SIMVASTATIN STADA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Simvastatin STADA 10 mg film-coated tablets EFG

Simvastatin STADA 20 mg film-coated tablets EFG

Simvastatin STADA 40 mg film-coated tablets EFG

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 and other information

• What is Simvastatin Stada and what is it used for
  1. What you need to know before you take Simvastatin Stada
  2. How to take Simvastatin Stada
  3. Possible side effects
  4. Storage of Simvastatin Stada
  5. Pack contents and further information

1. What is Simvastatin Stada and what is it used for

Simvastatin Stada contains the active substance simvastatin. Simvastatin is used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. It also increases the levels of "good" cholesterol (HDL cholesterol). Simvastatin belongs to a group of medicines called statins.

Cholesterol is one of the fatty substances that can be found in the blood. Your total cholesterol level is made up mainly 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. This narrowing can reduce or completely block the flow of blood 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 in the blood that can increase the risk of heart disease.

While you are taking this medicine, you should also 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 hypercholesterolaemia) or high levels of fatty substances in the blood (mixed hyperlipidaemia).
• a hereditary disease (homozygous familial hypercholesterolaemia) which 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 diseases of the blood vessels). Simvastatin can prolong your life by reducing the risk of heart problems, regardless of the level 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 Stada

Do not take simvastatin:

• if you are allergic 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 breast-feeding.
• if you are taking medicines with one or more of the following active ingredients:

• itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections).
• erythromycin, clarithromycin or telithromycin (antibiotics).
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used to treat HIV infections that cause AIDS).
• boceprevir or telaprevir (used to treat hepatitis C virus infection).
• nefazodone (used to treat depression).
• cobicistat
• gemfibrozil (used to lower cholesterol).
• cyclosporin (used in patients with transplanted organs).
• 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, in the last 7 days, have taken or been given a medicine called fusidic acid (used to treat bacterial infections) by mouth 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 serious genetic cholesterol disorders).

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

Warnings and precautions

Consult your doctor or pharmacist before you start taking Simvastatin Stada.

Tell your doctor:

• about all your medical problems, including allergies.
• if you have or have had myasthenia (a disease that causes generalised 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).
• if you drink 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 the simvastatin tablets for a short time.
• if you are Asian, as you may need a different dose.

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.

Consult your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because, on rare occasions, muscle problems can be serious, including muscle breakdown, which can cause kidney damage; and, very rarely, deaths have occurred.

The risk of muscle breakdown is greater with higher doses of simvastatin, especially with the 80 mg dose. The risk of muscle breakdown is also greater in certain patients. Talk to your doctor if any of the following 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 female
• you have ever had muscle problems during treatment with cholesterol-lowering medicines called "statins" or fibrates
• • you or a close family member have a hereditary muscle disorder.

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

Children and adolescents

The efficacy and safety of simvastatin treatment 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). Simvastatin has not been studied in children under 10 years. For more information, consult your doctor.

Other medicines and Simvastatin Stada

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Taking simvastatin with any of the following medicines may increase the risk of muscle problems (some of these are already included in the section above "Do not take simvastatin").

• 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 simvastatin treatment. Taking simvastatin with fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4
• cyclosporin (often used in transplant patients)

• 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 (used to treat fungal infections)
• fibrates with an active ingredient such as gemfibrozil and bezafibrate (used to lower 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 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)
• lomitapide (used to treat rare and serious genetic cholesterol disorders)
• daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteraemia). The risk of side effects that affect the muscles may be greater when this medicine is taken during simvastatin treatment. Your doctor may decide that you should stop taking simvastatin for a while
• colchicine (used to treat gout)
• ticagrelor (antiplatelet medicine)

As well as the medicines mentioned above, tell your doctor or pharmacist if you are taking or have recently taken or might take any 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 clots, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants)
• fenofibrate (also used to lower cholesterol)
• niacin (also used to lower cholesterol)
• rifampicin (used to treat tuberculosis).

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

Taking Simvastatin Stada with food, drinks and alcohol

Simvastatin can be taken with or without food.

You should avoid drinking grapefruit juice while taking simvastatin, as it can increase the levels of simvastatin in the blood.

Simvastatin should be used with caution in patients who consume alcohol. If you regularly drink alcohol, consult your doctor.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Simvastatin is contraindicated during pregnancy.

If you become pregnant or suspect you are pregnant while taking simvastatin, stop the treatment and inform your doctor as soon as possible.

Do not take simvastatin if you are breast-feeding, as it is not known whether this medicine passes into breast milk.

Driving and using machines

At normal doses, simvastatin does not affect the ability to drive or use machines. However, if you notice symptoms of dizziness, do not drive or use machines until you know how the medicine affects you.

Simvastatin Stada contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Simvastatin Stada

Follow exactly the instructions of your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how long to take simvastatin. Do not stop treatment before then.

Before you start taking simvastatin, you should be following a low-cholesterol diet.

Dosage

The recommended dose is one tablet once a day, taken orally.

Adults

The recommended starting dose is 10 to 40 mg per day, taken in a single dose in the evening.

After at least 4 weeks, your doctor may adjust your dose up to a maximum of 80 mg per day, taken in a single dose in the evening. Do not take more than 80 mg per day.

Your doctor may prescribe lower doses, especially if you are taking certain medicines mentioned above 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 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, taken in the evening. The recommended maximum daily dose is 40 mg.

Elderly patients

No dose adjustment is necessary.

Method of administration

The tablets should be taken in the evening and can be taken with water, with or without food.

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

The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

If you take more Simvastatin Stada than you should

If you have taken more simvastatin than you should, consult your doctor or pharmacist immediately and/or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Simvastatin Stada

Do not take a double dose to make up for forgotten doses.

Take the next dose at the usual time.

If you have any further questions on 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 the 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)
  • Atypical bruising, skin rashes, and swelling (dermatomyositis), urticaria, 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)
• Inflammation of the liver 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)
• 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 (drug-induced lichenoid eruptions)
• 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 and vision impairment
• Digestive disorders (abdominal pain, constipation, gas, indigestion, diarrhea, nausea, vomiting)
• Skin rash, itching, hair loss
• 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
• 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
• Severe myasthenia (a disease that causes generalized muscle weakness, which 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. This is more likely if you have high levels of sugars and fats in your 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 stopping treatment with simvastatin (frequency not known).

Complementary tests

In some blood tests, elevations of liver function (transaminases) and a muscle enzyme (creatine 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 leaflet. 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 Stada

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

Store in the original packaging.

Do not use Simvastatina Stada after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Simvastatina Stada

The active ingredient is simvastatin.

Simvastatina 10 mg: Each tablet contains 10 mg of simvastatin.

Simvastatina 20 mg: Each tablet contains 20 mg of simvastatin.

Simvastatina 40 mg: Each tablet contains 40 mg of simvastatin.

The other components (excipients) are lactose, microcrystalline cellulose, pregelatinized cornstarch, butylhydroxyanisole (E320), magnesium stearate, talc, hypromellose, hydroxypropylcellulose, and titanium dioxide (E171).

Appearance of the Product and Package Contents

Simvastatina Stada 10 mg is presented in the form of film-coated tablets, white, oblong, biconvex, with a score line on one side. The tablets are marked with "SVT" on the non-scored side and with "10" on the scored side. Each package contains 28 or 500 (clinical package) tablets.

Simvastatina Stada 20 mg is presented in the form of film-coated tablets, white, oblong, biconvex, with a score line on one side. The tablets are marked with "SVT" on the non-scored side and with "20" on the scored side. Each package contains 28 or 500 (clinical package) tablets.

Simvastatina Stada 40 mg is presented in the form of film-coated tablets, white, oblong, biconvex, with a score line on one side. The tablets are marked with "SVT" on the non-scored side and with "40" on the scored side. Each package contains 28 or 500 (clinical package) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Manufacturer

Synthon Hispania S.L

Castelló 1, Polígono Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

STADA Arzneimittel AG

Stadastraße 2 – 18

D-61118 Bad Vilbel

Germany

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

Date of the Last Revision of this Leaflet:October 2023

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