Last Updated on eMC 13-03-2015 View medicine  | Alliance Pharmaceuticals Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life

Date of revision of text on the SPC:03-03-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Amend 6.3 Shelf life from two years to three years

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:16-12-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to section 4 to include adverse reaction reporting statement

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC:15-04-2013

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Changes are highlighted in red below:

4.2     
Posology and method of administration

      Children under one year of age:

 

For single dose therapy, 1 g or 5 ml per kg bodyweight taken as soon as possible after ingestion of the poison. For multiple dose therapy, the dose may be repeated every 4-6 hours.

 

Induction of emesis is not recommended because there is no evidence that it affects absorption and it may increase the risk of aspiration.

 

When syrup of ipecac is used to produce emesis, administration of Actidose-Aqua Advance should be delayed until 30-60 minutes after vomiting has ceased.

 

4.4      Special warnings and precautions for use

  

Both the patient and health care professionals should be aware that Actidose-Aqua Advance will produce black stools (see section 4.8 ‘Undesirable effects’). A laxative may be given concurrently to accelerate the removal of the activated charcoal-toxin complex, but should be used with caution and only intermittently during multiple dose activated charcoal therapy since profuse and protracted diarrhoea may lead to fluid and electrolyte imbalance.

 

Aspiration of activated charcoal has been reported to produce airways obstruction and appropriate precautions should be taken (see section 4.8 ‘Undesirable effects’).

 

 

4.8      Undesirable effects

 

Undesirable effects are listed by MedDRA System Organ Classes.

 

Assessment of undesirable effects is based on the following frequency groupings:

Very common: ≥1/10

Common: ≥1/100 to <1/10

Uncommon: ≥1/1,000 to <1/100

Rare: ≥1/10,000 to <1/1,000

Very rare: <1/10,000

Not known: cannot be estimated from the available data

 

 

Respiratory, thoracic and mediastinal disorders

 

Not known:

 

Airways obstruction1

 

 

Gastrointestinal disorders

 

Not known:

 

Black stools (see section 4.4 ‘Special warnings and precautions for use)

 

Gastrointestinal obstruction2

 

Gastrointestinal disturbances including vomiting, constipation and diarrhoea

 

 

1 Aspiration of activated charcoal has been reported to produce airways obstruction (see section 4.4 ‘Special warnings and precautions for use’).

2 Associated with the use of multiple dose activated charcoal therapy.

 

Both the patient and health care professionals should be aware that Actidose-Aqua Advance will produce black stools. A laxative may be given concurrently to accelerate the removal of the activated charcoal-toxin complex, but should be used with caution and only intermittently during multiple dose activated charcoal therapy since profuse and protracted diarrhoea may lead to fluid and electrolyte imbalance.

 

Aspiration of activated charcoal has been reported to produce airways obstruction and appropriate precautions should be taken. Gastrointestinal obstruction associated with the use of multiple dose activated charcoal therapy has been reported rarely.

 

 

 

6.6      Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product (use “Instructions for use, handling and disposal” on eMC/IPHA)

 

 

 

 

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)

Date of revision of text on the SPC:14-07-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



1.             MARKETING AUTHORISATION HOLDER

 

Alliance Pharmaceuticals Ltd

Avonbridge House

2 Bath Road

Chippenham

Wiltshire,

SN15 2BB

UK

 

2.             MARKETING AUTHORISATION NUMBER

 

        PL 16853/ 0119

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC