Alcosin 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ALCOSIN 10 mg film-coated tablets

Simvastatin

Read all of this leaflet carefully before you start taking this medicine.

• 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 personally and must not be given to others. It could harm them, even if their symptoms are the same as yours.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What ALCOSIN is and what it is used for
2. Before you take ALCOSIN
3. How to take ALCOSIN
4. Possible side effects
5. How to store ALCOSIN
6. Further information

1. What ALCOSIN is and what it is used for

Simvastatin belongs to a group of medicines known as hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, which work by lowering lipid, cholesterol, and triglyceride levels in the blood.

It is indicated for:

• The treatment of elevated blood cholesterol levels (primary hypercholesterolemia or mixed dyslipidemia) together with diet, when diet or exercise alone have not reduced cholesterol sufficiently.

• The treatment of elevated blood cholesterol levels (homozygous familial hypercholesterolemia) together with diet and other cholesterol-lowering therapies.

• The prevention of cardiovascular problems and cardiovascular death in patients with atherosclerosis or diabetes, regardless of whether cholesterol levels are high or normal, in combination with other treatments.

2. Before taking ALCOSIN

Do not take ALCOSIN:

• If you are allergic (hypersensitive) to simvastatin or to any of the other components of this medicine.
• If you have active liver disease or elevated transaminases (liver enzymes).
• If you are pregnant or breastfeeding.
• If you are taking any of the following medicines:
  • Itraconazole or ketoconazole (medicines used to treat fungal infections).
  • Erythromycin, clarithromycin, or telithromycin (antibiotics).
  • HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines used to treat HIV infection that causes AIDS).
  • Nefazodone (a medicine used to treat depression).

Warnings and precautions

Talk to your doctor or pharmacist before taking ALCOSIN if you:

• Have severe respiratory insufficiency.
  • Are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and simvastatin may cause serious muscle problems (rhabdomyolysis).
  • Have or have had myasthenia gravis (a disease characterized by 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).

While you are taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk is higher if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Take special care with ALCOSIN:

• If you experience muscle pain, tenderness, or weakness. Inform your doctor immediately. Rarely, simvastatin may cause serious muscle problems that can lead to kidney damage.

This risk is greater in patients taking high doses of ALCOSIN or taking ALCOSIN together with a medicine that increases simvastatin blood levels and, therefore, increases the risk of muscle-related side effects. These medicines include:

• Fibrates and niacin (medicines that lower cholesterol levels).

• Amiodarone, verapamil, and diltiazem (medicines used to treat heart problems).

• Cyclosporine (a medicine used to prevent transplant rejection).

• If you have kidney problems or hypothyroidism, have a family history of muscle disorders, have previously experienced muscle problems, or regularly consume alcohol, inform your doctor, as these factors may increase the risk of muscle-related side effects.

• If you have had liver disease. Moderate increases in transaminase levels may occur, which in most cases return to normal without discontinuing treatment.

• If you are scheduled for surgery, it is advisable to stop taking ALCOSIN at least a few days before the procedure.

Your doctor may want to perform blood tests or liver function tests to ensure your liver is working properly before and during treatment with ALCOSIN.

Consult your doctor, even if any of the above conditions occurred in the past.

Taking ALCOSIN with food and drinks:

ALCOSIN can be taken with or without food.

Grapefruit juice increases simvastatin blood concentrations. Consumption of grapefruit juice should be avoided during treatment with ALCOSIN.

ALCOSIN should be used with caution in patients who consume alcohol. If you regularly drink alcohol, consult your doctor.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine. ALCOSIN is contraindicated during pregnancy and breastfeeding.

If you become pregnant or suspect pregnancy, you must stop treatment and inform your doctor immediately.

Driving and using machines:

At normal doses, ALCOSIN does not affect the ability to drive or operate machinery. However, if you experience symptoms of dizziness, do not drive or use machines until you know how you react to the medicine.

Important information about some of the components of ALCOSIN:

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

Use of other medicines:

Tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription.

Certain medicines may interact with ALCOSIN and increase the risk of muscle-related adverse effects; in such cases, it may be necessary to adjust the dose or discontinue one of the medicines.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• Fibrates and niacin (medicines that lower cholesterol levels).
• Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone. The use of simvastatin is contraindicated with these medicines (see section 2. Do not take ALCOSIN).
• Cyclosporine (a medicine used to prevent transplant rejection).
• Danazol (a synthetic hormone).
• Verapamil, diltiazem, and amiodarone (medicines used to treat heart problems).
• Ribociclib (used to treat breast cancer).
• Palbociclib (used to treat breast cancer).

It is also very important that you inform your doctor if you are taking or have recently taken:

• Oral anticoagulants (medicines to prevent blood clots), as their anticoagulant effect may be enhanced when taken with ALCOSIN.

If you need to take oral fusidic acid to treat a bacterial infection, you must stop using this medicine. Your doctor will advise you when you can restart treatment with simvastatin. Using simvastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

3. How to take ALCOSIN

Follow the administration instructions for ALCOSIN as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist.

Your doctor will determine the duration of your treatment with ALCOSIN. Do not stop treatment prematurely. The tablets should be taken at night and may be taken with water, with or without food. The usual starting dose is 10 to 40 mg once daily, administered as a single dose at night.

Your doctor may adjust your dose up to a maximum of 80 mg daily, administered as a single dose at night.

Your doctor may prescribe lower doses, especially if you are taking certain medications mentioned above or if you have certain kidney disorders.

Children and adolescents:

The efficacy and safety of ALCOSIN in children have not been established. Therefore, the use of ALCOSIN in children is not recommended.

Elderly patients:

Dose adjustment is not necessary.

If you take more ALCOSIN than you should:

In case of overdose, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medicine package and leaflet to the healthcare professional.

If you forget to take ALCOSIN:

Do not take a double dose to make up for missed doses. Wait until your next scheduled dose and continue taking ALCOSIN as usual.

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

4. Possible adverse effects

Like all medicines, ALCOSIN may produce adverse effects, although not everyone experiences them.

Very common (affects more than 1 in 10 people), common (affects between 1 and 10 in 100 people), uncommon (affects between 1 and 10 in 1,000 people), rare (affects between 1 and 10 in 10,000 people), very rare (affects fewer than 1 in 10,000 people), and isolated cases.

Blood and lymphatic system disorders:

Rare: anaemia.

Gastrointestinal disorders:

Rare: constipation, abdominal pain, flatulence, indigestion, diarrhoea, nausea, vomiting, inflammation of the pancreas.

General disorders:

Rare: weakness.

Hepatobiliary disorders:

Rare: hepatitis, yellowing of the skin and eyes (jaundice).

Musculoskeletal, connective tissue and bone disorders:

Rare: myopathy, rhabdomyolysis, muscle pain, muscle cramps.

Frequency not known: persistent muscle weakness.

Nervous system disorders:

Rare: headache, tingling sensation, dizziness, peripheral neuropathy.

Skin and subcutaneous tissue disorders:

Rare: skin rash, itching, hair loss.

Rarely, an apparent allergic syndrome has been reported, including some of the following features: angioedema, lupus-like syndrome, polymyalgia rheumatica, inflammation of blood vessels, thrombocytopenia, eosinophilia, increased erythrocyte sedimentation rate, arthritis and joint pain, itching, photosensitivity, fever, flushing, breathing difficulty and general malaise.

The following rare serious adverse effects have been reported: hypersensitivity (allergic) reactions including swelling of the face, tongue and throat, which may cause breathing difficulty (angioedema).

The following very rare serious adverse effects have been reported: a severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction).

Other possible adverse effects

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems including persistent cough and/or difficulty breathing or fever.

Diabetes. This is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Adverse reactions with frequency not known:

Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).

Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience arm or leg weakness that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additional tests:

Rare: increase in blood levels of transaminases, alkaline phosphatase, and creatine kinase (CK).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

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

5. Storage of ALCOSIN

Keep ALCOSIN out of the reach and sight of children. Do not store above 30°C.

Expiry:

Do not use ALCOSIN after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.

6. Information for the user

Composition of ALCOSIN:

The active substance is simvastatin. Each tablet contains 10 mg of simvastatin.

The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch (gluten-free), butylhydroxyanisole (E320), ascorbic acid, citric acid, anhydrous colloidal silica, talc, magnesium stearate, hypromellose, red iron oxide (E172), yellow iron oxide (E172), triethyl citrate, titanium dioxide (E171) and povidone.

Appearance of the medicinal product and contents of the pack:

ALCOSIN 10 mg is presented as pink, oval, biconvex, film-coated tablets with a break-line. Each pack contains 28 or 30 tablets.

Other presentations:

ALCOSIN 20 mg tablets. ALCOSIN 40 mg tablets.

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)

Manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/ Laguna 66-68-70, Polígono Industrial Urtinsa II - 28923 ALCORCÓN (Madrid)

Or

Laboratorios BELMAC, S.A.U., Polígono Malpica c/C nº 4 Zaragoza 50016 Spain

Date of the most recent revision of this leaflet: March 2026

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