Simvastatin Pensa 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Simvastatine Pensa 40 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 must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Simvastatine Pensa 40 mg film-coated tablets are and what they are used for.
2. Before taking Simvastatine Pensa 40 mg film-coated tablets.
3. How to take Simvastatine Pensa 40 mg film-coated tablets.
4. Possible side effects.
5. How to store Simvastatine Pensa 40 mg film-coated tablets.
6. Further information.

1. What SIMVASTATIN PENSA 40 MG FILM-COATED TABLETS is and what it is used for

Simvastatin Pensa 40 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.

Simvastatin Pensa 40 mg is indicated for:

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

• Treatment of elevated blood cholesterol levels (homozygous familial hypercholesterolemia) in combination 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 addition to other treatments.

2. BEFORE TAKING SIMVASTATIN PENSA 40 MG FILM-COATED TABLETS

Do not take Simvastatin Pensa 40 mg film-coated tablets

• if you are allergic (hypersensitive) to simvastatin or to any of the other components of Simvastatin Pensa 40 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 associated with 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 a medicine containing fusidic acid (used to treat bacterial infection) by oral route or by injection. The combination of fusidic acid and Simvastatin Pensa may cause serious muscle problems (rhabdomyolysis).
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Take special care with Simvastatin Pensa 40 mg film-coated tablets

• 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.

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

• This risk is higher in patients taking high doses of Simvastatin Pensa or taking Simvastatin Pensa together with a medicine that increases simvastatin blood levels, and therefore increases 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 problems).

• 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-related side effects.

• 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 of developing diabetes. This risk is higher 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 40 mg film-coated tablets”).

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

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

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

• 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 the anticoagulant effect may be enhanced when taken together with simvastatin.

Taking Simvastatin Pensa 40 mg film-coated tablets with food and drink

Simvastatin Pensa can 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 taking any medication.

Simvastatin Pensa is contraindicated during pregnancy and breastfeeding.

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

Driving and operating machinery

At normal doses, Simvastatina Pensa does not affect the ability to drive or operate machinery. However, if you experience symptoms of dizziness, do not drive or operate machinery until you know how you tolerate the medicine.

Important information about some of the components of Simvastatina Pensa 40 mg film-coated tablets

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

3. How to take SIMVASTATIN PENSA 40 MG FILM-COATED TABLETS

Follow exactly the dosing instructions for Simvastatin Pensa 40 mg provided by your physician. 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 Simvastatin Pensa 40 mg. Do not discontinue 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, administered 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 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 Simvastatin Pensa 40 mg is not recommended in children.

Use in elderly patients

Dose adjustment is not necessary.

If you take more Simvastatin Pensa 40 mg film-coated tablets than you should

If you have taken more Simvastatin Pensa 40 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 40 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 40 mg film-coated tablets

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 Pensa 40 mg can cause adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be serious, 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 destruction).

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 (inflammation of the pancreas)

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 levels of blood sugar and fats, overweight, and high blood pressure. Your doctor will monitor you while you are taking this medicine.

Hypersensitivity

The following rare but 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:

Inflammation 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), vasculitis (inflammation of blood vessels), thrombocytopenia (reduced number of platelets, a type of blood cell), eosinophilia (increased 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 40 MG FILM-COATED TABLETS

Keep out of the reach and sight of children.

Do not store above 30 °C.

Store in the original packaging.

Do not use Simvastatin Pensa 40 mg after the expiry date stated on the packaging. 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 Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Simvastatin Pensa 40 mg film-coated tablets

• The active substance is simvastatin. Each film-coated tablet contains 40 mg of simvastatin.
• The other components are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, butylhydroxyanisole (E320), ascorbic acid, citric acid, colloidal anhydrous silica, talc, magnesium stearate, hypromellose, iron oxide red (E172), iron oxide yellow (E172), triethyl citrate, titanium dioxide (E171) and povidone.

Appearance of the product and contents of the pack

Simvastatin Pensa 40 mg is presented as film-coated tablets. The tablets are deep pink, oval-shaped and biconvex. Each pack contains 28 film-coated tablets.

Other presentations

Simvastatin Pensa 10 mg film-coated tablets EFG: Pack containing 28 tablets.

Simvastatin Pensa 20 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 revision of this leaflet: February 2026

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