KOBEY 10 mg Coated Tablet

Содержание инструкции

1. KOBEY 10 mg tablets
   1. What is KOBEY and what is it 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

KOBEY 10 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take KOBEY
• 3. How to take KOBEY
• 4. Possible side effects
• 5. How to store KOBEY
• 6. Contents of the pack and other information

1. What is KOBEY and what is it used for

KOBEY is a medicine to reduce elevated cholesterol levels.
KOBEY decreases levels of total cholesterol, 'bad' cholesterol (LDL cholesterol) and fats
called triglycerides in the blood. KOBEY also increases levels of 'good' cholesterol (HDL
cholesterol).
Ezetimibe, the active ingredient of KOBEY, works by decreasing the absorption of cholesterol from
the intestine.
The decrease in cholesterol levels due to KOBEY is added to that due to statins,
a group of medicines that work by reducing the production of cholesterol by the body itself.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is mainly composed of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls
of the arteries forming plaques. Over time, this build-up in the form of plaque
can lead to a narrowing of the arteries. This narrowing can slow down or block the
flow of blood to vital organs such as the heart and brain. This blockage of 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 form of fat in the blood that can increase the risk of
heart disease.
It is used for patients who cannot control cholesterol levels by reducing cholesterol levels with diet alone. You must follow a diet to reduce cholesterol during the
therapy with this medicine.

KOBEY is used in addition to a cholesterol-lowering diet if you have:

• an elevated blood cholesterol level (primary hypercholesterolemia [familial and non-familial heterozygous]) or together with a statin, when cholesterol is not adequately controlled with a statin alone, or alone, when treatment with statins is not appropriate or is not tolerated.
• an inherited disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You will also be prescribed a statin and you may be prescribed other 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

medicinal product.

Do not take KOBEY if:

• you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medicinal product (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. Tell your doctor about any medical conditions you have, including allergies.
• Your doctor may prescribe a blood test before starting therapy together with a statin. This is to check how your liver is working.
• Your doctor may also ask you to have blood tests to check how your liver is working after starting to take this medicinal product together with a statin.

If you have moderate or severe liver problems, the use of KOBEY is not recommended.
The co-administration of KOBEY and fibrates (medicines that reduce cholesterol)
should be avoided because the safety and efficacy of the combined use of
KOBEY with fibrates have not been established.

Children and adolescents
Do not give this medicine to children and adolescents between 6 and 17 years of age unless directed by
a specialist, as there are limited data on safety and efficacy.
Do not give this medicine to children under 6 years of age as there are no data
available in this age group.

Other medicines and KOBEY
Tell 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 with one of the
following active ingredients:

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take KOBEY together with a statin if you are pregnant, are trying to become pregnant or
think you might be pregnant. If you become pregnant while taking KOBEY together
with a statin, you should immediately stop both treatments 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 during breastfeeding, as it is not known whether the two
medicines are excreted in human milk.
KOBEY, even if taken alone without a statin, should not be used during breastfeeding.
Ask your doctor for advice.

Driving and using machines
No effects of KOBEY on the ability to drive vehicles or use machines are expected. However,
it should be taken into consideration 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 intolerance
to certain sugars, contact them before taking this medicine.

3. How to take KOBEY

Take this medicine following the instructions of your doctor exactly. Continue to
take other medicines to lower cholesterol, unless your doctor tells you to
stop taking them. If you have any doubts, consult your doctor or pharmacist.

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

The recommended dose is one 10 mg KOBEY tablet once a day, to be taken by
mouth.
You can take KOBEY at any time of the day. You can take it independently of
meals.
If your doctor has prescribed KOBEY together with a statin, the two medicines can be taken
at the same time. In this case, also consult the dosage instructions contained in the package
leaflet of the other medicine.
If your doctor has prescribed KOBEY together with another medicine to lower cholesterol
containing the active ingredient 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 a missed dose, it is sufficient to resume the
usual dose of KOBEY at the usual time the next day.

If you stop taking KOBEY
Consult your doctor or pharmacist because cholesterol may increase again.
If you have any questions about 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 following terms are used to describe how often 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 in case of unexplained muscle pain, tenderness or
muscle weakness. This is because, in rare cases, muscle problems, including muscle tissue
injury leading to kidney damage, can be serious and potentially life-threatening.
Allergic reactions, including swelling of the face, lips, tongue, and/or throat which can cause
difficulty breathing or swallowing (requiring immediate treatment), have been reported with
common use of the medicine.
When used alone, the following side effects have been reported:
Common: abdominal pain; diarrhoea; flatulence; feeling tired.
Uncommon: increases in the values of some liver tests (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 the values of some liver function tests (transaminases); headache; muscle
pain, tenderness or weakness.
Uncommon: sensation of tingling; 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 the general use of the medicine, the following side effects have been reported:
dizziness; muscle pain; liver problems; allergic reactions including skin rash and hives; raised red
rash, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness or
weakness; muscle tissue injury; gallstones or inflammation of the gallbladder (which can cause
abdominal pain, nausea, vomiting); inflammation of the pancreas often accompanied by severe
abdominal pain; constipation; reduced number of blood cells, which can cause bruising/bleeding
(thrombocytopenia); sensation of tingling; depression; unusual tiredness or weakness; shortness of
breath.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through 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 which is stated on the blister, the carton or the 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 any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What KOBEY contains

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

Description of the appearance of KOBEY and package contents
Product description: uncoated tablets of white to off-white color, capsule-shaped,
flat with beveled edge imprinted with “10” on one side and smooth on the other side.
Pack sizes:
7, 10, 14, 20, 28, 30, 50, 98, 100 or 300 tablets in aluminum-aluminum blisters or
aluminum/PVC/Aclar.
30 and 100 tablets in HDPE bottles with a polypropylene cap.
Not all pack sizes may be marketed.

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

Manufacturer
Accord Healthcare Limited
Ground Floor, Sage House, 319 Pinner Road, Harrow, Middlesex,
HA1 4HF
United Kingdom
Wessling Hungary Kft
Fòti ùt 56., Budapest
1047
Hungary

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: