Phenergan 25mg Film-Coated Tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

PROMETHAZINE HYDROCHLORIDE

Доступна с:

Sanofi-Aventis Ireland Limited T/A SANOFI

код АТС:

R06AD; R06AD02

ИНН (Международная Имя):

PROMETHAZINE HYDROCHLORIDE

дозировка:

25 milligram(s)

Фармацевтическая форма:

Film-coated tablet

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

Phenothiazine derivatives; promethazine

Статус Авторизация:

Marketed

Дата Авторизация:

1979-04-01

тонкая брошюра

_promethazine hydrochloride_
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PHENERGAN® 25MG
FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
11503869-02
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
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 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 they are 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 THEY ARE 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 given 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
breathing problems, swelling of you

Характеристики продукта

Health Products Regulatory Authority
27 February 2019
CRN008K14
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenergan 25mg 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
27 February 2019
CRN008K14
Page 2 of 5
Since the drug is metabolized in the liver, promethazine sh