Simvacard 40

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Simvacard 40

40 mg, film-coated tablets

Simvastatin

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

The medicine is absolutely contraindicated in pregnancy

Table of contents of the leaflet:

• 1. What is Simvacard 40 and what is it used for
• 2. Important information before taking Simvacard 40
• 3. How to take Simvacard 40
• 4. Possible side effects
• 5. How to store Simvacard 40
• 6. Contents of the packaging and other information

1. What is Simvacard 40 and what is it used for

Simvacard 40 contains the active substance simvastatin. Simvacard 40 is a medicine used to lower the level of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. Additionally, Simvacard 40 increases the level of "good" cholesterol (HDL cholesterol). Simvacard 40 belongs to a group of medicines called statins.
Cholesterol is one of several fatty substances present 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 or blocking the flow of blood to vital organs such as the heart and brain.
Restricting blood flow can lead to a 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 can increase the risk of developing heart disease.
While taking this medicine, you should follow a cholesterol-lowering diet.
Simvacard 40 is used as a complementary measure to a cholesterol-lowering diet in the following cases:

• high blood cholesterol (primary hypercholesterolemia) or high blood fat (mixed hyperlipidemia);
• a hereditary disorder (homozygous familial hypercholesterolemia) that causes high blood cholesterol. 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). Simvacard 40 may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.

In most people, high cholesterol does not cause any symptoms. Your doctor may assess your cholesterol level by ordering a simple blood test. You should regularly attend check-ups, monitor your blood cholesterol levels, and discuss your treatment goals with your doctor.

2. Important information before taking Simvacard 40

When not to take Simvacard 40

• 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)
• nefazodone (used to treat depression)
• cobicistat
• gemfibrozil (used to lower cholesterol)
• 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 in the last 7 days a medicine called fusidic acid (used to treat bacterial infections) orally or by injection. Taking fusidic acid with Simvacard 40 can lead to serious muscle problems (rhabdomyolysis). Do not take Simvacard 40 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 the above medicines, consult your doctor.

Warnings and precautions

Before starting Simvacard 40, discuss it with your doctor or pharmacist.
You should inform your doctor:

• about all your illnesses, including allergies.
• about consuming large amounts of alcohol.
• about having had liver disease in the past. Taking Simvacard 40 may not be suitable.
• about planned surgery. It may be necessary to stop taking Simvacard 40 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 Simvacard 40 and during treatment if you have any liver problems. The purpose of the test is to assess liver function.
Your doctor may also perform blood tests to assess liver function after starting Simvacard 40.
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 blood sugar and fat levels, are overweight, and have high blood pressure.
You should inform your doctor about severe lung diseases.

You should contact your doctor immediately if you experience:

unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems can be serious, including muscle breakdown leading to

kidney damage, and in very rare cases, death.
The risk of muscle damage is higher when taking higher doses of Simvacard 40, particularly the 80 mg dose. The risk of muscle breakdown is also higher in some patients. You should tell your doctor if:

• you consume 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 hereditary muscle disorders.

You should also inform 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 simvastatin 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 Simvacard 40").
No studies have been conducted on simvastatin in children under the age of 10. For more information, consult your doctor.

Simvacard 40 and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Taking these medicines with Simvacard 40 can increase the risk of muscle problems (some of which are listed above).

• If it is necessary to take fusidic acid orally for the treatment of a bacterial infection, it will be necessary to temporarily stop taking this medicine. Your doctor will inform you when it is safe to restart Simvacard 40. Taking Simvacard 40 with fusidic acid can, in rare cases, lead to 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 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)
• 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, 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 (a medicine 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 during simvastatin treatment (e.g., Simvacard 40). Your doctor may decide to stop Simvacard 40 for a while,
• colchicine (used to treat gout).

You should also tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, you should tell your doctor about medicines containing any of the following active substances:

• medicines that prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulant medicines)
• fenofibrate (also used to lower cholesterol)
• niacin (also used to lower cholesterol)
• rifampicin (used to treat tuberculosis)
• tikagrelor (used to prevent heart attack or stroke)

You should also inform any doctor who prescribes a new medicine that you are taking Simvacard 40.

Simvacard 40 with food and drink

Grapefruit juice contains one or more compounds that affect the action of some medicines in the body, including Simvacard 40. You should avoid drinking grapefruit juice.

Pregnancy and breastfeeding

Do not take Simvacard 40 if you are pregnant, plan to have a child, or suspect you may be pregnant. If you become pregnant while taking Simvacard 40, you should stop treatment immediately and consult your doctor.
Do not take Simvacard 40 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

Simvacard 40 does not affect the ability to drive or use machines. However, you should take into account that some people may experience dizziness after taking Simvacard 40.

Simvacard 40 contains lactose.

Simvacard 40 tablets contain a sugar called lactose. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Simvacard 40

Your doctor will determine the dose of Simvacard 40 suitable for you, depending on your current treatment and individual risk.
This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
While taking Simvacard 40, you should follow a cholesterol-lowering diet.
Dosage
Adults:
The initial dose is 10, 20, or in some cases 40 mg per day. Your doctor may adjust the dose after at least 4 weeks of treatment to a maximum of 80 mg per day.

Do not take more than 80 mg per day.

Your doctor may recommend lower doses, especially if you are taking certain medicines listed above or have certain kidney problems.
A dose of 80 mg is recommended only for adult patients with very high blood cholesterol and a high risk of developing heart disease, who have not achieved the target cholesterol level with a lower dose.

Use in children and adolescents

For children and adolescents (aged 10-17 years), the recommended initial dose is 10 mg once daily in the evening.
The maximum recommended dose is 40 mg per day.
Method of administration:
Simvacard 40 should be taken once daily, in the evening. The medicine can be taken with or without food. Simvacard 40 should be taken continuously until your doctor advises you to stop it.
If your doctor has prescribed Simvacard 40 with another cholesterol-lowering medicine containing a bile acid sequestrant, you should take Simvacard 40 at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Simvacard 40 than recommended

• Consult your doctor or pharmacist.

Missing a dose of Simvacard 40

• Do not take a double dose to make up for a missed dose. Take the next dose of Simvacard 40 at the usual time the next day.

Stopping Simvacard 40

• Do not stop taking the medicine unless your doctor advises you to. After stopping Simvacard 40, your cholesterol level may rise again. Consult your doctor or pharmacist, as your cholesterol level may increase again.

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Simvacard 40 can cause side effects, although not everyone gets them.
The following terms are used to describe how often side effects are reported:

• rare (may affect up to 1 in 100 people)
• very rare (may affect up to 1 in 10,000 people)
• frequency not known (cannot be estimated from the available data)

The following are rare, serious side effects.

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

• muscle pain, tenderness, or weakness. In rare cases, these problems can be serious and include muscle breakdown 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, and chills
• shortness of breath and malaise
• symptoms of lupus-like disease (including rash, joint pain, and blood cell changes)
• liver inflammation with symptoms of yellowing of the skin and eyes, itching, dark urine, or light-colored stools, fatigue, or weakness, loss of appetite, liver failure (very rare)
• pancreatitis, often with severe abdominal pain
• a severe allergic reaction that causes breathing difficulties or dizziness (anaphylaxis) (very rare)

Rarely, the following side effects have also been reported:

• decreased red blood cell count (anemia)
• numbness or weakness of the hands and feet
• headache, tingling, dizziness
• gastrointestinal problems (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting)
• rash, itching, hair loss
• weakness
• memory loss, confusion
• blurred vision and vision disturbances*

Very rarely, the following side effects have been reported:

• muscle rupture*
• gynecomastia (breast enlargement in men)*
• a rash that can occur on the skin or mouth ulcers (drug-induced lupus-like reactions)*
• sleep disturbances
• memory impairment

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 causing breathing problems, including persistent cough and/or shortness of breath or fever
• tendon problems, sometimes complicated by tendon rupture

*Side effects observed in patients taking ezetimibe with simvastatin or medicines containing ezetimibe or simvastatin as active substances
Additional possible side effects reported during the use of 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 Simvacard 40.
• muscle pain, tenderness, or persistent weakness, which may not resolve after stopping Simvacard 40 (frequency not known)

Laboratory test results
Increased 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, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.

5. How to store Simvacard 40

Store in a temperature below 25°C, in the original packaging.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
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 packaging and other information

What Simvacard 40 contains

The active substance of Simvacard 40 is simvastatin.
Each film-coated tablet contains 40 mg of simvastatin.
The other ingredients are:
Lactose, pregelatinized starch, microcrystalline cellulose, talc, magnesium stearate,
butylhydroxyanisole.
Coating: hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), talc.

What Simvacard 40 looks like and contents of the packaging

White, oval, film-coated tablets with a score line on both sides and marking on one side: "SVT 40".
Pack size: 28 tablets.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Zentiva k.s., U kabelovny 130, 102 37 Prague 10, Dolní Mecholupy, Czech Republic

Manufacturer:

Zentiva k.s., U kabelovny 130, 102 37 Prague 10, Dolní Mecholupy, Czech Republic

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Romania, the country of export:1759/2009/01

Parallel import authorization number: 399/22 Date of leaflet approval: 07.11.2022

[Information about the trademark]