Package Insert: Information for the Patient

Alcotina 10 mg Film-Coated Tablets EFG

Rosuvastatin

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others 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 are not listed in this package insert. See section 4.

1. What isAlcotinaand for what it is used

2. What you need to know before starting to takeAlcotina

3. How to takeAlcotina

4. Possible adverse effects

5. Storage ofAlcotina

6. Contents of the package and additional information

Rosuvastatin, the active ingredient in Alcotina, belongs to a group of medications called statins.

They have prescribed Alcotina for you:

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

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

Do not take Alcotina

•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 rosuvastatin, stop taking it immediately and inform your doctor.Women should avoid becoming pregnant during treatment with Rosuvastatina 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 combination of sofosbuvir/velpatasvir/voxilaprevir medicines (used for a liver infection called hepatitis C).

•If you are taking a medicine called ciclosporina(used, for example, after an organ transplant).

• If you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth sores after taking Alcotina or other related medicines.

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

Also, do not take the highest dose (Alcotina 40 mg):

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

•If your thyroid glanddoes not work 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 again.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rosuvastatina

•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 constant muscle weakness.

•If you regularly consume large amounts of alcohol.

•If your thyroid glanddoes not work 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) or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir, seeOther medicines and Alcotina

•If you are taking or have taken in the last 7 days a medicine called acid

fusidic(a medicine to treat bacterial infections), by mouth or by injection. The combination of acid fusidic and rosuvastatin may cause severe muscle problems (rhabdomyolysis), please see “Other medicines and Alcotina”.

•If you are over 70 years old(since your doctor must establish the starting dose of rosuvastatina suitable 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 starting dose of rosuvastatina suitable for you.

• Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) associated with Rosuvastatina treatment have been reported. Stop using Alcotina and seek medical attention immediately if you notice any of the symptoms described in section 4.
• 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 ocular myasthenia (a disease that causes weakness of the eye muscles), as statins sometimes can worsen the disease or cause myasthenia (see 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 rosuvastatina.

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 (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function test) before and after treatment with rosuvastatina

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: Rosuvastatina should not be administered to children under 6 years of age.

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

Other medicines and Alcotina

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:

-ciclosporina (used after an organ transplant),

-warfarina, 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 ezetimiba),

-treatments for indigestion (used to neutralize 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)

-darolutamida (used to treat cancer),

-hormone replacement therapy

-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 may be modified by rosuvastatina or may change the effect of rosuvastatina.

If you need to take acid fusidic orally to treat a bacterial infection, you must stop taking this medicine temporarily. Your doctor will indicate when it is safe to start taking Rosuvastatina again. Taking Rosuvastatina with acid fusidic may rarely cause weakness, sensitivity or muscle pain (rhabdomyolysis). See more information about rhabdomyolysis in section4.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Alcotina contains lactose

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.

Alcotinacontainstartrazine (E-102) and yellow orange S (E-110)

This medicine may cause allergic reactions because it contains tartrazine (E-102) and yellow orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid

Alcotina contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; that is, it 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:

Initial dose

Your treatment with rosuvastatin 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 initial 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 initial dose of rosuvastatin for you.

Your doctor may decide to start treatment with the lower dose (5 mg):

•If you are ofAsian 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 is 5 mg per day and your doctor may increase your dose gradually to reach the right dose of rosuvastatin for you. The maximum recommended 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 rosuvastatin 40 mg tablets to 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 checks

It is essential to visit your doctor regularly for cholesterol 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 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 condition, inform the healthcare staff that you are taking Rosuvastatin.

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 treatment with rosuvastatin

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 Alcotina and 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, not elevated, 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 flu-like symptoms (Stevens-Johnson syndrome).

• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking Alcotina and consult your doctor immediately

If you experience unjustified 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 side effects, which, very rarely, have resulted in a potentially fatal muscle injury calledrabdomiolysis.

•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 reverts 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 reverts to normal on its own without the need to interrupt treatment with rosuvastatina tablets (only for rosuvastatina 5 mg, 10 mg, and 20 mg).

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 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 (frequency cannot be estimated from available data) that may include:

• Diarrhea (loose stools), Stevens-Johnson syndrome (severe skin rash in the form of blisters on the skin, mouth, eyes, and genitals), 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 damage, 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 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 prospectus. 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 medication does not require special conservation 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

container/pouch/label after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash. Dispose of the containers 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 containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Alcotina

- The active ingredient is rosuvastatina. The film-coated tablets contain rosuvastatina calcium equivalent to 10 mg of rosuvastatina.

- The other components are:

Core:

Calcium citrate, microcrystalline cellulose, hydroxypropyl cellulose, mannitol, lactose, crospovidone, and magnesium stearate.

Coating:

Polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350 (E 1521), talc, tartrazine (E 102), allura red AC (E 129), yellow iron oxide (E 110), and indigo carmine (E 132).

Appearance of the product and contents of the packaging

Alcotina is presented in blister packs of 28 tablets.

Alcotina 10 mg film-coated tablets are pink, round, and biconvex.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 68-70. Polígono Industrial URTINSAII

28923 (Alcorcón) Madrid

Spain

Responsible manufacturer:

Biofarm Sp. z o.o., ul.Walbrzyska 13, 60-198 Poznan, Poland

Ó

Galenicum Health, S.L., Avda.Cornellá 144, 7ª-1ª, Edificio Lekla, Esplugues de Llobregat 08950, Barcelona, Spain

Ó

SAG Manufacturing, S.L.U., Crta.N-I, Km 36, San Agustin deGuadalix, 28750 Madrid, Spain

Ó

Industria Química y Fca. VIR, S.A.

C/Laguna 66-68-70. P.I. Urtinsa II

28923Alcorcón (Madrid)Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

ABABOR PHARMACEUTICALS, S.L.

C/ Chile 4, edificio 1, oficina 1, Las Matas,

28290, Las Rozas, Madrid. Spain

Phone: +34 91630 82 75

Last review date of this leaflet: May 2023

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