Nurofen Express 200 mg Tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Ibuprofen

Pieejams no:

Reckitt Benckiser Ireland Ltd

ATĶ kods:

M01AE; M01AE01

SNN (starptautisko nepatentēto nosaukumu):

Ibuprofen

Deva:

200 milligram(s)

Zāļu forma:

Coated tablet

Receptes veids:

Product not subject to medical prescription

Ārstniecības joma:

Propionic acid derivatives; ibuprofen

Autorizācija statuss:

Marketed

Autorizācija datums:

2011-05-27

Lietošanas instrukcija

NUROFEN EXPRESS 200MG TABLETS
Ibuprofen (as sodium dihydrate)
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Nurofen Express 200mg Tablets
carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not
improve after 3 days.
• 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
1 What Nurofen Express 200mg Tablets are and what they are used for
2 Before you take Nurofen Express 200mg Tablets
3 How to take Nurofen Express 200mg Tablets
4 Possible side effects
5 How to store Nurofen Express 200mg Tablets
6 Further information
1.
WHAT NUROFEN EXPRESS 200MG TABLETS ARE AND WHAT ARE THEY USED FOR:
The active ingredient (which makes the medicine work) in Nurofen
Express 200mg Tablets is ibuprofen 200 mg
(as sodium dihydrate 256mg). Ibuprofen belongs to a group of medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs). These medicines work by changing how the
body responds to pain, swelling and
high temperature.
Nurofen Express 200mg Tablets are used for the relief of fever and
mild to moderate pain such as:
• headaches, period pain, and dental pain
• muscle pain and backache
• symptoms of colds and flu, and high temperature (fever)
2.BEFORE YOU TAKE NUROFEN EXPRESS 200MG TABLETS
Do not take these tablets if you:
• are allergic (hypersensitive) to ibuprofen or any of the other
ingredients (see Section 6: Further Information)
• are allergic (hypersensitive) to aspirin or to other painkillers
• have or ever had a stomach ulcer, perforation or bleeding in the
stomach
• have ever had gastrointestinal bleeding in relation to NSAID
therapy
• have severe liver or kidney problems

Produkta apraksts

Health Products Regulatory Authority
22 May 2023
CRN00DDJT
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen Express 200 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 200mg (as sodium dihydrate)
Excipients with known effect:
Each tablet contains Sodium: 27.94mg (1.21mmol) of sodium per tablet.
Sucrose: 93.1mg per tablet.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Coated Tablet.
A white to off-white, biconvex, round, sugar coated tablet with an
identifying logo in black on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anti-inflammatory, analgesic and antipyretic for short-term
management of mild to moderate pain such as is associated
with headache, dental pain, fever, period pain, muscular strain,
backache, and for the management of the symptoms of head
colds and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short term use only.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4).
Adults and children over 12 years: Initial dose is one or two tablets
and subsequently if necessary, one or two tablets every four
hours with a maximum of 6 tablets in a 24 hour period i.e. a maximum
dose of 1200mg in a 24 hour period.
If the medicinal product is required for more than 3 days or if the
symptoms worsen, the patient should consult a doctor.
If in adolescents this medicinal product is required for more than 3
days, or if symptoms worsen a doctor should be consulted.
Not suitable for children under 12 years of age without medical advice
NSAIDs should be used with particular caution in elderly patients who
are more prone to adverse events. The lowest dose
compatible with adequate safe clinical control should be employed
please refer to section 4.4. Treatment should be reviewed
at regular intervals and discontinued if no benefit is seen or
intolerance occurs.
4.3 CONTRAINDICATIONS
History of gastrointestinal