Simvacard 20

Package leaflet: Information for the patient

Simvacard 10, 10 mg, film-coated tablets
Simvacard 20, 20 mg, film-coated tablets
Simvacard 40, 40 mg, film-coated tablets
(Simvastatinum)
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

This medicine is absolutely contraindicated during pregnancy
Leaflet contents:

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 pack and other information

1. What Simvacard is and what it is used for

Simvacard is used as a supplement to a cholesterol-lowering diet in the following cases:

• elevated blood cholesterol levels (primary hypercholesterolemia) or elevated blood lipid levels (mixed hyperlipidemia);
• inherited disorder (homozygous familial hypercholesterolemia) causing increased blood cholesterol levels. In such cases, other treatment methods may also be used;
• 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 may prolong patient's life by reducing the risk of heart disease development 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 regularly attend follow-up visits, monitor your blood cholesterol levels, and discuss treatment goals with your doctor.

2. Important information before using Simvacard

When not to use Simvacard

• 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 any of the following medicinal products containing one or more of the following active substances are being used:
  • 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 (protease inhibitors of HIV virus used in the treatment of HIV infection)
  • boceprevir and telaprevir (used in the treatment of 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 in the treatment of endometriosis, a condition in which the tissue lining the uterus grows outside the uterus)
• if the patient is currently taking or has taken within the last 7 days oral or injectable fusidic acid (used to treat bacterial infections). Concomitant use of fusidic acid with Simvacard may lead to serious muscle problems (rhabdomyolysis). Simvacard must not be used at doses exceeding 40 mg if the patient is taking lomitapide (used to treat a severe and rare genetic cholesterol disorder).

If in doubt whether any of the above-mentioned medicines are being used, consult a doctor.
Warnings and precautions
Before starting Simvacard, 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. Use of Simvacard may not be appropriate.

• if you are scheduled for surgery. Temporary discontinuation of Simvacard may be necessary.

• if you are of Asian descent, as a different dose may be appropriate for you.

• if you have or have had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms or lead to the development of myasthenia (see section 4).

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 monitor liver function after starting Simvacard.
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 exists in people who have high blood sugar and fat levels, overweight, and 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 higher when higher doses of Simvacard are used, particularly the 80 mg dose. The risk of muscle breakdown is also higher in certain patients. Inform 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 experienced muscle problems during treatment with cholesterol-lowering medicines called "statins" or "fibrates"
• you or a close relative have been diagnosed with inherited muscle disorders.

Inform your doctor or pharmacist if muscle weakness persists. Additional tests and possibly additional medicines may be required 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 started menstruation at least one year earlier (see section 3 "How to use Simvacard"). Simvastatin has not been studied in children under 10 years of age. For additional information, consult your doctor.
Simvacard and other medicines
Inform your doctor about all medicines you are currently using, have recently used, or plan to use. Taking these medicines together with Simvacard may increase the risk of muscle problems (some of which are listed above under "When not to use Simvacard").

• If oral fusidic acid is required for the treatment of a bacterial infection, temporary discontinuation of Simvacard will be necessary. Your doctor will inform you when it is safe to resume Simvacard.
  Concomitant use of Simvacard with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis).
  Additional information regarding rhabdomyolysis is provided in section 4.

• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteraemia). The risk of muscle-related side effects may be increased when this medicine is taken during treatment with simvastatin (e.g. Simvacard). Your doctor may decide to temporarily stop treatment with Simvacard,
• colchicine (used to treat gout).

As with the medicines listed above, you must tell 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 must 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).

You must 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 how certain medicines work in the body, including Simvacard. You should avoid drinking beverages containing grapefruit juice.
Pregnancy and breastfeeding
Do not take Simvacard if you are pregnant, planning to become pregnant, or suspect you may be pregnant. If you become pregnant while taking Simvacard, stop treatment immediately and contact your doctor.
Do not take Simvacard 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 does not affect the ability to drive or operate machinery. However, you should consider that dizziness may occur in some people after taking Simvacard.
Simvacard contains lactose.
Simvacard 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

Your doctor will determine the appropriate dose of the medicine for you, depending on your current treatment and individual risk factors.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
While taking Simvacard, you should follow a cholesterol-lowering diet.

Dosage

Adults:
The initial dose is 10, 20 or in some cases 40 mg once daily. Your doctor may adjust the dose after at least 4 weeks of treatment, up to a maximum of 80 mg once daily.
Do not take more than 80 mg per day.
Your doctor may recommend lower doses, especially if you are taking certain of the medicines listed above or have certain kidney problems.
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 lower doses.

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 should be taken once daily in the evening. It can be taken during meals or independently of food. Simvacard should be taken continuously unless your doctor advises stopping it.
If your doctor has prescribed Simvacard together with another cholesterol-lowering medicine containing any bile acid sequestrant, Simvacard should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking more Simvacard than prescribed

• Contact your doctor or pharmacist.

If you forget to take Simvacard

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

Stopping Simvacard

• Do not stop taking Simvacard unless your doctor tells you to. After stopping Simvacard, cholesterol levels may rise again. Consult your doctor or pharmacist, as cholesterol levels may increase once more. If you have any further doubts about using 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 the adverse reactions have been reported:

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

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

• 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 joints
  • Rash with muscle weakness in 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
  • Shortness of breath (dyspnea) and malaise
  • Symptoms of lupus-like illness (including rash, joint problems, and blood cell changes)
• Hepatitis 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
• Severe allergic reaction causing difficulty 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 disorders (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 men)*
• Rash which may occur on the skin or ulceration of the oral mucosa (lichenoid mucocutaneous 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 dyspnoea or fever
• Tendon disorders, sometimes complicated by tendon rupture
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing)
• Ocular myasthenia (a disease causing weakness of eye muscles). Patients should consult a doctor if they experience weakness in hands or feet that worsens with activity, double vision or drooping eyelids, difficulty swallowing, or breathing difficulties.

Additional possible adverse reactions reported during use of some statins:

• Sleep disorders, including nightmares
• Sexual dysfunction
• Diabetes. The occurrence 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.
• Pain, tenderness, or persistent muscle weakness that may not resolve after discontinuation of Simvacard (frequency not known)

Laboratory findings
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 those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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: 22 49 21 301, Fax: 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Simvacard

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

6. Contents of the package and other information

What Simvacard contains
The active substance is simvastatin.
Simvacard 10: each coated tablet contains 10 mg of simvastatin.
Simvacard 20: each coated tablet contains 20 mg of simvastatin.
Simvacard 40: each coated tablet contains 40 mg of simvastatin.
The other ingredients are:
Lactose, gelatinized corn starch, microcrystalline cellulose, talc, magnesium stearate,
butylhydroxyanisole.
Film-coating ingredients: hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), talc.

What Simvacard looks like and contents of the pack
Simvacard 10, Simvacard 40: white, oval, film-coated tablets with a central breakline on both sides and engraved with the appropriate marking on one side: “SVT 10” for Simvacard 10 and “SVT 40” for Simvacard 40.
Simvacard 20: white to almost white, oval, film-coated tablets with a central breakline and engraved “SVT 20” on one side.
Pack size: 28 tablets.

Marketing Authorisation Holder and Manufacturer
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

For further information, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00