Isovurex

Package leaflet: Information for the user

Isovurex, 10 mg, tablets
Ezetimibe
Read the entire leaflet carefully before using 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 consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Isovurex is and what it is used for

Isovurex is a medicine used to lower elevated cholesterol levels.
Isovurex reduces blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fat substances called triglycerides. In addition, Isovurex increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Isovurex 10 mg tablets, reduces the absorption of cholesterol in the gastrointestinal tract.
Isovurex complements the action of statins, a group of medicines that reduce cholesterol produced in the body.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol consists mainly of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can deposit in the walls of arteries as atherosclerotic plaques. Accumulation of these plaques may eventually lead to narrowing of the arteries, which can slow down or block blood flow to vital organs such as the heart and brain. Blocked blood flow may result in 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 an increased risk of heart disease.
This medicine is used in patients in whom a cholesterol-lowering diet alone is not sufficient to control cholesterol levels in the blood. A cholesterol-lowering diet should be maintained during treatment with this medicine.
Isovurex is used as an adjunct to a cholesterol-lowering diet when:

• the patient has elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial])
• in combination with a statin, if cholesterol levels are not adequately controlled with statin therapy alone
• as monotherapy, if statin therapy is not appropriate or is poorly tolerated
• the patient has a hereditary condition (homozygous familial hypercholesterolemia) causing increased blood cholesterol levels. The patient will be treated with a statin and other treatment methods may also be used.
• the patient has a hereditary condition (homozygous sitosterolemia, also known as phytosterolemia) causing increased levels of plant sterols in the blood.

If the patient has heart disease, Isovurex used in combination with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, procedures to improve blood flow to the heart, or hospitalization due to chest pain.
Isovurex has no effect on weight loss.

2. Important information before taking Isovurex

If the patient is taking Isovurex together with a statin, the package leaflet for that medicine should be consulted.
When not to use Isovurex:

• if the patient is allergic (hypersensitive) to ezetimibe or to any of the other ingredients of this medicine (see section 6: Contents of the pack and other information).

When not to use Isovurex in combination with a statin:

• if the patient currently has liver problems.
• if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting Isovurex, discuss this with a doctor or pharmacist.

• Inform the doctor about all medical conditions, including allergies.
• Before starting Isovurex with a statin, the doctor should perform blood tests to assess liver function.
• The doctor may also perform blood tests to monitor liver function after starting treatment with Isovurex and a statin.

Isovurex is not recommended for use in patients with moderate or severe liver impairment.
The safety and efficacy of Isovurex in combination with certain cholesterol-lowering drugs, fibrates, have not been established.

Children and adolescents
This medicine should not be used in children and adolescents (aged 6 to 17 years) unless specifically prescribed by a specialist due to lack of data on safety and efficacy.
This medicine should not be used in children under 6 years of age due to lack of data in this age group.

Interaction of Isovurex with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• cyclosporine (often used in patients who have received an organ transplant)
• medicines containing active substances that prevent blood clotting, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)
• cholestyramine (also used to lower cholesterol levels), as it affects the action of Isovurex
• fibrates (also used to lower cholesterol levels)

Pregnancy and breastfeeding
Do not take Isovurex with a statin if the patient is pregnant, planning to become pregnant, or suspects she may be pregnant. If pregnancy occurs during treatment with Isovurex and a statin, the patient should immediately stop taking both medicines and contact her doctor.
There are no data on the use of Isovurex without a statin during pregnancy. If the patient is pregnant, she should consult her doctor before taking Isovurex.
Do not take Isovurex with a statin during breastfeeding, as it is unknown whether the medicines pass into breast milk.
Isovurex without a statin should not be used in breastfeeding women. The patient should consult her doctor for advice.
Consult a doctor or pharmacist before using any medicine.

Driving and operating machinery
Isovurex is not expected to affect the ability to drive or operate machinery. However, it should be noted that dizziness may occur in some patients after taking Isovurex.

Isovurex contains lactose
Isovurex tablets contain a sugar called lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Isovurex contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Isovurex

This medicine should always be taken exactly as directed by your doctor. Unless otherwise advised by your doctor, you should continue taking any cholesterol-lowering medicines you were previously using. If in doubt, consult your doctor or pharmacist.

• Before starting Isovurex, you should follow a cholesterol-lowering diet.
• While taking Isovurex, you should continue to follow a cholesterol-lowering diet. The recommended dose is one Isovurex tablet, 10 mg orally, once daily.

Isovurex can be taken at any time of day. It may be taken with or without food.
If your doctor has prescribed Isovurex together with a statin, both medicines may be taken at the same time.
In this case, please refer to the patient information leaflet for the respective medicine regarding dosing instructions.
If your doctor has prescribed Isovurex together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant resin, Isovurex should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant resin.

Taking more Isovurex than prescribed
Contact your doctor or pharmacist.

If you miss a dose of Isovurex
Do not take a double dose to make up for the missed tablet. Simply take your next dose at the usual time the following day.

Stopping Isovurex
Discuss this with your doctor or pharmacist, as cholesterol levels may rise again.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Isovurex may cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions is classified as follows:

• Very common (may occur in more than 1 in 10 patients)
• Common (may occur in up to 1 in 10 patients)
• Uncommon (may occur in up to 1 in 100 patients)
• Rare (may occur in up to 1 in 1,000 patients)
• Very rare (may occur in up to 1 in 10,000 patients, including single cases).

You should contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. In rare cases, muscle-related symptoms, including rhabdomyolysis leading to kidney damage, may be severe and progress to a potentially life-threatening condition.
Allergic reactions have been reported during routine use, including facial, lip, tongue, and/or throat swelling, which may cause difficulty in breathing or swallowing (requiring immediate treatment).
When used as monotherapy, the following adverse reactions have been reported:
Common: abdominal pain; diarrhoea; flatulence; feeling of fatigue.
Uncommon: increased liver function test parameters (aminotransferases) or muscle parameters (CK); cough; indigestion; heartburn; nausea; joint pain; muscle cramps; neck pain; decreased appetite; chest pain; sudden flushing of the face; high blood pressure.
Additionally, when used concomitantly with a statin, the following adverse reactions have been reported:
Common: increased liver function test parameters (aminotransferases); headache; muscle pain, tenderness, or weakness.
Uncommon: tingling sensation; dry mouth; itching; rash; urticaria; back pain; muscle weakness; pain in arms and legs; unexplained fatigue or weakness; swelling, particularly in hands and feet.
When used in combination with fenofibrate, the following common adverse reaction has been reported:

• abdominal pain.

Furthermore, during routine use, the following adverse reactions have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; red, raised rash, sometimes with lesions in the shape of a target (erythema multiforme); muscle pain, tenderness, or weakness; rhabdomyolysis; gallstones or cholecystitis (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; decreased blood cell counts, which may lead to bruising/bleeding (thrombocytopenia); tingling sensation; depression; unexplained fatigue or weakness; shortness of breath.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Isovurex

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and on each bottle or label following: EXP. The expiry date refers to the last day of the stated month.

Shelf life after first opening the bottle: 100 days.
No special storage conditions required.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Isovurex contains

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, hypromellose (E 464), sodium croscarmellose (E 468), sodium lauryl sulphate, microcrystalline cellulose (PH 102), crospovidone type B (E 1202), magnesium stearate (E 470b).

What Isovurex looks like and contents of the pack
Isovurex tablets are white or almost white, capsule-shaped tablets (approximately 8 mm in length and 4 mm in width), embossed with the code "E10" on one side and smooth on the other.

Pack sizes:
HDPE bottles with child-resistant closure containing 100 tablets (1 bottle) or 300 tablets (3 bottles each containing 100 tablets), packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147
{logo of the Marketing Authorisation Holder}

Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the European Economic Area member states under the following names:
Czech Republic: Isovurex
Croatia: Isovurex 10 mg tablete
Slovenia: Isovurex 10 mg tablete
Romania: Isovurex 10 mg comprimate
Poland: Isovurex
Bulgaria: Isovurex 10 mg tablets
Изовурекс 10 mg таблетки