SIMVASTATIN PHARMA COMBIX 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Simvastatin Pharma Combix 20 mg Film-Coated Tablets EFG

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, as it may harm them, even if their symptoms are the same as yours.
• If you experience 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 Simvastatin Pharma Combix is and what it is used for
2. What you need to know before you take Simvastatin Pharma Combix
3. How to take Simvastatin Pharma Combix
4. Possible side effects
5. Storage of Simvastatin Pharma Combix
6. Contents of the pack and other information

1. What Simvastatin Pharma Combix is and what it is used for

Simvastatin Pharma Combix is a medicine used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. It also increases the levels of "good" cholesterol (HDL cholesterol). While taking this medicine, you should follow a low-cholesterol diet. Simvastatin Pharma Combix belongs to a group of medicines called statins.

Simvastatin Pharma Combix is used together with a diet in cases of:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fatty substances 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 disease). Simvastatin Pharma Combix may 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 Pharma Combix

Do not takeSimvastatin Pharma Combix

• 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
• if you are pregnant or breastfeeding
• if you are taking:
• • itraconazole, ketoconazole, posaconazole (medicines for fungal infections)
  • erythromycin, clarithromycin, or telithromycin (antibiotics for infections)
  • HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used to treat HIV infections)
  • nefazodone (a medicine for depression)

Warnings and precautions

Consult your doctor or pharmacist before taking Simvastatin Pharma Combix if you:

1. have severe respiratory insufficiency.

• If you have or have had myasthenia (a disease characterized by generalized 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).

Tell your doctor or pharmacist:

• about all your medical problems, including allergies.
• if you consume large amounts of alcohol.
• if you have ever had liver disease. Simvastatin may not be suitable for you.
• if you are scheduled for surgery. You may need to stop taking Simvastatin Pharma Combix tablets for a short period.
• if you have severe lung disease
• if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.
• 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 Pharma Combix can cause serious muscle problems (rhabdomyolysis).

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.

Consult 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 higher with high doses of simvastatin and is 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 disorder.

Using Simvastatin Pharma Combix with other medicines

It is especially important that you inform your doctor if you are taking any of the following medicines. Taking Simvastatin Pharma Combix with any of these medicines can increase the risk of muscle problems (some of these are already included in the "Do not take Simvastatin Pharma Combix" section).

• cyclosporin (a medicine often used in patients with organ transplants)
• danazol (a synthetic hormone used to treat endometriosis)
• medicines such as itraconazole, ketoconazole, fluconazole, or posaconazole (medicines for fungal infections)
• fibrates such as gemfibrozil and bezafibrate (medicines to lower cholesterol)
• erythromycin, clarithromycin, telithromycin, or fusidic acid (medicines for bacterial infections)
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines for AIDS)
• nefazodone (a medicine for depression)
• amiodarone (a medicine for irregular heart rhythm)
• verapamil, diltiazem, or amlodipine (medicines for high blood pressure, chest pain associated with heart disease, or other heart diseases)
• colchicine (a medicine used to treat gout)
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Simvastatin Pharma Combix. The use of Simvastatin Pharma Combix with fusidic acid can cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

As well as the medicines mentioned 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 any of the following:

• medicines to prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants)
• fenofibrate (another medicine to lower cholesterol)
• niacin (another medicine to lower cholesterol)
• rifampicin (a medicine used to treat tuberculosis)

If you are Chinese, also inform your doctor if you are taking niacin (nicotinic acid) or a product that contains niacin.

Taking Simvastatin Pharma Combix with food and drinks

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

Pregnancy, breastfeeding, and fertility

Do not take simvastatin 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 simvastatin if you are breastfeeding, as it is not known whether this medicine passes into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Simvastatin Pharma Combix contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Simvastatin Pharma Combix

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

Before starting to take Simvastatin Pharma Combix, you should be following a low-cholesterol diet.

The dose is 1 tablet of Simvastatin Pharma Combix 20 mg once a day by mouth.

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

A dose of 80 mg 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.

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

Take Simvastatin Pharma Combix in the evening. You can take it with or without food. The usual starting dose is 20 mg per day. Your doctor may adjust your dose after at least 4 weeks, 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. Continue taking Simvastatin Pharma Combix until your doctor tells you to stop.

If your doctor has prescribed Simvastatin Pharma Combix along with a bile acid sequestrant (medicines to lower cholesterol), you should take Simvastatin Pharma Combix at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Simvastatin Pharma Combix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Simvastatin Pharma Combix

Do not take a double dose to make up for forgotten doses.

The next day, take your normal amount of Simvastatin Pharma Combix at the usual time.

If you stop taking Simvastatin Pharma Combix

If you stop taking Simvastatin Pharma Combix, your cholesterol may rise again.

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

4. Possible side effects

Like all medicines, Simvastatin Pharma Combix can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects are reported:

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

The following serious rare side effects have been reported.

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

• muscle pain, tenderness, or weakness. In rare cases, these muscle problems can be serious, including muscle failure, which can cause kidney damage; muscle rupture (may affect up to 1 in 10,000 people); and very rarely, deaths have occurred.
• gynecomastia (breast enlargement in men) (may affect up to 1 in 10,000 people) allergic reactions, 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 muscle weakness in the limbs and neck
  • joint pain or inflammation
  • inflammation of blood vessels
  • unusual bruising, skin rash, and swelling, urticaria, sensitivity to sunlight, fever, flushing
  • difficulty breathing and general discomfort
  • pseudolupus syndrome (including skin rash, joint disorders, and effects on blood cells)
• liver inflammation with yellowing of the skin and eyes, itching, dark urine, or pale stools, liver failure (very rare)
• pancreatitis, often with severe abdominal pain.

The following side effects have also been reported rarely:

• low red blood cell count (anemia)
• numbness or weakness in the arms and legs
• headache, tingling sensation, dizziness
• digestive disorders (abdominal pain, constipation, gas, indigestion, diarrhea, nausea, vomiting)
• skin rash, itching, hair loss
• blurred vision and vision impairment (may affect up to 1 in 1,000 people)
• skin rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people)
• weakness
• sleep problems (very rare)
• poor memory (very rare)

The following serious very rare side effects have been reported:

• a severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction)

Side effects reported with some statins:

• sleep disorders, including insomnia and nightmares
• memory loss
• sexual dysfunction
• depression
• respiratory problems, including persistent cough and/or difficulty breathing or fever.

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.

Frequency not known: Persistent muscle weakness.Additional tests

Elevations in some blood tests of liver function (transaminases) and a muscle enzyme (creatine kinase) have been observed.

Severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).

Ocular myasthenia (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin Pharma Combix

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

Do not use Simvastatin Pharma Combix after the expiration date stated on the carton after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Content and Additional Information

Composition ofSimvastatina Pharma Combix

The active ingredient is simvastatin. Each film-coated tablet of Simvastatina Pharma Combix contains 20 mg of simvastatin.

The other components (excipients) are:

Anhydrous lactose, pregelatinized corn starch, butylhydroxyanisole (E320), anhydrous citric acid (E330), ascorbic acid (E300), magnesium stearate (E572), coating agent (hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172)).

Product Appearance and Packaging Content

The film-coated tablets of Simvastatina Pharma Combix 20 mg are brown, oval, biconvex, with beveled edges, with a score line on one face and smooth on the other.

The tablet can be divided into equal doses.

Simvastatina Pharma Combix 20 mg is available in packages containing 28 tablets in PVC/PE/PVDC-Al blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of the Last Revision of this Leaflet: April 2023

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