Losec MUPS 10mg Gastro-resistant Tablets
- Name:
Losec MUPS 10mg Gastro-resistant Tablets
- Company:
AstraZeneca Pharmaceuticals (Ireland) DAC
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/01/21
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AstraZeneca Pharmaceuticals (Ireland) DAC
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Company Products
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 18 January 2021 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
2. What you need to know before you take Losec
...
Losec tablets contain sucrose and sodium
Losec gastro-resistant tablets contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Losec gastro-resistant tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
4. Possible side effects
...
Reporting of side effects
...
Ireland:
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
6. Contents of the pack and other information
...
Marketing Authorisation Holder and Manufacturer
...
Losec MUPS are manufactured by AstraZeneca AB, Gärtunavägen, SE-151 85, Södertälje, Sweden. or AstraZeneca GmbH, Tinsdaler Weg 183, D-22880 Wedel, Germany.
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Member State |
Name of medicinal product |
|
Belgium, Cyprus, Denmark, Finland, Greece, Iceland, Ireland, Luxemburg, Malta, The Netherlands, Norway, |
Losec |
|
Germany |
Antra |
This leaflet was last revised in September 2018 October 2020.
Updated on 18 January 2021 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
(Inserted Text; Deleted Text)
4.4 Special warnings and precautions for use
...
Losec gastro-resistant tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
4.8 Undesirable effects
...
Reporting of suspected adverse reactions
....
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
10. DATE OF REVISION OF THE TEXT
7th January 2019 11th January 2021
Updated on 15 January 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 14 January 2019 SPC
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: Product subject to medical prescription which may be renewed (B)
Updated on 12 May 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 June 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 June 2017 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2- Editorial changes
Section 4.8- Addition of new side effect, ‘fundic gland polyps (benign)’
Section 10- Revision date updated
Updated on 31 May 2017 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 31 May 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 7 February 2017 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 – Addition of information including CgA levels.
Section 5.1 – Addition of information including CgA levels.
Section 10 – Update to Date of Revision
Updated on 2 February 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 14 October 2016 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 1 August 2016 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2– Changes relating to QRD update
Section 4.1 – Changes relating to QRD update
Section 4.2 – Changes relating to QRD update
Section 4.3 – Changes relating to QRD update
Section 4.4 – Addition of information to include Clostridium Difficile infections
Section 4.5 – Changes relating to QRD update
Section 4.6 – Changes relating to QRD update
Section 5.1 – Changes relating to QRD update and addition of information to include Clostridium Difficile infections
Section 5.2 – Changes relating to QRD update
Section 10 – Update to Date of Revision
Updated on 29 July 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to improve clarity and readability
Updated on 18 January 2016 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4 - Clinical particulars
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2- Editorial changes relating to latest QRD template
Section 4- Editorial changes relating to latest QRD template
Section 4.2- Editorial changes relating to latest QRD template
Section 4.4- Addition of PRAC wording: ‘SCLE (subacute cutaneous lupus erythematosus)’
Section 4.6- Editorial changes relating to latest QRD template
Section 4.8- Addition of PRAC wording: ‘SCLE (subacute cutaneous lupus erythematosus)’and editorial changes relating to latest QRD template
Section 5.2- Editorial changes relating to latest QRD template
Section 10 - Update to Date of Revision
Updated on 15 January 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 11 September 2014 SPC
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 4.6 - 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Change to improve clarity and readability
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Section 2 Reword the cross reference to section 6.1 in line with QRD template
- Section 4.2 Reword of some subheadings in line with QRD template
- Section 4.3 Minor additions in line with QRD template
- Section 4.6 Reword the section heading in line with QRD. Fertility details added
- Section 4.8 Subheadings and reporting of suspected adverse reactions added in line with QRD template
- Section 5.1 Minor editorial changes in line with QRD template
- Section 5.2 Subheading changes in line with QRD
- Section 6.5 100 (2x50) added in packsize
- Section 10 Update date of this revision.
Updated on 5 September 2014 PIL
Reasons for updating
- Addition of information on reporting a side effect.
- Improved electronic presentation
Updated on 3 March 2014 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Section 4.8 – Addition of side effect: hypomagnesaemia may also be associated with hypokalaemia.
- Section 10 – Date of revision
Updated on 6 November 2013 PIL
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 5 June 2013 SPC
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Section 4.4 – editorial
- Section 4.5 – PK/PD info
- Section 4.8 – addition of severe hypomagnesaemia may result in hypocalcaemia
- Section 5.1 – Further info on CgA
- Section 10 - updated date of revision
Updated on 22 February 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to further information section
- Change to date of revision
Updated on 1 November 2012 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.5
Addition of warning concerning co-administration with methotrexate.
Section 4.8
Addition of microscopic colitis as a side effect.
Section 10
Date of revision amended to 24th October 2012.
Updated on 26 October 2012 PIL
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 23 August 2012 SPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 3
Removal of one tablet imprint design.
Section 4.4
Addition of information about severe hypomagnesaemia and increased risk of hip, wrist and spine fracture.
Section 4.8
Change of frequency descriptor for hypomagnesaemia and addition of Fracture of the hip, wrist or spine as an undesirable effect.
Section 6.1
Administrative updates to excipients.
Section 10
Update to "Date of Revision" to 15th August 2012.
Updated on 17 August 2012 PIL
Reasons for updating
- Change of inactive ingredient
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to appearance of the medicine
- Addition of manufacturer
Updated on 2 February 2012 SPC
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4
New Paragraph inserted after Paragraph 4
Interference with laboratory tests
Increased CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference the omeprazole treatment should be temporarily stopped five days before CgA measurements.
Section 5.1
Other effects related to acid inhibition
Paragraph 3 amended to:
Chromogranin A (CgA) also increases due to decreased gastric acidity. This CgA modifying effect can not be demonstrated five days after stopping treatment with PPIs.
Section 10
Date of revision changed to 20th January 2012
Updated on 9 February 2011 PIL
Reasons for updating
- Change to date of revision
- Change due to harmonisation of patient information leaflet
Updated on 13 July 2010 PIL
Reasons for updating
- Change of trade or active ingredient name
- Change due to user-testing of patient information
Updated on 19 September 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 13 July 2007 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 26 January 2006 PIL
Reasons for updating
- Change of manufacturer
- Change to storage instructions
- Change to date of revision
- Change from the BAN of the active substance to the rINN
Updated on 6 August 2004 PIL
Reasons for updating
- Change to date of revision
Updated on 28 July 2004 PIL
Reasons for updating
- New PIL for medicines.ie