Kobey

Patient Information Leaflet

KOBEY 10 mg tablets

Equivalent medicine
Please read 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What KOBEY is and what it is used for
2. What you need to know before taking KOBEY
3. How to take KOBEY
4. Possible side effects
5. How to store KOBEY
6. Package contents and other information

1. What KOBEY is and what it is used for

KOBEY is a medicine used to reduce elevated cholesterol levels.
KOBEY lowers total cholesterol levels, "bad" cholesterol (LDL cholesterol), and fats known as triglycerides in the blood. KOBEY also increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in KOBEY, works by reducing the absorption of cholesterol from the intestine.
The cholesterol-lowering effect of KOBEY adds to that provided by statins, a group of medicines that work by reducing the body's own production of cholesterol.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is made up mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This blockage of blood flow may 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 form of fat in the blood that may increase the risk of heart disease.
It is used for patients who cannot control their cholesterol levels by reducing cholesterol through diet alone. You must follow a cholesterol-lowering diet while being treated with this medicine.
KOBEY is used in addition to a cholesterol-lowering diet when you have:

• elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial]), either in combination with a statin when cholesterol is not adequately controlled with a statin alone, or alone when treatment with statins is not appropriate or not tolerated.
• an inherited disease (homozygous familial hypercholesterolemia) that increases blood cholesterol levels. You will also be prescribed a statin, and you may be given additional treatments.
• an inherited disease (homozygous sitosterolemia, also known as phytosterolemia) that increases levels of plant sterols in the blood.

KOBEY does not help with weight loss.

2. What you need to know before taking KOBEY

If KOBEY is prescribed together with a statin, please read the package leaflet of that specific medicine.
Do not take KOBEY if:

• you are allergic (hypersensitive) to ezetimibe or to any of the other ingredients of this medicine (listed in section 6, "Contents of the pack and other information").

Do not take KOBEY together with a statin if:

• you currently have liver problems
• you are pregnant or breastfeeding.

Warnings and precautions

• Talk to your doctor or pharmacist before taking KOBEY. Inform your doctor about all medical conditions you have, including allergies.
• Your doctor should arrange for a blood test before starting treatment with KOBEY together with a statin, to check how well your liver is functioning.
• Your doctor may also ask you to have blood tests to monitor liver function after you start taking this medicine in combination with a statin.

If you have moderate or severe liver problems, the use of KOBEY is not recommended.
The concomitant administration of KOBEY and fibrates (medicines used to lower cholesterol) should be avoided, as the safety and efficacy of combining KOBEY with fibrates have not been established.
Children and adolescents
Do not give this medicine to children and adolescents aged 6 to 17 years unless specifically directed by a specialist, due to limited data on safety and efficacy.
Do not give this medicine to children under 6 years of age, as no data are available for this age group.
Other medicines and KOBEY
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor if you are taking medicines containing any of the following active substances:

• cyclosporine (often used in organ transplant patients)
• medicines with an active ingredient that prevents blood clotting, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• cholestyramine (also used to lower cholesterol), as it may alter the effect of ezetimibe
• fibrates (also used to lower cholesterol).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take KOBEY together with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking KOBEY with a statin, stop both treatments immediately and contact your doctor.
There is no experience with the use of KOBEY without a statin during pregnancy.
Do not take KOBEY together with a statin while breastfeeding, as it is not known whether these two medicines are excreted in human milk.
KOBEY, even when taken alone without a statin, should not be used during breastfeeding.
Please consult your doctor for advice.
Driving and use of machines
KOBEY is not expected to affect your ability to drive or operate machinery. However, you should be aware that some people may experience dizziness after taking KOBEY.
KOBEY contains lactose
KOBEY contains a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take KOBEY

Take this medicine exactly as your doctor has told you. Continue taking any other medicines for lowering cholesterol unless your doctor tells you otherwise. If in doubt, consult your doctor or pharmacist.

• Before starting this medicine, you must follow a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking this medicine.

The recommended dose is one 10 mg KOBEY tablet taken once daily by mouth.
You may take KOBEY at any time of day. It can be taken regardless of meals.
If your doctor has prescribed KOBEY together with a statin, both medicines may be taken at the same time. In this case, also refer to the dosing instructions provided in the package leaflet of the other medicine.
If your doctor has prescribed KOBEY together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing bile acid sequestrants, you must take KOBEY at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more KOBEY than you should
Contact your doctor or pharmacist if you have taken more KOBEY than you should.

If you forget to take KOBEY
Do not take a double dose to make up for the missed dose. Simply take your usual dose at the next scheduled time.

If you stop taking KOBEY
Consult your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following terms are used to describe how often the side effects have been reported:

• 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)

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or
muscle weakness. This is because, in rare cases, muscle problems, including damage to muscle
tissue leading to kidney damage, can be serious and potentially life-threatening.
Allergic reactions have been reported with the use of this medicine, including swelling of the
face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing (requiring
immediate treatment).
When the medicine has been used alone, the following side effects have been reported:
Common: abdominal pain; diarrhoea; flatulence; feeling of tiredness.
Uncommon: increases in blood test values indicating liver function (transaminases) or muscle
function (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain;
decreased appetite; pain; chest pain; hot flushes; high blood pressure.
In addition, when the medicine has been used together with a statin, the following side effects
have been reported:
Common: increases in blood test values indicating liver function (transaminases); headache;
muscle pain, tenderness or muscle weakness.
Uncommon: tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness;
pain in arms and legs; unusual tiredness or weakness; swelling, especially of the hands and feet.
When used together with fenofibrate, the following common side effect has been reported:
abdominal pain.
In addition, with general use of the medicine, the following side effects have been reported:
dizziness; muscle pain; liver problems; allergic reactions including rash and hives; raised red
rash, sometimes with target-shaped lesions (erythema multiforme); muscle pain, tenderness or
muscle weakness; damage to muscle tissue; gallstones or inflammation of the gallbladder (which
may cause abdominal pain, nausea, vomiting); inflammation of the pancreas, often accompanied
by severe abdominal pain; constipation; reduction in blood cell counts, which may cause
bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or
weakness; shortness of breath.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or
pharmacist. You can also report side effects directly via the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help
provide more information on the safety of this medicine.

5. How to store KOBEY

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister, packaging, or bottle after "EXP". The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.

Blister: store in the original packaging to protect the medicine from moisture.
Bottle: keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What KOBEY contains

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other components are: monohydrate lactose, croscarmellose sodium (E468), povidone K-30 (E1201), sodium lauryl sulfate, magnesium stearate (E470b), Polysorbate 80 (E433).

Description of the appearance of KOBEY and contents of the pack
Product description: uncoated tablets, white to off-white in colour, capsule-shaped,
flat with bevelled edges, imprinted with "10" on one side and smooth on the other.
Pack sizes:
7, 10, 14, 20, 28, 30, 50, 98, 100 or 300 tablets in aluminium-aluminium or
aluminium/PVC/Aclar blisters.
30 and 100 tablets in HDPE bottles with polypropylene caps.
Not all pack sizes may be marketed.

Marketing Authorization Holder
I.B.N. SAVIO S.r.l.
Via del Mare, n.36
00071 POMEZIA (RM)
Italy

Manufacturer
Accord Healthcare Limited
Ground Floor, Sage House, 319 Pinner Road, Harrow, Middlesex,
HA1 4HF
United Kingdom
Wessling Hungary Kft
Fòti ùt 56., Budapest
Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names: