Simvachol

Package leaflet: Information for the patient

SIMVACHOL, 10 mg, film-coated tablets
SIMVACHOL, 20 mg, film-coated tablets
SIMVACHOL, 40 mg, film-coated tablets
Simvastatinum
Please read this leaflet carefully before using the medicine, as it contains important information
for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Simvachol is and what it is 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 Simvachol is and what it is used for

Simvachol contains the active substance simvastatin. Simvachol is a medicine used to lower blood levels of total cholesterol, the so-called "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides. In addition, Simvachol increases the level of "good" cholesterol (HDL cholesterol). Simvachol belongs to a group of medicines called statins.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol consists mainly of LDL cholesterol and HDL cholesterol fractions.
LDL cholesterol is often called "bad" cholesterol because it can deposit on the walls of arteries, forming atherosclerotic plaques. Eventually, these plaques can narrow the arteries, restricting or blocking blood flow to vital organs such as the heart and brain. Blocked blood flow may 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 in the blood that may contribute to an increased risk of heart disease.
While taking this medicine, you should follow a cholesterol-lowering diet.
Simvachol is used as an adjunct to a cholesterol-lowering diet in the following cases:

• elevated blood cholesterol levels (primary hypercholesterolemia) or elevated blood fat levels (mixed hyperlipidemia);
• inherited disorder (homozygous familial hypercholesterolemia) causing increased blood cholesterol levels. Other treatment methods may also be used in such cases;
• ischemic heart disease (coronary artery disease) or high risk of developing ischemic heart disease (due to diabetes, previous stroke, or other vascular diseases). Simvachol may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.

Most people do not experience direct symptoms of elevated cholesterol levels. Your doctor can assess your cholesterol levels by ordering a simple blood test. You should attend regular check-ups, monitor your blood cholesterol levels, and discuss treatment goals with your doctor.

2. Important information before using Simvachol

When not to use Simvachol

• if the patient is allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6);
• if there are currently liver function disorders;
• if the patient is pregnant or breastfeeding;
• if the following medicinal product(s) containing at least one of the active substances listed below are being used simultaneously:
• 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 in the treatment of HIV infection),
• boceprevir and telaprevir (used in the treatment of hepatitis C),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to reduce cholesterol levels),
• cyclosporine (used in patients after organ transplantation),
• danazol (a synthetic hormone used in the treatment of endometriosis, a condition in which the tissue lining the uterus grows outside the uterus),
• if the patient is currently taking or has taken within the last 7 days (or has been administered) fusidic acid (used to treat bacterial infections) orally or by injection. Taking fusidic acid in combination with Simvachol may lead to serious muscle problems (rhabdomyolysis). Simvachol must not be used at doses higher than 40 mg if the patient is taking lomitapide (used to treat a severe and rare genetic disorder affecting cholesterol levels).

If in doubt whether any of the above-mentioned medicines are being used, consult a doctor.
Warnings and precautions
Inform your doctor:

• about all current medical conditions, including allergies,
• if you consume large amounts of alcohol,
• if you have a history of liver disease. The use of Simvachol may not be appropriate,
• if you are scheduled for surgery. It may be necessary to temporarily discontinue Simvachol,
• if you are of Asian descent, as a different dose may be suitable for you.

Your doctor should perform a blood test before starting Simvachol and during treatment if you have any liver disorders. The purpose of the test is to assess liver function. Your doctor may also carry out blood tests to monitor 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. The risk of developing diabetes exists in people who have high levels of blood sugar and fats, overweight, and high blood pressure.
Inform your doctor about serious lung diseases.
Contact your doctor immediately if you experience unexplained muscle pain,
tenderness or muscle weakness. In rare cases, muscle problems may be serious, including breakdown of muscle tissue leading to kidney damage, and in very rare cases, death.
The risk of muscle damage is higher when higher doses of Simvachol are used, particularly the 80 mg dose. The risk of muscle tissue breakdown is also higher in certain patients. Inform your doctor if:

• the patient consumes large amounts of alcohol;
• the patient has kidney disease;
• the patient has thyroid disorders;
• the patient is 65 years of age or older;
• the patient is female;
• the patient has ever experienced muscle problems during treatment with cholesterol-lowering medicines called statins or fibrates;
• the patient or a close relative has ever been diagnosed with inherited muscle disorders.

Inform your doctor or pharmacist if muscle weakness persists. Additional tests and treatment with other medicines may be necessary to diagnose and treat this condition.
Children and adolescents
The safety and efficacy of this medicine have been studied in boys aged 10–17 years and in girls who have had menstruation for at least one year (see section 3 “How to use Simvachol”). Simvachol has not been studied in children under 10 years of age. Consult your doctor for additional information.
Simvachol with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. In particular, inform your doctor if you are taking medicines containing any of the following active substances.
Taking these medicines together with Simvachol may increase the risk of muscle-related side effects (some of which are listed earlier in the section titled “When not to use Simvachol”).

• If oral fusidic acid is required for the treatment of a bacterial infection, temporary discontinuation of Simvachol will be necessary. Your doctor will inform you when it is safe to restart Simvachol. Taking Simvachol together with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). Additional information on rhabdomyolysis is provided in section 4.
• cyclosporine (commonly used in patients after organ transplantation);
• danazol (a synthetic hormone used in the treatment of endometriosis, a condition in which the tissue lining 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 and bezafibrate (used to reduce cholesterol levels);
• erythromycin, clarithromycin or telithromycin (medicines used to treat bacterial infections);
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used in the treatment of AIDS);
• antiviral medicines used in the treatment of hepatitis C, such as boceprevir, telaprevir, elbasvir or grazoprevir (used in the treatment of hepatitis C); nefazodone (used to treat depression);
• medicines containing the active substance cobicistat;
• amiodarone (used to treat heart rhythm disorders);
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain related to heart disease or other heart conditions);
• lomitapide (used to treat a severe and rare genetic disorder affecting cholesterol levels);
• daptomycin (a medicine 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. Simvachol). Your doctor may decide to temporarily stop Simvachol,
• colchicine (used to treat gout),
• ticagrelor (an antiplatelet medicine).

Similarly to the medicines listed above, inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription, as well as any medicines you plan to take. In particular, inform your doctor about taking medicines containing any of the following active substances:

• medicines containing active substances that prevent blood clotting, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants);
• fenofibrate (also used to reduce cholesterol levels);
• niacin (also used to reduce cholesterol levels);
• rifampicin (used to treat tuberculosis).

Inform any doctor prescribing a new medicine that you are taking Simvachol.
Simvachol with food and drink
Grapefruit juice contains one or more compounds that affect the action of certain medicines in the body, including Simvachol. Avoid drinking beverages containing grapefruit juice.
Pregnancy and breastfeeding
Do not use Simvachol in women who are pregnant, planning pregnancy, or suspect they may be pregnant. If pregnancy occurs during treatment with Simvachol, stop treatment immediately and contact your doctor.
Do not use Simvachol during 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 operate machinery. However, consider that dizziness may occur in some patients after taking Simvachol.
Simvachol contains lactose
Simvachol tablets contain a sugar called lactose. If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

3. How to use Simvachol

Your doctor will determine the appropriate dose of the medicine for you, depending on your current treatment and individual risk factors.
This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
While being treated with Simvachol, you should follow a cholesterol-lowering diet.

Dosage
The recommended dose is 1 tablet of Simvachol 10 mg, 20 mg or 40 mg taken orally once daily.

Adults
The initial dose is 10 mg, 20 mg or, in some cases, 40 mg once daily. After at least 4 weeks of treatment, your doctor may adjust the dose up to a maximum of 80 mg once daily. Do not use more than 80 mg per day.
Your doctor may recommend 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 blood cholesterol levels and a high risk of heart disease, in whom target cholesterol levels have not been achieved with lower doses.

Children and adolescents
For children (aged 10–17 years), the usual initial dose is 10 mg once daily 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 meals or independently of food. Simvachol should be taken continuously until your doctor advises you to stop.
If your doctor has prescribed Simvachol to be taken together with any bile acid sequestrants (cholesterol-lowering medicines), Simvachol should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking more Simvachol than recommended
Contact your doctor or pharmacist immediately.

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

Stopping Simvachol
Consult your doctor or pharmacist before stopping treatment, as cholesterol levels may increase again.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following terms are used to describe how frequently adverse reactions have been reported:

• rare (may affect 1 in 1,000 people);
• very rare (may affect 1 in 10,000 people);
• unknown (frequency cannot be estimated from the available data).

If any of these serious adverse reactions occur, stop taking the medicine immediately and contact your doctor
or go to the nearest hospital emergency department without delay.
The following rare serious adverse reactions have been reported:

• muscle pain, tenderness, weakness, or cramps. In rare cases, these symptoms may be severe and associated with muscle breakdown leading to kidney damage; very rare fatal cases have been reported.
• hypersensitivity reactions (allergic reactions) such as:
• swelling of the face, tongue, and throat causing breathing difficulties (angioedema),
• severe muscle pain, usually in the shoulder and hip joint areas,
• rash with muscle weakness in limbs and neck,
• joint pain or inflammation (polymyalgia rheumatica),
• inflammation of blood vessels (vasculitis),
• unusual bruises, skin lesions, and swelling (dermatomyositis), urticaria, photosensitivity, fever, hot flushes,
• shallow breathing (dyspnoea) and malaise,
• symptoms of lupus-like disease (including rash, joint problems, and blood cell changes).
• hepatitis with symptoms of yellowing of the skin and whites of the eyes (jaundice), itching, dark-coloured urine or pale-coloured stools, fatigue or weakness, loss of appetite, liver failure (very rare).
• pancreatitis, often with severe abdominal pain.

The following very rare serious adverse reactions have been reported:

• severe allergic reaction causing breathing difficulties or dizziness (anaphylaxis),
• gynaecomastia (enlargement of breasts in men),
• rash which may affect the skin or cause ulceration of the mucous membranes in the mouth (lichenoid mucosal lesions),
• muscle damage.

The following adverse reactions have also been rarely reported:

• decrease in red blood cells (anaemia);
• numbness or weakness in hands and feet;
• headaches, tingling sensations, dizziness;
• blurred vision; visual disturbances;
• gastrointestinal disorders (abdominal pain, constipation, bloating, indigestion, diarrhoea, nausea, vomiting);
• rash, itching, hair loss;
• weakness;
• sleep disorders (very rare);
• poor memory (very rare), memory loss, confusion.

The following adverse reactions have also been reported, but their frequency cannot be determined from
the available data (frequency unknown):

• erectile dysfunction;
• depression;
• lung inflammation causing breathing problems, including persistent cough and/or dyspnoea or fever;
• tendon disorders, sometimes complicated by tendon rupture.

Additional possible adverse reactions reported during the use of certain statins:

• sleep disorders, including nightmares;
• sexual dysfunction;
• diabetes. The occurrence of diabetes is more likely in individuals with high blood sugar and lipid levels, overweight, and high blood pressure. Your doctor will monitor your health during treatment with this medicine.
• muscle pain, tenderness, or weakness, which in very rare cases may persist despite discontinuation of Simvachol.

Laboratory test results
Increased activity of muscle enzymes (creatine kinase) in blood and abnormal liver function test results have been observed.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.
Adverse reactions may also be reported to the marketing authorisation holder.

5. How to store Simvachol

Do not store above 25°C.
Keep the medicine in a place invisible and out of reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Simvachol contains
The active substance is simvastatin.
Other ingredients are:
Monohydrate lactose 200 mesh
Microcrystalline cellulose 101
Pregelatinized corn starch
Butylhydroxyanisole
Ascorbic acid
Citric acid
Magnesium stearate

Tablet coating composition:
10 mg tablets: Opadry II Pink 33G24737:
Hypromellose
Monohydrate lactose
Titanium dioxide
Macrogol /PEG 3000
Glyceryl triacetate
Iron oxide red
Iron oxide black
Aluminum indigo carmine lake

20 mg tablets: Opadry II Yellow 39G22514:
Hypromellose
Monohydrate lactose
Titanium dioxide
Macrogol /PEG 3000
Glyceryl triacetate
Iron oxide yellow
Iron oxide red
Iron oxide black

40 mg tablets: Opadry II Brown 33G26729:
Hypromellose
Monohydrate lactose
Titanium dioxide
Macrogol /PEG 3350
Glyceryl triacetate
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.
Film-coated tablets containing 10 mg of simvastatin are pink, with a diameter of approximately 6 mm;
Film-coated tablets containing 20 mg of simvastatin are yellow, with a diameter of approximately 8 mm;
Film-coated tablets containing 40 mg of simvastatin are brown, with a diameter of approximately 10 mm.

Pack sizes:
Simvachol, 10 mg
28 film-coated tablets
Simvachol, 20 mg
28, 56 film-coated tablets
Simvachol, 40 mg
28 film-coated tablets
Not all pack sizes and tablet strengths may be marketed.

Marketing Authorisation 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 further information, please 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
[email protected]

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