Zocor 20

PATIENT INFORMATION LEAFLET

Enclosed leaflet: patient information

ZOCOR 10, 10 mg, film-coated tablets

ZOCOR 20, 20 mg, film-coated tablets

ZOCOR 40, 40 mg, film-coated tablets

Simvastatin

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

• You should 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

• 1. What Zocor is and what it is used for
• 2. Before you take 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 used to lower the level of cholesterol in the blood, particularly in people with high cholesterol levels or people with a high risk of heart disease.

Cholesterol is one of several fats found in the blood. Total cholesterol is mainly made up of LDL (bad) cholesterol and HDL (good) cholesterol.

LDL cholesterol can build up in the walls of the arteries forming plaques. Eventually, these plaques can cause the arteries to narrow, reducing or blocking the blood flow to important organs such as the heart and brain. Reduced blood flow can lead to a heart attack or stroke.

HDL cholesterol helps prevent the buildup of LDL cholesterol 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 follow a low-cholesterol diet.

Zocor is used as an adjunct to diet in the following conditions:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• a hereditary condition (homozygous familial hypercholesterolemia) that causes high levels of cholesterol in the blood. Other treatments may also be used;
• heart disease (coronary heart disease) or a high risk of heart disease (due to diabetes, a history of stroke, or other blood vessel diseases). Zocor may help prolong life by reducing the risk of heart disease, regardless of cholesterol levels.

Most people do not experience symptoms of high cholesterol levels. Your doctor can assess your cholesterol levels with a simple blood test. You should have regular check-ups, monitor your cholesterol levels, and discuss your treatment goals with your doctor.

2. Before you take Zocor

Do not take Zocor

• 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 any of the following medicines: o itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections), o erythromycin, clarithromycin, or telithromycin (used to treat infections), o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infection), o boceprevir or telaprevir (used to treat hepatitis C), o nefazodone (used to treat depression), o cobicistat,
• if you are currently taking or have taken in the last 7 days a medicine called fusidic acid (used to treat bacterial infections) orally or by injection. Taking fusidic acid with Zocor can cause serious muscle problems (rhabdomyolysis). Do not take Zocor at a dose greater than 40 mg if you are taking lomitapide (used to treat a rare genetic cholesterol disorder).

If you are unsure if you are taking any of the above medicines, consult your doctor.

Warnings and precautions

Tell your doctor:

• about any medical conditions, including allergies,
• if you drink large amounts of alcohol,
• if you have had liver disease in the past. Zocor may not be suitable for you.
• if you are scheduled for surgery. You may need to stop taking Zocor for a short time.
• if you are of Asian origin, as a different dose may be suitable for you.
• if you have or have had muscle weakness (myasthenia) or eye muscle weakness (ocular myasthenia), as statins can sometimes worsen the condition or cause myasthenia (see section 4).

Your doctor should perform a blood test before starting Zocor and during treatment if you have liver problems. The test will check your liver function.

Your doctor may also perform blood tests to check your liver function after starting Zocor.

During treatment, your doctor will closely monitor your health if you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure.

Tell your doctor about any serious lung diseases.

Contact your doctor immediately if you experience

unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems can be serious, including muscle breakdown, which can cause kidney damage, and in very rare cases, death.

• if you drink large amounts of alcohol,
• if you have kidney problems,
• if you have thyroid problems,
• if you are 65 years or older,
• if you are female,
• if you have had muscle problems while taking cholesterol-lowering medicines called statins or fibrates,
• if you or a close relative have had muscle problems.

If you experience muscle weakness, tell your doctor or pharmacist. You may need additional tests and treatments.

Children and adolescents

The safety and efficacy of Zocor have been studied in boys aged 10-17 years and girls who have had their first period at least one year before (see section 3). Zocor has not been studied in children under 10 years old. Consult your doctor for more information.

Zocor with other medicines

Tell your doctor about all medicines you are taking, including those you have bought without a prescription, and any you plan to take.

• If you need to take fusidic acid by mouth to treat a bacterial infection, you may need to stop taking Zocor temporarily. Your doctor will tell you when it is safe to restart Zocor.

Taking Zocor with fusidic acid can, in rare cases, cause muscle weakness, tenderness, or pain (rhabdomyolysis).

Additional information on rhabdomyolysis can be found in section 4.

• cyclosporin (often used in patients who have had organ transplants),
• danazol (a synthetic hormone used to treat endometriosis, a condition where the lining of the womb grows outside the womb),
• medicines containing the active substances itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates containing the active substances gemfibrozil or bezafibrate (used to lower cholesterol levels),
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS),
• antiviral medicines used to treat hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir,
• nefazodone (used to treat depression),
• medicines containing the active substance cobicistat,
• amiodarone (used to treat irregular heartbeats),
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain, or other heart conditions),
• lomitapide (used to treat a rare genetic cholesterol disorder),
• daptomycin (used to treat complicated skin and soft tissue infections and bacteremia). It is possible that muscle side effects may be greater when this medicine is taken with simvastatin (e.g., Zocor). Your doctor may decide to stop Zocor for a while,
• colchicine (used to treat gout),
• tikagrelor (an antiplatelet medicine).

You should also tell your doctor or pharmacist about any other medicines you have taken recently, including those you have bought without a prescription, especially:

• medicines that prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants),
• fenofibrate (also used to lower cholesterol levels),
• niacin (also used to lower cholesterol levels),
• rifampicin (used to treat tuberculosis).

You should also inform any doctor who prescribes you a new medicine that you are taking Zocor.

Zocor with food and drink

Grapefruit juice contains one or more compounds that affect the activity of some medicines in the body, including Zocor. You should avoid drinking grapefruit juice.

Pregnancy and breastfeeding

Do not take Zocor if you are pregnant, planning to become pregnant, or think you may be pregnant. If you become pregnant while taking Zocor, stop treatment and consult your doctor. Do not take Zocor while breastfeeding, as it is not known whether the medicine is excreted in breast milk. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Zocor does not affect the ability to drive or use machines. However, you should be aware that some people may experience dizziness after taking Zocor.

Zocor contains lactose

Zocor tablets contain a sugar called lactose. If you have been told that you have an intolerance to some sugars, consult your doctor before taking Zocor.

3. How to take Zocor

Your doctor will determine the dose of Zocor that is right for you, depending on your current treatment and individual risk factors.

This medicine should always be taken exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

While taking Zocor, you should follow a low-cholesterol diet.

Dosage:

The recommended dose is 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg of simvastatin, taken orally once a day.

Adults:

The initial dose is 10 mg, 20 mg, or in some cases 40 mg per day. Your doctor may adjust the dose after at least 4 weeks of treatment to a maximum of 80 mg per day. Do not take more than 80 mg per day.

Your doctor may recommend lower doses, especially if you are taking certain medicines or have kidney problems.

A dose of 80 mg is only recommended for adults with very high cholesterol levels and a high risk of heart disease who have not reached their target cholesterol level on lower doses.

Use in children and adolescents:

For children (aged 10-17 years), the recommended initial dose is 10 mg once daily in the evening. The maximum recommended dose is 40 mg per day.

Method of administration:

Zocor should be taken in the evening. You can take Zocor with or without food. You should continue to take Zocor until your doctor tells you to stop.

If your doctor has prescribed Zocor 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

• Consult your doctor or pharmacist.

If you forget to take Zocor

• Do not take a double dose to make up for a forgotten dose. Take your next dose of Zocor at the usual time the next day.

If you stop taking Zocor

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following terms are used to describe the frequency of side effects:

• 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 you experience any of the following serious side effects, stop taking Zocor and contact your doctor immediately or go to the emergency department at your nearest hospital.

The following serious side effects have been reported rarely:

• muscle pain, tenderness, or weakness, which can be serious and cause kidney damage, and in very rare cases, death,
• allergic reactions (hypersensitivity) such as swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema), severe muscle pain, usually in the shoulders and hips, rash with weakness of the limbs and neck, joint pain or inflammation, inflammation of blood vessels (vasculitis), unusual bruising, skin rash, and swelling (dermatomyositis), hives, sensitivity to sunlight, fever, flushing, shortness of breath (dyspnea), and feeling unwell,
• liver inflammation with symptoms of yellowing of the skin and eyes, itching, dark urine, or pale stools, fatigue, or weakness, loss of appetite, liver failure (very rare),
• pancreatitis, often with severe abdominal pain.

The following very rare serious side effects have been reported:

• a severe allergic reaction that can cause difficulty breathing or dizziness (anaphylaxis),
• a skin rash that can occur on the skin or ulcers in the mouth (drug-induced lupus),
• muscle rupture,
• breast enlargement in men (gynecomastia).

The following side effects have also been reported rarely:

• reduced red blood cell count (anemia),
• numbness or weakness of the hands and feet,
• headache, feeling of tingling, dizziness,
• blurred vision; vision problems,
• gastrointestinal problems (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting),
• skin rash, itching, hair loss,
• weakness,
• sleep disturbances (very rare),
• memory loss (very rare), confusion.

The following side effects have also been reported, but their frequency is not known:

• erectile dysfunction,
• depression,
• lung inflammation that can cause breathing problems, including persistent cough and (or) shortness of breath or fever, tendon problems, sometimes complicated by tendon rupture,
• myasthenia gravis (a condition that causes muscle weakness, including muscles used for breathing),
• ocular myasthenia (a condition that causes weakness of the eye muscles).

Consult your doctor if you experience weakness of the arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Additional possible side effects that have been reported with some statins:

• sleep disturbances, including nightmares,
• sexual problems,
• diabetes. The development of diabetes is more likely in people with high levels of sugar and fats in the blood, who are overweight, or have high blood pressure. Your doctor will monitor your health during treatment with this medicine,
• muscle pain, tenderness, or weakness that may not resolve after stopping Zocor (frequency not known).

Laboratory test results

Increased levels of muscle enzymes (creatine kinase) in the blood and abnormal liver function test results have been observed.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder.

5. How to store Zocor

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

Store in a cool, dry place, below 30°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zocor contains

• The active substance is simvastatin. Each film-coated tablet contains 10 mg, 20 mg, or 40 mg of simvastatin.
• The other ingredients are: Core:butylhydroxyanisole, ascorbic acid, citric acid monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate, lactose monohydrate. Coating: hypromellose, hydroxypropylcellulose, titanium dioxide, talc, iron oxide red, iron oxide yellow (in Zocor 10 and Zocor 20 tablets).

What Zocor looks like and contents of the pack

Available packs:

• Zocor 10, Zocor 40 - PVC/PE/PVDC/Al blisters in a carton containing 28 film-coated tablets.
• Zocor 20 - PVC/PE/PVDC/Al blisters in a carton containing 28 or 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warszawa
Tel. (+48) 22 105 50 01
organonpolska@organon.com

Manufacturer/Importer

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Date of last revision of the leaflet: