SIMVASTATIN COMBIX 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Simvastatin Vegal 10 mg film-coated tablets EFG

Simvastatin Vegal 20 mg film-coated tablets EFG

Simvastatin Vegal 40 mg film-coated tablets EFG

Simvastatin

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

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Simvastatin Vegal and what is it used for
2. What you need to know before you take Simvastatin Vegal
3. How to take Simvastatin Vegal
4. Possible side effects
5. Storage of Simvastatin Vegal
6. Contents of the pack and other information

1. What is Simvastatin Vegal and what is it used for

Simvastatin Vegal contains the active substance simvastatin. Simvastatin Vegal is a medicine used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and a type of fat called triglycerides in the blood. It also increases the levels of "good" cholesterol (HDL cholesterol). Simvastatin belongs to a group of medicines called statins.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol level 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 can lead to a narrowing of the arteries, which can reduce or block blood flow to vital organs such as the heart and brain. This reduction or blockage of blood flow can 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 found in the blood that can increase the risk of heart disease.

While taking this medicine, you should follow a cholesterol-lowering diet.

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

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia)
• a hereditary disease (homozygous familial hypercholesterolemia) that increases the level of cholesterol 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 diseases). Simvastatin Vegal can prolong your life by reducing the risk of heart problems, regardless of the amount of cholesterol in your blood.

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

2. What you need to know before you take Simvastatin Vegal

Do not take Simvastatin Vegal

• if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine (listed in section 6. Contents of the pack and other information),
• if you currently have liver problems,
• if you are pregnant or breastfeeding,
• if you are taking medicines with one or more of the following active substances:
• • itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections),
  • erythromycin, clarithromycin, or telithromycin (used to treat infections),
  • HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used to treat HIV infections),
  • boceprevir or telaprevir (used to treat hepatitis C virus infection),
  • nefazodone (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 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 that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Simvastatin Vegal can cause serious muscle problems (rhabdomyolysis).

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

Consult 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. Simvastatin Vegal may not be suitable for you,
• if you are scheduled for surgery. You may need to stop taking Simvastatin Vegal tablets for a short time,
• if you are Asian, as you may need a different dose.

Your doctor will perform a blood test before you start taking Simvastatin Vegal and also if you have any symptoms of liver problems while taking Simvastatin Vegal. 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 Vegal.

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.

If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects 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).

The risk of muscle failure is higher with high doses of Simvastatin Vegal, 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 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 medications may be necessary to diagnose and treat this problem.

Children and adolescents

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

Taking Simvastatin Vegal with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Taking Simvastatin Vegal 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 Vegal" section).

• cyclosporine (used in organ 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 substance such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates with an active substance 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 substance 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),
• colchicine (used to treat gout).

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 substances:

• medicines with an active substance 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 Simvastatin Vegal.

Taking Simvastatin Vegal with food and drinks

Grapefruit juice contains one or more components that alter how the body uses some medicines, including Simvastatin Vegal. You should avoid consuming grapefruit juice.

Pregnancy and breastfeeding

Do not take Simvastatin Vegal if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Simvastatin Vegal, stop taking it immediately and tell your doctor. Do not take Simvastatin Vegal if you are breastfeeding, as 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 Vegal is not expected to interfere with your ability to drive or use machines. However, you should be aware that some people experience dizziness after taking Simvastatin Vegal.

Simvastatin Vegal contains lactose

Simvastatin Vegal tablets contain a sugar called 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 Vegal

Your doctor will determine the appropriate dose of Simvastatin Vegal for you, depending on your condition, current treatment, and personal risk situation.

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist again.

Before starting to take Simvastatin Vegal, you should be following a cholesterol-lowering diet.

Dosage:

The recommended dose is 10 mg, 20 mg, or 40 mg of simvastatin once a day by mouth.

Adults:

The usual starting dose is 10, 20, or, in some cases, 40 mg per day. After at least 4 weeks, your doctor may adjust your dose, up to a maximum of 80 mg per day. 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 if you 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 Vegal in the evening. You can take it with or without food. Continue taking Simvastatin Vegal until your doctor tells you to stop.

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

If you take more Simvastatin Vegal than you should

• in case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone: 91 562 04 20, consult your doctor or pharmacist.

If you forget to take Simvastatin Vegal

• do not take a double dose to make up for forgotten doses. The next day, take your normal dose of Simvastatin Vegal at the usual time.

If you stop taking Simvastatin Vegal

• talk to your doctor or pharmacist because your cholesterol levels may rise again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following terms are used to describe how often adverse effects have been reported:

• Rare (may affect up to 1 in 1,000 people).
• Very rare (may affect up to 1 in 10,000 people).
• Frequency not known (cannot be estimated from the available data).

The following serious rare adverse effects have been reported.

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

• Muscle pain, sensitivity to pressure, weakness, or muscle cramps. In rare cases, these muscle problems can be serious, including muscle failure leading to kidney damage; and very rarely, deaths have occurred.
• Hypersensitivity reactions (allergic) including:
• 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 malaise,
• Pseudolupus syndrome (including skin rash, joint disorders, and effects on blood cells),
• Inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-colored urine or pale-colored 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 that causes difficulty breathing or dizziness (anaphylactic reaction).

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,
• Digestive disorders (abdominal pain, constipation, gas, indigestion, diarrhea, nausea, vomiting),
• Skin rash, itching, hair loss, reddened and swollen rash, sometimes with target-shaped lesions (erythema multiforme)
• Blurred vision and vision impairment
• Weakness,
• Sleep problems (very rare),
• Poor memory (very rare), memory loss, confusion.

The following serious very rare adverse effects have been reported:

• 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, tendon problems, sometimes complicated by tendon rupture,
• Gynecomastia (enlargement of the breast in men)

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

• Erectile dysfunction,
• Depression,
• Inflammation of the lungs, which can cause breathing problems, including persistent cough and/or difficulty breathing or fever,
• Tendon problems, sometimes complicated by tendon rupture.

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 sugars and fats in the 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 Simvastatina Vegal (frequency not known).
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (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.

Complementary tests

In some blood tests, elevations of liver function (transaminases) and a muscle enzyme (creatine kinase) have been observed.

Reporting of 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 does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Simvastatina Vegal

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

Do not use this medicine after the expiration date that appears on the packaging after CAD.

Do not store above 30°C. Store in the original packaging.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information:

Composition of Simvastatina Vegal:

The active ingredient is simvastatin (10 mg, 20 mg, or 40 mg).

The other components are: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized cornstarch, butylhydroxyanisole (E320), ascorbic acid (E300), citric acid (E330), colloidal anhydrous silica, talc, magnesium stearate (E572). The tablet coating contains hypromellose (E464), red iron oxide (E172), yellow iron oxide (E172), triethyl citrate, titanium dioxide (E171), talc, and povidone.

Appearance of the Product and Packaging Content:

Simvastatina Vegal 10 mg is presented in the form of film-coated tablets, scored, pink, oval, and biconvex.

Each package contains 28 tablets.

Simvastatina Vegal 20 mg is presented in the form of film-coated tablets, pink, oval, and biconvex.

Each package contains 28 tablets.

Simvastatina Vegal 40 mg is presented in the form of film-coated tablets, pink, oval, and biconvex.

Each package contains 28 tablets.

Marketing Authorization Holder and Manufacturer:

Vegal Farmacéutica, S.L.

Vía de las Dos Castillas 9C, portal 2, 2ºC

28224 Pozuelo de Alarcón, Madrid

Spain

Manufacturer Responsible for Release:

Atlantic Pharma – Produçoes Farmacêuticas, S.A.

Rua da Tapada Grande nº2, Abrunheira, Sintra, 2710-089, Portugal

or

Farmaprojects, S.A.

Calle Baldiri Reixac 4/12 I 15. Polígono Industrial Parc Cientific de Barcelona. 08028 Barcelona. Spain

or

GENERIS FARMACEUTICA S.A.

Rua Joao de Deus nº19, Venda Nova, 2700-487 Amadora. Portugal or

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR S.A.

Laguna, 66-68-70. Polígono Industrial Urtinsa II. Alcorcón (Madrid). Spain

Date of the Last Revision of this Prospectus: April 2024

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

Date of the Last Revision of this Prospectus: April 2024

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