Ibuprofen 200 mg soft capsules

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

IBUPROFEN PH. EUR.

Sẵn có từ:

Bristol Laboratories Limited

Mã ATC:

M01AE; M01AE01

INN (Tên quốc tế):

IBUPROFEN PH. EUR.

Liều dùng:

200 milligram(s)

Dạng dược phẩm:

Capsule, soft

Khu trị liệu:

Propionic acid derivatives; ibuprofen

Tình trạng ủy quyền:

Not marketed

Ngày ủy quyền:

2019-05-31

Tờ rơi thông tin

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1
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6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBUPROFEN 200 MG SOFT CAPSULES
IBUPROFEN
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.
-
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, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE
IS AND WHAT IT IS USED FOR
The active ingredient (which makes the medicine work) is Ibuprofen. lt
belongs to a
group of medicines known as non-steroidal anti-inflammatory drugs
(NSAIDs).
NSAIDs provide relief by changing the body's response to pain,
swelling, and high
temperature.
Ibuprofen 200mg Liquid capsules is used for the relief of:
•
HEADACHES AND MIGRAINE PAIN
•
DENTAL PAIN AND NEURALGIA
•
PERIOD PAIN
•
RHEUMATIC, MUSCULAR AND BACK PAIN
•
FEVERISHNESS AND SYMPTOMS AT COLD AND FLU.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
DO NOT TAKE THIS MEDICINE:
•
if you are allergic to the active substance or any of the other
ingredients of this
medicine (listed in section 6).
Page
2
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6
•
have (or have had two or more episodes of) a stomach ulcer,
perforation or
bleeding
•
have had a worsening of asthma, skin rash, itchy runny nose or
facial swelling when previously taking ibuprofen, aspirin or similar
medicines
•
have had gastrointestinal bleeding or perforation when previously
taking NSAIDs (Non-steroidal anti-inflammatory drugs)
•
are taking other N

Đặc tính sản phẩm

Health Products Regulatory Authority
05 June 2019
CRN008LGZ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200 mg soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Ibuprofen 200 mg
Excipients with known effect: Also contains 18.67 mg Potassium per
capsule.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft.
Transparent, oval shaped soft gelatin capsule, printed 'BL200' in
white ink, containing clear solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults and children over 12 years:
Ibuprofen 200mg liquid capsules are indicated as an anti-inflammatory,
analgesic and antipyretic for short term management
of mild to moderate pain, fever and inflammation associated with
headache, dental pain, period pain, muscular strain,
neuralgia, rheumatic pain and migraine and for the management of the
symptoms of head colds and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS:
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
If in children and adolescents this medicinal product is required for
more than 3 days, or if symptoms worsen a doctor should
be consulted.
Adults should consult a doctor if symptoms persist or worsen, or if
the product is required for more than 10 days.
ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS: 200 - 400mg taken with
water up to three times a day as required. Leave at
least four hours between doses with a maximum of 1200mg in any 24 hour
period.
NOT FOR USE BY CHILDREN UNDER 12 YEARS OF AGE.
ELDERLY: 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
(See Section 4.4).
Method of administration
For oral administration and short-term use only.
4.3 CONTRAINDICATIONS
- Hypersensitivity to the active su