Flarin 200 mg capsules, zacht

국가: 네덜란드

언어: 네덜란드어

출처: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

유효 성분:

IBUPROFEN

제공처:

Infirst Healthcare Limited

ATC 코드:

M01AE01

INN (국제 이름):

IBUPROFEN

약제 형태:

Capsule, zacht

구성:

GELATINE (E 441) ; HYPROMELLOSE (E 464) ; KALIUMHYDROXIDE (E 525) ; MACROGOL 600 ; PROPYLEENGLYCOL (E 1520) ; SORBITOL VLOEIBAAR, GEDEELTELIJK GEDEHYDRATEERD ; TITAANDIOXIDE (E 171) ; WATER, GEZUIVERD ; WITTE INKT,

관리 경로:

Oraal gebruik

치료 영역:

Ibuprofen

제품 요약:

Hulpstoffen: GELATINE (E 441); HYPROMELLOSE (E 464); KALIUMHYDROXIDE (E 525); MACROGOL 600; PROPYLEENGLYCOL (E 1520); SORBITOL VLOEIBAAR, GEDEELTELIJK GEDEHYDRATEERD; TITAANDIOXIDE (E 171); WATER, GEZUIVERD; WITTE INKT;

승인 날짜:

2012-07-18

환자 정보 전단

1
Flarin 200 mg soft capsules
November 2015
Version 5.0
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLARIN 200 MG CAPSULES, ZACHT
Ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use 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.Adults: You must talk to a doctor if you do
not feel better or if you feel worse
after 3 days in fever and 5 days in pain.
-
Children and adolescents: You must talk to a doctor if a child or
adolescent does not feel better or if
they feel worse after 3 days in fever and pain.
WHAT IS IN THIS LEAFLET:
1.
What Flarin is and what it is used for
2.
What you need to know before you use Flarin
3.
How to use Flarin
4.
Possible side effects
5.
How to store Flarin
6.
Contents of the pack and other information
1.
WHAT FLARIN IS AND WHAT IT IS USED FOR
Flarin contains ibuprofen which belongs to a group of medicinal
products called NSAIDs (non-steroidal
anti-inflammatory drugs). This medicinal product works by reducing
pain, inflammation and fever.
Flarin 200 mg soft capsules are used to provide relief from mild to
moderate pain such as headache,
including migraine headache, dental pain, period pain, back-, muscle-
and joint pain and fever.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FLARIN
DO NOT USE FLARIN

if you are allergic to ibuprofen or any of the other ingredients of
this medicine (listed in section 6)

if you have had allergic reactions such as asthma, runny nose, itchy
skin rash or swelling of the lips,
face, tongue, or throat after you have taken medicines containing
acetylsalicylic acid (such as aspirin)
or other drugs for pain and inflammation (NSAIDs).

if you have suffered from an ulcer or bleeding i

제품 특성 요약

1
Flarin 200 mg soft capsules
June 2015
Version 2.0
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Flarin 200 mg capsules, zacht
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_200 mg:_ Each soft capsule contains 200 mg ibuprofen.
Excipients:
_200 mg: _Sorbitol 55.6 mg/capsule._ _
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft.
A pale yellow, oval-shaped transparent soft gelatin capsule printed
with “Flarin” in white ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mild to moderate pain, such as headache including migraine headache,
dental pain and back-, muscle- and
joint pain.
Fever.
Primary dysmenorrhoea.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary
to control symptoms (see section 4.4). This product is for short-term
use only.
The ibuprofen dose depends on patient’s age and body weight.
The capsules should be taken with an adequate amount of liquid (e.g. a
glass of water).
_MILD TO MODERATE PAIN AND FEVER_
_Adults and adolescents over 12 years (≥40 kg): _
200 mg-400 mg given as a single dose or 3- 4 times daily with an
interval of 4 to 6 hours. The dosage in
migraine headache should be: 400 mg given as a single dose, if
necessary 400 mg with intervals of 4 to
6 hours.
The maximum daily dose should not exceed 1200 mg.
In adults aged from 18 years this medicinal product is required for
more than 3 days in fever and 5 days in
pain or if symptoms persist or worsen, a doctor should be consulted.
_Children 6 - 12 years (> 20 kg): _
Children 6-9 years (20-29 kg): 200 mg 1-3 times a day with intervals
of 4 to 6 hours as required.
The maximum daily dose should not exceed 600 mg.
2
Flarin 200 mg soft capsules
June 2015
Version 2.0
Children 10-12 years (30-40 kg): 200 mg 1-4 times a day with intervals
of 4 to 6 hours as required.
The maximum daily dose should not exceed 800 mg
.
If in children aged from 6 years and in adolescents this m