KRUSTAT 40 mg Tabletki Powlekane

Treść ulotki

1. KRUSTAT 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What KRUSTAT is and what it is used for
   2. What you need to know before taking KRUSTAT
   3. HOW TO TAKE KRUSTAT
   4. Possible side effects
   5. HOW TO STORE KRUSTAT
   6. Contents of the pack and other information

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

1. What KRUSTAT is and what it is used for

KRUSTAT contains the active ingredient simvastatin. KRUSTAT 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, KRUSTAT increases levels of "good"
cholesterol (HDL cholesterol). KRUSTAT belongs to a group of medicines called statins.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is composed mainly 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 blood flow can cause a heart attack or a 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 present in the blood that can increase the risk of
heart disease.
You must follow a diet to reduce cholesterol during therapy with this
medicine.
KRUSTAT 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 disease (familial homozygous hypercholesterolemia) that increases your cholesterol levels in the blood. It is possible that you are also being treated with other therapies
• 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). KRUSTAT can prolong survival by reducing the risk of problems related to heart disease, regardless of blood cholesterol levels. In most people, no immediate symptoms appear due to high cholesterol. Your doctor is able to 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 taking KRUSTAT

Do not take KRUSTAT:

• if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information)
• 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: o itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections) o 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) o boceprevir or telaprevir (used to treat hepatitis C virus infection) o nefazodone (used to treat depression) o cobicistat o gemfibrozil (used to lower cholesterol) o cyclosporine (used in patients who have undergone organ transplantation) or 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 a medicine called fusidic acid (a medicine used to treat bacterial infection) orally or by injection. The combination of fusidic acid and KRUSTAT may cause serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of KRUSTAT 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
Tell your doctor:
o about any medical conditions you have, including allergies
o if you consume significant amounts of alcohol
o if you have ever had a liver disease. In this case, KRUSTAT may not be suitable for you
o if you need to undergo surgery. You may need to stop taking
KRUSTAT for a short period
o if you are Asian, because a different dose may be appropriate for you
o 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).
Your doctor will need to have a blood test done before giving you KRUSTAT and if you have
symptoms of liver problems while taking KRUSTAT. 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 treatment with KRUSTAT.
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
muscular for undetermined causes. 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 KRUSTAT, particularly with
the 80 mg dose. The risk of muscle injury is also greater in some patients. Talk to the
doctor if any of the following conditions apply to you:

• you consume significant amounts of alcohol
• you have kidney problems
• you have thyroid problems
• you are 65 years of age or older
• you are female
• you 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 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 simvastatin 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 KRUSTAT). Simvastatin has not been studied in
children under 10 years of age. For more information, ask your doctor.

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

• 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 KRUSTAT. Taking KRUSTAT 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 or 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 infection)
• 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 conditions)
• lomitapide (used to treat a severe and rare genetic cholesterol condition)
• 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 those available without a prescription. 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 from forming, 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 the doctor who is prescribing you a new medicine that you are taking
KRUSTAT.

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

Pregnancy and breastfeeding
Do not use KRUSTAT if you are pregnant, intend to become pregnant or suspect
you are pregnant. If you become pregnant while taking KRUSTAT, stop
immediately and contact your doctor.
Do not use KRUSTAT 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
KRUSTAT is not expected to interfere with your ability to drive or operate machinery.
However, it should be noted that dizziness has been reported
after taking KRUSTAT.
KRUSTAT contains lactose
The tablets of KRUSTAT contain a sugar called lactose. If you have been
diagnosed with intolerance to certain sugars, contact your doctor before taking the medicine.

3. HOW TO TAKE KRUSTAT

The doctor will determine the appropriate tablet dosage for you, based on your condition, your
current treatment and your risk profile.
Always take this medicine exactly as your doctor has instructed. If you have any doubts
consult your doctor or pharmacist.
During treatment with KRUSTAT, you must follow a diet to lower your
cholesterol levels.
Dosage:
The usual dose of KRUSTAT is 20 mg or 40 mg by mouth once a day.
Adults:
The initial dose is usually 20, 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 of simvastatin, especially if you are
taking some of the medicines listed above or have certain 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 (ages 10-17 years), the usual recommended starting dose of simvastatin is 10 mg per
day administered in the evening. The maximum recommended dose is 40 mg per day.
Method of administration:
Take KRUSTAT in the evening. You can take it independently of meals. Continue to take
KRUSTAT unless your doctor tells you to stop treatment.
If your doctor has prescribed KRUSTAT with another medicine to lower cholesterol
containing a bile acid sequestrant, you must take KRUSTAT at least 2 hours before or
4 hours after taking the bile acid sequestrant medicine.

If you take more KRUSTAT than you should

• contact your doctor or pharmacist.

If you forget to take KRUSTAT

• do not take a double dose to make up for a missed tablet; just take your usual dose of KRUSTAT the next day at the usual time.

If you stop taking KRUSTAT

• talk to your doctor or pharmacist as your cholesterol may increase 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, KRUSTAT can cause side effects, although not everybody gets them.
For describing the frequency with which side effects occur, the following terms are used:

• Rare (may affect up to 1 in 1,000 people).
• Very rare (may affect up to 1 in 10,000 people).
• 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 treatment and immediately contact your doctor or go to the nearest hospital emergency room:

• pain, tenderness, weakness or muscle cramps. muscle breakdown (which can affect up to 1 in 10,000 people); 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 (which includes 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, liver failure (very rare)
• inflammation of the pancreas often associated with severe abdominal pain.

The following very rare serious side effect has been reported:

• a severe allergic reaction that causes difficulty breathing or dizziness (anaphylaxis)

The following side effects have been reported rarely:

• decrease in the number of 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 falling asleep (very rare)
• poor memory (very rare), memory loss, confusion.

In addition, the following side effects have been reported in people taking medicines
containing the active substance simvastatin:

• blurred vision and impaired vision (may affect up to 1 in 1,000 people)
• skin rash that can occur on the skin or ulcers in the mouth (lichenoid drug eruptions) (may affect up to 1 in 10,000 people)
• gynecomastia (enlargement of the breasts in men) (may affect up to 1 in 10,000 people)

The following side effects have also been reported with unknown frequency (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 tendon 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.

Further 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
• pain, tenderness or weakness in muscles that is constant and may not disappear after stopping treatment with Simvastatin (frequency not known).

Diagnostic 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 KRUSTAT

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 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 KRUSTAT contains
The active ingredient is simvastatin (20 mg, 40 mg).

KRUSTAT 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.

KRUSTAT 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.

Pharmaceutical form and content
KRUSTAT 20 mg film-coated tablets(pack of 10 and 28 tablets of 20 mg).

KRUSTAT 40 mg film-coated tablets(pack of 10 and 28 tablets of 40 mg).

Marketing Authorisation Holder
S.F. Group Srl – via Tiburtina, 1143 – 00156 Roma

MANUFACTURER
Special Product’s Line S.p.A.- Via Paduni, 240 – 03012 Anagni (Frosinone).