SIMVASTATINA 10 mg Tabletki Powlekane

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1. SIMVASTATINA ABC 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What is Simvastatina ABC and what it is used for
   2. What you need to know before taking Simvastatina ABC
   3. How to take Simvastatina ABC
   4. Possible side effects
   5. How to store Simvastatina ABC
   6. Contents of the pack and other information

SIMVASTATINA ABC 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 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 Simvastatina ABC is and what it is used for
• 2. What you need to know before you take Simvastatina ABC
• 3. How to take Simvastatina ABC
• 4. Possible side effects
• 5. How to store Simvastatina ABC
• 6. Contents of the pack and other information

1. What is Simvastatina ABC and what it is used for

Simvastatina ABC 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 cholesterol) and
fatty substances called triglycerides in the blood.
In addition, Simvastatina ABC increases levels of “good” cholesterol (HDL cholesterol).
Cholesterol is one of the fats present in the blood.
Total cholesterol is composed mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is commonly known as “bad” cholesterol because it can build up 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 blockage of blood flow
to vital organs such as the heart and brain and, consequently, 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, 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.
Simvastatina ABC is used in addition to diet to reduce cholesterol if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia)
• an inherited condition (familial homozygous 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). Simvastatina ABC can 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.
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See your doctor regularly, keep track of your cholesterol levels, and discuss your
treatment goals to achieve with your doctor.

2. What you need to know before taking Simvastatina ABC

Do not take Simvastatina ABC

• 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:
• itraconazole, ketoconazole, posaconazole or voriconazole (used for the treatment of fungal infections),
• erythromycin, clarithromycin, telithromycin (used for the treatment of infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used for the treatment of HIV infections),
• boceprevir or telaprevir (used for the treatment of hepatitis C virus infection),
• nefazodone (used for the treatment of depression),
• Cobicistat (used in the therapy of HIV infections),
• 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 grows outside the uterus)
• if you are taking or have taken in 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 Simvastatina ABC may determine serious muscle problems (rhabdomyolysis). Do not take more than 40 mg of Simvastatina ABC if you are taking lomitapide (used to treat a severe and rare genetic condition of cholesterol). Ask your doctor for advice if you are not sure whether the medicine you are using is among those listed above.

Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatina ABC.
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 may sometimes worsen myasthenia or cause it to appear (see section 4).
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, Simvastatina ABC may not be suitable for you,
• if you are going to have surgery. It may be necessary to stop taking Simvastatina ABC for a short period of time,
• if you are Asian, because a different dosage may be more appropriate for you. Your doctor will perform a blood test before you start taking Simvastatina ABC and if you show symptoms of liver problems during treatment with Simvastatina ABC in order to check your liver function. Your doctor may also perform a blood test to check your liver function after you have started taking Simvastatina ABC.

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During treatment with this medicine, your 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 your 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 weakness.
This is necessary because, in rare cases, muscle problems can be serious and include muscle tissue damage that can cause kidney damage; very rarely, deaths have occurred.
The risk of muscle injury is greater with higher doses of Simvastatina ABC, especially 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:

• 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 during treatment with 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 have persistent muscle weakness. Further tests and medicines may be needed for diagnosis and treatment of this condition.

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

Other medicines and SIMVASTATINA ABC
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.
Taking Simvastatina ABC with any of the following medicines may increase the risk of muscle problems (some of these are already listed in the section “do not take Simvastatina ABC”):

• if you need to take fusidic acid orally to treat a bacterial infection you will have to temporarily interrupt the use of this medicine. Your doctor will tell you when it is safe to restart treatment with Simvastatina ABC. Taking Simvastatina ABC 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), 3/8
• cobicistat (used in the therapy of HIV infections),
• 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 condition of cholesterol),
• 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. Simvastatina ABC). Your doctor may decide to interrupt the intake of Simvastatina ABC 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 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)

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

Simvastatina ABC with food, drinks and alcohol
Grapefruit juice contains one or more substances that alter the way the body uses some medicines, including Simvastatina ABC. 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 may be pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine. Do not take Simvastatina ABC if you are pregnant, are trying to become pregnant or suspect you may be pregnant. If you discover that you are pregnant during treatment with Simvastatina ABC, stop taking the tablets immediately and contact your doctor.
Do not take Simvastatina ABC 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
Simvastatina ABC is not expected to affect your ability to drive or operate machinery.
However, be aware that dizziness has been reported after taking Simvastatina ABC.

Simvastatina ABC contains lactose
The tablets of Simvastatina ABC 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 Simvastatina ABC

The doctor will determine the 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.
During treatment with Simvastatina ABC, you should follow a diet to lower your cholesterol levels.
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Take Simvastatina ABC by mouth once a day, at the dosage prescribed by your doctor.
Dosage

Adults
The usual starting dose is 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 if you have kidney problems.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and a high
risk of heart disease who have not reached their ideal cholesterol level with lower doses.

Use in children and adolescents
For children (ages 10-17 years), the usual recommended starting dose is 10 mg per day, administered in the
evening. The maximum recommended dose is 40 mg per day.
Method of administration
Take Simvastatina ABC in the evening. You can take the tablet with or without food. Continue to take
Simvastatina ABC until your doctor tells you to stop treatment.
If your doctor has prescribed Simvastatina ABC with another medicine containing a bile acid sequestrant to lower your cholesterol levels, you should take Simvastatina ABC at least 2 hours before or
4 hours after taking the bile acid sequestrant medicine.

If you take more Simvastatina ABC than you should
In case of ingestion/taking an excessive dose of Simvastatina ABC, contact your
doctor or pharmacist immediately.

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

If you stop taking Simvastatina ABC
Contact your doctor or pharmacist as your cholesterol levels may rise again.
If you have any further questions on 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 any of the following serious side effects occur, stop treatment with
Simvastatina ABC and immediately inform your doctor 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 injury leading to kidney damage; and very rarely, cases of death have occurred;
• hypersensitivity reactions (allergies) including:
• swelling of the face, tongue and throat that can cause difficulty breathing (angioedema),
• severe muscle pain usually in the shoulders or hips, 5/8
• skin rash with weakness in the legs and neck muscles,
• joint pain or inflammation (rheumatic polymyalgia),
• inflammation of blood vessels (vasculitis),
• unusual bruising, skin rashes and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, flushing,
• shortness of breath (dyspnea) and feeling unwell
• a set of symptoms like lupus (including skin rash, joint disorders, and effects on blood cells);
• 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,
• pancreatitis 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 (drug-induced lichenoid eruptions),
• muscle rupture,
• gynecomastia (enlargement of the breasts in men),
• liver failure.

The following side effects have been reported rarely:

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

• low red blood cell count (anemia),
• numbness or weakness in the arms and legs,
• headache, tingling, 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 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 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 blood sugar and fat levels, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine,

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• pain, tenderness or muscle weakness that is constant, which may not improve after stopping treatment with Simvastatina ABC (frequency not known).

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the website:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Simvastatina ABC

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 pack after “Exp.:”.
The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
Do not dispose of any medicine in waste water 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 SIMVASTATINA ABC contains
SIMVASTATINA ABC 10 mg film-coated tablets
The active ingredient is simvastatin
The other ingredients are: lactose monohydrate, pregelatinized starch, butylated hydroxyanisole, ascorbic acid,
citric acid monohydrate, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropylcellulose,
titanium dioxide, talc, yellow iron oxide, red iron oxide

Simvastatina ABC 20 mg film-coated tablets
The active ingredient is simvastatin
The other ingredients are: lactose monohydrate, pregelatinized starch, butylated hydroxyanisole, ascorbic acid,
citric acid monohydrate, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropylcellulose,
titanium dioxide, talc, yellow iron oxide.

Simvastatina ABC 40 mg film-coated tablets
The active ingredient is simvastatin
The other ingredients are: lactose monohydrate, pregelatinized starch, butylated hydroxyanisole, ascorbic acid,
citric acid monohydrate, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropylcellulose,
titanium dioxide, talc, red iron oxide.

Description of the appearance of Simvastatina ABC and contents of the pack
SIMVASTATINA ABC 10 mg film-coated tablets
Pack of 20 tablets of 10 mg.
SIMVASTATINA ABC 20 mg film-coated tablets
Pack of 10 and 28 tablets of 20 mg.
SIMVASTATINA ABC 40 mg film-coated tablets
Pack of 10 and 28 tablets of 40 mg.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II,72 -10121 Torino
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Manufacturer for Simvastatina ABC 10 mg and 40 mg:
Special Product’s Line S.p.A.- Via Campobello, 15-00040 Pomezia (RM)
Manufacturer for Simvastatina ABC 20 mg:
ABC Farmaceutici S.p.A. Canton Moretti, 29 – 10015 San Bernardo d’Ivrea (TO)
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