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, as you may need to read it again.
• In case of any doubts, 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.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the 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 fatty substances found in the blood. Total cholesterol is mainly made up of LDL cholesterol and HDL cholesterol.

LDL cholesterol is often referred to as "bad" cholesterol because it can build up on the walls of arteries, forming plaques. These plaques can eventually cause the arteries to narrow, restricting blood flow to vital organs such as the heart and brain. Reduced blood flow can lead to heart attacks or strokes.

HDL cholesterol is often referred to as "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, which can increase the risk of developing heart disease.

While taking this medicine, you should follow a cholesterol-lowering diet.

Vasilip is used as an adjunct to a cholesterol-lowering diet in the following cases:

• high cholesterol levels in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• a hereditary disorder (homozygous familial hypercholesterolemia) that causes high cholesterol levels 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). Vasilip may 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 noticeable symptoms. A doctor can assess cholesterol levels by ordering a simple blood test. Regular check-ups, monitoring cholesterol levels, and discussing treatment goals with a doctor are necessary.

2. Important information before taking Vasilip

When not to take Vasilip

• if the patient is allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6),
• if there are current liver function disorders,
• if the patient is pregnant or breastfeeding,
• if the patient is taking certain medicines (listed below) that may interact with Vasilip:
• 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),
• nefazodone (used to treat depression),
• cobicistat (used to treat HIV infection),
• gemfibrozil (used to lower cholesterol levels),
• cyclosporine (used in organ transplant patients),
• danazol (a synthetic hormone used to treat endometriosis),
• if the patient is taking or has 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 lead to 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 cholesterol disorder). If in doubt about any of the above medicines, consult a doctor.

Warnings and precautions

Before taking Vasilip, consult a doctor or pharmacist.

Inform your doctor:

• about all your medical conditions, including allergies,
• about consuming large amounts of alcohol,
• about any history of liver disease. Taking Vasilip may not be suitable,
• about any planned surgery. It may be necessary 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 perform a blood test before starting Vasilip and during treatment if you have any liver function disorders. The test will assess liver function.

Your doctor may also perform blood tests to assess liver function after starting Vasilip.

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.

Inform your doctor about any serious lung diseases.

Immediately contact your doctor 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 Vasilip, particularly 80 mg. The risk of muscle breakdown is also higher in patients:

• who consume large amounts of alcohol,
• with kidney problems,
• with thyroid problems,
• aged 65 or older,
• female,
• who have previously experienced muscle problems while taking cholesterol-lowering medicines called "statins" or fibrates,
• who have or have had muscle disorders in themselves or their close relatives. If any of the above applies to you, inform your doctor.

Also, inform your doctor or pharmacist if muscle weakness persists. To diagnose and treat this condition, additional tests and medicines may be necessary.

Children and adolescents

The safety and efficacy of simvastatin have been studied in boys aged 10-17 and girls who have had their first menstrual period at least one year before (see section 3, "How to take Vasilip"). No studies have been conducted in children under 10 years old. For more information, consult a doctor.

Vasilip and other medicines

Tell your doctor about all medicines you are currently taking or plan to take, including those without a prescription.

Some medicines may interact with Vasilip, including:

• cyclosporine (used in organ transplant patients),
• danazol (a synthetic hormone used to treat endometriosis),
• medicines used to treat fungal infections, such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole,
• fibrates, such as gemfibrozil or bezafibrate (used to lower 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,
• nefazodone (used to treat depression),
• cobicistat (used to treat HIV infection),
• amiodarone (used to treat irregular heartbeats),
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain, or other heart conditions),
• lomitapide (used to treat a rare genetic cholesterol disorder),
• daptomycin (used to treat complicated skin and soft tissue infections or bacteremia). The risk of muscle damage may be higher when taking this medicine with Vasilip. Your doctor may decide to stop Vasilip for a while,
• colchicine (used to treat gout),
• tikagrelor (an antiplatelet medicine).

Also, inform your doctor or pharmacist about all medicines you are currently taking or plan to take, including those without a prescription, especially:

• 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).

Inform any doctor who prescribes 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. Avoid drinking grapefruit juice.

Pregnancy and breastfeeding

Do not take Vasilip if you are pregnant, planning to become pregnant, or suspect you may be pregnant. If you become pregnant while taking Vasilip, stop taking the medicine and consult your doctor. Do not take Vasilip while 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 plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Vasilip contains lactose

If you have been diagnosed with an intolerance to some sugars, consult 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, consult your doctor or pharmacist.

While taking Vasilip, 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 or have 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 reached their target cholesterol level with a lower dose.

Use in children and adolescents

The usual recommended initial dose for children (aged 10-17) is 10 mg once daily in the evening. The maximum recommended dose is 40 mg per day.

Method of administration

Take Vasilip in the evening. You can take Vasilip with or without food. Continue taking Vasilip until your doctor tells you to stop.

If your doctor has prescribed Vasilip with another cholesterol-lowering medicine that contains 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

Consult your doctor or pharmacist.

Missing a dose of Vasilip

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

Stopping Vasilip treatment

Consult your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any further questions about taking this medicine, consult 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 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 these serious side effects, stop taking Vasilip and immediately consult your doctor or go to the emergency department of your nearest hospital.

• muscle pain, tenderness, or weakness, which can be signs of muscle breakdown, leading to kidney damage, and in very rare cases, death,
• allergic reactions (hypersensitivity) such as:
• 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 limbs and neck,
• rash that may occur on the skin or mucous membranes (drug-induced lupus-like reactions),
• joint pain or inflammation (polymyalgia rheumatica),
• inflammation of blood vessels (vasculitis),
• unusual bruising, skin rash, and swelling (dermatomyositis), hives, increased sensitivity to sunlight, fever,
• shortness of breath and feeling unwell,
• symptoms of lupus-like disease (including rash, joint pain, and changes in blood cells),
• liver inflammation with symptoms of yellowing of the skin and eyes, itching, dark urine, or pale stools, fatigue, or weakness, liver failure (very rare),
• pancreatitis, often with severe abdominal pain.

The following side effects have also been reported:

• reduced red blood cell count (anemia),
• numbness or weakness of the hands and feet,
• headache, tingling, dizziness,
• blurred vision and changes in vision,
• gastrointestinal problems (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting),
• rash, itching, hair loss,
• weakness,
• sleep disturbances (very rare),
• memory loss (very rare), confusion.

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

• severe allergic reaction, which can cause 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, causing breathing problems, including persistent cough and (or) shortness of breath or fever,
• tendon problems, 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). Consult 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 with some statins:

• sleep disturbances, including nightmares,
• sexual problems,
• 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 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, inform your doctor or pharmacist. 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: +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.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Vasilip

Keep this medicine out of the sight and reach of children.

10 mg and 20 mg film-coated tablets

Store in a temperature below 25°C, in the original packaging.

40 mg film-coated tablets

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.

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: 10 mg and 20 mg film-coated tablets: lactose monohydrate, maize starch, butylhydroxyanisole, citric acid, ascorbic acid, maize starch, microcrystalline cellulose, magnesium stearate; coating: hypromellose, talc, propylene glycol, titanium dioxide. 40 mg film-coated tablets: lactose monohydrate, modified maize starch, butylhydroxyanisole, citric acid, ascorbic acid, maize 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 biconvex film-coated tablets with a beveled edge

20 mg: white, round, slightly biconvex film-coated tablets with a beveled edge

40 mg: white, round, slightly biconvex 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 Warsaw

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 Warsaw

Tel: 22 57 37 500

Date of last revision of the leaflet: