Simvacard 40

Leaflet accompanying the packaging: patient information

Simvacard 10, 10 mg, film-coated tablets
Simvacard 20, 20 mg, film-coated tablets
Simvacard 40, 40 mg, film-coated tablets
(Simvastatin)

You should carefully read the contents of the leaflet before taking 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

The medicine is absolutely contraindicated in pregnancy

Table of contents of the leaflet:

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

1. What Simvacard is and what it is used for

Simvacard is used as an adjunct to a low-cholesterol diet in the following cases:

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

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 cholesterol level, and discuss your treatment goals with your doctor.

2. Important information before taking Simvacard

When not to take Simvacard

• if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6)
• if you currently have liver function disorders
• 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 (used to treat HIV infection)
• boceprevir and telaprevir (used to treat hepatitis C virus infection)
• 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 disease in which the lining of the uterus grows outside the uterus)
• if you are currently taking or have 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 may cause serious muscle problems (rhabdomyolysis). Do not take Simvacard 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 treatment with Simvacard, discuss it with your doctor or pharmacist.
You should inform your doctor:

• about all your medical conditions, including allergies.
• about consuming large amounts of alcohol.
• about any history of liver disease. Taking Simvacard may not be suitable.
• about any planned surgery. It may be necessary to stop taking Simvacard for a short time.

Simvacard for a short time.

• if you are of Asian origin, as a different dose may be suitable for you.
• if you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness, including eye muscles), as statins can sometimes exacerbate symptoms or cause myasthenia (see section 4).

Your doctor should perform a blood test before starting treatment with Simvacard and during treatment if you have any liver disorders. The purpose of the test is to assess liver function.
Your doctor may also perform blood tests to assess liver function after starting treatment with Simvacard.
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.
You should inform your doctor about any serious 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, particularly at a dose of 80 mg. 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 of age 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 been diagnosed with 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 Simvacard 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"). No studies have been conducted in children under the age of 10. For more information, consult your doctor.

Simvacard 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 may 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 Simvacard. Your doctor will inform you when it will be safe to restart Simvacard. Taking Simvacard with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis).

Additional information on rhabdomyolysis can be found in section 4.

• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). It is possible that side effects affecting the muscles may be greater when this medicine is taken with simvastatin (e.g., Simvacard). Your doctor may decide to stop Simvacard for a while,
• colchicine (used to treat gout).

You should also 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, you should inform your doctor about medicines containing any of the following active substances:

• medicines that prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants)
• fenofibrate (also used to lower cholesterol levels)
• niacin (also used to lower cholesterol levels)
• 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.

Simvacard with food and drink

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

Pregnancy and breastfeeding

Do not take Simvacard if you are pregnant, planning to have a baby, or think you may be pregnant. If you become pregnant while taking Simvacard, stop treatment and consult your doctor immediately.
Do not take Simvacard 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 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.

Simvacard contains lactose

Simvacard 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 Simvacard

Your doctor will determine the dose of Simvacard 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, you should follow a low-cholesterol 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 prescribe 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 cholesterol levels in the blood and a high risk of developing heart disease, who have not achieved the target cholesterol level with lower doses.

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 should be taken once daily, in the evening. The medicine can be taken with or without food. Simvacard should be taken continuously until your doctor advises you to stop.

Taking a higher dose of Simvacard than recommended

• Consult your doctor or pharmacist.

Missing a dose of Simvacard

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

Stopping treatment with Simvacard

• Do not stop taking the medicine unless your doctor advises you to do so. After stopping treatment with Simvacard, cholesterol levels may rise again. Consult your doctor or pharmacist, as your cholesterol levels may rise again. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Simvacard 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 rare but serious side effects have been reported:

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

• muscle pain, tenderness, or weakness. In rare cases, these problems can be serious and are associated with 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 difficulty breathing (angioedema)
• severe muscle pain, usually in the shoulder and hip areas
• rash with muscle weakness in the arms and neck
• joint pain or inflammation (polyarthralgia)
• inflammation of blood vessels (vasculitis)
• unusual bruising, skin lesions, and swelling (dermatomyositis), hives, sun sensitivity, fever, and flushing
• shortness of breath (dyspnea) and poor health
• 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 pale stools, fatigue, or weakness, loss of appetite, liver failure (very rare)
• pancreatitis, often with severe abdominal pain.
• a severe allergic reaction that causes difficulty breathing or dizziness (anaphylaxis) (very rare)

The following side effects have also been rarely reported:

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

The following side effects have been very rarely reported:

• muscle rupture*
• gynecomastia (breast enlargement in men)*
• a rash that can occur on the skin or mouth ulcers (drug-induced lupus)*
• 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 that causes breathing problems, including persistent cough and (or) shortness of breath or fever
• tendon disorders, sometimes complicated by tendon rupture
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• myasthenic syndrome (a disease that causes muscle weakness, including eye muscles) You should discuss with your doctor if you experience muscle weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Additional possible side effects reported during treatment with 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. Your doctor will monitor your health during treatment with Simvacard. muscle pain, tenderness, or persistent weakness, which may not resolve after stopping Simvacard (frequency not known)

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 side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Simvacard

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 carton and blister.
The expiry date refers to the last day of the month stated.

6. Contents of the packaging and other information

What Simvacard contains

The active substance of Simvacard is simvastatin.
Simvacard 10: each film-coated tablet contains 10 mg of simvastatin.
Simvacard 20: each film-coated tablet contains 20 mg of simvastatin.
Simvacard 40: each film-coated tablet contains 40 mg of simvastatin.
Other ingredients are:
Lactose, maize starch, microcrystalline cellulose, talc, magnesium stearate, butylhydroxyanisole.
Coating: hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), talc.

What Simvacard looks like and contents of the pack

White, oval, film-coated tablets with a score line on both sides and the following markings on one side: "SVT 10" for Simvacard 10, "SVT 20" for Simvacard 20, and "SVT 40" for Simvacard 40.
Pack size: 28 tablets.

Marketing authorization holder and manufacturer

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

For more information, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00

Date of last revision of the leaflet: