Zocor 80

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
ZOCOR 80, 80 mg, film-coated tablets
Simvastatinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask 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 the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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 can narrow the arteries, thereby 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 lipid levels (mixed hyperlipidemia);
• an inherited 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 blood vessel diseases). Zocor may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.

Most people do not experience direct symptoms of high cholesterol levels. Your doctor can assess your 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. Important 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 there are currently liver function abnormalities,
• if the patient is pregnant or breastfeeding,
• if the following medicines are being used simultaneously, containing any of the active substances listed below:
  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 (HIV protease inhibitors used in the treatment of HIV infection),
  o boceprevir and telaprevir (used in the treatment of hepatitis C),
  o nefazodone (used to treat depression),
  o cobicistat,
  o gemfibrozil (used to reduce cholesterol levels),
  o cyclosporine (used in organ transplant patients),
  o danazol (a synthetic hormone used in the treatment of endometriosis, a condition in which the tissue lining the uterus grows outside the uterus).
• if the patient is currently taking or has taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). Taking fusidic acid together with Zocor may lead to serious muscle problems (rhabdomyolysis). 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 above medicines are being used, 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. Use of Zocor may not be appropriate.
• 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 suitable for you,
• if you have or have had myasthenia (a disease characterized by general muscle weakness, including in some cases muscles used for breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may occasionally worsen the condition or lead to the development of myasthenia (see section 4).

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

Your doctor may also carry out blood tests to monitor liver function after starting Zocor.

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 who have high levels of blood sugar and fats, overweight, and 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-related symptoms may be serious, including muscle breakdown leading to kidney damage, and in very rare cases, death.
The risk of muscle damage is greater 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 if muscle weakness persists. Additional tests and medications may be required to diagnose and treat this condition.

Children and adolescents

The safety and efficacy 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. Consult your doctor for additional information.

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, especially those containing any of the following active substances. Taking Zocor together with any of the following medicines may increase the risk of muscle-related side effects (some of these are listed above under "When not to use Zocor").

• If oral fusidic acid is required to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise when it is safe to restart 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 in the treatment of 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 in the treatment of AIDS),

• antiviral medicines used in the treatment of hepatitis C, such as boceprevir, telaprevir, elbasvir or grazoprevir (used in the treatment of 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 more pronounced when this medicine is taken during simvastatin treatment (e.g. Zocor). Your doctor may decide to temporarily discontinue Zocor,

• colchicine (used to treat gout),

• ticagrelor (an antiplatelet medicine).

Similarly to the medicines listed above, inform your doctor or pharmacist about all medicines you are currently taking, 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 clotting, 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 use Zocor if you are pregnant, planning to become pregnant, or suspect you may be pregnant. If you become pregnant while taking Zocor, stop treatment immediately and contact your doctor. Do not use 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 operating machinery

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 as directed by your doctor. If in doubt, consult your doctor or pharmacist.
While taking Zocor, a cholesterol-lowering diet should be maintained.

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

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, up 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 the patient is taking certain medicines listed above or has certain kidney-related conditions.
The 80 mg dose is recommended exclusively for adult patients with very high blood cholesterol levels and a high risk of heart disease, in whom target cholesterol levels have not been achieved with lower doses.

Use in children and adolescents:
For children (aged 10–17 years), the usual 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. It may be taken with meals or independently of food. Zocor should be taken continuously until your doctor advises stopping.
If your doctor has prescribed Zocor together with another cholesterol-lowering medicine containing any bile acid-binding agent, Zocor should be taken at least 2 hours before or 4 hours after taking the bile acid-binding agent.

Taking more Zocor than recommended

• 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 of Zocor the following day at the usual time.

Stopping Zocor

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following terms are used to describe how often the side effects listed below 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 side 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 side effects have been reported rarely:

• Muscle pain, tenderness, weakness, or cramps. In rare cases, these symptoms may be severe and associated with muscle breakdown leading to kidney damage; very rare cases of death have been reported.
• Hypersensitivity reactions (allergic reactions) such as: swelling of the face, tongue, and throat which may cause difficulty in breathing (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 (polyarthritis); inflammation of blood vessels (vasculitis); unusual bruising, skin lesions, and swelling (dermatomyositis); urticaria (hives), photosensitivity (increased skin sensitivity to sunlight), fever, hot flushes, shortness of breath (dyspnoea), malaise, and symptoms of lupus-like illness (including rash, joint problems, and blood cell abnormalities).

The following serious side effects have been reported very rarely:

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

The following side effects have also been reported rarely:

• Decrease in the number of red blood cells (anaemia).
• Numbness or weakness in the hands and feet.
• Headache, tingling sensation, dizziness.
• Blurred vision; visual disturbances.
• Gastrointestinal disturbances (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 side effects have also been reported, but their frequency cannot be estimated 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).

Contact your doctor immediately if the patient experiences weakness in the arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Additional possible side effects reported during the use of some statins:

• Sleep disturbances, including nightmares.
• Sexual dysfunction.
• Diabetes. The risk of developing diabetes is higher in people with elevated levels of blood sugar and fats, overweight, and high blood pressure. Your doctor will monitor your 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
Increased levels of muscle enzymes (creatine kinase) in the blood and abnormal liver function tests have been observed.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safe use of this medicine.

5. How to store Zocor

Keep this medicine out of the sight and reach of children.
Store the medicine at a temperature not exceeding 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 pack and other information

What Zocor contains

• The active substance is simvastatin. Zocor 10 coated tablet contains 10 mg of simvastatin. Zocor 20 coated tablet contains 20 mg of simvastatin. Zocor 40 coated tablet contains 40 mg of simvastatin. Zocor 80 coated tablet contains 80 mg of simvastatin.
• Other components are: Tablet core: butylhydroxyanisole, ascorbic acid, monohydrate citric acid, microcrystalline cellulose, pregelatinized starch, magnesium stearate, monohydrate lactose. Coating composition: 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, Zocor 80 – 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 Warszawa
Tel.: + 48 22 105 50 01
[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