Package Leaflet: Information for the User

Simvastatina Teva-ratio40 mgCoated Tablets EFG

Simvastatina Teva-ratio is a medication used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol) and certain types of fat called triglycerides that circulate in the blood. Additionally, Simvastatina Teva-ratio increases the levels of "good" cholesterol (HDL cholesterol). Simvastatina Teva-ratio 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 composed mainly of LDL and HDL cholesterol.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can slow down or interrupt blood flow to vital organs such as the heart and brain. 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 the arteries and protects them from cardiovascular diseases.

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

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

Simvastatina Teva-ratio is used in combination with diet if you have:

• elevated levels of cholesterol in the blood (primary hypercholesterolemia) orelevated levels of fat in the blood (mixed hyperlipidemia).

• a genetic disorder (familial hypercholesterolemia), 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 coronary heart disease (because you have diabetes, a history of stroke or other vascular disease). Simvastatina Teva-ratio may 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, monitor your cholesterol, and discuss your goals with your doctor.

Do not takeSimvastatina Teva-ratio:

• if you are allergic (hypersensitive) to simvastatin or to 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 one of the following medicines:

• itraconazole, ketoconazole, posaconazole or voriconazole (medicines used to treat fungal infections)
• erythromycin, clarithromycin or telithromycin (used to treat infections)
• protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir and saquinavir (protease inhibitors for HIV are used to treat HIV infections)
• boceprevir or telaprevir (used to treat hepatitis C infection)
• nefazodone (a medicine used to treat depression)
• cobicistat
• gemfibrozil (used to reduce cholesterol)
• ciclosporin (used in patients who have had an organ transplant)
• 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 medicine that contains fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and simvastatin may cause severe muscle problems (rhabdomyolysis).
• Do not take more than 40 mg of Simvastatina if you are taking lomitapide (used to treat rare and severe genetic cholesterol disorders).

Consult your doctor if you are unsure if your medicine is on the above list.

Warnings and precautions

Inform your doctor:

• of 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 due to have an operation. You may need to stop taking Simvastatina Teva-ratio for a short period of time.
• if you are of Asian origin, as you may need a different dose.
• if you have or have had myasthenia (a condition that causes generalised muscle weakness, which in some cases affects the muscles used for breathing) or myasthenic eye disease (a condition that causes weakness of the eye muscles), as statins may sometimes worsen the condition or cause myasthenia (see section 4).

Your doctor will make a blood test before you start taking simvastatin and also if you have any symptoms of liver problems while taking simvastatin. This is to check how well your liver is working.

Your doctor may also want to make blood tests to check how well your liver is working after you start taking simvastatin.

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 sugar and fat in your blood, are overweight and have high blood pressure.

Inform your doctor if you have a severe lung disease.

Consult 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 which can cause kidney damage; and very rarely, deaths have occurred..

The risk of muscle failure is greater with high doses of simvastatin and is greater in certain patients. Talk to 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 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.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this problem.

Children and adolescents

The efficacy and safety were studied in children aged 10 to 17 years and in girls, at least one year after their first menstrual period (see How to take Simvastatina Teva-ratio).

Simvastatin has not been studied in children under 10 years.

For more information, consult your doctor.

Other medicines and Simvastatina Teva-ratio

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

Taking Simvastatina Teva-ratio with any of these medicines may increase the risk of muscle problems (some of which are already included in the section above "Do not take Simvastatina Teva-ratio").

• if you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can restart the treatment with Simvastatina Teva-ratio. The use of Simvastatina Teva-ratio with fusidic acid rarely may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4
• ciclosporin (often used in patients who have had an organ transplant)
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus)
• medicines with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (medicines for fungal infections)
• fibrates with an active ingredient such as gemfibrozil and bezafibrate (used to reduce cholesterol)
• erythromycin, clarithromycin, telithromycin (used to treat bacterial infections)
• protease inhibitors for HIV, such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat HIV/AIDS)
• antivirals for hepatitis C such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C infection)
• nefazodone (a medicine used to treat depression)
• medicines with the active ingredient cobicistat
• 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)
• lomitapide (used to treat rare and severe genetic cholesterol disorders)
• daptomycin (a medicine used to treat skin and skin structure infections and bacteremia). The muscle effects may be greater when this medicine is taken during treatment with simvastatin (for example, simvastatin). Your doctor may decide that you should stop taking simvastatin for a time
• colchicine (a medicine used to treat gout)
• ticagrelor (an antiplatelet medicine).

As with the medicines mentioned above, inform your doctor or pharmacist if you are taking or have taken recently other medicines, even those bought without a prescription. In particular, inform your doctor if you are takingmedicines with any of the active ingredients:

• medicines with an active ingredient to prevent blood clotting, such as warfarin, phenindione or acenocoumarol (anticoagulants)
• fenofibrate (another medicine to reduce cholesterol)
• niacin (another medicine to reduce cholesterol).
• rifampicin (a medicine used to treat tuberculosis)

You must also inform any doctor who prescribes a new medicine that you are taking simvastatin.

Taking Simvastatina with food, drinks and alcohol

Orange juice contains one or more components that affect how the body uses some medicines, including Simvastatina Teva-ratio. You should avoid consuming orange juice.

Pregnancy and breastfeeding

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.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Simvastatin is not expected to interfere with your ability to drive or use machines. However, some people may experience dizziness after taking simvastatin.

Simvastatina Teva-ratio contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

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 Simvastatina Teva-ratio as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting to take this medication, you must be following a diet to reduce cholesterol.

Posology:

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

Adults:

The recommended 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 medications indicated 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 complications who have not achieved their cholesterol reduction 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 at night. The maximum recommended daily dose is 40 mg.

Method of administration:

Take simvastatin at night. You can take it with or without food. Continue taking this medication 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 must take this medication at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take moreSimvastatina Teva-ratiothan you should:

If you have taken more simvastatin than you should, contact your doctor or pharmacist or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 0420.

If you forgot to takeSimvastatina Teva-ratio:

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

If you interrupt treatment with Simvastatina Teva-ratio

Talk to your doctor or pharmacist because your cholesterol may rise 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 how often side 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)

•Unknown frequency (cannot be estimated from available data)

If any of the serious side effects mentioned below occur, stop taking the medicine and inform your doctor immediately or go to the emergency service of your nearest hospital.

The following serious side effects have been reported:Rare:

• Muscle pain, sensitivity to pressure, weakness, or muscle cramps. In rare cases, these muscle problems can be severe, including muscle failure leading to kidney 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
  • Erupción cutánea con debilidad de los músculos de los miembros y del cuello
  • Joint pain or inflammation (polymyalgia rheumatica)
  • Vasculitis (inflammation of the blood vessels)
  • Atypical hematomas, skin eruptions, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flashes
  • Difficulty breathing (dyspnea) and general discomfort
  • Pseudolupus syndrome (including skin eruptions, joint problems, and effects on blood cells)
• Inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark urine or pale stools, feeling tired or weak, loss of appetite; liver insufficiency (very rare)
• Inflammation of the pancreas, often with severe abdominal pain.

The following serious side effects have been reported:Very rare:

• A severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction)
• Eruptions that can occur on the skin or ulcers in the mouth (medication-induced lichenoid eruptions)
• Muscle rupture
• Gynecomastia (breast enlargement in men)

Rarely, the following side effects have also been reported:

• Anemia (low red blood cell count)
• Numbness or weakness of the arms and legs
• Headache, tingling sensation, dizziness
• Digestive problems (abdominal pain, constipation, gas, indigestion, diarrhea, nausea, vomiting)
• Skin eruptions, itching, hair loss
• Blurred vision and vision deterioration
• 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 available data (unknown frequency):

• 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
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing)
• Myasthenia ocular (a disease that causes weakness of the eye muscles)

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.
• Muscle pain, sensitivity, or weakness that is permanent and, in very rare cases, may not disappear when stopping simvastatin.

Additional tests

Some blood tests showed elevations in liver function (transaminases) and in a muscle enzyme (creatine kinase).

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.esBy reporting side effects, you can contribute to providing information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above30 °C.

Do not usethis medicationafter the expiration date that appears on the packaging 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 unused medicines at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Simvastatina Teva-ratio 40 mg

• The active ingredient is simvastatina. Each tablet contains 40 mg of simvastatina.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, butylhydroxyanisole (E320), ascorbic acid, citric acid, anhydrous colloidal silica, talc, magnesium stearate, hypromellose, red iron oxide (E172), yellow iron oxide (E172), triethyl citrate, titanium dioxide (E171), and povidone.

Appearance of the product and contents of the packaging

Simvastatina Teva-ratio 40 mg is presented in the form of film-coated tablets, of intense pink color. Each package contains 28 tablets conditioned in blister or in HDPE bottle (contains desiccant).

Holder of the marketing authorization andresponsible for manufacturing

Holderof the marketing authorization

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing

Teva Pharma, S.L.U.

Malpica Industrial Estate, street C.4,

50016-Zaragoza

Spain

Last review date of this leaflet: September 2023

“Detailed and updated 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 with your smartphone the QR code included in the carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66857/P_66857.html