SIMVASTATIN TECNIGEN 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Simvastatin TecniGen 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Simvastatin TecniGen and what is it used for
2. What you need to know before you take Simvastatin TecniGen
3. How to take Simvastatin TecniGen
4. Possible side effects
5. Storage of Simvastatina TecniGen

1. Contents of the pack and further information

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

Simvastatin TecniGen contains the active substance simvastatin. Simvastatin TecniGen is a medicine used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and substances called triglycerides that circulate in the blood. Additionally, Simvastatin TecniGen increases the levels of "good" cholesterol (HDL cholesterol). Simvastatin TecniGen belongs to a group of medicines called statins.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is mainly made up 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 buildup of plaque can cause your arteries to narrow. This narrowing can slow down or block the blood flow to vital organs such as the heart and brain. This blockage of blood flow 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 them from heart disease.

Triglycerides are another type of fat in your blood that can increase the risk of heart disease.

While taking this medicine, you should follow a cholesterol-reducing diet.

Simvastatin TecniGen is indicated, along with a cholesterol-reducing diet, if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fatty substances in the blood (mixed dyslipidemia)

• a hereditary disease (homozygous familial hypercholesterolemia), 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 blood vessel disease). Simvastatin TecniGen may prolong your life by reducing the risk of heart problems, regardless of the amount 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 TecniGen

Do not take Simvastatin TecniGen if:

• you are allergic to simvastatin or 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 with 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 disease in which the inner lining of the uterus grows outside the uterus)
• if you are taking or have taken, in the last 7 days, a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Simvastatin TecniGen can cause serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of Simvastatin TecniGen if you are taking lomitapide (used to treat rare and severe 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 starting to take Simvastatin TecniGen.

Tell your doctor:

• about all your medical problems, including allergies,
• if you consume large amounts of alcohol,
• if you have ever had liver disease. Simvastatin TecniGen may not be suitable for you,
• if you are scheduled for surgery. You may need to stop taking Simvastatin TecniGen tablets for a short period of time,
• if you are Asian, as you may need a different dose.
• if you have or have had myasthenia (a disease that causes generalized 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).

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

Your doctor may also want to perform blood tests to check how well your liver is working after you start treatment with Simvastatin TecniGen.

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 pain, tenderness, or unexplained muscle weakness. This is because, in rare cases, muscle problems can be serious, including muscle failure, which can cause kidney damage; and very rarely, deaths have occurred.

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

• you consume 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-reducing medicines called "statins" or fibrates,
• you or a close relative have a hereditary muscle problem.

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

Children and adolescents

The efficacy and safety of treatment with Simvastatin 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 before (see section 3). Simvastatin TecniGen has not been studied in children under 10 years of age. For more information, consult your doctor.

Other medicines and Simvastatin TecniGen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Taking Simvastatin TecniGen with some of the following medicines may increase the risk of muscle problems (some of these are already included in the "Do not take Simvastatin TecniGen" section).

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Simvastatin TecniGen. The use of Simvastatin with fusidic acid can cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

It is important to tell your doctor if you are taking or have recently taken any of the following medicines:

• Cyclosporine (often used in organ 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 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).
• Antivirals for hepatitis C such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection).
• Nefazodone (used to treat depression).
• Medicines with 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 diseases)
• Lomitapide (used to treat rare and severe genetic cholesterol disorders).
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteremia). The adverse effects that affect the muscles may be greater when this medicine is taken during treatment with simvastatin (such as Simvastatin TecniGen). Your doctor may decide that you should stop taking Simvastatin TecniGen for a while.
• Colchicine (used to treat gout).

As well as the medicines listed above, tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. In particular, tell your doctor if you are taking medicines with any of the following active substances:

• medicines with an active substance to prevent blood clots, 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 tell any doctor who prescribes you a new medicine that you are taking Simvastatin TecniGen.

Taking Simvastatin TecniGen with food, drinks, and alcohol

Grapefruit juice contains one or more components that alter how the body uses some medicines, including Simvastatin TecniGen.

Pregnancy, breastfeeding, and fertility:

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

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines:

Simvastatin TecniGen is not expected to interfere with your ability to drive or use machines. However, it should be noted that some people experience dizziness after taking Simvastatin TecniGen.

Simvastatin TecniGen 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.

Simvastatin TecniGen contains Orange Yellow S (E-110) and Ponceau 4R. It may cause allergic reactions.

3. How to take Simvastatin TecniGen

Your doctor will determine the appropriate dose of Simvastatin TecniGen for you, depending on your condition, current treatment, and personal risk situation.

Follow exactly the administration instructions of this medicine indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Before starting to take Simvastatin TecniGen, you should be following a cholesterol-reducing diet.

Dosage

The recommended dose is 10 mg, 20 mg, or 40 mg of simvastatin once a day by mouth.

Adults:

The usual starting dose is 10, 20, 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 medicines indicated 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.

Children and adolescents

In children and adolescents aged 10 to 17 years, the recommended daily starting dose is 10 mg, in the evening. The maximum recommended daily dose is 40 mg.

Method of administration:

Take Simvastatin TecniGen in the evening. You can take it with or without food. Continue taking Simvastatin TecniGen until your doctor tells you to stop.

If your doctor has prescribed Simvastatin TecniGen along with another cholesterol-reducing medicine that contains a bile acid sequestrant, 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 or pharmacist or the nearest hospital.

In case of overdose or accidental ingestion, consult 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 forgotten doses. The next day, take your normal dose of Simvastatin TecniGen at the usual time.

If you stop taking Simvastatin TecniGen

Talk to your doctor or pharmacist because your cholesterol may rise again.

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).

The following serious rare 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 emergency department of the nearest hospital.

• Muscle pain, sensitivity to pressure, weakness, or muscle cramps. In rare cases, these muscle problems can be serious, including muscle failure, which can cause kidney damage; and very rarely, deaths have occurred.
• Hypersensitivity reactions (allergic) that include:
• • 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 limb and neck muscles,
  • 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 discomfort,
  • 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 very rare adverse effects have been reported:

• 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, 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 that, 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 disturbances, including insomnia and nightmares
• Sexual problems

• Diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Constant muscle pain, sensitivity, or weakness that may not disappear after stopping treatment with Simvastatina TecniGen (frequency not known).

Complementary tests

In some blood tests, elevations of liver function and 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 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: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Simvastatina TecniGen

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

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

Do not use this medicine after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packages and medicines you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Simvastatina TecniGen

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

The other components (excipients) are: lactose monohydrate (32.92 mg), pregelatinized starch, microcrystalline cellulose, butylhydroxyanisole, 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), yellow sunset lake (E110)

Appearance of the Product and Package Contents

Simvastatina Tecnigen 40 mg is presented in the form of film-coated tablets, oblong, and salmon-colored. The tablets are packaged in transparent PVC/Alu blisters. Each package contains 20, 28, 30, 60, or 500 tablets. Not all presentations 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) ESPAÑA

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 approved in the EEA Member States under the following names:

Spain: Simvastatina TecniGen

Date of the Last Revision of this Leaflet: August 2023

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