Co-codamol 30mg/500mg effervescent tablets

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:

Effervescent tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100; GTIN: 5060010017776

Patient Information leaflet

• Do n ot store above 25
o
C. Keep the tubes tightly closed in order to protect
from moisture.
Medicines should not be disposed of via wastewater. Ask your
pharmacist how to
dispose of medicines no longer required. These measures will help to
protect the
environment.
6. FURTHER INFORMATION
WHAT CO-CODAMOL EFFERVESCENT TABLETS CONTAIN:
• The active substances are codeine phosphate hemihydrate 30mg and
paracetamol 500mg.
• The other ingredients are sodium hydrogen carbonate, sodium
carbonate
anhydrous, citric acid anhydrous, sodium docusate, sorbitol, saccharin
sodium, dimeticone, sodium benzoate, macrogol 6000 and spray-dried
natural
grapefruit flavour.
WHAT CO-CODAMOL EFFERVESCENT TABLETS LOOK LIKE AND CONTENTS OF THE
PACK:
Co-codamol Effervescent tablets are white circular tablets with a
score line on one
face, although your tablets are scored they must not be halved as they
will not give
an equal dose.
Co-codamol Effervescent tablets are available in aluminium:
polyethylene foils
strips packs of 100 effervescent tablets (25 strips of 4 tablets) or
in
polypropylene tubes.
Each tube contains 16 tablets and 6 tubes are packed in cardboard
containers to
give a pack size of 96 tablets.
Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER:
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William Street, London, EC4N 7BL, UK
MANUFACTURED BY:
Unither Industries,
ZI du Malcourlet, 03800 Gannat, France.
This leaflet was last revised in January 2014.
101777/LF/3
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.
The name of your medicine is Co-codamol 30mg/500mg Effervescent
Tablets. It

Summary of Product characteristics

CO-CODAMOL 30MG/500MG EFFERVESCENT TABLETS
Summary of Product Characteristics Updated 30-Jun-2014 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Co-codamol 30mg/500mg Effervescent Tablets
2. Qualitative and quantitative composition
Each tablet contains Codeine Phosphate hemihydrate 30mg and
Paracetamol 500mg.
Excipients: Each tablet also contains 487mg of sorbitol and 413 mg of
sodium.
For a full list of excipients see 6.1.
3. Pharmaceutical form
Effervescent Tablet
Bevelled, flat, round, white tablet with a scoreline on one face
Although Co-codamol Effervescent tablets have a score line the tablets
are not to be halved as they do not
divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of mild to severe acute pain.
Codeine is indicated for the treatment of acute moderate pain which is
not considered to be relieved by
other analgesics such as paracetamol or ibuprofen.
4.2 Posology and method of administration
Method of administration: Oral
The tablets should be placed in a glass of water and allowed to be
dissolved completely. The resulting
solution should be drunk immediately.
Adults: The usual dose is one or two tablets every four hours as
required. The total daily dose should not
exceed 4 g paracetamol (8 tablets in a day).
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: As for adults, however a reduced dose may be required (see
section 4.4)
Paediatric population: Not recommended in children below the age of 18
years (see section 5.1).
4.3 Contraindications
Hypersensitivity to either paracetamol or codeine, or any of the
excipients of Co-codamol Effervescent
tablets.
Conditions where morphine and opioids ar