Vastan

Leaflet accompanying the packaging: patient information

Vastan, 10 mg, film-coated tablets

Vastan, 20 mg, film-coated tablets

Simvastatin

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Vastan and what is it used for
• 2. Important information before taking Vastan
• 3. How to take Vastan
• 4. Possible side effects
• 5. How to store Vastan
• 6. Package contents and other information

1. What is Vastan and what is it used for

Vastan contains the active substance simvastatin. Vastan is a medicine used to lower the level of total cholesterol, so-called "bad" cholesterol (LDL cholesterol fraction) and fats called triglycerides in the blood. Additionally, Vastan increases the level of "good" cholesterol (HDL cholesterol fraction). Vastan 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 atherosclerotic plaques. Eventually, these plaques can cause narrowing of the arteries, resulting in restricted or blocked blood flow to vital organs, such as the heart and brain. Restricted blood flow can lead to a 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 developing heart disease.
While taking this medicine, a cholesterol-lowering diet should be followed.
Vastan is used as a supplementary treatment to a cholesterol-lowering diet in patients:

• with high cholesterol levels in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• with a hereditary disease (homozygous familial hypercholesterolemia) that is associated with high cholesterol levels in the blood. In these patients, other treatments may also be used;
• with coronary heart disease (coronary artery disease) or at high risk of developing coronary heart disease (due to diabetes, a history of stroke, or other vascular diseases). Vastan may help reduce the risk of heart disease, regardless of cholesterol levels in the blood, and thus prolong life for these patients.

In most people, there are no direct symptoms of high cholesterol levels. The doctor may assess cholesterol levels by ordering a simple blood test. Regular check-ups, monitoring of cholesterol levels in the blood, and discussion of intended treatment goals with the doctor are necessary.

2. Important information before taking Vastan

When not to take Vastan

• if the patient is allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has liver function disorders;
• if the patient is pregnant or breastfeeding;
• if the patient is taking any of the following medicines:
• itraconazole, ketoconazole, posaconazole, or voriconazole (medicines used to treat fungal infections),
• erythromycin, clarithromycin, or telithromycin (antibiotics used to treat bacterial infections,
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors used to treat HIV infection),
• boceprevir and telaprevir (medicines used to treat hepatitis C virus infection)
• nefazodone (an antidepressant),
• cobicistat (a medicine that increases the effect of certain antiviral medicines, used to treat HIV infection),
• gemfibrozil (a medicine used to lower cholesterol levels);
• cyclosporine (a medicine used in patients who have undergone organ transplants);
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the lining of the uterus grows outside the uterus).

Vastan should not be taken in a dose greater than 40 mg if the patient is taking lomitapide (used to treat a rare genetic disorder of high cholesterol levels).
Vastan should not be taken if the patient is currently taking or has taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. Taking fusidic acid with Vastan may lead to severe muscle damage (rhabdomyolysis).
In case of doubt about taking any of the above-mentioned medicines, the doctor should be consulted.

Warnings and precautions

Before starting to take Vastan, the doctor should be consulted. The doctor should be informed:

• about all conditions, including allergies;
• about consuming large amounts of alcohol;
• about a history of liver disease. Taking Vastan in such cases may not be suitable;
• about planned surgery. The doctor should be informed, as it may be necessary to stop taking Vastan for a while;
• if the patient is of Asian origin, as a different dose may be suitable 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 may sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4).

Before starting to take Vastan, the doctor should order a blood test to check liver function. The doctor may also consider it necessary to perform such tests during treatment with Vastan.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high levels of sugar and fats in the blood, being overweight, and having high blood pressure may be at risk of developing diabetes.
The doctor should be informed about any serious lung diseases.

It is necessary to contact the doctor immediately in case of unexplained muscle pain, muscle tenderness, or weakness. In rare cases, muscle symptoms can be severe, including muscle tissue breakdown leading to kidney damage, and in very rare cases, death.

The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
The risk of muscle damage is higher when taking higher doses of Vastan, particularly the 80 mg dose. The risk of muscle tissue breakdown is also higher in some patients. The doctor should be told if:

• the patient drinks large amounts of alcohol;
• the patient has kidney function disorders;
• the patient has thyroid function disorders;
• the patient is 65 years old or older;
• the patient is female;
• the patient has previously experienced muscle symptoms while taking cholesterol-lowering medicines, such as statins or fibrates;
• the patient or their close relatives have been diagnosed with hereditary muscle diseases.

Children and adolescents

The efficacy and safety of simvastatin have been studied in boys aged 10 to 17 years and in girls who have started menstruation (menstruation) at least one year earlier (see section 3: "How to take Vastan"). No studies have been conducted in younger children under the age of 10. For further information, the doctor should be consulted.

Vastan and other medicines

The doctor should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is particularly important to inform the doctor if the patient is taking any of the following medicines. Taking these medicines with Vastan may increase the risk of muscle symptoms (some of these medicines are listed above in the section "When not to take Vastan"):

If it is necessary to take fusidic acid orally for the treatment of a bacterial infection, it will be necessary to temporarily stop taking Vastan. The doctor will inform when it is safe to restart taking Vastan.

Taking Vastan 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 patients who have undergone organ transplants);
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the lining of the uterus grows outside the uterus);
• medicines such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections);
• medicines from the fibrate group, such as gemfibrozil and bezafibrate (used to lower cholesterol levels);
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections) medicines from the HIV protease inhibitor group, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS);
• antiviral medicines, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection);
• medicines containing the active substance cobicistat;
• nefazodone (used to treat depression);
• amiodarone (used to treat heart rhythm disorders);
• verapamil, diltiazem, and amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases);
• lomitapide (used to treat a rare genetic disorder of high cholesterol levels);
• colchicine (used to treat gout).

In addition to the medicines listed above, the doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, including those available without a prescription. This is especially important for:

• medicines that prevent blood clots (anticoagulants), such as warfarin, phenprocoumon, and acenocoumarol;
• fenofibrate (a medicine that lowers cholesterol levels);
• niacin (a medicine that lowers cholesterol levels);
• rifampicin (a medicine used to treat tuberculosis).

The doctor should also be informed about taking Vastan when prescribing a new medicine.

Vastan with food and drink

Grapefruit juice contains at least one compound that affects the action of some medicines in the body, including Vastan. Grapefruit juice should be avoided while taking Vastan.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Vastan should not be taken if the woman is pregnant, plans to become pregnant, or thinks they may be pregnant. If the patient becomes pregnant while taking Vastan, treatment should be stopped immediately, and the doctor should be consulted.
Women who are breastfeeding should not take Vastan, as it is not known whether the medicine is excreted in breast milk.
Before taking any medicine, the doctor or pharmacist should be consulted.

Driving and using machines

Vastan does not affect the ability to drive or use machines. However, it should be taken into account that some patients may experience dizziness after taking Vastan.

Vastan contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking Vastan.

3. How to take Vastan

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
The doctor will determine the dose of Vastan suitable for the patient, depending on the current treatment and individual risk assessment for the patient.
While taking Vastan, a cholesterol-lowering diet should be followed.
Dosage:
The recommended dose of Vastan is 10 mg, 20 mg, 40 mg, or 80 mg orally, once a day, in the evening.
Adults:
The initial dose is usually 10, 20, or in some cases 40 mg per day. After at least 4 weeks, the doctor may increase the dose to a maximum of 80 mg per day.

Do not take more than 80 mg per day.

The doctor may recommend taking the medicine in a lower dose, especially in patients taking the medicines listed above or suffering from certain kidney diseases.
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 achieved the target cholesterol level while taking the medicine in a lower dose.

Use in children and adolescents

In children (aged 10 to 17 years), the recommended initial dose is usually 10 mg once a day, in the evening. The maximum recommended dose is 40 mg per day.
Method of administration:
Vastan should be taken in the evening. The medicine can be taken with or without food.
Vastan should be taken continuously until the doctor recommends stopping it.
If the doctor has prescribed Vastan with another cholesterol-lowering medicine containing a bile acid sequestrant, Vastan should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Vastan than recommended

In case of taking a higher dose than recommended, the doctor or pharmacist should be consulted.

Missing a dose of Vastan

A double dose should not be taken to make up for a missed dose. The next dose of Vastan should be taken the next day at the usual time.

Stopping Vastan treatment

The doctor or pharmacist should be consulted, as stopping Vastan treatment may lead to a recurrence of high cholesterol levels in the blood.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Vastan can cause side effects, although not everybody gets them.
The following side effects have been reported:

• rare (may affect up to 1 in 1000 people);
• very rare (may affect up to 1 in 10,000 people);
• frequency not known (frequency cannot be estimated from the available data).

The following are rare, serious side effects.

If any of these serious side effects occur, treatment should be stopped, and the doctor or the emergency department of the nearest hospital should be informed immediately:

• muscle pain, tenderness, weakness, or cramps. In rare cases, these symptoms can be severe and associated with muscle tissue 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 that can cause breathing difficulties (angioedema);
• severe muscle pain, usually in the shoulder and hip area;
• rash with muscle weakness and neck and limb stiffness;
• joint pain or inflammation (polymyalgia rheumatica);
• inflammation of blood vessels (vasculitis);
• unusual bruising, skin lesions, and swelling (drug-induced lupus-like reactions), hives, sun sensitivity, fever;
• shortness of breath (dyspnea) and malaise;
• symptoms of lupus-like disease (including rash, joint pain, and changes in blood cells);
• liver inflammation with symptoms of jaundice and yellowing of the eyes, itching, dark urine, or pale stools, fatigue, or weakness, loss of appetite, liver failure (very rare);
• pancreatitis, often with severe abdominal pain.

The following side effects have also been rarely reported:

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

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

• a severe allergic reaction that can cause breathing difficulties or dizziness (anaphylaxis).

The following very rare side effects have also been reported:

• a rash that can occur on the skin or mouth ulcers (drug-induced lichenoid reactions);
• muscle damage;
• breast enlargement in men (gynecomastia).

The following side effects have been reported, but their frequency is unknown (frequency not known):

• erectile dysfunction;
• depression;
• inflammation of the lungs, causing breathing difficulties, 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).

The doctor should be consulted if the patient experiences weakness in the hands or feet, 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 disorders, including nightmares;
• sexual disorders;
• diabetes. The development of diabetes is more likely in people with high levels of sugar and fats in the blood, being overweight, and having high blood pressure. The doctor will monitor the patient's health during treatment with this medicine;
• muscle pain, tenderness, or persistent weakness, which may not resolve after stopping Vastan treatment (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 any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 can help gather more information on the safety of the medicine.

5. How to store Vastan

Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Vastan contains

• The active substance of Vastan is simvastatin. Each film-coated tablet of Vastan contains 10 mg or 20 mg of simvastatin.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose (E 460), pregelatinized starch, butylhydroxyanisole (E 320), ascorbic acid (E 300), anhydrous citric acid (E 330), magnesium stearate (E 572). Coating:hypromellose, hydroxypropylcellulose (E 463), titanium dioxide (E 171), talc (E 553b), macrogol, iron oxide red (E 172).

What Vastan looks like and what the pack contains

Vastan is a film-coated tablet.
The film-coated tablets are packaged in PVC/PVDC/Aluminum blisters. Each blister contains 14 tablets. The carton contains 2 blisters with a patient information leaflet.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów, Poland
Bausch Health Poland sp. z o.o.
Przemysłowa 2
35-959 Rzeszów, Poland
Date of last revision of the leaflet:March 2023