Boots Ibuprofen and Codeine 200mg/12.8mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Ibuprofen; Codeine phosphate

Beszerezhető a:

The Boots Company Plc

ATC-kód:

N02AJ08

INN (nemzetközi neve):

Ibuprofen; Codeine phosphate

Adagolás:

200mg ; 12.8mg

Gyógyszerészeti forma:

Oral tablet

Az alkalmazás módja:

Oral

Osztály:

Schedule 5 (CD Inv)

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 10010100; GTIN: 5045095632236 5045095632229

Betegtájékoztató

PATIENT INFORMATION LEAFLET
INFORMATION FOR THE USER
Ibuprofen and Codeine 200 mg/12.8 mg Tablets
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription to treat minor
conditions. However, you still
need to take it carefully to get the best results from it.

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

Keep this leaflet, you may need to read it again

Ask your pharmacist if you need more information or advice
WHAT THIS MEDICINE IS FOR
This medicine can 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 contains Codeine. Codeine belongs to a group of
medicines called opioid
analgesics which act to relieve pain.
This codeine-containing medicine can be used in adults and children
aged 12 years and
over.
This medicine also contains Ibuprofen. Ibuprofen, a non-steroidal
anti-inflammatory medicine
(NSAID), also acts to reduce swelling (inflammation).
BEFORE YOU TAKE THIS MEDICINE

THIS MEDICINE CONTAINS CODEINE WHICH CAN CAUSE ADDICTION
(physiological and
psychological dependence) if you take it continuously for more than 3
days. This can

Termékjellemzők

OBJECT 1
BOOTS IBUPROFEN AND CODEINE 200MG/12.8MG
TABLETS (FILM-COATED TABLETS)
Summary of Product Characteristics Updated 25-Apr-2018 | THE BOOTS
COMPANY PLC
1. Name of the medicinal product
Ibuprofen and Codeine 200mg/12.8mg film-coated Tablets _(UK only)_
Boots Pharmaceuticals Ibuprofen and Codeine 200mg/12.8mg film-coated
Tablets _(IE only)_
2. Qualitative and quantitative composition
Active ingredient
mg/tablet
Ibuprofen
200 mg
Codeine Phosphate Hemihydrate
12.8 mg
For 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