ALCOSIN 10 mg FILM-COATED TABLETS

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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. Storage of ALCOSIN
6. Further information

1. What ALCOSIN is and what it is used for

Simvastatin belongs to a group of medicines known as HMG-CoA reductase inhibitors, which act by reducing blood lipid, cholesterol, and triglyceride levels.

It is indicated in:

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

• Treatment of high blood cholesterol levels (homozygous familial hypercholesterolemia) in conjunction with diet and other cholesterol-reducing treatments.

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

2. Before you take ALCOSIN

Do not take ALCOSIN:

• If you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine.
• If you have active liver disease or elevated liver enzymes (transaminases).
• 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 infections that cause AIDS).
  • Nefazodone (a medicine 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 in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and simvastatin can cause serious muscle problems (rhabdomyolysis).
  • Have or have had myasthenia (a disease characterized by generalized muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure.

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

Be careful with ALCOSIN:

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

This risk is higher in patients taking high doses of ALCOSIN or taking ALCOSIN with certain medicines that increase simvastatin blood levels and, therefore, the risk of muscle disorders. These medicines are:

• 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, if you have a family history or have previously had muscle disorders, or if you normally consume alcohol, inform your doctor, as these factors can increase the risk of muscle disorders.

• If you have had liver disease. Moderate increases in transaminase levels 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 operation.

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

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Taking ALCOSIN with food and drinks:

ALCOSIN can be taken with or without food.

Grapefruit juice increases simvastatin concentrations in the blood. You should avoid consuming grapefruit 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 medicine. ALCOSIN is contraindicated during pregnancy and breastfeeding.

In case of pregnancy or suspected pregnancy, you should stop treatment and inform your doctor as soon as possible.

Driving and using machines:

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

Important information about some of the ingredients of ALCOSIN:

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

Use of other medicines:

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

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

It is essential 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).

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 the anticoagulant effect is enhanced if taken with ALCOSIN.

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

3. How to take ALCOSIN

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

Your doctor will indicate the duration of your treatment with ALCOSIN. Do not stop treatment before. The tablets should be taken at night and can be administered with water, with or without food. The normal starting dose is 10 to 40 mg per day, administered in a single dose at night.

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

Your doctor may prescribe lower doses, especially if you are taking certain medicines indicated above 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 is not recommended in children.

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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take ALCOSIN:

Do not take a double dose to make up for forgotten doses, wait for the next dose and continue taking ALCOSIN as usual.

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

4. Possible side effects

Like all medicines, ALCOSIN can cause side effects, although not everybody gets them.

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

Blood and lymphatic system disorders:

Rare: anemia.

Digestive disorders:

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

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: 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 allergic syndrome has been reported, which has included some of the following characteristics: angioedema, lupus-like syndrome, polymyalgia rheumatica, vasculitis, thrombocytopenia, eosinophilia, increased erythrocyte sedimentation rate, arthritis, and joint pain, itching, photosensitivity, fever, flushing, difficulty breathing, and general malaise.

The following serious rare side effects have been reported: allergic reactions (including angioedema, which can cause difficulty breathing).

The following very rare serious side effects have been reported: a severe allergic reaction that can cause 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. 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 unknown frequency:

Severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).

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

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

Complementary tests:

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

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side 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.

Expiration date:

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

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the pharmacy's SIGRE point. Ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Further information

Composition of ALCOSIN:

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

The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, corn starch, butylhydroxyanisole (E320), ascorbic acid, citric acid, colloidal anhydrous 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 package contents:

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

Other presentations:

ALCOSIN 20 mg tablets. ALCOSIN 40 mg tablets.

Marketing authorization holder and manufacturer:

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 España

Date of the last revision of this leaflet:

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