Simvastatin Vir 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SIMVASTATINA VIR 10 mg film-coated tablets EFG

Read the entire 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 you must not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you consider any of the side effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

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

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

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

It is indicated for:

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

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

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

2. Before taking SIMVASTATIN VIR

Do not take SIMVASTATIN VIR if:

• You are allergic (hypersensitive) to simvastatin or to any of the other ingredients of this medicine.
• You have active liver disease or elevated transaminases.
• You are pregnant or breastfeeding.
• 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 associated with AIDS).
  • Nefazodone (a medicine used to treat depression).

Warnings and precautions

Talk to your doctor or pharmacist before taking SIMVASTATIN VIR 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 (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 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 or treatments may be needed to diagnose and manage this condition.

Take special care with SIMVASTATIN VIR:

• 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 higher in patients taking high doses of SIMVASTATIN VIR or taking another medicine together with SIMVASTATIN VIR 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 impairment or hypothyroidism, if you have a family history of muscle disorders or have previously experienced muscle problems, or if you regularly consume alcohol, inform your doctor, as these factors may increase the risk of muscle-related side effects.

• If you have had any liver disease. Mild 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 SIMVASTATIN VIR 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 SIMVASTATIN VIR.

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

Taking SIMVASTATIN VIR with food and drink:

SIMVASTATIN VIR can be taken with or without food.

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

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

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking any medicine.

SIMVASTATIN VIR is contraindicated during pregnancy and breastfeeding.

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

Driving and using machines:

At normal doses, SIMVASTATIN 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 react to the medicine.

Important information about some of the ingredients of SIMVASTATIN VIR:

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:

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

Certain medicines may interact with SIMVASTATIN VIR and increase the risk of muscle-related adverse reactions; 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 SIMVASTATIN VIR).
• Cyclosporine (a medicine used to prevent transplant rejection).
• 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 together with SIMVASTATIN VIR.

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. The use of simvastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

3. How to take SIMVASTATIN VIR

Follow these instructions unless your doctor has given you different advice. Remember to take your medicine.

Your doctor will determine how long you should take SIMVASTATIN VIR. 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, taken 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 medicines mentioned above or if you have certain kidney disorders.

Children and adolescents:

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

Elderly patients:

Dosage adjustment is not necessary.

If you think that the effect of SIMVASTATIN VIR is too strong or too weak, tell your doctor or pharmacist.

If you take more SIMVASTATIN VIR than you should:

Contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount taken.

It is recommended to bring the medicine pack and leaflet to the healthcare professional.

If you forget to take SIMVASTATIN VIR:

Do not take a double dose to make up for missed doses. Wait until the next dose and continue taking SIMVASTATIN VIR as usual.

4. Possible adverse effects

Like all medicines, SIMVASTATIN VIR can have adverse effects.

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 less 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, redness, 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 difficulty breathing (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 weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additional tests:

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

If you notice any of the adverse effects listed above or any other adverse effect not described in this leaflet, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SIMVASTATINA VIR

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

Keep in the original packaging.

Expiry:

Do not use SIMVASTATINA VIR after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Additional Information

Composition of SIMVASTATINA VIR:

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

The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, butylated hydroxyanisole (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 content of the container:

SIMVASTATINA VIR 10 mg is presented as pink, oval-shaped, biconvex, film-coated tablets with a score line. Each pack contains 28 tablets.

Other presentations:

SIMVASTATINA VIR 20 mg film-coated tablets. Pack containing 28 tablets.

SIMVASTATINA VIR 40 mg film-coated tablets. Pack containing 28 tablets.

Marketing Authorization Holder and 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. Poligono Malpica c/C nº 4 Zaragoza 50016

Date of the most recent review 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