Label: information for the user

ALCOSIN 10 mg film-coated tablets

Simvastatina

Read this label carefully before starting to take the medicine.

• Keep this label. You may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally and should not be given to others. It may harm them, even if their symptoms are the same as yours.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist. See section 4.

1. What ALCOSIN is and for what it is used

2. Before taking ALCOSIN

3. How to take ALCOSIN

4. Possible adverse effects

5. Storage of ALCOSIN

6.Additional information

Simvastatina belongs to a group of medications known as HMG-CoA reductase inhibitors that act by reducing levels of lipids, cholesterol, and triglycerides in the blood.

It is indicated for:

-Treatment of elevated levels of cholesterol in the blood (primary hypercholesterolemia or mixed dyslipidemia) in conjunction with diet, when diet or exercise have not reduced cholesterol levels.

-Treatment of elevated levels of cholesterol in the blood (familial homozygous hypercholesterolemia) in conjunction with diet and other treatments to reduce cholesterol levels.

-Prevention of cardiovascular problems and cardiovascular death in patients with atherosclerosis or diabetes, with high or normal cholesterol levels, in conjunction with other treatments.

Do not take ALCOSIN:

− If you are allergic (hypersensitive) to simvastatin or to any of the other components of this medication.

− If you have an active liver disease or have elevated liver enzymes (transaminases).

− If you are pregnant or breastfeeding.

− If you are taking one of the following medications:

•Itraconazole or ketoconazole (medications used to treat fungal infections).

•Erythromycin, clarithromycin, or telithromycin (antibiotics).

•Protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir, and saquinavir (medications used to treat HIV infections that cause AIDS).

•Nefazodone (medication used to treat depression).

Warnings and precautions

Consult your doctor or pharmacist before taking ALCOSIN if you:

•Have severe respiratory insufficiency

• Are taking or have taken within the last 7 days a medication containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and simvastatin may cause severe muscle problems (rhabdomyolysis).
• Have or have had myasthenia (a disease that causes generalized 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 may sometimes worsen the disease or cause myasthenia (see section 4).

While you are taking this medication, your doctor will monitor if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fats in your blood, obesity, and high blood pressure.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Be especially careful with ALCOSIN:

-If you experience pain, sensitivity to pressure, or muscle weakness.Inform your doctor immediately. In rare cases, simvastatin may cause severe muscle problems that can cause kidney damage.

This risk is higher in patients taking high doses of ALCOSIN or taking it with

ALCOSIN some medications that increase simvastatin levels in the blood and, therefore, the risk of muscle problems. These medications are:

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

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

•Ciclosporin (medication used to prevent transplant rejection).

-If you experience kidney problems or hypothyroidism, if you have a family history or have previously had muscle problems, or if you normally consume alcohol, inform your doctor, as these factors may increase the risk of muscle problems.

-If you have had liver disease. It is possible that moderate increases in liver enzymes may occur, which, in most cases, return to normal without the need to discontinue treatment.

-If you are scheduled for surgery, it is recommended that you stop taking ALCOSIN at least a few days before the procedure.

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

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Taking ALCOSIN with food and drinks:

ALCOSIN can be taken with or without food.

Orange juice increases simvastatin levels in the blood. Avoid consuming orange juice while taking ALCOSIN.

ALCOSIN should be administered 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 a medication. ALCOSIN is contraindicated during pregnancy and lactation.

In the event of pregnancy or suspected pregnancy, you should discontinue treatment and inform your doctor as soon as possible.

Driving and operating machinery:

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 operate machinery until you know how you tolerate the medication.

Important information about some of the components of ALCOSIN:

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

Use of other medications:

Inform your doctor or pharmacist if you are using, or have used recently, any other medication, including those purchased without a prescription.

Certain medications may interact with ALCOSIN and may increase the risk of muscle side effects; in these cases, it may be necessary to change the dose or discontinue treatment with one of them.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

-Fibrates and niacin (medications that lower cholesterol levels).

-Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, protease inhibitors for HIV, and nefazodone. The use of simvastatinis contraindicatedwith these medications (see section 2. Do not take ALCOSIN).

-Ciclosporin (medication used to prevent transplant rejection).

-Danazol (synthetic hormone).

-Verapamil, diltiazem, and amiodarone (medications used to treat heart problems).

Also, it is very important to inform your doctor if you are taking or have taken recently:

-Oral anticoagulants (medications to prevent blood clots), as they may potentiate the anticoagulant effect if taken with ALCOSIN.

If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop using this medication. Your doctor will indicate when you can restart simvastatin treatment. The use of simvastatin with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Follow the administration instructions for ALCOSIN as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

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

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

Children and Adolescents:

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

Elderly Patients:

No dose adjustment is necessary.

If you take more ALCOSIN than you should:

In case of overdose, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take ALCOSIN:

Do not take a double dose to compensate for the missed doses, wait for the next scheduled dose and continue taking ALCOSIN as usual.

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

Like all medicines, ALCOSIN may cause side effects, although not everyone will experience them.

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

Blood and lymphatic system disorders:

Rare: anemia.

Digestive system disorders:

Rare: constipation, abdominal pain, gas, indigestion, diarrhea, nausea, vomiting, pancreatitis.

General disorders:

Rare: weakness.

Hepatobiliary system 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: Constant 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 allergy syndrome has been reported, which has included some of the following characteristics: angioedema, lupus-like syndrome, polymyalgia rheumatica, inflammation of the blood vessels, thrombocytopenia, eosinophilia, increased erythrocyte sedimentation rate, arthritis, joint pain, itching, photosensitivity, fever, redness, difficulty breathing and general malaise.

The following serious adverse reactions have been reported: hypersensitivity reactions (allergic) that include: swelling of the face, tongue and throat, which can cause difficulty breathing (angioedema)

The following serious adverse reactions have been reported: a severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction).

Other possible side effects

•Sleep disorders, including insomnia and nightmares

•Memory loss

•Sexual dysfunction

•Depression

•Respiratory problems, including persistent cough and/or difficulty breathing or fever.

Diabetes. It is more likely if you have high blood sugar and fat levels, obesity and high blood pressure. Your doctor will monitor you while taking this medication.

Adverse reactions of unknown frequency:

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 or eyelid drooping, difficulty swallowing or difficulty breathing.

Complementary tests:

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

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report themdirectlyto the Spanish Medicament Vigilance System of Human Use:www.notificaram.es.Reporting side effects may contribute to providing more information on the safety of this medication.

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

Expiration Date:

Do not use ALCOSIN after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of ALCOSIN:

The active ingredient is simvastatina. Each tablet contains 10 mg of simvastatina.

The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch without gluten, 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 product and contents of the package:

ALCOSIN 10 mg is presented in the form of film-coated, scored, pink-colored, oval, and biconvex tablets. Each package contains 28 tablets.

Other presentations:

ALCOSIN 20 mg tablets. ALCOSIN 40 mg tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder::

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70, Polígono Industrial Urtinsa II - 28923 ALCORCÓN (Madrid)

Responsible for manufacturing:

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 España

Date of the last review of this prospectus:

The detailed and updated information on this medication is available on the website of the

Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es