Label:information for the user

Zocor10film-coated tablets

Zocor20film-coated tablets

Simvastatina

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, 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 label. See section 4.

6. Contents of the pack and additional information

Zocorcontains the active ingredient simvastatin. Zocoris a medication used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally,Zocorincreases the levels of "good" cholesterol (HDL cholesterol).Zocoris a member of a class of medications called statins.

Cholesterol is one of the fatty substances found in the bloodstream. Its total cholesterol is composed mainly 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 cardiovascular diseases.

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.

Zocor is used, along with a cholesterol-reducing diet, if you have:

• elevated levels of cholesterol in the blood (primary hypercholesterolemia) or elevated levels in the blood ofother fatty substances (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). Zocorcan prolong your life by reducing the risk of cardiovascular 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 Zocor

• if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine (listed in section 6. Contents of the pack and other information for healthcare professionals),
• if you have liver problems currently,
• 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),
  • 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 infection),
  • nefazodone (used to treat depression),
  • cobicistat,
  • gemfibrozil (used to reduce cholesterol),
  • ciclosporin (usedin 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 7days, a medicine that contains fusidic acid, (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid andZocormay cause severe muscle problems (rhabdomyolysis).

Do not take more than 40mg of Zocorif 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

Inform your doctor:

• of all your medical problems, including allergies,
• if you consume large amounts of alcohol,
• if you have ever had liver disease. Zocormay not be suitable for you,
• if you are scheduled for surgery. You may need to stop taking Zocortablets for a short period of time,
• if you are of Asian origin, as you may need a different dose,
• if you have or have had myasthenia (a condition that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a condition that causes weakness of the eye muscles), as statins may sometimes worsen the condition or cause myasthenia (see section4).

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

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.

The risk of muscle failure is higher with high doses of Zocor, especially with the 80mg 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 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.

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 Zocorhave 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 Zocor). Zocorhas not been studied in children under 10 years of age. For more information, consult your doctor.

Taking Zocor 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 Zocorwith 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 Zocor").

• if you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can restart the treatment withZocor. Taking Zocorwith fusidic acid rarely may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.
• 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),
• 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 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 an active ingredient such as 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),
• 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. Zocor). Your doctor may decide that you should stop taking Zocorfor 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, including 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 clotting, 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 Zocor.

Taking Zocor with food and drinks

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

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using anymedicine.

Driving and operating machinery

Zocoris not expected to interfere with your ability to drive or operate machinery. However, some people may experience dizziness after taking Zocor.

Zocor contains lactose

This medicine containslactose. 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 Zocor, 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 Zocor at night. You can take it with or without food. Continue taking Zocor until your doctor tells you to stop.

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

If you take more Zocor than you should

• in case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20, consult your doctor or pharmacist.

If you forget to take Zocor

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

If you interrupt treatment with Zocor

• 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 service.

The following serious side effects have been reported:Rare:

• Muscle pain, sensitivity to pressure, 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 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 rare:

• 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 (enlargement of breast tissue 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 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,
• 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, 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 Zocor (frequency not known).

Additional tests

In some blood tests, elevated 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, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. 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.

Do not store above 86° F. Store in the original packaging.

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

Composition ofZocor

The active ingredient is simvastatin (10mg or 20mg).

The other components are: butylhydroxyanisole (E-320), ascorbic acid (E-300), citric acid monohydrate (E-330), microcrystalline cellulose (E-460), pregelatinized cornstarch, magnesium stearate (E-572) and lactose monohydrate. The coating of the tablet contains hypromellose (E-464), hydroxypropylcellulose (E-463), titanium dioxide (E-171) and talc (E-553b).

The Zocor 10mg and Zocor 20mg tablets also contain yellow iron oxide (E-172) and red iron oxide (E-172).

Appearance of the product and contents of the package

Simvastatin 10mg tablet: coated tablet with a peach-colored film, oval, engraved with “MSD 735” on one side and unengraved on the other.

Simvastatin 20mg tablet: coated tablet with a brown-colored film, oval, engraved with “MSD 740” on one side and unengraved on the other.

Package sizes: 1, 4, 10, 14, 15, 20, 28, 30, 49, 50, 60, 98, 100 or 500tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

This medicinal product is authorized in the member states of the European Economic Area with the following names:

ZOCOR in:Belgium, Finland, France, Germany, Greece, Ireland, Luxembourg, Netherlands, Norway, Portugal, Spain andUnited Kingdom.

ZOCORD in: Austria and Sweden.

SINVACOR in: Italy.

Last review date of this leaflet:07/2023.

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