Ibuprofen 200mg Soft capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Pfizer Healthcare Ireland

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosage:

200 milligram(s)

Pharmaceutical form:

Capsule, soft

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization status:

Marketed

Authorization date:

2002-03-08

Patient Information leaflet

Black
Dieline
Technical
2/5 code
Area reserved
Product Name:
INS-IBUPROFEN 200MG LIQUIGEL
Draft No:
05 -
Date:
09/04/2020 -
Operator: 009E
Barcode Type(s):
-
X-Hight Rule:
N
Std Spec / Label Text Number:
N/A
Dieline:
170 X 360 MM
2 of 5 code :
N/A
Standard Color:
0032
Item Code:
MK-PAA123352 PIL 2
PAR:
2019-0008884
Market:
IRELAND
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PF - v.13
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription, for you to treat a
mild illness without a doctor’s help. Nevertheless, you still need
to use your medicine
carefully to get the best results. Always take this medicine exactly
as described in this leaflet or as your doctor or pharmacist has told
you. Keep this
leaflet, you may need to read it again. Ask your pharmacist if you
need more information or advice. If you get any side effects, or if
any of the side effects
get serious, please tell your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4. You
must see a doctor if
your symptoms worsen or persist. See section 3.
WHAT IS IN THIS LEAFLET:
1.
What your medicine is and what it is used for
2.
What you need to know before you take your medicine
3.
How to take your medicine
4.
Possible side effects
5.
How to store your medicine
6.
Contents of the pack and other information
1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR
Each liquid-filled soft capsule contains 200 mg of ibuprofen.
Ibuprofen belongs to a group of medicines called Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs) that work by relieving pain and
reducing
inflammation, swelling and fever. Your medicine is for the relief of
mild to moderate pain including: rheumatic and muscular pain,
backache, headache,
dental pain, period pain, feverishness and the symptoms of colds an

Summary of Product characteristics

Health Products Regulatory Authority
26 May 2020
CRN009935
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200mg Soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains ibuprofen 200 mg.
Excipients : sorbitol (E 420), soya lecithin.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Soft capsule
Green translucent, oval soft gelatin capsule printed ‘Advil’ on
one side in white ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ibuprofen is indicated for the relief of mild to moderate pain
including rheumatic and muscular pain, backache, headache,
dental pain, dysmenorrhoea, feverishness and for the relief of
symptoms of cold and influenza
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only.
For all indications:
Adults, older people and children and adolescents between 12-18 years
of age.
If in children or adolescents between 12 -18 years of age, this
medicinal product is required for more than 3 days, or if
symptoms worsen, a doctor should be consulted.
For adults aged 18 years or older, the lowest effective dose should be
used for the shortest duration necessary to relieve
symptoms and minimise undesirable effect (see section 4.4). The
patient should consult a doctor if symptoms persist or worsen,
or if the product is required for more than 10 days.
1 or 2 capsules up to three times per day as required. The respective
dosing interval should be chosen in line with the observed
symptoms and the maximum recommended daily dose. Doses should be given
approximately every 6-8 hours, with a minimum
interval of 4 hours between each dose. A total dose of 1200 mg of
ibuprofen (6 capsules) should not be exceeded in any 24
hour period. The capsules should be taken with water.
Not to be used for children under 12 years of age.
4.3 CONTRAINDICATIONS
Hypersensitivity to ibuprofen or any of the other ingredients in the
product (see Section 4.4 Special Warnings and
Precautions.
Use in patients hypersensi