Alcotina 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Alcotina 20 mg film-coated tablets EFG

Rosuvastatin

Read the entire 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 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Alcotina is and what it is used for

Alcotina contains the active substance rosuvastatin, which belongs to a group of medicines known as statins.

You have been prescribed Alcotina because:

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

• You have been advised to take a statin because changes in your diet and increased physical activity have not been sufficient to correct your cholesterol levels. You must maintain a cholesterol-lowering diet and continue exercising while taking rosuvastatin.

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

Heart attacks, strokes, and other related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why it is important that you continue taking Alcotina

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

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 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, as they produce no symptoms. However, if left untreated, fatty deposits can build up 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, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other related health problems.

You need to continue taking rosuvastatin, even after your cholesterol levels have normalized, because it prevents cholesterol levels from rising again and stops the formation of fatty deposits. However, you should stop treatment if your doctor instructs you to do so, or if you become pregnant.

2. What you need to know before taking Alcotina

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 pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatin by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you experience repeated or unexplained muscle pain and cramps.

If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medicines
(used to treat a viral liver infection called hepatitis C).

• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).
  • If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Alcotina or other related medicines.

If any of the above situations apply to you (or you 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 gland is not functioning properly.
• If you have repeated or unexplained muscle pain and cramps, a personal or family history of muscle problems, or a previous history of muscle problems while taking other cholesterol-lowering medicines.
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other cholesterol-lowering medicines called fibrates.

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

Warnings and precautions

Talk to 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 pain and cramps, a personal or family history of muscle problems, or a previous history of muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if accompanied by general malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland is not functioning properly.
• If you are taking other cholesterol-lowering medicines called fibrates. Read this leaflet carefully, even if you have previously taken cholesterol-lowering medicines.
• If you are taking medicines to treat HIV (AIDS virus) or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir; see "Other medicines and Alcotina".
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections), taken orally or by injection. The combination of fusidic acid and rosuvastatin may cause serious muscle problems (rhabdomyolysis); please see “Other medicines and Alcotina”.
• If you are over 70 years old (as your doctor must determine the appropriate starting dose of rosuvastatin for you).
• If you have severe respiratory failure.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate starting dose of rosuvastatin for you.
  • Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop using Alcotina and seek immediate medical attention if you notice any of the symptoms described in section 4.
  • If you have or have had myasthenia (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

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

•Do not take the highest dose of 40 mg and consult your doctor or pharmacist before starting any dose of rosuvastatin.

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing increased levels of liver enzymes (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) before and during 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 are likely 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: Rosuvastatin should not be given to children under 6 years of age.

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

Other medicines and Alcotina

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

Inform your doctor if you are taking any of the following medicines:

• cyclosporine (used after organ transplantation),
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant medicine such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
• medicines for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic – please see below and in Warnings and precautions),
• oral contraceptives (the pill),
• hormone replacement therapy,
• regorafenib (used to treat cancer),

• darolutamide (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 altered by rosuvastatin, or they may alter the effect of rosuvastatin.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart rosuvastatin. Taking rosuvastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive vehicles and operate machinery while being treated 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.

Alcotina contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Alcotina contains tartrazine (E-102) and orange yellow S (E-110)

This medicine may cause allergic reactions as it contains tartrazine (E-102) and orange yellow 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; hence, it is essentially "sodium-free."

3. How to take Alcotina

Follow exactly the instructions for use of this medicine as given 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 treatment with rosuvastatin should begin with a dose of 5 mg or 10 mg, even if you have previously taken a higher dose of another statin. The choice of starting dose will depend on:

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

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

Your doctor may decide to start treatment with 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 pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you receive the appropriate rosuvastatin dose for your condition. If you started with a 5 mg dose, 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 10 mg dose, your doctor may decide to double the dose to 20 mg and then to 40 mg, if necessary. There will be an interval of four 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 heart attack or stroke whose cholesterol levels do not decrease sufficiently with 20 mg.

If you are taking rosuvastatin to reduce the risk of heart attack, stroke, or related health problems:

The recommended dose is 20 mg 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 for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual starting dose is 5 mg daily, and your doctor may gradually increase the dose until reaching the appropriate rosuvastatin dose 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 condition being treated. Take your dose once daily. Rosuvastatin 40 mg tablets must not be administered to children.

How to take the tablets

Swallow each tablet whole with water.

Take rosuvastatin once daily. You may take it at any time of day, with or without food.

Try to take the tablets at the same time each day. This will help you remember to take them.

Regular monitoring of cholesterol levels

It is important that you 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 receive the appropriate rosuvastatin dose for your condition.

If you take more Alcotina than you should

Contact your doctor or nearest hospital for advice.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Alcotina

Do not worry; simply take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Alcotina

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

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time.

Stop taking Alcotina and seek immediate medical attention if 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 hives).

Red, flat spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).

• Widespread 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 unexplained muscle pain and cramps lasting longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with 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 breakdown.

• If you develop a syndrome with symptoms resembling lupus (including hives, joint disorders, and effects on blood cells).

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

• Headache, stomach pain, constipation, nausea, muscle pain, weakness, dizziness.
• Increased levels of protein in urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin tablets (frequent adverse effect only with the 40 mg daily dose 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 monitor you closely while you are taking this medicine.

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

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

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, and severe skin itching (with hives). If you think you are having an allergic reaction, stop taking rosuvastatin and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking rosuvastatin and consult your doctor immediately if you have unexplained muscle pain or cramps lasting longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increased liver enzymes (transaminases) in blood.
• Bleeding or bruising more easily than normal due to low platelet count in the blood.
• Syndrome with symptoms resembling lupus (including hives, 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 traces in urine, nerve damage in arms and legs (with numbness or tingling), joint pain, memory loss, and enlargement of the breasts in men (gynecomastia).

Adverse effects with unknown frequency (frequency cannot be estimated from available data) which may include:

• Diarrhea (loose stools), Stevens-Johnson syndrome (severe blistering skin rash affecting 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 injuries, and persistent muscle weakness.
• Myasthenia gravis (a condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing). Ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://wwwnotificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alcotina

This medicine does not require any special storage conditions.

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

Do not use this medicine after the expiry date stated on the

pack/blister/label after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alcotina

• The active substance is rosuvastatin. The film-coated tablets contain calcium rosuvastatin equivalent to 20 mg of rosuvastatin.
• The other components are:

Core:

Calcium citrate, microcrystalline cellulose, hydroxypropylcellulose, 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), sunset yellow FCF (E 110) and indigo carmine (E 132).

Appearance of the medicine and contents of the pack

Alcotina is available in blister packs containing 28 and 30 tablets.

Alcotina 20 mg film-coated tablets are pink, oval, biconvex tablets, scored on one side.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-68-70. Polígono Industrial Urtinsa II

28923 (Alcorcón) Madrid

Spain

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

ABABOR PHARMACEUTICALS, S.L.

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

28290, Las Rozas, Madrid.

Tel.: +34 91 630 82 75

Manufacturer:

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

Or

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

Or

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

Or

Industria Química y Fca. VIR, S.A.

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

28923 Alcorcón (Madrid) Spain

Date of the most recent revision of this leaflet: May 2023

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