Zocor 20 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zocor 10 mg film-coated tablets

Zocor 20 mg 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Zocor is and what it is used for

2. What you need to know before taking Zocor

3. How to take Zocor

4. Possible side effects

5. How to store Zocor

6. Contents of the pack and other information

1. What Zocor is and what it is used for

Zocor contains the active substance simvastatin. Zocor is a medicine used to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, Zocor increases levels of "good" cholesterol (HDL cholesterol). Zocor belongs to a class of medicines known as statins.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol 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 plaque buildup can cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This interruption in blood flow may lead to 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 in your blood that may increase the risk of heart disease.

While taking this medicine, you must follow a cholesterol-lowering diet.

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

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high blood levels of fatty substances (mixed hyperlipidemia),
• an inherited disease (homozygous familial hypercholesterolemia), which increases blood cholesterol levels. You may also receive other treatments,
• coronary heart disease (CHD) or are at high risk of coronary heart disease (because you have diabetes, a history of stroke, or another blood vessel disease). Zocor may prolong your life by reducing the risk of heart-related problems, regardless of your blood cholesterol levels.

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

2. What you need to know before taking Zocor

Do not take Zocor

• if you are allergic (hypersensitive) to simvastatin or to any of the other components of this medicine (listed in section 6. Package contents and other information),
• if you currently have liver problems,
• if you are pregnant or breastfeeding,
• if you are taking medicines containing 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 lower cholesterol),
  • cyclosporine (used in organ transplant patients),
  • 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 containing fusidic acid (used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and Zocor may cause serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of Zocor if you are taking lomitapide (used to treat rare, severe genetic cholesterol disorders).

Consult your doctor if you are unsure whether your medicine is included in the list above.

Warnings and precautions

Tell your doctor:

• about all your medical conditions, including allergies,
• if you consume 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 period of time,
• if you are of Asian origin, as you may require a different dose,
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Your doctor will perform a blood test before you start taking Zocor and also if you develop any symptoms of liver problems while taking Zocor. This is to check how well your liver is functioning.

Your doctor may also want to perform blood tests to monitor liver function after you start treatment with Zocor.

While taking this medicine, your doctor will monitor you for diabetes or risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

Inform your doctor if you have a severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because, rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is higher with higher doses of Zocor, especially the 80 mg dose. The risk of muscle breakdown is also higher in certain patients. Talk to your doctor if any of the following apply to you:

• you consume large amounts of alcohol,
• you have kidney problems,
• you have thyroid problems,
• you are 65 years of age or older,
• you are female,
• you have ever had muscle problems while taking cholesterol-lowering medicines called “statins” or fibrates,
• you or a close family member have an inherited muscle disorder.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Children and adolescents

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

Taking Zocor with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicine containing any of the following active substances. Taking Zocor 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 Zocor”).

• if you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when you can restart Zocor treatment. Using Zocor with fusidic acid rarely may cause muscle weakness, tenderness or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.
• cyclosporine (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 containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections),
• fibrates containing active substances 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),
• hepatitis C antivirals such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines containing the active substance 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),
• lomitapide (used to treat rare, severe genetic cholesterol disorders),
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). Adverse effects affecting 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 temporarily,
• colchicine (used to treat gout),
• ticagrelor (an antiplatelet medicine).

As with the medicines listed above, inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• medicines containing active substances 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 inform any doctor prescribing you a new medicine that you are taking Zocor.

Taking Zocor with food and drink

Grapefruit juice contains one or more components that alter how the body processes certain medicines, including Zocor. Consumption of grapefruit juice should be avoided.

Pregnancy and breastfeeding

Do not take Zocor if 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 Zocor while 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

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

Zocor contains lactose

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

3. How to take Zocor

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment, and your individual risk situation.

Follow exactly the instructions for administration of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting to take Zocor, you should already be on a cholesterol-lowering diet.

Posology:

The recommended dose is 10 mg, 20 mg, or 40 mg of simvastatin once daily, taken orally.

Adults:

The usual starting dose is 10 mg, 20 mg, 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 daily. Do not take more than 80 mg per day.

Your doctor may prescribe lower doses, especially if you are taking certain medications 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 disease-related problems who have not reached their cholesterol target with lower doses.

Use in children and adolescents:

In children and adolescents aged between 10 and 17 years, the recommended starting daily dose is 10 mg, taken at night. The maximum recommended daily dose is 40 mg.

Method of administration:

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

If your doctor has prescribed Zocor together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must 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. Telephone: 91 562 04 20, or consult your doctor or pharmacist.

If you forget to take Zocor

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

If you stop taking Zocor

• talk to your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any further questions about 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 everyone experiences them.

The following terms are used to describe how frequently the 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 serious adverse effects listed below occur, stop taking the medicine immediately and contact your doctor or go to the nearest hospital emergency department without delay.

The following serious rare adverse effects have been reported:

• Muscle pain, tenderness to pressure, muscle weakness or cramps. In rare cases, these muscle problems may be severe, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.

• Hypersensitivity (allergic) reactions including:

  • swelling of the face, tongue and throat, which may cause difficulty breathing (angioedema),
  • severe muscle pain, usually in the shoulders and hips,
  • skin rash with weakness of the limb and neck muscles,
  • joint pain or inflammation (polymyalgia rheumatica),
  • inflammation of blood vessels (vasculitis),
  • atypical bruising, skin rashes and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, hot flushes,
  • difficulty breathing (dyspnea) and general malaise,
  • pseudolupus syndrome (including skin rash, joint disorders and effects on blood cells),

• Liver inflammation, with the following symptoms: yellowing of the skin and eyes (jaundice), itching, dark-colored urine or pale stools, feeling tired or weak, loss of appetite; liver failure (very rare).

• Inflammation of the pancreas, often with severe abdominal pain.

The following serious very rare adverse effects have been reported:

• A severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction),
• Skin rash, which may also affect the mouth (drug-induced lichenoid eruptions),
• Muscle rupture,
• Gynaecomastia (enlargement of the breasts in men).

Rarely, the following adverse effects have also been reported:

• Low red blood cell count (anaemia),
• Numbness or weakness in the arms and legs,
• Headache, tingling sensation, dizziness,
• Blurred vision; visual disturbances,
• Gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
• Skin rash, itching, hair loss,
• Weakness,
• Sleep disorders (very rare),
• Poor memory (very rare), memory loss, confusion.

The following adverse effects have also been reported, but based on available information, their frequency cannot be estimated (frequency not known):

• Erectile dysfunction,
• Depression,
• Lung inflammation causing breathing problems, including persistent cough and/or shortness of breath or fever,
• Tendon problems, sometimes complicated by tendon rupture,
• Myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects the muscles used for breathing),
• Ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs 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, or have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• Persistent muscle pain, tenderness or weakness, which may not resolve after stopping treatment with Zocor (frequency not known).

Additional tests

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

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Zocor

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

The other components 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: peach-colored, oval, film-coated tablet, engraved with “MSD 735” on one side and unmarked on the other.

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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

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

ZOCORD in: Austria and Sweden.

SINVACOR in: Italy.

Date of the most recent review of this leaflet: 07/2023.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)