Simvastatin Benel 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Simvastatina Benel 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents: 1. What Simvastatina Benel is and what it is used for

1. What you need to know before taking Simvastatina Benel
2. How to take Simvastatina Benel
3. Possible side effects
4. How to store Simvastatina Benel
5. Contents of the pack and other information

1. What Simvastatina Benel is and what it is used for

Simvastatina Benel 20 mg belongs to a group of medicines known as hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, which work by reducing lipid, cholesterol, and triglyceride levels in the blood.

Simvastatina Benel 20 mg is indicated for:

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

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

• 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. What you need to know before taking Simvastatina Benel

Do not take Simvastatina Benel if:

• You are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6).
• 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 causing AIDS).
  • Nefazodone (a medicine used to treat depression).

Warnings and precautions

Talk to your doctor or pharmacist before taking Simvastatina Benel if you:

• Experience muscle pain, tenderness, or weakness. Inform your doctor immediately. Rarely, simvastatin may cause serious muscle problems that could lead to kidney damage.

This risk is higher in patients taking high doses of Simvastatina Benel or taking Simvastatina Benel together with a medicine that increases simvastatin blood levels, thereby increasing the risk of muscle disorders, such as:

• 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).

• Have severe respiratory failure.

• Inform your doctor if you have kidney impairment, hypothyroidism, a personal or family history of muscle disorders, or if you regularly consume alcohol, as these factors may increase the risk of muscle problems.

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

• Are scheduled for surgery. It is advisable to stop taking Simvastatina Benel at least a few days before surgery.

• This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him or her before taking this medicine.

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

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

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

Talk to your doctor or pharmacist before starting Simvastatina Benel if you 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).

Taking Simvastatina Benel with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Simvastatina Benel 20 mg and increase the risk of muscle-related adverse reactions; in such cases, it may be necessary to adjust the dose or discontinue treatment with 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 Simvastatina Benel 20 mg).
• Cyclosporine (a medicine used to prevent transplant rejection).
• 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 their anticoagulant effect may be enhanced when taken together with Simvastatina Benel.

Taking Simvastatina Benel with food and drink:

Simvastatina Benel 20 mg can be taken with or without food.

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

Simvastatina Benel 20 mg 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 taking any medicine.

Simvastatina Benel 20 mg is contraindicated during pregnancy and breastfeeding.

If you become pregnant or suspect pregnancy, stop treatment and inform your doctor as soon as possible.

Driving and using machines:

At normal doses, Simvastatina Benel 20 mg does not affect the ability to drive or operate machinery. However, if you experience dizziness, do not drive or use machines until you know how you react to the medicine.

3. How to take Simvastatina Benel

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine how long you should take Simvastatina Benel. Do not stop treatment earlier.

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 once daily, taken as a single dose at night.

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

Children and adolescents:

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

Elderly patients:

Dose adjustment is not necessary.

If you think that the effect of Simvastatina Benel 20 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Simvastatina Benel 20 mg than you should:

If you have taken more Simvastatina Benel 20 mg than you should, contact your doctor or pharmacist or the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Simvastatina Benel 20 mg:

Do not take a double dose to make up for missed doses. Wait until the next scheduled dose.

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

4. Possible adverse effects

Like all medicines, Simvastatin Benel may cause adverse effects, although not everyone experiences them.

Some patients may experience these effects during treatment or when stopping treatment.

If you notice any of the adverse effects listed below, whether or not they may be related to simvastatin, consult your doctor or pharmacist.

Possible adverse effects during treatment

• 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 sugar and fats in your blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.

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

The following serious adverse effects have been reported rarely.

If any of these serious adverse effects occur, stop taking the medicine immediately and contact your doctor right away or go to the nearest hospital emergency department.

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).

Blood and lymphatic system disorders:

Rare: anemia.

Gastrointestinal disorders:

Rare: constipation, stomach pain, gas, indigestion, diarrhea, nausea, vomiting, inflammation of the pancreas.

General disorders and administration site conditions:

Rare: weakness.

Hepatobiliary disorders:

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

Musculoskeletal, connective tissue and bone disorders:

Rare: myopathy, rhabdomyolysis (muscle damage), muscle pain, muscle cramps.

Very rare: muscle rupture (may affect up to 1 in 10,000 people).

Frequency not known: persistent muscle weakness.

Nervous system disorders:

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

Frequency not known: worsening of myasthenia gravis (a disease causing generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Eye disorders:

Rare: blurred vision and visual impairment (may affect up to 1 in 1,000 people).

Frequency not known: ocular myasthenia (a condition causing weakness of the eye muscles).

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

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: hives, lupus-like syndrome, polymyalgia rheumatica, vasculitis (inflammation of blood vessels), thrombocytopenia, eosinophilia (decrease in certain blood cells: platelets and eosinophils), increased erythrocyte sedimentation rate, arthritis and joint pain, itching, photosensitivity, fever, redness, difficulty breathing, and general malaise.

Very rare: skin eruptions or mouth ulcers (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people).

Reproductive system and breast disorders:

Very rare: gynecomastia (enlargement of breast tissue in men) (may affect up to 1 in 10,000 people).

Investigations:

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

If any of these symptoms become bothersome or worsen, inform your doctor.

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 Simvastatin Benel

Keep this medicine out of the sight and reach of children.

Do not store above 25 °C.

Keep in the original packaging.

Do not use this medicine after the expiry date stated on the container, following “EXP”. 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 collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Contents of Simvastatina Benel 40 mg

• The active substance is simvastatin. Each tablet contains 20 mg of simvastatin.

• The other components (excipients) are:

Lactose monohydrate (32.92 mg), pregelatinized starch (from corn) gluten-free, microcrystalline cellulose, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol 400, yellow iron oxide (E172), Ponceau 4R lake (E124), indigo carmine lake (E132) and sunset yellow FCF lake (E110).

Appearance of the medicine and pack contents

Simvastatina Benel 20 mg is presented as salmon-coloured, film-coated, oblong, scored tablets on both sides. Each pack contains 28 or 500 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LABORATORIO FARMALIDER, S.A
C/ Aragoneses, 15 - Pol. Ind. Alcobendas
28108 Madrid (Spain).

Manufacturer:

West Pharma - Producções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº 11, Venda Nova, 2700 Amadora.

This leaflet was approved in May 2024**

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