Tredaptive

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

laropiprant, nicotinic acid

Available from:

Merck Sharp Dohme Ltd.

ATC code:

C10AD52

INN (International Name):

laropiprant, nicotinic acid

Therapeutic group:

Lipid modifying agents

Therapeutic area:

Dyslipidemias

Therapeutic indications:

Tredaptive is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (LDL) cholesterol and triglycerides and low high-density-lipoprotein (HDL) cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).Tredaptive should be used in patients in combination with 3-hydroxy-3-methyl-glutaryl-co-enzyme-A (HMG-CoA)-reductase inhibitors (statins), when the cholesterol-lowering effect of HMG-CoA-reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA-reductase inhibitors are considered inappropriate or not tolerated. Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Tredaptive.

Product summary:

Revision: 11

Authorization status:

Withdrawn

Authorization date:

2008-07-03

Patient Information leaflet

29
B. PACKAGE LEAFLET
Medicinal product no longer authorised
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TREDAPTIVE 1,000 MG/20 MG MODIFIED-RELEASE TABLETS
nicotinic acid/laropiprant
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 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.
WHAT IS IN THIS LEAFLET:
1.
What Tredaptive is and what it is used for
2.
What you need to know before you take Tredaptive
3.
How to take Tredaptive
4.
Possible side effects
5.
How to store Tredaptive
6.
Contents of the pack and other information
1.
WHAT TREDAPTIVE IS AND WHAT IT IS USED FOR
The name of your medicine is Tredaptive. It contains two different
active substances:
•
nicotinic acid, a lipid modifying medicine, and
•
laropiprant, which reduces symptoms of flushing, a common side effect
of nicotinic acid.
HOW TREDAPTIVE WORKS
TREDAPTIVE IS USED IN ADDITION TO DIET
•
to lower your ‘bad’ cholesterol level. It does this by lowering
the levels of total cholesterol,
LDL cholesterol, fatty substances called triglycerides and apo B (a
part of LDL) in the blood;
•
to raise levels of ‘good’ cholesterol (HDL cholesterol) and apo
A-I (a part of HDL).
WHAT SHOULD I KNOW ABOUT CHOLESTEROL AND TRIGLYCERIDES?
Cholesterol is one of several fats found in your blood. Your total
cholesterol is made up mainly of
‘bad’ (LDL) and ‘good’ (HDL) cholesterol.
LDL cholesterol is often called ‘bad’ cholesterol because it can
build up in the walls of your arteries
and form plaque. Over time, this plaque build-up can lead to a
clogging of your arteries. This clogging
can slow or block blood flow to vital

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Tredaptive 1,000 mg/20 mg modified-release tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 1,000 mg of nicotinic acid and
20 mg of laropiprant.
Excipient(s) with known effect:
Each modified-release tablet contains 128.4 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablet.
Capsule-shaped, white to off-white tablet, with “552” debossed on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tredaptive is indicated for the treatment of dyslipidaemia,
particularly in adult patients with combined
mixed dyslipidaemia (characterised by elevated levels of
LDL-cholesterol and triglycerides and low
HDL-cholesterol) and in adult patients with primary
hypercholesterolaemia (heterozygous familial and
non-familial).
Tredaptive should be used in patients in combination with HMG-CoA
reductase inhibitors (statins),
when the cholesterol lowering effect of HMG-CoA reductase inhibitor
monotherapy is inadequate. It
can be used as monotherapy only in patients in whom HMG-CoA reductase
inhibitors are considered
inappropriate or not tolerated. Diet and other non-pharmacological
treatments (e.g. exercise, weight
reduction) should be continued during therapy with Tredaptive.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The starting dose is one modified-release tablet (1,000 mg nicotinic
acid/20 mg laropiprant) once a
day. After four weeks, it is recommended that patients be advanced to
the maintenance dose of
2,000 mg/40 mg taken as two modified-release tablets (1,000 mg/20 mg
each) once daily. Daily doses
greater than 2000 mg/40 mg have not been studied and therefore are not
recommended.
If Tredaptive is missed for less than 7 consecutive days, patients can
resume therapy at the last
administered dose. If Tredaptive is missed for 7 or more consecutive
days, therapy should be resumed
at the