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 medication, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be re-read.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. It should not be given to others. The medication 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 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 medication 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 medications 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, resulting in restricted or blocked blood flow to vital organs, such as the heart and brain. Restricted 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 medication, the patient should follow a cholesterol-lowering diet.
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 condition (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, previous 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.

In most cases, high cholesterol levels do not cause direct symptoms. The doctor can assess cholesterol levels by ordering a simple blood test. Regular check-ups, monitoring of cholesterol levels, and discussion of 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 medication (listed in section 6);
• if the patient currently has liver function disorders;
• if the patient is pregnant or breastfeeding;
• if the patient is taking certain medications, including:
• itraconazole, ketoconazole, posaconazole, or voriconazole (medications 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 (medications used to treat hepatitis C virus infection)
• nefazodone (an antidepressant medication),
• cobicistat (a medication that increases the effect of certain antiviral medications, used to treat HIV infection),
• gemfibrozil (a medication used to lower cholesterol levels);
• cyclosporine (a medication used in patients who have undergone organ transplants);
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).

Vastan should not be taken in doses 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 medication 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 the use of any of the above medications, the patient should consult their doctor.

Warnings and precautions

Before starting Vastan, the patient should discuss it with their doctor. The patient should inform their doctor:

• about all their medical conditions, including allergies;
• about consuming large amounts of alcohol;
• about any history of liver disease. Taking Vastan in such cases may not be suitable;
• about any planned surgery. The patient should inform their doctor, as it may be necessary to temporarily stop taking Vastan;
• 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 condition that causes general muscle weakness, including muscles involved in breathing) or ocular myasthenia (a condition that causes muscle weakness in the eyes), as statins may sometimes worsen symptoms or lead to myasthenia (see section 4).

Before starting 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 medication. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.
The patient should inform their doctor about any serious lung diseases.

The patient should immediately contact their doctor if they experience unexplained muscle pain, tenderness, or weakness.

This can lead to kidney damage and, in very rare cases, death.
The patient should also inform their doctor or pharmacist if muscle weakness persists. Additional tests and medications may be necessary to diagnose and treat this condition.
The risk of muscle damage is higher when taking higher doses of Vastan, particularly 80 mg. The risk of muscle tissue breakdown is also higher in some patients. The patient should tell their doctor if:

• they drink large amounts of alcohol;
• they have kidney function disorders;
• they have thyroid function disorders;
• they are 65 years or older;
• they are female;
• they have previously experienced muscle problems while taking cholesterol-lowering medications, such as statins or fibrates;
• they or their close relatives have been diagnosed with hereditary muscle diseases.

Children and adolescents

The effectiveness and safety of simvastatin have been studied in boys aged 10 to 17 years and girls who have started menstruation (at least one year before). Simvastatin has not been studied in children under the age of 10. For further information, the patient should consult their doctor.

Vastan and other medications

The patient should tell their doctor about all medications they are currently taking or plan to take.
It is especially important to inform the doctor if the patient is taking any of the following medications, as they may increase the risk of muscle problems (some of these medications are listed above in the "When not to take Vastan" section):

If oral fusidic acid is necessary to treat a bacterial infection, it may be necessary to temporarily stop taking Vastan. The doctor will inform the patient when it is safe to restart 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 condition in which the lining of the uterus grows outside the uterus);
• medications such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections);
• fibric acid derivatives, such as gemfibrozil and 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 medications, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection);
• medications 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 conditions);
• lomitapide (used to treat a rare genetic disorder of high cholesterol levels);
• colchicine (used to treat gout).

Besides the medications listed above, the patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, including those available without a prescription. This is especially important for:

• blood-thinning medications, such as warfarin, phenprocoumon, and acenocoumarol;
• fenofibrate (a medication used to lower cholesterol levels);
• niacin (a medication used to lower cholesterol levels);
• rifampicin (a medication used to treat tuberculosis).

The patient should also inform any doctor who prescribes a new medication about their use of Vastan.

Vastan with food and drink

Grapefruit juice contains at least one compound that affects the action of certain medications in the body, including Vastan. The patient should avoid drinking grapefruit juice while taking Vastan.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medication.
Vastan should not be taken if the patient is pregnant, plans to become pregnant, or thinks they may be pregnant. If the patient becomes pregnant while taking Vastan, they should stop treatment immediately and contact their doctor.
Women who are breastfeeding should not take Vastan, as it is not known whether the medication is excreted into breast milk.
Before taking any medication, the patient should consult their doctor or pharmacist.

Driving and operating machinery

Vastan does not affect the ability to drive or operate machinery. However, the patient should consider that Vastan may cause dizziness in some cases.

Vastan contains lactose

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

3. How to take Vastan

This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will determine the dose of Vastan suitable for the patient, depending on their current treatment and individual risk assessment.
While taking Vastan, the patient should follow a cholesterol-lowering diet.
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 mg, 20 mg, 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 a lower dose, especially in patients taking certain medications or with certain kidney disorders.
A dose of 80 mg is recommended only for adult patients with very high cholesterol levels in the blood and a high risk of heart disease, who have not achieved the target cholesterol level with a lower dose.

Use in children and adolescents

In children (aged 10 to 17 years), the recommended initial dose is 10 mg once a day, in the evening. The maximum recommended dose is 40 mg per day.
Administration:
Vastan should be taken in the evening. The medication 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 medication containing a bile acid sequestrant, Vastan should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking more than the recommended dose of Vastan

In case of taking a higher dose than recommended, the patient should contact their doctor or pharmacist.

Missing a dose of Vastan

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

Stopping Vastan

The patient should consult their doctor or pharmacist, as stopping Vastan may lead to increased cholesterol levels in the blood.
In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Vastan can cause side effects, although not everyone will experience 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 (cannot be estimated from the available data).

The following are rare, serious side effects that have been reported.

If the patient experiences any of these serious side effects, they should stop taking Vastan and immediately contact their doctor or go to the emergency department of the nearest hospital:

• muscle pain, tenderness, weakness, or cramps. In rare cases, these symptoms 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 difficulty breathing (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 (dermatomyositis), hives, sun sensitivity, fever;
• shortness of breath (dyspnea) and malaise;
• symptoms of lupus-like disease (including rash, joint pain, and blood cell changes);
• liver inflammation with symptoms of jaundice, itching, dark urine, or pale stools, fatigue, 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 in the hands and feet;
• headache, tingling, dizziness;
• gastrointestinal problems (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting);
• rash, itching, hair loss;
• weakness;
• blurred vision and visual 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 difficulty breathing 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 lupus-like syndrome);
• muscle damage;
• breast enlargement in men (gynecomastia).

The following side effects have been reported with a frequency that 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 condition that causes general muscle weakness, including muscles involved in breathing);
• ocular myasthenia (a condition that causes muscle weakness in the eyes).

The patient should talk to their doctor if they experience weakness in their 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 disorders, including nightmares;
• sexual disorders;
• diabetes. The development of diabetes is more likely in patients with high blood sugar and fat levels, overweight, and high blood pressure. The doctor will monitor the patient's health during treatment with this medication;
• muscle pain, tenderness, or persistent weakness, which may not resolve after stopping Vastan (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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist or nurse. 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 can help gather more information on the safety of this medication.

5. How to store Vastan

Store at a temperature below 25°C. Store in the original packaging to protect from light and moisture.
The medication should be stored in a place that is out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the month.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medications 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.
• 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 ingredients:hypromellose, hydroxypropylcellulose (E 463), titanium dioxide (E 171), talc (E 553b), macrogol, iron oxide red (E 172).

What Vastan looks like and package contents

Vastan is a film-coated tablet.
The 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