Label: Information for the User

Simvastatina MABO-FARMA 20 mg Film-Coated Tablets EFG

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

• Keep this label, 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 only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Simvastatina is a medication used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides that circulate in the blood. Additionally, simvastatina increases the levels of "good" cholesterol (HDL cholesterol). Simvastatina is a member of a class of medications called statins.

Cholesterol is one of the fatty substances found in the bloodstream. Its total cholesterol is mainly composed of LDL and HDL cholesterol.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can slow down or interrupt blood flow to vital organs such as the heart and brain. This interruption of blood flow can cause a heart attack or stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects them from cardiovascular diseases.

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

Simvastatina is used, along with a cholesterol-reducing diet, if you have:

• elevated levels of cholesterol in the blood (primary hypercholesterolemia) or elevated levels of fatty substances in the blood (mixed hyperlipidemia),
• a hereditary disease (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You may also receive other treatments,
• coronary heart disease (CHD) or if you have a high risk of coronary heart disease (because you have diabetes, a history of stroke, or other vascular disease). Simvastatina can prolong your life by reducing the risk of cardiovascular problems, regardless of the amount of cholesterol in your blood.

Most people do not have immediate symptoms of high cholesterol. Your doctor may measure your cholesterol with a simple blood test. Visit your doctor regularly, monitor your cholesterol, and discuss your goals with your doctor.

Do not take Simvastatina Mabo-Farma:

• If you are allergic to simvastatin or any of the other components of this medication (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 the following medications with one of the following active principles:

• Itraconazole, ketoconazole, posaconazole, or voriconazole (medications used to treat fungal infections).
• Erythromycin, clarithromycin, or telithromycin (used to treat infections).
• Protease inhibitors for HIV (used to treat HIV infections).
• Boceprevir or telaprevir (used to treat hepatitis C infection).
• Nefazodone (medication used to treat depression).
• Cobicistat.
• Gemfibrozil (used to reduce cholesterol).
• Ciclosporin (used in patients with organ transplants).
• 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 medication containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and simvastatin may cause severe muscle problems (rhabdomyolysis).
• Do not take more than 40 mg of simvastatin if you are taking lomitapida (used to treat rare and severe genetic cholesterol disorders).

Consult your doctor if you are unsure if your medication is on this list.

Warnings and precautions

Inform your doctor:

• About all your medical problems, including allergies,
• If you consume large amounts of alcohol,
• If you have ever had liver disease. This medication may not be suitable for you,
• If you are scheduled for surgery. You may need to stop taking simvastatin tablets for a short period of time,
• If you are Asian, as you may need a different dose,
• If you have or have had myasthenia (a condition characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a condition that causes weakness of the eye muscles), as statins may sometimes worsen the condition 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 medication. 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 taking simvastatin.

Your doctor will monitor you for diabetes or risk of developing diabetes while you are taking this medication. This risk of diabetes increases if you have high levels of sugars and fats in your blood, overweight, and high blood pressure.

Inform your doctor if you have a severe lung disease.

Consult your doctor immediately if you experience muscle pain, sensitivity to pressure, or unexplained muscle weakness. This is because, in rare cases, muscle problems can be severe, including muscle failure, which can cause kidney damage; and very rarely, deaths have occurred.

The risk of muscle failure is higher with high doses of simvastatin, especially with the 80 mg dose. The risk of muscle failure is also higher 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 medications called "statins" or fibrates,
• You or a close relative have a hereditary muscle disorder.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medications may be necessary to diagnose and treat this condition.

Children and adolescents

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

Other medications and Simvastatina Mabo-Farma

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. Taking this medication with any of the following medications may increase the risk of muscle problems (some of which are already included in the previous section "Do not take Simvastatina Mabo-Farma").

• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medication. Your doctor will tell you when you can restart the simvastatin treatment. The use of simvastatin with fusidic acid rarely may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Ciclosporin (often used in transplant patients),
• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus),
• Medications with an active principle such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• Fibrates with an active principle such as gemfibrozil and bezafibrate (used to reduce cholesterol),
• Erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections),
• Protease inhibitors for HIV, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections),
• Antivirals for hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C infection),
• Nefazodone (used to treat depression),
• Medications with the active principle 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 diseases),
• Lomitapida (used to treat rare and severe genetic cholesterol disorders),
• Daptomycin (a medication used to treat skin and skin structure infections and bacteremia). The risk of muscle problems may be greater when this medication is taken during simvastatin treatment. Your doctor may decide that you should stop taking this medication for a time,
• Colchicine (used to treat gout),
• Ticagrelor (antiplatelet medication).

As with the medications listed above, inform your doctor or pharmacist if you are taking or have taken recently other medications, even those purchased without a prescription. In particular, inform your doctor if you are taking medications with any of the following active principles:

• Medications with an active principle to prevent blood clot formation, 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 a new medication that you are taking this medication.

Simvastatina Mabo-Farma with food and drinks

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

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

Pregnancy and breastfeeding

Do not take this medicationif 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 medicationif you are breastfeeding, as it is unknown whether this medication passes into breast milk.

Consult your doctor or pharmacist before using anymedication.

Driving and operating machines

Simvastatin is not expected to interfere with your ability to drive or operate machines. However, some people may experience dizziness after taking simvastatin.

Simvastatina Mabo-Farma contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Followexactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The tablets should be taken at night and can be administered with water or with or without food.

Before starting to take this medication, you must be following a diet to reduce cholesterol.

The recommended starting dose is10 to40 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. Do not take more than 80 mg per day.

Your doctor may prescribe lower doses, especially if you are taking certain medications indicated 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 disease problems who have not achieved 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 for treatment is 10 mg, at night. The maximum recommended daily dose is 40 mg.

Administration method:

Take simvastatin at night. 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 medication 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 estimate that the effect of this medication 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 can also call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take Simvastatina Mabo-Farma

Remember to take your medication.

Do not take a double dose to compensate for the missed doses. The next day, take your usual amount of simvastatin at the usual time.

If you interrupt treatment with Simvastatina 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 medication, consult your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

These side effects may occur with certain frequencies, which are defined as follows:

• Very common (more than 1 person in 10).
• Common (less than 1 person in 10 but more than 1 person in 100).
• Uncommon (less than 1 person in 100 but more than 1 person in 1,000)
• Rare (less than 1 person in 1,000)
• Very rare (less than 1 person in 10,000)
• Unknown frequency: cannot be estimated from available data.

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

The following serious side effects have been reported:Rare:

• Muscle pain, pressure sensitivity, weakness, or muscle cramps. In rare cases, these muscle problems can be severe, including muscle failure, which can cause kidney damage; and very rarely, deaths have occurred.
• Allergic reactions that include:
• Swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema),
• Intense muscle pain, usually in the shoulders and hips,
• Skin rash with weakness of the muscles of the limbs and neck,
• Joint pain or inflammation (polymyalgia rheumatica),
• Inflammation of blood vessels (vasculitis),
• Atypical hematomas, skin rash, 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 insufficiency (very rare).
• Pancreatitis, often with intense abdominal pain.

The following serious side effects have been reported:Very rare:

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

Rarely, the following side 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 disturbances,
• Digestive problems (abdominal pain, constipation, gas, indigestion, diarrhea, nausea, vomiting),
• Skin rash, itching, hair loss,
• Weakness,
• Sleep problems (very rare),
• Poor memory (very rare), memory loss, confusion.

The following side effects have also been reported, but the frequency cannot be estimated from the available information:Unknown frequency:

• Erectile dysfunction,
• Depression,
• Lung inflammation, which 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, which, in some cases, affects the muscles used for breathing).

Myasthenia oculis (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.

Possible additional side effects reported with some statins:

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

Additional tests:

Rare:Increased levels in the blood of transaminases, alkaline phosphatase, and creatine kinase (CK).

Reporting side effects

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

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

Store below 30°C.

Do not usethis medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Unused medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment..

• The active ingredient is simvastatina. Each tablet contains 20 mg of simvastatina.

The other components (excipients) are:

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

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

Product appearance and packaging content

Simvastatina Mabo-Farma 20 mgis presented in the form of film-coated tablets, intense pink in color, oval, and biconvex.

Each package contains28tablets.

Marketing authorization holder

MABO-FARMA S.A.

Calle Rejas 2, planta 1

28821 Coslada (Madrid)

Responsible for manufacturing

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.,

C/Laguna 66-70.Polígono Industrial URTINSA II

28923 Alcorcón (Madrid) España

JABA RECORDATI, S.A.

Rua da Tapada Grande nº 2, Abrunheira

Sintra - 2710-089 - Portugal

Last review date of this prospectus:April 2023

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