Package Insert: Information for the User

Simvastatina Davur 10 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. 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 the 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 down 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 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, monitor your cholesterol, and discuss your goals with your doctor.

Do not take Simvastatina Davur:

• 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 any 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 lomitapida (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 Davur tablets for a short 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 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 do 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 do 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 kidney damage; and very rarely, deaths have occurred..

The risk of muscle damage is higher with high doses of simvastatin and is higher in certain patients. Talk to your doctor if any of the following situations apply to 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 medicines called "statins" or fibrates
• you or a close relative have a hereditary muscle disorder.

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 Davur).

Simvastatin has not been studied in children under 10 years.

For more information, consult your doctor.

Other medicines and Simvastatina Davur

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

Taking Simvastatina Davur 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 Davur").

• if you need to take fusidic acid orally to treat a bacterial infection, you will temporarily need to stop taking this medicine. 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 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 infections)
• antivirals for hepatitis C such as boceprevir, telaprevir, elbasvir, or grazoprevir
• 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)
• lomitapida (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 listed above, inform your doctor or pharmacist if you are taking or have taken recently other medicines, including those obtained without a prescription. In particular, inform your doctor if you are taking medicines with any of the active ingredients:

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

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

Taking Simvastatina Davur with food, drinks, and alcohol:

Orange juice contains one or more components that affect how the body uses some medicines, including Simvastatina Davur. 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 because it is unknown whether this medicine passes into breast milk.

Consult your doctor or pharmacist before starting any medicine.

Driving and operating machines:

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

Simvastatina Davur 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 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 oral route.

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 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 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 Toxicology 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
  • Pain or inflammation of the joints(polimialgia reumática)
  • Inflammation of the blood vessels(vasculitis)
  • Atypical hematomas, skin eruptions, and swelling (dermatomiositis), urticaria, skin sensitivity to sunlight, fever, hot flashes
  • Difficulty breathing (disnea) and general discomfort
  • Syndrome pseudolúpico (including skin eruption, 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 intense 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 (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 eruption, 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):

• 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

Elevations in some liver function blood tests (transaminases) and in one muscle enzyme (creatine kinase) were observed.

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 the 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 at 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 10 mg film-coated tablets

• The active ingredient is simvastatina. Each tablet contains 10 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 contents of the packaging

Simvastatina Davur 10 mg is presented in the form of film-coated tablets, pale pink in color and scored. The tablet can be divided into equal doses.

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/ ”