ZOCOR 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the user

Zocor10mg film-coated tablets

Zocor20mg film-coated tablets

Simvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Zocor and what is it used for
2. What you need to know before you take Zocor
3. How to take Zocor
4. Possible side effects
5. Storing Zocor

1. Contents of the pack and other information

1. What is Zocor and what is it used for

Zocor contains the active substance simvastatin. Zocor is a medicine used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and a type of fat called triglycerides in the blood. It also increases the levels of "good" cholesterol (HDL cholesterol). Zocor belongs to a group of medicines called statins.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol level 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 can lead to a narrowing of the arteries, which can reduce or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can cause 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 found in the blood that can increase the risk of heart disease.

While taking this medicine, you should maintain a cholesterol-lowering diet.

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

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia),
• a hereditary disease (homozygous familial hypercholesterolemia) that increases the level of cholesterol in the blood. You may also receive other treatments,
• coronary heart disease (CHD) or if you are at high risk of coronary heart disease (because you have diabetes, a history of stroke, or other blood vessel diseases). Zocor may prolong your life by reducing the risk of heart problems, regardless of the amount of cholesterol in your blood.

In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, monitor your cholesterol, and discuss your goals with your doctor.

2. What you need to know before you take Zocor

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),
• 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),
  • 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 lower 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 containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Zocor can cause serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of Zocor if you are taking lomitapida (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

Tell your doctor:

• about all your medical problems, including allergies,
• if you drink large amounts of alcohol,
• if you have ever had liver disease. Zocor may not be suitable for you,
• if you are scheduled for surgery. You may need to stop taking Zocor tablets for a short time,
• if you are Asian, as you may need a different dose,
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness that can affect 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 Zocor and 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 perform blood tests to check how well your liver is working after you start treatment with 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 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 greater with higher doses of Zocor, especially with the 80 mg dose. The risk of muscle failure is also greater in certain patients. Talk to your doctor if any of the following situations apply to you:

• you drink 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-lowering medicines called "statins" or fibrates,
• you or a close relative have a hereditary muscle disorder.

Also, tell your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medications may be necessary to diagnose and treat this problem.

Children and adolescents

The efficacy and safety of treatment with Zocor have been studied in boys aged 10 to 17 years and in girls who had their first menstrual period at least one year before (see section 3. How to take Zocor). Zocor has not been studied in children under 10 years of age. For more information, consult your doctor.

Taking Zocor 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 Zocor with certain medicines can increase the risk of muscle problems (some of these are already included in the "Do not take Zocor" section above).

• 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 Zocor.Taking Zocor 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 ingredient used to treat fungal infections, such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole,
• fibrates with an active ingredient 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),
• 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 ingredient 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 diseases),
• lomitapida (used to treat rare and severe genetic cholesterol disorders),
• daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteremia). The risk of side effects that affect the muscles may be greater when this medicine is taken during treatment with simvastatin (e.g., Zocor). Your doctor may decide that you should stop taking Zocor 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 ingredients:

• medicines with an active ingredient 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 tell any doctor who prescribes you a new medicine that you are taking Zocor.

Taking Zocor with food and drinks

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

Pregnancy and breastfeeding

Do not take Zocor 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 Zocor, stop taking it immediately and inform your doctor. Do not take Zocor if you are breastfeeding because it is not known whether this medicine passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Zocor is not expected to interfere with your ability to drive or use machines. However, it should be noted that some people experience dizziness after taking Zocor.

Zocor contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Zocor

Your doctor will determine the appropriate dose of Zocor 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 Zocor, you should be following a cholesterol-lowering 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 mentioned 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 Zocor in the evening. 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 medicine that contains a bile acid sequestrant, you should 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, contact the Toxicology 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 forgotten doses. The next day, take your normal dose of Zocor at the usual time.

If you stop taking Zocor

• talk to your doctor or pharmacist because your cholesterol levels 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 often 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, tenderness, 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 the breast 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; visual disturbance,
• 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, which can cause 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 possible 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, tenderness, or weakness that may not disappear after stopping treatment with Zocor (frequency not known).

Complementary tests

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is 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 Zocor

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

Do not use this medicine after the expiration date that appears on the packaging after CAD.

Do not store above 30°C. Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE 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 ofZocor

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

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

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

Appearance of the Product and Package Contents

10 mg simvastatin tablet: film-coated tablet, peach-colored, oval, engraved with "MSD 735" on one side and unmarked on the other.

20 mg simvastatin tablet: film-coated tablet, tan-colored, oval, engraved with "MSD 740" on one side and unmarked on the other.

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

This medicine is authorized in the Member States of the European Economic Area under the following names:

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

ZOCORD in: Austria and Sweden.

SINVACOR in: Italy.

Date of the last revision of this leaflet:07/2023.

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