Patient Information Leaflet

Simvastatina cinfamed 40 mg Film-Coated Tablets

Read this 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. Do 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 leaflet. See section 4.

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 side effects

5.Storage of Simvastatina cinfamed

6.Contents of the pack and additional information

Simvastatina cinfamed contains the active ingredient simvastatina. Simvastatina is a medication used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides in the blood. Additionally, simvastatina increases 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 arteries forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make blood flow to vital organs such as the heart and brain slower or interrupted. 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 arteries and protects them from cardiovascular diseases.

Triglycerides are another type of fat in the blood that can increase the risk of cardiovascular disease.

While taking this medication, you must follow a cholesterol-reducing diet.

Simvastatina is used in conjunction with a cholesterol-reducing diet if you have:

-high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fat in the blood (mixed hyperlipidemia).

-an inherited disease (familial hypercholesterolemia homozygote), 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 CHD (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, keep a record of your cholesterol levels, and discuss your goals with your doctor.

Do not take Simvastatina cinfamed

-if you are allergic to simvastatina or any of the other components of this medication (listed in section 6).

-if you currently have liver problems.

-if you are pregnant or breastfeeding.

-if you are taking medications with one or more of the following active ingredients:

?itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections).

?erythromycin, clarithromycin, or telithromycin (used to treat infections).

?protease inhibitors for HIV, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections).

?boceprevir or telaprevir (used to treat hepatitis C infection).

?nefazodone (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, in the last 7 days, a medication that contains fusidic acid, (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and simvastatina may cause severe muscle problems (rhabdomyolysis).

Do not take more than 40 mg of simvastatina if you are taking lomitapida (used to treat rare and severe cholesterol disorders).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Simvastatina cinfamed

Inform your doctor:

-of all your medical problems, including allergies.

-if you consume large amounts of alcohol.

-if you have ever had liver disease. Simvastatina may not be suitable for you.

-if you are scheduled for surgery. You may need to stop taking simvastatina 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 disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

Your doctor should do a blood test before starting you on simvastatina and also if you have any symptoms of liver problems while taking simvastatina. This is done to check how your liver is working.

Your doctor may also do blood tests to check how your liver is working after you have started taking simvastatina.

While taking this medication, 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 sugar and fat in your blood, overweight, and 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, in rare cases, muscle problems can be severe, including muscle failure that causes kidney damage; and very rarely, deaths have occurred.

The risk of muscle failure is higher with high doses of simvastatina, especially with doses of 80 mg, and in certain patients. Inform your doctor if any of the following situations affect you:

-you consume large amounts of alcohol

-you have kidney problems

-you have thyroid problems

-you are 65 years or older

-you are a woman

-you have 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 problem.

Children and adolescents

The efficacy and safety of simvastatina 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). Simvastatina has not been studied in children under 10 years of age. For more information, consult your doctor.

Other medications and Simvastatina cinfamed

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

Taking simvastatina with any of the following medications may increase the risk of muscle problems (some of which are already included in the section above "Do not take Simvastatina cinfamed"):

-if you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking simvastatina. Your doctor will tell you when you can restart the treatment with simvastatina. The use of simvastatina with fusidic acid rarely may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

-ciclosporin (often 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).

-medications with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections).

-fibrates with an active ingredient 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 ingredient 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 cholesterol disorders).

-daptomycin (a medication used to treat skin and skin structure infections and bacteremia). It is possible that the muscle side effects may be greater when this medication is taken during treatment with simvastatina. Your doctor may decide that you should stop taking simvastatina for a time.

-colchicine (used to treat gout).

-Ticagrelor (antiplatelet medication).

As with the medications mentioned above, inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription. In particular, inform your doctor if you are taking medications with any of the following active ingredients:

-medications with an active ingredient to prevent blood clotting 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 simvastatina.

Simvastatina cinfamed with food and drinks

Orange juice contains one or more components that alter the way the body uses some medications, including simvastatina. Consumption of orange juice should be avoided.

Pregnancy and breastfeeding

Do not take this medication if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking this medication, stop taking it immediately and inform your doctor. Do not take this medication if you are breastfeeding because it is unknown whether this medication passes into breast milk.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

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

Simvastatina cinfamed contains lactose

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor.If in doubt,consult your doctor or pharmacist again.

You should follow a diet to reduce cholesterol while taking this medication.

Dosage:

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

Adults:

The usual initial dose is 10, 20, 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 medications 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 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 is 10 mg per day, at night. The maximum recommended dose is 40 mg per day.

Administration form

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.

If you take more Simvastatin cinfamed than you should

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

If you forgot to take Simvastatin cinfamed

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

If you interrupt the treatment with Simvastatin cinfamed

Talk to your doctor or pharmacist because your cholesterol level may increase again.

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

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

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

-Rare (may affect up to 1 in 1,000 people).

-Very rare (may affect up to 1 in 10,000 people).

-Unknown frequency (cannot be estimated from available data).

The following rare severe side effects have been reported.

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

-Muscle pain, pressure sensitivity, weakness, or muscle cramps. In rare cases, muscle problems can be severe, including muscle rupture with renal damage; and very rarely, deaths have occurred.

-Allergic reactions, including:

-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 in the limbs and neck muscles.

-Joint pain or inflammation (polymyalgia rheumatica).

-Inflammation of blood vessels (vasculitis).

-Atypical hematomas, skin eruptions, and swelling (dermatomyositis), urticaria, sun sensitivity, fever, hot flashes.

-Difficulty breathing (dyspnea) and general discomfort.

-Pseudolupus syndrome (including skin rash, joint disorders, and blood cell effects).

-Liver inflammation with the following symptoms:yellowing of the skin and eyes, itching, dark urine or pale stools, feeling tired and weak, loss of appetite, liver insufficiency (very rare).

-Pancreatitis, often with intense abdominal pain.

The following very rare severe side effects have been reported:

-A severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction).

-A skin rash that can occur on the skin or ulcers in the mouth (medication-induced lichenoid eruptions).

-Muscle rupture.

-Gynecomastia (breast enlargement in men).

The following side effects have also been reported rarely:

-Anemia (low red blood cell count).

-Numbness or weakness of the arms and legs.

-Headache, tingling sensation, dizziness.

-Blurred vision, vision deterioration.

-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.

-Pulmonary inflammation that causes respiratory problems such as persistent cough and/or difficulty breathing or fever.

-Tendon problems, sometimes complicated by tendon rupture.

• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (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, eyelid drooping, difficulty swallowing, or difficulty breathing.

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 taking this medicine.

-Constant muscle pain, sensitivity, or weakness that may not disappear after stopping simvastatin treatment (unknown frequency).

Laboratory values

Some blood tests have shown elevated liver function tests and a muscle enzyme (creatine kinase).

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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.

Do not store at a temperature above 30°C. Store in the original packaging to protect it from light and humidity.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Simvastatina cinfamed

- The active ingredient is simvastatina. Each film-coated tablet contains 40 mg of simvastatina.

- The other components are:

Core of the tablet: Lactose monohydrate, microcrystalline cellulose (E460), pregelatinized cornstarch, butylhydroxyanisole (E320), butylhydroxytoluene (E321), ascorbic acid (E300), citric acid (E330), anhydrous colloidal silica (E551), talc (E553b), magnesium stearate (E470b).

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

Appearance of the product and contents of the package

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

The tablets are packaged in blisters within a box, containing 10, 20, 28, 30, 98, and 100 tablets. Some package sizes may not be commercially available.

Simvastatina cinfamed is also available in 10 mg and 20 mg tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – España

Responsible manufacturer

Pharmaceutical Works Polpharma S.A.

19 Pelplinska street

83-200 Starogard Gdanski

Polonia

or

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – España

Last review date of this leaflet: May 2023

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70235/P_70235.html

QR code to: https://cima.aemps.es/cima/dochtml/p/70235/P_70235.html