Difflam 3 % w/w Cream

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

BENZYDAMINE HYDROCHLORIDE

Commercializzato da:

Mylan IRE Healthcare Limited

Codice ATC:

M02AA; M02AA05

INN (Nome Internazionale):

BENZYDAMINE HYDROCHLORIDE

Dosaggio:

3 percent weight/weight

Forma farmaceutica:

Cream

Tipo di ricetta:

Product not subject to medical prescription

Area terapeutica:

Antiinflammatory preparations, non-steroids for topical use; benzydamine

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

2007-07-06

Foglio illustrativo

PACKAGE LEAFLET
Package leaflet: Information for the user
DIFFLAM CREAM 3% W/W CREAM
Benzydamine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE 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. See section 4.
The name of your medicine is Difflam 3% w/w Cream, which will be
called Difflam Cream
throughout this leaflet
WHAT IS IN THIS LEAFLET:
1.
What Difflam Cream is and what it is used for
2.
What you need to know before you use Difflam Cream
3.
How to use Difflam Cream
4.
Possible side effects
5.
How to store Difflam Cream
6.
Contents of the pack and other information
1.
WHAT DIFFLAM CREAM IS AND WHAT IT IS USED FOR
Difflam Cream belongs to a group of medicines called non-steroidal
anti-inflammatory drugs
or NSAIDS.
Difflam Cream works by stopping pain and swelling (inflammation). When
rubbed into the
skin of the affected area it is used to treat aches and pains
including:

Sprains

Strains

Bruises

Sore muscles

Stiff joints

Rheumatism
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DIFFLAM CREAM
DO NOT USE DIFFLAM CREAM:
-
If you are allergic to benzydamine or any of the other ingredients of
this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Difflam Cream.
-
The cream should be kept away from your eyes and mucosal surfaces
(such as mouth,
nose, genitals or anus).
-
Avoid sun exposure during treatment.
Take special care with Difflam:
- If you have a history of Asthma.
- If you are allergic to acetylsalicylic acid or to other
anti-inflammatory painkillers
called NSAIDs
OTHER MEDICINES AND DIFFLAM CREAM
Tell

Scheda tecnica

Health Products Regulatory Authority
04 December 2018
CRN008KDW
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Difflam 3 % w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains benzydamine hydrochloride 3% w/w.
Difflam Cream also contains Cetyl Alcohol 6%w/w. Methyl
hydroxybenzoate (E218)
0.18%w/w, Propyl hydroxybenzoate (E216) 0.02%w/w, Propylene glycol
5%w/wand
Eumulgin B1 4%w/w. Eumulgin B1 may contain cetyl and stearyl alcohol.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cream
Collapsible internally lined aluminium tubes containing a white to
ivory-white
homogeneous, perfumed cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Benzydamine exerts an anti-inflammatory and analgesic effect by
stabilising the
cellular membrane and inhibiting prostaglandin synthesis.
Benzydamine cream may be used as an anti-inflammatory agent in the
treatment of
symptoms associated with painful conditions of the musculo-skeletal
system such as:
myalgia, bursitis, rheumatism and traumatic conditions such as: soft
tissue injuries,
sprains, strains, contusions and the after effects of fractures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
May be applied and massaged lightly into the skin up to three times a
day, and in
more severe conditions up to six times daily.
4.3 CONTRAINDICATIONS
Use in patient with a known hypersensitivity to the active ingredient,
benzydamine
hydrochloride, or to any of the other ingredients.
Health Products Regulatory Authority
04 December 2018
CRN008KDW
Page 2 of 6
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product should not be applied to the eyes or mucosal surfaces.
The excipients methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl
alcohol and
propylene glycol may cause allergic reactions.
Methyl hydroxybenzoate and propyl hydroxybenzoate may cause allergic
reactions
(possibly delayed)
Benzydamine use is not advisable in patients with hypersensitivity to
acetylsalicylic
acid or other NSAIDs.
Bronchospasm may be precipitated in patient