SIMVASTATIN NORMON 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Simvastatin NORMON 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 or pharmacist.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Simvastatin NORMON and what is it used for
2. What you need to know before you take Simvastatin NORMON
3. How to take Simvastatin NORMON
4. Possible side effects
5. Storage of Simvastatin NORMON
6. Contents of the pack and further information

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

Simvastatin NORMON contains the active substance simvastatin. This medicine is used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and a type of fat called triglycerides in the blood. It also increases the levels of "good" cholesterol (HDL cholesterol). This medicine Simvastatin NORMON 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 can lead to a narrowing of the arteries. This narrowing can slow down or block the blood flow to vital organs such as the heart and brain. This blockage 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 against heart disease.

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

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

This medicine is used, along with a low-cholesterol diet, if you have:

High levels of cholesterol in the blood (primary hypercholesterolaemia) or high levels of fats in the blood (mixed hyperlipidaemia).

A hereditary disease (homozygous familial hypercholesterolaemia) that 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 diseases of the blood vessels). Simvastatin can 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 NORMON

Do not take Simvastatin NORMON

• If you are allergic to simvastatin or any of the other ingredients of 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 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 lining of the uterus grows outside the uterus)

• If you are taking, have taken, or have been given, in the last 7 days, a medicine that contains fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and simvastatin can cause serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of simvastatin 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 this medicine.

Tell your doctor:

• About all your medical problems, including allergies.
• If you drink large amounts of alcohol.
• If you have ever had liver disease. Simvastatin may not be suitable for you.

if you are scheduled to have an operation. You may need to stop taking simvastatin tablets for a short time.

• If you are Asian, as you may need a different dose.
• If you have or have had myasthenia (a disease that causes generalised 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 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 treatment with 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 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 muscle pain, tenderness, or 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 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 apply to you:

• you drink 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-lowering medicines called "statins" or fibrates
• you or a close family member have a hereditary muscle disorder.

Also, tell your doctor or pharmacist if you experience persistent muscle weakness. You may need further tests and additional medicines to diagnose and treat 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 had their first menstrual period (menstruation) at least one year before (see section 3). Simvastatin has not been studied in children under 10 years. For more information, consult your doctor.

Other medicines and Simvastatin NORMON

Taking Simvastatin NORMON with other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking simvastatin 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 Simvastatin NORMON").

• cyclosporine (often used in transplant patients)
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the lining of the uterus grows outside the uterus)

medicines with an active substance such as itraconazole, ketoconazole, fluconazole, or posaconazole or voriconazole (used to treat fungal infections)

• fibrates with an active substance 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 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). It is possible that the adverse effects that affect the muscles may be greater when this medicine is taken during simvastatin treatment. Your doctor may decide that you should stop taking this medicine for a while

• colchicine (used to treat gout)
• ticagrelor (antiplatelet medicine)

As well as the medicines listed above, 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

Taking Simvastatin NORMON with food and drinks

Grapefruit juice contains one or more components that alter how the body uses some medicines, including this medicine. You should avoid drinking grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 not known whether this medicine passes into breast milk.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Simvastatin is not expected to affect your ability to drive or use machines. However, it should be taken into account that some people experience dizziness after taking simvastatin

Simvastatin NORMON contains lactose

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

3. How to take Simvastatin NORMON

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

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

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

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 medicines mentioned above 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 problems who have not reached 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, in the evening. The maximum recommended daily dose is 40 mg.

Method of administration:

Take this medicine in the evening. 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 medicine 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 Simvastatin NORMON than you should

In case of overdose or accidental ingestion, consult 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 Simvastatin NORMON

Do not take a double dose to make up for forgotten doses. The next day, take your normal dose of this medicine at the usual time.

If you stop taking Simvastatin NORMON

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 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 following serious adverse effects occur, stop taking the medicine and

inform your doctor immediately or go to the emergency department of the nearest hospital.

The following serious adverse effects have been reported rarely:

• muscle pain, sensitivity to pressure, weakness, or muscle cramps. In rare cases, these muscle problems can be serious, including muscle failure leading to kidney damage; and very rarely, deaths have occurred.
• hypersensitivity reactions (allergic) including:

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,

sensitivity of the skin to sunlight, fever, hot flashes

difficulty breathing (dyspnea) and general malaise

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 adverse effects have been reported very rarely:

• 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; visual disturbance,
• digestive disorders (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 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, which 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 disorders, including nightmares
• sexual dysfunction

• diabetes. This is more likely if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• persistent muscle pain, sensitivity, or weakness that may not disappear after stopping treatment with simvastatin (frequency not known).

Complementary tests

In some blood tests, elevations of liver function (transaminases) and a muscle enzyme (creatine kinase) have been observed.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them

directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Simvastatina NORMON

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

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Simvastatina NORMON

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

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 Package Contents

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

Marketing Authorization Holder and 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 Revision of this Prospectus:April 2023

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

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