Motusol Max 2 % w/w gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diclofenac sodium

Available from:

Teva B.V.

ATC code:

M02AA15

INN (International Name):

Diclofenac sodium

Dosage:

2 percent weight/weight

Pharmaceutical form:

Gel

Therapeutic area:

diclofenac

Authorization status:

Marketed

Authorization date:

2020-08-25

Patient Information leaflet

PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOTUSOL
TM MAX 2 % W/W GEL
diclofenac sodium
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 Motusol Max is and what it is used for
2.
What you need to know before you use Motusol Max
3.
How to use Motusol Max
4.
Possible side effects
5.
How to store Motusol Max
6.
Contents of the pack and other information
1.
WHAT MOTUSOL MAX IS AND WHAT IT IS USED FOR
Motusol Max contains the active substance diclofenac which belongs to
a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
Motusol Max is indicated in adults and adolescents aged 14 years and
over.
FOR ADULTS AND ADOLESCENTS AGED 14 YEARS AND OVER
For the local symptomatic treatment of pain in acutestrains, sprains
or contusions following blunt
trauma
For adolescents aged 14 years and over the medicine is intended for
short term treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MOTUSOL MAX
DO NOT USE MOTUSOL MAX:
•
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 as well as
on eczema or mucous
membranes;
•
in the

Summary of Product characteristics

Health Products Regulatory Authority
10 June 2021
CRN00C3SK
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Motusol Max 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.
Excipient(s) with known effect
1 g of gel contains 54 mg of propylene glycol (E1520), 0.2 mg
butylhydroxytoluene (E321) and 1 mg fragrance (contains 0.15
mg/g benzyl alchohol, citral, citronellol, coumarin, eugenol,
farnesol, geraniol, d-limonene, linalool).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
White to almost white, homogeneous gel
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FOR ADULTS AND ADOLESCENTS AGED 14 YEARS AND OVER
For local symptomatic treatment of pain in acute strains, sprains or
contusions following blunt trauma.
For adolescents aged 14 years and over the medicinal product is
intended for short term treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents aged 14 years and over:_
Motusol Max 2 % w/w Gel 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. Motusol Max 2 % w/w Gel should not be used
longer than 1 week without medical advice.
If symptoms worsen or do not improve after 3 -5 days, a doctor should
be consulted.
Special patient groups
_Elderly patients_:
No special dose adjustment is required. Because of the potential
undesirable effect profile, elderly people should be carefully
monitored.
_Patient with renal impair