SINCOL 20 mg Film-Coated Tablets

Зміст інструкції

1. SINCOL 20 mg film-coated tablets
   1. What is SINCOL and what it is used for
   2. What you need to know before taking SINCOL
   3. How to take Sincol
   4. Possible side effects
   5. How to store SINCOL
   6. Contents of the pack and other information

SINCOL 20 mg film-coated tablets

SINCOL 40 mg film-coated tablets
Simvastatin
Generic Equivalent Medicine

Read this leaflet carefully before 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 they have the same symptoms as you, as it may 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 SINCOL is and what it is used for
• 2.What you need to know before you take SINCOL
• 3.How to take SINCOL
• 4.Possible side effects
• 5.How to store SINCOL
• 6.Contents of the pack and other information

1. What is SINCOL and what it is used for

SINCOL contains the active ingredient simvastatin. SINCOL is a medicine used to reduce levels of
total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances in the blood
called triglycerides. Furthermore, SINCOL increases levels of “good” cholesterol (HDL cholesterol). SINCOL
belongs to a group of medicines called statins.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is mainly composed of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can accumulate in the walls
of the arteries forming plaques. Over time, this accumulation in the form of plaque
can lead to narrowing of the arteries. This narrowing can slow down or block the
flow of blood to vital organs such as the heart and brain. This blockage of blood flow can
cause a heart attack or stroke.
HDL cholesterol is often called “good” cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects against heart disease.
Triglycerides are another form of fat in the blood that can increase the risk of
heart disease.
You must follow a diet to reduce cholesterol during therapy with this medicine.
SINCOL is used, in addition to a cholesterol-lowering diet, if you have:

• elevated cholesterol levels in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia).
• an inherited disease (familial homozygous hypercholesterolemia), which 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 (because you have diabetes, or have had a stroke or another vascular disease). SINCOL can prolong survival by reducing the risk of problems related to heart disease, regardless of cholesterol levels in the blood.

In most people, no immediate symptoms appear due to high cholesterol.
Your doctor is able to check your cholesterol with a simple blood test. Go
regularly to your doctor, keep track of your cholesterol levels, and define with your doctor
the goals to achieve.

2. What you need to know before taking SINCOL

Do not take SINCOL:

• if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6).
• if you have current liver problems.
• if you are pregnant or breastfeeding
• if you are taking one or more of the medicines with the following active ingredients:
• itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used for HIV infections)
• boceprevir, telaprevir (used to treat hepatitis C virus infections),
• erythromycin, clarithromycin, telithromycin (used to treat bacterial infections),
• nefazodone (used to treat depression), - cobicistat
• gemfibrozil (used to lower cholesterol),
• cyclosporine (used in patients undergoing organ transplantation),
• danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus develops outside the uterus).
• if you are taking or, within the last 7 days, have taken or have been given a medicine called fusidic acid (used to treat bacterial infection) orally or by injection. The combination of fusidic acid and SINCOL may cause serious muscle problems (rhabdomyolysis). Do not take more than 40 mg of SINCOL if you are taking lomitapide (used to treat a

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genetic condition of severe and rare cholesterol)
Ask your doctor for advice if you are not sure whether the medicine you are taking is among those listed above
.

Warnings and precautions
Tell your doctor:• about all medical conditions including allergies.

• If you consume significant amounts of alcohol.
• If you have had a liver disease. In this case SINCOL may not be suitable for you.
• If you have a serious lung disease.
• If you are going to have surgery. You may need to stop taking SINCOL for a short period.
• If you are Asian, because a different dose may be appropriate for you.

The doctor will need to have a blood test done before giving you SINCOL and if you have symptoms of
liver problems while taking SINCOL. This test is done to see if the
liver is working properly.
The doctor may also prescribe blood tests to check liver function after
starting therapy with SINCOL.
During treatment with this medicine, the doctor will carefully monitor that you do not have
diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have
high levels of sugars 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 because, rarely, muscle problems
can be serious and can include muscle tissue damage leading to kidney damage; very rarely, deaths have occurred.
The risk of muscle injury is greater at higher doses of SINCOL, particularly with the 80 mg dose. The risk of muscle injury is also greater in some patients. Talk to your doctor if
any of the following conditions apply to you:
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• consume significant amounts of alcohol
• have kidney problems
• have thyroid problems
• are 65 years of age or older
• are female
• have ever had muscle problems while taking cholesterol-lowering medicines called “statins” or fibrates
• you or a close family member suffers from an inherited muscle disease.

Also, tell your doctor or pharmacist if you have a constant muscle weakness. Further tests and medicines may be needed for diagnosis and treatment of this condition.

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

Use in the elderly
No dosage adjustments are necessary in the elderly. If you are over 65 years of age, you should
consider that you may be predisposed to muscle damage.

Other medicines and SINCOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine with any of the following active ingredients.
It is particularly important that the doctor is informed if you are taking any of
the following medicines. Taking SINCOL with any of these medicines may increase the
risk of muscle problems (some have already been listed above in the “Do not take
SINCOL” 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 whenit is safe to restart treatment with SINCOL. Taking SINCOL withfusidic 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 develops outside the uterus)
• medicines with active ingredients such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections) 4 / 10
• fibrates such as gemfibrozil and bezafibrate (used to reduce cholesterol)
• erythromycin, clarithromycin, telithromycin, or fusidic acid (used to treat bacterial infections). Do not take fusidic acid while using this medicine (see also the “ Do not take SINCOL”section)
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS)
• antiviral agents for hepatitis C such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection)

medicines with the active ingredient cobicistat

• nefazodone (used to treat depression)
• amiodarone (used to treat an irregular heartbeat)
• verapamil, diltiazem, amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart conditions)
• colchicine (used to treat gout).

lomitapide (used to treat a genetic condition of severe and rare cholesterol)
As with the medicines listed above, you should always tell your doctor or pharmacist if you
are taking or have recently taken any other medicine, including those without
prescription. In particular, tell your doctor if you are taking a(one) medicine(s) with one
of the following active ingredients:

• medicines with an active ingredient to prevent blood clot formation, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants)
• fenofibrate (also used to lower cholesterol)
• niacin (also used to lower cholesterol)
• rifampicin (used to treat tuberculosis).

You should also inform any doctor who is prescribing you a new medicine that you are
taking SINCOL.

SINCOL with food and drink
Grapefruit juice contains one or more substances that change the way the body uses
some medicines, including SINCOL. Consumption of grapefruit juice should be avoided.

Pregnancy and breastfeeding
Do not use SINCOL if you are pregnant, if you are planning to become pregnant or if you suspect you
are pregnant. If you become pregnant while taking SINCOL, stop
immediately and contact your doctor.
Do not use SINCOL during breastfeeding as it is not known whether the medicine passes into
breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
SINCOL is not expected to interfere with your ability to drive or use machines.
However, it should be noted that dizziness has been reported after
taking SINCOL.
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SINCOL contains lactose
The tablets of SINCOL contain a sugar called lactose. If you have been
diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Sincol

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
During treatment with SINCOL you must follow a diet to lower cholesterol levels.
The doctor will determine the right tablet dosage for you based on your condition, your
current treatment and your risk profile.
Dosage:
The recommended dose of SINCOL is one 5 mg, 10 mg, 20 mg, 40 mg or 80 mg tablet
by mouth once a day.
Take SINCOL in the evening. You can take it independently of meals.
Adults:
The initial dose is usually 10, 20 or, in some cases, 40 mg per day. The doctor may adjust
the dose after at least 4 weeks 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 listed above or have certain kidney problems. Continue taking SINCOL unless
your doctor tells you to stop treatment.
The 80 mg dose is recommended only in 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:
Children and adolescents:
For children and adolescents (10-17 years), the usual recommended initial dose is 10 mg
per day administered in the evening. The maximum recommended dose is 40 mg per day.
Method of administration:
Take SINCOL in the evening. You can take it independently of meals. Continue taking
SINCOL unless your doctor tells you to stop treatment.
If your doctor has prescribed SINCOL with a bile acid sequestrant (medicine used to
lower cholesterol), you must take SINCOL at least 2 hours before or 4 hours after taking the
bile acid sequestrant medicine.
The tablets can be divided into equal parts.
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If you take more SINCOL than you should:
contact your doctor or pharmacist.

If you forget to take SINCOL
Do not take a double dose to make up for a missed tablet, just take
the usual dose of SINCOL the next day, at the usual time.

If you stop taking SINCOL

Talk to your doctor or pharmacist as your cholesterol 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, SINCOL can cause side effects, although not everybody gets them.
To describe how often side effects occur, the following terms are used:

• Rare (affects 1 to 10 people in 10,000)
• Very rare (affects less than 1 person in 10,000)
• Not known (frequency cannot be estimated from the available data)

The following serious side effects have been reported in rare cases.

If any of the following serious side effects occur, you must stop taking the
medicine and immediately contact your doctor or go to the nearest hospital emergency
room.
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• 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
• allergic reactions including: o swelling of the face, tongue and throat which can cause difficulty breathing (angioedema) o severe muscle pain usually in the shoulders or hips o skin rash with weakness in the legs and neck muscles o pain or inflammation in the joints (rheumatic polymyalgia) o inflammation of the blood vessels (vasculitis) o unusual bruising, skin rashes and swelling (dermatomyositis), hives, skin sensitivity to the sun, fever, hot flushes or shortness of breath (dyspnea) and feeling unwell o a lupus-like syndrome (including rash, joint disorders, and effects on blood cells) o a severe allergic reaction causing difficulty breathing or dizziness
• liver inflammation with the following symptoms: yellowing of the skin and eyes, itching, dark urine or pale stools, feeling tired or weak, loss of appetite, liver failure (very rare)
• inflammation of the pancreas, often associated with severe abdominal pain.

The following side effects have also been reported rarely:

• decrease in red blood cells (anemia)
• numbness or weakness in the arms and legs
• headache, tingling sensation, dizziness
• digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhea, nausea, vomiting)
• skin rash, itching, hair loss
• weakness
• difficulty sleeping (very rare)
• poor memory (very rare), memory loss, confusion

The following side effects have also been reported but the frequency cannot be estimated
based on the available information (frequency not known):

• erectile dysfunction
• depression
• lung inflammation causing breathing problems including persistent cough and/or shortness of breath or fever
• tendon problems, sometimes complicated by tendon rupture.

Further possible side effects reported with some statins include:
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• sleep disturbances, including nightmares
• sexual difficulties
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

muscle pain, tenderness or weakness
that is constant and may not disappear after stopping treatment with
SINCOL (frequency not known).

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store SINCOL

Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date that is reported on the packaging after expiry:. The
expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Store at a temperature below 25°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. Contents of the pack and other information

What SINCOL 20 mg film-coated tablets contain

• The active ingredient is simvastatin. Each tablet contains 20 mg of simvastatin.
• The other ingredients are: Lactose monohydrate, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide, talc, yellow iron oxide, red iron oxide.

What SINCOL 40 mg film-coated tablets contain

• The active ingredient is simvastatin. Each tablet contains 40 mg of simvastatin
• The other ingredients are: Lactose monohydrate, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide, talc, red iron oxide.

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Description of the appearance of SINCOL and contents of the pack
SINCOL 20 mg film-coated tablets - packs of 10 and 28 tablets
SINCOL 40 mg film-coated tablets - packs of 10 and 28 tablets

Marketing Authorisation Holder
S.F. GROUP Srl
Via Tiburtina, 1143
00156 Roma

Manufacturer
Famar Italia S.p.A.
Via Zambeletti, 25
Baranzate (Milan)
Splecial Product’s Line
Strada Paduni, 240
03012
Anagni (Frosinone)
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