ALZIL 15 mg FILM-COATED TABLETS

2. What you need to know before you take Alzil

Do not take Alzil

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

if you are:

• Pregnant or breast-feeding. If you become pregnant while taking rosuvastatin, stop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant while taking rosuvastatin and should use 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 sofosbuvir/velpatasvir/voxilaprevir(used to treat hepatitis C infection).
• If you have ever developed a severe rash or blistering of the skin and mucous membranes (Stevens-Johnson syndrome), or a severe skin rash with flaking skin (toxic epidermal necrolysis) after taking rosuvastatin or other medicines similar to rosuvastatin.

If you are in any of these situations (or are unsure), please go back and see your doctor.

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 while taking 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). Your doctor will need to choose the right starting dose of rosuvastatin for you.
• If you are taking other medicines called fibrates to lower your cholesterol.

If you are in any of these situations (or are unsure), please go back and see your doctor.

Warnings and precautions

• Consult your doctor or pharmacist before taking 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 while taking other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle pains, especially if you feel unwell or have a fever. Also, tell your doctor 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, such as ritonavir, 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 infections) by mouth or by injection. The combination of fusidic acid and rosuvastatin can, rarely, cause serious muscle problems (rhabdomyolysis), see section 4.
• 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 muscle weakness(a disease that causes muscle weakness, such as muscular dystrophy), as statins can, rarely, cause muscle weakness.

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 these situations (or are unsure), do not take rosuvastatin 30 mg or 40 mg and consult your doctor or pharmacist before taking any dose of rosuvastatin.

In a small number of people, statins can affect the liver. This is 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 carry out blood tests (liver function tests) before and after starting treatment with rosuvastatin.

While you are on this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high blood sugar levels, 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 taking any of the following medicines:

• ciclosporin (used after organ transplants),
• 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),
• indigestion treatments (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - see also "Warnings and precautions"),
• 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 may change 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 serious muscle problems (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 should avoid becoming pregnant while taking rosuvastatin and should use 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 in doubt, consult your doctor or pharmacist again.

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 the 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 lowest 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).

Increasing the dose and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the dose of rosuvastatin that is right 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 gap of at least 4 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 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 as needed. 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 one dose once daily. Do not give 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 back to your doctor regularly to have your cholesterol levels checked to make sure they have returned to normal and remain at the right levels.

Your doctor may decide to increase your dose so that you are taking the dose of rosuvastatin that is right for you.

If you take more rosuvastatin than you should

Contact your doctor or the nearest hospital for advice.

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 other 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 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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet. 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 stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This 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 15 mg of rosuvastatin.
• The other ingredients (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 15 mg are film-coated tablets, white, round, biconvex, approximately 8.4 mm in diameter, and marked "15" on one side.

Alzil 15 mg is presented in aluminum/polyamide-aluminum-PVC blisters.

Package sizes:

Alzil 15 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 Last Revision of this Leaflet: 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/.