Simvastatin Teva-Ratio 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Simvastatin Teva-ratio 20 mg film-coated tablets EFG

Package leaflet:

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

1. What Simvastatina Teva-ratio is and what it is used for

Simvastatina Teva-ratio is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, Simvastatina Teva-ratio increases levels of "good" cholesterol (HDL cholesterol). Simvastatina Teva-ratio 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 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 diet when you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high blood levels of fatty substances (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 Teva-ratio 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 treatment goals with your doctor.

2. What you need to know before taking Simvastatina Teva-ratio 20 mg

Do not take Simvastatina Teva-ratio:

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

• itraconazole, ketoconazole, posaconazole or voriconazole (medicines 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 (a medicine 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 infections) by mouth 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, serious genetic 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 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 Simvastatina Teva-ratio 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), since statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Your doctor will 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 want to perform blood tests to monitor liver function after you start treatment with simvastatin.

While taking this medicine, your doctor will monitor you for diabetes or 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.

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, 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 higher doses of simvastatin and is 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 previously experienced muscle problems while taking 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 condition.

Children and adolescents

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

Simvastatin has not been studied in children under 10 years of age.

For further information, consult your doctor.

Other medicines and Simvastatina Teva-ratio

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

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

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when you can restart treatment with Simvastatina Teva-ratio. Rarely, using Simvastatina Teva-ratio with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about 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 (medicines for fungal infections).
• fibrates containing active substances such as gemfibrozil and bezafibrate (used to lower cholesterol).
• erythromycin, clarithromycin, telithromycin (medicines 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 (a medicine used to treat depression).
• medicines containing the active substance cobicistat.
• amiodarone (a medicine for irregular heart rhythm).
• verapamil, diltiazem or amlodipine (medicines used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions).
• lomitapide (used to treat rare, serious genetic cholesterol disorders).
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). Adverse effects affecting muscles may be increased when this medicine is taken during treatment with simvastatin (e.g., simvastatin). Your doctor may decide that you should stop taking simvastatin temporarily.
• colchicine (a medicine used to treat gout).
• ticagrelor (an antiplatelet medicine).

As well as 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 with active substances 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).
• ribociclib (used to treat breast cancer).
• palbociclib (used to treat breast cancer).

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

Taking Simvastatin with food, drinks and alcohol

Grapefruit juice contains one or more components that alter how the body processes certain medicines, including Simvastatina Teva-ratio. Consumption of grapefruit juice should be avoided.

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 while breastfeeding, as it is unknown whether this medicine passes into breast milk.

Consult your doctor or pharmacist before starting any medicine.

Driving and using machines

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

Simvastatina Teva-ratio contains 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 Teva-ratio

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

Always follow exactly the instructions for taking Simvastatin Teva-ratio provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting this medicine, you should already be on a cholesterol-lowering diet.

Dosage:

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

Adults:

The recommended 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 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-lowering goals with lower doses.

Use in children and adolescents

For 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 simvastatin at night. It may be taken with or without food. Continue taking this medicine until your doctor tells you to stop.

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

If you take more Simvastatin Teva-ratio than you should:

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 0420.

If you forget to take Simvastatin Teva-ratio:

Do not take a double dose to make up for a missed dose. On the following day, take your usual dose of Simvastatin Teva-ratio at the regular time.

If you stop taking Simvastatin Teva-ratio:

Talk to 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 experiences them.

The following terms are used to describe how frequently 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)

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

The following serious rare adverse effects have been reported:

• Muscle pain, tenderness to pressure, muscle weakness or cramps. In rare cases, these muscle problems can 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 the shoulders and hips
  • skin rash associated with weakness of the limb and neck muscles
  • joint pain or inflammation (polymyalgia rheumatica)
  • inflammation of blood vessels (vasculitis)
  • atypical bruising, skin rashes, and swelling (dermatomyositis), hives, 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)
• Liver inflammation with the following symptoms: yellowing of the skin and eyes, itching, dark-colored urine or pale stools, feeling tired or weak, loss of appetite; liver failure (very rare)
• Inflammation of the pancreas, often with severe abdominal pain.

The following serious very rare adverse effects have been reported:

• A severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction)
• Skin rash or mouth ulcers (drug-induced lichenoid eruptions)
• Muscle rupture
• Gynaecomastia (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
• Gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)
• Skin rash, itching, hair loss
• Blurred vision and deterioration of vision
• Weakness
• Sleep disorders (very rare)
• Memory impairment (very rare), memory loss, confusion.

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
• Lung inflammation causing breathing problems, including persistent cough and/or shortness of breath or fever
• Tendon problems, sometimes complicated by tendon rupture
• 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).

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 the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Muscle pain, tenderness, or weakness that is permanent and, in very rare cases, may not resolve after stopping simvastatin.

Additional tests

Increases were observed in certain blood tests indicating liver function (transaminases) and in a muscle enzyme (creatine kinase).

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin Teva-ratio

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

Do not store above 30 °C.

Do not use this medicine after the expiry date stated on the packaging 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 a SIGRE 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 Simvastatin Teva-ratio 20 mg

• The active substance is simvastatin. Each tablet contains 20 mg of simvastatin.
• The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, butylhydroxyanisole (E320), ascorbic acid, citric acid, colloidal anhydrous 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 pack

Simvastatin Teva-ratio 20 mg is presented as film-coated tablets, pink in colour.

Each pack contains 28 tablets packed in blisters or in HDPE bottles (containing desiccant).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Teva Pharma, S.L.U.

Polígono Malpica, Calle C.4,

50016-Zaragoza

Spain

Date of the most recent revision of this package 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 Medical Devices (AEMPS) http://www.aemps.gob.es/”

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66858/P_66858.html