Zocor

Package leaflet: Information for the patient

Zocor 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Simvastatin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this 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 (belonging to a group of medicines called statins)
and is used to reduce levels of total cholesterol, "bad" cholesterol (LDL), and fatty substances called triglycerides in the blood.
In addition, Zocor increases levels of "good" cholesterol (HDL).
Cholesterol is one of the fats present in the blood.
Total cholesterol is mainly composed of LDL cholesterol and HDL cholesterol.
LDL cholesterol is commonly known as "bad" cholesterol because it can accumulate in the walls of arteries and form plaques. Over time, these plaques grow larger and can block the arteries. This narrowing may slow down or block blood flow to vital organs such as the heart and brain, thereby causing a heart attack or stroke.
HDL cholesterol is commonly known as "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries, thus protecting against heart disease.
Triglycerides are another type of fat present in the blood. They may increase the risk of heart disease.
While being treated with this medicine, you must follow a cholesterol-lowering diet.
Zocor is used in addition to a cholesterol-lowering diet to reduce cholesterol if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or elevated levels of fats in the blood (mixed hyperlipidemia),
• an inherited disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You may also be receiving other treatments,
• coronary heart disease (CHD) or are at high risk of CHD (due to diabetes, previous stroke, or other blood vessel diseases). Zocor may prolong survival by reducing the risk of heart problems, regardless of the amount of cholesterol in the blood.

In most people, high cholesterol does not cause immediate symptoms. Your doctor can measure your cholesterol level with a simple blood test.
Have regular check-ups with your doctor, keep track of your cholesterol values, 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 ingredients of this medicine (listed in section 6);
• 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 (used to treat HIV infections), boceprevir or telaprevir (used to treat hepatitis C virus infection), nefazodone (used to treat depression), cobicistat (used in HIV therapy), gemfibrozil (used to lower cholesterol), cyclosporine (used in organ transplant patients), or danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus);
• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infection). The combination of fusidic acid and Zocor can cause serious muscle problems (rhabdomyolysis). Do not take more than 40 mg of Zocor if you are taking lomitapide (used to treat a rare, severe genetic cholesterol condition). Ask your doctor for advice if you are unsure whether the medicine you are taking is included in the list above.

Warnings and precautions
Talk to your doctor or pharmacist before taking Zocor.
Inform your doctor:

• about your medical conditions, including allergies,
• if you drink large amounts of alcohol,
• if you have ever had liver disease. In this case, Zocor may not be suitable for you,
• if you are due to undergo surgery. You may need to stop taking Zocor temporarily,
• if you are of Asian origin, as a different dosage may be more appropriate for you,
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may sometimes worsen myasthenia or trigger its onset (see section 4).

Your doctor will perform a blood test before you start taking Zocor and if you develop symptoms of liver problems during treatment with Zocor, to monitor your liver function.
Your doctor may also carry out blood tests to monitor your liver function after you start taking Zocor.
While being treated with this medicine, your doctor will closely monitor whether 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, and have high blood pressure.
Inform your doctor if you have a serious lung disease.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is important because, rarely, muscle problems can be severe and include damage to muscle tissue that can lead to kidney damage; very rarely, cases of death have occurred.
The risk of muscle injury is higher with higher doses of Zocor, particularly with the 80 mg dose. The risk of muscle injury is also increased in certain patients. Talk to your doctor if any of the following conditions apply to you:

• you consume large amounts of alcohol,
• you have kidney problems,
• you have thyroid problems,
• you are aged 65 years or older,
• you are female,
• you have experienced muscle problems during treatment with cholesterol-lowering medicines known as "statins" or fibrates,
• you or a close family member have a hereditary muscle disease.
  Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be needed to diagnose and treat this condition.

Children and adolescents
The safety and effectiveness of Zocor have been studied in boys and girls aged between 10 and 17 years, and in girls who have had their menstrual period (menstruation) for at least one year (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.

Other medicines and Zocor
Inform your doctor or pharmacist if you are taking, have recently taken, or might 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 have already been listed in the section “Do not take Zocor”):

• if you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart Zocor treatment. Taking Zocor with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.
• cyclosporine (often used in organ transplant patients),
• danazol (an artificial hormone used to treat endometriosis, a condition in which the 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 with active ingredients gemfibrozil and bezafibrate (used to reduce cholesterol),
• erythromycin, clarithromycin or telithromycin (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat HIV infections),
• antiviral agents for hepatitis C such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infections),
• nefazodone (used to treat depression),
• cobicistat (used in HIV therapy),
• amiodarone (used to treat irregular heartbeat),
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions),
• lomitapide (used to treat a rare, severe genetic cholesterol condition),
• daptomycin (used to treat complicated skin and soft tissue infections and bacteremia). The risk of muscle-related side effects may be increased when this medicine is taken during treatment with simvastatin (e.g., Zocor). Your doctor may decide to have you stop taking Zocor temporarily,
• colchicine (used to treat gout). As with the medicines listed above, inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those obtained without a prescription. In particular, inform your doctor if you are taking medicines with any of the following active substances:
  • medicines with an active ingredient 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).

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

Zocor with food, drinks and alcohol
Grapefruit juice contains one or more substances that alter how the body processes certain medicines, including Zocor. Therefore, grapefruit juice should be avoided.
Inform your doctor if you consume large amounts of alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Zocor if you are pregnant, trying to become pregnant, or suspect you are pregnant. If you find out you are pregnant while taking Zocor, stop taking the tablets immediately and contact your doctor.
Do not take Zocor while breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines
Zocor is not expected to affect your ability to drive or use machines. However, bear in mind that dizziness has been reported after taking Zocor.

ZOCOR contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Zocor

Your doctor will determine the most appropriate tablet dosage for you, based on your condition,
your current treatment, and your risk factors.
Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult
your doctor or pharmacist.
While being treated with Zocor, you must follow a diet aimed at reducing cholesterol levels.
Take Zocor by mouth once daily, at the dose prescribed by your doctor.

Dosage

Adults
The usual starting dose is 10, 20, or in some cases, 40 mg daily. Your doctor may adjust the dose after at least 4 weeks have passed, up to a maximum of 80 mg daily.
Do not take more than 80 mg daily.
Your doctor may prescribe a lower dose, especially if you are taking certain medicines as listed above, or if you have kidney problems.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and at high risk of heart disease who have not reached their target cholesterol levels with lower doses.

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

Method of administration
Take Zocor in the evening. You may take the tablet with or without food. Continue taking Zocor until your doctor tells you to stop treatment.
If your doctor has prescribed Zocor together with another medicine containing a bile acid sequestrant to lower cholesterol levels, you must take Zocor at least 2 hours before or 4 hours after taking the bile acid sequestrant medicine.

If you take more Zocor than you should
If you take or ingest too much Zocor, contact your doctor or pharmacist immediately.

If you forget to take Zocor
Do not take a double dose to make up for the missed tablet. Continue treatment with the usual dose of Zocor the following day at the regular time.

If you stop taking Zocor
Consult your doctor or pharmacist, as your cholesterol levels may rise again.
If you have any questions about 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 everyone will experience them.
If you experience any of the following serious side effects, stop taking Zocor and contact your doctor immediately or go to the nearest hospital Emergency Department.
The following serious rare side effects have been reported:

• muscle pain, tenderness, weakness, or cramps. In rare cases, these muscle problems can be severe and may include damage to muscle tissue, leading to kidney damage; very rarely, cases of death have occurred;
• hypersensitivity reactions (allergies) including: swelling of the face, tongue, and throat which may cause breathing difficulties (angioedema), or severe muscle pain usually in shoulders and hips, or skin rash with weakness in legs and neck muscles, or joint pain or inflammation (polymyalgia rheumatica), or inflammation of blood vessels (vasculitis), or unusual bruising, skin rashes, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flushes, shortness of breath (dyspnea), feeling unwell, or symptoms resembling systemic lupus (including skin rash, joint problems, and effects on blood cells);
• liver inflammation with the following symptoms: yellowing of the skin or eyes (jaundice), itching, dark urine or pale stools, feeling tired or weak, loss of appetite;
• inflammation of the pancreas, often associated with severe abdominal pain.

The following serious very rare side effects have been reported:

• a severe allergic reaction causing difficulty breathing or dizziness (anaphylaxis),
• skin rash which may appear on the skin or ulcers in the mouth (drug-induced lichenoid eruptions),
• muscle breakdown,
• gynaecomastia (enlargement of breast tissue in men),
• liver failure.

Other reported side effects:
Rare (may affect up to 1 in 1,000 people)

• decrease in red blood cell count (anaemia),
• numbness or weakness in arms and legs,
• headache, tingling sensation, dizziness,
• blurred vision, visual disturbances,
• digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
• skin rash, itching, hair loss,
• weakness.

Very rare (may affect up to 1 in 10,000 people)

• difficulty falling asleep (insomnia),
• memory impairment, memory loss, confusion.

Not known (frequency cannot be estimated from the available data)

• erectile dysfunction,
• depression,
• lung inflammation causing breathing problems including persistent cough and/or shortness of breath and fever,
• tendon problems, sometimes complicated by rupture,
• Myasthenia gravis (a disease causing generalized muscle weakness, in some cases affecting muscles used for breathing),
• Ocular myasthenia (a disease causing weakness of eye muscles). Consult your doctor if you experience muscle weakness in arms or legs that worsens with activity, double vision, drooping eyelids, difficulty swallowing, or shortness of breath.

Other possible side 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 during treatment with this medicine,
• persistent muscle pain, tenderness, or weakness that does not improve after stopping Zocor (frequency not known).

Laboratory tests
Increases in blood test values related to liver function and muscle enzyme (creatine kinase) have been observed.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the appropriate national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 the wording
“Exp.”. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Zocor contains
The active substance is simvastatin. Each tablet contains 10 mg, 20 mg or 40 mg of simvastatin.
The other components are: butylated hydroxyanisole (E320), ascorbic acid (E300), citric acid monohydrate (E330), microcrystalline cellulose (E460), pregelatinized starch, magnesium stearate (E572) and lactose monohydrate.
The film coating of the 10 mg and 20 mg tablets contains: hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172).
The film coating of the 40 mg tablet contains: hypromellose (E464), hydroxypropylcellul游戏副本