Codinex Codeine Phosphate 15mg/5ml Oral Solution

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Codeine phosphate

Commercializzato da:

Pinewood Laboratories Ltd

Codice ATC:

R05DA; R05DA04

INN (Nome Internazionale):

Codeine phosphate

Dosaggio:

15 mg/5ml

Forma farmaceutica:

Oral solution

Composizione:

Each 5 ml contains 15 mg codeine phosphate (equivalent to 11.8 mg codeine). Each 5 ml also contains 75 micrograms sunset yellow (E110), 645 mg sorbitol and 0.32 micrograms ethanol.

Tipo di ricetta:

Product not subject to medical prescription

Area terapeutica:

Opium alkaloids and derivatives; codeine

Indicazioni terapeutiche:

Codinex contains codeine and is used to treat a dry or painful cough.

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1981-08-25

Foglio illustrativo

IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF CODINEX
Codinex contains:
•
SUNSET YELLOW (E110): which may cause allergic reactions
•
SORBITOL (E420): if you have been told that you have an intolerance to
some sugars, contact your doctor before
taking this product.
•
ETHANOL: This medicinal product contains small amounts of ethanol
(alcohol), less than 100 mg per dose.
3.
HOW TO TAKE CODINEX
Always take this medicine exactly as the doctor or pharmacist has told
you; you should check with him/her if you are not sure.
To be taken by mouth only. Do not exceed the stated dose.
Codinex is normally used for short-term relief of symptoms, take this
medicine for as long as your doctor tells you to.
ADULTS: one to one and a half 5 ml spoonfuls (5 ml to 7.5 ml), three
to four times a day.
ELDERLY / DEBILITATED PATIENTS: the dose should be reduced. Your
doctor will advise you.
ADOLESCENTS (12 TO 18 YEARS): one to one and a half 5 ml spoonfuls (5
ml to 7.5 ml), three to four times a day.
CHILDREN (UNDER 12 YEARS): not for use in children under the age of 12
years.
IF YOU TAKE MORE CODINEX THAN YOU SHOULD
If you, or someone else, have taken too much medicine, contact your
doctor immediately or go to your nearest hospital
accident and emergency department. Take this leaflet and/or the pack
with you.
IF YOU FORGET TO TAKE CODINEX
If you miss a dose, take one as soon as you remember, unless it is
nearly time to take the next one. Take the remaining dose
at the correct time. Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Codinex can cause side effects, although not
everybody gets them.
STOP taking Codinex and SEEK MEDICAL HELP IMMEDIATELY if you have any
of the following which may be signs of an ALLERGIC REACTION:
•
difficulty breathing or swallowing
•
swelling of the face, lips, tongue or throat
•
severe itching of the skin, with a red rash or raised bumps.
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Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Codinex Codeine Phosphate 15mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 15 mg codeine phosphate (equivalent to 11.8 mg
codeine).
Each 5 ml also contains 75 micrograms sunset yellow (E110), 645 mg
sorbitol and 0.32 micorgrams ethanol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, dark yellow, orange flavoured oral solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anti-tussive for unproductive cough.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adult dosage: The usual dose is 5 to 7.5 ml (15 mg to 22.5 mg) –
(equivalent to 11.8 – 17.6 mg of Codeine base) three
to four times a day.
Dosage should be reduced in elderly or debilitated patients.
Dose may be repeated every 4 – 6 hours if required.
Paediatric population:
Children aged less than 12 years:
Codeine is contraindicated in children below the age of 12 years (see
sections 4.3).
Children aged 12 years to 18 years:
Codeine is not recommended for use in children aged 12 years to 18
years with compromised respiratory function (see
section 4.4).
4.3 CONTRAINDICATIONS
Hypersensitivity to codeine.
Liver disease: drug may accumulate.
Ventilatory failure: condition may be exacerbated.
In children below the age of 12 years due to an increased risk of
developing serious and life-threatening adverse
reactions.
In women during breastfeeding (see section 4.6).
In patients for whom it is known they are CYP2D6 ultra-rapid
metabolisers.
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