Simvahol

Package Leaflet: Information for the Patient

SIMVACHOL, 10 mg, coated tablets
SIMVACHOL, 20 mg, coated tablets
Simvastatin
Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What is Simvachol and what is it used for

Simvachol contains the active substance simvastatin. Simvachol is used to lower the level of cholesterol (a type of fat) in the blood, including "bad" cholesterol (low-density lipoprotein, LDL) and triglycerides. It also increases the level of "good" cholesterol (high-density lipoprotein, HDL). Simvachol belongs to a group of medicines called statins.
Cholesterol is one of several fats found in the blood. Total cholesterol is mainly made up of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of the arteries, forming plaques. Eventually, these plaques can cause the arteries to narrow, reducing or blocking blood flow to vital organs such as the heart and brain. Reduced blood flow can lead to heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the buildup of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat found in the blood that can increase the risk of heart disease.
While taking this medicine, you should follow a cholesterol-lowering diet.

Simvachol is used as an adjunct to diet to reduce the level of cholesterol in the blood in:

• high cholesterol (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• a genetic disorder (homozygous familial hypercholesterolemia) that causes high cholesterol levels in the blood. Other treatments may also be used;
• heart disease (coronary heart disease) or a high risk of developing heart disease (due to diabetes, a history of stroke, or other blood vessel diseases). Simvachol may help prolong life by reducing the risk of heart disease, regardless of cholesterol levels in the blood. Most people do not have any symptoms of high cholesterol. Your doctor can assess your cholesterol level by ordering a simple blood test. You should have regular check-ups, monitor your cholesterol level, and discuss your treatment goals with your doctor.

2. Important information before taking Simvachol

When not to take Simvachol

• if you are allergic 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 of the following medicines:
• 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 used to treat HIV infection),
• boceprevir and telaprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to lower cholesterol levels),
• cyclosporine (used in organ transplant patients),
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• if you are currently taking or have taken in the last 7 days a medicine called fusidic acid (used to treat bacterial infections) orally or by injection. Taking fusidic acid with Simvachol can cause serious muscle problems (rhabdomyolysis). Do not take Simvachol at a dose greater than 40 mg if you are taking lomitapide (used to treat a rare genetic cholesterol disorder). If you are unsure whether you are taking any of these medicines, consult your doctor.

Warnings and precautions

Tell your doctor:

• about any current medical conditions, including allergies;
• about drinking large amounts of alcohol;
• about any history of liver disease. Taking Simvachol may not be suitable if you have or have had liver disease;
• if you are planning surgery. You may need to stop taking Simvachol for a short time;
• if you are of Asian origin, as you may need a different dose. Your doctor will perform a blood test before starting Simvachol and during treatment if you have any liver problems. The test will check your liver function. Your doctor may also perform blood tests to check your liver function after starting Simvachol. During treatment, your doctor will closely monitor your health if you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high blood sugar and fat levels, are overweight, or have high blood pressure. Tell your doctor about any serious lung diseases.

Contact your doctor immediately if you experience:

unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems can be serious, including muscle breakdown, which can cause kidney damage, and in very rare cases, death.
The risk of muscle damage is higher when taking higher doses of Simvachol, especially the 80 mg dose. The risk of muscle breakdown is also higher in some patients. Tell your doctor if:

• you drink large amounts of alcohol;
• you have kidney problems;
• you have thyroid problems;
• you are 65 years or older;
• you are female;
• you have had muscle problems while taking cholesterol-lowering medicines called statins or fibrates;
• you or a close relative have had muscle disorders. You should also tell your doctor or pharmacist if you experience persistent muscle weakness.

Children and adolescents

The safety and efficacy of Simvachol have been studied in boys aged 10-17 years and girls who have had their first period (menstruation) at least one year ago (see section 3 "How to take Simvachol"). Simvachol has not been studied in children under the age of 10. For more information, consult your doctor.

Simvachol and other medicines

Tell your doctor about all medicines you are taking, have recently taken, or plan to take. In particular, tell your doctor if you are taking any of the following medicines:

• cyclosporine (often used in organ transplant patients);
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus);
• medicines containing the active substances itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections);
• fibrates containing the active substances gemfibrozil or bezafibrate (used to lower cholesterol levels);
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections);
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS);
• antiviral medicines used to treat hepatitis C virus infection, such as boceprevir, telaprevir, elbasvir, or grazoprevir;
• nefazodone (used to treat depression);
• medicines containing the active substance cobicistat;
• amiodarone (used to treat irregular heartbeats);
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain, or other heart conditions);
• lomitapide (used to treat a rare genetic cholesterol disorder);
• daptomycin (used to treat complicated skin and soft tissue infections and bacteremia). It is possible that muscle side effects may be greater when this medicine is taken with simvastatin (e.g., Simvachol). Your doctor may decide to stop Simvachol for a while;
• colchicine (used to treat gout);
• tikagrelor (an antiplatelet medicine).

Simvachol with food and drink

Grapefruit juice contains one or more compounds that affect the action of some medicines in the body, including Simvachol. You should avoid drinking grapefruit juice.

Pregnancy and breastfeeding

Do not take Simvachol if you are pregnant, planning to become pregnant, or think you may be pregnant. If you become pregnant while taking Simvachol, stop taking the medicine immediately and consult your doctor.
Do not take Simvachol while breastfeeding, as it is not known whether the medicine is excreted in breast milk.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Simvachol does not affect the ability to drive or use machines. However, you should consider that some people may experience dizziness after taking Simvachol.

Simvachol contains lactose

Simvachol tablets contain a sugar called lactose. If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Simvachol

Your doctor will determine the dose of Simvachol that is right for you, depending on your current treatment and individual risk factors.
Always take Simvachol exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
While taking Simvachol, you should follow a cholesterol-lowering diet.

Dosage
The recommended dose of Simvachol is 10 mg, 20 mg, or 40 mg, taken orally once a day.

Adults
The initial dose is 10 mg, 20 mg, or in some cases 40 mg per day. After at least 4 weeks of treatment, your doctor may adjust the dose 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 certain medicines or have kidney problems.

The 80 mg dose is only recommended for adult patients with very high cholesterol levels in the blood and a high risk of heart disease, who have not reached their target cholesterol level on lower doses.

Children and adolescents
For children (aged 10-17 years), the recommended initial dose is 10 mg per day in the evening.
The maximum recommended dose is 40 mg per day.

Method of administration
Simvachol should be taken in the evening. The medicine can be taken with or without food. Simvachol should be taken continuously until your doctor tells you to stop.

If your doctor has prescribed a medicine that binds to bile acids (cholesterol-lowering medicines), take Simvachol at least 2 hours before or 4 hours after taking the bile acid-binding medicine.

What to do if you take more Simvachol than you should

Contact your doctor or pharmacist.

What to do if you forget to take Simvachol

Do not take a double dose to make up for a forgotten dose. Take the next dose of Simvachol at the usual time the next day.

What to do if you stop taking Simvachol

Consult your doctor or pharmacist, as your cholesterol level may rise again.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Simvachol can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects are experienced:

• 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).

If you experience any of these serious side effects, stop taking Simvachol and contact your doctor or go to the emergency department of your nearest hospital immediately.

The following serious side effects have been reported rarely:

• muscle pain, tenderness, or weakness. In rare cases, these problems can be serious and cause muscle breakdown, leading to kidney damage, and in very rare cases, death;
• allergic reactions (including anaphylaxis), which can cause:
• swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema),
• severe muscle pain, usually in the shoulders and hips,
• rash with muscle weakness in the arms and neck,
• joint pain or inflammation (polymyalgia rheumatica),
• inflammation of blood vessels (vasculitis),
• unusual bruising, skin rashes, and swelling (dermatomyositis), hives, increased sensitivity of the skin to the sun, fever,
• shortness of breath (dyspnea) and feeling unwell,
• symptoms of lupus-like disease (including rash, joint pain, and changes in blood cells).
• liver inflammation with symptoms of yellowing of the skin and eyes, itching, dark urine, or pale stools, fatigue or weakness, loss of appetite, liver failure (very rare).
• pancreatitis, often with severe abdominal pain.

Tell your doctor if you experience:

weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Other possible side effects that have been reported with some statins:

• sleep disturbances, including nightmares;
• sexual problems;
• diabetes. You are more likely to develop diabetes if you have high blood sugar and fat levels, are overweight, or have high blood pressure. Your doctor will monitor your health during treatment with this medicine;
• muscle pain, tenderness, or weakness, which in very rare cases can persist even after stopping Simvachol. Laboratory test resultsElevated levels of muscle enzymes (creatine kinase) in the blood and abnormal liver function tests have been observed.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Simvachol

Do not store above 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Medicines should not be disposed of 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 Simvachol contains

The active substance is simvastatin.
One tablet contains 10 mg or 20 mg of simvastatin.
The other ingredients are:
Lactose monohydrate 200 mesh
Microcrystalline cellulose 101
Maize starch
Butylhydroxyanisole
Ascorbic acid
Citric acid
Magnesium stearate
Coating:
10 mg tablets: Opadry II Pink 33G24737:
Hypromellose
Lactose monohydrate
Titanium dioxide
Macrogol /PEG 3000
Glycerol trioctanoate
Iron oxide red
Iron oxide black
Indigo carmine aluminum lake
20 mg tablets: Opadry II Yellow 39G22514:
Hypromellose
Lactose monohydrate
Titanium dioxide
Macrogol /PEG 3000
Glycerol trioctanoate
Iron oxide yellow
Iron oxide red
Iron oxide black

What Simvachol looks like and contents of the pack

Simvachol is a round, biconvex, film-coated tablet.
The 10 mg tablets are pink, approximately 6 mm in diameter;
The 20 mg tablets are yellow, approximately 8 mm in diameter;
Pack sizes:
Simvachol, 10 mg
28 film-coated tablets
Simvachol, 20 mg
28, 56 film-coated tablets
Not all pack sizes and tablet strengths may be available.

Marketing authorization holder and manufacturer

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: +48 (22) 755 50 81
For more detailed information, contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet:

((logo of the marketing authorization holder))
((pharmacode))