Simvastatin Normon 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Simvastatina NORMON 40 mg film-coated tablets EFG

Read the 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, consult your doctor or pharmacist.

This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.

If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Simvastatina NORMON contains the active substance simvastatina. This medicine is used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, it increases levels of "good" cholesterol (HDL cholesterol). Simvastatina NORMON 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 may slow down or block blood flow to vital organs such as the heart and brain. Such interruption of 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 follow a cholesterol-lowering diet.

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

Elevated levels of cholesterol in the blood (primary hypercholesterolemia) or elevated levels of fatty substances in the blood (mixed hyperlipidemia).

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 (because you have diabetes, 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 NORMON

Do not take Simvastatina NORMON

• If you are allergic to simvastatin or any of the other ingredients of this
  medicinal product (listed in section 6).
• If you currently have liver problems.
• If you are pregnant or breastfeeding.
• If 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)
protease inhibitors of HIV 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)

• If you are taking, have taken, or have been given, within the last 7 days, a medicine containing fusidic acid (used to treat bacterial infections) by oral or injectable route. 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, 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 this medicine.

Inform your doctor:

• About all your medical conditions, including allergies.
• 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.
• 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), 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 this medicine 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 this medicine.

While taking this medicine, your doctor will monitor whether you have diabetes or are at 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, although rarely, muscle problems can be serious, including muscle breakdown (rhabdomyolysis) 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 previously experienced 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 problem.

Children and adolescents

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

Other medicines and Simvastatina NORMON

Taking Simvastatina NORMON with other medicines.

Inform 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 previous section “Do not take Simvastatina NORMON”).

• If you need to take oral fusidic acid to treat a bacterial infection, you will temporarily need to stop taking this medicine. Your doctor will advise you when you can restart simvastatin treatment. Rarely, using simvastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about 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 reduce cholesterol)

• erythromycin, clarithromycin, 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 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, severe genetic cholesterol disorders)

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

• colchicine (used to treat gout)

• ticagrelor (an antiplatelet medicine)

•

As with the medicines listed above, inform your doctor if you are taking medicines containing any of the following active substances:

• medicines containing active substances 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)
• ribociclib (used to treat breast cancer)
• palbociclib (used to treat breast cancer)

You should also inform any doctor prescribing you a new medicine that you are taking simvastatin.

Taking Simvastatina NORMON with food and drink

Grapefruit juice contains one or more components that alter how the body processes certain medicines, including this one. Consumption of grapefruit juice should be avoided.

Pregnancy and breastfeeding

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.

If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor.

Do not take this medicine 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

Simvastatin is not expected to affect your ability to drive or use machines. However, you should be aware that some people may experience dizziness after taking simvastatin.

Simvastatina NORMON contains lactose.

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

3. How to take Simvastatina NORMON

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

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

Before starting to take this medicine, you should already be following a cholesterol-lowering diet.

Dosage:

The recommended dose is 1 tablet once daily by oral administration.

Adults:

The usual starting dose is 10, 20, or in some cases, 40 mg once daily. 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 medicines mentioned above or if you have certain renal disorders.

The 80 mg dose is only recommended 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.

Use in children and adolescents:

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

Method of administration:

Take this medicine at night. It can be taken with or without food. Continue taking it as long as your doctor has instructed you to do so.

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.

If you take more Simvastatina NORMON than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Simvastatina NORMON

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

If you stop taking Simvastatina NORMON

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 patients)
• Very rare (may affect up to 1 in 10,000 patients)
• 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.

The following serious rare adverse effects have been reported:

• Muscle pain, tenderness, weakness, or cramps. In rare cases, these muscle problems can be severe, including muscle breakdown leading to kidney damage; 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 muscle weakness in the limbs and neck
  joint pain or swelling (polymyalgia rheumatica)
  inflammation of blood vessels (vasculitis)
  unusual 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-colored urine or pale stools, feeling tired or weak, loss of appetite

• Liver failure (very rare)

• Pancreatitis, 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 breast tissue in men)

The following adverse effects have also been reported rarely:

• Low red blood cell count (anaemia)
• Numbness or weakness in arms and legs
• Headache, tingling sensation, dizziness
• Blurred vision; visual disturbances
• 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 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 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, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin NORMON

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

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.

Do not store above 30°C. Store in the original packaging.

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. 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 NORMON

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

The other components (excipients) are: pregelatinized corn starch, microcrystalline cellulose, monohydrate lactose, butylated hydroxyanisole (E-320), magnesium stearate, ascorbic acid, citric acid, hypromellose, titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), talc and macrogol 6000.

Appearance of the product and contents of the pack

Simvastatin NORMON is presented as film-coated tablets, pink in colour, round, biconvex and scored. Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other presentations

Simvastatin NORMON 10 mg film-coated tablets EFG

Simvastatin NORMON 20 mg film-coated tablets EFG

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/65199/P_65199.html