Changes in SmPC and PIL following Paediatric Assessment Report for Diclofenac published on 27 November 2010

Changes are made in red;

SmPC :

4.2       Posology and method of administration

For cutaneous use only.

Adults

Sufficient solution of Diclofenac Sodium Spray Gel should be sprayed onto the skin of the affected site. Depending on the size of area to be treated 4-5 pump strokes (0.8-1.0 g of spray containing 32-40 mg of diclofenac sodium) should be applied 3 times daily in regular intervals. A maximum single dose of 1.0 g of the product should not be exceeded. The maximum daily dose is 15 pump strokes (3.0 g of spray containing 120 mg of diclofenac sodium).

Diclofenac Sodium Spray Gel should be massaged gently into the skin. After this the hands should be washed unless they are the site to be treated. After application some minutes for drying should be allowed before dressing or binding the treated area.

The treatment may be discontinued when the symptoms (pain and swelling) have subsided. Treatment should not be continued beyond 7-8 days without review. The patient is requested to consult the doctor if no improvement is seen after 3 days.

Elderly

The posology is the same as for adults.

Children

There is no experience in children, therefore  Diclofenac Sodium Spray Gel is not recommended for use in children below 15 years of age.

Children and adolescents:

There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age (see also contraindications section 4.3).

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.

Patients with hepatic or renal insufficiency

For the use of Diclofenac Sodium Spray Gel in patients with hepatic or renal insufficiency see section 4.4.

4.3       Contraindications

·                     Hypersensitivity to the active substance or to any of the excipients.

·                     Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)

·                     Patients with or without asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents.

·                     The last trimester of pregnancy.

·                     Application to the breast area of nursing mothers

·                     Children and adolescents: the use in children and adolescents aged less than 14 years is contraindicated not recommended.

10.       DATE OF REVISION OF THE TEXT

06/2011

Changes in red

4.8  Undesirable effects

System organ class

4.9  Overdose

is recommended to wipe off the surplus Difene Spray Gel

Section 7.        MARKETING AUTHORISATION HOLDER

Changed from:

Astellas Pharma GmbH

81673 Mnchen

GERMANY

To.

Astellas Pharma Co. Ltd

25 The Courtyard

Kilcarbery Business Park

Clondalkin

Dublin 22

Ireland

Section 8.        MARKETING AUTHORISATION NUMBER

PA 731/4/1 changed to PA 1241/12/8

Seciton 9.        DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

2 changed to 2nd

13 changed to 13^th

Section 10.       DATE OF REVISION OF THE TEXT

Changed from May 2008 to October 2008

section 1.      Name of the medicinal product

Difene 4 % Spray Gel updated to read Difene Spray Gel 4% w/w cutaneous spray, solution

Section 2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

For excipients see 6.1. update to read Excipient: 150 mg propylene glycol (E1520) / gram solutionFor a full list of excipients see section 6.1.

Section 4.2        Posology and method of administration

Not to be administered orally. Had been removed

Adults updated to read:

Sufficient solution of Difene Spray Gel should be sprayed onto the skin of the affected site.  Depending on the size of the area to be treated  4-5 pump strokes (0.8-1.0 g of spray containing 32-40 mg of diclofenac sodium) should be applied 3 times daily  in regular intervals. A maximum single dose of 1.0 g of the product should not be exceeded. The maximum daily dose is 15 pump strokes (3.0 g of spray containing 120 mg of diclofenac sodium).

Children updated to read:

The use in children under the age of 15 years is not assessed and therefore not recommended. Was updated to read:

There is no experience in children, therefore Difene Spray Gel is not recommended for  use in children below 15 years of age.

Patients with hepatic or renal insufficiency: 4% omitted.

Section 4.3        Contraindications

Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) or any excipients of the finished medicinal product.

Updated to read

¡¤                     Hypersensitivity to the active substance or to any of the excipients

¡¤                     Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)

¡¤                     The word In,  was removed from the following sentence, The last trimester of pregnancy.

Addition of: Application to the breast area of nursing mothers.

Section 4.4        Special warnings and precautions for use

Difene 4 % Spray Gel should only be administered onto intact skin, not on open wounds or diseased skin areas. Contact with eyes and mucous membranes as well as oral use should be avoided.

Format updated to:

Contact with eyes and mucous membranes as well as oral use should be avoided.

Difene Spray Gel should only be administered onto intact skin, not on open wounds or diseased skin areas.

Difene 4% Spray Gel updated to Difene Spray Gel,

see interaction omitted, see section 4.5 added.

Section 4.5        Interactions with other medicinal products and other forms of interaction. See section 4.4 added.

Section 4.6        Pregnancy and lactation

There is insufficient experience for the use during pregnancy and lactation. Has been changed to read There are no adequate data from the use of Difene Spray Gel in pregnant and nursing women.

Therefore, Difene 4 % Spray Gel should be used with caution and only if clearly necessary during the first six months of pregnancy and must not be applied to a large area of the skin (i.e. more than 600 square centimetres of the body surface). It must not be used for long-term treatment ( > three weeks). Treatment with Difene 4 % Spray Gel is contraindicated during the last trimester of pregnancy.

Has been changed to read

Therefore, during the first six months of pregnancy Difene Spray Gel should not be used  unless clearly necessary and must not be applied to a large area of the skin (i.e. more than 600 square centimetres of the body surface). It must not be used for long-term treatment (> three weeks). Difene Spray Gel is contraindicated (see 4.3) during the last trimester of pregnancy.

Studies in animals have shown reproductive toxicity (see 5.3). The potential risk for humans is unknown.

The following sentence was omitted: In preclinical studies of toxicity to reproduction, diclofenac showed adverse effects (see section 5.3).

Section 4.8        Undesirable effects:

Instances of side effects etc very common (¡Ý1/10), format updated.

Addition of very rare and not known, instances of side effects into the table

Addition of (equivalent to 5 pump strokes)

Section 4.9        Overdose, addition of the following sentence:  It is recommended to wipe off the surplus Difene Spray Gel.

Is recommended has been changed to should be given.

4% removed from section 4.9, 5.2 and 5.3

Section 5.3        Preclinical safety data

Preclinical data based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential of diclofenac reveal no special hazard for humans other than already mentioned in earlier sections of this SPC.

Changed to read

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential of diclofenac.

Section 6.1        List of excipients

Added:

(E1520)

for pH ¨Cadjustment

Purified water

Section 6.3        Shelf-life

Unopened bottle (30 ml and 15 ml): 3 years

Unopened bottles (10 ml): 2 years

Has been changed to read

Unopened bottle (25g solution in 30 ml bottle and 12.5g solution in 15 ml bottle):     3 years

Unopened bottles (7.5g solution in 10 ml bottle)                            2 years

Section 6.5        Nature and contents of container

Glass bottle with metering pump/nozzle/spray valve and cap, 7.5 g, 12.5 g and 25 g solution.

Changed to read

Glass bottle with metering pump/nozzle/spray valve and cap.

Pack sizes of 7.5 g (10 ml bottle), 12.5 g (15 ml bottle) and 25 g (30 ml bottle) solution.

Section 7.         MARKETING AUTHORISATION HOLDER

Neumarkter Str. 61 removed

Section 9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION.

2 May 2003

Updated to read: Date of first authorization:  2 May 2003

                          Date of last renewal: 13 May 2007

Section 10.        DATE OF REVISION OF THE TEXT

Updated to May 2008

Changes Document (September 2006 v November 2003)

Difene Spray Gel SPC

Section 6.1 List of Excipients – deleted “purified water”.

Section 7 Marketing Authorisation Holder: Change to MAH name from Fujisawa GmbH to Astellas Pharma GmbH

Section 10 Date of revision of the text: changed to September 2006