SIMVASTATIN BENEL 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Simvastatin Benel 20 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:1. What Simvastatin Benel is and what it is used for

1. What you need to know before you take Simvastatin Benel
2. How to take Simvastatin Benel
3. Possible side effects
4. Storage of Simvastatin Benel
5. Contents of the pack and further information

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

Simvastatin Benel 20 mg belongs to a group of medicines known as HMG-CoA reductase inhibitors, which act by reducing blood lipid, cholesterol, and triglyceride levels.

Simvastatin Benel 20 mg is indicated in:

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

in combination with diet and other treatments to reduce cholesterol levels.

• Treatment of high blood cholesterol levels (homozygous familial hypercholesterolemia)

prevention of cardiovascular problems and cardiovascular death in patients with atherosclerosis or diabetes, with high or normal cholesterol levels, in combination with other treatments.

• The

2. What you need to know before you take Simvastatin Benel

Do not take Simvastatin 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 one 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

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

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

This risk is higher in patients taking high doses of Simvastatin Benel or taking Simvastatin Benel with certain medicines that increase simvastatin blood levels, and therefore 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 insufficiency

• Tell your doctor if you have kidney failure, hypothyroidism, a family history of, or have previously suffered from muscle disorders, or if you normally consume alcohol, 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 Simvastatin Benel at least a few days before the operation.

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

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

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 Simvastatin Benel.

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 sugar and fat levels in your blood, are overweight, and have high blood pressure.

Talk to your doctor or pharmacist before taking Simvastatin Benel if you 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).

Taking Simvastatin Benel with other medicines:

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

Certain medicines can interact with Simvastatin Benel 20 mg 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 Simvastatin Benel 20 mg).
• Cyclosporine (a medicine used to prevent transplant rejection).
• Verapamil, diltiazem, and amiodarone (medicines used to treat heart problems).

It is also crucial that you inform your doctor if you are taking or have recently taken:

• Oral anticoagulants (medicines to prevent blood clots), as the anticoagulant effect may be enhanced if taken with Simvastatin Benel.

Taking Simvastatin Benel with food and drinks:

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

Grapefruit juice increases simvastatin blood levels. You should avoid consuming grapefruit juice while taking Simvastatin Benel.

Simvastatin Benel 20 mg 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 taking any medicine.

Simvastatin Benel 20 mg 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, Simvastatin Benel 20 mg does not affect the ability to drive or use machines. However, if you experience symptoms of dizziness, do not drive or use machines until you know how you tolerate the medicine.

3. How to take Simvastatin Benel

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Simvastatin Benel. Do not stop treatment before.

The tablets should be taken at night and can be administered with water or 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 medicines mentioned earlier or have certain kidney disorders.

Children and adolescents:

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

Elderly patients:

No dose adjustment is necessary.

If you think the action of Simvastatin Benel 20 mg is too strong or too weak, talk to your doctor or pharmacist.

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

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

If you forget to take Simvastatin Benel 20 mg:

Do not take a double dose to make up for forgotten doses, wait for the next dose.

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

4. Possible side effects

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

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

If you observe any of the following side effects, which may or may not be related to simvastatin, consult your doctor or pharmacist.

Possible side 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 sugar and fat levels in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

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

The following serious rare side effects have been reported.

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

Allergic reactions (including:

Swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema).

The following serious very rare side effects have been reported:

A severe allergic reaction that can cause difficulty breathing or dizziness (anaphylactic reaction).

Blood and lymphatic system disorders:

Rare: anemia.

Gastrointestinal disorders:

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

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 lesions), muscle pain, muscle cramps.

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

Frequency not known: constant muscle weakness.

Nervous system disorders:

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

Frequency not known: severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).

Eye disorders:

Rare: blurred vision and vision loss (can affect up to 1 in 1,000 people).

Frequency not known: ocular myasthenia (a disease that causes weakness of the eye muscles).

Talk to your doctor if you experience weakness in your arms or legs that worsens 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, which has included some of the following characteristics: hives, lupus-like syndrome, polymyalgia rheumatica, vasculitis, thrombocytopenia, eosinophilia (decrease in certain blood cells: platelets and eosinophils), increased erythrocyte sedimentation rate, arthritis, and joint pain, itching, sensitivity to light, fever, redness, difficulty breathing, and general malaise.

Very rare: skin rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (can affect up to 1 in 10,000 people).

Reproductive system and breast disorders:

Very rare: gynecomastia (breast enlargement in men) (can 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 start to become bothersome or worsen, inform your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side 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.

Store in the original package.

Do not use this medicine after the expiry date which is stated on the carton, after “EXP”. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Simvastatin Benel 40 mg content

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

• The other ingredients (excipients) are:

Lactose monohydrate (32.92 mg), pregelatinized cornstarch, microcrystalline cellulose, butylhydroxyanisole, 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 lake (E110).

Appearance and packaging of the product

Simvastatin Benel 20 mg is presented in the form of film-coated tablets, salmon-colored, oblong, and scored on both sides. Each pack contains 28 or 500 tablets.

Marketing authorization holder and manufacturer

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 inMay 2024

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/