Zocor 40

Package leaflet: information for the patient

ZOCOR 10, 10 mg, film-coated tablets
ZOCOR 20, 20 mg, film-coated tablets
ZOCOR 40, 40 mg, film-coated tablets
Simvastatinum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform 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 a medicine used to lower blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides. In addition, Zocor increases the level of "good" cholesterol (HDL cholesterol). Zocor belongs to a group of medicines called statins.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol consists mainly of LDL cholesterol and HDL cholesterol fractions.
LDL cholesterol is often called "bad" cholesterol because it can deposit on the walls of arteries, forming atherosclerotic plaques. Eventually, these plaques may narrow the arteries, restricting or blocking blood flow to vital organs such as the heart and brain. Blocked blood flow may lead to heart attack or stroke.
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 in the blood that may contribute to an increased risk of heart disease.
While taking this medicine, you should follow a cholesterol-lowering diet.
Zocor is used as an adjunct to a cholesterol-lowering diet in the following cases:

• elevated blood cholesterol levels (primary hypercholesterolemia) or elevated blood fat levels (mixed hyperlipidemia);
• a hereditary disorder (homozygous familial hypercholesterolemia) causing high blood cholesterol levels. Other treatment methods may also be used in such cases;
• ischemic heart disease (coronary artery disease) or high risk of developing ischemic heart disease (due to diabetes, previous stroke, or other vascular diseases). Zocor may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.

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

2. Information before using Zocor

When not to use Zocor

• if the patient is allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information),
• if the patient currently has liver function abnormalities,
• if the patient is pregnant or breastfeeding,
• if the patient is currently taking or has taken within the last 7 days oral or injectable fusidic acid (a medicine used to treat bacterial infections). Taking fusidic acid together with Zocor may lead to serious muscle problems (rhabdomyolysis).
• if the patient is taking any of the following medicines containing one or more of the active substances listed below:
  • 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 used in the treatment of HIV infection),
  • boceprevir or telaprevir (used in the treatment of hepatitis C),
  • nefazodone (used to treat depression),
  • cobicistat,
  • gemfibrozil (used to reduce cholesterol levels),
  • cyclosporine (used in organ transplant patients),
  • danazol (a synthetic hormone used to treat endometriosis, a condition in which the tissue lining the uterus grows outside the uterus).

Do not use Zocor at a dose higher than 40 mg if the patient is taking lomitapide (used to treat a severe and rare genetic disorder affecting cholesterol levels).

If in doubt whether any of the medicines listed above are being taken, consult a doctor.

Warnings and precautions

Tell your doctor:

• about all medical conditions, including allergies,
• if you consume large amounts of alcohol,
• if you have had liver disease in the past. Treatment with Zocor may not be suitable.
• if you are scheduled for surgery. It may be necessary to temporarily stop taking Zocor.
• if you are of Asian descent, as a different dose may be appropriate for you.
• if you have or have had myasthenia (a disease causing general muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or cause myasthenia to occur (see section 4).

Your doctor should perform a blood test before starting treatment with Zocor and during treatment if you have any liver abnormalities. The test will assess liver function.

Your doctor may also perform blood tests to evaluate liver function after starting treatment with Zocor.

Your doctor will closely monitor your health during treatment if you have diabetes or are at risk of developing diabetes. The risk of developing diabetes exists in people who have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

Inform your doctor about serious lung diseases.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. In rare cases, muscle problems may be serious, including muscle breakdown leading to kidney damage, and in very rare cases, death.

The risk of muscle damage is higher when higher doses of Zocor are used, particularly the 80 mg dose. The risk of muscle breakdown is also higher in certain patients. Tell your doctor if:

• 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 experienced muscle problems during treatment with cholesterol-lowering medicines called "statins" or "fibrates",
• you or a close relative have been diagnosed with inherited muscle disorders.

Inform your doctor or pharmacist also if muscle weakness persists. Additional tests and additional medicines may be needed to diagnose and treat this condition.

Children and adolescents

The safety and effectiveness of Zocor have been studied in boys aged 10–17 years and in girls who have had their first menstrual period at least one year earlier (see section 3: How to take Zocor). Zocor has not been studied in children under 10 years of age.

For additional information, consult your doctor.

Zocor and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take that contain any of the following active substances. Taking Zocor together with any of the following medicines may increase the risk of muscle problems (some of which are listed above under "When not to use Zocor"):

• If oral fusidic acid is required to treat a bacterial infection, temporary discontinuation of Zocor will be necessary. Your doctor will advise when it is safe to restart taking Zocor. Taking Zocor together with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). Additional information about rhabdomyolysis is provided in section 4.
• cyclosporine (commonly used in organ transplant patients),
• danazol (a synthetic hormone used to treat endometriosis),
• 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 reduce 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 (used to treat hepatitis C),
• nefazodone (used to treat depression),
• medicines containing the active substance cobicistat,
• amiodarone (used to treat heart rhythm disorders),
• 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 severe and rare genetic disorder affecting cholesterol levels),
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). Muscle-related side effects may be greater when this medicine is taken during treatment with simvastatin (e.g. Zocor). Your doctor may decide to temporarily stop taking Zocor,
• colchicine (used to treat gout),
• ticagrelor (an antiplatelet medicine).

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

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

Inform any doctor prescribing a new medicine that you are taking Zocor.

Zocor with food and drink

Grapefruit juice contains one or more compounds that affect how certain medicines work in the body, including Zocor. Avoid drinking beverages containing 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 immediately and contact 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 operate machinery. However, consider that dizziness may occur in some people after taking Zocor.

Zocor contains lactose

Zocor tablets contain a sugar called lactose. If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Zocor

Your doctor will determine the appropriate dose of the medicine for each individual patient, depending on the current treatment and individual risk factors.
This medicine should always be taken exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.
While taking Zocor, you should follow a cholesterol-lowering diet.

Dosage:
The recommended dose is 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg of simvastatin, taken orally once daily.

Adults:
The starting dose is 10 mg, 20 mg, or in some cases 40 mg once daily. Your doctor may adjust the dose after at least 4 weeks of treatment to a maximum of 80 mg once daily. Do not use more than 80 mg daily.
Your doctor may prescribe lower doses, especially if you are taking any of the medicines listed above or have certain kidney-related conditions.
The 80 mg dose is recommended only for adult patients with very high blood cholesterol levels and a high risk of heart disease, in whom the target cholesterol level has not been achieved with lower doses.

Use in children and adolescents:
For children (aged 10–17 years), the usual starting dose is 10 mg once daily in the evening. The maximum recommended dose is 40 mg daily.

Method of administration:
Zocor should be taken in the evening. It may be taken with or without food. Zocor should be taken continuously unless your doctor advises otherwise.
If your doctor has prescribed Zocor together with another cholesterol-lowering medicine containing any bile acid-binding drug, Zocor should be taken at least 2 hours before or 4 hours after the bile acid-binding medicine.

Taking more Zocor than prescribed

• Contact your doctor or pharmacist immediately.

If you forget to take Zocor

• Do not take a double dose to make up for the missed dose. Take the next dose at the usual time the following day.

Stopping Zocor

• Consult your doctor or pharmacist, as cholesterol levels may rise again if treatment is stopped.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following terms are used to describe how often the adverse reactions have been reported:

• Rare (may affect 1 in 1,000 people).
• Very rare (may affect 1 in 10,000 people).
• Frequency not known (frequency cannot be estimated from the available data).

If any of the serious adverse reactions listed below occur, the medicine must be discontinued and
the doctor must be contacted immediately or the patient must go to the nearest hospital emergency
department without delay.
The following rare but serious adverse reactions have been reported:

• Muscle pain, tenderness, weakness, or cramps. In rare cases, these symptoms may be severe and associated with muscle breakdown leading to kidney damage; very rarely, fatal outcomes have been reported.
• Hypersensitivity reactions (allergic reactions) manifesting as: swelling of the face, tongue, and throat causing breathing difficulties (angioedema), severe muscle pain, usually in the shoulder and hip joints, skin rash with muscle weakness in the limbs and neck, joint pain or inflammation (polymyalgia rheumatica), inflammation of blood vessels (vasculitis), unusual bruising, skin lesions, and swelling (dermatomyositis), urticaria, photosensitivity, fever, hot flushes, shortness of breath (dyspnoea), malaise, symptoms of lupus-like illness (including rash, joint problems, and blood cell changes).

The following very rare serious adverse reactions have been reported:

• Severe allergic reaction causing difficulty in breathing or dizziness (anaphylaxis),
• Skin rash or oral mucosal ulceration (lichenoid mucosal lesions),
• Muscle rupture,
• Gynaecomastia (enlargement of breasts in males).

The following adverse reactions have also been rarely reported:

• Decrease in the number of red blood cells (anaemia),
• Numbness or weakness in the hands and feet,
• Headaches, tingling sensations, dizziness,
• Blurred vision; visual disturbances,
• Gastrointestinal disorders (abdominal pain, constipation, bloating, indigestion, diarrhoea, nausea, vomiting),
• Rash, itching, hair loss,
• Fatigue,
• Sleep disorders (very rare),
• Poor memory (very rare), memory loss, confusion.

The following adverse reactions have also been reported, but their frequency cannot be determined from the available data (frequency not known):

• Erectile dysfunction,
• Depression,
• Lung inflammation causing breathing problems, including persistent cough and/or dyspnoea or fever, tendon disorders, sometimes complicated by tendon rupture,
• Myasthenia gravis (a disease causing generalised muscle weakness, including in some cases the muscles used for breathing),
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Patients should contact their doctor if they experience weakness in the arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Additional possible adverse reactions reported during the use of certain statins:

• Sleep disturbances, including nightmares,
• Sexual dysfunction,
• Diabetes. The development of diabetes is more likely in individuals with high levels of blood sugar and fats, overweight, and high blood pressure. The doctor will monitor the patient's health during treatment with this medicine,
• Muscle pain, tenderness, or persistent muscle weakness, which may not resolve after discontinuation of Zocor (frequency not known).

Laboratory test results
Elevated levels of muscle enzymes (creatine kinase) in the blood and abnormal liver function tests have been observed.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zocor

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

6. Contents of the package and other information

What Zocor contains

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

What Zocor looks like and contents of the pack
Available pack sizes:

• Zocor 10, Zocor 40 – PVC/PE/PVDC/Al blisters in cardboard boxes containing 28 coated tablets.
• Zocor 20 – PVC/PE/PVDC/Al blisters in cardboard boxes containing 28 or 60 coated tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warsaw
Tel. + 48 22 306 57 64
[email protected]
Manufacturer/Importer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium