SIMVASTATIN MABO-FARMA 40 mg FILM-COATED TABLETS

2. What you need to know before you take Simvastatin Mabo-Farma

Do not take Simvastatin 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, suffer from active liver disease, or have elevated transaminases.
• if you are pregnant or breastfeeding.
• if you are taking any of the following medicines:

• 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 patients with organ transplants).
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the inner lining of the uterus grows outside the uterus).

• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and simvastatin can cause serious muscle problems (rhabdomyolysis).
• do not take more than 40 mg of simvastatin if you are taking lomitapide (used to treat rare and severe genetic cholesterol disorders).

Tell your doctor if you are not sure if your medicine is on the list above.

Warnings and precautions

Tell your doctor:

• about all your medical problems, 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 time.
• if you are Asian, as you may need a different dose.
• if you have or have had myasthenia (a disease that causes generalised 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).

Your doctor will perform a blood test before you start taking simvastatin and also if you have any symptoms of liver problems while taking this medicine. This is to check how well your liver is working.

Your doctor may also want to perform blood tests to check how well your liver is working after you start treatment with simvastatin.

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 levels of sugars and fats in the blood, are overweight, and have high blood pressure.

Tell your doctor if you have severe lung disease.

Tell your doctor immediately if you experience muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems can be serious, including muscle failure, which can cause kidney damage; and very rarely, deaths have occurred.

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

• you consume large amounts of alcohol.
• you have kidney problems.
• you have thyroid problems.
• you are 65 years or older.
• you are female.
• you have ever had muscle problems during treatment with cholesterol-lowering medicines called "statins" or fibrates.
• you or a close relative have a hereditary muscle problem.

Also, tell your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this problem.

Children and adolescents

The efficacy and safety of simvastatin have been studied in boys aged 10 to 17 years and in girls who had their first menstrual period at least one year before (see section 3). Simvastatin has not been studied in children under 10 years. For more information, consult your doctor.

Other medicines and Simvastatin Mabo-Farma

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Taking this medicine with any of the following medicines can increase the risk of muscle problems (some of these are already included in the "Do not take Simvastatin Mabo-Farma" section).

• if you need to take fusidic acid orally to treat a bacterial infection, you will temporarily need to stop using this medicine. Your doctor will tell you when you can restart treatment with simvastatin. The use of simvastatin with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• cyclosporine (often used in transplant patients).
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the inner lining of the uterus grows outside the uterus).
• medicines with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections).
• fibrates with an active ingredient 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).
• antivirals for hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection).
• nefazodone (used to treat depression).
• medicines with the active ingredient cobicistat.
• amiodarone (used to treat irregular heartbeat).
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases).
• lomitapide (used to treat rare and severe genetic cholesterol disorders).
• daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteremia). The risk of side effects that affect the muscles may be greater when this medicine is taken during treatment with simvastatin. Your doctor may decide that you should stop taking this medicine for a while.
• colchicine (used to treat gout).
• ticagrelor (an antiplatelet medicine).

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

• medicines with an active ingredient to prevent blood clots, 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 tell any doctor who prescribes you a new medicine that you are taking this medicine.

Taking Simvastatin Mabo-Farma with food and drink

Grapefruit juice increases the levels of simvastatin in the blood. You should avoid consuming grapefruit juice while taking simvastatin.

Simvastatin should be used with caution in patients who consume alcohol. If you drink alcohol regularly, 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 tell your doctor. Do not take this medicine if you are breastfeeding because it is not known 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 experience dizziness after taking simvastatin.

Simvastatin Mabo-Farma contains lactose

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

3. How to take Simvastatin Mabo-Farma

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The tablets should be taken in the evening and can be taken with water or with or without food.

Before starting to take this medicine, you should be following a low-cholesterol diet.

The recommended starting dose is 10 to 40 mg per day, taken in a single dose in the evening.

Your doctor may adjust your dose up to a maximum of 80 mg per day, taken in a single dose in the evening. Do not take more than 80 mg per day.

Your doctor may prescribe lower doses, especially if you are taking certain medicines mentioned earlier 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 problems who have not reached their cholesterol goal with lower doses.

Use in children and adolescents

In children and adolescents aged 10 to 17 years, the recommended daily starting dose is 10 mg, taken in the evening. The maximum recommended daily dose is 40 mg.

Method of administration:

Take simvastatin in the evening. You can take it with or without food. Continue taking simvastatin until your doctor tells you to stop.

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

Use in elderly patients

No dose adjustment is necessary.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Simvastatin Mabo-Farma than you should

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

If you forget to take Simvastatin Mabo-Farma

Remember to take your medicine.

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

If you stop taking Simvastatin Mabo-Farma

Talk to your doctor or pharmacist because your cholesterol may rise again.

If you have any other 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 all people suffer from them.

These adverse effects may occur with certain frequencies, which are defined below:

• Very frequent (more than 1 person in every 10).
• Frequent (less than 1 person in every 10 but more than 1 person in every 100).
• Infrequent (less than 1 person in every 100 but more than 1 person in every 1,000)
• Rare (less than 1 person in every 1,000)
• Very rare (less than 1 person in every 10,000)
• Frequency unknown: cannot be estimated from the available data.

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

The following serious adverse effects have been reported rarely:

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

The following serious adverse effects have been reported very rarely:

• A severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction),
• A rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions),
• Muscle rupture,
• Gynecomastia (enlargement of the breast in men).

Rarely, the following adverse effects have also been reported:

• Low red blood cell count (anemia),
• Numbness or weakness of the arms and legs,
• Headache, tingling sensation, dizziness,
• Blurred vision; visual disturbance,
• Digestive disorders (abdominal pain, constipation, gas, indigestion, diarrhea, 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 their frequency cannot be estimated from the available data (unknown frequency):

• Erectile dysfunction,
• Depression,
• Lung inflammation that causes breathing problems, including persistent cough and/or difficulty breathing or fever,
• Tendon problems, sometimes complicated by tendon rupture.
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Myasthenic ocular (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, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additional possible adverse effects reported with some statins:

• Sleep disorders, including nightmares,
• Sexual dysfunction,
• Diabetes. It is more likely if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• Constant muscle pain, sensitivity, or weakness that may not disappear after stopping treatment with simvastatin.

Complementary tests:

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Simvastatina Mabo-Farma

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

Store below 30°C.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

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

The other components (excipients) are:

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

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

Appearance of the Product and Package Contents

Simvastatina Mabo-Farma 40 mg is presented in the form of film-coated tablets, intense pink in color, oval, and biconvex.

Each package 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 Last Revision of this Prospectus:April 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/