ISOVUREX 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Isovurex, 10 mg, tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
3. What Isovurex is and what it is used for
4. Before you take Isovurex
   1. When not to take Isovurex:
   2. When not to take Isovurex with a statin:
   3. Warnings and precautions
   4. Children and adolescents
   5. Isovurex and other medicines
   6. Pregnancy and breast-feeding
   7. Driving and using machines
   8. Isovurex contains lactose
   9. Isovurex contains sodium
5. How to take Isovurex
   1. If you take more Isovurex than you should
   2. If you forget to take Isovurex
   3. If you stop taking Isovurex
6. Possible side effects
   1. Immediately contact your doctor if you experience unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems can be serious and potentially life-threatening.
   2. Reporting of side effects
7. How to store Isovurex
8. Contents of the pack and other information
   1. What Isovurex contains
   2. What Isovurex looks like and contents of the pack
   3. Marketing Authorisation Holder and Manufacturer
   4. Marketing Authorisation Holder:
   5. Manufacturer/Importer:
   6. This medicine is authorised in the Member States of the European Economic Area under the following names:
   7. Czech Republic:
   8. Croatia:
   9. Slovenia:
   10. Romania:
   11. Poland:
   12. Bulgaria:
   13. Date of last revision of the package leaflet:

Package Leaflet: Information for the User

Isovurex, 10 mg, tablets

Ezetimibe

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Isovurex is and what it is used for
• 2. Before you take 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 blood cholesterol levels.
Isovurex reduces the amount of cholesterol and other fats, called triglycerides, in the blood. It also increases the level of 'good' cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient in Isovurex, 10 mg tablets, reduces the absorption of cholesterol from the gut.
Isovurex complements the action of statins, a group of medicines used to lower blood cholesterol levels produced in the body.
Cholesterol is one of several fats found in the blood. Total cholesterol is mainly made up of LDL and HDL cholesterol.
LDL cholesterol is often called 'bad' cholesterol because it can build up in the walls of the arteries forming plaques. The buildup of these plaques can eventually lead to a narrowing of the arteries, which can reduce or block blood flow to important organs such as the heart and brain. Blocking blood flow can cause a heart attack or stroke.
HDL cholesterol is often called 'good' cholesterol because it helps prevent 'bad' cholesterol from building up in the arteries and protects against heart disease.
Triglycerides are another type of fat found in the blood, which can also contribute to the risk of heart disease.
This medicine is used in patients who do not get enough of a reduction in their cholesterol levels from diet alone. While taking this medicine, you should continue with a low-cholesterol diet.
Isovurex is used as an addition to a low-cholesterol diet, if:

• you have high levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous familial and non-familial])
• in combination with a statin, if cholesterol levels are not adequately controlled with a statin alone
• as monotherapy, if statin therapy is not appropriate or is not tolerated
• you have a rare inherited cholesterol condition (homozygous familial hypercholesterolaemia) that causes very high cholesterol levels in the blood. You may also receive other treatments
• you have a rare inherited condition (homozygous sitosterolaemia, also known as phytosterolaemia) that causes very high levels of plant sterols in the blood

If you have heart disease, Isovurex, in combination with statins, reduces the risk of heart attack, stroke, the need for procedures to increase blood flow to the heart, or hospitalisation due to chest pain.
Isovurex does not affect weight loss.

2. Before you take Isovurex

If you are taking Isovurex with a statin, read the package leaflet that comes with your statin medicine.

When not to take Isovurex:

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

When not to take Isovurex with a statin:

• if you currently have liver problems.
• if you are pregnant or breast-feeding.

Warnings and precautions

Before taking Isovurex, tell your doctor or pharmacist if you have:

• told your doctor about all your medical conditions, including allergies.
• had liver problems or have liver problems now.
• had muscle problems or have muscle problems now.

Isovurex is not recommended for people with moderate or severe liver problems.
The safety and effectiveness of Isovurex in combination with certain cholesterol-lowering medicines called fibrates have not been established.

Children and adolescents

Do not give this medicine to children and adolescents (6 to 17 years of age) unless it has been prescribed by a specialist. There is not enough information on the use of this medicine in children and adolescents.
Do not give this medicine to children under 6 years of age because there is no information on its use in this age group.

Isovurex and other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
In particular, tell your doctor if you are taking any of the following:

• cyclosporine (often used in patients who have had an organ transplant)
• medicines that prevent the formation of blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulant medicines)
• cholestyramine (also used to lower cholesterol levels), as it affects the action of Isovurex
• fibrates (also used to lower cholesterol levels)

Pregnancy and breast-feeding

Do not take Isovurex with a statin if you are pregnant, planning to become pregnant, or think you may be pregnant. If you become pregnant while taking Isovurex with a statin, stop taking both medicines immediately and tell your doctor.
There is no information on the use of Isovurex alone in pregnant women. If you are pregnant, ask your doctor for advice before taking Isovurex.
Do not take Isovurex with a statin if you are breast-feeding, as it is not known whether the medicines are passed into breast milk.
Isovurex alone should not be used in breast-feeding women. Ask your doctor for advice before taking Isovurex.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Isovurex is unlikely to affect your ability to drive or use machines. However, some people may experience dizziness while taking Isovurex.

Isovurex contains lactose

Isovurex tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Isovurex contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially 'sodium-free'.

3. How to take Isovurex

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Before taking Isovurex, you should follow a low-cholesterol diet.
While taking Isovurex, you should continue to follow a low-cholesterol diet.

• The recommended dose is one Isovurex 10 mg tablet, taken by mouth, once a day.

Isovurex can be taken at any time of the day, with or without food.
If your doctor has prescribed Isovurex with a statin, you can take them together at the same time. In this case, read the package leaflet that comes with your statin medicine for instructions on how to take it.
If your doctor has prescribed Isovurex with another cholesterol-lowering medicine called a bile acid sequestrant, such as cholestyramine, take Isovurex at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Isovurex than you should

Contact your doctor or pharmacist.

If you forget to take Isovurex

Do not take a double dose to make up for a forgotten tablet. Just take your normal dose of Isovurex at the usual time the next day.

If you stop taking Isovurex

Consult your doctor or pharmacist before stopping treatment with Isovurex, as your cholesterol levels may increase again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is classified into the following categories:

• Very common (may affect more than 1 in 10 people)
• Common (may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people)
• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people, including isolated cases).

Immediately contact your doctor if you experience unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems can be serious and potentially life-threatening.

During treatment with Isovurex, the following side effects have been reported:

• Common: abdominal pain; diarrhoea; flatulence; feeling tired
• Uncommon: increased levels of some liver or muscle enzymes in your blood; cough; indigestion; heartburn; nausea; joint pain; muscle cramps; neck pain; decreased appetite; pain; chest pain; flushing

In addition, when Isovurex is taken with a statin, the following side effects have been reported:

• Common: increased levels of some liver enzymes in your blood; headache; muscle pain, tenderness, or weakness
• Uncommon: tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness; pain in the arms and legs; unexplained tiredness or weakness; swelling, particularly of the hands and feet

During treatment with Isovurex and fenofibrate, the following common side effect has been reported:

• abdominal pain

In addition, the following side effects have been reported during treatment with Isovurex:

dizziness; muscle pain; liver problems; allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing (which require immediate medical attention); hives; rash; red, raised, and itchy rash (sometimes on the skin that resembles targets); muscle pain, tenderness, or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); pancreatitis (which may cause severe abdominal pain); constipation; low blood cell counts, which may cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unexplained tiredness or weakness; shortness of breath

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system listed in the 'Contact details for reporting side effects' section below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Isovurex

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and on each blister/bottle after EXP. The expiry date refers to the last day of that month.

Shelf-life after first opening the bottle: 100 days.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater 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 sulfate, 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 long and 4 mm wide) with 'E10' engraved on one side and a smooth surface on the other.
Pack sizes: HDPE bottles with a child-resistant closure, containing 100 tablets (1 bottle) or 300 tablets (3 bottles of 100 tablets each), 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
Phone: (+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 medicine is authorised in the Member States of the European Economic Area under the following names:

Czech Republic:

Isovurex

Croatia:

Isovurex 10 mg tablets

Slovenia:

Isovurex 10 mg tablets

Romania:

Isovurex 10 mg tablets

Poland:

Isovurex

Bulgaria:

Isovurex 10 mg tablets
Изовурекс 10 mg таблетки

Date of last revision of the package leaflet: