Package Insert: Information for the User

Simvastatina TecniGen 40 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Simvastatina TecniGen contains the active ingredient simvastatina. Simvastatina TecniGen is a medication used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides that circulate in the blood. Additionally, Simvastatina TecniGen increases the levels of "good" cholesterol (HDL cholesterol). Simvastatina TecniGen is a member of a class of medications called statins.

Cholesterol is one of the fatty substances found in the bloodstream. Its total cholesterol is composed mainly of LDL and HDL cholesterol.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can slow down or interrupt blood flow to vital organs such as the heart and brain. This interruption of blood flow can cause a heart attack or stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects them from cardiovascular diseases.

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

While taking this medication, you must follow a cholesterol-reducing diet.

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

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

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

• coronary heart disease (CHD) or if you have a high risk of coronary heart disease (because you have diabetes, a history of stroke, or other vascular disease). Simvastatina TecniGen may prolong your life by reducing the risk of cardiovascular problems, regardless of the amount of cholesterol in your blood

Most people do not have immediate symptoms of high cholesterol. Your doctor may measure your cholesterol with a simple blood test. Visit your doctor regularly, monitor your cholesterol, and discuss your goals with your doctor.

Do not take Simvastatina Tecnigen if:

• you are allergic to simvastatin or any of the other ingredients in 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 ingredients:

• Itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections).
• Erythromycin, clarithromycin, or telithromycin (used to treat infections).
• Protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections).
• Boceprevir or telaprevir (used to treat hepatitis C infection).
• Nefazodone (used to treat depression).
• Cobicistat
• Gemfibrozil (used to reduce cholesterol).
• Ciclosporin (used in patients with organ transplants).
• 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 taking or have taken, in the last 7 days, a medicine that contains fusidic acid, (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and Simvastatina TecniGen may cause severe muscle problems (rhabdomyolysis).

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Simvastatina TecniGen.

Inform your doctor:

• of all your medical problems, 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 an operation. You may need to stop taking the Simvastatina TecniGen tablets for a short period of time,
• if you are of Asian origin, as you may need a different dose.
• if you have or have had myasthenia (a condition that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenic eye (a condition that causes weakness of the eye muscles), as statins may sometimes worsen the condition or cause myasthenia (see section 4).

Your doctor will do a blood test before you start taking Simvastatina TecniGen and also if you have any symptoms of liver problems while taking Simvastatina TecniGen. 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 Simvastatina 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 your blood, are overweight, and have high blood pressure.

Inform your doctor if you have a severe lung disease.

Consult your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems can be severe, including muscle failure that causes kidney damage; and very rarely, deaths have occurred.

The risk of muscle failure is higher with high doses of Simvastatina 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 affect you:

• you consume large amounts of alcohol,
• you have kidney problems,
• you have thyroid problems,
• you are 65 years or older,
• you are a woman,
• you have ever had muscle problems during treatment with cholesterol-lowering medicines called "statins" or fibrates,
• you or a close relative have a hereditary muscle disorder.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this problem.

Children and adolescents

The effectiveness and safety of Simvastatina TecniGen treatment were studied in boys aged 10 to 17 years and in girls who had their first menstrual period (menstruation) at least one year earlier (see section 3). Simvastatina TecniGen has not been studied in children under 10 years old. For more information, consult your doctor.

Other medicines and Simvastatina TecniGen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Taking Simvastatina TecniGen with some 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 fusidic acid orally to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Simvastatina TecniGen.

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

• Ciclosporin (often used in 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 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 reduce cholesterol).
• Erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections).
• Protease inhibitors for HIV, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections).
• Antivirals for hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C infection).
• Nefazodone (used to treat depression).
• Medicines with an active ingredient such as 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 diseases).
• Lomitapida (used to treat rare and severe genetic cholesterol disorders).
• Daptomycin (a medicine used to treat skin and skin structure infections and bacteremia). It is possible that the muscle-related side effects may be greater when this medicine is taken during treatment with simvastatin (such as Simvastatina TecniGen). Your doctor may decide that you should stop taking Simvastatina TecniGen for a time.
• Colchicine (used to treat gout).

As well as with the medicines mentioned above, inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. In particular, inform your doctor if you are taking medicines with any of the following active ingredients:

• medicines with an active ingredient to prevent blood clot formation, 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 a new medicine that you are taking Simvastatina TecniGen.

Simvastatina TecniGen with food, drinks, and alcohol

Orange juice contains one or more components that affect how the body uses some medicines, including Simvastatina TecniGen.

Pregnancy, lactation, and fertility:

If you are pregnant or breastfeeding, or think you may be 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 may 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 operating machinery:

Simvastatina TecniGen is not expected to interfere with your ability to drive or operate machinery. However, some people may experience dizziness after taking Simvastatina TecniGen.

Simvastatina TecniGen contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult your doctor before taking this medicine.

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting to take Simvastatina TecniGen, you must be following a diet to reduce cholesterol.

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 medications indicated earlier 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 problems who have not achieved their cholesterol goal with lower doses.

Children and adolescents

In children and adolescents aged 10 to 17 years, the recommended daily starting dose for treatment is 10 mg, at night. The maximum recommended daily dose is 40 mg.

Method of administration:

Take Simvastatina TecniGen at night. You can take it with or without food. Continue taking Simvastatina TecniGen until your doctor tells you to stop.

If your doctor has prescribed Simvastatina TecniGen along with another cholesterol-lowering medication that contains a bile acid sequestrant, you must take Simvastatina TecniGen at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Simvastatina TecniGen than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 0420.

If you forgot to take Simvastatina TecniGen

Do not take a double dose to make up for the missed doses. The next day, take your usual amount of Simvastatina TecniGen at the usual time.

If you interrupt treatment with Simvastatina TecniGen

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following terms are used to describe how often side 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 available data).

The following serious rare side effects have been reported:

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

• Muscle pain, pressure sensitivity, weakness, or muscle cramps. In rare cases, these muscle problems can be severe, including muscle failure leading to kidney damage; and very rarely, deaths have occurred.
• Allergic reactions (hypersensitivity) that include:
• • Swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema),
  • Intense 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 hematomas, skin rash, 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),
• 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 insufficiency (very rare).
• Pancreatitis, often with intense abdominal pain.

The following serious very rare side effects have been reported:

• A severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction).
• Rash that can occur on the skin or ulcers in the mouth (medication-induced lichenoid eruptions)
• Muscle rupture.
• Gynecomastia (breast enlargement in men).

Rarely, the following side 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 deterioration.
• Digestive problems (abdominal pain, constipation, gas, indigestion, diarrhea, nausea, vomiting),
• Skin rash, itching, hair loss,
• Weakness,
• Sleep problems (very rare),
• Poor memory (very rare), memory loss, confusion.

The following side effects have also been reported, but the frequency cannot be estimated from the available information (frequency not known):

• Erectile dysfunction,
• Depression,
• Lung inflammation that causes breathing problems, including persistent cough and/or difficulty breathing or fever,
• Tendon problems, sometimes complicated by tendon rupture.
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

Possible additional side effects reported with some statins:

• Sleep disturbances, including insomnia and nightmares
• Sexual problems

• Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while 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 in liver function and a muscle enzyme (creatine kinase) were observed.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 25 °C. Store in the original packaging.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Simvastatina TecniGen

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

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), sunset yellow lake (E110)

Appearance of the product and content of the packaging

Simvastatina TecniGen 40 mg is presented in the form of 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.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

TECNIMEDE ESPAÑA, Pharmaceutical Industry, S.A.

Avda. de Bruselas, 13, 3rd D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing:

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

Last review date of this leaflet: August 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es