Actiprofen 200 mg tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Ibuprofen

제공처:

Haleon Ireland Limited

ATC 코드:

M01AE; M01AE01

INN (국제 이름):

Ibuprofen

복용량:

200 milligram(s)

약제 형태:

Film-coated tablet

처방전 유형:

Product not subject to medical prescription

치료 영역:

Propionic acid derivatives; ibuprofen

승인 상태:

Marketed

승인 날짜:

1992-03-24

환자 정보 전단

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTIPROFEN 200MG TABLETS IBUPROFEN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE ACTIPROFEN
TABLETS BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any questions, or if you do not understand anything, ask
your doctor or pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. This
included any possible side effects not
listed in this leaflet.
IN THIS LEAFLET
1.
What Actiprofen tablets are and what they are used for
2.
What you need to know before you take Actiprofen tablets
3.
How to take Actiprofen tablets
4.
Possible side effects
5.
How to store Actiprofen tablets
6.
Contents of the pack and other information
1.
WHAT ACTIPROFEN TABLETS ARE AND WHAT THEY ARE USED FOR
Actiprofen 200 mg tablets contain the active ingredient ibuprofen.
Ibuprofen is an analgesic (pain reliever) and
anti-inflammatory which relieves pain and eases stiffness. Actiprofen
tablets are used for the short term
management of mild to moderate pain associated with rheumatic and
muscular pain, backache, nerve pain ,
migraine, headache, toothache, period pain, feverishness and symptoms
of cold and flu.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACTIPROFEN TABLETS
CHECK BEFORE YOU TAKE THIS MEDICINE.
DO NOT TAKE ACTIPROFEN TABLETS:
•
If you are allergic to ibuprofen or any of the other ingredients of
Actiprofen tablets, aspirin or other pain
relievers.
•
If you are taking any other products containing ibuprofen or other
NSAID medicines, including drugs known
as COX-2 inhibitors.
•
If you suffer from asthma.
•
If you have had or are suffering from stomach ulcers, perforation or
bleeding of the stomach or other
stomach disorders.
•
If it is to be administered to children under the age of 12.
•
If you have severe liver, kidney or heart failure.
•
If you are in the last 3 months of pregnancy.
Anti-inflammatory/pain-killer medicines like ibuprofen may be
associated with a small

제품 특성 요약

Health Products Regulatory Authority
20 June 2023
CRN00DKSP
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actiprofen 200 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 200 mg
Excipient: Contains 50mg lactose. Printing ink contains carmoisine
(E122).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-Coated Tablet
White, capsule-shaped film coated tablet with flat edges printed with
the name ‘Actiprofen’ in red on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short term management of mild to moderate pain such as is
associated with rheumatic and muscular pain, backache,
neuralgia, migraine, headache, dental pain, dysmenorrhoea,
feverishness, symptoms of cold and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Do not exceed the stated dose
Tablets should be swallowed with water. Preferably with or after food.
Adults, elderly and children aged 12 years and over:
Dosage: The usual initial dose is 400mg and subsequently, if
necessary, 200- 400mg every 4 – 6 hours. Maximum dose is
1200mg in divided doses in a 24 hour period. Do not take more often
than every 4 - 6 hours.
Undesirable effects may be minimized by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
Patients should consult a doctor if symptoms persist or worsen or if
the product is required for more than 3 days for fever and
10 days for pain.
Treatment should be reviewed at regular intervals and discontinued if
no benefit is seen or intolerance occurs.
Children 12 - 18 years: If this medicinal product is required for more
than 3 days, or if symptoms worsen a doctor should be
consulted.
This product is not suitable for use in 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.
Renal Impairment:
Patients wit