Diclac 1% w/w Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diclofenac sodium

Available from:

Rowex Ltd

ATC code:

M02AA; M02AA15

INN (International Name):

Diclofenac sodium

Dosage:

1 percent weight/weight

Pharmaceutical form:

Gel

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antiinflammatory preparations, non-steroids for topical use; diclofenac

Authorization status:

Marketed

Authorization date:

1999-08-23

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DICLAC RELIEF 1% W/W GEL
diclofenac sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or
nurse has 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 or
nurse. 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 7 days.
WHAT IS IN THIS LEAFLET
:
1.
What Diclac Relief Gel is and what it is used for
2.
What you need to know before you use Diclac Relief Gel
3.
How to use Diclac Relief Gel
4.
Possible side effects
5.
How to store Diclac Relief Gel
6.
Contents of the pack and other information.
1.
WHAT DICLAC RELIEF GEL IS AND WHAT IT IS USED FOR
DICLAC
belongs to a group of medicines called non-steroidal anti-inflammatory
drugs (NSAIDs), which are
used to treat pain and inflammation.
Diclac Relief Gel can be used topically to treat pain and inflammation
in:

Localised forms of soft tissue rheumatism

Trauma of tendons, ligaments, muscle and joints e.g. due to sprains,
strains and bruises.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DICLAC RELIEF GEL
DO NOT USE DICLAC RELIEF GEL IF:
-
you are allergic to the active substance or any of the other
ingredients of this medicine (listed in
section 6)
-
you are an asthmatic
-
you have ever had an allergic reaction after taking medicines to treat
inflammation or pain (e.g.
acetylsalicylic acid/aspirin, diclofenac or ibuprofen). Reactions may
include asthma, runny nose, skin
rash, face swelling. If you think you may be allergic, ask your doctor
for advice.
-
you have broken or denuded skin
-
you are pregnant or breast feeding
-
you are a child or adolescent younger than 14 years of age
If any of these apply t

Summary of Product characteristics

Health Products Regulatory Authority
15 November 2019
CRN009C71
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclac 1% w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100g of Diclac 1% w/w Gel contains Diclofenac Sodium 1g.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel.
A slightly yellow emulsion, cutaneous gel with an alcoholic smell.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-Post-traumatic inflammation of the tendons, ligaments, muscles, and
joints, e.g. due to sprains, strains and bruises
-Localised forms of soft-tissue rheumatism
It is recommended that treatment should be reviewed after 14 days in
these indications. These indications should not warrant
treatment for more than 6 weeks.
-For the symptomatic treatment of osteoarthritis of superficial joints
such as the knee
Therapy should be reviewed after 4 weeks.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical.
RECOMMENDED DOSAGE SCHEDULE:
Adults and children 14 years and over:
Diclofenac gel is applied locally to the skin 3 or 4 times daily and
rubbed in gently. The amount needed depends on the size of
the painful site. For example, 2 to 4 g Diclofenac gel (a quantity
ranging from the size of a cherry to the size of a walnut) is
sufficient to treat an area of about 400 to 800 cm
2
. After application, the hands should be washed, unless they are the
site
being treated. The duration of treatment depends on the indication and
the response obtained. It is recommended that
treatment be reviewed after 2 weeks. These indications should not
warrant treatment for more than 6 weeks.
In children aged 14 years and over, if this product is required for
more than 7 days for pain relief, or if the symptoms worsen,
the patient/ parents of the adolescent is/are advised to consult a
doctor.
Children and adolescents below 14 years:
There are insufficient data on efficacy and safety available for
children and adolescents below 14 years of age (see also
contraindications section 4.3).
Elderly
Ther