Phenergan Nightime 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Promethazine hydrochloride

Available from:

Sanofi Consumer Healthcare

ATC code:

R06AD02

INN (International Name):

Promethazine hydrochloride

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
PHENERGAN NIGHT TIME
25MG FILM-COATED TABLETS
promethazine hydrochloride
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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 the leaflet or as your
doctor or pharmacist has told you.
•
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
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 7 days.
WHAT IS IN THIS LEAFLET:
1. What Phenergan Night Time is and
what it is used for
2. What you need to know before you
take Phenergan Night Time
3. How to take Phenergan Night Time
4. Possible side effects
5. How to store Phenergan Night Time
6. Contents of the pack and other
information
1. WHAT PHENERGAN NIGHT TIME
IS AND WHAT IT IS USED FOR
Phenergan Night Time 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.
WHAT PHENERGAN NIGHT TIME IS USED FOR
Phenergan Night Time is used to treat
the following conditions:
•
For short term use: to treat adults
with difficulty sleeping (insomnia)
•
For short term use: as a sedative for
children aged 16 years and above
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE PHENERGAN NIGHT TIME
DO NOT TAKE THIS MEDICINE IF:
 The person taking the medicine is
under 16 years of age
 You are allergic (hypersensitive) to
promethazine hydrochloride or any of
the other ingredients of Phenergan
Night Time (listed in section 6 below)
The signs of an allergic reaction
include: a rash, swallowing or
breathing p

Summary of Product characteristics

OBJECT 1
PHENERGAN NIGHT TIME 25 MG FILM-COATED
TABLETS
Summary of Product Characteristics Updated 14-Sep-2017 | SANOFI
1. Name of the medicinal product
Phenergan Night Time 25 mg Film-coated Tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 25 mg of the active substance
promethazine hydrochloride.
Also contains 173.52 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablets (tablets)
Pale blue film coated tablets marked PN 25 on one side.
4. Clinical particulars
4.1 Therapeutic indications
For short term use in the treatment of insomnia in adults and as a
sedative in children over 16 years of
age.
4.2 Posology and method of administration
Method of administration: For oral use.
Adults (including the elderly) and children over 16 years of age 25mg
or 50mg as a single night time
dose.
Paediatric population: Not to be used in children under 16 years of
age.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Phenergan Night Time should not be used in patients in coma or
suffering from CNS depression of any
cause.
Phenergan Night Time should be avoided in patients taking monoamine
oxidase inhibitors up to 14 days
previously.
4.4 Special warnings and precautions for use
Phenergan Night Time may thicken or dry lung secretions and impair
expectoration. It should therefore
be used with caution in patients with asthma, bronchitis or
bronchiectasis.
Use with care in patients with severe coronary artery disease, narrow
angle glaucoma, epilepsy or hepatic
and renal insufficiency.
Caution should be exercised in patients with bladder neck or
pyloro-duodenal obstruction.
The use of promethazine should be avoided in children and adolescents
with signs and symptoms
suggestive of Reye's Syndrome.
Promethazine may mask the warning signs of ototoxicity caused by
ototoxic drugs e.g. salicylates. It may
also delay the early diagnosis of intestinal obstruction or raised
intracr