Omistat

Package leaflet: Information for the patient

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

Simvastatin
Generic Medicine
Please read all of 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OMISTAT is and what it is used for

OMISTAT contains the active substance simvastatin. OMISTAT is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fats called triglycerides in the blood. In addition, OMISTAT increases levels of "good" cholesterol (HDL cholesterol). OMISTAT belongs to a group of medicines called statins.

Cholesterol is one of several types of fat 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. 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 building up in the arteries and protects against heart disease.

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

You must follow a cholesterol-lowering diet while taking this medicine.

OMISTAT is used in addition to diet to lower cholesterol if 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 your blood cholesterol levels. 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). OMISTAT can 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 with your doctor the goals you should aim to achieve.

2. What you should know before taking OMISTAT

Do not take OMISTAT

• if you are allergic (hypersensitive) to simvastatin or to any of the other ingredients of this medicine (listed in section 6. Package leaflet contents and other information)
• if you currently have liver problems
• if you are pregnant or breastfeeding
• if you are taking a medicine(s) containing any 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)
  • boceprevir or telaprevir (used to treat hepatitis C virus infection)
  • nefazodone (used to treat depression)
  • cobicistat
  • gemfibrozil (used to lower cholesterol)
  • ciclosporin (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, or have been administered, a medicine called fusidic acid (used to treat bacterial infection) within the last 7 days
• do not take more than 40 mg of OMISTAT if you are taking lomitapide (used to treat a rare, severe genetic cholesterol condition)

Ask your doctor for advice if you are unsure whether the medicine you are taking is included in the list above.
Warnings and precautions
Inform your doctor:

• about all your medical conditions, including allergies
• if you consume large amounts of alcohol
• if you have ever had liver disease. In this case, OMISTAT may not be suitable for you
• if you are due to undergo surgery. You may need to stop taking OMISTAT for a short period
• if you are of Asian origin, as you may require a different dose.

Your doctor will perform a blood test before you start taking OMISTAT and if you develop symptoms of
liver problems while taking OMISTAT. This test is performed to check whether your liver is functioning properly.
Your doctor may also prescribe blood tests to monitor liver function after starting treatment with OMISTAT.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high levels of sugar and fats in the blood, being overweight, and having high blood pressure.
Inform 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, although rarely, muscle problems can be serious and may include muscle tissue damage leading to kidney damage; very rare cases of death have occurred.
The risk of muscle injury is higher at higher doses of OMISTAT, particularly with the 80 mg dose. The risk of muscle injury is also increased in certain patients. Talk to your doctor if any of the following conditions apply to you:

• 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.

In addition, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be needed to diagnose and treat this condition.
Consult your doctor or pharmacist before taking OMISTAT
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 causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or cause its onset (see section 4).
Children and adolescents
The safety and efficacy of OMISTAT have been studied in adolescents aged between 10 and 17 years and in girls who have had their menstrual period (menstruation) for at least one year (see section 3: How to take OMISTAT).
OMISTAT has not been studied in children under 10 years of age. For further information, consult your doctor.
Other medicines and OMISTAT
Inform your doctor if you are taking, have recently taken or might take any other medicine containing any of the following active substances.
Taking OMISTAT with any of the following medicines may increase the risk of muscle problems (some of these have already been listed in the section “Do not take OMISTAT”).

• ciclosporin (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)
• fibrates containing active substances such as gemfibrozil or 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 section 4 of this leaflet.
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS)
• boceprevir or telaprevir (used to treat hepatitis C virus infection)
• nefazodone (used to treat depression)
• medicines containing the active substance cobicistat
• amiodarone (used to treat irregular heartbeat)
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart conditions)
• lomitapide (used to treat a rare, severe genetic cholesterol condition)
• colchicine (used to treat gout).

As with the medicines listed above, you should always inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those available without a prescription. In particular, tell your doctor if you are taking a medicine(s) 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 must inform any doctor who prescribes you a new medicine that you are taking OMISTAT.
OMISTAT with food and drink
Grapefruit juice contains one or more substances that alter how the body processes certain medicines, including OMISTAT. Consumption of grapefruit juice should be avoided.
Pregnancy and breastfeeding
Do not use OMISTAT if you are pregnant, planning to become pregnant, or suspect you may be pregnant. If you become pregnant while taking OMISTAT, stop treatment immediately and contact your doctor.
Do not use OMISTAT 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
OMISTAT is not expected to affect your ability to drive or use machines. However, you should be aware that dizziness has been reported after taking OMISTAT.
OMISTAT contains lactose
OMISTAT 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 OMISTAT

Your doctor will determine the appropriate tablet dosage for you based on your condition, current treatment, and risk profile.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
During treatment with OMISTAT, you must follow a diet aimed at reducing cholesterol levels.

Dosage:
The recommended dose is OMISTAT 10 mg, 20 mg, or 40 mg taken orally once daily.

Adults:
The usual starting dose is typically 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.
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 target cholesterol level with lower doses.

Use in children and adolescents:
For children (aged 10–17 years), the usual recommended starting dose is 10 mg daily, taken in the evening. The maximum recommended dose is 40 mg per day.

Method of administration:
Take OMISTAT in the evening. You may take it regardless of meals. Continue taking OMISTAT unless your doctor tells you otherwise.
If your doctor has prescribed OMISTAT together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must take OMISTAT at least 2 hours before or 4 hours after taking the bile acid sequestrant medicine.

If you take more OMISTAT than you should

• Contact your doctor or pharmacist.

If you forget to take OMISTAT

• Do not take a double dose to make up for the missed tablet. Take only your usual dose of OMISTAT at the next usual time.

If you stop taking OMISTAT

• Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, OMISTAT can cause side effects, although not everyone gets them.
The following terms are used to describe how frequently side effects occur:

• 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 rarely.
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.

• Muscle pain, tenderness, weakness, or cramps. In rare cases, these muscle problems may be severe and may include muscle tissue damage leading to kidney injury; and very rarely, cases of death have been reported.
• Hypersensitivity reactions (allergies) including:
  • swelling of the face, tongue, and throat which may cause difficulty breathing (angioedema)
  • severe muscle pain, usually in the shoulders or hips
  • skin rash with weakness in the legs and neck muscles
  • joint pain or inflammation (polymyalgia rheumatica)
  • inflammation of blood vessels (vasculitis)
  • unusual bruising, skin rashes and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, hot flushes
  • shortness of breath (dyspnoea) and feeling unwell
  • lupus-like symptoms (including skin rash, joint problems, and effects on blood cells)

The following very rare serious side effect has been reported:

• A severe allergic reaction causing breathing difficulties or dizziness (anaphylaxis)
• 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 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
• Inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever
• Tendon problems, sometimes complicated by tendon rupture
• Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

Contact your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Additional possible side effects reported with some statins:

• Sleep disorders, including nightmares
• Sexual difficulties
• Diabetes. This is more likely if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.
• Muscle pain, tenderness, or weakness that is persistent and may not resolve after stopping treatment with OMISTAT (frequency not known).

Laboratory values
Increases have been observed in certain blood test values related to liver function and a muscle enzyme (creatine kinase).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OMISTAT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What OMISTAT contains
The active substance is simvastatin (20 mg or 40 mg).
The excipients are: monohydrate lactose, microcrystalline cellulose, sodium starch glycolate, hydrogenated castor oil, pregelatinized starch, talc, magnesium stearate, hypromellose, anhydrous colloidal silica, macrogol 6000, titanium dioxide, butyl-hydroxyanisole.

Description of the appearance of OMISTAT and contents of the pack
OMISTAT 20 mg film-coated tablets (28 tablets of 20 mg)
OMISTAT 40 mg film-coated tablets (28 tablets of 40 mg)

Marketing Authorization Holder
AGIPS Farmaceutici Srl - Via Amendola, 4 - 16035 Rapallo (GE)

Manufacturer
FINE FOODS & Pharmaceutical N.T.M. Spa - pharmaceutical plant in Brembate - Via Grignano 43, 24041 Brembate (BG)