Ibuprofen 200 mg soft capsules

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Ibuprofen ph. eur.

Հասանելի է:

Brillpharma (Ireland) Limited

ATC կոդը:

M01AE; M01AE01

INN (Միջազգային անվանումը):

Ibuprofen ph. eur.

Դոզան:

200 milligram(s)

Դեղագործական ձեւ:

Capsule, soft

Թերապեւտիկ տարածք:

Propionic acid derivatives; ibuprofen

Լիազորման կարգավիճակը:

Not marketed

Հաստատման ամսաթիվը:

2019-05-31

Տեղեկատվական թերթիկ

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8 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 soft 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).
•
have (or have had two or more episodes of) a stomach ulcer,
perforation or bleeding
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8
•
have had a
shortness of breath, worsening of asthma, allergic rash or itchy,
runny
nose or swelling of lips, face tongue or throat when previously taking
ibuprofen,
aspirin or similar medicines
•
have had gastrointestinal bleeding or perforation when previously
taking NSAIDs (Non-steroid

Ապրանքի հատկությունները

Health Products Regulatory Authority
09 February 2024
CRN00D3R3
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 soft 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:
The lowest effective dose should be used for the shortest duration
necessary to relieve 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 substance or to any of the exci