Vasilip

Leaflet accompanying the packaging: patient information

Vasilip, 10 mg, film-coated tablets

Vasilip, 20 mg, film-coated tablets

Vasilip, 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.
• 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 packaging and other information

1. What is Vasilip and what is it used for

Vasilip contains the active substance simvastatin. Vasilip is a medicine used to lower the level of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. Additionally, Vasilip increases the level of "good" cholesterol (HDL cholesterol). Vasilip belongs to a group of medicines called statins.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol consists mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate on the walls of arteries, forming plaques. Eventually, these plaques can cause narrowing of the arteries, which can limit or block blood flow to vital organs such as the heart and brain. Reduced blood flow can lead to heart attack or stroke.
HDL cholesterol is often referred to as "good" cholesterol because it helps prevent the accumulation of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat present in the blood that can contribute to an increased risk of 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 cases of:

• high blood cholesterol (primary hypercholesterolemia) or high blood fat (mixed hyperlipidemia);
• inherited disorder (homozygous familial hypercholesterolemia) that causes high blood cholesterol. Other treatments may also be used;
• ischemic heart disease (coronary artery 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 blood cholesterol levels.

In most people, there are no direct symptoms of high cholesterol. A doctor can assess cholesterol levels by ordering a simple blood test. Regular check-ups, monitoring of blood cholesterol levels, and discussion of 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 currently liver function disorders,
• if the patient is pregnant or breastfeeding,
• if the patient is taking a medicine containing at least one of the following active substances:
• 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 (HIV protease inhibitors 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),
• 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 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 severe muscle problems (rhabdomyolysis).

Do not take Vasilip in a dose greater than 40 mg if the patient is taking lomitapide (used to treat a rare genetic cholesterol disorder).
In case of doubt about the use of any of the above-mentioned medicines, consult a doctor.

Warnings and precautions

Before starting Vasilip, consult a doctor or pharmacist.
Inform your doctor:

• about all conditions, including allergies,
• about consuming large amounts of alcohol,
• about a history of liver disease. Taking Vasilip may not be suitable,
• about planned surgery. It may be necessary to stop taking Vasilip for a short time,
• if the patient is of Asian origin, as a different dose may be appropriate for this patient,
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms or lead to myasthenia (see section 4).

The doctor should perform a blood test before starting Vasilip and during treatment if the patient has any liver disorders. The purpose of the test is to assess liver function.
The doctor may also perform blood tests to assess liver function after starting Vasilip.
During therapy, the doctor will closely monitor the patient's health if they 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, are overweight, and have high blood pressure.
Inform your doctor about serious lung diseases.

Immediately contact a doctor if you experience unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems can be severe, 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 the 80 mg dose. The risk of muscle tissue 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 whose close relatives have had hereditary muscle disorders. If any of the above applies to the patient, inform the doctor.

Also, inform the 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 and girls who have started menstruating (at least one year before). No studies have been conducted in children under the age of 10. For more information, consult a doctor.

Vasilip and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those containing any of the following active substances. Taking Vasilip with any of the following medicines may increase the risk of muscle problems (some of which are listed in the "When not to take Vasilip" section):

• if oral fusidic acid is necessary to treat a bacterial infection, it may be necessary to temporarily stop taking Vasilip. The doctor will inform you when it is safe to restart Vasilip. Taking Vasilip with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). Additional information on rhabdomyolysis can be found in section 4,
• cyclosporine (often 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),
• medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates containing active substances such as 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, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C),
• nefazodone (used to treat depression),
• cobicistat (used to treat HIV infection),
• amiodarone (used to treat heart rhythm disorders),
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases),
• lomitapide (used to treat a rare genetic cholesterol disorder),
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). It is possible that muscle-related side effects may be greater when taking this medicine with simvastatin (e.g., Vasilip). The doctor may decide to stop Vasilip for a while,
• colchicine (used to treat gout),
• tikagrelor (an antiplatelet medicine).

Similarly, 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, including those available without a prescription. In particular, inform your doctor about medicines containing any of the following active substances:

• 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).

Also, inform any doctor who prescribes a new medicine about 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 treatment and consult a doctor immediately. 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 a 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 a doctor before taking Vasilip.

3. How to take Vasilip

The doctor will determine the appropriate dose of Vasilip for the patient based on their current treatment and individual risk.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, 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. The 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.
The doctor may recommend lower doses, especially if the patient is taking certain medicines listed above or has 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 who have not achieved their target cholesterol level with a lower dose.
Use in children and adolescents
The 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
Vasilip should be taken in the evening. The medicine can be taken with or without food. Vasilip should be taken continuously until the doctor decides to stop it.
If the 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 a higher dose of Vasilip than recommended

Consult a 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

Consult a doctor or pharmacist, as cholesterol levels may rise again.
If you have any further questions about taking this medicine, consult a 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 how often side effects are reported:

• 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, serious side effects have been reported:

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

• muscle pain, tenderness, weakness, muscle rupture, or muscle cramps. In rare cases, these problems can be severe and lead to muscle tissue breakdown, causing 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 breathing difficulties (angioedema),
• severe muscle pain, usually in the shoulder and hip area,
• rash with weakness of the limbs and neck,
• rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid reactions),
• joint pain or inflammation (polymyalgia rheumatica),
• inflammation of blood vessels (vasculitis),
• unusual bruising, skin rashes, and swelling (dermatomyositis), hives, sun sensitivity, fever,
• shortness of breath (dyspnea) and malaise,
• systemic lupus erythematosus-like syndrome (including rash, joint pain, and blood changes),
• liver inflammation with symptoms of jaundice and eye yellowing, itching, dark urine, or light-colored stools, fatigue or weakness, loss of appetite, liver failure (very rare),
• pancreatitis, often with severe abdominal pain.

The following side effects have also been reported:

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

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

• severe allergic reaction that can cause breathing difficulties or dizziness (anaphylaxis),
• gynecomastia (breast enlargement in men).

The following side effects have also been reported, but their frequency cannot be estimated from the available data (frequency not known):

• erectile dysfunction,
• depression,
• lung inflammation that 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). Consult a 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 during the use of 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. The doctor will monitor the patient's condition during treatment with Vasilip.
• persistent muscle pain, tenderness, or weakness that may not resolve even after stopping Vasilip (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 those not listed in this leaflet, inform 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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 gather more information on the safety of this medicine.

5. How to store Vasilip

Keep the 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Vasilip contains

• The active substance of Vasilip is simvastatin. Each film-coated tablet contains 10 mg, 20 mg, or 40 mg of simvastatin.
• Other ingredients are: Film-coated tablets 10 mg and 20 mg: lactose monohydrate, pregelatinized starch, butylhydroxyanisole, citric acid, ascorbic acid, cornstarch, 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, cornstarch, 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 packaging

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 dividing 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 detailed information about this medicine, consult the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of the last update of the leaflet: