NIASPAN 500 Milligram Tablet Prolonged Release

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

NICOTINIC ACID

Inapatikana kutoka:

Abbott Laboratories Ireland Ltd

INN (Jina la Kimataifa):

NICOTINIC ACID

Kipimo:

500 Milligram

Dawa fomu:

Tablet Prolonged Release

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2012-05-16

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Niaspan 500 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 500mg nicotinic acid.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
White to off-white capsule-shaped tablet. Each tablet is embossed with the tablet strength on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia, characterised by elevated
levels
of
LDL-cholesterol
and
triglycerides
and
low
HDL-cholesterol,
and
in
patients
with
primary
hypercholesterolaemia. Niaspan 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. Niaspan
can be used as monotherapy only in patients who do not tolerate HMG-CoA reductase inhibitors. Diet and other non-
pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Niaspan.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Niaspan should be taken at bedtime, after a low-fat snack (e.g. an apple, low fat yoghurt, slice of bread) and doses
should be individualised according to the patient’s response.
_Initial dose_
Therapy with Niaspan must be initiated with a low dose and increased gradually.
The recommended dose escalation schedule is shown below in Table 1:
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/10/2010_
_CRN 2086926_
_page number: 1_
Table 1: Dose escalation schedule
_Maintenance dose_
The recommended maintenance dose is 1000 mg (two 500 mg tablets) to 2000 mg (two 1000 mg table