Nurofen Advance 200mg Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Ibuprofen lysinate

Verfügbar ab:

Reckitt Benckiser Ireland Ltd

ATC-Code:

M01AE; M01AE01

INN (Internationale Bezeichnung):

Ibuprofen lysinate

Dosierung:

200 milligram(s)

Darreichungsform:

Film-coated tablet

Therapiebereich:

Propionic acid derivatives; ibuprofen

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2001-07-13

Gebrauchsinformation

LEAFLET COPY
Nurofen Advance 200mg Tablets
(Ibuprofen Lysine)
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
Advance 200mg Tablets carefully to get the best results from them.
-
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-effect not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1. What Nurofen Advance 200mg Tablets are and what they are used for:
2. Before you take Nurofen Advance 200mg Tablets
3. How to take Nurofen Advance 200mg Tablets
4. Possible side-effects
5. How to store Nurofen Advance 200mg Tablets
6. Further Information
1.
WHAT NUROFEN ADVANCE 200MG TABLETS ARE AND WHAT THEY ARE USED FOR?
Nurofen Advance contains ibuprofen 200mg as ibuprofen lysinate.
Ibuprofen belongs to a group of medicines
called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines
provide relief by changing the body’s
response to pain, swelling and high temperature. Nurofen Advance 200mg
tablets provide fast and effective
relief from headaches, migraine, dental pain, period pain, backache,
muscular pain, for the symptomatic
treatment of cold and flu symptoms and fever.
2.
BEFORE YOU TAKE NUROFEN ADVANCE 200MG TABLETS
DO NOT TAKE NUROFEN ADVANCE 200MG TABLETS IF YOU:
-
Are allergic to ibuprofen or any of the ingredients of Nurofen Advance
200mg Tablets listed in section 6.
-
Have experienced shortness of breath, worsening of asthma, allergic
rash or an itchy runny nose or
swelling of the lips, face, tongue or throat when taking ibuprofen,
aspirin or other similar medicines have
ever had stomach bleeding or perforation after taking ibuprofen,
aspirin or other similar medicines have
(or have had two or more episodes of) a stomach ulcer, perforatio

Fachinformation

Health Products Regulatory Authority
22 May 2023
CRN00DDJT
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen Advance 200mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 200mg (as lysine salt).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, film-coated capsule shaped tablet, printed with an identifying
logo in black on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anti-inflammatory, analgesic and anti-pyretic for the relief of
mild to moderate pain, such as headache, migraine, dental
pain, feverishness, period pain, muscular strain and backache. For the
symptomatic relief of fever, colds and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4).
If this medicinal product is required for more than 3 days, or if
symptoms worsen a doctor should be consulted.
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. For short-term use
only (see above).
Children under 12 years of age: Not recommended.
Elderly: See section 4.4 Special Warnings and Precautions for Use.
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 bleeding or perforation related to
previous NSAIDs therapy.
Active or history of recurrent peptic ulcer/haemorrhage (two or more
distinct episodes of proven ulceration or bleeding) or
other gastrointestinal disorder.
Patients with a known history of hy