Prospect: Information for the user

Alzil plus 5 mg/10 mg film-coated tablets

Alzil plus 10 mg/10 mg film-coated tablets

Alzil plus 20 mg/10 mg film-coated tablets

Alzil plus 40 mg/10 mg film-coated tablets

rosuvastatina / ezetimiba

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

• Keep this prospect, 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 must not give it to other people 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 do not appear in this prospect. See section 4.

1. What Alzil plus is and for what it is used

2. What you need to know before starting to take Alzil plus

3. How to take Alzil plus

4. Possible adverse effects

5. Storage of Alzil plus

6. Contents of the package and additional information

This medication contains two different active principles in a film-coated tablet. One of the active principles is rosuvastatina calcium, which belongs to the group of medications called statins, the other active principle is ezetimiba.

Alzil plus is a medication used to reduce total cholesterol levels, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. In addition, Alzil plus increases the concentrations of "good" cholesterol (HDL cholesterol). This medication acts by reducing cholesterol in two ways: reducing the cholesterol absorbed in the digestive tract, as well as the cholesterol produced by the body itself.

For 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 accumulate in the walls of blood vessels and narrow them.

Sometimes, these narrowed blood vessels can become blocked, cutting off blood supply to the heart or brain, which would cause a heart attack or stroke. By reducing cholesterol levels, the risk of having a heart attack, stroke, or other related health problems can be reduced.

This medication is used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you must follow a cholesterol-reducing diet.

Your doctor may prescribe Alzil plus if you are already taking rosuvastatina and ezetimiba at the same dose level.

Alzil plus is used if you have:

• High cholesterol levels in the blood (primary hypercholesterolemia)

This medication does not help with weight loss.

Do not take Alzil plus if:

• You are allergic to rosuvastatin, ezetimibe, or any of the other components of this medication (listed in section 6),
• You have liver disease,
• You have severe kidney problems,
• You have repeated or unjustified muscle pain and cramps (myopathy),
• You are taking a medication called ciclosporina (used, for example, after an organ transplant),
• You are pregnant or breastfeeding. If you become pregnant while taking Alzil plus, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medication using an appropriate contraceptive method.
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking Alzil plus or other related medications.

In addition, do not take Rosuvastatin 40 mg (the highest dose):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland does not function correctly (hypothyroidism)
• 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 medications called fibrates to lower cholesterol (see section “Other medications and Alzil plus”).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alzil plus if:

• You have kidney problems,
• You have liver problems,
• 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 constant muscle weakness,
• You are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must establish the appropriate dose of Alzil plus for you,
• You are taking medications to treat infections, including HIV (AIDS virus) or hepatitis C, such as lopinavir/ritonavir and/or atazanavir or simeprevir. See “Other medications and Alzil plus”,
• You have severe respiratory failure,
• You are taking other medications called fibrates to lower cholesterol, see “Taking Alzil plus with other medications”,
• You regularly consume large amounts of alcohol,
• Your thyroid gland does not function correctly (hypothyroidism),
• You are over 70 years old, (since your doctor must choose the appropriate dose of Alzil plus for you).
• You are taking or have taken within the last 7 days a medication called fusidic acid (a medication for bacterial infection) orally or injectable. The combination of fusidic acid and Alzil plus may cause severe muscle problems (rhabdomyolysis).
• 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 sometimes worsen the disease or cause myasthenia (see section 4).

If you find yourself in any of these situations mentioned above (or are unsure): consult your doctor or pharmacist before starting to take any dose of Alzil plus.

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 in the blood. For this reason, your doctor will normally perform blood tests (liver function test) during treatment with this medication. It is essential that you visit your doctor for the tests.

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 and fat levels, are overweight, and have high blood pressure.

Be especially careful with Alzil plus:

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

Children and adolescents

Alzil plus is not recommended for use in children and adolescents under 18 years of age.

Other medications and Alzil plus

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 taking any of the following medications:

• Ciclosporina (used, for example, after an organ transplant to prevent organ rejection. The effect of rosuvastatin increases with its use together).Do not take Alzil plus if you are taking ciclosporina.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking this medication together), ticagrelor, or clopidogrel.
• Other medications to lower cholesterol called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). During concurrent use, the effect of rosuvastatin increases.
• Colestiramine (a medication to lower cholesterol), as it affects how ezetimibe works.
• Antacids containing aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatin in plasma). This effect can be mitigated by taking this type of medication 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases with its use together.
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking this medication. Your doctor will indicate when you can safely take Alzil plus again. Taking this medication with fusidic acid may occasionally cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
• Oral contraceptive (the pill). The levels of sex hormones absorbed from the pill are increased.
• Hormone replacement therapy (increase of hormone levels in the blood).
• Regorafenib (used to treat cancer).
• Any of the following medications 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.

If you visit a hospital or receive treatment for another condition, inform the medical staff that you are taking Alzil plus.

Alzil plus with alcohol

Do not take Alzil plus 40 mg/ 10 mg (the high dose), if you regularly consume large amounts of alcohol.

Pregnancy and breastfeeding

Do not take Alzil plus if you are pregnant, think you may be pregnant, or intend to become pregnant. If you become pregnant while taking this medication, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with Alzil plus.

Do not take Alzil plus if you are breastfeeding, as it is unknown whether the medication passes into breast milk.

Driving and operating machinery

This medication is not expected to interfere with your ability to drive or operate machinery. However, some people may feel dizzy after taking Alzil plus. If you feel dizzy, consult your doctor before attempting to drive or operate machinery.

Alzil plus contains lactose

Alzil plus tablets contain a sugar called lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Alzil plus contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You should continue to maintain a low-cholesterol diet and exercise while taking Alzil plus.

The recommended daily dose for adults is one tablet of the indicated dose.

Take Alzil plus once a day.

You can take it at any time of the day, with or without food. Swallow each tablet whole with water.

Take your medication at the same time every day.

Alzil plus is not suitable for starting treatment. The start of treatment or dose adjustments, if necessary, should only be made by taking the active ingredients separately, and once the appropriate doses have been adjusted, it is possible to switch to the appropriate dose of Alzil plus.

The maximum daily dose of rosuvastatin 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 your doctor has prescribed Alzil plus together with other cholesterol-lowering medications that contain the active ingredient cholestyramine or another medication that contains a bile acid sequestrant, you should take Alzil plus at least 2 hours before or 4 hours after taking these medications.

Regular cholesterol level checks

It is essential that you attend your doctor regularly for cholesterol checks, in order to verify that your cholesterol levels have normalized and are maintained at appropriate levels.

If you take more Alzil plus than you should

Contact your doctor or the nearest hospital's emergency service as you may need medical assistance.

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 forget to take Alzil plus

Do not worry, omit the missed dose and take the next scheduled dose at the scheduled time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Alzil plus

Consult your doctor if you want to interrupt treatment with Alzil plus. Your cholesterol levels may increase again if you stop taking Alzil plus.

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 important that you know which side effects may occur.

Stop taking Alzil plus and seek medical help 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.
• Severe skin itching (with raised bumps).
• Rash on the trunk, red, flat, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking Alzil plus 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 called rhabdomyolysis.
• If you experience muscle rupture.
• If you experience a lupus-like syndrome(which includes skin rash, joint disorders, and effects on blood cells).

The following terms are used to describe how often side effects have been reported:

Very common side effects (may affect more than 1 in 10 people)

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

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

Rare side effects (may affect up to 1 in 1,000 people)

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

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

• Headache;
• Constipation;
• General feeling of being unwell;
• Muscle pain;
• Weakness;
• Dizziness;
• Diabetes. This is more likely if you have high blood sugar and lipid levels, being overweight, and high blood pressure. Your doctor will monitor you while taking this medicine;
• Stomach pain;
• Diarrhea;
• Flatulence (excess gas in the intestinal tract);
• Feeling tired;
• High levels of certain liver function test results (transaminases) in the blood.
• Increased protein levels in urine, which usually returns to normal on its own without the need to stop treatment with Alzil plus (only for Alzil plus 40 mg/10 mg tablets).

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

• Skin rash, itching, urticaria;
• Increased protein levels in urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets(only for Alzil plus 5 mg/10 mg, 10 mg/10 mg, and 20 mg/10 mg).
• High levels of certain muscle function test results (Creatine Kinase);
• Cough;
• Indigestion;
• Heartburn;
• Joint pain;
• Muscle spasms;
• Neck pain;
• Loss of appetite;
• Pain;
• Chest pain;
• Hot flashes;
• High blood pressure;
• Tickling sensation;
• Dry mouth;
• Stomach inflammation;
• Back pain;
• Muscle weakness;
• Pain in the arms and legs;
• Swelling, especially of the hands and feet.

Rare side effects (may affect up to 1 in 1,000 people)

• Pancreatitis, which causes severe stomach pain that may radiate to the back; low platelet count.

• Lupus-like syndrome.
• Muscle rupture.

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

Jaundice (yellowing of the skin and eyes); liver inflammation (hepatitis); blood in the urine; nerve damage in the legs and arms (such as numbness); memory loss; breast enlargement in men (gynecomastia).

Unknown frequency (cannot be estimated from available data)

Difficulty breathing; edema (swelling); sleep disturbances, including insomnia and nightmares; sexual dysfunction; depression; respiratory problems, including persistent cough and/or difficulty breathing or fever; tendon damage; persistent muscle weakness; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing); myasthenia gravis (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, 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:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep in the original packaging to protect it from light and humidity. This medication does not require any special temperature for conservation.

Keep this medication out of sight and reach of children.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Alzil plus

The active principles are rosuvastatina (as rosuvastatina calcium) and ezetimiba.

Alzil plus 5 mg/10 mg:

Each film-coated tablet contains 5.20 mg of rosuvastatina calcium (equivalent to 5 mg of rosuvastatina) and 10 mg of ezetimiba.

Alzil plus 10 mg/10 mg:

Each film-coated tablet contains 10.40 mg of rosuvastatina calcium (equivalent to 10 mg of rosuvastatina) and 10 mg of ezetimiba.

Alzil plus 20 mg/10 mg:

Each film-coated tablet contains 20.80 mg of rosuvastatina calcium (equivalent to 20 mg of rosuvastatina) and 10 mg of ezetimiba.

Alzil plus 40 mg/10 mg:

Each film-coated tablet contains 41.60 mg of rosuvastatina calcium (equivalent to 40 mg of rosuvastatina) and 10 mg of ezetimiba

- The other components are:

Core tablet (same for all doses):Microcrystalline cellulose (E460); Anhydrous colloidal silica (E-551); Magnesium stearate (E-572); Povidone (E-1201); Sodium croscarmellose (E-468); Sodium lauryl sulfate (E-487); Lactose monohydrate; Hypromellose (E-464).

Coating:

Opadry Yellow (5mg/10mg):Hypromellose (E-464); Titanium dioxide (E-171); Macrogol (E-1521); Yellow iron oxide (E-172); Talc (E-553b); Red iron oxide (E-172).

Opadry Beige (10mg/10mg):Hypromellose (E-464); Titanium dioxide (E-171); Macrogol (E-1521); Yellow iron oxide (E-172); Talc (E-553b).

Vivacoat Yellow (20mg/10mg):Hypromellose (E-464); Titanium dioxide (E-171); Macrogol (E-1521); Yellow iron oxide (E-172); Talc (E-553b).

Opadry White (40mg/10mg):Lactose monohydrate; Hypromellose (E-464); Titanium dioxide (E-171); Macrogol (E-1521).

Appearance of the product and contents of the package

Alzil plus 5 mg/ 10 mg film-coated tablets are yellowish-colored, round, biconvex tablets, approximately 10 mm in diameter, with the marking "EL 5" on one face.

Alzil plus 10 mg/ 10 mg film-coated tablets are beige-colored, round, biconvex tablets, approximately 10 mm in diameter, with the marking "EL 4" on one face.

Alzil plus 20 mg/ 10 mg film-coated tablets are yellow-colored, round, biconvex tablets, approximately 10 mm in diameter, with the marking "EL 3" on one face.

Alzil plus 40 mg/ 10 mg film-coated tablets are white-colored, round, biconvex tablets, approximately 10 mm in diameter, with the marking "EL 2" on one face.

Alzil plus is presented in blister packs of 30 and 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona (Spain)

Responsible for manufacturing

Elpen Pharmaceutical Co.Inc.

Marathonos 95

190 09 Pikermi – Attica (Greece)

or

ELPEN Pharmaceutical Co Inc

Zapani, Block 1048

Keratea, 19001, (Greece)

or

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. BOX 3012 Larissa Industrial Area

Larissa, 41500, Greece

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Spain:

Alzil plus 5 mg/ 10 mg film-coated tablets

Alzil plus 10 mg/ 10 mg film-coated tablets

Alzil plus 20 mg/ 10 mg film-coated tablets

Alzil plus 40 mg/ 10 mg film-coated tablets

Portugal:

Rosuvastatina + Ezetimiba Ferrer 5 mg + 10 mg film-coated tablets

Rosuvastatina + Ezetimiba Ferrer 10 mg + 10 mg film-coated tablets

Rosuvastatina + Ezetimiba Ferrer 20 mg + 10 mg film-coated tablets

Rosuvastatina + Ezetimiba Ferrer 40 mg + 10 mg film-coated tablets

Last revision date of this leaflet:April 2023

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/