Vastan

Patient leaflet: information for the user

Vastan, 10 mg, film-coated tablets
Vastan, 20 mg, film-coated tablets
Simvastatinum
Please read this leaflet carefully before taking this medicine, as it contains important information
for you.

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

Table of contents:

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

1. What Vastan is and what it is used for

Vastan contains the active substance simvastatin. Vastan is a medicine used to lower blood levels of total cholesterol, the so-called "bad" cholesterol (LDL cholesterol fraction), and fats known as triglycerides. In addition, Vastan increases levels 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 called "bad" cholesterol because it can deposit on the walls of arteries, forming atherosclerotic plaques. Eventually, these plaques may narrow the arteries, thereby restricting or blocking blood flow to vital organs such as the heart and brain. Blocked blood flow may lead to 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 in the blood that may contribute to increased risk of heart disease.
While taking this medicine, you should follow a cholesterol-lowering diet.
Vastan is used as an adjunct to a cholesterol-lowering diet in patients:

• who have been diagnosed with high blood cholesterol levels (primary hypercholesterolemia) or high blood fat levels (mixed hyperlipidemia);
• with an inherited condition (homozygous familial hypercholesterolemia) associated with high blood cholesterol levels. In these patients, additional treatments may also be used;
• with ischemic heart disease (coronary heart disease), or who are at high risk of developing ischemic heart disease (due to diabetes, previous stroke, or other vascular diseases). Vastan may help reduce the risk of heart disease independently of blood cholesterol levels, thereby contributing to increased life expectancy in these individuals.

In most people, elevated cholesterol levels do not cause direct symptoms. Your doctor can assess your cholesterol levels by ordering a simple blood test. You should attend regular check-ups, monitor your blood cholesterol levels, and discuss treatment goals with your doctor.

2. 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 abnormalities;
• if the patient is pregnant or breastfeeding;
• if the patient is concurrently taking medicines containing one or more of the following active substances:
  • 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 in the treatment of HIV infection),
  • boceprevir and telaprevir (medicines used in the treatment of hepatitis C),
  • nefazodone (an antidepressant),
  • cobicistat (a medicine that enhances the effect of certain antiviral drugs, used in the treatment of HIV infections),
  • gemfibrozil (a medicine used to reduce cholesterol levels),
  • cyclosporine (a medicine used in organ transplant patients),
  • danazol (a synthetic hormone used in the treatment of endometriosis, a condition in which the tissue lining the uterus grows outside the uterus).

Vastan must not be used in doses higher than 40 mg if the patient is taking lomitapid
(used in the treatment of a severe and rare genetic disorder affecting cholesterol levels).
Vastan must not be used if the patient is currently taking or has taken (or has been administered) within the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection.
Concomitant use of fusidic acid and Vastan may lead to severe muscle damage (rhabdomyolysis).
If in doubt whether any of the above-mentioned medicines are being used, consult a doctor.

Warnings and precautions

Before starting to take Vastan, discuss this with your doctor. Inform your doctor:

• about all medical conditions, including allergies;
• if you consume large amounts of alcohol;
• if you have previously had liver disease. The use of Vastan in such cases may not be appropriate;
• if you are scheduled for surgery. Inform your doctor, as it may be necessary to discontinue Vastan temporarily;
• if you are of Asian descent, as a different dose may be appropriate for you;
• if you have or have had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may occasionally worsen symptoms or lead to the development of myasthenia (see section 4).

Before starting treatment with Vastan, your doctor should order blood tests to check liver function. Your 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 blood sugar and fat levels, overweight, and high blood pressure may be at increased risk of developing diabetes.

Inform your doctor about serious lung diseases.

Contact your doctor immediately if you experience unexplained
muscle pain, tenderness or weakness. In rare cases, muscle-related symptoms may be serious, including muscle breakdown leading to kidney damage, and in very rare cases, death.

Inform your doctor or pharmacist if muscle weakness persists. Additional tests and medications may be required to diagnose and treat this condition.

The risk of muscle damage is higher when higher doses of Vastan are used, particularly the 80 mg dose. The risk of muscle tissue breakdown is also higher in certain patients. Inform your doctor if:

• you drink large amounts of alcohol;
• you have kidney function abnormalities;
• you have thyroid function abnormalities;
• you are 65 years of age or older;
• you are female;
• you previously experienced muscle-related symptoms while taking cholesterol-lowering medicines known as statins or fibrates;
• you or your close relatives have been diagnosed with inherited muscle disorders.

Children and adolescents

The efficacy and safety of simvastatin have been studied in boys aged 10 to 17 years and in girls who have had their first menstrual period at least one year prior (see section 3: "How to take Vastan"). Studies on simvastatin have not been conducted in younger children under 10 years of age. For further information, consult your doctor.

Vastan 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.

It is especially important to inform your doctor if you are taking any of the following medicines. Concomitant use of these medicines with Vastan may increase the risk of muscle-related side effects (some of these medicines are listed above in section: "When not to take Vastan"):

• If oral fusidic acid is required for the treatment of a bacterial infection, temporary discontinuation of Vastan will be necessary. Your doctor will advise when it is safe to restart Vastan. Concomitant use of 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 (commonly used in organ transplant patients);
• danazol (a synthetic hormone used in the treatment of endometriosis, a condition in which the tissue lining the uterus grows outside the uterus);
• medicines such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections);
• medicines in the fibrate class, 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 in the treatment of AIDS);
• antiviral medicines such as boceprevir, telaprevir, elbasvir or grazoprevir (used in the treatment of hepatitis C);
• medicines containing the active substance cobicistat;
• nefazodone (used in the treatment of depression);
• amiodarone (used to treat heart rhythm disorders);
• verapamil, diltiazem and amlodipine (used to treat high blood pressure, chest pain related to heart disease or other heart conditions);
• lomitapid (used in the treatment of a severe and rare genetic disorder affecting cholesterol levels);
• colchicine (used in the treatment of gout).

In addition to the medicines listed above, inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription. This includes particularly:

• anticoagulant medicines (blood thinners) 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).

Inform any doctor prescribing a new medicine that you are taking Vastan.

Vastan with food and drink

Grapefruit juice contains at least one compound that affects the action of certain medicines in the body, including Vastan. Avoid drinking beverages containing grapefruit juice while taking Vastan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Do not take Vastan if you are pregnant, planning a pregnancy, or suspect you may be pregnant. If you become pregnant while taking Vastan, stop treatment immediately and contact your doctor.

Breastfeeding women should not take Vastan, as it is not known whether the medicine is excreted in breast milk.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Vastan does not affect the ability to drive or operate machinery. However, bear in mind that dizziness may occur in some patients after taking Vastan.

Vastan contains lactose

If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Vastan

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The doctor will determine the appropriate dose of the medicine for the individual patient, depending on the current
treatment and individual assessment of risk in the given patient.
During treatment with Vastan, a low-cholesterol diet should be followed.
Dosage:
The recommended dose of Vastan is 10 mg, 20 mg, 40 mg or 80 mg orally, once daily, 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 up to a maximum of 80 mg per day.
Do not take more than 80 mg per day.
The doctor may recommend a lower dose of the medicine, especially in patients taking the
medicines listed above or suffering from certain kidney disorders.
The 80 mg dose is recommended only for adult patients with very high blood cholesterol levels and a high risk of
heart disease, in whom the target cholesterol level has not been achieved with a lower dose.
Use in children and adolescents
In children (aged 10 to 17 years), the usual recommended starting dose is 10 mg once daily in the evening. The maximum recommended dose is 40 mg per day.
Administration method:
Vastan should be taken in the evening. The medicine may be taken with or without food.
Vastan should be taken continuously until the doctor advises stopping it.
If the doctor has prescribed Vastan together with another cholesterol-lowering medicine containing
any bile acid-binding agent, Vastan should be taken at least 2 hours before or
4 hours after the bile acid-binding medicine.
Taking more Vastan than recommended
If more medicine has been taken than recommended, contact your doctor or pharmacist immediately.
Missing a dose of Vastan
Do not take a double dose to make up for a missed dose. Take the next dose of Vastan at the usual time the following day.
Stopping Vastan
Consult your doctor or pharmacist, as discontinuation of Vastan may result in a renewed increase in blood cholesterol levels.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have occurred:

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

Listed below are rare, serious adverse reactions.
If any of these serious adverse reactions occur, treatment must be discontinued immediately
and the doctor should be contacted without delay or the patient should go to the emergency
department of the nearest hospital:

• Muscle pain, tenderness, weakness or cramps. In rare cases, these symptoms may be severe and associated with muscle breakdown leading to kidney damage; very rare cases of death have been reported;
• Hypersensitivity reactions (allergic reactions) such as:
  • swelling of the face, tongue and throat causing breathing difficulties (angioedema);
  • severe muscle pain, usually around the shoulder and hip joints;
  • rash with muscle weakness in the limbs and neck;
  • joint pain or inflammation (polymyalgia rheumatica);
  • inflammation of blood vessels (vasculitis);
  • unusual bruising, skin lesions and swelling (dermatomyositis), urticaria, photosensitivity, fever, hot flushes;
  • shortness of breath (dyspnoea) and malaise;
  • symptoms of a lupus-like illness (including rash, joint problems and blood cell abnormalities);
• Hepatitis with symptoms such as yellowing of the skin and whites of the eyes (jaundice), itching, dark urine or pale stools, fatigue or weakness, loss of appetite, liver failure (very rare);
• Pancreatitis, often with severe abdominal pain.

The following adverse reactions have also been reported rarely:

• Decrease in red blood cells (anaemia);
• Numbness or weakness in the hands and feet;
• Headache, tingling sensation, dizziness;
• Gastrointestinal disturbances (abdominal pain, constipation, bloating, indigestion, diarrhoea, 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 adverse reaction has been reported:

• Severe allergic reaction causing difficulty in breathing or dizziness (anaphylaxis).

Additionally, the following very rare adverse reactions have been reported:

• Rash affecting the skin or ulceration of the oral mucosa (lichenoid mucocutaneous lesions);
• Muscle damage;
• Breast enlargement in men (gynaecomastia).

The following adverse reactions have also been reported, for which frequency cannot be estimated
from the available data (frequency not known):

• Erectile dysfunction;
• Depression;
• Lung inflammation causing breathing problems, including persistent cough and/or dyspnoea or fever;
• Tendon disorders, sometimes complicated by tendon rupture;
• Myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing);
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Patients should speak to their doctor if they experience weakness in the arms or legs, worsening after
periods of activity, double vision or drooping eyelids, difficulty swallowing or
breathing difficulties.
Additional possible adverse reactions reported during use of some statins:

• Sleep disorders, including nightmares;
• Sexual dysfunction;
• Diabetes. The occurrence 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 health during treatment with this medicine;
• Muscle pain, tenderness or persistent muscle weakness, which may not resolve after discontinuation of Vastan (frequency not known).

Laboratory test results
Increased activity of muscle enzymes (creatine kinase) in the blood and abnormal liver function tests have been observed.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions to Medicinal Products, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vastan

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

6. Contents of the pack and other information

What Vastan contains

• The active substance is simvastatin. Each coated tablet of Vastan contains 10 mg or 20 mg of simvastatin.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose (E 460), pregelatinized starch, butylated hydroxyanisole (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, red iron oxide (E 172).

What Vastan looks like and contents of the pack
Vastan is a coated tablet.
Coated tablets are packed in blisters made of PVC/PVDC/Aluminium foil. Each blister contains 14 tablets. Each cardboard box contains 2 blisters together with the patient information leaflet.

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

Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów, Poland