Package Insert: Information for the User

SIMVASTATINA VIR 20 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medication.

• Keep this package insert. You may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only 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 effects you are experiencing is severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

1. What SIMVASTATINA VIR is and for what it is used

2. Before taking SIMVASTATINA VIR

3. How to take SIMVASTATINA VIR

4. Possible adverse effects

5. Storage of SIMVASTATINA VIR

6. Additional information

SIMVASTATINA VIR belongs to a group of medicines 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 SIMVASTATINA VIR if:

-You are allergic (hypersensitive) to simvastatin or to any of the other components of this medication.

-You have active liver disease or have elevated transaminases.

-You are pregnant or breastfeeding.

-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).

Advertencias and precautions

Consult with your doctor or pharmacist before taking SIMVASTATINA VIR if you:

•Have severe respiratory insufficiency

• You 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).
• You 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 sugars and fats in your blood, overweight, 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 SIMVASTATINA VIR:

-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 SIMVASTATINA VIR or taking SIMVASTATINA VIR with a medication that increases the levels of simvastatin 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 have kidney insufficiency or hypothyroidism, if you have a family history or have previously experienced 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 transaminase levels may occur, which, in most cases, return to their initial level without the need to discontinue treatment.

- If you have a scheduled surgical procedure, it is recommended that you stop taking SIMVASTATINA VIR 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 your treatment with SIMVASTATINA VIR.

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

Taking SIMVASTATINA VIR with food and drinks:

SIMVASTATINA VIR can be taken with or without food.

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

SIMVASTATINA VIR should be administered with caution in patients who consume alcohol. If you habitually drink alcohol, consult with your doctor.

Pregnancy and breastfeeding:

Consult with your doctor or pharmacist before taking a medication.

SIMVASTATINA VIR 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, SIMVASTATINA VIR does not affect the ability to drive or operate machinery.

However, if you experience dizziness, do not drive or operate machinery until you know how you tolerate the medication.

Important information about some of the components of SIMVASTATINA VIR:

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 recently used, any other medication, including those purchased without a prescription.

Certain medications may interact with SIMVASTATINA VIR and may increase the risk of adverse muscle reactions; 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 recently taken 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 simvastatin is contraindicated with these medications (see section 2. Do not take SIMVASTATINA VIR).

- Ciclosporin (medication used to prevent transplant rejection).

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

Tell your doctor if you are taking or have recently taken:

-Oral anticoagulants (medications to prevent blood clots), as the anticoagulant effect is potentiated if taken with SIMVASTATINA VIR.

If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking 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 these instructions unless your doctor has given you different instructions. Remember to take your medicine.

Your doctor will tell you how long you should take SIMVASTATINA VIR. Do not stop treatment before.

The tablets should be taken at night and can be taken with water, with or without food. The usual 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 medications mentioned earlier or if you have certain kidney disorders.

Children and adolescents:

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

Elderly patients:

No dose adjustment is necessary.

If you think the effect of SIMVASTATINA VIR is too strong or too weak, inform your doctor or pharmacist.

If you take more SIMVASTATINA VIR than you should:

Contact 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 SIMVASTATINA VIR:

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

Like all medicines, SIMVASTATINA VIR may cause side effects.

Very common (affects more than 1 person in 10), common (affects between 1 and 10 people in 100), uncommon (affects between 1 and 10 people in 1000), rare (affects between 1 and 10 people in 10,000), very rare (affects less than 1 person in 10,000) and isolated cases.

Blood and lymphatic system disorders:

Rare:anemia.

Digestive disorders:

Rare:constipation, abdominal pain, gas, 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.

Unknown frequency: 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, inflammation of blood vessels, thrombocytopenia, eosinophilia, increased erythrocyte sedimentation rate, arthritis and joint pain, itching, photosensitivity, fever, redness, difficulty breathing and general discomfort.

The following serious rare 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 very rare adverse reactions have been reported: a severe allergic reaction that causes 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. 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).

Myasthenic eye (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 blood of transaminases, alkaline phosphatase and creatine kinase (CK).

If you observe any of the above-mentioned side effects or any other side effect not described in this prospectus, consult your doctor or pharmacist.

Reporting of adverse 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 them directly to the Spanish Medicament Vigilance System for Human Use:www.notificaram.es. Reporting adverse effects may contribute to providing more information about the safety of this medication.

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

Store in the original packaging.

Expiration Date:

Do not use SIMVASTATINA VIR 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 the packaging and medicines you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of SIMVASTATINA VIR:

The active ingredient is simvastatina. Each tablet contains 20 mg of simvastatina.

The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, 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:

SIMVASTATINA VIR 20 mg is presented in the form of film-coated tablets, pink in color, oval and biconvex. Each package contains 28 tablets.

Other presentations:

SIMVASTATINA VIR 10 mg film-coated tablets. Package with 28 tablets.

SIMVASTATINA VIR 40 mg film-coated tablets. Package with 28 tablets.

Holder of the marketing authorization and responsible for manufacturing:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

or

LABORATORIOS BELMAC, S.A.U Poligono Malpica c/C nº 4 Zaragoza 50016

Revision date of this prospectus:

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

Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)http://www.aemps.gob.es