SIMVACARD 20 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
2. What Simvacard is and what it is used for
3. Important information before taking Simvacard
   1. When not to take Simvacard
   2. Warnings and precautions
   3. 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
   4. Children and adolescents
   5. Simvacard and other medicines
   6. Simvacard with food and drink
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Simvacard contains lactose
4. How to take Simvacard
   1. Do not take more than 80 mg per day.
   2. Use in children and adolescents
   3. Taking a higher dose of Simvacard than recommended
   4. Missing a dose of Simvacard
   5. Stopping Simvacard treatment
5. Possible side effects
   1. 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.
   2. Reporting side effects
6. How to store Simvacard
7. Contents of the packaging and other information
   1. What Simvacard contains
   2. What Simvacard looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. For more information, contact the representative of the marketing authorization holder in Poland:
   5. Date of last revision of the leaflet:

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)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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.
• 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 cholesterol-lowering diet in the following cases:

• high blood cholesterol levels (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• homozygous familial hypercholesterolemia, a genetic disorder that causes high blood cholesterol levels. Other treatments may also be used;
• coronary heart disease (coronary artery disease) or a high risk of developing coronary 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 blood cholesterol levels.

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

2. Important information before taking Simvacard

When not to take Simvacard

• 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 lower cholesterol levels)
• cyclosporine (used in organ transplant patients)
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)

In case of doubt, consult your doctor to see if you are taking any of the above medicines.

Warnings and precautions

Before starting Simvacard, discuss it with your doctor or pharmacist.
Tell your doctor:

• about all your medical conditions, including allergies.
• if you drink large amounts of alcohol.
• if you have had liver disease in the past. Taking Simvacard may not be suitable.
• if you are scheduled for surgery. You may need to stop taking Simvacard for a short time.

Simvacard for a short time.

Your doctor should perform a blood test before starting Simvacard and during treatment if you have any liver disorders. The test will assess liver function.
Your doctor may also perform blood tests to assess liver function after starting 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.
Tell 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 the 80 mg dose. The risk of muscle breakdown is also higher in some patients. Tell your doctor if:

• you drink 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 Simvacard have been studied in boys aged 10-17 years and girls who have started menstruation (at least one year before). Simvacard has not been studied in children under 10 years. For more information, consult your doctor.

Simvacard and other medicines

Tell your doctor about all medicines you are currently taking or plan to take. Taking these medicines with Simvacard can increase the risk of muscle problems (some of which are listed above).

• If you need to take fusidic acid orally for a bacterial infection, you will need to stop taking Simvacard temporarily. Your doctor will tell you when it is safe to restart Simvacard. Taking Simvacard with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis).

Additional information on rhabdomyolysis can be found in section 4.

• daptomycin (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 with simvastatin (e.g., Simvacard). Your doctor may decide to stop Simvacard for a while.
• colchicine (used to treat gout).

You should also tell your doctor or pharmacist about all medicines you are currently taking or plan to take, especially those containing:

• blood-thinning medicines, such as warfarin, phenprocoumon, or acenocoumarol
• fenofibrate (also used to lower cholesterol levels)
• niacin (also used to lower cholesterol levels)
• rifampicin (used to treat tuberculosis)
• tikagrelor (used to prevent heart attacks or strokes)

You should also inform any doctor prescribing 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 immediately and consult your doctor.
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 consider 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 an intolerance to some sugars, consult your doctor before taking Simvacard.

3. How to take Simvacard

Your doctor will determine the dose of Simvacard suitable for you, depending on your current treatment and individual risk.
Always take Simvacard as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
While taking Simvacard, 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 kidney problems.
The 80 mg dose is only recommended for adults with very high blood cholesterol levels and a high risk of developing heart disease, who have not reached their 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:
Take Simvacard once daily, in the evening. You can take Simvacard with or without food. Take Simvacard continuously until your doctor tells you to stop.
If your doctor prescribes Simvacard with another cholesterol-lowering medicine containing a bile acid sequestrant, take Simvacard at least 2 hours before or 4 hours after taking the bile acid sequestrant.

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 Simvacard treatment

• Do not stop taking Simvacard unless your doctor tells you to. After stopping Simvacard, your cholesterol level may rise again. Consult your doctor or pharmacist, as your cholesterol level 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 are rare, serious side effects.

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 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, which 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 (polymyalgia rheumatica)
• 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 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 difficulty breathing or dizziness (anaphylaxis) (very rare)

Rarely, the following side effects have also been reported:

• decreased red blood cell count (anemia)
• numbness or weakness in the hands and feet
• headaches, 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 lichenoid 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
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease that causes eye muscle weakness) You should discuss with your doctor if you experience 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 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.
• pain, tenderness, or persistent weakness in the muscles, which may not resolve after stopping Simvacard (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, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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.
Keep 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.
Package 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: