Vasilip

Package Leaflet: Information for the Patient

Vasilip, 10 mg, Film-Coated Tablets

Vasilip, 20 mg, Film-Coated Tablets

Vasilip, 40 mg, Film-Coated Tablets

Simvastatin

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Vasilip and what is it used for

Vasilip contains the active substance simvastatin. Vasilip is used to lower the level of cholesterol and other fats in the blood. It also increases the level of "good" cholesterol (HDL cholesterol). Vasilip belongs to a group of medicines called statins. Cholesterol is one of several fats found in the blood. Total cholesterol is made up mainly of LDL cholesterol and HDL cholesterol. LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of the arteries, forming plaques. Over time, these plaques can cause the arteries to narrow, reducing or blocking the flow of blood to important organs such as the heart and brain. Blocking the flow of blood can lead to a 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 found in the blood that can increase the risk of heart disease. While taking this medicine, you should follow a low-cholesterol diet. Vasilip is used as an additional treatment to diet to reduce the level of cholesterol in the blood in patients with:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• a genetic disorder (homozygous familial hypercholesterolemia) that causes high levels of cholesterol in the blood. Other treatments may also be used;
• heart disease (coronary heart disease) or a high risk of developing heart disease (due to diabetes, a history of stroke, or other blood vessel diseases). Vasilip may help prolong life by reducing the risk of heart disease, regardless of the level of cholesterol in the blood.

Most people do not experience symptoms of high cholesterol. Your doctor may check your cholesterol level by doing a simple blood test. You should have regular check-ups, monitor your cholesterol level, and discuss your treatment goals with your doctor.

2. Important information before taking Vasilip

When not to take Vasilip

• if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6),
• if you currently have liver problems,
• 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 or telaprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• cobicistat (used to treat HIV infection),
• gemfibrozil (used to lower cholesterol),
• cyclosporine (used in patients who have had organ transplants),
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• if you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. Taking Vasilip with fusidic acid may cause serious muscle problems (rhabdomyolysis).

Do not take Vasilip in doses greater than 40 mg if you are taking lomitapide (used to treat a rare genetic disorder of high cholesterol). If you are unsure whether you are taking any of these medicines, consult your doctor.

Warnings and precautions

Before taking Vasilip, consult your doctor or pharmacist. You should inform your doctor:

• about all your medical conditions, including allergies,
• about drinking large amounts of alcohol,
• about any history of liver disease. Taking Vasilip may not be suitable for you,
• about any planned surgery. You may need to stop taking Vasilip 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 muscle weakness (myasthenia) or eye muscle weakness (ocular myasthenia), as statins can sometimes worsen symptoms or cause myasthenia (see section 4).

Your doctor should do a blood test before and during treatment with Vasilip if you have any liver problems. The test will check your liver function. Your doctor may also do blood tests to check your liver function after starting Vasilip. 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 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, which can cause kidney damage, and in very rare cases, death.

The risk of muscle damage is higher when taking higher doses of Vasilip, especially the 80 mg dose. The risk of muscle breakdown is also higher in patients who:

• drink large amounts of alcohol,
• have kidney problems,
• have thyroid problems,
• are 65 years of age or older,
• are female,
• have had muscle problems while taking cholesterol-lowering medicines called "statins" or fibrates,
• have or have had muscle disorders in themselves or their close relatives. If any of these apply to you, tell your doctor.

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 simvastatin have been studied in boys aged 10-17 years and girls who have had their first period (menstruation) at least one year before (see section 3 "How to take Vasilip"). Simvastatin has not been studied in children under 10 years of age. For more information, consult your doctor.

Vasilip and other medicines

Tell your doctor about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription. Some medicines can interact with Vasilip and increase the risk of muscle problems (some of which are listed above in "When not to take Vasilip"):

• cyclosporine (often used in patients who have had organ transplants),
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• medicines containing the following active substances: itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates containing the following active substances: gemfibrozil and bezafibrate (used to lower cholesterol),
• 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 virus infection, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• cobicistat (used to treat HIV infection),
• amiodarone (used to treat irregular heartbeat),
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain related to heart disease, or other heart diseases),
• lomitapide (used to treat a rare genetic disorder of high cholesterol),
• 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 during treatment with simvastatin (e.g., Vasilip). Your doctor may decide to stop Vasilip for a while,
• colchicine (used to treat gout),
• tikagrelor (an antiplatelet medicine).

You should also tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription, especially:

• medicines that prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulant medicines),
• fenofibrate (also used to lower cholesterol),
• niacin (also used to lower cholesterol),
• rifampicin (used to treat tuberculosis).

You should also inform any doctor who prescribes you a new medicine that you are taking Vasilip.

Vasilip with food and drink

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

Pregnancy and breastfeeding

Do not take Vasilip if you are pregnant, planning to become pregnant, or think you may be pregnant. If you become pregnant while taking Vasilip, stop taking the medicine immediately and consult your doctor. Do not take Vasilip if you are breastfeeding, as it is not known whether the medicine is excreted in breast milk. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Vasilip does not affect the ability to drive or use machines. However, you should consider that some people may experience dizziness after taking Vasilip.

Vasilip contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking Vasilip.

3. How to take Vasilip

Your doctor will determine the dose of Vasilip that is right for you, depending on your current treatment and individual risk. Always take Vasilip exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. While taking Vasilip, you should follow a low-cholesterol diet. Dosage The recommended dose is 10 mg, 20 mg, 40 mg, or 80 mg taken orally once a day. Adults The initial dose is 10 mg, 20 mg, 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 kidney problems. The 80 mg dose is recommended only for adult patients with very high cholesterol levels in the blood and a high risk of heart disease, who have not reached their target cholesterol level with lower doses. Use in children and adolescents The usual initial dose in children (aged 10-17 years) is 10 mg once daily in the evening. The maximum recommended dose is 40 mg per day. Method of administration Vasilip should be taken in the evening. The medicine can be taken with or without food. Vasilip should be taken continuously until your doctor tells you to stop. If your doctor has prescribed Vasilip with another cholesterol-lowering medicine containing a bile acid sequestrant, take Vasilip at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking more than the recommended dose of Vasilip

Contact your doctor or pharmacist.

Forgetting to take a dose of Vasilip

Do not take a double dose to make up for a forgotten dose. Take the next dose of Vasilip at the usual time the next day.

Stopping treatment with Vasilip

Consult your doctor or pharmacist, as your cholesterol level may rise again. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vasilip can cause side effects, although not everybody gets them. The following terms are used to describe the frequency of side effects:

• rare (may affect up to 1 in 1000 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 these serious side effects, stop taking Vasilip and contact your doctor immediately or go to the emergency department of your nearest hospital.

• muscle pain, tenderness, or weakness, which can be signs of muscle breakdown, which can cause kidney damage; very rare cases of death have been reported,
• allergic reactions (hypersensitivity) including:
• swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema),
• severe muscle pain, usually in the shoulders and hips,
• rash with weakness of the muscles of the arms and neck,
• rash that may occur on the skin or mouth ulcers (drug-induced lupus-like reactions),
• muscle pain or inflammation of the joints (polymyalgia rheumatica),
• inflammation of blood vessels (vasculitis),
• unusual bruising, skin rash, and swelling (dermatomyositis), hives, increased sensitivity of the skin to the sun, fever, flushing,
• shortness of breath (dyspnea) and feeling unwell,
• symptoms of lupus-like disease (including rash, joint pain, and changes in blood cells),
• inflammation of the liver 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),
• inflammation of the pancreas, often with severe abdominal pain.

The following side effects have also been reported:

• decrease in the number of red blood cells (anemia),
• numbness or weakness of the hands and feet,
• headache, feeling of tingling, dizziness,
• blurred vision and changes in vision,
• gastrointestinal disorders (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting),
• rash, itching, hair loss,
• weakness,
• sleep disorders (very rare),
• poor memory (very rare), memory loss, confusion.

The following very rare but serious side effect has been reported:

• a severe allergic reaction that causes difficulty breathing or dizziness (anaphylaxis),
• breast enlargement in men (gynecomastia).

The following side effects have also been reported, but their frequency is not known:

• erectile dysfunction,
• depression,
• inflammation of the lungs, which can cause 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 muscle weakness in the eyes). You should talk to 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 that have been reported with some statins:

• sleep disorders, 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 Vasilip.
• persistent muscle pain, tenderness, or weakness, which may not resolve even after stopping Vasilip (frequency not known).

Laboratory test resultsElevated muscle enzyme levels (creatine kinase) in the blood and abnormal liver function test results have been observed. Reporting side effectsIf you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vasilip

Keep this medicine out of the sight and reach of children. Film-coated tablets 10 mg and 20 mg Store in a temperature below 25°C, in the original packaging. Film-coated tablets 40 mg Store in a temperature below 30°C, in the original packaging. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vasilip contains

• The active substance is simvastatin. Each film-coated tablet contains 10 mg, 20 mg, or 40 mg of simvastatin.
• The other ingredients are: Film-coated tablets 10 mg and 20 mg: lactose monohydrate, pregelatinized starch, butylhydroxyanisole, citric acid, ascorbic acid, corn starch, microcrystalline cellulose, magnesium stearate; coating: hypromellose, talc, propylene glycol, titanium dioxide. Film-coated tablets 40 mg: lactose monohydrate, modified starch, butylhydroxyanisole, citric acid, ascorbic acid, corn starch, microcrystalline cellulose, magnesium stearate; coating: hypromellose, talc, propylene glycol, titanium dioxide. See section 2 "Vasilip contains lactose".

What Vasilip looks like and contents of the pack

10 mg: white, round, slightly convex film-coated tablets with a beveled edge 20 mg: white, round, slightly convex film-coated tablets with a beveled edge 40 mg: white, round, slightly convex film-coated tablets with a beveled edge and a score line on one side Packaging:28 film-coated tablets in blisters, in a cardboard box

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

Vasilip, 10 mg, 20 mg, film-coated tablets KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warszawa KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Vasilip, 40 mg, film-coated tablets KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia For more information about this medicine, contact the local representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o. ul. Równoległa 5 02-235 Warszawa Tel. 22 57 37 500

Date of last revision of the package leaflet: