Duphalac 3.335 g / 5 ml Oral Solution

  • Name:

    Duphalac 3.335 g / 5 ml Oral Solution

  • Company:
    info
  • Active Ingredients:

    Lactulose

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/08/18

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Summary of Product Characteristics last updated on medicines.ie: 27/8/2018

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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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 27 August 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Updated on 27 August 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 4 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 4 July 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

7.  MARKETING AUTHORISATION HOLDER

Mylan IRE Healthcare Limited

Unit 35/36

Grange Parade

Baldoyle Industrial Estate

Dublin 13

Ireland

BGP Products Ireland Limited

4051 Kingswood Drive,

Citywest Business Campus,

Dublin 24

8. MARKETING AUTHORISATION NUMBER

 

PA 2010/9/1 2007/4/1

 

10. DATE OF REVISION OF THE TEXT

 

June 2017

Updated on 30 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 June 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 31 March 2016 PIL

Reasons for updating

  • Change of distributor details

Updated on 29 March 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2 - Deletion of "or where a soft stoll is considered of medical benefit" in line with approved indications, Update of starting dose details for Dosing in Hepatic Encephalopathy

Updated on 29 March 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to dosage and administration

Updated on 8 April 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7: Marketing authorisation holder changed from Abbott Healthcare Products Ltd. to BGP Products Ltd.
Section 8: PA number updated

Updated on 31 March 2015 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 31 March 2015 SmPC

Reasons for updating

  • 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 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.1 - Therapeutic indications

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.1 - Amendment of indication wording to include hepatic coma and precoma
Section 4.2 - Update of dosage details, addition of measuring cup information
Section 4.3 - Amendment of contraindication regarding gastrointestinal obstruction/perforation
Section 4.4 - Update of warnings relating to chronic use, diabetes, addition of warning regarding painful abdominal symptoms before treatment is started
Section 4.6 - Addition of fertility information
Section 4.8 - Addition of adverse reactions table including frequencies, addition of information for reporting of adverse reactions.

Updated on 20 March 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to dosage and administration
  • Addition of joint PIL covering all presentations
  • Addition of information on reporting a side effect.

Updated on 21 July 2014 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7:
Change of Abbott Healthcare Products Limited address

from:  Southampton, UK

to:  Abbott House,
      Vanwall Business Park
      Vanwall Road
      Maidenhead, SL6 4XE,
      UK

Updated on 16 July 2014 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 12 February 2014 PIL

Reasons for updating

  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 31 January 2014 SmPC

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2 the following was added:  The lactulose solution may be administered diluted or undiluted.
A single dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time.
The posology shoudl be adjusted according to the individual needs of the patient.  In case of a single daily dose, this should be taken at the same time e.g. during breakfast.  During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5 - 2 litres, equal to 6-8 glasses) during the day.

Section 4.3 has been changed to: Hypersensitivity to the active substance or to any of the ingredients

Section 4.4 the following was added: In case of insufficient therapeutic effect after several days consultation of a physician is advised.
The dose normally used in consitpation should not pose a problem for diabetics.  The dose used in the treatment of hepatic encephalopathy is usually much higher and may need to be taken into consideration for diabetics.
It should be taken into account that the defaecation reflex could be disturbed during the treatment.  This product contains lactose, galactose and small amounts of fructose.  Therefore, patients with the rare hereditary problem of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Section 4.5 has been changed to: No interaction studies have been performed

Section 4.6 the following was added:  Pregnancy: No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible.  A large amound ot data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor foeto/neonatal toxicity of lactulose.
Duphalac can be used when considered necessary by the physician.
Lactation: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to lactulose is negligible.  Duphalac can be used during breastfeeding.

Section 4.7 has been changed to: Duphalac has no or negligible influence on the ability to drive and use machines.

Section 4.8 the following was added:  Because the following reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.
Gastrointestinal disorders: Flatulence, abdominal pain, nausea and vomiting; if dosed too high: diarrhoea
Investigations: Electrolyte imbalance due to diarrohea

Section 4.9 has been changed to:  If the dose is too high the following may occur:
Sympton: diarrhoea and abdiminal pain.
Treatment: cessation of treatment or dose reduction.  Extensive dluid loss by diarrhoea or vomiting may require correction of electolyte disturbances.

Section 5.1 the following was added:
Pharmacotherapeutic group:  Osmotically acting laxatives.  ATC code: A 6A D11

Section 5.1 the following was added:  Laculose is poorly absorbed after oral administration.
In reproduction and teratology experiments in rabbits, rats or mice no adverse effects were found.

Section 6.1 was changed to:  Duphalac does not contain any excipients, but may contain small amounts of relates sugars (e.g.lactose, galatose, eiplactose, fructose) from the route of synthesis.

Section 6.4 was changed to:  This medicinal product does not require any special storage conditions


Section 6.5 was changed to:  300 or 1000 ml, with a polypropylene measuring cup
The graduations on the measuring cup are: 2.5ml, 5ml, 10ml, 15ml, 20ml, 25ml and 30ml







Updated on 22 February 2012 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 5 April 2011 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The following section has been updated as highlighted;

 

 

Section 7

 

Abbott Healthcare Products Limited

Mansbridge Road

West End

Southampton 

SO18 3JD

UK

 

Updated on 4 April 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details
  • Change to name of manufacturer

Updated on 15 December 2009 PIL

Reasons for updating

  • Change of manufacturer
  • Change to appearance of the medicine
  • Change to improve clarity and readability

Updated on 9 November 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The following sections of the SPC have been revised;


Section 2:

From:

Lactulose solution containing 3.335 g of lactulose per 5 ml.

For excipients, see 6.1

To:

Lactulose solution containing 3.335 g of lactulose per 5 ml.

 

 For a full list of excipients, see section 6.1


Section 6.1:

From:

Purified water.

Duphalac may also contain small amounts of lactose, galactose, epilactose, hydrogen peroxide and sodium hydroxide.

To:

Purified Water

Section 6.5:

From:

Opaque white multidose bottles of HDPE with a polypropylene screw cap containing 300ml or 1 litre.

To:

Opaque white multidose bottles of HDPE with a polypropylene screw cap containing 300ml or 1 litre.

 

Not all pack sizes may be marketed


Section 9:

From:

1 April 1993/ 1 April 2003

To:

Date of first authorisation: 01 April 1983

 

Date of last renewal: 01 April 2008

Updated on 27 August 2008 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 5 July 2006 PIL

Reasons for updating

  • Change of active ingredient

Updated on 29 June 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 1. Name of Medicinal Product
 
Changed from Duphalac Solution to Duphalac 3.335g/5ml Oral Solution

Updated on 15 February 2005 PIL

Reasons for updating

  • New PIL for new product

Updated on 31 August 2004 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition

Legal category: Supply through pharmacy only

Updated on 5 May 2004 SmPC

Reasons for 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 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Updated on 24 June 2003 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only