Last Updated on eMC 16-09-2015 View medicine  | Forum Health Products Limited 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 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:10-09-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



1.       Section 2

Added ‘For a full list of excipients, see section 6.1’

The statement has been added in order to comply with the QRD template

 

1.       Section 4.2

Added ‘If symptoms persist for more than 7 days, or worsen, seek medical advice.’

‘Renal Insufficiency: Not to be used when treating infants with known or suspected impairment of renal function (see section 4.3).’

The information has been added to align with the CCDS

 

‘Method of administration:’

‘Posology’

The subheadings have been added to comply with the QRD template.

 

1.       Section 4.3

Added ‘Hypersensitivity to sodium alginate and magnesium alginate or any of the excipients listed in section 6.1.’

 

To align with the QRD template

 

1.       Section 4.4

Addition of ‘Significant or sustained changes in bowel habit or stool consistency e.g. diarrhoea or constipation, should be investigated.’

‘Not to be used when treating infants with known or suspected impairment of renal function as the sodium content (approximately 21 mg or 0.92 mmol per dose) may add to the risk of hypernatraemia.’

 

To align with CCDS

 

1.       Section 4.6

Addition of sub-headings: “Pregnancy”, “Breastfeeding” and “Fertility”

Aligns with QRD template

 

1.       Section 4.8

Addition of Adverse events which have been associated with sodium alginate and magnesium alginate are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

 

Aligns with CCDS

 

 

System Organ Class

Frequency

Adverse Events

Immune System Disorders

Not known

Hypersensitivity

Gastrointestinal Disorders

Very rare

Constipation and diarrhoea.

Not known

Intestinal obstruction, flatulence, abdominal distension and bezoar.


Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard

 

Aligns with QRD template and CCDS

 

1.       Section 4.9

Addition of ‘Symptoms

Overdosage with Gaviscon Infant may lead to the formation of an intragastric mass.’

‘Management

In the event of overdose, symptomatic treatment should be given.’

The addition of the subheadings are to align with the QRD template whereas the information with the subheadings are to align with the CCDS

 

1.       Section 5.1

Addition of ‘Pharmacotherapeutic group: Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); ATC Code: A02BX13’

To align with QRD template

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:08-02-2011

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The amendment instructs the parent to give Gaviscon Infant half way through the feed rather than at the end of the feed.    This has been made because we have found through the consumer feedback that breast fed infants are often not hungry at the end of the feed and parents find it difficult to get their infant to take the full dose of Gaviscon.     Insufficient dosing could lead to a loss of effectiveness of the product.

Reasons for adding or updating:

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

Date of revision of text on the SPC:01-01-0001

Legal Category:P

Black Triangle (CHM): NO