DICLOFENAC POTASSIUM NCH

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

DICLOFENAC POTASSIUM

Disponível em:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

Código ATC:

M01AB05

DCI (Denominação Comum Internacional):

DICLOFENAC POTASSIUM

Dosagem:

12.5 Milligram

Forma farmacêutica:

Film Coated Tablet

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

diclofenac

Status de autorização:

Not Marketed

Data de autorização:

2009-12-22

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
DICLOFENAC POTASSIUM NCH 12.5 MG FILM COATED TABLETS
Diclofenac potassium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always
take
this
medicine
exactly
as
described
in
this
leaflet
or
as
your
doctor
or
pharmacist has told you.
•
You must consult your doctor if your symptoms worsen or do not
improve.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If any of the side effects gets serious, or if you notice any side
effects not listed
in this leaflet, please tell your doctor or pharmacist.
•
In this leaflet, Diclofenac Potassium NCH 12.5 mg film coated tablets
will be
called Diclofenac Potassium NCH tablets.
IN THIS LEAFLET
1.
What Diclofenac Potassium NCH tablet is and what it is used for
2.
Before you take Diclofenac Potassium NCH tablets
3.
How to take Diclofenac Potassium NCH tablets
4.
Possible side effects
5.
How to store Diclofenac Potassium NCH tablets
6.
Further information
1.
WHAT DICLOFENAC POTASSIUM NCH TABLET IS AND WHAT IT IS USED FOR
WHAT DICLOFENAC POTASSIUM NCH TABLET IS
Diclofenac Potassium
NCH 12.5 mg film coated tablets contain diclofenac which
belongs to a
group of medicines called “non-steroidal anti-inflammatory drugs”
(NSAIDs).
Diclofenac
Potassium
NCH
tablets
are
pain
relievers
which
also
reduce
inflammation (swelling) and lower body temperature.
WHAT DICLOFENAC POTASSIUM NCH TABLETS IS USED FOR
Diclofenac Potassium NCH tablets provide fast relief from:
•
Headache, dental pain, period pain, rheumatic and muscular pains,
backaches.
•
Symptoms of colds and flu (including aches and pains, sore throat
pain). They also
reduce fever.
How Diclofenac Potassium NCH tablets work
Diclofenac Potassium NCH tablets relieve the symptoms of inflammation,
such as pain

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclofenac potassium NCH 12.5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 12.5 mg diclofenac potassium.
Excipient with known effect: Lactose monohydrate (33.45 mg)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (Tablets).
White oblong (capsule-shaped) film coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of painful conditions such as headache, dental pain, period
pain, rheumatic and muscular pain, backache. Relief
of symptoms of colds and flu, including fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4 Special warnings and precautions for use).
ADULTS AND CHILDREN AGED 14 YEARS AND OVER:
For oral administration:
Initially two tablets, followed by one or two tablets every 4 to 6
hours as needed. No more than 6 tablets (75 mg)
should be taken in any 24 hour period.
Diclofenac potassium NCH is intended for short-term use, up to 5 days
for relief of pain and 3 days for relief of fever.
The tablets should be swallowed whole with a drink of water,
preferably with or after food.
SPECIAL POPULATION
CHILDREN AND ADOLESCENTS BELOW 14 YEARS:
Diclofenac potassium NCH tablets are not recommended for use in
children under 14 years of age.
RENAL IMPAIRMENT
Diclofenac Potassium NCH is contraindicated in patients with renal
failure (see section 4.3 Contraindications).
No specific studies have been carried out in patients with renal
impairment; therefore, no specific dose adjustment
recommendations can be made. Caution is advised when administering
Diclofenac Potassium NCH to patients with
mild to moderate renal impairment (See section 4.4. Special warnings
and precautions for use).
HEPATIC IMPAIRMENT
Diclofenac Potassium NCH is contraindicated in patients with severe
hepatic impairment (see section 4.3
Contraindicati