DICLOFENAC POTASSIUM NCH 12.5 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
31-01-2015
Summary of Product characteristics
(SPC)
29-01-2016
Active ingredient:
DICLOFENAC POTASSIUM
Available from:
Novartis Consumer Health UK Limited
ATC code:
M01AB05
INN (International Name):
DICLOFENAC POTASSIUM
Dosage:
12.5 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Acetic acid derivatives and related substances
Authorization status:
Transfer Pending
Authorization date:
2009-12-22
Patient Information leaflet
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 ta
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Summary of Product characteristics
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 pa
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