Simvacard 20

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Simvacard 20

20 mg, film-coated tablets
Simvastatin

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

The medicine is absolutely contraindicated in pregnancy

Table of contents of the leaflet:

• 1. What is Simvacard 20 and what is it used for
• 2. Important information before taking Simvacard 20
• 3. How to take Simvacard 20
• 4. Possible side effects
• 5. How to store Simvacard 20
• 6. Contents of the packaging and other information

1. What is Simvacard 20 and what is it used for

Simvacard 20 contains the active substance simvastatin. Simvacard 20 is a medicine used to reduce the level of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. Additionally, Simvacard 20 increases the level of "good" cholesterol (HDL cholesterol). Simvacard 20 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 called "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 a heart attack or stroke.
HDL cholesterol is often called "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 increase the risk of developing heart disease.
While taking this medicine, the patient should follow a diet that reduces cholesterol levels.
Simvacard 20 is used as a supplementary treatment to a cholesterol-reducing diet in the following cases:

• high blood cholesterol levels (primary hypercholesterolemia) or high blood fat levels (mixed hyperlipidemia);
• a hereditary disorder (homozygous familial hypercholesterolemia) that causes high blood cholesterol levels. Other treatment methods 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). Simvacard 20 may prolong the patient's life by reducing the risk of developing heart disease, regardless of their cholesterol level. In most cases, high cholesterol levels do not cause any direct symptoms. The doctor may assess cholesterol levels by ordering a simple blood test. The patient should regularly attend follow-up appointments, monitor their blood cholesterol levels, and discuss their treatment goals with their doctor.

2. Important information before taking Simvacard 20

When not to take Simvacard 20

• if the patient is allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has liver function disorders;
• if the patient is pregnant or breastfeeding;
• if the patient is 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 (used to treat 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 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 the patient is currently taking or has taken within the last 7 days a medicine called fusidic acid (used to treat bacterial infections) orally or by injection. Taking fusidic acid with Simvacard 20 can lead to serious muscle problems (rhabdomyolysis). Simvacard 20 should not be taken in doses greater than 40 mg if the patient is taking lomitapide (used to treat a rare genetic cholesterol disorder).

In case of doubt about the use of any of the above-mentioned medicines, the doctor should be consulted.

Warnings and precautions

Before starting treatment with Simvacard 20, the patient should discuss it with their doctor or pharmacist.
The patient should inform their doctor:

• about all their conditions, including allergies;
• about consuming large amounts of alcohol;
• about any history of liver disease. Taking Simvacard 20 may not be suitable;
• about any planned surgery. It may be necessary to stop taking Simvacard 20 for a short time;
• if the patient is of Asian origin, as a different dose may be suitable for this patient.

The doctor should perform a blood test before starting treatment with Simvacard 20 and during treatment if the patient has any liver disorders. The purpose of the test is to assess liver function.
The doctor may also perform blood tests to assess liver function after starting treatment with Simvacard 20.
During therapy, the doctor will closely monitor the patient's health if they 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.
The patient should inform their doctor about any serious lung diseases.

The patient should immediately contact their doctor if they 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 20, particularly the 80 mg dose. The risk of muscle breakdown is also higher in some patients. The patient should tell their doctor if:

• they consume large amounts of alcohol;
• they have kidney problems;
• they have thyroid problems;
• they are 65 years or older;
• they are female;
• they have previously experienced muscle problems while taking cholesterol-reducing medicines called "statins" or "fibrates";
• they or a close relative have been diagnosed with a hereditary muscle disorder.

The doctor or pharmacist should also be informed 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 Simvacard 20 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 20"). No studies have been conducted in children under the age of 10. For more information, the patient should consult their doctor.

Simvacard 20 and other medicines

The patient should tell their doctor about all medicines they are currently taking or plan to take. Taking these medicines with Simvacard 20 can increase the risk of muscle problems (some of which are listed in the "When not to take Simvacard 20" section).

• If it is necessary to take fusidic acid orally for the treatment of a bacterial infection, it will be necessary to temporarily stop taking Simvacard 20. The doctor will inform the patient when it is safe to restart Simvacard 20. Taking Simvacard 20 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 active substances itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections);
• fibrates containing the active substances gemfibrozil and bezafibrate (used to reduce 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, 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 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 taking this medicine with simvastatin (e.g., Simvacard 20). The doctor may decide to stop Simvacard 20 for a while;
• colchicine (used to treat gout).

The patient should also inform their doctor or pharmacist about all medicines they are currently taking or plan to take. In particular, the patient should inform their 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 reduce cholesterol levels);
• niacin (also used to reduce cholesterol levels);
• rifampicin (used to treat tuberculosis);
• tikagrelor (used to prevent heart attack or stroke).

The patient should also inform any doctor prescribing a new medicine about taking Simvacard 20.

Simvacard 20 with food and drink

Grapefruit juice contains one or more compounds that affect the action of some medicines in the body, including Simvacard 20. The patient should avoid drinking grapefruit juice.

Pregnancy and breastfeeding

Simvacard 20 should not be taken if the patient is pregnant, plans to have a child, or suspects they may be pregnant. If the patient becomes pregnant while taking Simvacard 20, they should stop treatment immediately and contact their doctor.
Simvacard 20 should not be taken during breastfeeding, as it is not known whether the medicine is excreted in breast milk.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Simvacard 20 does not affect the ability to drive or use machines. However, the patient should consider that Simvacard 20 may cause dizziness in some individuals.

Simvacard 20 contains lactose

Simvacard 20 tablets contain a sugar called lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Simvacard 20

The doctor will determine the dose of Simvacard 20 suitable for the patient based on their current treatment and individual risk.
This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
Simvacard 10 (10 mg), Simvacard 20 (20 mg), and Simvacard 40 (40 mg) are available on the market.
While taking Simvacard 20, the patient should follow a low-cholesterol diet.
Dosage
Adults:
The initial dose is 10, 20, or in some cases 40 mg per day. The 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.
The doctor may recommend lower doses, especially if the patient is taking certain medicines listed above or has certain kidney-related conditions.
A dose of 80 mg is recommended only for adult patients with very high blood cholesterol levels and a high risk of developing heart disease, who have not achieved their 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 20 should be taken once daily, in the evening. The medicine can be taken with or without food. Simvacard 20 should be taken continuously until the doctor decides to stop it.
If the doctor has prescribed Simvacard 20 with another cholesterol-reducing medicine containing a bile acid sequestrant, Simvacard 20 should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Simvacard 20 than recommended

The patient should contact their doctor or pharmacist.

Missing a dose of Simvacard 20

The patient should not take a double dose to make up for a missed dose. The next dose of Simvacard 20 should be taken the following day at the usual time.

Stopping treatment with Simvacard 20

The patient should not stop taking the medicine unless their doctor tells them to. After stopping Simvacard 20, cholesterol levels may rise again. The patient should consult their doctor or pharmacist, as their cholesterol levels may increase again.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Simvacard 20 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 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 but serious side effects that have been reported.

If the patient experiences any of the following serious side effects, they should stop taking the medicine and immediately contact their 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 cause 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 and limb stiffness;
• joint pain or inflammation (polymyalgia rheumatica);
• inflammation of blood vessels (vasculitis);
• unusual bruising, skin lesions, and swelling (dermatomyositis), hives, sun sensitivity, fever;
• shortness of breath and poor health;
• symptoms of lupus-like disease (including rash, joint problems, and blood cell changes);
• 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;
• a severe allergic reaction that causes breathing difficulties or dizziness (anaphylaxis) (very rare).

The following side effects have also been reported rarely:

• reduced red blood cell count (anemia);
• numbness or weakness in 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 visual disturbances*.

The following side effects have been reported very rarely:

• 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 disorders, 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 disorders;
• diabetes. The development of diabetes is more likely in people with high blood sugar and fat levels, overweight, and high blood pressure. The doctor will monitor the patient's health during treatment with Simvacard 20. Pain, tenderness, or persistent weakness of the muscles, which may not resolve after stopping Simvacard 20 (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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, National Institute of Public Health, ul. Chocimska 24, 00-791 Warsaw, Poland, phone: +48 22 57 27 100, fax: +48 22 57 27 109, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Simvacard 20

Store in a temperature below 25°C, in the original packaging.
Store out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Simvacard 20 contains

The active substance of Simvacard 20 is simvastatin.
Each film-coated tablet contains 20 mg of simvastatin.
The other ingredients are:
Lactose, maize starch, microcrystalline cellulose, talc, magnesium stearate, butylhydroxyanisole.
Coating: hypromellose, hydroxypropylcellulose, titanium dioxide, talc.

What Simvacard 20 looks like and contents of the pack

White, oval, film-coated tablets with a score line on both sides and marking "SVT 20" on one side.
PVC-PE-PVDC/Al blisters in a cardboard box.
Package size: 28 tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

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

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Romanian marketing authorization number, country of export:
1758/2009/01
1758/2009/02

Parallel import authorization number: 546/12 Date of approval of the leaflet: 29.09.2022

[Information about the trademark]