SIMVASTATIN DAVUR 40 mg FILM-COATED TABLETS

2. What you need to know before you take Simvastatin Davur

Do not take Simvastatin Davur:

• if you are allergic (hypersensitive) to simvastatin or 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).
• 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 reduce cholesterol)
• cyclosporine (used in patients with organ transplants)
• danazol (a synthetic hormone used to treat endometriosis, a disease 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) orally or by injection. The combination of fusidic acid and simvastatin can cause serious muscle problems (rhabdomyolysis).
• Do not take more than 40 mg of Simvastatin if you are taking lomitapide (used to treat rare and severe genetic cholesterol diseases).

Tell your doctor if you are not sure if your medicine is on the list above.

Warnings and precautions

Tell your doctor:

• about 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 scheduled to have surgery. You may need to stop taking Simvastatin Davur tablets for a short time.
• if you are Asian, as you may need a different dose.
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease 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 treatment with 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 the blood, are overweight, and have high blood pressure.

Tell your doctor if you have severe lung disease.

Tell your doctor immediately if you experience muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems can be serious, 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 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-reducing medicines called "statins" or fibrates
• you or a close relative have a hereditary muscle problem.

Also, tell your doctor or pharmacist if you experience constant muscle weakness. You may need additional tests and medicines to diagnose and treat this problem.

Children and adolescents

The efficacy and safety have been studied in children aged 10 to 17 years and in girls at least one year after their first menstrual period (see How to take Simvastatin Davur).

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

For more information, consult your doctor.

Other medicines and Simvastatin Davur

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

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

• if you have to take oral fusidic acid to treat a bacterial infection, you will temporarily have to stop using this medicine. Your doctor will tell you when you can restart treatment with Simvastatin Davur. The use of Simvastatin Davur with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• cyclosporine (used in patients with organ transplants)
• danazol (a synthetic hormone used to treat endometriosis, a disease 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)
• 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 (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 diseases)
• daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteremia). The adverse effects that affect the muscles may be greater when this medicine is taken during treatment with simvastatin (e.g., simvastatin). Your doctor may decide that you should stop taking simvastatin for a while.
• colchicine (a medicine used to treat gout).
• ticagrelor (an antiplatelet medicine).

As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking medicines with any of the following 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 tell any doctor who prescribes you a new medicine that you are taking simvastatin.

Taking Simvastatin Davur with food, drinks, and alcohol:

Grapefruit juice contains one or more components that alter how the body uses some medicines, including Simvastatin Davur. You should avoid consuming grapefruit 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 tell your doctor. Do not take simvastatin if you are breastfeeding because it is not known whether this medicine passes into breast milk.

Consult your doctor or pharmacist before starting to take any medicine.

Driving and using machines:

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

Simvastatin Davur contains lactose

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

3. How to take Simvastatin Davur

Your doctor will determine the appropriate dose of Simvastatin Davur for you, depending on your condition, current treatment, and personal risk situation.

Follow the instructions for taking this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

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 medicines indicated above or have certain kidney disorders.

The dose of 80 mg 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 medicine until your doctor tells you to stop.

If your doctor has prescribed simvastatin along with another cholesterol-reducing medicine that contains a bile acid sequestrant, you should take this medicine at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Simvastatin 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 medicine and the amount taken.

If you forget to take Simvastatin Davur:

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

If you stop taking Simvastatin Davur

Talk to your doctor or pharmacist because your cholesterol may rise again.

If you have any other 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 all people suffer from them.

The following terms are used to describe how often 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 following serious adverse effects occur, stop taking the medicine and inform your doctor immediately or go to the emergency department of your nearest hospital.

The following serious adverse effects have been reported rarely:

• Muscle pain, tenderness to pressure, weakness, or muscle cramps. In rare cases, these muscle problems can be serious, including muscle failure leading to kidney damage; and very rarely, deaths have occurred.
• Hypersensitivity reactions (allergic) including:
• • Swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema)
  • Severe muscle pain, usually in the shoulders and hips
  • Skin rash with weakness of the muscles of the limbs and neck
  • Pain or inflammation of the joints (polymyalgia rheumatica)
  • Inflammation of the blood vessels (vasculitis)
  • Unusual bruising, skin rashes, and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, hot flashes
  • 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-colored stools, feeling tired or weak, loss of appetite; liver failure (very rare)
• Pancreas inflammation, often with severe abdominal pain.

The following serious adverse effects have been reported very rarely:

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

Rarely, the following adverse effects have also been reported:

• Low red blood cell count (anemia)
• Numbness or weakness of the arms and legs
• Headache, tingling sensation, dizziness
• Digestive disorders (abdominal pain, constipation, gas, indigestion, diarrhea, nausea, vomiting)
• Skin rash, itching, hair loss
• Blurred vision and vision impairment
• Weakness
• Sleep disorders (very rare)
• Poor memory (very rare), memory loss, confusion.

The following adverse effects have also been reported, but their frequency cannot be estimated from the available data (frequency not known):

• Erectile dysfunction
• Depression
• Lung inflammation causing breathing problems, including persistent cough and/or difficulty breathing or fever
• Tendon problems, sometimes complicated by tendon rupture
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

Additional 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 fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Pain, tenderness, or muscle weakness that is permanent and, in very rare cases, may not disappear after stopping simvastatin.

Complementary tests

Elevations in some blood tests of liver function (transaminases) and in a muscle enzyme (creatine kinase) have been observed.

Reporting of adverse effects

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

5. Storage of Simvastatina 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 CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Simvastatina Davur 40 mg film-coated tablets EFG

• The active ingredient is simvastatin. Each tablet contains 40 mg of simvastatin.

• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, 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 package contents

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

Each package contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Pharma, S.L.U.,

Polígono Industrial Malpica calle C.4,

50016-Zaragoza

Spain

Date of the last revision of this leaflet: September 2023

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