Simvachol

Package leaflet: Information for the patient

SIMVACHOL, 10 mg, film-coated tablets
SIMVACHOL, 20 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 so that you can read it again if necessary.
• 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. The medicine may harm someone else, 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.

Table of contents of the leaflet

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 mainly consists 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 may narrow the arteries, thereby 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 present 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);
• A hereditary 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 blood vessel diseases). Simvachol may prolong life by helping to reduce 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 cholesterol levels by ordering a simple blood test. You should attend regular check-ups to monitor your blood cholesterol levels and discuss treatment goals with your doctor.

2. 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 abnormalities;
• if the patient is pregnant or breastfeeding;
• if the following medicinal products 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 to treat 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 to treat endometriosis, a condition in which the tissue lining the uterus grows outside the uterus),
• if the patient is currently taking or has taken (or has been administered) fusidic acid (used to treat bacterial infections) orally or by injection within the last 7 days. Taking fusidic acid together with Simvachol may lead to serious muscle problems (rhabdomyolysis). Do not use Simvachol at a dose 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

Tell your doctor:

• about any 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 have or have had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4),
• about any planned surgical procedures. It may be necessary to temporarily stop taking Simvachol,
• if you are of Asian origin, as a different dose may be appropriate for you.

Your doctor should perform a blood test before starting Simvachol and during treatment if you have any liver abnormalities, to assess liver function. Your doctor may also perform blood tests to monitor liver function after starting Simvachol.

Your doctor will closely monitor your health if you have diabetes or are at risk of developing diabetes. The risk of developing diabetes is higher in people who have high blood sugar and fat levels, are overweight, and have 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-related symptoms may be serious, including breakdown of muscle tissue leading to kidney damage, and in very rare cases, death.

The risk of muscle damage is greater when higher doses of Simvachol are used, especially the 80 mg dose. The risk of muscle tissue breakdown is also higher in certain patients. Tell your doctor if:

• the patient consumes large amounts of alcohol;
• the patient has kidney disease;
• the patient has thyroid dysfunction;
• 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 had inherited muscle disorders.

Inform your doctor or pharmacist if muscle weakness persists. Additional tests and medications may be needed 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 started menstruation at least one year earlier (see section 3 “How to take Simvachol”). Simvachol has not been studied in children under 10 years of age. For additional information, consult your doctor.

Simvachol and 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 were mentioned earlier in the section titled “When not to use Simvachol”).

• If oral fusidic acid is required to treat a bacterial infection, temporary discontinuation of Simvachol will be necessary. Your doctor will inform you when it is safe to restart taking Simvachol. Taking Simvachol together with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). Additional information about rhabdomyolysis can be found in section 4.
• cyclosporine (commonly used in patients after organ transplantation);
• danazol (a synthetic hormone used to treat 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 to treat AIDS);
• antiviral medicines used to treat hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat 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).

Muscle-related side effects may be more pronounced when this medicine is taken during treatment with simvastatin (e.g., Simvachol). Your doctor may decide to temporarily discontinue Simvachol.

• colchicine (used to treat gout);
• ticagrelor (an antiplatelet medicine).

Similarly, 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 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, bear in mind that dizziness may occur in some people after taking Simvachol.

Simvachol contains lactose

Simvachol tablets contain a sugar called lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Simvachol

The doctor will determine the appropriate dose of the medicine for each patient depending on the current treatment and individual risk factors.
This medicine should always be used as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
During treatment with Simvachol, a cholesterol-lowering diet should be followed.

Dosage
The recommended dose of Simvachol is 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 per day. After at least 4 weeks of treatment, the doctor may adjust the dose up to a maximum of 80 mg once daily. Do not use a dose higher than 80 mg per day.
The doctor may recommend lower doses, especially if the patient is taking any of the medicines listed above or has 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 the target cholesterol level has not been achieved with a lower dose.

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 the doctor advises to stop.
If the doctor has recommended taking Simvachol together with any bile acid sequestrant (cholesterol-lowering medicines), Simvachol should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher than recommended dose of Simvachol
Contact a doctor or pharmacist.

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

Stopping Simvachol treatment
Consult a doctor or pharmacist, as cholesterol levels may increase again.
In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

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

• rare (may affect 1 in 1,000 people);
• very rare (may affect 1 in 10,000 people);
• not known (frequency cannot be estimated from the available data). If any of these severe adverse effects occur, the medicine must be discontinued immediately and the doctor should be informed without delay or the patient should go to the nearest hospital emergency department. The following rare severe adverse effects 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 cases of death have been reported.
• hypersensitivity reactions (allergic reactions) including:
• swelling of the face, tongue and throat, which may cause breathing difficulties (angioedema),
• severe muscle pain, usually in the shoulder and hip joints,
• rash with muscle weakness in the limbs and neck,
• joint pain or inflammation (polymyalgia rheumatica),
• inflammation of blood vessels (vasculitis),
• unusual bruising, skin rashes and swelling (dermatomyositis), urticaria, photosensitivity, fever, hot flushes,
• shortness of breath (dyspnoea) and malaise,
• symptoms of lupus-like illness (including rash, joint problems and blood cell changes).
• hepatitis with symptoms such as yellowing of the skin and whites of the eyes (jaundice), itching, dark-coloured urine or pale stools, fatigue or weakness, loss of appetite, liver failure (very rare).
• pancreatitis, often associated with severe abdominal pain. The following very rare severe adverse effects have been reported:
• severe allergic reaction causing difficulty in breathing or dizziness (anaphylaxis),
• gynaecomastia (enlargement of breasts in males),
• rash affecting the skin or ulceration of the mucous membranes of the mouth (lichenoid mucocutaneous lesions),
• muscle damage. The following adverse effects have also been rarely reported:
• reduction in the number of red blood cells (anaemia);
• numbness or weakness in the 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;
• fatigue;
• sleep disturbances (very rare);
• poor memory (very rare), memory loss, confusion. The following adverse effects have also been reported, but their frequency cannot be estimated from the available data (frequency not known):
• erectile dysfunction;
• depression;
• lung inflammation causing breathing problems, including persistent cough and/or dyspnoea or fever;
• tendon disorders, sometimes complicated by tendon rupture;
• myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing);
• ocular myasthenia (a disease causing weakness of the eye muscles). Patients should consult a doctor if they experience weakness in the hands or feet that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath. Additional possible adverse effects reported during the use of certain statins:
• sleep disorders, including nightmares;
• sexual dysfunction;
• diabetes. The occurrence of diabetes is more likely in people with high blood sugar and lipid levels, overweight and high blood pressure. The doctor will monitor the patient's 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 tests have been observed. Reporting of adverse effects If any adverse effects occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse effects can be reported

directly to the Department for Monitoring Adverse Drug Reactions of the 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 adverse effects, additional information on the safety of the medicine can be collected.
Adverse effects can 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 inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. Such practices will help protect the environment.

6. Contents of the package and other information

What Simvachol contains
The active substance is simvastatin.
Each tablet contains 10 mg or 20 mg of simvastatin.
The other ingredients are:
Monohydrate lactose 200 mesh
Microcrystalline cellulose 101
Pregelatinized corn starch
Butylated hydroxyanisole
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 trioctanoate
Red iron oxide
Black iron oxide
Indigo carmine aluminium lake

20 mg tablets: Opadry II Yellow 39G22514:
Hypromellose
Monohydrate lactose
Titanium dioxide
Macrogol / PEG 3000
Glyceryl trioctanoate
Yellow iron oxide
Red iron oxide
Black iron oxide

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.

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 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]

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