Pholcodex 5mg/5ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pholcodine

Available from:

Pinewood Laboratories Ltd

ATC code:

R05DA; R05DA08

INN (International Name):

Pholcodine

Dosage:

5 mg/5ml

Pharmaceutical form:

Oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Opium alkaloids and derivatives; pholcodine

Authorization status:

Not marketed

Authorization date:

1980-06-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PHOLCODEX 5 MG/5 ML ORAL SOLUTION
PHOLCODINE 5 MG/5 ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
has told you. This medicine is available from your pharmacy without
prescription; however,
you still need to take Pholcodex 5 mg/5 ml Oral Solution carefully to
get the best results from
it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

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.

You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
WHAT IS IN THIS LEAFLET:
1. What Pholcodex is and what it is used for
2. What you need to know before you take Pholcodex
3. How to take Pholcodex
4. Possible side effects
5. How to store Pholcodex
6. Contents of the pack and other information
1. WHAT PHOLCODEX IS AND WHAT IT IS USED FOR
Pholcodex 5 mg/5 ml Oral Solution is a medicine which helps you to
stop coughing,
especially if you have a dry non-productive cough. It is related to
morphine and codeine, and
it acts to stop your automatic cough response. Pholcodex should only
be taken when other
treatments have failed.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHOLCODEX
DO NOT TAKE PHOLCODEX:

if you are allergic (hypersensitive) to pholcodine or any of the other
ingredients of this
medicine (_listed in Section 6 and end of Section 2_)._ _

if you have:

liver disease.

breathing problems.

a hereditary intolerance to some sugars.

taken/given any other cough and cold medicine.

ever developed a severe skin rash or skin that peels, blisters and /
or sores in the
mouth after taking pholcodine.
Children under 6 years of age should not be given this medicine.
TAKE SPECIAL CARE WITH PHOLCODEX IF

Summary of Product characteristics

Health Products Regulatory Authority
25 May 2022
CRN00CYJJ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pholcodex 5mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 5 mg Pholcodine.
Excipients with known effect:
Sunset yellow (E110) 0.375 mg/5 ml
Sorbitol solution (E420) 651.0 mg/5 ml
Sodium benzoate (E211) 6 mg/5 ml
Sodium 6.38 mg/5 ml
Propylene glycol 93 mg/5 ml
_For a full list of excipients, see Section 6.1_
3 PHARMACEUTICAL FORM
Oral solution
Clear, yellow oral solution with a citrus flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of non-productive cough. This product is indicated
for second line use only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 10 ml every three to four hours as required
Paediatric posology
Children (Aged 6-12 years): 5 ml every three to four hours as required
Method of administration
For oral administration.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Use in children under 6 years of age.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1.
Not more than 4 doses should be given in any 24 hours. Do not exceed
the stated dose.
2.
Do not take with any other cough and cold medicine.
3.
Consult a pharmacist or other healthcare professional before using
this medicine.
4.
Side effects include occasional nausea and drowsiness.
5.
This product should only be used for suppression of a non-productive
cough.
6.
Cough suppressants may depress respiration and should be used with
caution in patients with asthma, chronic
bronchitis or bronchiectasis.
7.
Special care should be taken in patients with renal or hepatic
impairment.
Health Products Regulatory Authority
25 May 2022
CRN00CYJJ
Page 2 of 5
8.
The use of this product should be restricted to no more than 5 days.
9.
This product should only be indicated for second line use.
10.
Severe cutaneous adverse reactions (SCARs) including acute generalized
exanthematous pustulosis (