Diclac Relief 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 not subject to medical prescription

Therapeutic area:

Antiinflammatory preparations, non-steroids for topical use; diclofenac

Authorization status:

Marketed

Authorization date:

2004-07-30

Patient Information leaflet

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 in adults, the elderly and
adolescents aged 14 years and over to
relieve pain and reduce swelling in a number of painful conditions
affecting the joints and muscles e.g.
sprains, strains and bruises. It is also used to relieve the pain of
muscular rheumatism.
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
-

Summary of Product characteristics

Health Products Regulatory Authority
09 January 2024
CRN00DHGZ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclac Relief 1% w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g of Diclac Relief 1% w/w Gel contains Diclofenac Sodium 10 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
A slight yellow emulsion, cutaneous gel with an alcoholic smell.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the local symptomatic relief of pain and inflammation in:
- trauma of the tendons, ligaments, muscles and joints,
- e.g. due to sprains, strains and bruises.
- localised forms of soft tissue rheumatism.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and children 14 years or over:_
Diclac Relief Gel should be rubbed gently into the skin. Depending on
the size of the affected site to be treated 2-4g (a circular
shaped mass approximately 2.0-2.5cm in diameter) should be applied 3-4
times a day. After application, the hands should be
washed unless they are the site being treated. Fire, flame and smoking
must be avoided until Diclac Relief has dried.
It is recommended that treatment be limited to 7 days.
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).
_Use in the elderly:_
The usual adult dosage may be used.
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1

Patients with or without chronic asthma in whom attacks of asthma,
urticaria or acute rhinitis are precipitated by
aspirin or other non-steroidal anti-inflammatory agents.

Hypersensitivity to diclofenac, acetylsalicylic acid or other
non-steroidal anti-inflammatory drugs.
