Solaraze 3% Gel

  • Name:

    Solaraze 3% Gel

  • Company:
    info
  • Active Ingredients:

    Diclofenac Sodium

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/01/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 20/1/2020

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Almirall Limited

Large-ALM_AW_LOGO_MV_Positive_CMYK_1579525802

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Medicine Name Ilumetri 100 mg solution for injection in pre-filled syringe Active Ingredients Tildrakizumab
Medicine Name Meptid 100 mg/ml Solution for Injection Active Ingredients Meptazinol hydrochloride
Medicine Name Meptid 200 mg Film-Coated Tablets Active Ingredients Meptazinol hydrochloride
Medicine Name Skilarence 30 mg gastro-resistant tablets Active Ingredients Dimethyl fumarate
Medicine Name Skilarence 30 mg, 120 mg gastro-resisistant tablets Active Ingredients Dimethyl fumarate
Medicine Name Solaraze 3% Gel Active Ingredients Diclofenac Sodium
Medicine Name Vaniqa 11.5% cream Active Ingredients Eflornithine hydrochloride monohydrate
1 - 0 of 8 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20 January 2020 PIL

Reasons for updating

  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

3) How to use Solaraze - addition of:

Gently smooth a small amount of gel onto the skin over the area to be treated. The amount of gel
needed will vary depending upon the size of the area to be treated. Usually 0.5 grams of gel
(about the size of a pea) will be enough for one area (5cm x 5cm) but not more than 8 grams
should be used per day.

Updated on 20 January 2020 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology and method of administration

Addition of

Maximum daily amount of 8 g of product allows simultaneous treatment of up to 200 cm2 skin surface.

(Removal of: Long term efficacy has not been established.)

Updated on 27 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 27 March 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 - QRD template update
Section 4.1- Indication corrected to: actinic keratosis (AK)
Section 4.2 -  Removal of long term efficacy has not been established plus editiorial and QRD updates.
Section 4.4 - addition of full wording for NSAIDs - nosteroidal anti-inflammatory drugs
Section 4.6 - QRD template updates
Section 4.8 - Improved QRD template ordering of side-effects.
Section 5.1 - Inclusion of a summary of clinical efficacy and safety data from clinical trials.
Section 5.2 - Correction of two minor typographical errors.
Section 6.6 - QRD template updates
Section 8 - QRD template updates
Section 10 - date of revision February 2018


Updated on 26 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 March 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 26 November 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8

Addition of QRD template ADR reporting statement

 

Section 10 - Date of revision of text

August 2015

Updated on 24 November 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 7 February 2012 SmPC

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.3 - clarified trimester of pregnancy

4.4 - additional precautions added

4.5 - information reworded



4.6 - information reworded



4.7 - information expanded



4.8 - additional undesirable effects added and frequencies changed



4.9 - additional overdose information added

Updated on 3 February 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery

Updated on 23 March 2010 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The updates are to the following sections of the SmPC:

Section 6.3: the following sentence added " after 1st opening: 6 months"

Section 7: Name change of MAH from Laboratorios Almirall to "Almirall, S.A."

Section 10: to reflect latest date of revision/approval of SmPC

Updated on 17 March 2010 PIL

Reasons for updating

  • Change of licence holder
  • Change to storage instructions

Updated on 4 June 2009 SmPC

Reasons for updating

  • Addition of separate SPCs covering individual presentations

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 1 June 2009 PIL

Reasons for updating

  • New PIL for medicines.ie