ZOCOR 10 mg Tabletki Powlekane

Treść ulotki

1. Zocor 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What is Zocor and what is it 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. Package contents and other information

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

Simvastatina

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 ingredient simvastatin (belonging to the 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 the arteries and form plaques. Over time, these plaques increase in
size and can obstruct the arteries. This narrowing can cause a slowing or a
blockage of blood flow to vital organs such as the heart and brain and, consequently, cause a
heart attack or stroke.
HDL cholesterol is commonly known as “good” cholesterol because it helps prevent
bad cholesterol from accumulating in the arteries, protecting against heart disease.
Triglycerides are another type of fat present in the blood. They can increase the risk of
heart disease.
During treatment with this medicine, you must follow a diet to reduce cholesterol.
Zocor is used in addition to a cholesterol-lowering diet if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high 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 if you are at high risk of CHD (due to diabetes, previous stroke or other blood vessel diseases). Zocor can prolong survival by reducing the risk of heart problems, regardless of cholesterol levels.

In most people, high cholesterol does not cause immediate symptoms. Your doctor can
measure your cholesterol level with a simple blood test.
See your doctor regularly, keep track of your cholesterol levels, 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 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 ingredients: o itraconazole, ketoconazole, posaconazole or voriconazole (used for the treatment of fungal infections), o erythromycin, clarithromycin or telithromycin (used for the treatment of infections), o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used for the treatment of HIV infections), o boceprevir or telaprevir (used for the treatment of hepatitis C virus infection), o nefazodone (used for the treatment of depression), o cobicistat (used in HIV infection therapy), o gemfibrozil (used to lower cholesterol), o cyclosporine (used in patients undergoing organ transplantation), 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 a medicine called fusidic acid (a medicine used to treat bacterial infection) orally or by injection. The combination of fusidic acid and Zocor may cause serious muscle problems (rhabdomyolysis). Do not take more than 40 mg of Zocor if you are taking lomitapide (used to treat a severe and rare genetic condition of cholesterol). Ask your doctor if you are not sure whether the medicine you are taking is among those listed above.

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

• about your health conditions, including allergies,
• if you drink significant amounts of alcohol,
• if you have ever suffered from liver disease. In this case, Zocor may not be suitable for you,
• if you are going to have surgery. It may be necessary to stop taking Zocor for a short period of time,
• if you are Asian, because 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 that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see section 4).

The doctor will perform a blood test before you start taking Zocor and if you show
symptoms of liver problems during treatment with Zocor to check your liver activity.
The doctor may also perform blood tests to check your liver function after you have started taking Zocor.
During treatment with this medicine, your doctor will carefully monitor you for diabetes or risk of developing diabetes. You are at risk of developing diabetes if you have
high levels of sugar and fats in the blood, if you are overweight and have high blood pressure.
Tell your doctor if you have a serious lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or
muscle weakness. This is necessary because, in rare cases, muscle problems can
be severe and include muscle tissue damage that can cause kidney damage; very
rarely, deaths have occurred.
The risk of muscle injury is higher with higher doses of Zocor, especially with the 80
mg dose. The risk of muscle injury is also higher in some patients. Talk to your doctor if any
of the following conditions apply to you:

• consume significant amounts of alcohol,
• suffer from kidney problems,
• suffer from thyroid problems,
• are 65 years of age or older,
• are female,
• have suffered from muscle problems while taking medicines that lower cholesterol levels, called “statins” or fibrates,
• you or a close family member suffers from an inherited muscle disease. Also, tell your doctor or pharmacist if you experience persistent muscle weakness. Further tests and medications may be needed for the diagnosis and treatment of this condition.

Children and adolescents
The safety and efficacy of Zocor have been studied in boys aged 10 to 17 years, and
in girls who have started to have their menstrual period (menstruation) at least one year before (see
section 3 “How to take Zocor”). Zocor has not been studied in children under 10 years of age.
For more information, ask your doctor.

Other medicines and Zocor
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine containing any of the following active ingredients. Taking Zocor with
any of the following medicines may increase the risk of muscle problems (some of these
have already been listed in the “Do not take Zocor” section):

• if you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart treatment with Zocor. Taking Zocor with fusidic acid can rarely lead to weakness, tenderness or muscle pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.
• cyclosporine (often used in patients undergoing organ transplantation),
• danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• medicines containing active ingredients such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used for the treatment of fungal infections),
• fibrates with gemfibrozil and bezafibrate as active ingredients (used to reduce cholesterol),
• erythromycin, clarithromycin or telithromycin (used for the treatment of bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used for the treatment of HIV infections),
• antiviral agents for hepatitis C such as boceprevir, telaprevir, elbasvir or grazoprevir (used for the treatment of hepatitis C virus infections),
• nefazodone (used for the treatment of depression),
• cobicistat (used in HIV infection therapy),
• amiodarone (used for the treatment of irregular heartbeat),
• verapamil, diltiazem or amlodipine (used for the treatment of high blood pressure, chest pain associated with heart disease or other heart conditions),
• lomitapide (used to treat a severe and rare genetic cholesterol condition),
• daptomycin (used to treat complicated skin and soft tissue infections and bacteremia). It is possible that side effects affecting the muscles may be greater when this medicine is taken during treatment with simvastatin (e.g. Zocor). Your doctor may decide to stop you from taking Zocor for a period of time,
• colchicine (used to treat gout). As with the medicines listed above, tell 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, tell your doctor if you are taking medicines with any of the following active ingredients:
• 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).

Tell any doctor who needs to prescribe you a new medicine that you are taking Zocor.

Zocor with food, drinks and alcohol
Grapefruit juice contains one or more substances that alter the way the body uses
some medicines, including Zocor. Therefore, consumption of grapefruit juice should be avoided.
Tell your doctor if you consume significant amounts of alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Zocor if you are pregnant, are trying to become pregnant or suspect you are
pregnant. If you discover that you are pregnant during treatment with 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 operate machinery. However,
be aware that dizziness has been reported after taking Zocor.

ZOCOR contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking
this medicine.

3. How to take Zocor

The doctor will determine the most appropriate tablet dosage for you, based on your condition,
your current treatment and your risk factors.
Take this medicine following the doctor's instructions exactly at all times. If you have any doubts, consult
your doctor or pharmacist.
During treatment with Zocor, you must follow a diet to reduce cholesterol levels.
Take Zocor by mouth once a day, at the dosage prescribed by your doctor.
Dosage

Adults
The usual initial dose is 10, 20 or, in some cases, 40 mg per day. The doctor may
adjust the dose, after at least 4 weeks have passed, up to a maximum of 80 mg per day.

Do not take more than 80 mg per day.
The doctor may prescribe lower doses, especially if you are taking some of the
medicines as listed above or if you suffer from 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 ideal cholesterol level with
lower doses.

Use in children and adolescents
For children and adolescents (ages 10-17), the usual recommended initial dose is 10 mg per
day, to be taken in the evening. The maximum recommended dose is 40 mg per day.
Method of administration
Take Zocor in the evening. You can take the tablet with or without food. Continue to take 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
In case of ingestion/taking an excessive dose of Zocor, contact your doctor or
pharmacist immediately.

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

If you stop treatment with Zocor
Contact your doctor or pharmacist as your cholesterol may increase again.
If you have any doubts about the use of this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following serious side effects occur, stop taking
Zocor and tell your doctor immediately or go to the nearest hospital emergency room.
The following serious side effects have been reported rarely:

• pain, tenderness, weakness or muscle cramps. In rare cases, these muscle problems can be severe and can include muscle tissue damage leading to kidney damage; and very rarely, cases of death have occurred;
• hypersensitivity reactions (allergies) including: o swelling of the face, tongue and throat which can cause difficulty breathing (angioedema), o severe muscle pain usually in the shoulders and hips, o skin rash with weakness in the legs and neck muscles, o pain or inflammation in the joints (polymyalgia rheumatica), o inflammation of blood vessels (vasculitis), o unusual bruising, skin rashes and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, flushing, or shortness of breath (dyspnea) and feeling unwell, or a lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells);
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, 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 side effects have been reported very rarely:

• a severe allergic reaction that causes difficulty breathing or dizziness (anaphylaxis),
• skin rash that may occur on the skin or ulcers in the mouth (lichenoid drug eruptions),
• muscle breakdown,
• gynecomastia (enlargement of breast tissue in men),
• liver failure.

The following side effects have also been reported:

Rare (may affect up to 1 in 1,000 people)

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

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

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

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

• erectile dysfunction,
• depression,
• inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath and fever,
• tendon problems, sometimes complicated by rupture,
• Myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles used for breathing),
• Ocular myasthenia (a disease that causes weakness of the eye muscles). See 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.

Other possible side effects reported with some statins:

• sleep disturbances, including nightmares,
• sexual difficulties,
• diabetes. This is more likely if you have high levels of sugar and fat in your blood, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine,
• pain, tenderness or weakness in muscles that is constant, which may not improve after stopping Zocor (frequency not known).

Laboratory tests
Increases in some blood test values concerning liver function
and muscle enzyme (creatine kinase) have been observed.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
adverse. 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 which is stated on the packaging after the wording
“Scad.” The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Zocor and package contents
ZOCOR 10 mg
Packaged in blister packs made of a three-layer film composed of polyvinyl chloride (PVC)/polyethylene
(PE)/polyvinylidene chloride (PVDC) with an aluminum foil as a cover.
Packs of 1, 4, 10, 14, 15, 20, 28, 30, 50, 60, 98 or 100 tablets.
Packaged in blister packs composed of polyvinyl chloride (PVC) with an aluminum foil as
cover.
Packs of 4, 10, 28 or 30 tablets.
Amber glass bottle with a metal closure.
Packs of 30 or 50 tablets.
Polypropylene bottle.
Pack of 50 tablets.
High-density polyethylene (HDPE) bottle.
Packs of 30, 50 or 100 tablets.
Unit-dose blisters containing a three-layer film composed of polyvinyl chloride (PVC)/polyethylene
(PE)/polyvinylidene chloride (PVDC) with an aluminum foil as a cover.
Packs of 49 or 500 tablets.

ZOCOR 20 mg
Packaged in blister packs made of a three-layer film composed of polyvinyl chloride (PVC)/polyethylene
(PE)/polyvinylidene chloride (PVDC) with an aluminum foil as a cover.
Packs of 1, 4, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 168 tablets.
Packaged in blister packs composed of polyvinyl chloride (PVC) with an aluminum foil as
cover.
Packs of 14, 28, 30, 50 or 90 tablets.
Amber glass bottle with a metal closure.
Packs of 30 or 50 tablets.
Polypropylene bottle.
Pack of 50 tablets.
High-density polyethylene (HDPE) bottle.
Packs of 30, 50 or 100 tablets.
Unit-dose blisters containing a three-layer film composed of polyvinyl chloride (PVC)/polyethylene
(PE)/polyvinylidene chloride (PVDC) with an aluminum foil as a cover.
Packs of 28, 49, 84, 98 or 500 tablets.

ZOCOR 40 mg
Packaged in blister packs made of a three-layer film composed of polyvinyl chloride (PVC)/polyethylene
(PE)/polyvinylidene chloride (PVDC) with an aluminum foil as a cover.
Packs of 1, 4, 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100 or 168 tablets.
Packaged in blister packs composed of polyvinyl chloride (PVC) with an aluminum foil as
cover.
Packs of 7, 14, 28, 30, 49, 50 or 90 tablets.
Amber glass bottle with a metal closure.
Packs of 30 or 50 tablets.
Polypropylene bottle.
Pack of 50 tablets.
High-density polyethylene (HDPE) bottle.
Packs of 30, 50 or 100 tablets.
Unit-dose blisters containing a three-layer film composed of polyvinyl chloride (PVC)/polyethylene
(PE)/polyvinylidene chloride (PVDC) with an aluminum foil as a cover.
Packs of 28, 49, 98 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milano

Manufacturer

Zocor 10 mgfilm-coated tablets:
Vamfarma S.r.l.
Via Kennedy, 5 – 26833 Comazzo (Lodi)

Zocor 20 mg film-coated tablets
Doppel farmaceutici S.r.l.
Via Volturno, 48, Quinto dè Stampi - 20089 Rozzano (Milano)
Vamfarma S.r.l.
Via Kennedy, 5 – 26833 Comazzo (Lodi)

Zocor 40 mg film-coated tablets:
Doppel farmaceutici S.r.l.
Via Volturno, 48, Quinto dè Stampi - 20089 Rozzano (Milano)
Vamfarma S.r.l.
Via Kennedy, 5 – 26833 Comazzo (Lodi)