Simvastatin Tecnigen 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Simvastatina TecniGen 20 mg film-coated tablets EFG

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, pharmacist or nurse.
• 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, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if the side effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Simvastatina TecniGen contains the active substance simvastatin. Simvastatina TecniGen is a medicine used to lower blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides. In addition, Simvastatina TecniGen increases levels of "good" cholesterol (HDL cholesterol). Simvastatina TecniGen belongs to a class of medicines known as 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 must continue to follow a cholesterol-lowering diet.

Simvastatina TecniGen is indicated, 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 dyslipidemia)

• a hereditary disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments

• coronary heart disease (CHD) or if you are at high risk of coronary heart disease (due to diabetes, history of stroke, or other blood vessel diseases). Simvastatina TecniGen may prolong your life by reducing the risk of heart-related problems, regardless of your blood cholesterol levels

In most people, high cholesterol does not cause immediate symptoms. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, monitor your cholesterol levels, and discuss your target goals with your doctor.

2. What you need to know before taking Simvastatina TecniGen

Do not take Simvastatina TecniGen if:

• you are allergic to simvastatin or to any of the other ingredients of this medicine (listed in section 6).

• you currently have liver problems.

• you are pregnant or breastfeeding.

• you are taking medicines containing any 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).

• you are taking or have taken, within the last 7 days, a medicine containing fusidic acid (used to treat bacterial infection) by oral or injectable route. The combination of fusidic acid and Simvastatina TecniGen may cause serious muscle problems (rhabdomyolysis).

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Simvastatina TecniGen.

Inform your doctor:

• about all your medical conditions, including allergies,
• if you consume large amounts of alcohol,
• if you have ever had liver disease. Simvastatina TecniGen may not be suitable for you,
• if you are scheduled for surgery. It may be necessary to stop taking Simvastatina TecniGen tablets for a short period of time,
• if you are of Asian origin, as you may require a different dose.
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Your doctor will perform a blood test before you start taking Simvastatina TecniGen and also if you develop any symptoms of liver problems while taking Simvastatina TecniGen. 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 Simvastatina TecniGen.

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 blood sugar and fats, are overweight, or have high blood pressure.

Inform your doctor if you have a serious lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, 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 higher doses of Simvastatina TecniGen, especially with 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 experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Children and adolescents

The efficacy and safety of Simvastatina TecniGen 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). Simvastatina TecniGen has not been studied in children under 10 years of age. For further information, consult your doctor.

Other medicines and Simvastatina TecniGen

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Taking Simvastatina TecniGen 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 Simvastatina TecniGen”).

• If you need to take oral fusidic acid to treat a bacterial infection, you must stop taking this medicine. Your doctor will advise you when you can restart Simvastatina TecniGen. Using Simvastatina with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

It is important that you inform your doctor if you are taking, have recently taken, or might need to take any of the following medicines:

• 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 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 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 and severe 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 simvastatin treatment (e.g., Simvastatina TecniGen). Your doctor may decide that you should stop taking Simvastatina TecniGen temporarily.
• Colchicine (used to treat gout).
• Ribociclib (used to treat breast cancer).
• Palbociclib (used to treat breast cancer).

As well as the medicines listed above, inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. 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 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 who prescribes you a new medicine that you are taking Simvastatina TecniGen.

Taking Simvastatina TecniGen with food, drinks, and alcohol

Grapefruit juice contains one or more components that alter how the body processes certain medicines, including Simvastatina TecniGen.

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.

Do not take Simvastatina TecniGen if you are pregnant, trying to become pregnant, or think you might be pregnant. If you become pregnant while taking Simvastatina TecniGen, stop taking it immediately and inform your doctor. Do not take Simvastatina TecniGen if you are breastfeeding, as it is unknown whether this medicine passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

Simvastatina TecniGen 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 TecniGen.

Simvastatina TecniGen contains lactose

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

3. How to take Simvastatin TecniGen

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

Always follow exactly the instructions for use of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Dosage

The recommended dose is 10 mg, 20 mg, or 40 mg of simvastatin 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 have certain renal disorders.

The 80 mg dose is recommended only for adult patients with very high cholesterol levels and a high risk of heart disease complications who have not reached their cholesterol target with lower doses.

In children and adolescents

For children and adolescents aged between 10 and 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 Simvastatin TecniGen at night. You may take it with or without food. Continue taking Simvastatin TecniGen for as long as your doctor tells you to.

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

If you take more Simvastatin TecniGen than you should

If you have taken more Simvastatin TecniGen than you should, contact your doctor, pharmacist, or nearest hospital.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 0420.

If you forget to take Simvastatin TecniGen

Do not take a double dose to make up for a missed dose. On the following day, take your usual amount of Simvastatin TecniGen at the usual time.

If you stop taking Simvastatin TecniGen

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

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 will experience them.

The following terms are used to describe how frequently 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 rare serious adverse effects have been reported:

If any of these serious adverse effects occur, stop taking the medicine immediately and inform your doctor or go to the nearest hospital emergency department.

• Muscle pain, tenderness, weakness, or cramps. In rare cases, these muscle problems can be serious, 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 with 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,
  • 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 very rare serious 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 men).

Rarely, the following adverse effects have also been reported:

• Low red blood cell count (anaemia),
• Numbness or weakness in the arms and legs,
• Headache, tingling sensation, dizziness,
• Blurred vision, visual impairment,
• Gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, 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 from the available information, their frequency cannot be estimated (frequency not known):

• Erectile dysfunction,
• Depression,
• Lung inflammation causing breathing problems including persistent cough and/or difficulty breathing 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 disturbances, including insomnia and nightmares

• Sexual problems

• 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 Simvastatina TecniGen (frequency not known).

Additional tests

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin TecniGen

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

Do not store above 25 °C. Store in the original container.

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.

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

6. Contents of the pack and other information

Composition of Simvastatin TecniGen

The active substance is simvastatin. Each tablet contains 20 mg of simvastatin.

The other components (excipients) are: monohydrate lactose (60.46 mg), pregelatinized starch, microcrystalline cellulose, butylhydroxyanisole, ascorbic acid, citric acid monohydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol 400, yellow iron oxide (E172).

Appearance of the medicine and contents of the pack

Simvastatin TecniGen 20 mg is presented as white, film-coated tablets. The tablets are packed in transparent PVC/Alu blisters. Each pack contains 20, 28, 30, 60 or 500 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Tecnimede España, Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas (Madrid) SPAIN

Manufacturer:

IBERFAR INDUSTRIA FARMACEUTICA, S.A.
Estrada Consiglieri Pedroso, - 123 Queluz de Baixo
2734-501 Barcarena, Portugal

OR

ATLANTIC PHARMA PRODUÇOES FARMACEUTICAS, S.A.
Rua da Tapada Grande, 2 (Abrunheira. Sintra)
2710-089 - Portugal

This medicine is authorized in the EEA Member States under the following names:

Spain: Simvastatin TecniGen

Date of the most recent review of this leaflet: March 2026

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