Boots Ibuprofen and Codeine 200mg / 12.8 mg film-coated tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Ibuprofen; Codeine phosphate hemihydrate

Disponible desde:

Taw Pharma (Ireland) Ltd

Código ATC:

N02AJ; N02AJ08

Designación común internacional (DCI):

Ibuprofen; Codeine phosphate hemihydrate

Dosis:

200 mg/12.8 milligram(s)

formulario farmacéutico:

Film-coated tablet

Área terapéutica:

Opioids in combination with non-opioid analgesics; codeine and ibuprofen

Estado de Autorización:

Not marketed

Fecha de autorización:

2010-12-17

Información para el usuario

INFORMATION FOR THE USER
[BOOTS LOGO] Ibuprofen and Codeine 200 mg/12.8 mg film-coated tablets
Ibuprofen, Codeine Phosphate Hemihydrate
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 within 3 days
-
This medicine can only be used for the short term treatment of acute
moderate pain such as
headaches, rheumatic and muscular pain, backache, migraine, period
pain, dental pain and
neuralgia that is not relieved by aspirin, ibuprofen or paracetamol
alone
-
This medicine should only be taken when necessary
-
YOU SHOULD ONLY TAKE THIS PRODUCT FOR A MAXIMUM OF 3 DAYS at a time.
If you need to take it
for longer than 3 days you should see your doctor or pharmacist for
advice
-
THIS MEDICINE CONTAINS CODEINE WHICH CAN CAUSE ADDICTION if you take
it continuously for
more than 3 days. This can give you withdrawal symptoms from the
medicine when you stop
taking it
-
IF YOU TAKE THIS MEDICINE FOR HEADACHES FOR MORE THAN 3 DAYS it can
make them worse
1.
What Ibuprofen and Codeine 200 mg/12.8 mg film-coated tablets are and
what they are
used for
2.
What you need to know before you take Ibuprofen and Codeine 200
mg/12.8 mg film-coated
tablets
3.
How to take Ibuprofen and Codeine 200 mg/12.8 mg film-coated tablets
4.
Possible side effects
5.
How to store Ibuprofen and Codeine 200 mg/12.8 mg film-coated tablets
6.
Contents of the pack and other information
1.
WHAT IBUPROFEN AND CODEINE 200 MG/12.8 MG FILM-COATED TABLETS ARE AND
WHAT THEY ARE
USED FOR
This medicine contains codeine. Codeine belongs to a group of
medicines

Ficha técnica

Health Products Regulatory Authority
06 January 2023
CRN00D7CN
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Ibuprofen and Codeine 200mg / 12.8 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient mg/tablet
Ibuprofen 200 mg
Codeine Phosphate Hemihydrate 12.8 mg
Excipients with known effect mg/tablet
Sodium Starch Glycolate (Type A) 45 mg (11 mg Sodium)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film Coated Tablet (Tablet)
White capsule-shaped tablet embossed with ‘I +’
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicine is indicated in patients older than 12 years of age.
For the short term treatment of acute moderate pain which is not
considered to be relieved by other analgesics (e.g.
paracetamol, ibuprofen or aspirin) alone, such as: rheumatic and
muscular pain, backache, neuralgia, migraine, headache,
dental pain, dysmenorrhoea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
RECOMMENDED DOSAGE:
_ADULTS OVER 18 YEARS:_ One or two tablets every four to six hours.
Do not take more than 6 tablets in 24 hours.
Leave at least four hours between doses.
_CHILDREN AGED 12 YEARS TO 18 YEARS:_ The recommended dose for
children 12 years and older is one or two tablets every 6
hours when necessary up to a maximum of 6 tablets in 24 hours.
_CHILDREN UNDER 12 YEARS:_ This medicine should not be used in
children below the age of 12 years because of the risk of opioid
toxicity due to the variable and unpredictable metabolism of codeine
to morphine (see sections 4.3 and 4.4).
_ELDERLY:_
No special dosage modifications are required for elderly patients,
unless renal or hepatic function is impaired, in which case
dosage should be assessed individually.
Do not take for more than 3 days continuously without medical review.
The pa