Simvahol

Leaflet accompanying the packaging: patient information

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

• 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 specifically for you. 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.

Table of contents of the 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 packaging and other information

1. What is Simvachol and what is it used for

Simvachol contains the active substance simvastatin. Simvachol is a medicine used to lower the level of cholesterol in the blood, so-called "bad" cholesterol (LDL cholesterol) and 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.
LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate on the walls of arteries, forming plaques. Eventually, these plaques can cause narrowing of the arteries, resulting in restricted or blocked blood flow to vital organs such as the heart and brain. Restricted blood flow can lead to heart attack or stroke.
HDL cholesterol is often referred to as "good" cholesterol because it helps prevent the accumulation of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat present in the blood that can contribute to an increased risk of heart disease.
While taking this medicine, you should follow a cholesterol-lowering diet.
Simvachol is used as a supplement to a cholesterol-lowering diet, in the case of:

• high cholesterol levels in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• hereditary disorders (homozygous familial hypercholesterolemia) that cause high cholesterol levels in the blood. Other treatments may also be used;
• ischemic heart disease (coronary artery disease) or a high risk of developing ischemic heart disease (due to diabetes, a history of stroke or other vascular diseases). Simvachol may prolong life by reducing the risk of heart disease, regardless of cholesterol levels in the blood. In most people, there are no direct symptoms of high cholesterol levels. Your doctor may assess your cholesterol level by ordering a simple blood test. You should regularly attend 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 function disorders;
• 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 infections),
• 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 disease in which the lining of the uterus grows outside the uterus),
• if you are currently taking or have taken within the last 7 days a medicine called fusidic acid (used to treat bacterial infections) orally or by injection. Taking fusidic acid with Simvachol may lead to 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 all your current illnesses, including allergies,
• about consuming large amounts of alcohol,
• about having had liver disease in the past. Taking Simvachol may not be suitable,
• if you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenia gravis (a disease that causes muscle weakness), because statins can sometimes exacerbate symptoms or lead to myasthenia (see section 4),

about planned surgery. It may be necessary to stop taking Simvachol for a short time,

• if you are of Asian origin, 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 perform blood tests to assess liver function after starting Simvachol. During therapy, 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 sugar and fats in the blood, are overweight, and have high blood pressure. Tell your doctor about any serious lung diseases.

You should contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness.

This can be a sign of a rare but serious side effect that can lead to kidney damage, and in very rare cases, death.
The risk of muscle damage is higher when taking higher doses of Simvachol, particularly the 80 mg dose. The risk of muscle damage is also higher in some patients. Tell your doctor if:

• you drink large amounts of alcohol;
• you have kidney disease;
• you have thyroid disorders;
• you are 65 years of age 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 hereditary muscle disorders. You should also tell your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this condition.

Children and adolescents

The safety and efficacy of Simvachol have been studied in boys aged 10-17 years and girls who have started menstruation (menstruation) at least one year earlier (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 currently taking 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 disease in which the lining of the uterus grows outside the uterus);
• medicines containing the following active substances: itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections);
• fibrates containing the following active substances: gemfibrozil and 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 heart rhythm disorders);
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases);
• 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-related 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). Similarly, tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those that are available without a prescription, as well as any medicines you plan to take. In particular, tell your doctor about medicines containing any of the following active substances:
• medicines containing substances that prevent blood clotting, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulant medicines);
• fenofibrate (also used to lower cholesterol levels);
• niacin (also used to lower cholesterol levels);
• rifampicin (used to treat tuberculosis). You should also inform any doctor who prescribes 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 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 treatment and consult your doctor immediately.
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, 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 intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Simvachol

Your doctor will determine the dose of Simvachol suitable for you, depending on your current treatment and individual risk.
Always take this medicine 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, 20, or in some cases 40 mg per day. After at least 4 weeks of treatment, your doctor may adjust the dose to a maximum of 80 mg taken once a day. Do not take more than 80 mg per day.
Your doctor may recommend lower doses, especially if you are taking certain medicines mentioned above or have certain kidney problems.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels in the blood and a high risk of heart disease, who have not achieved the target cholesterol level with lower doses.
Children and adolescents
For children (aged 10-17 years), the recommended initial dose is 10 mg once a 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 advises you to stop it.

Taking a higher dose of Simvachol than recommended

Consult your doctor or pharmacist.

Missing a dose of Simvachol

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

Stopping Simvachol treatment

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 reported:

• 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 the medicine and contact your doctor immediately or go to the emergency department of your nearest hospital.

The following serious side effects have been reported rarely:

• muscle pain, tenderness, or weakness. In rare cases, these symptoms can be severe and associated with muscle damage, leading to kidney damage; very rare cases of death have been reported.
• allergic reactions (hypersensitivity) in the form of:
• swelling of the face, tongue, and throat that can cause breathing difficulties (angioedema),
• -severe muscle pain, usually in the shoulder and hip area,
• rash with muscle weakness and neck stiffness,
• joint pain or inflammation (polymyalgia rheumatica),
• inflammation of blood vessels (vasculitis),
• unusual bruising, skin rashes, and swelling (dermatomyositis), hives, sun sensitivity, fever,
• shortness of breath (dyspnea) and malaise,
• symptoms of lupus-like disease (including rash, joint pain, and changes in blood cells).
• liver inflammation with symptoms of yellowing of the skin and whites of the eyes, itching, dark urine, or pale stools, fatigue, or weakness, loss of appetite, liver failure (very rare).
• pancreatitis, often with severe abdominal pain. The following very rare but serious side effects have been reported:
• severe allergic reaction that causes breathing difficulties or dizziness (anaphylaxis),
• gynecomastia (breast enlargement in men),
• rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid reactions),
• muscle damage. Rarely, the following side effects have also been reported:
• decreased red blood cell count (anemia);
• numbness or weakness of hands and feet;
• headache, tingling sensation, dizziness;
• blurred vision; vision disturbances,
• gastrointestinal disorders (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting);
• rash, itching, hair loss;
• weakness;
• sleep disorders (very rare);
• poor memory (very rare), memory loss, confusion. The following side 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 shortness of breath or fever;
• tendon disorders, sometimes complicated by tendon rupture;
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing);
• myasthenia gravis (a disease that causes muscle weakness).

Talk to 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.

Additional possible side effects reported during the use of some statins:

• sleep disorders, including nightmares;
• sexual disorders;
• diabetes. The development of diabetes is more likely in people with high levels of sugar and fats in the blood, overweight, and high blood pressure. Your doctor will monitor your health during treatment with this medicine.
• pain, tenderness, or weakness of muscles, which in very rare cases can persist even after stopping Simvachol. Laboratory test resultsElevated muscle enzyme activity (creatine kinase) in the blood and abnormal liver function test results have been observed.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
By reporting side effects, you can help gather more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Simvachol contains

The active substance of Simvachol is simvastatin.
One tablet contains 10 mg or 20 mg of simvastatin.
The other ingredients are:
Lactose monohydrate 200 mesh
Microcrystalline cellulose 101
Corn starch
Butylhydroxyanisole
Ascorbic acid
Citric acid
Magnesium stearate
Coating:
10 mg tablets: Opadry II Pink 33G24737:
Hypromellose
Lactose monohydrate
Titanium dioxide
Polyethylene glycol 3000
Glycerol triacetate
Iron oxide red
Iron oxide black
Indigo carmine aluminum lake
20 mg tablets: Opadry II Yellow 39G22514:
Hypromellose
Lactose monohydrate
Titanium dioxide
Polyethylene glycol 3000
Glycerol 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.
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 strengths may be marketed.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet:

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