Simvastatin Cinfamed 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Simvastatina cinfamed 10 mg film-coated tablets EFG

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

• Keep this leaflet, as 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, and you should not give it 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Simvastatin cinfamed contains the active substance simvastatin. Simvastatin is a medicine used to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, simvastatin increases the levels of "good" cholesterol (HDL cholesterol). Simvastatin belongs to a class of medicines called statins.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol 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 plaque buildup can cause 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 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 in your blood that may increase the risk of heart disease.

While taking this medicine, you must continue to follow a cholesterol-lowering diet.

Simvastatin is used together with a cholesterol-lowering diet if you have:

• high cholesterol levels in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia).
• a hereditary disease (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 CHD (because you have diabetes, a history of stroke, or other blood vessel disease). Simvastatin may prolong your life by reducing the risk of heart 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, keep track of your cholesterol levels, and discuss your goals with your doctor.

2. What you need to know before starting to take Simvastatina cinfamed

Do not take Simvastatina cinfamed

• if you are allergic to simvastatin or any of the other components of this medicine (listed in section 6).
• if you currently have liver problems.
• if you are pregnant or breastfeeding.
• if you are taking medicines containing 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 lower 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 last 7 days a medicine containing fusidic acid (used to treat bacterial infection) orally or by injection. The combination of fusidic acid and simvastatin may cause serious muscle problems (rhabdomyolysis).

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

Consult your doctor if you are unsure whether your medicine is included in the list above.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Simvastatina cinfamed.

Inform your doctor:

• about all your medical conditions, 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 tablets for a short period of time.
• if you are of Asian descent, as you may require a different dose.
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

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

Your doctor may also perform blood tests to monitor your liver function after you have started taking simvastatin.

While taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Inform your doctor if you have severe lung disease.

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

The risk of muscle breakdown is higher with high doses of simvastatin, especially with 80 mg doses, and in certain patients. Inform 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 during treatment with cholesterol-lowering medicines called “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 problem.

Children and adolescents

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

Other medicines and Simvastatina cinfamed

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking simvastatin with any of these medicines may increase the risk of muscle problems (some of which are already listed in the section above “Do not take Simvastatina cinfamed”):

• if you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will advise you when you can restart simvastatin treatment. Using simvastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• cyclosporine (often 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).
• medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections).
• fibrates containing active substances such as gemfibrozil and 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).
• antivirals for hepatitis C 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 serious genetic cholesterol disorders).
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). Adverse effects affecting muscles may be greater when this medicine is taken during treatment with simvastatin. Your doctor may decide that you should stop taking simvastatin temporarily.
• colchicine (used to treat gout).
• ticagrelor (an antiplatelet medicine).
• 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, have recently taken, or might need to take any other medicine, even those obtained without a prescription. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• medicines with active substances used to prevent blood clots such as warfarin, phenprocoumon, 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 who prescribes you a new medicine that you are taking simvastatin.

Taking Simvastatina cinfamed with food and drinks

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

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 this medicine, stop taking it immediately and inform your doctor. Do not take this medicine 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 using machines

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

Simvastatina cinfamed contains lactose

This medicine contains 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 Simvastatin cinfamed

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

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

You must follow a cholesterol-lowering diet while taking this medicine.

Dosage:

The recommended dose is 10 mg, 20 mg, 40 mg, or 80 mg of simvastatin taken orally once daily.

Adults:

The usual starting dose is 10 mg, 20 mg, or in some cases, 40 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 above 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 disease who have not reached their cholesterol goal with lower doses.

Use in children and adolescents

In children and adolescents aged between 10 and 17 years, the recommended daily dose to start treatment is 10 mg per day, taken at night. The maximum recommended dose is 40 mg per day.

Method of administration

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

The score on the 10 mg tablet is intended only for ease of swallowing if you have difficulty taking the tablet whole.

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

If you take more Simvastatin cinfamed than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Simvastatin cinfamed

Do not take a double dose to make up for missed doses. On the following day, take your usual dose of simvastatin at the regular time.

If you stop taking Simvastatin cinfamed

Talk to your doctor or pharmacist, as your cholesterol level 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 experiences them.

The following terms are used to describe the frequency of reported adverse effects:

• 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 rare serious adverse effects have been reported.

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

• Muscle pain, tenderness to pressure, weakness, or muscle cramps. In rare cases, muscle problems may be severe, including muscle breakdown leading to kidney damage; and 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 shoulders and hips.
• Skin rash with weakness in the limbs and neck muscles.
• Joint pain or inflammation (polymyalgia rheumatica).
• Inflammation of blood vessels (vasculitis).
• Unusual bruising, skin rashes, and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, hot flushes.
• 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 (jaundice), itching, dark urine or pale stools, feeling tired and 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).
• Rash which may appear on the skin or cause mouth ulcers (drug-induced lichenoid eruptions).
• Muscle rupture.
• Gynecomastia (enlargement of the breast in men).

The following adverse effects have also been reported rarely:

• Low red blood cell count (anaemia).
• Numbness or weakness in arms and legs.
• Headache, tingling sensation, dizziness.
• Blurred vision, deterioration of vision.
• Gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting).
• Skin rash, itching, hair loss.
• Weakness.
• Sleep problems (very rare).
• Memory impairment (very rare), memory loss, confusion.

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

• Erectile dysfunction.
• Depression.
• Inflammation of the lungs causing breathing problems such as persistent cough and/or difficulty breathing or fever.
• Tendon problems, sometimes complicated by tendon rupture.
  • Myasthenia gravis (a disease causing generalized muscle weakness that, 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 arms or legs 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. This is more likely if you have high levels of blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Muscle pain, tenderness, or persistent weakness, which may not resolve after stopping treatment with simvastatin (frequency not known).

Laboratory values

Elevations have been observed in certain blood tests for liver function and in a muscle enzyme (creatine kinase).

Reporting of adverse effects:

If you experience any adverse effect, talk to 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin cinfamed

Keep this medicine out of sight and reach of children.

Do not store above 30°C. Keep in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Simvastatin cinfamed

• The active substance is simvastatin. Each film-coated tablet contains 10 mg of simvastatin.
• The other components are:

Tablet core: Lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, butylhydroxyanisole (E320), butylhydroxytoluene (E321), ascorbic acid (E300), citric acid (E330), colloidal anhydrous silica (E551), talc (E553b), magnesium stearate (E470b).

Coating: Hypromellose (E464), red iron oxide (E172), yellow iron oxide (E172), triethyl citrate (E1505), titanium dioxide (E171), talc (E553b) and povidone.

Appearance of the product and contents of the pack

Simvastatin cinfamed 10 mg is presented as film-coated, biconvex, oval tablets, peach-colored, with a score line on one side.

The tablets are packed in blisters within a carton, containing 10, 20, 28, 30, 98 and 100 tablets. Only certain pack sizes may be commercially available.

Simvastatin cinfamed is also available in 20 mg and 40 mg tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Street

83-200 Starogard Gdanski

Poland

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the most recent revision of this leaflet: April 2026

Detailed 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/).

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70230/P_70230.html

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