SIMVASTATIN SUN 10 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

SIMVASTATIN SUN 10 mg FILM-COATED TABLETS EFG

simvastatin

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Simvastatin SUN contains the active substance simvastatin. Simvastatin SUN is a medicine used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and a type of fat called triglycerides that circulate in the blood. It also increases the levels of "good" cholesterol (HDL cholesterol). Simvastatin is a member of a group of medicines called statins.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is mainly made up 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 can lead to a narrowing of the arteries, which can slow down or block the blood flow to vital organs such as the heart and brain. This blockage can cause 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 found in your blood that can increase the risk of heart disease. While taking this medicine, you should follow a low-cholesterol diet.

Simvastatin is used, along with a low-cholesterol diet, if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia).
• a hereditary disease (homozygous familial hypercholesterolemia) that increases the level of cholesterol in the blood. You may also receive other treatments.
• coronary heart disease (CHD) or if you are at high risk of coronary heart disease (because you have diabetes, a history of stroke, or other blood vessel diseases). Simvastatin can prolong your life by reducing the risk of heart problems, regardless of the amount of cholesterol in your blood.

In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, monitor your cholesterol, and discuss your goals with your doctor.

2. What you need to know before you take SIMVASTATIN SUN

Do not take Simvastatin SUN:

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

• itraconazole, ketoconazole, posaconazole, or voriconazole (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 (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)

Do not take more than 40 mg of Simvastatin SUN if you are taking lomitapide (used to treat rare and severe genetic cholesterol disorders).

Consult 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 drink 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 tablets for a short time.
• If you are Asian, as you may need a different dose.

Your doctor will perform 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 perform blood tests to check how well your liver is working after you start treatment with simvastatin.

While 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 sugars and fats in the blood, are overweight, and have high blood pressure.

Tell your doctor if you have severe lung disease.

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).

Consult 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 higher with high doses of Simvastatin 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 drink 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, inform your doctor or pharmacist if you experience persistent muscle weakness. You may need additional tests and medications to diagnose and treat this problem.

Children and adolescents

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

Taking Simvastatin SUN with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Taking Simvastatin SUN with some of the following medicines may increase the risk of muscle problems (some of which are already indicated in the "Do not take Simvastatin SUN" section):

• 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 tell you when it is safe to restart treatment with Simvastatin SUN. Taking simvastatin with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

• cyclosporine (often 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 substance such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)
• fibrates with an active substance such as gemfibrozil and bezafibrate (used to reduce cholesterol)
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections)
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS)
• hepatitis C antivirals such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection)
• nefazodone (used to treat depression)
• Medicines with the active substance 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)
• lomitapide (used to treat rare and severe genetic cholesterol disorders)
• 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 (such as Simvastatin SUN). Your doctor may decide that you should stop taking Simvastatin SUN for a while.
• colchicine (used to treat gout)
• ticagrelor (used to prevent blood clots)

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, inform your doctor if you are taking medicines with any of the following active substances:

• medicines with an active substance to prevent blood clots, 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 you a new medicine that you are taking Simvastatin SUN.

Taking Simvastatin SUN with food and drinks:

Grapefruit juice contains one or more components that alter how the body uses some medicines, including Simvastatin SUN. You should avoid consuming grapefruit juice.

Pregnancy and breastfeeding:

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

Do not take Simvastatin SUN if you are breastfeeding because it is not known whether this medicine passes into breast milk.

Consult your doctor or pharmacist before taking any other medicine.

Driving and using machines:

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

Simvastatin SUN contains lactose

The tablets of Simvastatin SUN contain a sugar called lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take SIMVASTATIN SUN

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

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting to take Simvastatin SUN, you should be following a low-cholesterol diet.

Dosage:

The recommended dose of Simvastatin is 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg 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 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 problems who have not reached 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, in the evening. The maximum recommended daily dose is 40 mg.

Method of administration:

Take Simvastatin SUN in the evening. You can take it with or without food. Continue taking Simvastatin SUN until your doctor tells you to stop.

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

If you take more Simvastatin SUN than you should:

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

It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Simvastatin SUN:

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

If you stop taking Simvastatin SUN:

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

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

4. Possible Adverse Effects

Like all medicines, Simvastatina SUN can cause adverse effects, although not all people suffer from them.

The following terms are used to describe how often the 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).

The following serious rare adverse effects have been reported.

If any of the following rare adverse effects occur, discontinue treatment with the medicine and inform your doctor immediately or go to the emergency department of the nearest hospital.

The following serious adverse effects have been reported rarely:

• Muscle pain, tenderness to pressure, weakness, or cramps in the muscles. In rare cases, these muscle problems can be serious, including muscle failure, which can cause kidney damage, and very rarely, deaths have occurred.
• Hypersensitivity reactions (allergic) including:
• Swelling of the face, tongue, or 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)
• Atypical bruising, skin rashes, and swelling (dermatomyositis), urticaria, skin sensitivity to sun exposure, fever, hot flashes
• Difficulty breathing (dyspnea) and general malaise
• 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-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 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 (lichenoid drug eruptions)

Medicines.

• Muscle rupture.
• Gynecomastia (enlargement of the breast 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
• Blurred vision; visual disturbance,
• 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 adverse effects have also been reported, but the frequency cannot be estimated from the available data (frequency not known):

• Erectile dysfunction
• Depression
• Inflammation of the lungs that causes difficulty breathing, including persistent cough and/or shorter breaths 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).
• Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additional possible adverse effects reported with some statins:

• Sleep disorders, including nightmares
• Sexual dysfunction
• Diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

• Constant muscle pain, tenderness, or weakness that may not disappear after discontinuing treatment with Simvastatina SUN (frequency not known)

Complementary tests

In some blood tests, elevations of liver function and a muscle enzyme (creatinine kinase) have been observed.

Reporting of adverse effects

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

5. Storage of SIMVASTATINA SUN

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Simvastatina SUN:

The active ingredient is simvastatin.

Each tablet contains 10 mg of simvastatin.

The other components (excipients) are:

Core of the tablet:Butylhydroxyanisole, lactose monohydrate, pregelatinized corn starch, partially pregelatinized corn starch, ascorbic acid, citric acid monohydrate, microcrystalline cellulose, magnesium stearate.

Coating: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 Package Contents

Simvastatina SUN 10 mg is presented in the form of film-coated tablets, 8.0 mm ± 0.3 mm long and 6.0 mm ± 0.3 mm wide, peach-colored, oval, engraved with "SST" on one side and with "10" on the other.

The tablets are packaged in blister strips formed by a transparent PVC film coated with PVdC. The back is formed by a hard aluminum foil for heat sealing with lacquer for thermosealing.

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.

Marketing Authorization Holder and Manufacturer

Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer:

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 under the following names:

SpainSimvastatina SUN 10 mg film-coated tablets EFG

FranceSimvastatine SUN 10 mg film-coated tablet

ItalySimvastatina SUN film-coated tablets

SwedenSimvastatin SUN 10 mg film-coated tablets

RomaniaSimvastatin Terapia 10 mg film-coated tablets

Date of the last revision of this prospectus: October 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.gob.es/