SIMVASTATIN ALMUS 10 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Simvastatin ALMUS??10 mgfilm-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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 and other information

1. What is Simvastatin Almus 10 mg and what is it used for
2. What you need to know before taking Simvastatin Almus 10 mg
3. How to take Simvastatin Almus 10 mg
4. Possible side effects
5. Storage of Simvastatin Almus 10 mg
6. Pack contents and further information

1. What is Simvastatin Almus 10 mg and what is it used for

Simvastatin Almus is a medicine used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Simvastatin Almus increases the levels of "good" cholesterol (HDL cholesterol). Simvastatin Almus belongs to a group of medicines called statins.

Cholesterol is one of the fatty substances that are found in the bloodstream. Your total cholesterol level is made up mainly of LDL cholesterol and HDL cholesterol.

LDL cholesterol is often referred to as "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this buildup of plaque can cause your arteries to narrow, which can lead to a reduction or interruption of 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 building up in your arteries and protects against heart disease.

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

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

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

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fatty substances in the blood (mixed hyperlipidemia),
• a hereditary disease (homozygous familial hypercholesterolemia) 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 blood vessel disease).

Simvastatin Almus may 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 taking Simvastatin Almus 10 mg

Do not take Simvastatin Almus 10 mg if:

• You are allergic to simvastatin or any of the other ingredients of Simvastatin Almus (listed in section 6. Pack contents and further information).
• You have active liver disease or elevated transaminases.
• You are pregnant or breastfeeding.
• You are taking one of the following medicines:

• Itraconazole or ketoconazole, posaconazole or voriconazole (medicines used to treat fungal infections).
• Erythromycin, clarithromycin or telithromycin (used to treat infections).
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used to treat HIV infections that cause AIDS).
• Nefazodone (a medicine used to treat depression).
• Boceprevir or telaprevir (used to treat hepatitis C virus infection).
• Cobicistat.
• Gemfibrozil (used to reduce cholesterol).
• Cyclosporine (used in patients with organ transplants).
• Danazol (a synthetic hormone used to treat endometriosis, a disease 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) orally 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 Almus 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 Simvastatin Almus:

• about all your medical problems, including allergies,
• if you consume significant amounts of alcohol,
• if you have ever had liver disease. Simvastatin Almus may not be suitable for you,
• if you are scheduled for surgery. You may need to stop taking Simvastatin Almus 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 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 perform a blood test before you start taking Simvastatin Almus and also if you have any symptoms of liver problems while taking Simvastatin Almus. This is to check how well your liver is working.

Your doctor may also want to perform blood tests to check how well your liver is working after you start treatment with Simvastatin Almus.

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 that cannot be explained. 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 higher with high doses of Simvastatin Almus, 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 apply to you:

• you consume 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 relative have a hereditary muscle problem.

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Tests and additional medications may be necessary to diagnose and treat this problem.

Children and adolescents

The efficacy and safety of treatment with Simvastatin Almus 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. How to take Simvastatin Almus). Simvastatin Almus has not been studied in children under 10 years of age. For more information, consult your doctor.

Use of simvastatin with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Certain medicines may interact with simvastatin and may increase the risk of muscle problems (some of these are already included in the "Do not take Simvastatin Almus" section); in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

It is essential that you inform your doctor if you are taking or have recently taken any of the following medicines:

• if you need to take oral fusidic acid to treat a bacterial infection, you will temporarily need to stop using this medicine. Your doctor will tell you when you can restart treatment with Simvastatin Almus. The use of Simvastatin Almus with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• cyclosporine (used in transplant patients),
• danazol (a synthetic hormone used to treat endometriosis, a disease 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),
• 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 ingredient 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). The adverse effects that affect the muscles may be greater when this medicine is taken during treatment with simvastatin (such as Simvastatin Almus). Your doctor may decide that you should stop taking Simvastatin Almus for a while,
• colchicine (used to treat gout).

As well as the medicines listed above, inform your doctor or pharmacist if you are taking or have recently taken other medicines, including those obtained without a prescription. 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 you a new medicine that you are taking Simvastatin Almus.

Taking Simvastatin Almus 10 mg with food and drinks:

Simvastatin Almus can be taken with or without food.

Grapefruit juice increases the levels of simvastatin in the blood. You should avoid consuming grapefruit juice while taking simvastatin.

Simvastatin should be administered with caution in patients who consume alcohol. If you regularly drink alcohol, consult your doctor.

Pregnancy and breastfeeding

Do not take Simvastatin Almus if you are pregnant, if you are trying to become pregnant, or if you think you may be pregnant. If you become pregnant while taking Simvastatin Almus, stop taking it immediately and inform your doctor. Do not take Simvastatin Almus if you are breastfeeding, as it is not known whether this medicine passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

At normal doses, simvastatin does not affect the ability to drive or use machines. However, if you notice symptoms of dizziness, do not drive or use machines until you know how the medicine affects you.

Simvastatin Almus 10 mg contains lactose

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

3. How to take Simvastatin Almus 10 mg

Follow the instructions for administration of Simvastatin Almus exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Dosage:

The recommended dose is 1 tablet of simvastatin 10 mg once a day orally.

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 indicated 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 administered in a single dose in the evening. The maximum recommended daily dose is 40 mg.

Method of administration:

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

The tablets should be taken in the evening and can be administered with water or with or without food.

Continue taking Simvastatin Almus until your doctor tells you to stop.

If your doctor has prescribed Simvastatin Almus along with another cholesterol-lowering medicine that contains a bile acid sequestrant, you should take Simvastatin Almus at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you think the action of Simvastatin 10 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more Simvastatin Almus 10 mg than you should

If you have taken more Simvastatin 10 mg than you should, contact your doctor or pharmacist or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Simvastatin Almus 10 mg

Do not take a double dose to make up for forgotten doses, wait for the next dose.

If you interrupt treatment with Simvastatin Almus

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

4. Possible Adverse Effects

Like all medicines, Simvastatina Almus 10 mg 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 people).
• Very rare (may affect up to 1 in 10,000 people).
• 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 rare adverse effects have been reported:

• Muscle pain, pressure sensitivity, 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 muscles of the limbs and neck,
• Pain or inflammation of the joints (polymyalgia rheumatica),
• Inflammation of the blood vessels (vasculitis),
• Atypical bruising, skin rashes, and swelling (dermatomyositis), urticaria,

Skin sensitivity to sunlight, fever, hot flashes,

• 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, itching, dark 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 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,
• Lung inflammation that causes 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 that, 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,
• Constant muscle pain, sensitivity, or weakness that may not disappear after stopping treatment with Simvastatina Almus (frequency not known).

Complementary tests:

Rarely:in some blood tests, elevations of liver function (transaminases) and a muscle enzyme (creatine kinase) were observed.

Reporting of Adverse Effects

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

5. Conservation of Simvastatina Almus 10 mg

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

Store in the original packaging.

Expiration Date

Do not use Simvastatina Almus 10 mg after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewage system or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Simvastatina Almus

• The active ingredient is simvastatin: Each tablet contains 10 mg of simvastatin.
• The other components (excipients) are: Anhydrous lactose, microcrystalline cellulose, pregelatinized corn starch, butylhydroxyanisole (E320), magnesium stearate, talc, hydroxypropylcellulose, hypromellose, titanium dioxide (E171).

Appearance of the Product and Package Contents

Simvastatina Almus 10 mg is presented in the form of white, oblong, biconvex film-coated tablets. The tablets are engraved with "SVT" on one side and scored and engraved with "10" on the other. Each package contains 28 tablets.

Other Presentations

Simvastatina ALMUS 20 mg film-coated tablets EFG.

Simvastatina ALMUS 40 mg film-coated tablets EFG.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

SYNTHON HISPANIA, S.L., C/ Castelló, 1. Polígono Las Salinas. 08830 Sant Boi de Llobregat (Spain)

Date of the Last Revision of this Prospectus:April 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.