Simvastatin Davur 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Simvastatina Davur 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given 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 effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

1. What Simvastatina Davur is and what it is used for

Simvastatina Davur is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, Simvastatina Davur increases levels of "good" cholesterol (HDL cholesterol). Simvastatina Davur 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 may 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 follow a cholesterol-lowering diet.

Simvastatina Davur is used together with diet if you have:

• high cholesterol levels in the blood (primary hypercholesterolemia) or high levels of fatty substances in the blood (mixed hyperlipidemia).
• an inherited condition (homozygous familial hypercholesterolemia), which increases blood cholesterol levels. 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 Davur 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 target goals with your doctor.

2. What you need to know before taking Simvastatina Davur

Do not take Simvastatina Davur:

• 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 tissue lining 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 injection. The combination of fusidic acid and simvastatin may cause serious muscle problems (rhabdomyolysis).

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

Consult your doctor if you are unsure whether your medicine is on 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 Davur tablets for a short period.
• if you are of Asian origin, 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 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 factors for developing diabetes. This risk is higher if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure.

Inform 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 (rhabdomyolysis) leading to kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is higher with high 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 known as "statins" or fibrates.
• you or a close family member have a hereditary muscle disorder.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests or 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 who are at least one year past their first menstrual period (see section "How to take Simvastatina Davur").

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

For further information, consult your doctor.

Other medicines and Simvastatina Davur

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

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

• 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 Davur. Using Simvastatina Davur 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 tissue lining 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 (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 (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). The risk of adverse effects affecting the muscles may be increased when this medicine is taken during treatment with simvastatin (e.g., simvastatin). Your doctor may decide that you should temporarily stop taking simvastatin.
• colchicine (a medicine used to treat gout).
• ticagrelor (an antiplatelet medicine).

As with 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 prescribing a new medicine that you are taking simvastatin.

Taking Simvastatina Davur with food, drinks, and alcohol:

Grapefruit juice contains one or more components that interfere with how the body processes certain medicines, including Simvastatina Davur. 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 if you are 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, bear in mind that some people may experience dizziness after taking simvastatin.

Simvastatina Davur contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Simvastatina Davur

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.

Before starting to take this medicine, you should already be following a cholesterol-lowering diet.

Dosage:

The recommended dose is 10 mg, 20 mg, or 40 mg of simvastatin once daily by oral administration.

Adults:

The usual 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 medicines mentioned above or have certain renal 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

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

Method of administration:

Take simvastatin at night. You may take it 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 Simvastatina Davur than you should:

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

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

If you forget to take Simvastatina Davur:

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

If you stop taking Simvastatina Davur:

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 will experience 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, 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 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 the 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 visual impairment
• Weakness
• Sleep disorders (very rare)
• Memory impairment (very rare), memory loss, confusion.

The following adverse effects have also been reported, but from 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 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 weakness that is permanent and, in very rare cases, may not resolve after stopping simvastatin.

Additional tests

Elevations were observed in certain blood tests for 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 adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin Davur

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 the abbreviation EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the container and additional information

Composition of Simvastatin Davur 10 mg film-coated tablets EFG

• The active substance is simvastatin. Each tablet contains 10 mg of simvastatin.

• The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, butylated hydroxyanisole (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 container

Simvastatin Davur 10 mg is presented as film-coated tablets, pale rosy in color and scored. The tablet can be divided into equal doses.

Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Pharma, S.L.U.,

Polígono Industrial Malpica, Calle C.4,

50016-Zaragoza

Spain

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

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/”