Codant 30 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Codeine phosphate hemihydrate

Available from:

Mercury Pharmaceuticals (Ireland) Ltd

ATC code:

R05DA; R05DA04

INN (International Name):

Codeine phosphate hemihydrate

Dosage:

30 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Opium alkaloids and derivatives; codeine

Authorization status:

Not marketed

Authorization date:

1978-04-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CODANT 30MG TABLETS
codeine phosphate hemihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their
signs of illness are the same as yours.
• 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.
WHAT IS IN THIS LEAFLET:
1. What Codant is and what it is used for
2. What you need to know before you take Codant
3. How to take Codant
4. Possible side effects
5. How to store Codant
6. Contents of the pack and other information
1.
WHAT CODANT IS AND WHAT IT IS USED FOR
Codant can be used in children over 12 years of age for the short-term
relief of moderate pain that is not
relieved by other painkillers such as paracetamol or ibuprofen alone.
This product contains codeine. Codeine
belongs to a group of medicines called opioid analgesics which act to
relieve pain. It can also be used for
relief of non-productive (dry) cough in adults
.
It can be used on its own or in combination with other pain
killers such as paracetamol
_ _
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CODANT
Do not take for longer than directed by your prescriber. Taking
codeine regularly for a long time can lead to
addiction, which might cause you to feel restless and irritable when
you stop the tablets. Taking a painkiller
for headaches too often or for too long can make them worse. Do not
use Codant for pain relief in children
and adolescents (0-18 years of age) after removal of their tonsils or
adenoids as Codant may cause
obstructive sleep apnoea syndrome (sleep disruption due to respiratory
pauses).
DO NOT TAKE CODANT
• if you are allergic to codeine phosphate hemihydrate or any of the
other ingredients o

Summary of Product characteristics

Health Products Regulatory Authority
01 February 2022
CRN00CK7N
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Codant 30 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Codeine Phosphate Hemihydrate 30 mg (equivalent
to 23.4 mg Codeine).
Excipient(s) with known effect
Also contains 43 mg of lactose monohydrate (equivalent to 40.9 mg
lactose).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
White, circular biconvex tablets of 5.5mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1) Management 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) As an anti-tussive for non-productive cough.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual dose is 30mg (one tablet), repeated 6 hourly as required.
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 240 mg.
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.
_Elderly: _
A reduced dosage may be necessary.
_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 240 mg daily. The dose is based on the body weight
(0.5-1mg/kg)."
Children aged less than 12 years:
Health Products Regulatory Authority
01 February 2022
CRN00CK7N
Page 2 of 7
"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 sections 4.3
and 4.4).
Dosage needs to be adjusted according to the s