taking other medicines called fibratesto lower your cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines before.
• If you are taking medicines to treat HIV infection(e.g., ritonavir with lopinavir and/or atazanavir), see “Other medicines and rosuvastatin”.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid(used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and rosuvastatin can cause muscle problems (rhabdomyolysis), see “Other medicines and rosuvastatin”.
• If you are over 70 years old, as your doctor will need to choose the right starting dose of rosuvastatin for you.
• If you have severe respiratory problems.
• If you are of Asian origin(e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will need to choose the right starting dose of rosuvastatin for you.
• If you have or have had myasthenia(a disease that causes muscle weakness, which can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes make these conditions worse (see section 4).

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

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

• Do not take rosuvastatin 30 mg and 40 mg (the highest 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 can be detected by a simple blood test that checks for increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally do blood tests (liver function tests) before and after starting you on rosuvastatin.

While you are on this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugar in your blood, are overweight, or have high blood pressure.

Children and adolescents

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

Other medicines and rosuvastatin

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

Tell your doctor if you are using any of the following medicines:

• ciclosporin (used after organ transplants),
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant, such as acenocoumarol),
• fibrates (e.g., gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
• indigestion treatments (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - see also “Warnings and precautions” and below),
• oral contraceptives (the pill),
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• capmatinib (used to treat cancer),
• simeprevir (used to treat chronic hepatitis C infection),
• hormone replacement therapy,
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high levels of uric acid in the blood),
• teriflunomide (used to treat multiple sclerosis),
• 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, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines can be altered by rosuvastatin or they can alter the effect of rosuvastatin.

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not takerosuvastatinif you are pregnant or breast-feeding.If you become pregnant while taking rosuvastatin, stop taking it immediatelyand inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatin using an appropriate contraceptive method.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Most patients can drive and use machines while taking rosuvastatinas it is unlikely to affect their ability. However, some people may feel dizzy while taking 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 some sugars, consult them before taking this medicine.

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

3. How to take Alzil

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist again.

The tablet can be divided into equal doses.

Usual dose in adults

If you are takingrosuvastatinfor high cholesterol:

Starting dose

Your treatment with rosuvastatin should start with a dose of 5 mg or 10 mg, even if you have taken a higher dose of another statin before.

The choice of starting dose will depend on:

• Your cholesterol levels.
• The level of risk you have of having a heart attack or stroke.
• If you have factors that make you more vulnerable to possible side effects.

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

Your doctor may decide to start you on 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 moderate kidney problems.
• If you are at risk of muscle pains(myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that 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 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 then to 30-40 mg if necessary. There will be a 4-week interval 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 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, stroke, or related health problems:

The recommended dose is 20 mg once daily. 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 dose range in children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual starting dose is 5 mg once daily, and your doctor may gradually increase your dose to the dose of rosuvastatin that is right for you. The maximum recommended daily dose of rosuvastatin is 10-20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once daily. Do notgive rosuvastatin 30 mg and 40 mgtablets to children.

Taking the tablets

Swallow each tablet whole with water.

Takerosuvastatinonce daily. You can take it at any time of day, with or without food. Try to take your tablets at the same time each day. This will help you remember to take them.

Regular checks of your cholesterol levels

It is important that you go to your doctor regularly to have your cholesterol levels checked, to make sure that your cholesterol levels have returned to normal and are being kept at the right 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 the nearest hospital for advice. If you have taken too much rosuvastatin, you may feel unwell.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you are admitted to hospital or receive treatment for another condition, inform the medical staff that you are taking rosuvastatin.

If you forget to take rosuvastatin

Do not worry, just take your next scheduled dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking rosuvastatin

Consult your doctor if you want to stop taking rosuvastatin. Your cholesterol levels may rise again if you stop taking rosuvastatin.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

It is essential that you know what these adverse effects can be. They are usually mild and disappear in a short period.

Stop takingrosuvastatinand seek immediate medical attentionif 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 can cause difficulty swallowing.
• Intense itching of the skin (with hives).
• Red spots on the torso, not elevated, in a target or circular shape, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking rosuvastatin and consult your doctor immediately:

• If you experience unjustified muscle pain and crampsthat last longer than expected. Muscle symptoms are more frequent in children and adolescents than in adults. As with other statins, a very small number of people have suffered unpleasant muscle effects that, very rarely, have resulted in a potentially fatal muscle injury called rhabdomyolysis.
• If you experience muscle rupture.
• If you present with a syndrome that has symptoms similar to lupus(including hives, joint disorders, and effects on blood cells).

Common 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 the urine – this usually reverses on its own without the need to interrupt treatment with rosuvastatin tablets (common adverse 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, are overweight, and have high blood pressure. Your doctor will closely monitor you 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 the urine – this usually reverses on its own without the need to interrupt treatment with rosuvastatin tablets (uncommon adverse effect with 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, intense itching of the skin (with hives). If you think you are having an allergic reaction, stop takingrosuvastatinand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop takingrosuvastatinand consult your doctor immediately if you have unjustified muscle pain or crampsthat 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 a low platelet count in the blood.
• Syndrome that has symptoms similar to lupus (including rash, joint disorders, and effects on blood cells).

Very Rare Adverse 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 breast enlargement in men (gynecomastia).

Adverse 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, severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing), ocular myasthenia (a disease that causes weakness of the eye muscles). 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Alzil

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

This medicine does not require special storage conditions.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Alzil

• The active ingredient is rosuvastatin. The film-coated rosuvastatin tablets contain rosuvastatin calcium equivalent to 30 mg of rosuvastatin.
• 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 Package Contents

Alzil 30 mg are film-coated tablets, white, round, biconvex, with a break line, approximately 11.2 mm in diameter, and marked with "30" on one side.

The tablet can be divided into equal doses.

Alzil 30 mg is presented in Aluminum/Poliamide-Aluminum-PVC blisters.

Package sizes:

Alzil 30 mg film-coated tablets: 28 tablets.

Marketing Authorization Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona

Spain

Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos (Madrid)

Spain

Date of the Last Revision of this Prospectus: March 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.