Simvahol

Leaflet attached to the packaging: patient information

SIMVACHOL, 10 mg, film-coated tablets
SIMVACHOL, 20 mg, film-coated tablets
SIMVACHOL, 40 mg, film-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 for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 pack 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 and triglycerides in the blood. It also increases the level of "good" cholesterol (HDL cholesterol). Simvachol belongs to a group of medicines called statins.
Cholesterol is one of several fatty substances found in the blood. Total cholesterol is mainly made up of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up on the walls of arteries, forming plaques. Eventually, these plaques can cause the arteries to narrow, restricting 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 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 developing heart disease.
While taking this medicine, you should follow a cholesterol-lowering diet.
Simvachol is used as an adjunct to diet to reduce cholesterol levels in:

• high cholesterol (primary hypercholesterolemia) or high levels of triglycerides (mixed hyperlipidemia);
• a genetic disorder (homozygous familial hypercholesterolemia) that causes high cholesterol levels. Other treatments may also be used;
• ischemic heart disease (coronary heart 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 most people, high cholesterol does not cause any symptoms. Your doctor can assess your cholesterol level by ordering a simple blood test. You should regularly attend follow-up appointments, monitor your cholesterol level, and discuss your treatment goals with your doctor.

2. Important information before taking Simvachol

When not to take Simvachol

• 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 (used to treat HIV infections),
• boceprevir and telaprevir (used to treat hepatitis C),
• 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 in doubt, 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,
• about planned surgery. It may be necessary to stop taking Simvachol for a short time,

Your doctor should perform a blood test before starting Simvachol and during treatment if you have any liver problems. The test will 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 is higher in people with high blood sugar and fat levels, overweight, and 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, particularly 80 mg. The risk of muscle breakdown is also higher in some patients. Tell your doctor if:

• you drink large amounts of alcohol;
• you have kidney disease;
• you have thyroid problems;
• you are 65 or older;
• you are female;
• you have ever had muscle problems while taking cholesterol-lowering medicines called statins or fibrates;
• you or a close relative have had muscle disorders.

Tell your doctor or pharmacist if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.

Children and adolescents

The safety and efficacy of Simvachol have been studied in boys aged 10-17 and girls who have started menstruating (at least one year before). Simvachol has not been studied in children under 10 years old. 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:

• If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking Simvachol temporarily. Your doctor will tell you when it is safe to restart Simvachol. Taking Simvachol with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). Additional information on rhabdomyolysis can be found in section 4.
• 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 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 HIV infections);
• antiviral medicines used to treat hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir;
• nefazodone (used to treat depression);
• medicines containing the active substance cobicistat;
• amiodarone (used to treat irregular heart rhythms);
• 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 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 taking this medicine with simvastatin (e.g., Simvachol). Your doctor may decide to stop Simvachol temporarily,
• colchicine (used to treat gout),
• tikagrelor (an antiplatelet medicine).

Similarly, tell your doctor or pharmacist about all medicines you are currently taking or plan to take, including those available without a prescription, and any medicines you plan to take. In particular, tell your doctor if you are taking any of the following:

• medicines containing active substances that prevent blood clots, 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).

Also, inform any doctor who prescribes you 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 that is right for you, depending on your current treatment and individual risk.
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
While taking Simvachol, you should follow a cholesterol-lowering diet.
Dosage
The recommended dose is one Simvachol tablet of 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 once daily. After at least 4 weeks of treatment, your doctor may adjust the dose to a maximum of 80 mg once daily. Do not take more than 80 mg per day.
Your doctor may prescribe lower doses, especially if you are taking certain medicines listed above or have kidney problems.
The 80 mg dose is only recommended for adult patients with very high cholesterol levels 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), the recommended initial dose is 10 mg once daily in the evening.
The maximum recommended dose is 40 mg once daily.
Administration
Take Simvachol in the evening. You can take the medicine with or without food. Take Simvachol continuously until your doctor tells you to stop.
If your doctor has prescribed a bile acid sequestrant (a cholesterol-lowering medicine), take Simvachol at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking more than the recommended dose of Simvachol

Consult your doctor or pharmacist.

Missing a dose of 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.

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 the frequency of side effects:

• 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 problems can be serious and include muscle breakdown, which can cause kidney damage, and in very rare cases, death;
• allergic reactions (hypersensitivity) in the form of:
• swelling of the face, tongue, and throat that can cause difficulty breathing (angioedema),
• -severe muscle pain, usually in the shoulder and hip area,
• rash with muscle weakness and neck and limb pain,
• 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 poor health,
• 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.

The following very rare but serious side effects have been reported:

• a severe allergic reaction that causes difficulty breathing or dizziness (anaphylaxis),
• gynecomastia (breast enlargement in men),
• a rash that can occur on the skin or mouth ulcers (drug-induced lichenoid reactions),
• muscle damage,

The following side effects have also been reported rarely:

• decreased red blood cell count (anemia);
• numbness or weakness in the hands and feet;
• headache, tingling, dizziness;
• blurred vision; vision disturbances,
• gastrointestinal problems (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting);
• rash, itching, hair loss;
• weakness;
• sleep disturbances (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;
• inflammation of the lungs that can cause breathing problems, including persistent cough and (or) shortness of breath or fever;
• tendon problems, sometimes complicated by tendon rupture.

Additional possible side effects reported with some statins:

• sleep disturbances, including nightmares;
• sexual problems;
• diabetes. The development of diabetes is more likely in people with high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor your health during treatment with this medicine
• muscle pain, tenderness, or weakness that can persist even after stopping Simvachol.

Laboratory test results
Elevated 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 any 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
Reporting side effects will 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 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.
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
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
40 mg tablets: Opadry II Brown 33G26729:
Hypromellose
Lactose monohydrate
Titanium dioxide
Polyethylene glycol 3350
Glycerol triacetate
Iron oxide yellow
Iron oxide red
Iron oxide black

What Simvachol looks like and contents of the pack

Simvachol is a 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;
The 40 mg tablets are brown, approximately 10 mm in diameter.
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 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:

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