Phenergan 25 mg film-coated tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Promethazine hydrochloride

Disponible depuis:

Opella Healthcare France SAS T/A Sanofi

Code ATC:

R06AD; R06AD02

DCI (Dénomination commune internationale):

Promethazine hydrochloride

Dosage:

25 milligram(s)

forme pharmaceutique:

Film-coated tablet

Domaine thérapeutique:

Phenothiazine derivatives; promethazine

Statut de autorisation:

Marketed

Date de l'autorisation:

1979-04-01

Notice patient

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
PHENERGAN
® 25MG FILM-COATED TABLETS
promethazine hydrochloride
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
Tablets
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet.
IN THIS LEAFLET:
1.
What Phenergan Tablets are and what it is used for
2.
What you need to know before you take Phenergan Tablets
3.
How to take Phenergan Tablets
4.
Possible side effects
5.
How to store Phenergan Tablets
6.
Contents of the pack and other information
1.
WHAT PHENERGAN TABLETS ARE AND WHAT IT IS USED FOR
Phenergan Tablets contain 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.
WHAT PHENERGAN TABLETS ARE USED FOR
•
To treat allergic conditions such as hay fever or rashes (like nettle
rash or hives).
•
To treat or stop you feeling sick (nausea) or being sick (vomiting)
such as travel sickness.
•
As a sedative. This is a medicine give to reduce awareness or make you
feel relaxed and at ease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENERGAN TABLETS
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 Tablets (listed in Section 6 below).
The signs of an allergic reaction include: a rash, swallowing or
bre

Résumé des caractéristiques du produit

Health Products Regulatory Authority
15 November 2023
CRN00DRFC
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenergan 25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Promethazine Hydrochloride 25 mg
Excipients - Contains Lactose Monohydrate 173.52mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
Pale blue, circular biconvex tablet with bevelled edges marked
‘PN25’ on one side and the other plain.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of allergic conditions and reactions.
As an antiemetic.
As a tranquilliser.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration: Oral.
​
Adults including
​
​
The Elderly:
​
​
The usual daily dose is 25-75 mg (1 to 3 tablets) either as a single
daily dose at bedtime or in 3 divided
doses, starting with the lower dose.
​
Children:
​
Children below 2 years: Not recommended.
​
​
Children 2-6 years: Use of Phenergan 5mg/5ml oral solution is
recommened in this age group.
​
As a tranquilliser:
​
​
Children 6-12 years: 25mg (1 tablet) once daily at bedtime.
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.
Phenergan should not be given to patients with a known
hypersensitivity to promethazine or 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 used in patients with pre-existing coronary
insufficiency. Adjustment of dosage may be necessary to avoid
postural hypotension, especially in the elderly.
Health Products Regulatory Authority
15 November 2023
CRN00DRFC
Page 2 of 5
Since the drug is metabolized in the liver, promethazine s