SIMBATRIX 10 mg Tabletki Powlekane

Treść ulotki

1. SIMBATRIX 10 mg FILM-COATED TABLETS, 20 mg FILM-COATED TABLETS, 40 mg FILM-COATED TABLETS

SIMBATRIX 10 mg FILM-COATED TABLETS, 20 mg FILM-COATED TABLETS, 40 mg FILM-COATED TABLETS

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

SIMBATRIX contains the active ingredient simvastatin. SIMBATRIX is a medicine used to
reduce levels of total cholesterol, of “bad” cholesterol (LDL cholesterol) and of fatty substances
called triglycerides in the blood. In addition, SIMBATRIX increases levels of “good” cholesterol
(HDL cholesterol). SIMBATRIX belongs to a group of medicines called statins. Cholesterol is one of
several fatty substances found in the bloodstream.
Total cholesterol is mainly made up of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can build up in the
walls of the arteries forming plaques. Over time, this build-up in the form
of plaque can lead to a 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 the flow of
blood can cause a heart attack or a 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 can increase the risk of
heart disease.
You must follow a cholesterol-lowering diet during treatment with this
medicine.
SIMBATRIX is used in addition to diet to reduce cholesterol if you have:

• increased levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• an inherited condition (familial hypercholesterolemia homozygote) that increases your cholesterol levels in the blood. You may also be taking other medicines.
• coronary heart disease (CHD) or if you are at high risk of CHD (because you have diabetes, or have had a stroke, or have another disease of the blood vessels). SIMBATRIX can prolong survival by reducing the risk of heart disease-related problems, regardless of cholesterol levels in the blood.

In most people, there are no immediate symptoms due to high cholesterol
levels. Your doctor can check your cholesterol with a simple blood test.
See your doctor regularly, keep track of your cholesterol levels and define goals to achieve with
your doctor.

• 2. What you need to know before you take SIMBATRIX

Do not take SIMBATRIX:

• 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 any medicine(s) containing one or more of the following active substances:
• itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections),
• erythromycin, clarithromycin or telithromycin (used to treat infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used for HIV infections),
• Hepatitis C antiviral agents for example boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• cobicistat (used in HIV infection therapy),
• 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 have taken, in the last 7 days, or have been given a medicine called fusidic acid (used to treat bacterial infection, orally or by injection). The combination of fusidic acid and SIMBATRIX can cause serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of SIMBATRIX 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 taking is among those listed
above.

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

• about all health conditions including allergies
• if you consume significant amounts of alcohol
• if you have ever had a liver disease. In this case SIMBATRIX may not be suitable for you
• if you are going to have surgery. You may need to stop taking SIMBATRIX for a short period
• if you are Asian, because a different dose may be appropriate for you.

Your doctor will need to have a blood test before giving you SIMBATRIX and if you have
symptoms of liver problems while taking SIMBATRIX. This test is done
to know if the liver is working properly.
Your doctor may also prescribe blood tests to check liver function
after starting therapy with SIMBATRIX.
During treatment with this medicine, your doctor will carefully monitor that you do not
have diabetes or are at risk of developing diabetes. There is a 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 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 damage is higher at higher doses of SIMBATRIX, particularly
with the 80 mg dose. The risk of muscle damage is also higher in some patients. Talk
to your doctor if any of the following conditions apply to you:

• 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.

In addition, 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 SIMBATRIX have been studied in boys aged 10 to
17 years and in girls who have started menstruating (menstruation) for at least one
year (see section 3 “How to take SIMBATRIX”). SIMBATRIX has not been studied in
children under 10 years of age. For more information, ask your doctor.

Other medicines and SIMBATRIX
Tell your doctor or pharmacist if you are taking, have recently taken or could
take any other medicine containing any of the following active substances.
Taking SIMBATRIX 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
SIMBATRIX” 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 start treatment with SIMBATRIX again. Taking SIMBATRIX 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 develops outside the uterus)
• medicines with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections)
• fibrates with active ingredients such as gemfibrozil and bezafibrate (used to reduce cholesterol)
• erythromycin, clarithromycin, telithromycin, (used to treat bacterial infections),
• 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 infections)
• nefazodone (used to treat depression)
• medicines with the active ingredient cobicistat
• amiodarone (used to treat an irregular heartbeat)
• verapamil or diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart disorders)
• 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. Simbatrix). Your doctor may decide to interrupt the administration of SIMBATRIX 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 or have
recently taken any other medicines, including over-the-counter medicines. In
particular, tell your doctor if you are taking any medicine(s) 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

You must also inform your doctor who is prescribing you a new medicine that you are taking
SIMBATRIX.

SIMBATRIX with food, drinks and alcohol
Grapefruit juice contains one or more substances that change the way the body
uses some medicines, including SIMBATRIX. You should avoid consuming grapefruit
juice. Tell your doctor if you consume significant amounts of alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become
pregnant, ask your doctor or pharmacist for advice before taking this medicine.
If you become pregnant while taking SIMBATRIX, stop taking it immediately
and contact your doctor.
Do not use SIMBATRIX 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
SIMBATRIX is not expected to impair your ability to drive or operate
machinery. However, you should be aware that dizziness has been reported
after taking SIMBATRIX.

SIMBATRIX contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.

• 3. How to take SIMBATRIX

Always take this medicine exactly as your doctor has told you. If you have doubts
consult your doctor or pharmacist.
Your doctor will determine the dose of the tablet suitable for you, based on your condition, your current
treatment and your risk profile.
During treatment with SIMBATRIX, you must follow a diet to lower your
cholesterol levels.
Dosage
The recommended dose is one SIMBATRIX tablet of 10 mg, 20 mg or 40 mg by mouth
once a day.

Adults
The initial dose is usually 10, 20 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.
The dose of 80 mg 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 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 SIMBATRIX in the evening. You can take it independently of meals.
Continue taking SIMBATRIX unless your doctor tells you to stop the
treatment.
If your doctor has prescribed SIMBATRIX with another medicine to lower cholesterol
containing a bile acid sequestrant, you must take SIMBATRIX at least 2 hours
before or 4 hours after taking the bile acid sequestrant medicine.

If you take more SIMBATRIX than you should
Contact your doctor or pharmacist.

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

If you stop taking SIMBATRIX
Talk to your doctor or pharmacist as your cholesterol may increase again.
If you have any questions about using this medicine, ask your doctor or pharmacist.

• 4. Possible side effects

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

If you experience any of the following serious side effects, you must stop the
treatment and contact your doctor immediately or go to the nearest hospital emergency room.
The following serious side effects have been reported rarely:

• pain, tenderness, weakness, 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:
• swelling of the face, tongue and throat which can cause difficulty breathing (angioedema)
• severe muscle pain usually in the shoulders or hips
• skin rash with weakness in the legs and neck muscles,
• pain or inflammation in the joints (polymyalgia rheumatica)
• inflammation of blood vessels (vasculitis)
• unusual bruising, skin rashes and swelling (dermatomyositis), hives, skin sensitivity to the sun, fever, hot flushes
• shortness of breath (dyspnea) and feeling unwell
• a collection of symptoms like lupus (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 can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions)
• muscle breakdown
• gynecomastia (enlargement of the breasts in men)
• liver failure.

The following side effects have also been reported:

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 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 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

Other possible side effects reported with some statins:

• sleep disturbances, including nightmares
• sexual difficulties
• diabetes. This is more likely if you have high sugar and fat levels 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, which in very rare cases, may not go away after stopping treatment with SIMBATRIX (frequency not known).

Laboratory tests
Increases in some values of blood tests 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 https://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 SIMBATRIX

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. The expiry date refers to the last day of that month.
Store below 30°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 SIMBATRIX contains
SIMBATRIX 10 mg film-coated tablets Each tablet contains:
Active ingredient: simvastatin 10 mg
Excipients: 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.

SIMBATRIX 20 mg film-coated tablets Each tablet contains:
Active ingredient: simvastatin 20 mg
Excipients: lactose monohydrate, pregelatinized starch, butylated hydroxyanisole, ascorbic acid,
citric acid monohydrate, microcrystalline cellulose, magnesium stearate, hypromellose,
hydroxypropylcellulose, titanium dioxide, talc, yellow iron oxide.

SIMBATRIX 40 mg film-coated tablets Each tablet contains:
Active ingredient: simvastatin 40 mg
Excipients: 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 SIMBATRIX and contents of the pack:
SIMBATRIX 10 mg film-coated tablets
blister pack of 20 tablets of 10 mg

SIMBATRIX 20 mg film-coated tablets
blister pack of 28 tablets of 20 mg

SIMBATRIX 40 mg film-coated tablets
blister pack of 28 tablets of 40 mg

Marketing Authorisation Holder

• S. F. GROUP srl Via Tiburtina, n° 1143 00156 Rome

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, n° 1 03012, Anagni (FR)

LACHIFARMA Srl, Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Zona Industriale
73010 Zollino (LE) - Italy