Simvastatin ABC

Package leaflet: Information for the patient

SIMVASTATIN ABC 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Simvastatin
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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Simvastatina ABC contains the active substance simvastatin (belonging to a group of medicines called statins) and is used to lower 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 made up mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is commonly known as "bad" cholesterol because it can build up in the walls of arteries and form plaques. Over time, these plaques grow larger and can block arteries. This narrowing may slow down or block blood flow to vital organs such as the heart and brain, thereby causing a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from accumulating in the arteries, thus protecting against heart disease.
Triglycerides are another type of fat present in the blood. Elevated levels may increase the risk of heart disease.
While taking this medicine, you must follow a cholesterol-lowering diet.
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 disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You may also be undergoing other treatments
• coronary heart disease (CHD) or are at high risk of CHD (due to diabetes, previous strokes, or other blood vessel diseases). Simvastatina ABC may 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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Visit your doctor regularly, keep track of your cholesterol values, and discuss your treatment goals with your doctor.

2. What you should know before taking Simvastatine ABC

Do not take Simvastatine ABC

• if you are allergic (hypersensitive) to simvastatin or to 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, 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 the treatment of HIV infections),
  • 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 Simvastatine ABC may cause serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of Simvastatine ABC 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 one of those listed above.

Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatine 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 causing weakness of the eye muscles), because statins may sometimes worsen myasthenia or cause its onset (see section 4).

Inform your doctor:

• about your health condition, including allergies,
• if you drink large amounts of alcohol,
• if you have ever had liver disease. In this case, Simvastatine ABC may not be suitable for you,
• if you are due to undergo surgery. You may need to stop taking Simvastatine ABC for a short period of time,
• if you are of Asian origin, as a different dosage may be more appropriate for you.

Your doctor will perform a blood test before you start taking Simvastatine ABC and if you develop symptoms of liver problems during treatment to monitor your liver function. Your doctor may also perform blood tests to monitor liver function after you have started taking Simvastatine ABC. During treatment with this medicine, your doctor will carefully 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. 2/8

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 important because, in rare cases, muscle problems can be serious and include damage to muscle tissue that can lead to kidney damage; very rarely, cases of death have occurred.
The risk of muscle injury is higher with higher doses of Simvastatine ABC, particularly with the 80 mg dose. The risk of muscle injury 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.

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.

Children and adolescents
The safety and efficacy of Simvastatine ABC have been studied in boys and girls aged between 10 and 17 years, and in girls who have had their menstrual periods (menstruation) for at least one year (see section 3 “How to take Simvastatine ABC”). Simvastatine ABC has not been studied in children under 10 years of age. For further information, consult your doctor.

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

• 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 Simvastatine ABC. Taking Simvastatine ABC with fusidic acid may rarely lead to muscle weakness, soreness or 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 containing gemfibrozil or 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 rare, severe 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 together with simvastatin (e.g. Simvastatine ABC). Your doctor may decide to temporarily stop your treatment with Simvastatine ABC,
• colchicine (used to treat gout),
• ribociclib (used to treat breast cancer),
• palbociclib (used to treat breast cancer).

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 containing active substances 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).

Inform any doctor who is prescribing you a new medicine that you are taking Simvastatine ABC.

Simvastatine ABC with food, drinks and alcohol
Grapefruit juice contains one or more substances that alter how the body processes certain medicines, including Simvastatine ABC. 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, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not take Simvastatine ABC if you are pregnant, trying to become pregnant, or suspect you may be pregnant. If you become pregnant while taking Simvastatine ABC, stop taking the tablets immediately and contact your doctor.
Do not take Simvastatine ABC while breastfeeding, as it is not known whether the medicine passes into breast milk.
Consult your doctor or pharmacist before taking any medicine.

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

Simvastatine ABC contains lactose
Simvastatine ABC tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Simvastatin ABC

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

Adults
The usual initial dose is 10, 20, or in some cases, 40 mg daily. Your doctor may adjust the dose after at least 4 weeks have passed, up to a maximum of 80 mg daily.
Do not take more than 80 mg daily.
Your doctor may prescribe a lower dose, especially if you are taking any 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 at high risk of heart disease who have not achieved their target cholesterol levels with lower doses.

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

Instructions for administration
Take Simvastatin ABC in the evening. You may take the tablet with or without food. Continue taking Simvastatin ABC until your doctor tells you to stop.
If your doctor has prescribed Simvastatin ABC together with another medicine containing a bile acid sequestrant to lower cholesterol levels, you must take Simvastatin ABC at least 2 hours before or 4 hours after taking the bile acid sequestrant medicine.

If you take more Simvastatin ABC than you should
If you have taken or ingested an excessive dose of Simvastatin ABC, contact your doctor or pharmacist immediately.

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

If you stop taking Simvastatin ABC
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 gets them.
If you experience any of the following serious side effects, stop treatment with Simvastatina ABC and contact your doctor immediately or go to the nearest hospital Emergency Department.

The following serious rare side effects have been reported:

• pain, tenderness, weakness, or muscle cramps. In rare cases, these muscle problems can 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 breathing difficulties (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), 5/8
• inflammation of blood vessels (vasculitis),
• unusual bruising, skin rashes and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flushes,
• shortness of breath (dyspnea) and feeling unwell,
• lupus-like symptoms (including skin rash, joint problems, 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 very rare side effects have been reported:

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

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

• decrease in red blood cell count (anaemia),
• numbness or weakness in arms and legs,
• headache, tingling sensation, dizziness,
• blurred vision, visual disturbances,
• digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, 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 the 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 weakness that is persistent and may not improve after stopping Simvastatina ABC (frequency not known).

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Laboratory tests
Increases in certain 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 can also report side effects directly via 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 Simvastatin ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.:”.
The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. 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 substance is simvastatin.
The other components are: monohydrate lactose, 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 substance is simvastatin.
The other components are: monohydrate lactose, 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 substance is simvastatin.
The other components are: monohydrate lactose, 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 pack sizes
SIMVASTATINA ABC 10 mg film-coated tablets
Pack size: 20 tablets of 10 mg.
SIMVASTATINA ABC 20 mg film-coated tablets
Pack sizes: 10 and 28 tablets of 20 mg.
SIMVASTATINA ABC 40 mg film-coated tablets
Pack sizes: 10 and 28 tablets of 40 mg.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 - 10121 Torino
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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