Motusol Rx 1 % w/w gel

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Diclofenac sodium

Boleh didapati daripada:

Teva B.V.

Kod ATC:

M02AA15

INN (Nama Antarabangsa):

Diclofenac sodium

Dos:

1 percent weight/weight

Borang farmaseutikal:

Gel

Kawasan terapeutik:

diclofenac

Status kebenaran:

Not marketed

Tarikh kebenaran:

2020-08-25

Risalah maklumat

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Motusol Rx 1 % w/w Gel
diclofenac (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 Motusol Rx 1 % w/w Gel
is and what it is used for
2.
What you need to know before you use Motusol Rx 1 % w/w Gel
3.
How to use Motusol Rx 1 % w/w Gel
4.
Possible side effects
5.
How to store Motusol Rx 1 % w/w Gel
6.
Contents of the pack and other information
1.
WHAT MOTUSOL RX 1 % W/W GEL IS AND WHAT IT IS USED FOR
Motusol Rx 1 % w/w Gel
contains the active substance diclofenac which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Motusol Rx 1 % w/w Gel
is indicated in adults and adolescents aged 14 years and over.
FOR ADULTS
For the symptomatic treatment of pain:
- in acute strains, sprains or contusions following blunt traumas
- of the soft tissues close to the joint (e.g. bursae, tendons, tendon
sheaths, ligaments, muscle insertions
and joint capsules) in osteoarthritis of knee and finger joints;
- in epicondylitis (inflammation of the tendon insertions in the area
of the elbow, also called tennis
elbow or golfer elbow);
- in acute muscular pain, e.g in the back area.
FOR ADOLESCENTS AGED 14 YEARS AND OVER
For short-term treatment.
For local, symptomatic treatment of pain in acute strains, sprains or
contusions following blunt trauma.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MOTUSOL RX 1 % W/W GEL
D

Ciri produk

Health Products Regulatory Authority
10 June 2021
CRN00C3SK
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Motusol Rx 1 % w/w gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains diclofenac as 11.6 mg of diclofenac diethylamine
corresponding to 10 mg of diclofenac sodium
Excipient(s) with known effect
1 g of gel contains 50 mg propylene glycol (E1520) and 1 mg fragance
(contains 0.15 mg/g benzyl alcohol, citral, citronellol,
coumarin, eugenol, farnesol, geranoil, d-limonene and 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
For the local symptomatic treatment of pain:
- of acute strains, sprains or contusions following blunt traumas
- of the soft tissues close to the joint (e.g. bursae, tendons, tendon
sheaths, ligaments, muscle insertions and joint capsules) in
osteoarthritis of knee and finger joints
- in epicondylitis;
- in acute muscular pain, e.g in the back area.
FOR ADOLESCENTS AGED 14 YEARS AND OVER
For short-term treatment.
For local, symptomatic treatment of pain in acute strains, sprains or
contusions following blunt trauma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents aged 14 years or older:_
Depending on the size of the affected site to be treated, a cherry to
walnut-sized quantity, corresponding to 1-4 g of gel (11.6 -
46.4 mg diclofenac diethylamine, corresponding to 10-40 mg diclofenac
sodium) should be applied 3-4 times daily. This is
sufficient to treat of an area of 400‑800 cm
2
.
The maximum daily dose is 16 g of gel corresponding to 185.6 mg of
diclofenac, diethylamine salt (corresponding to 160 mg
diclofenac sodium).
The duration of use depends on the symptoms and the underlying
disease. Motusol Rx 1 % w/w Gelshould 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