Simvastatin Combix 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Simvastatina Combix 10 mg film-coated tablets EFG

Simvastatina Combix 20 mg film-coated tablets EFG

Simvastatina Combix 40 mg film-coated tablets EFG

Simvastatin

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Simvastatina Combix is and what it is used for

Simvastatina Combix contains the active substance simvastatin. Simvastatina Combix 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, Simvastatina Combix 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 cholesterol 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 lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This interruption in blood flow may cause 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 continue to follow a cholesterol-lowering diet.

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

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fatty substances in the blood (mixed hyperlipidemia)
• a hereditary condition (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You may also receive other treatments.
• coronary heart disease (CHD) or are at high risk of coronary heart disease (due to diabetes, history of stroke, or other blood vessel disease). Simvastatina Combix 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 levels, and discuss your target goals with your doctor.

2. Before taking Simvastatine Combix

Contraindications

Do not take the medicine if you are allergic to simvastatin, ezetimibe, or any of the other components of this medicine (listed in section 6).
Do not take the medicine if you have or have had liver disease.
Do not take the medicine if you are pregnant or breastfeeding (see section on pregnancy and breastfeeding).
Do not take the medicine if you are taking danazol, colchicine, or fusidic acid (see section on taking other medicines).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if:
You have liver or kidney disease.
You have hypothyroidism (underactive thyroid).
You have a family history of muscle disorders or you have experienced muscle problems with other lipid-lowering medicines.
You consume large amounts of alcohol.
You are over 65 years old.
You are Asian (including Chinese, Japanese, Korean, Filipino, etc.).
You are taking other medicines (see section on taking other medicines).

Muscle problems

Statins, including simvastatin, can cause muscle problems that rarely can lead to a serious condition called rhabdomyolysis, which can result in kidney failure. The risk of muscle problems is higher:
If you are over 65 years old.
If you are female.
If you have kidney or liver disease.
If you have hypothyroidism.
If you consume large amounts of alcohol.
If you are Asian.
If you are taking certain other medicines (see section on taking other medicines).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever.

Liver problems

Your doctor may perform blood tests to check liver function before you start treatment and during treatment, especially if you have liver disease.

Diabetes

This medicine may increase blood glucose levels. Your doctor may monitor your blood glucose levels, especially if you have risk factors for diabetes (high blood glucose and triglycerides, abdominal obesity, high blood pressure).

Interactions

This medicine may interact with other medicines, including over-the-counter drugs and herbal supplements. Tell your doctor or pharmacist about all medicines you are taking or plan to take.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding (see section on pregnancy and breastfeeding).

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines. However, some people may experience dizziness or other side effects. If you experience any side effects that could affect your ability to drive or use machines, do not do so until the effects have passed.

Children

This medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and Simvastatine Combix

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This medicine may interact with other medicines, including over-the-counter drugs and herbal supplements.

Medicines that increase the risk of muscle problems:

• Danazol
• Colchicine
• Fusidic acid
• Other lipid-lowering medicines (e.g., gemfibrozil, fenofibrate)
• Ciclosporin
• Niacin (nicotinic acid) in high doses (>1 g/day)
• Amiodarone
• Verapamil
• Diltiazem
• Amlodipine
• Lomitapide
• Ivabradine
• Ranolazine
• Cobicistat-containing medicinal products
• Telithromycin
• Clarithromycin
• Itraconazole
• Ketoconazole
• Posaconazole
• Voriconazole
• HIV protease inhibitors
• Nefazodone
• Gemtuzumab ozogamicin

Medicines that may increase the risk of liver problems:

• Rifampicin
• St. John's wort (Hypericum perforatum)

Medicines that may decrease the effect of this medicine:

• Cholestyramine
• Colestipol
• Colesevelam

Food and drink

Do not drink grapefruit juice while taking this medicine, as it may increase the risk of side effects.
Avoid excessive alcohol consumption.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding.
If you become pregnant while taking this medicine, stop taking it immediately and contact your doctor.
This medicine may harm the unborn baby.
It is not known if this medicine passes into breast milk. However, because of the potential for serious side effects in breastfed infants, breastfeeding is not recommended while taking this medicine.

Fertility

There is no evidence that this medicine affects fertility.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines. However, some people may experience dizziness or other side effects. If you experience any side effects that could affect your ability to drive or use machines, do not do so until the effects have passed.

Do not take Simvastatina Combix

• if you are allergic (hypersensitive) to simvastatin or to any of the other components of this medicine (listed in section 6. Contents of the container and additional information),
• if you currently have liver problems,
• if you are pregnant or breastfeeding,
• if you are taking medicines containing any 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 condition in which the inner lining of the uterus grows outside the uterus).
• if you are taking or have taken, within the past 7 days, a medicine containing fusidic acid (used to treat bacterial infection) by mouth or injection. The combination of fusidic acid and Simvastatina Combix may cause serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of Simvastatina Combix if you are taking lomitapide (used to treat rare, inherited 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 drink large amounts of alcohol,
• if you have ever had liver disease. Simvastatina Combix may not be suitable for you,
• if you are scheduled for surgery. You may need to stop taking Simvastatina Combix tablets for a short period of time,
• if you are of Asian descent, as you may require a different dose.

Your doctor will perform a blood test before you start taking Simvastatina Combix and also if you develop any symptoms of liver problems while taking Simvastatina Combix. This is to check how well your liver is functioning.

Your doctor may also want to carry out blood tests to monitor liver function after you start treatment with Simvastatina Combix.

While you are taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk is higher 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 a serious lung disease.

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

If you have or have had myasthenia gravis (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

The risk of muscle breakdown is higher with high doses of Simvastatina Combix, 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 ever had muscle problems while taking cholesterol-lowering medicines known as "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 treatment with Simvastatina Combix has been studied in boys aged 10 to 17 years and in girls who had their first menstrual period (menstruation) at least one year prior (see section 3. How to take Simvastatina Combix). Simvastatina Combix has not been studied in children under 10 years of age. For more

information, consult your doctor.

Taking Simvastatina Combix with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines containing any of the following active substances. Taking Simvastatina Combix with any of the following medicines may increase the risk of muscle problems (some of which are already listed in the previous section “Do not take Simvastatina Combix”).

• if you need to take oral fusidic acid to treat a bacterial infection, you will temporarily have to stop using this medicine. Your doctor will advise you when you can restart treatment with Simvastatina Combix. The use of Simvastatina Combix with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• ciclosporine (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),
• medicines containing an active substance such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates containing an active substance such as gemfibrozil or bezafibrate (used to lower 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 and severe genetic cholesterol disorders),
• colchicine (used to treat gout),
• 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 an active substance used to prevent blood clots, such as warfarin, fenprocoumon, or acenocoumarol (anticoagulants),
• fenofibrate (also used to lower cholesterol),
• niacin (also used to lower cholesterol),
• rifampicin (used to treat tuberculosis).

You should also inform any doctor prescribing you a new medicine that you are taking Simvastatina Combix.

Taking Simvastatina Combix with food and drinks

Grapefruit juice contains one or more components that interfere with how the body processes certain medicines, including Simvastatina Combix. Consumption of grapefruit juice should be avoided.

Pregnancy and breastfeeding

Do not take Simvastatina Combix if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Simvastatina Combix, stop taking it immediately and inform your doctor. Do not take Simvastatina Combix 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 use of machines

Simvastatina Combix is not expected to interfere with your ability to drive or operate machinery. However, it should be noted that some people may experience dizziness after taking Simvastatina Combix.

Simvastatina Combix contains lactose

Simvastatina Combix tablets contain a sugar called lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Simvastatina Combix

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment, and your individual risk situation.

Follow exactly the dosing instructions provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting to take Simvastatina Combix, you should already be following a cholesterol-lowering diet.

Dosage:

The recommended dose is 10 mg, 20 mg, or 40 mg of simvastatin once daily by oral administration.

Adults:

The usual starting dose is 10 mg, 20 mg, 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 medications mentioned above or if you have certain renal disorders.

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

Use in children and adolescents:

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

Method of administration:

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

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

If you take more Simvastatina Combix than you should

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

If you forget to take Simvastatina Combix

• do not take a double dose to make up for the missed dose. The following day, take your usual dose of Simvastatina Combix at the regular time.

If you stop taking Simvastatina Combix

• speak with your doctor or pharmacist, as your cholesterol levels may rise again.

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

4. Possible adverse effects

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

The following terms are used to describe how frequently the 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 immediately and contact your doctor or go to the nearest hospital emergency department.

• Muscle pain, tenderness to pressure, muscle weakness, or muscle cramps. In rare cases, these muscle problems can be severe, including muscle breakdown leading to kidney damage; 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 weakness of the muscles in the limbs and neck,
• Joint pain or inflammation (polymyalgia rheumatica),
• Inflammation of blood vessels (vasculitis),
• Atypical bruising, skin rashes, and swelling (dermatomyositis), urticaria, 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),
• Inflammation of the liver with the following symptoms: yellowing of the skin and eyes (jaundice), itching, dark urine, pale stools, feeling tired or weak, loss of appetite; liver failure (very rare).
• Inflammation of the pancreas, often with severe abdominal pain.

The following very rare serious adverse effects have been reported:

• A severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction).

Rarely, the following adverse effects have also been reported:

• Low red blood cell count (anaemia),
• Numbness or weakness in arms and legs,
• Headache, tingling sensation, dizziness,
• Gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
• Skin rash, itching, hair loss, raised red rash, sometimes with target-like skin lesions (erythema multiforme),
• Blurred vision and visual impairment,
• Weakness,
• Sleep disorders (very rare),
• Memory impairment (very rare), memory loss, confusion.

The following very rare serious adverse effects have also been reported:

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

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

• Erectile dysfunction,
• Depression,
• Inflammation of the lungs causing breathing problems, including persistent cough and/or shortness of breath 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 sugar and fats in your blood, 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 Simvastatina Combix (frequency not known).
• 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 tests

In some blood tests, increases in liver function (transaminases) and in 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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin Combix

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

Do not use this medicine after the expiry date stated on the carton after EXP.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Simvastatina Combix:

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

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

Appearance of the product and contents of the pack:

Simvastatina Combix 10 mg is presented as pink, oval-shaped, biconvex, film-coated tablets, with a score line.

Each pack contains 28 tablets.

Simvastatina Combix 20 mg is presented as pink, oval-shaped, biconvex, film-coated tablets.

Each pack contains 28 tablets.

Simvastatina Combix 40 mg is presented as pink, oval-shaped, biconvex, film-coated tablets.

Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer:

Laboratorios Combix, S.L.U.
C/ Badajoz 2, Edificio 2
28223 Pozuelo de Alarcón (Madrid)
Spain

Manufacturer responsible for release:

Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande nº2, Abrunheira, Sintra, 2710-089, Portugal

or

Farmaprojects, S.A.
Calle Baldiri Reixac 4/12 y 15. Polígono Industrial Parc Cientific de Barcelona. 08028 Barcelona. Spain

or

GENERIS FARMACÊUTICA S.A.
Rua João de Deus nº19, Venda Nova, 2700-487 Amadora. Portugal

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR S.A.
Laguna, 66-68-70. Polígono Industrial Urtinsa II. Alcorcón (Madrid). Spain

Date of the most recent review 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