PATIENT INFORMATION LEAFLET

Simvastatina ALMUS??0 mgfilm-coated tablets

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. See section 4.

6. Contents of the pack and additional information

Simvastatina Almus is a medication used to reduce total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain types of fat called triglycerides in the blood. Additionally, Simvastatina Almus increases the levels of "good" cholesterol (high-density lipoprotein, HDL). Simvastatina Almus is a member of a class of medications called statins.

Cholesterol is one of the fatty substances found in the bloodstream. Its total cholesterol is primarily 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 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 cardiovascular disease.

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

This medicationis used, along with a cholesterol-reducing diet, if you have:

• elevated levels of cholesterol in the blood (primary hypercholesterolemia) or elevated levels offat 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 Almus can prolong your life by reducing the risk of cardiovascular problems, regardless of the amount of cholesterol in your blood.

In most people, there are no 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 Almus 40 mg if:

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

• You have active liver disease or have 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).
• Protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used to treat HIV infections that cause AIDS).
• Nefazodone (medicine used to treat depression).
• Boceprevir or telaprevir (used to treat hepatitis C infection).
• Cobicistat.
• Gemfibrozil (used to reduce cholesterol).
• Ciclosporin (used in patients who have undergone organ transplantation).
• 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, 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 Simvastatina Almus if you are taking lomitapida (used to treat rare and severe genetic cholesterol disorders).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Simvastatina Almus:

• All your medical problems, 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 an operation. You may need to stop taking the Simvastatina Almus tablets for a short period,
• 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 myasthenic eye disease (a condition that causes weakness of the eye muscles), as statins sometimes worsen the condition or cause myasthenia (see section 4).

Your doctor will make a blood test before you start taking Simvastatina Almus and also if you have any symptoms of liver problems while taking Simvastatina Almus. 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 Simvastatina 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 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 unexplained muscle pain, tenderness or weakness. This is because, in rare cases, muscle problems can be severe, including kidney failure; and very rarely, deaths have occurred.

The risk of muscle failure is higher with high doses of Simvastatina 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 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 efficacy and safety of Simvastatina Almus 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. How to take Simvastatina Almus). Simvastatina Almus has not been studied in children under 10 years old. For more information, consult your doctor.

Use of simvastatin with other medicines

Inform your doctor or pharmacist if you are using, or have recently used, any other medicine, including those bought 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 above section "Do not take Simvastatina Almus"); in these cases, you may need to change the dose or stop taking one of them.

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

• If you need to take fusidic acid orally to treat a bacterial infection, you will temporarily need to stop taking this medicine. Your doctor will tell you when you can restart treatment with Simvastatina Almus. The use of Simvastatina Almus with fusidic acid rarely may causemuscle weakness, sensitivity or pain (rhabdomyolysis). For more information on 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, 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),
• Protease inhibitors for HIV, such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat HIV infections that cause AIDS),
• Antivirals for hepatitis C, such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C infection),
• Nefazodone (used to treat depression),
• Medicines 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 conditions),
• Lomitapida (used to treat rare and severe genetic cholesterol disorders),
• Daptomycin (a medicine used to treat skin and skin structure infections and bacteremia). It is possible that the muscle-related side effects may be greater when this medicine is taken during treatment with simvastatin (e.g. Simvastatina Almus). Your doctor may decide that you should stop taking Simvastatina Almus for a time,
• Colchicine (used to treat gout).

As with the medicines mentioned above, inform your doctor or pharmacist if you are taking or have recently taken other medicines, including those bought 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 must also inform any doctor who prescribes a new medicine that you are taking Simvastatina Almus.

Taking Simvastatina Almus 40 mg with food and drinks:

Simvastatina Almus can be taken with or without food.

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

Simvastatina should be administered with caution in patients who consume alcohol. If you drink alcohol regularly, 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 if you are 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 your ability to drive or use machines. However, if you experience 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 told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

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

Dosage:

The recommended dose is 1 simvastatina 40 mg tablet 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 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 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, your current treatment, and your personal risk situation.

Tablets should be taken at night and can be administered with water or with or without food.

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

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

If you estimate that the action 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 the nearest hospital.

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 ingested.

If you forget to take Simvastatina Almus 40 mg:

Do not take a double dose to compensate for the missed doses, wait for the next scheduled dose.

If you interrupt treatment with Simvastatina Almus:

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

Like all medicines, Simvastatina Almus 40 mg 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 people).
• Very rare (may affect up to 1 in 10,000 people).
• 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 rare side effects have been reported:

• Muscle pain, sensitivity to pressure, weakness or muscle cramps. In rare cases, these muscle problems can be severe, including muscle failure that causes kidney damage; and very rarely, deaths have occurred.
• Severe 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,
• Joint pain or inflammation (polymyalgia rheumatica),
• Inflammation of blood vessels (vasculitis),
• Atypical hematomas, skin rash, and swelling (dermatomyositis), urticaria, skin sensitivity 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 insufficiency (very rare).
• Pancreatitis, often with severe abdominal pain.

The following very rare serious side effects have been reported:

• A severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction),
• Rash that can occur on the skin or ulcers in the mouth (drug-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 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 the arms or legs that worsens after periods of activity, double vision or 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 that may not disappear after stopping treatment with Simvastatina Almus (frequency not known).

Additional tests:

Rare: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, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use. Website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging.

Expiration Date

Do not useSimvastatina Almus 40 mgafter the expiration date indicated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointofthe pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Simvastatina Almus

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

- The other components (excipients) are:Lactose anhydrous, microcrystalline cellulose, pregelatinized cornstarch, butylated hydroxyanisole (E320), magnesium stearate, talc, hydroxypropyl cellulose, hypromellose, titanium dioxide (E171).

Appearance of the product and content of the packaging

Simvastatina Almus40 mg is presented in the form of white, oblong, biconvex tablets, coated with a film. The tablets are engraved with “SVT” on one side and scored and engraved with “40” on the other. Each package contains 28 tablets.

Other presentations

Simvastatina ALMUS 10 mg film-coated tablets.

Simvastatina ALMUS 20 mg film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible for manufacturing:

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

Date of the last review of this prospectus:April 2023

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