Package Leaflet: Information for the User

Simvastatina NORMON 40 mg Film-Coated Tablets

Read this 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 or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before you take Simvastatina NORMON

3. How to take Simvastatina NORMON

4. Possible side effects

5. Storage of Simvastatina NORMON

6. Contents of the pack and additional information

Simvastatina NORMON contains the active ingredient simvastatina. This medication is used to reduce total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain fatty substances called triglycerides that circulate in the blood. It also increases the levels of "good" cholesterol (high-density lipoprotein, HDL). This medication Simvastatina NORMON belongs to a class of medications called statins.

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

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 make blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can cause a myocardial infarction or a 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 cardiovascular disease.

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

This medication is used, 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 hyperlipidemia).

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 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 NORMON

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

• If you currently have liver problems.

• If you are pregnant or breastfeeding.

• If 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)

HIV protease inhibitors 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 who have had an organ transplant)

danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus)

• If you have taken, been given, 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 simvastatin can cause severe muscle problems (rhabdomyolysis).

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Inform your doctor:

• Of all your medical problems, 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 due to have an operation. You may need to stop taking the simvastatin tablets for a short 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 generalised muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (a condition that causes weakness of the eye muscles), as statins can sometimes worsen the condition or cause myasthenia (see section 4).

Your doctor will do a blood test before you start taking this medicine and also if you have any symptoms of liver problems while taking this medicine. 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 taking this medicine.

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 pain, sensitivity to pressure, or unexplained muscle weakness. This is because, in rare cases, muscle problems can be severe, including muscle failure which causes kidney damage; and very rarely, deaths have occurred.

The risk of muscle failure is greater with high doses of simvastatin, especially with the 80 mg dose. The risk of muscle failure is also greater 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 simvastatin treatment were 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 has not been studied in children under 10 years old. For more 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 taken recently, or may need to take any other medicine. Taking simvastatin with any of the following medicines

may increase the risk of muscle problems (some of which are already included in the section

above "Do not take Simvastatina NORMON").

• if you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can start taking simvastatin again. The use of simvastatin with fusidic acid rarely can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

• ciclosporin (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 ingredient such as itraconazole, ketoconazole, fluconazole, or posaconazole or voriconazole (used to treat fungal infections)

• fibrates with an active ingredient 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 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 the active ingredient 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 cholesterol disorders),

daptomycin (a medicine used to treat skin and skin structure infections and bacteremia). It is possible that the muscle side effects may be greater when this medicine is taken during treatment with simvastatin. Your doctor may decide that you should stop taking this medicine for a time

• colchicine (used to treat gout).

• ticagrelor (antiplatelet medicine).

As well as with the medicines listed above, inform your doctor if you are taking medicines with any of the following active ingredients:

• medicines with an active ingredient 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 a new medicine that you are taking simvastatin

Taking Simvastatina NORMON with food and drinks

Orange juice contains one or more components that affect how the body uses some medicines, including this medicine. You should avoid consuming orange juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 if you are breastfeeding because 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 interfere with your ability to drive or use machines. However, some people may experience dizziness after taking simvastatin

Simvastatina NORMON contains lactose.

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

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

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

Before starting to take this medication, you must be following a diet to reduce cholesterol.

Dosage:

The recommended dose is 1 tablet 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 if you 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.

Use in children and adolescents:

In 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 this medication at night. You can take it with or without food. Continue taking it until your doctor tells you to stop.

If your doctor has prescribed simvastatin along with another cholesterol-lowering medication that contains a bile acid sequestrant, you should 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone 91 562 04 20) indicating the medication and the amount taken.

If you forgot to take Simvastatina NORMON

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

If you interrupt treatment with Simvastatina NORMON

Speak with 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 patients)

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

• Frequency not known (cannot be estimated from available data).

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

Severe side effects have been reported as follows:

Severe side effects have been reported as follows:Rare:

• Muscle pain, sensitivity to pressure, 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)

Unusual bruises, skin rash, and swelling (dermatomyositis), urticaria,

Sensitivity of the skin 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;
• Acute liver failure (very rare)
• Pancreatitis, often with intense abdominal pain.

Very rare severe side effects have been reported as follows:

• 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; visual disturbances,
• 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 data (frequency not known):

• Impotence
• 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 your arms or legs that worsens after periods of activity, double vision, or eyelid drooping, difficulty swallowing, or difficulty breathing.

Additional side effects reported with some statins:

• Sleep disorders, including nightmares
• Sexual dysfunction

• 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 simvastatin treatment (frequency not known).

Additional tests

In some blood tests, elevated liver function (transaminases) and muscle enzyme (creatine kinase) levels were observed.

Reporting side effects

If you experience any type of side effect, consult your doctor or 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 Usehttps://www.notificaram.es.By reporting side effects, you can contribute toproviding more information about the safety of this medicine.

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

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.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and the

medications that you no longer need at the SIGRE pointof the pharmacy. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. This will help protect the environment.

Composition of Simvastatina NORMON

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

The other components (excipients) are: pregelatinized cornstarch, microcrystalline cellulose, lactose monohydrate, butylhydroxyanisole (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 packaging

Simvastatina NORMON is presented in the form of film-coated tablets, pink in color, round, biconvex, and scored. Each package contains 28 tablets.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

Other presentations

Simvastatina NORMON 10 mg film-coated tablets EFG

Simvastatina NORMON 20 mg film-coated tablets EFG

Date of the last review of this prospectus:April 2023

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

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the prospectus and packaging. You can also access this information at the following internet address:

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