go to medicines.ie homepage
  • Home  |  
  • About  |  
  • Links  |  
  • Help
Font Size
Search for:  
select
select
  • SPCs and PILs
  • SPCs Only
  • PILs Only
  Advanced Search
  • What's
    New
      
  • Browse
    Medicines
      
  • Browse
    Active Ingredients
      
  • Browse
    Companies
      
  • Codes
    of Practice
      
  • Adverse
    Reaction Reporting

Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited
7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 468 9200
Fax: +353 1 468 9299


Summary of Product Characteristics last updated on medicines.ie: 17/04/2012
SPC Gaviscon Suspension

Table of Contents

  • 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 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 excipient(s)
  • 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


Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

Gaviscon Oral Suspension

500mg/10ml sodium alginate

267mg/10ml sodium bicarbonate

160mg/10ml calcium carbonate


Go to top of the page
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients

mg/10ml

Sodium alginate

500

Sodium bicarbonate

267

Calcium carbonate

160

Other ingredients include:

Methyl parahydroxybenzoate (E218) 40mg/10 ml and Propyl parahydroxybenzoate (E216) 6mg/10 ml

For a full list of excipients, see section 6.1.


Go to top of the page
3. PHARMACEUTICAL FORM

Oral suspension.

An opaque, pink, viscous oral suspension with an odour of fennel.


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
4.1 Therapeutic indications

For the management of gastric reflux, reflux oesophagitis, hiatus hernia, heartburn (including heartburn of pregnancy) and similar gastric distress.


Go to top of the page
4.2 Posology and method of administration

For oral administration.

Adults and children over 12 years: 10-20 ml (two to four 5 ml spoonfuls) after meals and before retiring.

Children 6-12 years: 5-10 ml (one to two 5 ml spoonfuls) after meals and before retiring.


Go to top of the page
4.3 Contraindications

None known.


Go to top of the page
4.4 Special warnings and precautions for use

Each 10 ml dose has a sodium content of 141 mg (6.2 mmol). This should be taken into account when a highly restricted salt diet is recommended.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

None known.


Go to top of the page
4.6 Pregnancy and lactation

Alginate has no systemic activity and consequently can be taken during pregnancy and lactation.


Go to top of the page
4.7 Effects on ability to drive and use machines

None.


Go to top of the page
4.8 Undesirable effects

Very rarely (<1/10,000) patients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.


Go to top of the page
4.9 Overdose

In the event of overdosage symptomatic treatment should be given. The patient may notice abdominal distension.


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
5.1 Pharmacodynamic properties

On ingestion Gaviscon Suspension reacts with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents effectively impeding gastro-oesophageal reflux. In severe cases the raft itself may be refluxed into the oesophagus in preference to the stomach contents and exert a demulcent effect.


Go to top of the page
5.2 Pharmacokinetic properties

The mode of action of Gaviscon Suspension is physical and does not depend on absorption into the systemic circulation.


Go to top of the page
5.3 Preclinical safety data

No preclinical findings relevant to the prescriber have been reported.


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
6.1 List of excipient(s)

Carbomer

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Saccharin sodium

Fennel flavour

Erythrosine soluble

Sodium hydroxide

Purified water


Go to top of the page
6.2 Incompatibilities

Not applicable.


Go to top of the page
6.3 Shelf life

2 years


Go to top of the page
6.4 Special precautions for storage

Store below 30°C. Do not refrigerate.


Go to top of the page
6.5 Nature and contents of container

Amber glass Type III bottles with a polypropylene cap with a polyethylene tamper-evident band lined with an expanded polyethylene wad containing 100ml, 200ml or 500 ml. Not all pack sizes may be marketed.


Go to top of the page
6.6 Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

PA 979/15/1.


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 3rd May, 1978

Date of last renewal: 3rd May 2008


Go to top of the page
10. DATE OF REVISION OF THE TEXT

September 2008



Link to this document from your website:
http://www.medicines.ie/medicine/1263/SPC/Gaviscon+Suspension/

Document Links

 
  Link to this page
  View all medicines
from this company
Print this page
View document history
Bookmark and Share

Legal Categories

 
   Product subject to medical
prescription which may not
be renewed (A)
   Product subject to medical
prescription which may
be renewed (B)
   Product subject to
restricted prescription
(C)
   Supply through
general sale
   Supply through
pharmacy only

Active Ingredients

 
   Sodium Alginate
   Calcium Carbonate
   Sodium Bicarbonate

  • Terms & Conditions | 
  • Accessibility | 
  • Privacy Statement | 
  • Contact Us

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

This website is certified by Health On the Net Foundation. Click to verify.

This site complies with the HONcode standard for trustworthy health information: verify here.

logo