Package Insert: Information for the Patient

Simvastatina Alter 10 mg Film-Coated Tablets

Simvastatina Alter 20 mg Film-Coated Tablets

Simvastatina Alter 40 mg Film-Coated Tablets

Simvastatina

Read this package insert carefully before starting to take this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Simvastatina Altercontains the active ingredient simvastatina. Simvastatina Alter is a medication used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Simvastatina Alter increases the levels of "good" cholesterol (HDL cholesterol). Simvastatina 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 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 make blood flow to vital organs such as the heart and brain slower or interrupted. 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 heart disease.

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.

Simvastatina Alter 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 Alter may prolong your life by reducing the risk of heart 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 Alter

• 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 ingredients:

• Itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections).
• Erythromycin, clarithromycin, or telithromycin (used to treat infections).
• Protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir, and saquinavir (protease inhibitors for HIV are 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).
• 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 within 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 Simvastatina Alter may cause severe 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 unsure if your medicine is on the above list.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Simvastatina Alter.

Inform your doctor:

• About 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 simvastatin 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 may sometimes worsen the disease or cause myasthenia (see section 4).

Your doctor will do a blood test before you start taking simvastatin and also if you have any symptoms of liver problems while taking simvastatin. 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 taking simvastatin.

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 muscle failure that causes kidney damage; and very rarely, deaths have occurred.

The risk of muscle failure is higher with high doses of simvastatin, 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 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 simvastatin treatment were 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 Simvastatina Alter). Simvastatina has not been studied in children under 10 years of age. For more information, consult your doctor.

Simvastatina Alter with other medicines

Inform your doctor if you are taking, have taken recently, or may need to take any other medicine with any of the following active ingredients. Taking simvastatina with any of the following medicines may increase the risk of muscle problems (some of these are already included in the section above "Do not take Simvastatina Alter").

• 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 the treatment with Simvastatina Alter. The use of Simvastatina Alter with fusidic acid rarely may cause muscle 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).
• Antivirals for hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C infection).
• Nefazodone (used to treat depression).
• Medicines with the 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).
• Lomitapide (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 simvastatin treatment. Your doctor may decide that you should stop taking Simvastatina Alter for a time,
• Colchicine (used to treat gout).
• Ticagrelor (antiplatelet medicine).

As with the medicines mentioned above, inform your doctor or pharmacist if you are taking or have taken recently other medicines, even those purchased 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 a new medicine that you are taking simvastatin.

Simvastatina Alter with food, drinks, and alcohol

Orange juice contains one or more components that alter how the body uses some medicines, including simvastatin. You should avoid consuming orange juice.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Simvastatina Alter 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 Simvastatina Alter, stop taking it immediately and inform your doctor. Do not take Simvastatina Alter if you are breastfeeding, as it is unknown whether this medicine passes into breast milk.

Consult your doctor or pharmacist before using anymedicine.

Driving and operating machines

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

Simvastatina Alter contains lactose

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

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

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

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

Dosage:

The recommended dose is 10 mg, 20 mg, or 40 mg of simvastatin 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.

Method of administration:

Take simvastatin at night. You can take it with or without food. Continue taking simvastatin tablets until your doctor tells you to stop.

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

If you take more Simvastatina Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone: 91 562 04 20.

If you forgot to take Simvastatina Alter

Do not take a double dose to make up for the missed doses. The next day, take your usual amount of simvastatin at the usual time.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

If you interrupt treatment with Simvastatina Alter

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

If you have any other questions about the use of this product, 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 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 side effects have been reported:Rare:

• Muscle pain, pressure sensitivity, weakness, or muscle cramps. In rare cases, these muscle problems can be severe, including muscle failure leading to kidney damage; and very rarely, deaths have occurred.
• 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)
  • Atypical hematomas, skin rash, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flashes
  • Difficulty breathing (dyspnea) and general discomfort
  • 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 insufficiency (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 (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 and 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 information (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.

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, elevated liver function (transaminases) and muscle enzyme (creatine kinase) levels were observed.

Reporting side effects

If you experience any type of side effect, consult your doctor, 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 the Pharmacovigilance of Medicines for Human Use:https://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 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 above30°C.

Store in the original packaging.

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

Composition of Simvastatina Alter

• The active ingredient issimvastatina. Each tablet contains10 mg, 20 mg or 40 mg of simvastatina.

The other components are: butylhydroxyanisole (E320), citric acid, ascorbic acid, microcrystalline cellulose, pregelatinized cornstarch, lactose, crospovidone, magnesium stearate, hypromellose, titanium dioxide (E171), triacetin. See section 2Simvastatina Alter contains lactose.

Appearance of the product and contents of the packaging

Simvastatina Alter 10 mgis presented in the form of film-coated, biconvex tablets, white in color. It is presented in packs of 28 tablets.

Simvastatina Alter 20 mg is presented in the form of film-coated, biconvex tablets, white in color. It is presented in packs of 28 tablets.

Simvastatina Alter 40 mg is presented in the form of film-coated, biconvex tablets, white in color. It is presented in packs of 28 tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036, Madrid

Spain

Responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036, Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880, Meco (Madrid)

Spain

Last review date of this leaflet: March 2024.

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/