Zocor 40

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 the leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Zocor is and what it is used for
• 2. Important information 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 used to lower the level of cholesterol in the blood, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides. It also increases the level of "good" cholesterol (HDL cholesterol). Zocor belongs to a group of medicines called statins.
Cholesterol is one of several fatty substances found in the blood. Total cholesterol is mainly made up of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of arteries, forming plaques. Eventually, these plaques can cause the arteries to narrow, restricting blood flow to important organs such as the heart and brain. Reduced blood flow can lead to heart attacks or strokes.
HDL cholesterol is often called "good" cholesterol because it helps prevent the buildup of bad 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 developing heart disease.
While taking this medicine, you should follow a low-cholesterol diet. Zocor is used as an adjunct to diet to reduce cholesterol levels in cases of:

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

In most people, high cholesterol does not cause any symptoms. Your doctor can assess your cholesterol levels by ordering a simple blood test. You should have regular check-ups, monitor your cholesterol levels, and discuss your treatment goals with your doctor.

2. Important information before taking Zocor

When not to take Zocor

• if you are allergic 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 certain medicines (see below).

If in doubt, 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. Taking Zocor may not be suitable.
• 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 assess liver function.
Your doctor may also perform blood tests to assess 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. The risk of developing diabetes is higher in people with high blood sugar and fat levels, overweight, and high blood pressure.
Tell your doctor about any serious lung diseases.

Immediately contact your doctor if you experience:

unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems can be serious, including muscle breakdown leading to
kidney damage, and in very rare cases, death.
The risk of muscle damage is higher when taking higher doses of Zocor, particularly the 80 mg dose. The risk of muscle breakdown is also higher in some patients. Tell your doctor if:

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

Also, tell your doctor or pharmacist if muscle weakness persists. Additional tests and medications may be needed to diagnose and treat this condition.

Children and adolescents

The safety and efficacy of Zocor have been studied in boys aged 10-17 and girls who have started menstruation (at least one year before). No studies have been conducted in children under 10. For more information, consult your doctor.

Zocor and other medicines

Tell your doctor about all medicines you are currently taking or plan to take, including those that can be obtained without a prescription, and those that contain any of the following active substances. Taking Zocor with any of the following medicines can increase the risk of muscle problems (some of which are listed above in "When not to take Zocor").

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

Taking Zocor with fusidic acid can rarely 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 in which the lining of the uterus grows outside the uterus),
• 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 HIV/AIDS),
• antiviral medicines used to treat hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C),
• 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 related to heart disease, or other heart conditions),
• lomitapide (used to treat a rare genetic cholesterol disorder),
• daptomycin (an antibiotic used to treat complicated skin and soft tissue infections and bacteremia). It is possible that muscle-related side effects may be more common when taking this medicine with simvastatin (e.g., Zocor). Your doctor may decide to stop Zocor for a while,
• colchicine (used to treat gout),
• tikagrelor (an antiplatelet medicine).

Similarly, tell your doctor or pharmacist about all medicines you have taken recently, including those available without a prescription. In particular, tell your doctor about medicines containing any of the following active substances:

• 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).

Also, inform any doctor who prescribes a new medicine that you are taking Zocor.

Zocor with food and drink

Grapefruit juice contains one or more compounds that affect the action 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 have a baby, or think you may be pregnant. If you become pregnant while taking Zocor, stop treatment and consult your doctor immediately. 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, consider that some people may experience dizziness after taking Zocor.

Zocor contains lactose

Zocor tablets contain a sugar called lactose. If you have been diagnosed with 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.
Always take Zocor exactly as your doctor has told you. If you are unsure, ask 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), 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. The medicine can be taken with or without food. Zocor should be taken continuously until your doctor tells you to stop.
If your doctor has prescribed Zocor with another cholesterol-lowering medicine containing a bile acid sequestrant, take Zocor at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Zocor than recommended

• Contact your doctor or pharmacist.

Missing a dose of Zocor

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

Stopping treatment with Zocor

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

If you have any further questions about taking Zocor, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zocor 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 of 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) in the form of: facial swelling, tongue, and throat swelling that can cause breathing difficulties (angioedema), severe muscle pain, usually in the shoulder and hip areas, skin rash with muscle weakness in the arms and neck, joint pain or inflammation (polymyalgia rheumatica), inflammation of blood vessels (vasculitis), unusual bruising, skin rashes, and swelling (dermatomyositis), hives, increased sensitivity to sunlight, fever, flushing, shortness of breath (dyspnea), and malaise, symptoms of lupus-like disease (including rash, joint pain, and changes in blood cells),
• 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 causes breathing difficulties or dizziness (anaphylaxis),
• a skin rash that can occur on the skin or mouth ulcers (drug-induced lupus-like reaction),
• muscle rupture,
• breast enlargement in men (gynecomastia).

The following side effects have also been reported rarely:

• decreased red blood cell count (anemia),
• numbness or weakness in the hands and feet,
• headache, 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 general muscle weakness, including muscles used for breathing),
• eye muscle weakness (ocular myasthenia).

Contact 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 shortness of breath.
Additional possible side effects reported during treatment with some statins:

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

Laboratory test results
Elevated muscle enzyme levels (creatine kinase) in the blood and abnormal liver function test results have been observed.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Zocor

Keep the medicine out of the sight and reach of children.
Store the medicine at a temperature below 30°C.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Zocor contains

• The active substance is simvastatin. Zocor 10 mg film-coated tablets contain 10 mg of simvastatin. Zocor 20 mg film-coated tablets contain 20 mg of simvastatin. Zocor 40 mg film-coated tablets contain 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.
Marszałkowska Street 126/134
00-008 Warsaw
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: