Diclomel Max Strength 2% w/w gel

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

זמין מ:

Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland

קוד ATC:

M02AA15

INN (שם בינלאומי):

DICLOFENAC SODIUM 20 mg

טופס פרצבטיות:

GEL

הרכב:

DICLOFENAC SODIUM 20 mg

סוג מרשם:

OTC

איזור תרפויטי:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

leaflet_short:

Licence number in the source country: NOT APPLICAPABLE

מצב אישור:

Authorised

תאריך אישור:

2023-05-09

עלון מידע

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DICLOMEL MAX STRENGTH 2% W/W GEL
Diclofenac, corresponding to diclofenac sodium (as diclofenac
diethylamine)
For adults and adolescents aged 14 years and over
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have 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 possible 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 3-5 days.
WHAT IS IN THIS LEAFLET
1. What Diclomel Max Strength is and what it is used for
2. What you need to know before you use Diclomel Max Strength
3. How to use Diclomel Max Strength
4. Possible side effects
5. How to store Diclomel Max Strength
6. Contents of the pack and other information
1. WHAT DICLOMEL MAX STRENGTH IS AND WHAT IT IS USED FOR
Diclomel Max Strength contains the active substance diclofenac. It
belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
FOR ADULTS AND ADOLESCENTS AGED 14 YEARS AND OVER
For the short-term local symptomatic treatment of mild to moderate
pain in acute strains,
sprains or contusions following blunt trauma.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DICLOMEL MAX STRENGTH
DO NOT USE DICLOMEL MAX STRENGTH
•
if you are allergic to diclofenac or any of the other ingredients of
this medicine listed in
section 6
•
if you have ever developed breathing problems (asthma, bronchospasm),
hives, runny
nose, or swelling of the face or tongue after taking/using
acetylsalicylic acid or another non-
steroidal anti-inflammatory drugs (e.g. ibuprofen)
•
on open injuries, inflammations or infections of the skin or on eczema
and mucous
membranes
•
in the last three

מאפייני מוצר

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Diclomel Max Strength 2% w/w gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains diclofenac as 23.2 mg diclofenac diethylamine
corresponding to 20 mg of
diclofenac sodium.
Excipients with known effect
1 g of gel contains 50 mg of propylene glycol (E1520), 0.2 mg
butylhydroxytoluene (E321) and
perfume cream (contains eugenol and citral).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gel
White, homogeneous gel
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FOR ADULTS AND ADOLESCENTS AGED 14 YEARS AND OVER
For short-term local symptomatic treatment of mild to moderate pain in
acute strains, sprains
or contusions following blunt trauma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents aged 14 years and over: _
The occurrence of undesirable effects can be minimised by using the
lowest possible dose for
the shortest duration of treatment necessary to relieve symptoms.
Diclomel Max Strength is used 2 times a day (preferably morning and
evening).
Depending on the size of the affected site to be treated, cherry to
walnut size quantity is
required,
corresponding
to
1-4 g
of
gel
(23.2-92.8 mg
diclofenac,
diethylamine
salt)
corresponding to 20
‑
80 mg diclofenac sodium. This is sufficient to treat of an area of
400-
800 cm
2
.
The maximum daily dose is 8 g of gel corresponding to 185.6 mg of
diclofenac, diethylamine
(corresponding to 160 mg diclofenac sodium).
The duration of use depends on the symptoms and the underlying
disease. Diclomel Max
Strength should not be used longer than 7 days without medical advice.
If symptoms worsen or do not improve after 3-5 days, a doctor should
be consulted.
_SPECIAL POPULATIONS _
_Elderly patients _
Page 2 of 7
No special dose adjustment is required. Because of the potential
undesirable effect profile,
elderly people should be carefully monitored.
_Renal impairment _
No dose reduction is required in patients with renal impairment.
_He