SIMVASTATIN PENSA 40 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Simvastatin Pensa 40 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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, 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 Pensa 40 mg film-coated tablets are and what they are used for.
2. Before you take Simvastatin Pensa 40 mg film-coated tablets.
3. How to take Simvastatin Pensa 40 mg film-coated tablets.
4. Possible side effects.
5. Storing Simvastatin Pensa 40 mg film-coated tablets.
6. Further information.

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

Simvastatin Pensa 40 mg belongs to a group of medicines known as HMG-CoA reductase inhibitors, which act by reducing blood lipid, cholesterol, and triglyceride levels.

Simvastatin Pensa 40 mg is indicated in:

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

• Treatment of high blood cholesterol levels (homozygous familial hypercholesterolemia) in conjunction with diet and other cholesterol-reducing treatments.

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

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

Do not takeSimvastatin Pensa 40 mg film-coated tablets

• if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of Simvastatin Pensa 40 mg.
• if you have active liver disease or elevated liver 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 infections that cause 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 in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Simvastatin Pensa can cause serious muscle problems (rhabdomyolysis).
• If you have or have had myasthenia (a disease that causes 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).

Be especially careful withSimvastatin Pensa 40 mg film-coated tablets

• If you experience muscle pain, tenderness, or weakness. Inform your doctor immediately. In rare cases, simvastatin can cause serious muscle problems that can lead to kidney damage.
• Also, inform your doctor or pharmacist if you experience constant muscle weakness. Tests and additional medications may be necessary to diagnose and treat this problem.

• This risk is higher in patients who take high doses of Simvastatin Pensa or who take Simvastatin Pensa with other 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).

• Inform your doctor if you have kidney disease, hypothyroidism, if you have a family history or have previously had 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 blood transaminase levels (liver enzymes) may occur, which in most cases return to normal without the need to discontinue treatment.

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

• 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 blood sugar and fat levels, are overweight, and 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 operation.

• 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 Pensa.

• Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Use of other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Certain medicines can interact with Simvastatin Pensa and increase the risk of adverse muscle reactions; 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 "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 will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Simvastatin Pensa. The use of Simvastatin Pensa with fusidic acid can cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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 is enhanced if taken with simvastatin.

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

Simvastatin Pensa can be taken with or without food.

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

Simvastatin Pensa 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 using any medicine.

Simvastatin Pensa 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 Pensa does not affect the ability to drive or use machines. However, if you experience dizziness, do not drive or use machines until you know how the medicine affects you.

Important information about some of the ingredients ofSimvastatin Pensa 40 mg film-coated tablets

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.

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

Follow the administration instructions of Simvastatin Pensa 40 mg exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Simvastatin Pensa 40 mg. 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 the 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 indicated 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

No dose adjustment is 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 or pharmacist or the nearest hospital.

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

If you forget to take Simvastatin Pensa 40 mg film-coated tablets

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

If you stop taking Simvastatin Pensa 40 mg film-coated tablets

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

4. Possible side effects

Like all medicines, Simvastatin Pensa 40 mg can cause side effects, although not everybody gets them.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Very common (more than 1 in 10), 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.

Complementary tests:

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

Blood and lymphatic system disorders:

Rare: anemia

Nervous system disorders:

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

Gastrointestinal disorders:

Rare: constipation, abdominal pain, gas, indigestion, diarrhea, 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: Constant 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: it is more likely if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Hypersensitivity

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.

• Hypersensitivity reactions (allergic reactions) that include:

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

The following very rare serious side effects have been reported:

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

Adverse reactions with unknown frequency:

Severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).

Ocular myasthenia (a disease that causes 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.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Simvastatin Pensa 40 mg film-coated tablets

• The active ingredient is simvastatin. Each film-coated tablet contains 40 mg of simvastatin.
• The other ingredients are: lactose monohydrate, 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 packaging contents

Simvastatin Pensa 40 mg is presented in the form of film-coated tablets. The tablets are intense pink, oval, and biconvex. Each package contains 28 film-coated tablets.

Other presentations

Simvastatin Pensa 10 mg film-coated tablets EFG: Package with 28 tablets.

Simvastatin Pensa 20 mg film-coated tablets EFG: Package with 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 last revision of this leaflet: February 2023

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/