Codeine 60mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Codeine phosphate

Saatavilla:

Accord-UK Ltd

ATC-koodi:

R05DA04

INN (Kansainvälinen yleisnimi):

Codeine phosphate

Annos:

60mg

Lääkemuoto:

Oral tablet

Antoreitti:

Oral

luokka:

Schedule 5 (CD Inv)

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 04070200; GTIN: 5012617013330

Pakkausseloste

CODEINE PHOSPHATE CONTAINS LACTOSE
•
Patients who are intolerant to lactose should note that
Codeine Phosphate tablets contain a small amount of
lactose. If your doctor has told you that you have
intolerance to some sugars, contact your doctor before
taking this medicine.
HOW TO TAKE CODEINE PHOSPHATE
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor if you are not sure.
Your prescriber should have discussed with you, how long the
course of tablets will last. They will arrange a plan for stopping
treatment. This will outline how to gradually reduce the dose
and stop taking the medicine.
DO NOT TAKE A HIGHER DOSE OR MORE OFTEN THAN THE DOCTOR HAS
TOLD YOU.
The recommended dose is:
ADULTS
PAIN RELIEF
30 – 60 mg every four hours when necessary, up to a
maximum of 240 mg in 24 hours.
TREATMENT OF DIARRHOEA
30 mg three to four times daily.
TREATMENT OF COUGH
15 - 30 mg three to four times daily.
USE IN CHILDREN AND ADOLESCENTS
CHILDREN AGED 12 YEARS TO 18 YEARS
The recommended codeine dose for children 12 years and
older should be up to a maximum dose of codeine of 240 mg
daily.
ANALGESIC USE
30 - 60 mg every 6 hours as needed. The dose is based on the
body weight (0.5 - 1 mg/kg)
FOR COUGH
The dose is based on bodyweight 1 - 2 mg/kg daily in 4 to 6
divided doses.
The use of cough suppressants containing codeine is not
generally recommended in children.
ANTI-DIARRHOEAL USE
Not recommended.
CHILDREN AGED UNDER 12 YEARS:
Codeine Phosphate is not suitable for use in children under
12 years of age, due to the risk of severe breathing problems.
THE ELDERLY, OR PATIENTS WITH LIVER OR KIDNEY PROBLEMS:
•
A reduced adult dosage, as prescribed by your doctor.
The tablets should be swallowed preferably with a drink of
water.
The medicine should not be taken for more than 3 days and if
no effective pain relief is achieved the patients/carers should
be advised to seek the views of a physician.
IF YOU TAKE MORE CODEINE PHOSPHATE THAN YOU SHOULD
If you (or someone else) swallow

Valmisteyhteenveto

OBJECT 1
CODEINE PHOSPHATE TABLETS 60MG
Summary of Product Characteristics Updated 20-Oct-2016 | Accord-UK Ltd
1. Name of the medicinal product
CODEINE PHOSPHATE TABLETS BP 60mg
2. Qualitative and quantitative composition
Each tablet contains 60mg Codeine Phosphate PhEur.
Each tablet contains 3.60mg lactose BP.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
White uncoated tablets.
White, circular, biconvex uncoated tablets impressed “C” on one
face and the identifying letters “CS” on
the reverse.
4. Clinical particulars
4.1 Therapeutic indications
1) Indicated as an analgesic for the relief of mild to moderate 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).
2) For the symptomatic relief of unproductive cough and diarrhoea.
4.2 Posology and method of administration
Long term use – the risk benefit should be assessed regularly by the
prescriber.
Codeine should be used at the lowest effective dose for the shortest
period of time. This dose may be
taken, up to 4 times a day at intervals of not less than 6 hours.
Maximum daily dose should not exceed
240mg.
The duration of treatment should be limited to 3 days and if no
effective pain relief is achieved the
patients/carers should be advised to seek the views of a physician
_Posology _
_Analgesia _
Adults: 30-60mg every four hours to a maximum dosage of 240mg daily.
The analgesic effect is not materially enhanced by increasing the dose
to a greater level than that
recommended above.
Elderly: Dosage should be reduced in the elderly where there is
impairment of hepatic or renal function.
Paediatric population:
Children aged 12 years to 18 years:
The recommended codeine dose for children 12 years and older should be
30 to 60 mg every 6 hours
when necessary up to a maximum dose of 240mg daily. The dose is based
on the body weight (0.5-
1mg/kg).
Children aged less than 12 years:
Cod