Phenergan 5mg/5ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROMETHAZINE HYDROCHLORIDE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

R06AD; R06AD02

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

Dosage:

5 mg/5ml

Pharmaceutical form:

Oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Phenothiazine derivatives; promethazine

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

1
303719
719
PACKAGE LEAFLET:
INFORMATION FOR THE USER
PHENERGAN 5MG/5ML ORAL SOLUTION
_promethazine hydrochloride_
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Phenergan 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.
•
You must contact a doctor if your symptoms worsen or do not improve
after 7 days.
•
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1. What Phenergan Oral Solution is and what it is used for
2. What you need to know before you take Phenergan Oral Solution
3. How to take Phenergan Oral Solution
4. Possible side effects
5. How to store Phenergan Oral Solution
6. Contents of the pack and other information
1. WHAT PHENERGAN ORAL SOLUTION IS AND WHAT IT IS USED FOR
Phenergan Oral Solution contains a medicine called promethazine
hydrochloride. This belongs to a group
of medicines called phenothiazines. It works by blocking a natural
substance (histamine) that your body
makes during an allergic reaction. It also works directly on the brain
to help you feel more relaxed.
Phenergan 5mg/5ml oral solution also contains Sodium Metabisulphite
(E223), this may rarely cause severe
hypersensitivity reactions and broncospasm.
WHAT PHENERGAN ORAL SOLUTION IS USED FOR
•
To treat allergic conditions such as hay fever or rashes (like nettle
rash or hives).
•
To prevent nausea or vomiting (e.g. travel sickness).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENERGAN ORAL SOLUTION
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
The person taking the medicine is under 2 years of age.
•
You are allergic (hypersensitive) to promethazine hydrochloride or any
of the other ingredients of
Phenergan

Summary of Product characteristics

Health Products Regulatory Authority
16 October 2019
CRN009CZH
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenergan 5mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml spoonful contains Promethazine Hydrochloride 5 mg
Excipients - Contains Sodium Sulphite (E221) 5.0mg, Sodium Citrate
140.0mg, Sodium Metabisulphite (E223) 5.0mg, Sodium
Benzoate (E211) 5.0mg and Maltitol Liquid 4.44g
Sodium content is 37mg/5ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
A clear bright golden oral solution with an odour of oranges.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of allergic conditions and reactions.
As an antiemetic.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral
Not for use in children under the age of 2.
​
Adults:
​The usual daily dose is 25-75mg as a single daily dose or in 3
divided doses, starting with the lower dose.
​
Children:
​Children 2-5 years:
1-3 x 5ml spoonfuls (5-15mg) once daily at bedtime
Or 5mg twice daily
Maximum daily dose 15mg
​
​
Children 5-10 years:
2-5 x 5ml spoonfuls (10-25mg) once daily at bedtime
Or 5-10mg twice daily
Maximum daily dose 25mg
​
​When two doses are required in 24 hours, the lower dose should be
used.
4.3 CONTRAINDICATIONS
Phenergan should not be used in patients in pre-coma states, in a coma
or suffering from CNS depression of any cause.
It must not be given to neonates, or premature infants.
Health Products Regulatory Authority
16 October 2019
CRN009CZH
Page 2 of 6
Phenergan should not be given to patients with a known
hypersensitivity to promethazine or to any of the excipients.
Phenergan should be avoided in patients with blood dycrasias and in
patients taking monoamine oxidase inhibitors up to 14
days previously.
Promethazine is contraindicated for use in children less than two
years of age because of the potential for fatal respiratory
depression.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution should be us