Simvastatin Almus 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Simvastatin ALMUS 40 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Simvastatin Almus 40 mg is and what it is used for

2. What you need to know before taking Simvastatin Almus 40 mg

3. How to take Simvastatin Almus 40 mg

4. Possible side effects

5. How to store Simvastatin Almus 40 mg

6. Contents of the pack and other information

1. What Simvastatina Almus 40 mg is and what it is used for

Simvastatina Almus is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, Simvastatina Almus increases levels of "good" cholesterol (HDL cholesterol). Simvastatina Almus belongs to a group 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 cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This interruption in blood flow can lead to 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 continue to follow a cholesterol-lowering diet.

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

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high blood levels of fatty substances (mixed hyperlipidemia),
• an inherited disease (homozygous familial hypercholesterolemia) which increases cholesterol levels in the blood. You may also receive other treatments,
• coronary heart disease (CHD) or are at high risk of coronary heart disease (because you have diabetes, a history of stroke, or other blood vessel disease).

Simvastatina Almus 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 Almus 40 mg

Do not take Simvastatina Almus 40 mg if:

You are allergic to simvastatin or to any of the other components of Simvastatina Almus (listed in section 6. Contents of the pack and other information).

• You have active liver disease or elevated transaminases.

• You are pregnant or breastfeeding.

• You are taking any 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 infection that causes AIDS).

• Nefazodone (a medicine used to treat depression).

• Boceprevir or telaprevir (used to treat hepatitis C virus infection).

• Cobicistat.

• Gemfibrozil (used to lower 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 or have taken, within the last 7 days, a medicine containing fusidic acid (used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and simvastatin may cause serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of Simvastatina Almus 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 Simvastatina Almus:

• About all your medical conditions, including allergies,
• If you consume large amounts of alcohol,
• If you have ever had liver disease. Simvastatina Almus may not be suitable for you,
• If you are scheduled for surgery. You may need to stop taking Simvastatina Almus tablets for a short period of time,
• 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, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since 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 Simvastatina Almus and also if you develop any symptoms of liver problems while taking Simvastatina Almus. 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 Simvastatina Almus.

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 sugar and fats in the blood, are overweight, or have high blood pressure.

Inform your doctor if you have a severe 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 leading to kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is higher with higher doses of Simvastatina Almus, especially with the 80 mg dose. The risk of muscle breakdown is also greater 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 ever had 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 condition.

Children and adolescents

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

Taking simvastatin with other medicines

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

Certain medicines may interact with simvastatin and increase the risk of muscle problems (some of these are already listed in the section above “Do not take Simvastatina Almus”); in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

It is important 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 taking this medicine. Your doctor will advise you when you can restart treatment with Simvastatina Almus. Using Simvastatina Almus with fusidic acid may rarely 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 lower cholesterol),

• Erythromycin, clarithromycin or telithromycin (used to treat bacterial infections),

• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS),

• Hepatitis C antivirals 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). Adverse effects affecting muscles may be increased when this medicine is taken during treatment with simvastatin (e.g., Simvastatina Almus). Your doctor may decide that you should temporarily stop taking Simvastatina Almus,

• Colchicine (used to treat gout),

• Ribociclib (used to treat breast cancer),

• Palbociclib (used to treat breast cancer).

As with the medicines listed above, inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• Medicines used to prevent blood clots, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants),
• Fenofibrate (also used to lower cholesterol),
• Niacin (also used to lower cholesterol),
• Rifampicin (used to treat tuberculosis).

You should also inform any doctor who prescribes you a new medicine that you are taking Simvastatina Almus.

Taking Simvastatina Almus 40 mg with food and drink:

Simvastatina Almus can be taken with or without food.

Grapefruit juice increases the concentration of simvastatin in the blood. Consumption of grapefruit juice should be avoided during treatment with simvastatin.

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

Pregnancy and breastfeeding

Do not take Simvastatina Almus if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Simvastatina Almus, stop taking it immediately and inform your doctor. Do not take Simvastatina Almus 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

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

Simvastatina Almus 40 mg contains lactose

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

3. How to take Simvastatina Almus 40 mg

Follow exactly the instructions for use of Simvastatina Almus as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Dosage:

The recommended dose is 1 simvastatin 40 mg tablet once daily by oral administration.

Adults:

The usual starting dose is 10 mg, 20 mg, 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 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 achieved 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 administered as a single dose in the evening. The maximum recommended daily dose is 40 mg.

Method of administration:

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

The tablets should be taken at night and may be taken with water, with or without food.

Continue taking Simvastatina Almus for as long as your doctor tells you to.

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

If you feel that the effect of Simvastatina 40 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Simvastatina Almus 40 mg than you should

If you have taken more Simvastatina 40 mg than you should, contact your doctor or pharmacist or go to the nearest hospital.

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

If you forget to take Simvastatina Almus 40 mg

Do not take a double dose to make up for forgotten doses. Wait until your next scheduled dose.

If you stop taking Simvastatina Almus

Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

4. Possible adverse effects

Like all medicines, Simvastatina Almus 40 mg can cause adverse effects, although not everyone experiences them.

The following terms are used to describe how frequently the 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 serious adverse effects listed below occur, stop taking the medicine immediately and contact your doctor or go to the nearest hospital emergency department without delay.

The following rare serious adverse effects have been reported:

• Muscle pain, tenderness, weakness, or cramps. In rare cases, these muscle problems may be severe and include muscle breakdown leading to kidney damage; and 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 weakness of the muscles in the limbs and neck,
  • joint pain or inflammation (polymyalgia rheumatica),
  • inflammation of blood vessels (vasculitis),
  • atypical 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 urine, pale stools, feeling tired or weak, loss of appetite; liver failure (very rare).

• Inflammation of the pancreas, often with severe abdominal pain.

The following very rare serious adverse effects have been reported:

• Severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction),
• Skin rash or mouth ulcers (drug-induced lichenoid eruptions),
• Muscle rupture,
• Gynecomastia (enlargement of breast tissue in men).

Rarely, the following adverse effects have also been reported:

• Low red blood cell count (anaemia),
• Numbness or weakness in the 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 data their frequency cannot be estimated (frequency not known):

• Erectile dysfunction,
• Depression,
• Lung inflammation causing breathing problems including persistent cough and/or difficulty breathing or fever,
• Tendon problems, sometimes complicated by tendon rupture,
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the 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 blood sugar and fats, are overweight, or 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 treatment with Simvastatina Almus (frequency not known).

Additional tests:

• Rare: In some blood tests, increased liver function (transaminases) and increased levels of a muscle enzyme (creatine kinase) have been observed.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin Almus 40 mg

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

Store in the original packaging.

Expiry

Do not use Simvastatin Almus 40 mg after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Simvastatin Almus

• The active substance is simvastatin: Each tablet contains 40 mg of simvastatin.
• The other components (excipients) are: Anhydrous lactose, microcrystalline cellulose, pregelatinized corn starch, butylated hydroxyanisole (E320), magnesium stearate, talc, hydroxypropylcellulose, hypromellose, titanium dioxide (E171).

Appearance of the product and contents of the pack

Simvastatin Almus 40 mg is presented as white, oblong, biconvex, film-coated tablets. The tablets are marked with “SVT” on one side and scored and marked with “40” on the other. Each pack contains 28 tablets.

Other presentations

Simvastatin Almus 10 mg film-coated tablets EFG.

Simvastatin Almus 20 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

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

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

Date of the most recent review of this leaflet: February 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.