Simvastatin Tecnigen 40 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Simvastatine TecniGen 40 mg film-coated tablets EFG

Read this entire 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, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor, pharmacist, or nurse, even if the adverse reactions are not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before taking Simvastatine TecniGen

3. How to take Simvastatine TecniGen

4. Possible side effects

5. How to store Simvastatine 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 reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides in the blood. 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 mainly composed 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 may 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 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). 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 treatment 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 lower cholesterol).
  • Cyclosporine (used in organ transplant patients).
  • Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner layer 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) taken orally or by injection. 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, 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 to take 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. You may need 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 disease causing weakness of the eye muscles), since 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 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 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 treatment 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). Simvastatina TecniGen has not been studied in children under 10 years of age. For more 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 will need to stop using this medicine. Your doctor will advise you when you can restart treatment with Simvastatina TecniGen. The use of 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 patients).
• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner layer 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 the muscles may be increased when this medicine is taken during treatment with simvastatin (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 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 lower cholesterol),
• niacin (also used to lower 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 are planning 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 while 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.

Simvastatina TecniGen contains Orange Yellow S (E-110) and Ponceau 4R. These may cause allergic-type reactions.

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 provided by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting Simvastatin TecniGen, you should already be following a cholesterol-lowering diet.

Dosage

The recommended dose is 10 mg, 20 mg, or 40 mg of simvastatin once daily, taken orally.

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 daily. 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.

Children and adolescents

For children and adolescents aged 10 to 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 instructs.

If your doctor has prescribed Simvastatin TecniGen together with another cholesterol-lowering medicine containing a bile acid sequestrant, you should 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 prescribed, contact your doctor, pharmacist, or the 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 the missed dose. On the following day, take your usual dose of Simvastatin TecniGen at the regular 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 experiences 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 and inform your doctor immediately or go to the nearest hospital emergency department.

• Muscle pain, tenderness, weakness, or cramps. In rare cases, these muscle problems may be severe, including muscle breakdown (rhabdomyolysis) 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 (jaundice), itching, dark urine or pale stools, feeling tired or weak, loss of appetite; liver failure (very rare).
• Pancreatitis, 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 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 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 based on 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 your 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.

• Muscle pain, tenderness, or persistent weakness, which may not resolve after stopping treatment with Simvastatina TecniGen (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 type of adverse effect, talk to your doctor, pharmacist, or nurse, 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 Medicinal Products: 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 Point at your pharmacy. If you are in doubt, 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 Simvastatina TecniGen

The active substance is simvastatin. Each tablet contains 40 mg of simvastatin.

The other components (excipients) are: lactose monohydrate (32.92 mg), pregelatinized starch, microcrystalline cellulose, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide, polyethylene glycol 400, yellow iron oxide (E172), Ponceau 4R lake (E124), indigo carmine lake (E132), sunset yellow lake (E110).

Appearance of the medicine and contents of the pack

Simvastatina TecniGen 40 mg is presented as salmon-pink, film-coated, oblong 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 FARMACÊUTICA, S.A.

Estrada Consiglieri Pedroso, - 123 Queluz de Baixo

2734-501 Barcarena, Portugal

or

ATLANTIC PHARMA PRODUÇÕES FARMACÊUTICAS, 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: Simvastatina 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es