PATIENT INFORMATION LEAFLET

Simvastatina Pensa 40 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

1.What Simvastatina Pensa 40 mg Film-Coated Tablets are and what they are used for.

2.Before taking Simvastatina Pensa 40 mg Film-Coated Tablets.

3.How to take Simvastatina Pensa 40 mg Film-Coated Tablets.

4.Possible side effects.

5.Storage of Simvastatina Pensa 40 mg Film-Coated Tablets.

6.Further information.

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Simvastatina Pensa 40 mg belongs to a group of medicines known ashydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors that act by reducing the levels of lipids, cholesterol and triglycerides in the blood.

Simvastatina Pensa 40 mg is indicated for:

• The treatment of high levels of cholesterol in the blood (primary hypercholesterolemia or mixed dyslipidemia) along with diet, when diet or exercise have not reduced cholesterol.

• The treatment of high levels of cholesterol in the blood (familial homozygous hypercholesterolemia) along with diet and other treatments to reduce cholesterol.

The prevention of cardiovascular problems and cardiovascular death in patients with arteriosclerosis or diabetes, with high or normal cholesterol levels, along with other treatments.

Do not takeSimvastatina Pensa 40 mg film-coated tablets

• if you are allergic (hypersensitive) to simvastatin or to any of the other ingredients ofSimvastatina Pensa 40 mg.
• if you have active liver disease or have elevated liver enzymes.
• if you are pregnant or breastfeeding.
• if you are taking one of the following medicines:
• • Itraconazole or ketoconazole (medicines used to treat fungal infections).
  • Erythromycin, clarithromycin or telithromycin (antibiotics, medicines used to treat certain infections).
  • Protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used to treat HIV infections that cause AIDS).
  • Nefazodone (medicine used to treat depression).

Warnings and precautions

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

• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid, (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Simvastatina Pensa may cause severe muscle problems (rhabdomyolysis).
• If you have or have had myasthenia (a disease that runs with generalized muscle weakness that, in some cases, affects the muscles used to breathe) or myasthenic eye (a disease that causes weakness of the eye muscles), as statins sometimes can worsen the disease or cause myasthenia (see section 4).

Be especially careful withSimvastatina Pensa 40 mg film-coated tablets

• If you experience pain, sensitivity to pressure or muscle weakness.Inform your doctor immediately. In rare cases, simvastatin can cause severe muscle problems that may cause kidney damage.
• Also inform your doctor or pharmacist if you experience constant muscle weakness. Further tests and additional medicines may be necessary to diagnose and treat this problem.

• This risk is higher in patients taking high doses of Simvastatina Pensa or taking it with Simvastatina Pensa and another medicine that increases simvastatin levels in the blood, and therefore the risk of muscle problems, such as:

• Fibrates and niacin (medicines that lower cholesterol levels).
• Amiodarone, verapamil and diltiazem (medicines used to treat heart problems).
• Ciclosporin (medicine used to prevent rejection in transplants).

• Inform your doctor if you have kidney disease, hypothyroidism, if you have a family history or have previously had muscle problems or if you normally consume alcohol, as these factors may increase the risk of muscle problems.

• If you have had any liver disease. It is possible that moderate increases in liver enzymes may occur, which in most cases return to normal without the need to discontinue treatment.

• Consult your doctor or pharmacist before taking Simvastatina 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, obesity and high blood pressure.

• If you are scheduled for surgery, it is recommended that you stop taking Simvastatina Pensa at least a few days before the operation.

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

• Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Use of other medicines

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

Certain medicines may interact with Simvastatina Pensa and may increase the risk of adverse muscle reactions; in these cases, it may be necessary to change the dose or discontinue treatment with one of them.

It is essential to inform your doctor if you are taking or have taken recently any of the following medicines:

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

• Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, protease inhibitors for HIV and nefazodone. The use of simvastatin is contraindicated with these medicines (see section “Do not takeSimvastatina Pensa 40 mg film-coated tablets”).

• Ciclosporin (medicine used to prevent rejection in transplants).

• Verapamil, diltiazem and amiodarone, (medicines used to treat heart problems).
• If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop using this medicine. Your doctor will indicate when you can restart treatment with Simvastatina Pensa. The use of Simvastatina Pensa with fusidic acid may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Also, it is very important to inform your doctor if you are taking or have taken recently:

• Oral anticoagulants (medicines to prevent blood clots), as they potentiate the anticoagulant effect if taken with simvastatin.

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

Simvastatina Pensa can be taken with or without food.

Orange juice increases simvastatin levels in the blood. Avoid consuming orange juice while taking Simvastatina Pensa.

Simvastatina Pensa should be administered with caution in patients who consume alcohol. If you normally drink alcohol, consult your doctor.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Simvastatina Pensa is contraindicated during pregnancy and lactation.

In the event of pregnancy or suspected pregnancy, you should discontinue treatment and inform your doctor as soon as possible.

Driving and operating machines

At normal doses, Simvastatina 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 you tolerate the medicine.

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

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

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

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with Simvastatina Pensa 40 mg. Do not suspend the 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 medications indicated earlier 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 40 mg in children is not recommended.

Use in elderly patients

No dose adjustment is necessary.

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

If you have taken more Simvastatina Pensa 40 mg than you should, consult your doctor or pharmacist or the nearest hospital.

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

If you forgot to take Simvastatina Pensa 40 mg film-coated tablets

Do not take a double dose to compensate for the missed doses, wait for the next dose.

If you interrupt treatment with Simvastatina Pensa 40 mg film-coated tablets

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

Like all medicines, Simvastatina Pensa 40 mg can cause side effects, although not everyone will experience them.

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

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

Additional investigations:

Rare: increased levels in the blood 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 peripheral nerves).

Gastrointestinal disorders:

Rare: constipation, abdominal pain, gas, indigestion, diarrhea, nausea, vomiting, pancreatitis inflammation

Skin and subcutaneous tissue disorders:

Rare: skin rash, itching, hair loss

Musculoskeletal and connective tissue disorders:

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

Unknown frequency: 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 levels of sugar and fat in the blood, being overweight and high blood pressure. Your doctor will monitor you while taking this medication.

Hypersensitivity

The following serious rare adverse reactions have been reported.

If any of these serious adverse reactions occur, stop taking the medication and inform your doctor immediately or go to the nearest hospital emergency service.

• Severe hypersensitivity reactions (allergic reactions) including:

Deep skin layer inflammation, facial, tongue, and throat swelling, which can cause difficulty breathing (angioedema), pseudolupus syndrome, polymyalgia rheumatica (intense pain and stiffness of the shoulders and hips primarily), dermatomyositis (muscle inflammation), blood vessel inflammation, 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, joint pain, itching, photosensitivity (increased skin sensitivity to light), fever, redness, difficulty breathing, and general discomfort.

The following serious very rare adverse reactions have been reported:

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

Adverse reactions of unknown frequency:

Severe myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).

Myasthenia gravis (a disease that causes 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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not store above 30 °C.

Store in the original packaging.

Do not use Simvastatina Pensa 40 mg after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at 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. By doing so, you will help protect the environment.

Composition of Simvastatina Pensa 40 mg film-coated tablets

• The active ingredient is simvastatina. Each film-coated tablet contains 40 mg of simvastatina.
• The other components are: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, butylhydroxyanisole (E320), ascorbic acid, citric acid, anhydrous colloidal 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 package

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

Other presentations

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

Simvastatina 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

Responsible for manufacturing

Polpharma S.A. Pharmaceutical Works

Pelplinska 19

83-200 Starogard Gdanski

Poland

Date of the last review of this leaflet: February 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/