Simvastatin Stada 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Simvastatine STADA 10 mg film-coated tablets EFG

Simvastatine STADA 20 mg film-coated tablets EFG

Simvastatine 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, 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; do not pass it on to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents

• What Simvastatine Stada is and what it is used for
  1. What you need to know before taking Simvastatine Stada
  2. How to take Simvastatine Stada
  3. Possible side effects
  4. How to store Simvastatine Stada
  5. Contents of the pack and other information

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

Simvastatina Stada contains the active substance simvastatin. Simvastatin is used to lower blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides. 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 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 lead to 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 may result in 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 must continue to follow a cholesterol-lowering diet.

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

• high cholesterol levels in the blood (primary hypercholesterolemia) or high blood levels of fatty substances (mixed hyperlipidemia);
• a hereditary condition (homozygous familial hypercholesterolemia) that 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, a 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 levels, and discuss your treatment goals with your doctor.

2. What you need to know before taking Simvastatina Stada

Do not take simvastatin:

• If you are allergic to simvastatin or to 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 medicines containing one or more of the following active substances:

• 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 infection causing AIDS).

• Boceprevir or telaprevir (used to treat hepatitis C virus infection).

• Nefazodone (used to treat depression).

• Cobicistat

• Gemfibrozil (used to lower 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 currently taking, or have taken within the last 7 days, or have been given a medicine called fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and simvastatin may cause serious muscle problems (rhabdomyolysis).

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Simvastatina Stada.

Inform your doctor:

• About all your medical conditions, including allergies.
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which 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).
• 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 it. 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 you for diabetes or 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.

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 simvastatin, 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 during treatment 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 have persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

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 prior (see section 3). Simvastatin has not been studied in children under 10 years of age. For further information, consult your doctor.

Other medicines and Simvastatina Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 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 you can restart simvastatin treatment. Using simvastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4

• Cyclosporine (often used in 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 containing active substances 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 containing the active substance cobicistat

• Amiodarone (used to treat irregular heart rhythm)

• 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, serious genetic cholesterol disorders)

• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). Adverse effects affecting muscles may be greater when this medicine is taken during treatment with simvastatin. Your doctor may decide that you should stop taking simvastatin temporarily

• Colchicine (used to treat gout)

• Ticagrelor (an antiplatelet medicine)

• Ribociclib (used to treat breast cancer)

• Palbociclib (used to treat breast cancer)

As with the medicines listed above, inform 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 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 inform any doctor prescribing you a new medicine that you are taking simvastatin.

Taking Simvastatina Stada with food, drinks, and alcohol

Simvastatin can be taken with or without food.

Grapefruit juice should be avoided during treatment with simvastatin, as this juice increases simvastatin concentrations in the blood.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Simvastatin is contraindicated during pregnancy.

If you become pregnant or suspect pregnancy, you must stop treatment and inform your doctor immediately.

Do not take simvastatin if you are breastfeeding, as it is unknown 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 experience symptoms of dizziness, do not drive or operate machinery until you know how you react to the medicine.

Simvastatina Stada contains lactose

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

3. How to take Simvastatin Stada

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, 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 earlier.

Before starting to take simvastatin, you must be on a cholesterol-lowering diet.

Dosage

The recommended dose is one tablet once daily by oral administration.

Adults

The recommended starting dose is 10 to 40 mg once daily, taken as a single dose in the evening.

After at least 4 weeks, your doctor may adjust your dose up to a maximum of 80 mg daily, taken as 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 disease-related problems who have not reached 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 in the evening. The recommended maximum daily dose is 40 mg.

Elderly patients

Dose adjustment is not necessary.

Method of administration

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

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

The tablet's score line is only intended to facilitate splitting 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, contact your doctor or pharmacist immediately and/or call the Poison Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Simvastatin Stada

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

Take the next dose at your usual time.

If you have any further 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 everyone experiences them.

The following terms are used to describe how frequently 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).

If any of the serious adverse effects listed below occur, stop taking the 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 to pressure, muscle weakness, or muscle cramps. In rare cases, these muscle problems can be severe, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.
• hypersensitivity (allergic) reactions including:
  • swelling of the face, tongue, and throat, which may cause difficulty breathing (angioedema)
  • severe muscle pain, usually in the shoulders and hips
  • skin rash associated with weakness of the limb and neck muscles
  • joint pain or inflammation (polymyalgia rheumatica)
  • inflammation of blood vessels (vasculitis)
  • unusual bruising, skin rashes, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flushes
  • difficulty breathing (dyspnoea) 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 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 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 the breast in males)

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 and visual impairment
• gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)
• skin rash, itching, hair loss
• weakness
• sleep disorders (very rare)
• memory impairment (very rare), memory loss, confusion.

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

• erectile dysfunction
• depression
• lung inflammation causing breathing problems 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 sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• persistent muscle pain, tenderness, or weakness, which may not resolve after stopping simvastatin treatment (frequency not known).

Additional tests

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

Reporting of adverse effects:

If you experience any type of 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 Stada

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

Store in the original packaging.

Do not use Simvastatin Stada after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Simvastatin Stada

The active substance is simvastatin.

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

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

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

The other components (excipients) are lactose, microcrystalline cellulose, pregelatinized corn starch, butylated hydroxyanisole (E320), magnesium stearate, talc, hypromellose, hydroxypropylcellulose and titanium dioxide (E171).

Appearance of the product and contents of the pack

Simvastatin Stada 10 mg is presented as film-coated tablets, white, oblong, biconvex, with a notch on one side. The tablets are marked with “SVT” on the side without the notch and with “10” on the notched side. Each pack contains 28 or 500 tablets (clinical pack).

Simvastatin Stada 20 mg is presented as film-coated tablets, white, oblong, biconvex, with a notch on one side. The tablets are marked with “SVT” on the side without the notch and with “20” on the notched side. Each pack contains 28 or 500 tablets (clinical pack).

Simvastatin Stada 40 mg is presented as film-coated tablets, white, oblong, biconvex, with a notch on one side. The tablets are marked with “SVT” on the side without the notch and with “40” on the notched side. Each pack contains 28 or 500 tablets (clinical pack).

Only certain pack 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 most recent review of this leaflet: March 2026

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/