Difflam Spray

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

BENZYDAMINE HYDROCHLORIDE

Предлага се от:

Meda Pharmaceuticals Limited

АТС код:

A01AD02

INN (Международно Name):

BENZYDAMINE HYDROCHLORIDE

Лекарствена форма:

OROMUCOSAL SPRAY

Композиция:

BENZYDAMINE HYDROCHLORIDE 0.15 % (W/V)

Вид предписание :

OTC

Терапевтична област:

STOMATOLOGICAL PREPARATIONS

Статус Оторизация:

Authorised

Дата Оторизация:

2006-03-29

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIFFLAM 0.15% SPRAY
Benzydamine hydrochloride
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 it 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 Spray is and what it us used for
2. What you need to know before you use Difflam
Spray
3. How to use Difflam Spray
4. Possible side effects
5. How to store Difflam Spray
6.Contents of the pack and other information.
1. What Difflam Spray is and what it is used for
Difflam Spray contains the active substance
benzydamine hydrochloride and belongs to a group
of medicines called non-steroidal anti-inflammatory
drugs or NSAIDS.
Difflam Spray works by stopping pain
and swelling (inflammation). It is used to treat many
painful conditions of the mouth or throat including:
• Mouth ulcers
• Teething
• Sore throat
• Sore tongue or gums
• Discomfort associated with dentures or dental
work.
2. What you need to know before you take
Difflam Spray
Do not use Difflam Spray if:
• You are allergic to benzydamine hydrochloride
• You are allergic to any of the other ingredients
in Difflam Spray (listed in section 6).
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before
using Difflam Spray:
• 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 d

Данни за продукта

1 NAME OF THE MEDICINAL PRODUCT
Difflam 0.15% w/v Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose pump spray delivers Benzydamine hydrochloride 0.15%
w/v,
approximately 175 microlitres per puff.
Contains methyl parahydroxybenzoate and Ethanol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Difflam Spray is a metered dose pump throat spray.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Difflam Spray is a locally acting analgesic and anti-inflammatory
treatment for the throat
and mouth. It is especially useful for the relief of pain in traumatic
conditions such as
following tonsillectomy or the use of a naso-gastric tube; dental
surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, adolescents and elderly:_
4 to 8 puffs every 1½-3 hourly.
_Children(6-12):_
4 puffs every 1½-3 hourly.
_Children under 6:_
One puff to be administered per 4 kg body weight, up to a maximum of
4 puffs, 1½-3 hourly.
_Elderly: _
Because of the small amount of drug applied, elderly patients can
receive the same
dose as adults.
Method of administration
For oral administration
4.3 CONTRAINDICATIONS
Difflam Spray 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.
Page 1 of 5
Bronchospasm may be precipitated in patients suffering from or with a
previous history of
bronchial asthma. Caution should be exercised in these patients.
Avoid contact with the eyes.
If the condition is aggravated or not improved use should cease.
This medicinal product contains 10 vol % ethanol.
Methyl hydroxybenzoate may cause allergic reactions (possibly delayed)
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
Pregnancy
Difflam Spray should not be used in pregnancy unle