Simvacard 20

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Simvacard 20
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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

This medicine is absolutely contraindicated during pregnancy
Table of contents of the leaflet:

1. What Simvacard 20 is and what it is 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 pack and other information

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

Simvacard 20 contains the active substance simvastatin. Simvacard 20 is a medicine used to lower blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides. 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 fractions.
LDL cholesterol is often called "bad" cholesterol because it can deposit on the walls of arteries, forming atherosclerotic plaques. Eventually, these plaques can 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.
Simvacard 20 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);
• an inherited disorder (homozygous familial hypercholesterolemia) that causes 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 vascular diseases). Simvacard 20 may prolong life by reducing 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, monitor your blood cholesterol levels, and discuss treatment goals with your doctor.

2. Important information before using Simvacard 20

When not to use Simvacard 20

• 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 disorders;
• if the patient is pregnant or breastfeeding;
• if the patient is currently taking or has taken within the last 7 days (or has been administered) an oral or injectable medicine called fusidic acid (used to treat bacterial infections). Taking fusidic acid together with Simvacard 20 may lead to serious muscle problems (rhabdomyolysis). Do not use Simvacard 20 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 medicines listed above are being taken, consult a doctor.

Warnings and precautions

Before starting treatment with Simvacard 20, discuss this with your doctor or pharmacist.

Inform your doctor:

• about all medical conditions, including allergies;
• if you consume large amounts of alcohol;
• if you have previously had liver disease. Treatment with Simvacard 20 may not be appropriate;
• if you are scheduled for surgery. It may be necessary to temporarily stop taking Simvacard 20;
• if you are of Asian descent, as a different dose may be appropriate for you.

Your doctor should perform a blood test before starting Simvacard 20 and during treatment if you have any liver disorders. This test will assess liver function.

Your doctor may also carry out blood tests to monitor liver function after starting Simvacard 20.

During treatment, 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 weakness. In rare cases, muscle problems may be serious, including muscle breakdown leading to kidney damage, and in very rare cases, death.

The risk of muscle damage is greater when higher doses of Simvacard 20 are used, particularly the 80 mg dose. The risk of muscle breakdown is also higher in certain patients. Inform your doctor if:

• the patient consumes large amounts of alcohol;
• the patient has kidney problems;
• the patient has thyroid problems;
• 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 been diagnosed with inherited muscle disorders.

Inform your doctor or pharmacist if muscle weakness persists. Additional tests and medications may be necessary for diagnosis and treatment.

Children and adolescents

The safety and efficacy of Simvacard 20 have been studied in boys aged 10–17 years and in girls who have had their first menstrual period at least one year previously (see section 3 "How to use Simvacard 20"). Simvastatin has not been studied in children under 10 years of age. For additional information, consult your doctor.

Simvacard 20 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. Taking these medicines together with Simvacard 20 may increase the risk of muscle problems (some of which are listed above under "When not to use Simvacard 20").

• If oral fusidic acid is required for the treatment of a bacterial infection, temporary discontinuation of Simvacard 20 will be necessary. Your doctor will advise when it is safe to restart Simvacard 20. Concomitant use of Simvacard 20 with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). Additional information on rhabdomyolysis is provided 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 (used to treat infections);
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat HIV infection);
• 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). The risk of muscle-related side effects may be increased when this medicine is taken during treatment with simvastatin (e.g. Simvacard 20). Your doctor may decide to temporarily discontinue Simvacard 20;
• colchicine (used to treat gout).

Similarly to the medicines listed above, inform 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, inform your doctor if you are taking medicines containing any of the following active substances:

• medicines containing active substances that prevent blood clots, 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);
• ticagrelor (used to prevent heart attack or stroke).

Inform any doctor prescribing a new medicine that you are taking Simvacard 20.

Simvacard 20 with food and drink

Grapefruit juice contains one or more compounds that affect the way certain medicines work in the body, including Simvacard 20. Avoid drinking beverages containing grapefruit juice.

Pregnancy and breastfeeding

Do not use Simvacard 20 if you are pregnant, planning to become pregnant, or suspect you may be pregnant. If you become pregnant while taking Simvacard 20, stop treatment immediately and contact your doctor.

Do not use Simvacard 20 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

Simvacard 20 does not affect the ability to drive or operate machinery. However, consider that dizziness may occur in some people after taking Simvacard 20.

Simvacard 20 contains lactose

Simvacard 20 tablets contain a sugar called lactose. If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Simvacard 20

The doctor will determine the appropriate dose of the medicine for each individual patient, depending on the current treatment and individual risk factors.
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult a doctor or pharmacist.
The following products are available on the market: Simvacard 10 (10 mg), Simvacard 20 (20 mg), and Simvacard 40 (40 mg).
While taking Simvacard 20, a cholesterol-lowering diet should be followed.

Dosage
Adults:
The initial dose is 10 mg, 20 mg, or in some cases 40 mg once daily. The doctor may adjust the dose after at least 4 weeks of treatment, up to a maximum of 80 mg once daily. Do not use more than 80 mg per day.
The doctor may recommend lower doses, especially if the patient is taking certain of the medicines listed above or has certain kidney-related conditions.
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.

Use in children and adolescents
For children and adolescents (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
Simvacard 20 should be taken once daily in the evening. It may be taken with or without food. Simvacard 20 should be taken continuously unless the doctor advises otherwise.
If the doctor has prescribed Simvacard 20 together with another cholesterol-lowering 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.

Overdose of Simvacard 20
Contact a doctor or pharmacist immediately.

Missed dose of Simvacard 20
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time the following day.

Stopping Simvacard 20
Do not stop taking this medicine unless advised by a doctor. After stopping Simvacard 20, cholesterol levels may rise again. Consult a doctor or pharmacist, as cholesterol levels may increase once more.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• Rare (may occur in no more than 1 in 1,000 people);
• Very rare (may occur in no more than 1 in 10,000 people);
• Frequency not known (cannot be estimated from the available data).

Listed below are rare but serious adverse reactions.
If any of the following serious adverse reactions occur, stop taking the medicine immediately and contact your doctor without delay or go to the emergency department of the nearest hospital.

• 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) such as:
• Swelling of the face, tongue, and throat, which may cause difficulty in breathing (angioedema);
• Severe muscle pain, usually in the shoulder and hip joint areas;
• Rash with muscle weakness in the limbs and neck;
• Joint pain or inflammation (rheumatoid polyarthritis);
• Inflammation of blood vessels (vasculitis);
• Unusual bruising, skin rashes, and swelling (dermatomyositis), urticaria, photosensitivity, fever, hot flushes;
• Shallow breathing (shortness of breath) and malaise;
• Symptoms of lupus-like illness (including rash, joint problems, and blood cell changes);
• Liver inflammation with symptoms such as yellowing of the skin and eyes, itching, dark urine, or pale stools, fatigue or weakness, loss of appetite, liver failure (very rare);
• Inflammation of the pancreas, often with severe abdominal pain;
• Severe allergic reaction causing difficulty in breathing or dizziness (anaphylaxis) (very rare).

The following adverse reactions have also been reported rarely:

• Decrease in red blood cells (anaemia);
• Numbness or weakness in hands and feet;
• Headache, tingling sensation, dizziness;
• Gastrointestinal disturbances (abdominal pain, constipation, bloating, indigestion, diarrhoea, nausea, vomiting);
• Rash, itching, hair loss;
• Weakness;
• Memory loss, confusion;
• Blurred vision and visual disturbances*.

The following adverse reactions have been reported very rarely:

• Muscle rupture*;
• Gynaecomastia (enlargement of breasts in males)*;
• Rash affecting the skin or ulceration of the oral mucosa (lichenoid mucosal lesions)*;
• Sleep disorders;
• Memory impairment.

The following adverse reactions 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.

* Adverse reactions observed in patients treated with ezetimibe and simvastatin or medicines containing ezetimibe or simvastatin as active substances.
Additional possible adverse reactions reported during treatment with some 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. Your doctor will monitor your health during treatment with this medicine. Muscle pain, tenderness, or persistent muscle weakness, which may not resolve after discontinuation of Simvacard 20 (frequency not known).

Laboratory test results
Elevated levels of muscle enzymes (creatine kinase) in blood and abnormal liver function tests have been observed.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Simvacard 20

Store below 25°C, in the original packaging.
Keep in a place inaccessible and not visible to children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Simvacard 20 contains
The active substance is simvastatin.
Each coated tablet contains 20 mg of simvastatin.
Other ingredients:
Lactose, pregelatinized starch, microcrystalline cellulose, talc, magnesium stearate,
butylhydroxyanisole.
Coating composition: hypromellose, hydroxypropylcellulose, titanium dioxide, talc.

What Simvacard 20 looks like and contents of the pack
White, oval coated tablets with a break line on both sides and appropriate marking on one side: "SVT 20".
PVC-PE-PVDC/Al blisters in a cardboard box.
Pack size: 28 tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Romania, country of export:
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10, Czech Republic

Manufacturer:
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10, Czech Republic

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

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

Marketing Authorisation number in Romania, country of export: 1758/2009/01
1758/2009/02
Parallel Import Licence number: 546/12