Setorilin

Patient Information Leaflet

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

Simvastatin
Equivalent 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 they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Setorilin is and what it is used for

Setorilin contains the active substance simvastatin (belonging to a group of medicines called statins) and is used to reduce levels of total cholesterol, "bad" cholesterol (LDL), and fats known as triglycerides in the blood.
In addition, Setorilin increases levels of "good" cholesterol (HDL).
Cholesterol is one of the fats present in the blood.
Total cholesterol is mainly composed of LDL cholesterol and HDL cholesterol.
LDL cholesterol is commonly known as "bad" cholesterol because it can accumulate in the walls of arteries and form plaques. Over time, these plaques grow larger and may block the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain, leading to a heart attack or stroke.
HDL cholesterol is commonly known as "good" cholesterol because it helps prevent bad cholesterol from building up in the arteries, thereby protecting against heart disease.
Triglycerides are another type of fat present in the blood. Elevated triglyceride levels may increase the risk of heart disease.
While taking this medicine, you must follow a cholesterol-lowering diet.
Setorilin is used in addition to a cholesterol-lowering diet if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or elevated levels of fats in the blood (mixed hyperlipidemia);
• an inherited disease (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 (due to diabetes, previous stroke, or blood vessel diseases). Setorilin 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 levels with a simple blood test. Make sure to have regular check-ups, keep track of your cholesterol values, and discuss your treatment goals with your doctor.

2. What you need to know before taking Setorilin

Do not take Setorilin

• 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 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 (used to treat HIV infections),
  - boceprevir or telaprevir (used to treat hepatitis C virus infection),
  - nefazodone (used to treat depression),
  - cobicistat (used in HIV therapy),
  - 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 within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infection). The combination of fusidic acid and Setorilin can cause serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of Setorilin if you are taking lomitapide (used to treat a severe and rare 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
Talk to your doctor or pharmacist before taking Setorilin.
Inform your doctor:

• about your medical conditions, including allergies;
• if you drink large amounts of alcohol;
• if you have ever had liver disease. In this case, Setorilin may not be suitable for you;
• if you are due to undergo surgery. You may need to temporarily stop taking Setorilin;
• if you are of Asian origin, as a different dosage may be appropriate for you;
• 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 trigger its onset (see section 4). Your doctor will perform a blood test before you start taking Setorilin and if you develop symptoms of liver problems during treatment with Setorilin to monitor your liver function. Your doctor may also perform blood tests to monitor your liver function after you start taking Setorilin. 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, and have 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 necessary because, in rare cases, muscle problems can be severe and may include damage to muscle tissue that can lead to kidney damage; very rarely, cases of death have occurred.
The risk of muscle damage is higher with higher doses of Setorilin, particularly with the 80 mg dose. The risk of muscle damage is also higher 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 aged 65 years or older,
• you are female,
• you have experienced muscle problems during treatment with cholesterol-lowering medicines known as “statins” or fibrates,
• you or a close family member have a hereditary 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 Setorilin have been studied in boys and girls 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 Setorilin”). Setorilin has not been studied in children under 10 years of age. For further information, consult your doctor.

Other medicines and Setorilin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine containing any of the following active substances. Taking Setorilin 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 Setorilin”):

• 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 Setorilin. Taking Setorilin with fusidic acid may rarely lead to weakness, muscle tenderness or muscle pain (rhabdomyolysis). See more 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);

• fibrates with active substances 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 HIV infections);

• antiviral agents for hepatitis C such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection);

• nefazodone (used to treat depression);

• cobicistat (used in the treatment of HIV infections);

• 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 severe and rare genetic cholesterol condition);

• daptomycin (used to treat complicated skin and soft tissue infections and bacteremia).
  The risk of muscle-related side effects may be increased when this medicine is taken during treatment with simvastatin (e.g. Setorilin). Your doctor may decide to have you temporarily stop taking Setorilin.

• colchicine (used to treat gout).
  As with the medicines listed above, inform 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, inform your doctor if you are taking medicines containing any of the following active substances:

• medicines with an active substance to prevent blood clotting, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants);

• fenofibrate (also used to lower cholesterol);

• niacin (also used to lower cholesterol);

• rifampicin (used to treat tuberculosis).
  Inform your doctor that you are taking Setorilin if they are prescribing a new medicine.

Setorilin with food, drinks and alcohol
Grapefruit juice contains one or more substances that alter how the body processes certain medicines, including Setorilin. Therefore, grapefruit juice should be avoided.
Inform your doctor if you consume large amounts of alcohol.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Setorilin if you are pregnant, trying to become pregnant, or suspect you are pregnant. If you find out you are pregnant while taking Setorilin, stop taking the tablets immediately and contact your doctor.
Do not take Setorilin while breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines
Setorilin is not expected to affect your ability to drive or use machines. However, bear in mind that dizziness has been reported after taking Setorilin.

Setorilin contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Setorilin

Your doctor will determine the most appropriate tablet dosage for you based on your condition,
your current treatment, and your risk factors.
Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
During treatment with Setorilin, you must follow a diet aimed at reducing cholesterol levels.
Take Setorilin orally once daily, at the dosage prescribed by your doctor.

Dosage
Adults
The usual starting dose is 10, 20, or in some cases, 40 mg per day. Your doctor may adjust the dose after at least 4 weeks have passed, up to a maximum of 80 mg per day.
Do not take more than 80 mg per day.
Your doctor may prescribe you a lower dose, especially if you are taking certain medicines as 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 achieved their target cholesterol levels with lower doses.

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

Method of administration
Take Setorilin in the evening. You may take the tablet with or without food. Continue taking Setorilin for as long as your doctor advises you to continue treatment.
If your doctor has prescribed Setorilin together with another medicine containing a bile acid sequestrant to lower cholesterol levels, you must take Setorilin at least 2 hours before or 4 hours after taking the bile acid sequestrant medicine.

If you take more Setorilin than you should
In case of accidental overdose or ingestion of an excessive dose of Setorilin, contact your doctor or pharmacist immediately.

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

If you stop taking Setorilin
Consult 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, this medicine can cause side effects, although not everyone experiences them.
If you experience any of the following serious side effects, stop treatment with Setorilin and contact your doctor immediately or go to the nearest hospital emergency department.
The following rare serious side effects have been reported:

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

• a severe allergic reaction causing breathing difficulties or dizziness (anaphylaxis);
• skin rash which may occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions);
• muscle breakdown;
• gynaecomastia (enlargement of the breast in men);
• liver failure.

The following additional side effects have also been reported:
Rare side effects (may affect up to 1 in 1,000 people):

• reduction in red blood cell count (anaemia);
• numbness or weakness in the arms and legs;
• headache, tingling sensation, dizziness;
• blurred vision and visual disturbances;
• digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting);
• skin rash, itching, hair loss;
• weakness.

Very rare side effects (may affect up to 1 in 10,000 people):

• difficulty falling asleep (insomnia);
• poor memory, memory loss, confusion.

Not known frequency side effects (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 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 worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or breathlessness.

Other 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 persistent weakness which, in very rare cases, may not improve after stopping treatment with Setorilin (frequency not known).

Laboratory tests
Increases in blood test values related to liver function and 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 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 Setorilin

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date which is stated on the packaging after the term
“Exp.”.
The expiry date refers to the last day of that month.
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. Contents of the pack and other information

What Setorilin contains
Setorilin 20 mg film-coated tablet:
Each tablet contains 20 mg of simvastatin.
The other components are: monohydrate lactose, pregelatinized starch, butylhydroxyanisole, ascorbic acid, monohydrate citric acid, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide, talc, yellow iron oxide.
Setorilin 40 mg film-coated tablet:
Each tablet contains 40 mg of simvastatin.
The other components are: monohydrate lactose, pregelatinized starch, butylhydroxyanisole, ascorbic acid, monohydrate citric acid, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide, talc, red iron oxide.

Description of the appearance of Setorilin and contents of the pack
Setorilin 20 mg film-coated tablets – pack of 10 and 28 tablets.
Setorilin 40 mg film-coated tablets – pack of 10 and 28 tablets.

Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Rome – Italy

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