Boots Paracetamol Extra tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol; Caffeine

Available from:

The Boots Company Plc

ATC code:

N02BE51

INN (International Name):

Paracetamol; Caffeine

Dosage:

500mg ; 65mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Invalid to prescribe in NHS primary care

Product summary:

BNF: 04070100; GTIN: 5045094750917

Patient Information leaflet

BOOTS PHARMACEUTICALS
_ _
INFORMATION FOR THE USER
PARACETAMOL & CODEINE EXTRA
(Caffeine, Codeine Phosphate, Paracetamol)
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,
migraine, rheumatic pain, neuralgia, toothache and period pain that is
not relieved by aspirin,
ibuprofen, or paracetamol alone

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 or 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 headache, migraine,
rheumatic pain, neuralgia, toothache, and period pain 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 Paracetamol and Caffeine. Paracetamol, an
analgesic, acts to relieve pain. Caffeine
helps to increase the pain relief.
BEFORE YOU TAKE THIS MEDICINE

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 A PAINKILLER FOR HEADACHES FOR MO

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ultramol Soluble
Paracetamol & Codeine Extra.
Paracetamol & Codeine Extra Effervescent Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 500mg paracetamol, 8mg codeine
phosphate
and 30mg caffeine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Effervescent Tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the short-term treatment of acute moderate pain which is not
relieved by
paracetamol, ibuprofen or aspirin alone such as headaches, migraine,
neuralgia,
toothache, dysmenorrhoea and rheumatic pain.
Codeine is indicated in patients older than 12 years of age for the
treatment of acute
moderate pain which is not considered to be relieved by other
analgesics such as
paracetamol or ibuprofen (alone).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Do not take continuously for more than 3 days without consulting your
doctor.
Adults, including the elderly:_ _
Two tablets, to be dissolved in a glass of water, every 4 to 6 hours
when necessary up
to a maximum of 8 tablets in 24 hours.
Children aged 16 to 18 years:
One to two tablets every 6 hours when necessary up to a maximum of
four doses in
24 hours.
Children aged 12 to 15 years:
One tablet every 6 hours when necessary to a maximum of four doses in
24 hours.
Paediatric population
Children aged less than 12 years: Codeine 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 section 4.3 and
4.4).
METHOD OF ADMINISTRATION
For oral administration.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substances or any of the excipients
listed in section
6.1
•
In all paediatric patients (0-18 years of age) who undergo
tonsillectomy and/or
adenoidectomy for obstructive sleep apnoea syndrome due to an
increased risk of
developing serious and life-threatening adverse reactions (see section
4.4)
•
In women duri