Sincol

Package leaflet: Information for the patient

SINCOL 20 mg film-coated tablets, 40 mg film-coated tablets

Simvastatin
Generic medicine
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, 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 SINCOL is 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

1. What SINCOL is and what it is used for

SINCOL contains the active substance simvastatin. SINCOL is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and blood fats known as triglycerides. In addition, 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 made up mainly of LDL cholesterol and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such blockage of blood flow may cause a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat in the blood that may increase the risk of heart disease.

You must follow a cholesterol-lowering diet during treatment with this medicine. SINCOL is used, in addition to diet, to lower cholesterol when you have:

• elevated levels of cholesterol in the blood (primary hypercholesterolemia) or elevated levels of fats in the blood (mixed hyperlipidemia);
• an inherited condition (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 (because you have diabetes, have had a stroke, or have another blood vessel disease). SINCOL may prolong survival by reducing the risk of heart-related problems, regardless of your blood cholesterol levels.

In most people, high cholesterol does not cause immediate symptoms. Your doctor can check your cholesterol levels with a simple blood test. Visit your doctor regularly, keep track of your cholesterol values, and discuss cholesterol targets with your doctor.

2. What you need to know before taking SINCOL

Do not take SINCOL:

• if you are allergic 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 one or more of the following medicines:
  • 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 infection),
  • erythromycin, clarithromycin, telithromycin (used to treat bacterial infections),
  • nefazodone (used to treat depression), - cobicistat
  • gemfibrozil (used to lower cholesterol),
  • cyclosporine (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).
• if you are taking or have taken orally or by injection, or have been administered, a medicine called fusidic acid (used to treat bacterial infection) within the last 7 days. 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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rare, severe genetic cholesterol condition).
Ask your doctor for advice if you are unsure 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 large amounts of alcohol.
• If you have had liver disease. In this case, SINCOL may not be suitable for you.
• If you have a severe lung disease.
• If you are due to undergo surgery. You may need to stop taking SINCOL temporarily.
• If you are of Asian origin, as you may require a different dose.

Your doctor will perform a blood test before you start taking SINCOL and if you develop symptoms of liver problems while taking SINCOL. This test checks whether your liver is functioning properly.
Your doctor may also prescribe periodic blood tests to monitor liver function after starting treatment with SINCOL.
During treatment 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 the blood, are overweight, or have high blood pressure.
Inform your doctor if you have a severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness of unknown cause. This is because, rarely, muscle problems can be serious and may include muscle tissue damage leading to kidney damage; very rarely, cases of death have occurred.
The risk of muscle damage is higher at higher doses of SINCOL, particularly at the 80 mg dose. The risk of muscle damage is also increased in certain patients. Talk to your doctor if any of the following conditions apply to you:

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• 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 previously experienced muscle problems during treatment with cholesterol-lowering medicines known as “statins” or fibrates
• you or a close family member suffer from an inherited muscle disease.

Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and medications may be needed to diagnose and treat this condition.

Children and adolescents
The safety and efficacy of SINVACOR have been studied in adolescents aged between 10 and 17 years and in girls who have had menstrual periods (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 further information, consult your doctor.

Use in the elderly
Dosage adjustments are not necessary in the elderly. However, if you are over 65 years old, you should be aware that you may be more prone to muscle damage.

Other medicines and SINCOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines containing any of the following active substances.
It is particularly important that your doctor knows if you are taking any of the following medicines. Taking SINCOL together with any of these medicines may increase the risk of muscle problems (some of which have already been listed above in the section “Do not take SINCOL”).

• 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 treatment with SINCOL. Taking SINCOL with fusidic acid may rarely cause muscle weakness, pain, or soreness (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) 4 / 10
• fibrates such as gemfibrozil and bezafibrate (used to lower cholesterol)
• erythromycin, clarithromycin, telithromycin, or fusidic acid (used to treat bacterial infections). Do not take fusidic acid while using this medicine (see also section “Do not take SINCOL”)
• 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 containing the active substance cobicistat
• nefazodone (used to treat depression)
• amiodarone (used to treat 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 rare, severe genetic cholesterol condition)
As with the medicines listed above, you must always inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription. In particular, tell your doctor if you are taking a medicine containing any of the following active substances:

• medicines with an active substance 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).

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 alter how the body processes certain medicines, including SINCOL. Consumption of grapefruit juice should be avoided.

Pregnancy and breastfeeding
Do not use SINCOL during pregnancy, if you are planning a pregnancy, or if you suspect you are pregnant. If you become pregnant while taking SINCOL, stop treatment immediately and contact your doctor.
Do not use SINCOL while 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 affect your ability to drive or operate machinery.
However, you should be aware that dizziness has been reported after taking SINCOL.
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SINCOL contains lactose
SINCOL tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Sincol

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
During treatment with SINCOL, you must follow a diet aimed at reducing cholesterol levels.
Your doctor will determine the appropriate tablet dosage for you based on your condition, current
treatment, and risk profile.
Dosage:
The recommended dose of SINCOL is one tablet of 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg taken orally once daily.
Take SINCOL in the evening. You may take it regardless of meals.
Adults:
The usual starting dose is generally 10 mg, 20 mg, or, in some cases, 40 mg per day. Your 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. Your doctor may prescribe lower doses, especially if you are taking any 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 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:
Children and adolescents:
For children and adolescents (10–17 years of age), the usual recommended starting dose is 10 mg per day, taken in the evening. The maximum recommended dose is 40 mg per day.
Method of administration:
Take SINCOL in the evening. You may take it regardless of meals. Continue taking SINCOL unless your doctor tells you to stop treatment.
If your doctor has prescribed SINCOL together with a bile acid sequestrant (a 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 may 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 the missed tablet. Take only your usual dose of SINCOL the next day at the regular time.
If you stop taking SINCOL
Talk to your doctor or pharmacist, as your cholesterol levels may rise again.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, SINCOL may cause side effects, although not everybody experiences them.
The following terms are used to describe how often the side effects occur:

• Rare (affects 1 to 10 people in 10,000)
• Very rare (affects fewer 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 you experience any of the following serious side effects, you must stop treatment and contact your doctor immediately or go to the nearest hospital emergency department.
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• muscle pain, tenderness, weakness, or cramps. In rare instances, these muscle problems may be severe and may include muscle tissue damage leading to kidney problems; and very rarely, cases of death have been reported
• allergic reactions including:
  o swelling of the face, tongue, and throat which may 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 joint pain or inflammation (polymyalgia rheumatica)
  o inflammation of blood vessels (vasculitis)
  o unusual bruising, skin rash, and swelling (dermatomyositis)
  o hives, skin sensitivity to sunlight, fever, hot flushes, shortness of breath (dyspnea), feeling unwell
  o a set of symptoms similar to lupus (including skin rash, joint disorders, and effects on blood cells)
  o a severe allergic reaction causing breathing difficulties or dizziness
• liver inflammation with the following symptoms: yellowing of the skin and eyes (jaundice), itching, dark urine, 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, but rarely:

• decrease in red blood cell count (anaemia)
• numbness or weakness in the arms and legs
• headache, tingling sensation, dizziness
• digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, 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 their frequency cannot be determined from the available data (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.

Additional possible side effects reported with some statins include:
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• sleep disorders, including nightmares
• sexual difficulties
• diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.
• persistent muscle pain, tenderness, or weakness that may not resolve after stopping treatment with SINCOL (frequency not known).

Laboratory findings
Increases in certain blood test values related to liver function and a 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 may also report side effects directly via 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 stated on the pack after exp:. The expiry date refers to the last day of that month.
The expiry date applies to the product if it is properly packaged and stored correctly.
Store below 25°C.
Do not dispose of any medicine via 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 SINCOL 20 mg film-coated tablets contains

• The active substance is simvastatin. Each tablet contains 20 mg of simvastatin.
• The other components are: Monohydrate lactose, 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 contains

• The active substance is simvastatin. Each tablet contains 40 mg of simvastatin.
• The other components are: Monohydrate lactose, 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 Authorization Holder
S.F. GROUP Srl
Via Tiburtina, 1143
00156 Rome
Manufacturer
Famar Italia S.p.A.
Via Zambeletti, 25
Baranzate (Milan)
Special Product’s Line
Strada Paduni, 240
Anagni (Frosinone)
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