PROSPECTO: INFORMATION FOR THE USER

SIMVASTATINA SUN 10 mg FILM-COATED TABLETS

simvastatina

1. What is SIMVASTATINA SUN and for what it is used

2. What you need to know before starting to take SIMVASTATINA SUN

3. How to take SIMVASTATINA SUN

4. Possible adverse effects

5. Storage of SIMVASTATINA SUN

6. Contents of the package and additional information

Simvastatina SUNcontains the active ingredient simvastatina. Simvastatina SUNis a medication used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood.In addition, simvastatina increases the levels of "good" cholesterol (HDL cholesterol). Simvastatina is a member of a class of medications called statins.

Cholesterol is one of the fatty substances found in the bloodstream. Total cholesterol is mainly composed of LDL and HDL cholesterol.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can cause a heart attack or stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects them from cardiovascular diseases.

Triglycerides are another type of fat in your blood that can increase the risk of heart disease. While taking this medication, you must follow a cholesterol-lowering diet.

Simvastatina is used, along with a cholesterol-lowering 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 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 SUN:

• If you are allergic (hypersensitive) to simvastatin or to any of the other components of this medication (listed in section 6: Contents of the pack and additional information)
• If you currently have liver problems
• If you are pregnant or breastfeeding.
• If you are taking medications with one or more of the following active ingredients:

• itraconazole, ketoconazole, posaconazole, or voriconazole (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 (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 within the last 7 days an oral or injectable medication called fusidic acid (a medication to treat bacterial infections). The combination of fusidic acid and Simvastatina SUN may cause severe muscle problems (rhabdomyolysis).

Do not take more than 40 mg of Simvastatina SUN 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:

• About 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 simvastatin tablets for a short period of time.
• If you are Asian, as you may need a different dose.

Your doctor will make 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 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, being overweight, and high blood pressure.

Inform your doctor if you have a severe lung 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).

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 muscle failure, which can cause kidney damage; and very rarely, deaths have occurred.

The risk of muscle failure is higher with high doses of Simvastatina SUN, especially with the 80 mg dose. The risk of muscle failure is also 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 female
• 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. Further tests and additional medications may be necessary to diagnose and treat this problem.

Children and adolescents

The efficacy and safety of Simvastatina SUN treatment were studied in boys aged 10 to 17 years and in girls who had their first menstrual period (menstruation) at least one year earlier (see section 3. How to take Simvastatina SUN). Simvastatina SUN has not been studied in children under 10 years of age. For more information, consult your doctor.

Simvastatina SUN with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Taking Simvastatina SUN with any of the following medications may increase the risk of muscle problems (some of which have already been mentioned in the "Do not take Simvastatina SUN" section):

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily interrupt the use of this medication. Your doctor will tell you when it is safe to resume Simvastatina SUN treatment. Taking simvastatin with fusidic acid may rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information about rhabdomyolysis in 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)
• medications with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)
• fibrates with an active ingredient such as gemfibrozil and bezafibrate (used to reduce cholesterol)
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections)
• protease inhibitors for HIV, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections)
• agents for hepatitis C virus, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C infection)
• nefazodone (used to treat depression)
• Medications with the active ingredient cobicistat.
• amiodarone (used to treat irregular heartbeat)
• verapamil, diltiazem, or amlodipine (used to treat 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 and bacteremia). It is possible that muscle side effects may be greater when this medication is taken during Simvastatina (such as Simvastatina SUN) treatment. Your doctor may decide to stop taking Simvastatina SUN for a time,
• colchicine (used to treat gout)
• ticagrelor (used to prevent blood clots)

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

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

You should also inform any doctor who prescribes a new medication that you are taking Simvastatina SUN.

Simvastatina SUN with food and drinks:

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

Pregnancy and breastfeeding:

Do not take Simvastatina SUN if you are pregnant, think you may be pregnant, or plan to become pregnant. If you become pregnant during Simvastatina SUN treatment, stop treatment immediately and contact your doctor.

Do not take Simvastatina SUN if you are breastfeeding, as it is unknown whether this medication passes into breast milk.

Consult your doctor or pharmacist before taking any other medication.

Driving and operating machinery:

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

Simvastatina SUN contains lactose

Simvastatina SUN tablets contain a sugar called lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Before starting to take Simvastatina SUN, you should be following a diet to reduce cholesterol.

Posology:

The recommended dose of Simvastatina is 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg once a day orally.

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 if you 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 problems who have not achieved their cholesterol 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 Simvastatina SUN at night. You can take it with or without food. Continue taking Simvastatina SUN until your doctor tells you to stop.

If your doctor has prescribed Simvastatina SUN along with another cholesterol-lowering medication that contains a bile acid sequestrant, you should take Simvastatina SUN at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Simvastatina SUN than you should:

Please contact your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 0420, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Simvastatina SUN:

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

If you interrupt the treatment with Simvastatina SUN:

Consult with your doctor or pharmacist because your cholesterol may rise again.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, Simvastatina SUN 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)
• Unknown frequency (cannot be estimated from available data).

The following serious rare side effects have been reported.

If any of the following rare serious side effects occur, stop taking the medicine and inform your doctor immediately or visit the nearest hospital emergency department.

The following serious rare side effects have been reported:rare:

• Muscle pain, sensitivity to pressure, weakness or cramps in the muscles. In rare cases, these muscle problems can be severe, including muscle failure that causes kidney damage and very rarely have resulted in death.
• Allergic reactions (hypersensitivity) including:
• Swelling of the face, tongue or throat, which can cause difficulty breathing (angioedema).
• Intense 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)
• Atypical hematomas, skin rash and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flashes
• Difficulty breathing (dyspnea) and general discomfort
• Pseudo-lupus 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 urine or pale stools, feeling tired or weak, loss of appetite; liver insufficiency (very rare)
• Pancreatitis, often with severe abdominal pain

The following serious very rare side effects have been reported:

• 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 (lichenoid drug eruptions)

Rarely, the following side effects have also been reported:

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

The following side effects have also been reported but the frequency cannot be estimated from the available information (unknown frequency):

• Erectile dysfunction
• Depression
• Pneumonitis that causes difficulty breathing, including persistent cough and/or shorter breaths or fever
• Tendon problems, sometimes complicated by tendon rupture.
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).
• Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision or eyelid drooping, difficulty swallowing or difficulty breathing.

Additional side effects reported with some statins:

– Constant muscle pain, sensitivity or weakness that may not disappear after stopping treatment with Simvastatina SUN (unknown frequency)

Complementary tests

In some blood tests, elevations in liver function and a muscle enzyme (creatine kinase) were observed.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Simvastatina SUN:

The active ingredient is simvastatina.

Each tablet contains 10 mg of simvastatina.

The other components (excipients) are:

Core of the tablet:Butilhydroxyanisol,lactose monohydrate, cornstarch, partially pregelatinized cornstarch, ascorbic acid, citric acid monohydrate, microcrystalline cellulose, magnesium stearate.

Covering:Opadry 20A 54963 Pink: hydroxypropyl cellulose, hypromellose, titanium dioxide (E171), talc, yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the package

Simvastatina SUN 10 mg is presented in the form of film-coated tablets, 8.0 mm ± 0.3 mm in length and 6.0 mm ± 0.3 mm in width, orange in color, oval, engraved with “SST” on one face and with “10” on the other.

The tablets are packaged in strips of blisters formed by a transparent PVC film coated with PVdC. The reverse is formed by a hard aluminum foil for hot sealing with a heat-sealing lacquer.

The possible package sizes are: 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 film-coated tablets and 300 (10x30) film-coated tablets for hospitals.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Responsible for manufacturing:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

OR

TERAPIA, S.A.

124, Fabricii Street

400632 – Cluj Napoca

Romania

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona.

Spain

Tel.: +34 93 342 78 90

This medicine is authorized in the member states of the European Economic Area with the following names:

SpainSimvastatina SUN 10 mg film-coated tablets EFG

FranceSimvastatine SUN 10 mg coated tablet

ItalySimvastatina SUN film-coated tablets

SwedenSimvastatin SUN 10 mg film-coated tablets

RomaniaSimvastatin Terapia 10 mg film-coated tablets

Revision date of this leaflet: October 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/