Simvastatin Pensa 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Simvastatin Pensa 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Simvastatin Pensa 10 mg film-coated tablets are and what they are used for.
2. Before taking Simvastatin Pensa 10 mg film-coated tablets.
3. How to take Simvastatin Pensa 10 mg film-coated tablets.
4. Possible side effects.
5. How to store Simvastatin Pensa 10 mg film-coated tablets.
6. Further information.

1. What SIMVASTATIN PENSA 10 MG FILM-COATED TABLETS is and what it is used for

Simvastatin Pensa 10 mg belongs to a group of medicines known as hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, which work by lowering lipid, cholesterol, and triglyceride levels in the blood.

Simvastatin Pensa 10 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 events and cardiovascular death in patients with atherosclerosis or diabetes, regardless of whether their cholesterol levels are high or normal, in combination with other treatments.

2. BEFORE TAKING SIMVASTATIN PENSA 10 MG FILM-COATED TABLETS

Do not take Simvastatin Pensa 10 mg film-coated tablets

• if you are allergic (hypersensitive) to simvastatin or to any of the other components of Simvastatin Pensa 10 mg.
• if you have active liver disease or elevated transaminases (liver enzymes).
• 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 used to treat certain infections).
  • 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

Consult your doctor or pharmacist before starting to take Simvastatin Pensa.

• If you 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 Pensa may cause serious muscle problems (rhabdomyolysis).
• 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).

Take special care with Simvastatin Pensa 10 mg film-coated tablets

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

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

• The risk is higher in patients taking high doses of Simvastatin Pensa or those taking Simvastatin Pensa together with medicines that increase simvastatin blood levels, thereby increasing the risk of muscle-related side effects, such as:

• Fibrates and niacin (medicines that lower cholesterol levels).

• Amiodarone, verapamil, and diltiazem (medicines used to treat heart conditions).

• Cyclosporine (a medicine used to prevent transplant rejection).

• Inform your doctor if you have kidney disease, 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.

• If you have had liver disease. Mild increases in liver enzyme (transaminase) levels may occur, which in most cases return to normal without discontinuing treatment.

• Consult your doctor or pharmacist before taking Simvastatin Pensa if you have severe respiratory insufficiency.

• While taking this medicine, your doctor will monitor you for diabetes or risk factors for developing diabetes. This risk increases if you have high blood sugar and fat levels, are overweight, or have high blood pressure.

• If you are scheduled for surgery, it is recommended that you stop taking Simvastatin Pensa 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 Pensa.

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

Use of other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to take any other medicines.

Certain medicines may interact with Simvastatin Pensa 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 treatments.

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 "Do not take Simvastatin Pensa 10 mg film-coated tablets").

• Cyclosporine (a medicine used to prevent transplant rejection).

• Verapamil, diltiazem, and amiodarone (medicines used to treat heart conditions).

• 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 Simvastatin Pensa treatment. Using Simvastatin Pensa with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

• Ribociclib (used to treat breast cancer)

• Palbociclib (used to treat breast cancer)

It is also very important to 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 when taken together with simvastatin.

Taking Simvastatin Pensa 10 mg film-coated tablets with food and drinks

Simvastatin Pensa may be taken with or without food.

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

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

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Simvastatin Pensa is contraindicated during pregnancy and breastfeeding.

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

Driving and use of machines

At normal doses, Simvastatin Pensa 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 the medicine affects you.

Important information about some of the components of Simvastatin Pensa 10 mg film-coated tablets

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take SIMVASTATINA PENSA 10 MG FILM-COATED TABLETS

Follow exactly the administration instructions for Simvastatina Pensa 10 mg given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will determine the duration of your treatment with Simvastatina Pensa 10 mg. 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 medications mentioned above or have certain kidney disorders.

Use in children and adolescents

The efficacy and safety of use in children have not been established. Therefore, the use of Simvastatina Pensa 10 mg is not recommended in children.

Use in elderly patients

Dose adjustment is not required.

If you take more Simvastatina Pensa 10 mg film-coated tablets than you should

If you have taken more Simvastatina Pensa 10 mg than you should, consult your doctor, pharmacist, or the nearest hospital.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, Telephone 91562 0420.

If you forget to take Simvastatina Pensa 10 mg film-coated tablets

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

If you stop taking Simvastatina Pensa 10 mg film-coated tablets

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

4. Possible adverse effects

Like all medicines, Simvastatin Pensa 10 mg may cause adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, please inform your doctor or pharmacist.

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.

Additional investigations:

Rare: increased blood levels of transaminases and alkaline phosphatase (liver enzymes, indicators of liver function) and creatine kinase (CK) (an enzyme indicating muscle breakdown).

Blood and lymphatic system disorders:

Rare: anaemia

Nervous system disorders:

Rare: headache, tingling sensation, dizziness, peripheral neuropathy (disease of the peripheral nerves).

Gastrointestinal disorders:

Rare: constipation, abdominal pain, flatulence, indigestion, diarrhoea, nausea, vomiting, pancreatitis

Skin and subcutaneous tissue disorders:

Rare: skin rash, itching, hair loss

Musculoskeletal and connective tissue disorders:

Rare: myopathy (muscle disease), rhabdomyolysis (a type of skeletal muscle injury), muscle pain, muscle cramps

Frequency not known: Persistent muscle weakness.

General disorders and administration site conditions:

Rare: weakness

Hepatobiliary disorders:

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

Sleep disorders, including insomnia and nightmares

Memory loss

Sexual dysfunction

Depression

Respiratory problems including persistent cough and/or difficulty breathing or fever

Diabetes: more likely if you have high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor you while you are taking this medicine.

Hypersensitivity

The following rare serious adverse effects have been reported.

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

• Hypersensitivity (allergic) reactions including:

Swelling of the deeper layers of the skin, swelling of the face, tongue, and throat, which may cause difficulty breathing (angioedema), pseudolupus syndrome, polymyalgia rheumatica (intense pain and stiffness mainly in shoulders and hips), dermatomyositis (muscle inflammation), inflammation of blood vessels, thrombocytopenia (decrease in the number of platelets, a type of blood cell), eosinophilia (increase in the number of eosinophils, a type of blood cell), increased erythrocyte sedimentation rate, arthritis and joint pain, itching, photosensitivity (increased skin sensitivity to light), fever, redness, breathing difficulty, and general malaise.

The following very rare serious adverse effects have been reported:

• A severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction)

Adverse effects 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 your arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SIMVASTATIN PENSA 10 MG FILM-COATED TABLETS

Keep out of the reach and sight of children.

Do not store above 30°C.

Keep in the original packaging.

Do not use Simvastatin Pensa 10 mg after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines should 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 helps protect the environment.

6. ADDITIONAL INFORMATION

Composition of Simvastatin Pensa 10 mg film-coated tablets

• The active substance is simvastatin. Each film-coated tablet contains 10 mg of simvastatin.
• The other components are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, 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 pack

Simvastatin Pensa 10 mg is presented as film-coated tablets. The tablets are pale pink, oval-shaped and biconvex. Each pack contains 28 film-coated tablets.

Other pack sizes

Simvastatin Pensa 20 mg film-coated tablets EFG: Pack containing 28 tablets.

Simvastatin Pensa 40 mg film-coated tablets EFG: Pack containing 28 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Polpharma S.A. Pharmaceutical Works

Pelplinska 19

83-200 Starogard Gdanski

Poland

Date of the most recent review of this leaflet: February 2026

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/