SIMVASTATIN ALTER 40 mg FILM-COATED TABLETS

2. What you need to know before you take Simvastatin Alter

Do not take Simvastatin 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 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 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 Alter 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 Simvastatin Alter.

Tell your doctor:

• about all your medical problems, including allergies.
• if you consume large amounts of alcohol.
• if you have ever had liver disease. Simvastatin may not be suitable for you.
• if you are scheduled for surgery. You may need to stop taking simvastatin tablets for a short period.
• 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 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 perform blood tests to check how well your liver is working after you start treatment with 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 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 higher with high doses of simvastatin, 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-reducing medicines called "statins" or fibrates
• you or a close relative have a hereditary muscle problem.

Also, tell your doctor or pharmacist if you experience constant muscle weakness. You may need additional tests and medicines 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 Simvastatin Alter). Simvastatin has not been studied in children under 10 years of age. For more information, consult your doctor.

Taking Simvastatin Alter with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Taking simvastatin with some of the following medicines can increase the risk of muscle problems (some of these are already included in the "Do not take Simvastatin Alter" section).

• 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 Alter. The use of Simvastatin Alter with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Cyclosporine (often 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 substance such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections).
• Fibrates with an active substance 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 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 conditions).
• 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 treatment with simvastatin. Your doctor may decide that you should stop taking Simvastatin for a while.
• Colchicine (used to treat gout).
• Ticagrelor (an antiplatelet medicine).

As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, 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.

Simvastatin Alter with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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.

Do not take Simvastatin Alter if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Simvastatin Alter, stop taking it immediately and inform your doctor. Do not take Simvastatin Alter if you are breastfeeding, as 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 Alter is not expected to interfere with your ability to drive or use machines. However, you should be aware that some people experience dizziness after taking Simvastatin Alter.

Simvastatin Alter 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 Alter

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

Follow the instructions for taking this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

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 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, taken in the evening. The maximum recommended daily dose is 40 mg.

Method of administration:

Take simvastatin in the evening. 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-reducing medicine that contains a bile acid sequestrant, you should take the simvastatin tablets at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Simvastatin 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 forget to take Simvastatin Alter

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you stop taking Simvastatin Alter

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

If you have any further questions on the use of this product, 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 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 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 muscles of the limbs and neck
  • Pain or inflammation of the joints (polymyalgia rheumatica)
  • Inflammation of blood vessels (vasculitis)
  • Unusual 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)
• 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 breast tissue 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 and visual disturbances
• 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, causing 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 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 simvastatin (frequency not known).

Additional Tests

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

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. 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 Alter

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 any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Simvastatina Alter

• The active ingredient is simvastatin. Each tablet contains 10 mg, 20 mg, or 40 mg of simvastatin.

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

Appearance and Packaging of the Product

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

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

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

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036, Madrid

Spain

Manufacturer

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

Date of the Last Revision of this Leaflet: March 2024.

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