Simvastatin Mabo-Farma 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Simvastatina MABO-FARMA 40 mg film-coated tablets EFG

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

• 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Simvastatina Mabo-Farma is and what it is used for
2. What you need to know before taking Simvastatina Mabo-Farma
3. How to take Simvastatina Mabo-Farma
4. Possible side effects
5. How to store Simvastatina Mabo-Farma
6. Contents of the pack and other information

1. What Simvastatina Mabo-Farma is and what it is used for

Simvastatin is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, simvastatin increases levels of "good" cholesterol (HDL cholesterol). Simvastatin belongs to a class of medicines known as statins.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this plaque buildup can cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This disruption of blood flow may lead to a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another type of fat in your blood that may increase the risk of heart disease. While taking this medicine, you must follow a cholesterol-lowering diet.

Simvastatin is used, together with a cholesterol-lowering diet, if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high blood levels of fatty substances (mixed hyperlipidemia),
• an inherited disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments,
• coronary heart disease (CHD) or if you are at high risk of coronary heart disease (because you have diabetes, a history of stroke, or other blood vessel disease). Simvastatin may prolong your life by reducing the risk of heart-related problems, regardless of your blood cholesterol levels.

In most people, high cholesterol has no immediate symptoms. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, monitor your cholesterol, and discuss your cholesterol goals with your doctor.

2. What you need to know before taking Simvastatina Mabo-Farma

Do not take Simvastatina Mabo-Farma:

• If you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6).

• If you currently have liver problems, active liver disease, or elevated transaminases.

• If you are pregnant or breastfeeding.

• If you are taking any of the following medicines containing the following active substances:

• Itraconazole, ketoconazole, posaconazole, or voriconazole (medicines used to treat fungal infections).

• Erythromycin, clarithromycin, or telithromycin (used to treat infections).

• HIV protease inhibitors (used to treat HIV infections).

• Boceprevir or telaprevir (used to treat hepatitis C virus infection).

• Nefazodone (a medicine used to treat depression).

• Cobicistat.

• Gemfibrozil (used to reduce cholesterol).

• Cyclosporine (used in organ transplant patients).

• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus).

• if you are taking or have taken, within the last 7 days, a medicine containing fusidic acid (used to treat bacterial infection) by oral or injectable route. The combination of fusidic acid and simvastatin may cause serious muscle problems (rhabdomyolysis).

• Do not take more than 40 mg of simvastatin if you are taking lomitapide (used to treat rare, severe genetic cholesterol disorders).

Consult your doctor if you are unsure whether your medicine is included in the list above.

Warnings and precautions

Tell your doctor:

• about all your medical conditions, including allergies,
• if you consume large amounts of alcohol,
• if you have ever had liver disease. This medicine may not be suitable for you,
• if you are scheduled for surgery. You may need to stop taking simvastatin tablets for a short period,
• if you are of Asian origin, as you may require a different dose,
• if you have or have had myasthenia (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).

Your doctor will perform a blood test before you start taking simvastatin and may repeat it if you develop symptoms of liver problems while taking this medicine. This is to monitor your liver function.

Your doctor may also want to perform blood tests to monitor your liver function after you start treatment with simvastatin.

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

Inform your doctor if you have a severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, although rarely, muscle problems can be serious, including muscle breakdown (rhabdomyolysis) leading to kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is higher with higher doses of simvastatin, especially the 80 mg dose. The risk of muscle breakdown is also increased in certain patients. Talk to your doctor if any of the following apply to you:

• you consume large amounts of alcohol,
• you have kidney problems,
• you have thyroid problems,
• you are 65 years of age or older,
• you are female,
• you have previously experienced muscle problems during treatment with cholesterol-lowering medicines called "statins" or fibrates,
• you or a close family member have an inherited muscle disorder.

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.

Children and adolescents

The efficacy and safety of simvastatin treatment have been studied in boys aged 10 to 17 years and in girls who have had their first menstrual period (menstruation) at least one year prior (see section 3. How to take Simvastatina Mabo-Farma). Simvastatin has not been studied in children under 10 years of age. For further information, consult your doctor.

Other medicines and Simvastatina Mabo-Farma

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Taking this medicine with any of the following medicines may increase the risk of muscle problems (some of these are already included in the section above “Do not take Simvastatina Mabo-Farma”).

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when you can restart simvastatin treatment. Rarely, using simvastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Cyclosporine (commonly used in transplant patients),
• Danazol (a synthetic hormone used to treat endometriosis),
• Medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• Fibrates containing active substances such as gemfibrozil and bezafibrate (used to reduce cholesterol),
• Erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS),
• Hepatitis C antivirals such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection),
• Nefazodone (used to treat depression),
• Medicines containing the active substance cobicistat,
• Amiodarone (used to treat irregular heart rhythm),
• Verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions),
• Lomitapide (used to treat rare, severe genetic cholesterol disorders),
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). Adverse effects affecting muscles may be increased when this medicine is taken during simvastatin treatment. Your doctor may decide that you should temporarily stop taking this medicine,
• Colchicine (used to treat gout),
• Ticagrelor (an antiplatelet medicine),
• Ribociclib (used to treat breast cancer),
• Palbociclib (used to treat breast cancer).

As with the medicines listed above, inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• Medicines containing active substances to prevent blood clotting, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants),
• Fenofibrate (also used to reduce cholesterol),
• Niacin (also used to reduce cholesterol),
• Rifampicin (used to treat tuberculosis).

You should also inform any doctor who prescribes you a new medicine that you are taking this medicine.

Taking Simvastatina Mabo-Farma with food and drink

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

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

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking simvastatin, stop taking it immediately and inform your doctor. Do not take this medicine if you are breastfeeding, as it is unknown whether this medicine passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Simvastatin is not expected to affect your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking simvastatin.

Simvastatina Mabo-Farma contains lactose

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

3. How to take Simvastatina Mabo-Farma

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The tablets should be taken at night and may be taken with water, with or without food.

Before starting to take this medicine, you should already be on a cholesterol-lowering diet.

The recommended 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 once daily, taken as a single dose at night. Do not take more than 80 mg per day.

Your doctor may prescribe lower doses, especially if you are taking certain medicines mentioned above or have certain kidney disorders.

The 80 mg dose is only recommended for adult patients with very high cholesterol levels and a high risk of heart disease-related problems who have not achieved their cholesterol target with lower doses.

Use in children and adolescents

For children and adolescents aged 10 to 17 years, the recommended starting dose is 10 mg once daily at night. The maximum recommended daily dose is 40 mg.

Method of administration:

Take simvastatin at night. You may take it with or without food. Continue taking simvastatin until your doctor tells you to stop.

If your doctor has prescribed simvastatin together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must take simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Use in elderly patients

Dose adjustment is not necessary.

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Simvastatina Mabo-Farma than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or hospital immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Simvastatina Mabo-Farma

Remember to take your medicine.

Do not take a double dose to make up for forgotten doses. On the following day, take your normal dose of simvastatin at the usual time.

If you stop taking Simvastatina Mabo-Farma

Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

These adverse effects may occur with certain frequencies, defined as follows:

• Very common (more than 1 in 10 people)
• Common (less than 1 in 10 but more than 1 in 100 people)
• Uncommon (less than 1 in 100 but more than 1 in 1,000 people)
• Rare (less than 1 in 1,000 people)
• Very rare (less than 1 in 10,000 people)
• Frequency not known: cannot be estimated from available data

If any of the serious adverse effects listed below occur, stop taking the medicine immediately and contact your doctor right away or go to the nearest hospital emergency department.

The following serious rare adverse effects have been reported:

• Muscle pain, tenderness to pressure, muscle weakness or cramps. In rare cases, these muscle problems can be severe, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.
• Hypersensitivity (allergic) reactions, including:
• Swelling of the face, tongue, and throat, which may cause difficulty breathing (angioedema),
• Severe muscle pain, usually in the shoulders and hips,
• Skin rash with muscle weakness in the limbs and neck,
• Joint pain or inflammation (polymyalgia rheumatica),
• Inflammation of blood vessels (vasculitis),
• Unusual bruising, skin rashes, and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, hot flushes,
• Difficulty breathing (dyspnea) and general malaise,
• Pseudolupus syndrome (including skin rash, joint disorders, and effects on blood cells),
• Liver inflammation with the following symptoms: yellowing of the skin and eyes (jaundice), itching, dark urine or pale stools, feeling tired or weak, loss of appetite; liver failure (very rare).
• Inflammation of the pancreas, often with severe abdominal pain.

The following serious very rare adverse effects have been reported:

• A severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction),
• Skin rash or mouth ulcers (drug-induced lichenoid eruptions),
• Muscle rupture,
• Gynaecomastia (enlargement of the breast in men).

Rarely, the following adverse effects have also been reported:

• Low red blood cell count (anaemia),
• Numbness or weakness in the arms and legs,
• Headache, tingling sensation, dizziness,
• Blurred vision; visual disturbances,
• Gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
• Skin rash, itching, hair loss,
• Weakness,
• Sleep disorders (very rare),
• Poor memory (very rare), memory loss, confusion.

The following adverse effects have also been reported, but from the available data, their frequency cannot be estimated (frequency not known):

• Erectile dysfunction,
• Depression,
• Lung inflammation causing breathing problems, including persistent cough and/or difficulty breathing or fever,
• Tendon problems, sometimes complicated by tendon rupture.
• 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 worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additional possible adverse effects reported with some statins:

• Sleep disorders, including nightmares,
• Sexual dysfunction,
• Diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• Persistent muscle pain, tenderness, or weakness, which may not resolve after stopping treatment with simvastatin.

Additional tests:

• Rare: increased blood levels of transaminases, alkaline phosphatase, and creatine kinase (CK).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin Mabo-Farma

Keep this medicine out of the sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. 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 containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

• The active substance is simvastatin. Each tablet contains 40 mg of simvastatin.

The other components (excipients) are:

Core: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, butylated hydroxyanisole (E-320), ascorbic acid, citric acid, colloidal anhydrous silica, talc and magnesium stearate.

Coating: hypromellose (hydroxypropylmethylcellulose), iron oxide red (E-172), iron oxide yellow (E-172), triethyl citrate, titanium dioxide (E-171) and povidone K30.

Appearance of the product and contents of the pack

Simvastatin Mabo-Farma 40 mg is presented as film-coated tablets, deep pink in colour, oval and biconvex.

Each pack contains 28 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.,

C/Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid), Spain

JABA RECORDATI, S.A.

Rua da Tapada Grande nº 2, Abrunheira

Sintra - 2710-089 - Portugal

Date of the most recent revision of this leaflet: March 2026

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