Simvacard 40

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Simvacard 40
40 mg, coated tablets
Simvastatin
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

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

1. What Simvacard 40 is and what it is 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 pack and other information

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

Simvacard 40 contains the active substance simvastatin. Simvacard 40 is a medicine used to lower blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides. 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 mainly consists 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 40 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);
• a hereditary disorder (homozygous familial hypercholesterolemia) causing 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 blood vessel diseases). Simvacard 40 may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.

In most people, elevated cholesterol levels do not cause direct symptoms. Your doctor can assess your 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 40

When not to use Simvacard 40

• 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 abnormalities
• if the patient is pregnant or breastfeeding
• if the following active substance(s) are being used simultaneously:
• 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 in the treatment of 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 condition in which the tissue lining the uterus grows outside the uterus)
• if the patient is currently taking or has taken (or been administered) fusidic acid (used to treat bacterial infections) orally or by injection within the last 7 days. Concomitant use of fusidic acid with Simvacard 40 may lead to serious muscle problems (rhabdomyolysis). Do not use Simvacard 40 at a dose higher than 40 mg if the patient is taking lomitapid (used to treat a severe and rare genetic cholesterol disorder).

If in doubt whether any of the above medicines are being used, consult a doctor.
Warnings and precautions
Before starting Simvacard 40, 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 had liver disease in the past. Use of Simvacard 40 may not be appropriate.
• if you are scheduled for surgery. You may need to temporarily stop taking Simvacard 40.
• 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 40 and during treatment if you have any liver abnormalities. The test will assess liver function.
Your doctor may also perform blood tests to monitor liver function after starting Simvacard 40.
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, overweight, and high blood pressure.
Inform your doctor if you have serious lung diseases.
Contact your doctor immediately if you experience unexplained
muscle pain, tenderness or weakness. In rare cases, muscle-related side effects can 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 40 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 to diagnose and treat this condition.
Children and adolescents
Safety and efficacy have been studied in boys aged 10–17 years and in girls who have had menstruation (menarche) for at least one year (see section 3 "How to use Simvacard 40").
Studies with simvastatin have not been conducted in children under 10 years of age. For additional information, consult your doctor.
Simvacard 40 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 40 may increase the risk of muscle-related side effects (some of which are listed above under "When not to use Simvacard 40").

• If oral fusidic acid is required for the treatment of a bacterial infection, temporary discontinuation of Simvacard 40 will be necessary. Your doctor will advise when it is safe to restart Simvacard 40. Concomitant use of Simvacard 40 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 organ transplant patients)
• 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 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 related to heart disease or other heart conditions)
• lomitapid (used to treat a severe and rare genetic cholesterol disorder)
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). Muscle-related side effects may be more pronounced when this medicine is taken during simvastatin treatment (e.g. Simvacard 40). Your doctor may decide to temporarily discontinue Simvacard 40.
• colchicine (used to treat gout).

As with 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 clotting, 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 40.
Simvacard 40 with food and drink
Grapefruit juice contains one or more compounds that affect how certain medicines work in the body, including Simvacard 40. Avoid drinking beverages containing grapefruit juice.
Pregnancy and breastfeeding
Do not use Simvacard 40 if you are pregnant, planning to become pregnant, or suspect you may be pregnant. If pregnancy occurs while taking Simvacard 40, stop treatment immediately and contact your doctor.
Do not use Simvacard 40 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 operating machinery
Simvacard 40 does not affect the ability to drive or operate machinery. However, consider that dizziness may occur in some people after taking Simvacard 40.
Simvacard 40 contains lactose.
Simvacard 40 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 40

The doctor will determine the appropriate dose of the medicine for each patient depending on the current treatment and individual risk factors.
This medicine should always be used as prescribed by the doctor. If in doubt, consult a doctor or pharmacist.
While taking Simvacard 40, a cholesterol-lowering diet should be followed.

Dosage
Adults:
The initial dose is 10, 20 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 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 40 should be taken once daily in the evening. It can be taken during meals or independently of food. Simvacard 40 should be taken continuously unless the doctor advises otherwise.
If the doctor has prescribed Simvacard 40 together with another cholesterol-lowering medicine containing any bile acid sequestrant, Simvacard 40 should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Overdose of Simvacard 40

• Contact a doctor or pharmacist immediately.

Missed 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 following day.

Stopping Simvacard 40

• Do not stop taking this medicine unless advised by a doctor. After stopping Simvacard 40, cholesterol levels may rise again. Consult a doctor or pharmacist, as cholesterol levels may increase again.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people)
• Frequency not known (cannot be estimated from the available data)

Listed below are rare but serious adverse effects.
If any of the serious adverse effects listed below occur, treatment must be discontinued immediately
and a doctor should be contacted without delay or the patient should go to the nearest hospital emergency department.

• Muscle pain, tenderness, weakness, or cramps. In rare cases, these symptoms may be severe and associated with breakdown of muscle tissue leading to kidney damage; very rare fatal cases have been reported
• Hypersensitivity reactions (allergic reactions) such as:
• Swelling of the face, tongue, and throat, possibly causing breathing difficulties (angioedema)
• Severe muscle pain, usually in the shoulder and hip joints
• Rash with muscle weakness in the limbs and neck
• Joint pain or inflammation (rheumatic polyarthritis)
• Inflammation of blood vessels (vasculitis)
• Unusual bruising, skin lesions, and swelling (dermatomyositis), urticaria, photosensitivity, fever, hot flushes
• Shallow breathing (dyspnoea) 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-coloured urine or pale stools, fatigue or weakness, loss of appetite, liver failure (very rare)
• Pancreatitis, often with severe abdominal pain
• Severe allergic reaction causing difficulty breathing or dizziness (anaphylaxis) (very rare)

The following adverse effects have also been reported rarely:

• Decrease in the number of red blood cells (anaemia)
• Numbness or weakness in the 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 effects have been reported very rarely:

• Muscle rupture*
• Gynaecomastia (enlargement of breasts in males)*
• Rash which may affect the skin or cause ulceration of the oral mucosa (lichenoid mucocutaneous lesions)*
• Sleep disorders
• Memory impairment

The following adverse 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 dyspnoea or fever
• Tendon disorders, sometimes complicated by tendon rupture

*Adverse effects observed in patients treated with ezetimibe and simvastatin or medicines
containing ezetimibe or simvastatin as active substances
Additional possible adverse effects reported during treatment with certain statins:

• Sleep disorders, including nightmares
• Sexual dysfunction
• Diabetes. The development of diabetes is more likely in individuals 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 40 (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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Simvacard 40

Store below 25°C, in the original packaging.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

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

What Simvacard 40 looks like and contents of the pack
White, oval, film-coated tablets, with a breakline on both sides and engraved "SVT 40" on one side.
Pack size: 28 tablets.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Romania, 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, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing Authorisation Number in Romania, country of export: 1759/2009/01
Parallel Import Authorisation Number: 399/22