Co-codamol 30mg/500mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Codeine phosphate; Paracetamol

Available from:

Advanz Pharma

ATC code:

N02AJ06

INN (International Name):

Codeine phosphate; Paracetamol

Dosage:

30mg ; 500mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100; GTIN: 05060010285007

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
CO-CODAMOL 30mg/500mg CAPSULES
(Codeine Phosphate/Paracetamol)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
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. Do not pass it on to others. It
may harm them, even if their symptoms are the
same as yours. If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET
1. What Co-codamol 30mg/500mg Capsules are and what they are used for
2. Before you take Co-codamol 30mg/500mg Capsules
3. How to take Co-codamol 30mg/500mg Capsules
4. Possible side effects
5. How to store Co-codamol 30mg/500mg Capsules
6. Further information
1. WHAT CO-CODAMOL 30MG/500MG CAPSULES ARE AND WHAT THEY ARE USED FOR
Co-codamol 30mg/500mg Capsules contain paracetamol and codeine.
Paracetamol is an analgesic (relieves pain) and
an antipyretic (lowers raised temperatures). This product contains
codeine. Codeine belongs to a group of medicines
called opioid analgesics which act to relieve pain. It can be used on
its own or in combination with other pain killers.
Co-codamol 30mg/500mg Capsules are used for the relief of severe pain.
Co-codamol 30mg/500mg Capsules 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.
2. BEFORE YOU TAKE CO-CODAMOL 30MG/500MG CAPSULES
Co-codamol 30mg/500mg Capsules should not be taken longer than as
directed by your doctor. Taking codeine (an
active ingredient of Co-codamol 30mg/500mg Capsules) regularly for a
long time can lead to addiction, which might
cause you to feel restless and irritable when you stop the capsules.
If a pain killer is used too long for headaches, it can make them
worse.
DO NOT TAKE CO-CODAMOL 30MG/500MG CAPSULES IF:
• you know that you are allergic to para

Summary of Product characteristics

CO-CODAMOL 30MG/500MG CAPSULES
Summary of Product Characteristics Updated 20-Apr-2017 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Zapain 30mg/500mg Capsules
Co-codamol 30mg/500mg Capsules
2. Qualitative and quantitative composition
Each capsule contains Paracetamol 500 mg, and Codeine Phosphate 30mg.
3. Pharmaceutical form
Capsule.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of severe 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
Adults: The usual dose is one or two capsules every four to six hours
as required up to a maximum of 8
capsules in any 24 hour period.
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 16-18 years: 1-2 capsules every 6 hours when necessary
up to a maximum of 8 capsules in
24 hours.
Children aged 12 – 15 years: 1 capsule every 6 hours when necessary
up to a maximum of 4 capsules in
24 hours.
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 sections 4.3 and 4.4).
Dosage needs to be adjusted according to the severity of pain and the
response of the patient.
Tolerance to Codeine can develop with continued use. The incidence of
unwanted effects is dose related.
Doses of Codeine above 60 mg are associated with an increase in
unwanted effects.
Method of administration: