Package Leaflet: Information for the User

Simvastatina NORMON 10 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 start taking 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 (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. It also increases the levels of "good" cholesterol (HDL cholesterol). This medication belongs to a class of medications called statins.

Cholesterol is one of the fatty substances found in the bloodstream. Total cholesterol is mainly composed 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.

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 can 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 simvastatina or any of the other components of this medication (listed in section 6).

- If you currently have liver problems.

- If you are pregnant or breastfeeding.

- If you are taking medications with one or more of the following active ingredients:

. itraconazole, ketoconazole, or 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)

. cyclosporine (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 have taken, been given, or have taken in the last 7 days a medication containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and simvastatina may cause severe muscle problems (rhabdomyolysis).

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

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

Warnings and precautions

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

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 may not be suitable for you.

• If you are scheduled for surgery. You may need to stop taking the simvastatina 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, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

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

Your doctor may also want to make blood tests to check how well your liver is working after you start taking this medication.

While you are taking this medication, 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, overweight, and 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 can cause kidney damage; and very rarely, deaths have occurred.

The risk of muscle failure is higher with high doses of simvastatina, especially with a dose of 80 mg. 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 medications 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 medications may be necessary to diagnose and treat this problem.

Children and adolescents

The efficacy and safety of simvastatina 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 has not been studied in children under 10 years of age. For more information, consult your doctor.

Other medications Simvastatina NORMON

Taking Simvastatina NORMON with other medications. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication

Taking simvastatina with any of the following medications 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 temporarily need to stop taking this medication. Your doctor will tell you when you can restart the simvastatina treatment. The use of simvastatina with fusidic acid rarely may cause muscle weakness, sensitivity, 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),

• medications 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)

• medications with an 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 genetic cholesterol disorders),

• daptomycin (a medication used to treat skin and skin structure infections and bacteremia). It is possible that the muscle-related side effects may be greater when this medication is taken during simvastatina treatment. Your doctor may decide that you stop taking this medication for a time,

• colchicine (used to treat gout).,

• ticagrelor (antiplatelet medication).

As well as with the medications mentioned above,

inform your doctor if you are taking medications with any of the following active ingredients:

• medications 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 medication that you are taking simvastatina.

Taking Simvastatina NORMON with food and drinks

The grapefruit juice contains one or more components that alter how the body uses some medications, including this medication. You should avoid consuming grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant, or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

If you become pregnant while taking this medication, stop taking it immediately and inform your doctor. Do not take this medication if you are breastfeeding, as it is unknown whether this medication passes into breast milk.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Simvastatina NORMON contains lactose.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

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

Posology:

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 for treatment is 10 mg, at night. The maximum recommended daily dose is 40 mg.

Manner 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 simvastatina along with another cholesterol-lowering medication that contains a bile acid sequestrant, you should take simvastatina 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 compensate 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

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 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 department.

The following serious side effects have been reported:Rare:

• Muscle pain, sensitivity to pressure, weakness, or muscle cramps. In rare cases, these muscle problems can be severe, including muscle failure, which can cause kidney damage and, very rarely, death.
• 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

Pseudo-lupus 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 failure (very rare)
• Pancreatitis, often with intense abdominal pain.

The following serious side effects have been reported very rarely:

• 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:

• Anemia (low red blood cell count)
• 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, which 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, which, 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 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, which may not disappear after stopping simvastatin treatment (frequency not known).

Additional tests

In some blood tests, elevations in liver function (transaminases) and a muscle enzyme (creatine kinase) 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 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 packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Simvastatina NORMON

The active ingredient is simvastatina. Each tablet contains 10 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, of pinkish color, round, biconvex, and scored. Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Simvastatina NORMON 20 mg film-coated tablets EFG

Simvastatina NORMON 40 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 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/65200/P_65200.html