Zocor 10

PATIENT INFORMATION LEAFLET

Enclosed patient information leaflet

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, 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Zocor and what is it 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 is Zocor and what is it used for

Zocor contains the active substance simvastatin. Zocor is used to reduce the level of cholesterol and other fats in the blood. It also increases the level of "good" cholesterol (HDL cholesterol). Zocor belongs to a group of medicines called statins.

Cholesterol is one of several fats 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 on the walls of arteries, forming plaques. Eventually, these plaques can cause the arteries to narrow, restricting blood flow to vital organs such as the heart and brain. Reduced blood flow can 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 found in the blood that can increase the risk of heart disease.

While taking this medicine, you should follow a cholesterol-lowering diet.

Zocor is used as an adjunct to diet to reduce cholesterol levels in people with:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• a genetic disorder (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.

In most people, high cholesterol does not cause any symptoms. Your doctor may check 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. 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 have active liver disease,
• 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 disease. 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. 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.

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 lead to 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 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 disorders.

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

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). 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 or plan to take, including those listed below.

• if you need to take fusidic acid orally for 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 rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis).

Additional information on rhabdomyolysis can be found in section 4.

• cyclosporin (often used in organ transplant patients),
• danazol (a synthetic hormone used to treat endometriosis, a condition where 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),
• 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,
• 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 (an antibiotic used to treat complicated skin and soft tissue infections and bacteremia). The risk of muscle problems may be higher 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).

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 the following active substances:

• medicines that 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 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 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 become pregnant, 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. Consult your doctor or pharmacist before taking any medicine.

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, contact 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 cholesterol-lowering 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. You can take Zocor with or without food. Take Zocor continuously until your doctor tells you to stop.

If your doctor has prescribed Zocor with another cholesterol-lowering medicine that contains 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 missed 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 1000 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 (including anaphylaxis), which can cause difficulty breathing, swelling of the face, lips, tongue, or throat, and fainting,
• liver problems, including liver failure (very rare),
• pancreatitis, which can cause severe abdominal pain.

The following very rare but serious side effects have been reported:

• severe allergic reactions (anaphylaxis),
• skin reactions, including Stevens-Johnson syndrome or toxic epidermal necrolysis,
• muscle rupture,
• breast enlargement in men (gynecomastia).

The following side effects have been reported rarely:

• reduced 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 been reported, but their frequency is not known:

• erectile dysfunction,
• depression,
• lung inflammation, which can cause breathing problems, including persistent cough and (or) shortness of breath or fever,
• muscle weakness (myasthenia gravis),
• eye muscle weakness (ocular myasthenia gravis).

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

Additional possible side effects reported with some statins:

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

Laboratory test results

Increased 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, please inform your doctor or pharmacist. 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 Zocor out of the sight and reach of children.

Store Zocor below 30°C.

Do not use Zocor after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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 mg film-coated tablets contain 10 mg simvastatin. Zocor 20 mg film-coated tablets contain 20 mg simvastatin. Zocor 40 mg film-coated tablets contain 40 mg simvastatin.
• The other ingredients are: tablet 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 mg and Zocor 20 mg 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 126/134

00-008 Warsaw

Phone: (+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: