Solaraze 3% gel

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Diclofenac sodium

Tilgjengelig fra:

DE Pharmaceuticals

ATC-kode:

M02AA15

INN (International Name):

Diclofenac sodium

Dosering :

30mg/1gram

Legemiddelform:

Cutaneous gel

Administreringsrute:

Cutaneous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 13080100

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLARAZE
 3%, GEL
Diclofenac Sodium 3% w/w
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor of pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Solaraze is and what it is used for
2.
What you need to know before you use Solaraze
3.
How to use Solaraze
4.
Possible side effects
5.
How to store Solaraze
6.
Contents of the pack and other information
1. WHAT SOLARAZE IS AND WHAT IT IS USED FOR
Solaraze is a non-steroidal anti-inflammatory dermatological gel. When
applied to the skin, Solaraze
gel is used to treat a skin problem known as actinic or solar
keratosis that is caused by long-term sun
exposure.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOLARAZE
DO NOT USE SOLARAZE
•
If you are allergic to diclofenac or any of the ingredients of this
medicine (listed in section 6).
•
If you have had an allergic reaction such as skin rash (nettle rash),
breathing difficulties
(wheezing) or runny nose (allergic rhinitis) after taking aspirin or
any other non-steroidal anti-
inflammatory agents.
•
If you are in the final 3 months of your pregnancy.
WARNINGS AND PRECAUTIONS
•
The possibility of systemic side effects from application of Solaraze
cannot be excluded if the
product is used on large areas of skin and over a prolonged period.
Consult your doctor if:
•
you have, or have had in the past, a stomach ulcer or bleeding from
the stomach.
•
you have heart, liver or kidney problems.
•
you have any type of bleeding disorder or bruise very easily.
•
Avoid sun exposure, including tanning salons, w

Preparatomtale

OBJECT 1
SOLARAZE 3% GEL
Summary of Product Characteristics Updated 08-Jan-2019 | Almirall
Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Solaraze™ 3%, gel
2. Qualitative and quantitative composition
Each gram contains 30 mg diclofenac sodium (3% w/w).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gel
A clear, transparent, colourless or pale yellow gel.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of actinic keratosis (AK).
4.2 Posology and method of administration
_USE IN ADULTS: _Solaraze is applied locally to the affected area
twice daily, with the gel smoothed into the skin
gently. The amount needed depends on the size of the affected area.
Normally 0.5 grams (the size of a pea) of
the gel is used on a 5 cm x 5 cm lesion site. The maximum daily amount
of 8 grams of product allows
simultaneous treatment of up to 200 cm
2
skin surface area.
The usual duration of therapy is from 60 to 90 days. Maximum efficac