Difflam 0.15% Sore Throat Rinse

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Benzydamine hydrochloride

Доступна з:

Viatris UK Healthcare Ltd

Код атс:

A01AD02

ІПН (Міжнародна Ім'я):

Benzydamine hydrochloride

Дозування:

1.5mg/1ml

Фармацевтична форма:

Mouthwash

Адміністрація маршрут:

Oromucosal

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 12030100; GTIN: 5000485093530

інформаційний буклет

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
Always use this medicine exactly as described in
this leaflet or as your doctor, pharmacist or nurse
have told you.
•
This medicine is available without
prescription. However, you still need to use
i
t carefully to get the best results.
•
Keep this leaflet. You may need to read it
again.
•
Ask your doctor or pharmacist if you need
more information or advice.
•
You must contact a doctor if your symptoms
worsen or do not improve.
•
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1.
What Difflam Sore Throat Rinse is and what
it is used for
2. What you need to know before you use
Difflam Sore Throat Rinse
3
.
How to use Difflam Sore Throat Rinse
4. Possible side effects
5.
How to store Difflam Sore Throat Rinse
6.
Contents of the pack and other information.
1. What Difflam Sore Throat Rinse is and
what it is used for
Difflam Sore Throat Rinse contains the active
substance benzydamine hydrochloride and
belongs to a group of medicines called non-
steroidal anti-inflammatory drugs or NSAIDS.
D
ifflam Sore Throat Rinse works by stopping
pain and swelling (inflammation). It is used
to
treat many painful conditions of the throat
including:
•
Sore throat.
2. What you need to know before you use
Difflam Sore Throat Rinse
Do not use Difflam Sore Throat Rinse if
•
you are allergic to benzydamine hydro-
chloride
•
you are allergic to any of the other ingredients
of Difflam Sore Throat Rinse (see section 6).
If either of these applies to you, talk to your
doctor, dentist or pharmacist.
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before
using Difflam Sore Throat Rinse:
•
If you have a history of asthma
•
If you are allergic to acetylsalicylic acid or
other non-steroidal anti-inflammatory
(NSAID) drugs
If any of these apply, talk to your

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Difflam 0.15% w/v Sore Throat Rinse.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzydamine Hydrochloride 0.15% w/v.
Contains methyl parahydroxybenzoate and Ethanol.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for use as a gargle/oral rinse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Difflam 0.15% Sore Throat Rinse is a locally acting analgesic and
anti-
inflammatory treatment for the relief of painful inflammatory
conditions of the
throat including pharyngitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_ Rinse or gargle with 15ml (using measuring cup provided)
every 1½ to 3
hours as required for pain relief.
_Children: _ Not suitable for children aged 12 years or under.
_Elderly:_ No special dosage recommendations are made for elderly
patients.
Method of administration
Rinse or gargle.
The solution should be expelled from the mouth after use.
Difflam Sore Throat Rinse should generally be used undiluted, but if
‘stinging’
occurs the rinse may be diluted with water.
Uninterrupted treatment should not exceed seven days, except under
medical
supervision.
4.3
CONTRAINDICATIONS
Difflam 0.15% w/v Sore Throat Rinse is contra-indicated in patients
with known
hypersensitivity to the active substance benzydamine hydrochloride or
to any of the
excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Benzydamine use is not advisable in patients with hypersensitivity to
acetylsalicylic acid or other NSAIDs.
Bronchospasm may be precipitated in patients suffering from or with a
previous history of bronchial asthma. Caution should be exercised in
these
patients.
Difflam Sore Throat Rinse should generally be used undiluted, but if
‘stinging’
occurs the rinse may be diluted with water. Avoid contact with the
eyes.
This medicinal product contains 10 vol % ethanol.
Methyl hydroxybenzoate may cause allergic reactions (possibly delayed)
4.5
INTERACTION WITH OTHER MEDICINAL PRODUC