Package Leaflet: Information for the User

Simvastatina Davur 40 mg Film-Coated Tablets

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

• Keep this package 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 similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Simvastatina Davur is a medication used to reduce total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Simvastatina Davur increases concentrations of "good" cholesterol (high-density lipoprotein, HDL). Simvastatina Davur 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.

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 artery narrowing. This narrowing can slow or interrupt blood flow to vital organs such as the heart and brain. This interruption of blood flow can cause a myocardial infarction or a 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 heart disease.

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

Simvastatina Davur is used in combination with diet if you have:

elevated levels of cholesterol in the blood (primary hypercholesterolemia) or elevated levels of fatty substances in the blood (mixed hyperlipidemia).

• a hereditary disease (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 Davur 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 take Simvastatina Davur :

• if you are allergic (hypersensitive) to simvastatina or to 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 one of the following medications:

• itraconazole, ketoconazole, posaconazole, or voriconazole (medications 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 (medication 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 genetic cholesterol disorders).

Consult your doctor if you are unsure if your medication 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. Simvastatina may not be suitable for you.
• if you are scheduled for surgery. You may need to stop taking Simvastatina Davur for a short period of time.
• if you are Asian, as you may need a different dose.You have a disease
• if you have or have had myasthenia (a condition that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (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 perform a blood test before you start taking simvastatina and also if you have any symptoms of liver problems while taking simvastatina. This is to check how well your liver is working.

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

While you are taking this medication, your doctor will monitor 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 a severe lung disease.

Consult your doctor immediately if you experience unexplained muscle pain, sensitivity to pressure, or muscle 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 and is higher 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 a woman
• you have ever 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. Additional tests and medications 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 Davur).

Simvastatina has not been studied in children under 10 years.

For more information, consult your doctor.

Other medications and Simvastatina Davur

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

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

• if you need to take fusidic acid orally to treat a bacterial infection, you will temporarily need to stop taking this medication. Your doctor will tell you when you can restart the treatment with Simvastatina ratio. The use of Simvastatina Davur 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 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)
• medicationswith an active ingredientsuch as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (medications for fungal infections)
• fibrateswith an active ingredientsuch 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 asboceprevir, telaprevir,elbasvir, or grazoprevir(used to treat hepatitis C infection)
• nefazodone (used to treat depression)
• medications with the active ingredient cobicistat
• amiodarone (a medication for irregular heart rhythm)
• verapamil, diltiazem, or amlodipine (medications for high blood pressure, chest pain associated with heart disease, or other heart diseases)
• lomitapida (used to treat rare and severe genetic cholesterol disorders).
• daptomycin (a medication used to treat skin and skin structure infections with complications and bacteremia). The muscle effects may be greater when this medication is taken during treatment with simvastatina (for example, simvastatina). Your doctor may decide that you should stop taking simvastatinafor a time
• colchicine (a medication used to treat gout).
• ticagrelor (antiplatelet medication).

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

• medications with an active ingredient to prevent blood clot formation, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants)
• fenofibrate (another medication to reduce cholesterol)
• niacin (another medication to reduce cholesterol).
• rifampicin (a medication used to treat tuberculosis)

You must also inform any doctor who prescribes a new medication that you are taking simvastatina.

Simvastatina Davur with food, drinks, and alcohol:

The juice of grapefruit contains one or more components that alter how the body uses some medications, including Simvastatina Davur. You should avoid consuming grapefruit juice.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before starting any medication.

Driving and operating machinery:

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

Simvastatina Davur contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them 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. 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.

Dosage:

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

Adults:

The usual 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 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 withanother cholesterol-lowering medication that containssome 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 more Simvastatina Davur than 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 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 Simvastatina Davur:

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

If you interrupt treatment with Simvastatina Davur

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)

•Frequency not known (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)
  • Inflammation of blood vessels (vasculitis)
  • 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 rash, joint disorders, 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)
• A skin rash that can occur on the skin or ulcers in the mouth (drug-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 rash, 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 (frequency not known):

• Impotence
• Depression
• Inflammation of the lungs, which can cause breathing problems, including persistent cough and/or difficulty breathing or fever
• Problems with tendons, 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.

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30 °C.

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

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

Composition of Simvastatina Davur 40 mg film-coated tablets

• 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, iron oxide red (E172), iron oxide yellow (E172), triethyl citrate, titanium dioxide (E171), and povidone.

Appearance of the product and content of the packaging

Simvastatina Davur 40 mg is presented in the form of film-coated tablets, with an intense pink color.

Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

Teva Pharma, S.L.U.,

Polígono Industrial Malpica street C.4,

50016-Zaragoza

Spain

Last review date of this leaflet: September 2023

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es / ”