Simvastatin Sun 10 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

SIMVASTATIN SUN 10 mg FILM-COATED TABLETS EFG

simvastatin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this 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 and must not be given to others, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

What the leaflet contains

1. What SIMVASTATIN SUN is and what it is used for
2. What you need to know before taking SIMVASTATIN SUN
3. How to take SIMVASTATIN SUN
4. Possible side effects
5. How to store 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 levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, simvastatin increases levels of "good" cholesterol (HDL cholesterol). Simvastatin belongs to a class of medicines called statins.

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

Simvastatin is used, together with a cholesterol-lowering diet, if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high blood levels of fatty substances (mixed hyperlipidemia).
• an inherited disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.
• coronary heart disease (CHD) or are at high risk of coronary heart disease (because you have diabetes, history of stroke, or other blood vessel disease). Simvastatin may prolong your life by reducing the risk of heart-related problems, regardless of your blood cholesterol levels.

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

2. What you need to know before taking SIMVASTATINA SUN

Do not take SIMVASTATINA SUN:

• If you are allergic (hypersensitive) to simvastatin or to 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 medications containing 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 organ transplant patients)
  • 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 a medicine called fusidic acid (a medicine used to treat bacterial infections) orally or by injection. The combination of fusidic acid and SIMVASTATINA SUN may cause serious muscle problems (rhabdomyolysis).

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

Consult your doctor if you are unsure whether your medication is on the list above.

Warnings and precautions

Tell your doctor:

• about all your medical conditions, 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 for surgery. You may need to stop taking simvastatin tablets for a short period.
• If you are of Asian origin, as you may require a different dose.

Your doctor will perform a blood test before you start taking simvastatin and also if you develop any symptoms of liver problems while taking simvastatin. This is to check how well your liver is functioning.

Your doctor may also want to perform blood tests to monitor liver function after you start treatment with simvastatin.

While taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Inform your doctor if you have a severe lung disease.

If you have or have had myasthenia gravis (a disease characterized by generalized muscle weakness that in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is higher with high doses of SIMVASTATINA SUN, especially the 80 mg dose. The risk of muscle breakdown is also higher in certain patients. Talk to your doctor if any of the following apply to you:

• you consume large amounts of alcohol
• you have kidney problems
• you have thyroid problems
• you are 65 years of age or older
• you are female
• you have ever had muscle problems while being treated with cholesterol-lowering medicines called "statins" or fibrates
• you or a close family member have an inherited muscle disorder.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this problem.

Children and adolescents

The efficacy and safety of treatment with SIMVASTATINA SUN have been studied in boys aged 10 to 17 years and in girls who have had their first menstrual period (menstruation) at least one year prior (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.

Taking SIMVASTATINA SUN with other medicines:

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

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

• cyclosporine (often used in organ transplant patients)

• danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus)

• medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)

• fibrates with active substances 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 antiviral agents such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection)

• nefazodone (used to treat depression)

• medicines containing 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 conditions)

• lomitapide (used to treat rare, severe genetic cholesterol disorders)

• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). The adverse effects affecting muscles may be greater when this medicine is taken during treatment with simvastatin (e.g., SIMVASTATINA SUN). Your doctor may decide that you should temporarily stop taking SIMVASTATINA SUN

• colchicine (used to treat gout)

• ticagrelor (used to prevent blood clots)

As well as with the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• medicines with active substances to prevent blood clotting, 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 prescribing you a new medicine that you are taking SIMVASTATINA SUN.

Taking SIMVASTATINA SUN with food and drink:

Grapefruit juice contains one or more components that interfere with how the body processes certain medicines, including SIMVASTATINA SUN. Consumption of grapefruit juice should be avoided.

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 while taking SIMVASTATINA SUN, stop treatment immediately and contact your doctor.

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

Consult your doctor or pharmacist before taking any other medicine.

Driving and using machines:

SIMVASTATINA SUN is not expected to affect your ability to drive or use machines. However, it should be noted that 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 informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take SIMVASTATIN SUN

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment, and your individual risk situation.

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting to take Simvastatin SUN, you should already be on a cholesterol-lowering diet.

Dosage:

The recommended dose of Simvastatin is 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg once daily by oral administration.

Adults:

The usual starting dose is 10 mg, 20 mg, 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 mentioned 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 disease-related problems who have not achieved their cholesterol target with lower doses.

Use in children and adolescents:

In children and adolescents aged between 10 and 17 years, the recommended starting daily dose is 10 mg taken at night. The maximum recommended daily dose is 40 mg.

Method of administration:

Take Simvastatin SUN at night. You may take it with or without food. Continue taking Simvastatin SUN until your doctor tells you to stop.

If your doctor has prescribed Simvastatin SUN together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must 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 at telephone number: 91 562 0420, indicating the medication and the amount taken.

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

If you forget to take Simvastatin SUN:

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

If you stop taking Simvastatin SUN:

Consult your doctor or pharmacist, as your cholesterol levels may rise again.

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

4. Possible adverse effects

Like all medicines, Simvastatin SUN may cause adverse effects, although not everyone experiences 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, stop taking this medicine immediately and contact your doctor or go to the nearest hospital emergency department without delay.

The following serious rare adverse effects have been reported:

• Muscle pain, tenderness, weakness, or cramps. Occasionally, these muscle problems may be severe and include muscle breakdown, which can lead to kidney damage; death has occurred very rarely.
• Hypersensitivity (allergic) reactions, including:
  • Swelling of the face, tongue, or throat, which may cause difficulty breathing (angioedema)
  • Severe muscle pain, usually in the shoulders and hips
  • Skin rash accompanied by weakness of the limb and neck muscles
  • Joint pain or inflammation (polymyalgia rheumatica)
  • Inflammation of blood vessels (vasculitis)
  • Atypical bruising, skin rashes, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flushes
  • Difficulty breathing (dyspnea) and general malaise
  • Lupus-like 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, 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 very rare adverse effects have been reported:

• A severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction)
• Skin rash or mouth ulcers (drug-induced lichenoid eruptions)
• Muscle rupture
• Gynaecomastia (enlargement of breast tissue in men)

Rarely, the following adverse effects have also been reported:

• Low red blood cell count (anaemia)
• Numbness or weakness in arms and legs
• Headache, tingling sensation, dizziness
• Blurred vision; visual disturbances
• Gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)
• Skin rash, itching, hair loss
• Weakness
• Difficulty sleeping (very rare)
• Memory impairment (very rare), memory loss, confusion

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

• Erectile dysfunction
• Depression
• Lung inflammation causing difficulty breathing, including persistent cough and/or shortness of breath, or fever
• Tendon problems, sometimes complicated by tendon rupture
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)
• Consult your doctor if you experience worsening weakness in the arms or legs 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. This is more likely if you have high levels of blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

• Persistent muscle pain, tenderness, or weakness that may not resolve after stopping treatment with Simvastatin SUN (frequency not known)

Additional tests

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SIMVASTATIN SUN

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Simvastatin SUN:

The active substance is simvastatin.

Each tablet contains 10 mg of simvastatin.

The other components (excipients) are:

Tablet core: Butylated hydroxyanisole, 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).

Nature of the product and pack contents

Simvastatin SUN 10 mg is presented as film-coated tablets, 8.0 mm ± 0.3 mm in length and 6.0 mm ± 0.3 mm in width, peach-colored, oval-shaped, marked with “SST” on one side and “10” on the other.

The tablets are packed in blisters made of transparent PVC film coated with PVdC. The back consists of a hard aluminum foil sealed with heat-seal lacquer.

Available pack sizes are: 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 film-coated tablets, and 300 (10x30) film-coated tablets for hospital use.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The 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 medicinal product is authorized in the European Economic Area member states under the following names:

Spain Simvastatin SUN 10 mg film-coated tablets EFG

France Simvastatine SUN 10 mg comprimé pelliculé

Italy Simvastatina SUN compresse rivestite con film

Sweden Simvastatin SUN 10 mg filmdragerade tabletter

Romania Simvastatin Terapia 10 mg comprimate filmate

Date of the most recent revision of this leaflet: October 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/