Mucodyne 375mg Capsules- Discontinued
- Name:
Mucodyne 375mg Capsules- Discontinued
- Company:
Ipsen Pharmaceuticals Ltd
- 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: 20/12/17
(Click to Download)Click on this link to Download PDF directly
Ipsen Pharmaceuticals Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name Cabometyx Tablets | Active Ingredients Cabozantinib |
| Medicine Name Decapeptyl (triptorelin) 3-month | Active Ingredients triptorelin pamoate |
| Medicine Name Decapeptyl (triptorelin) SR | Active Ingredients triptorelin acetate |
| Medicine Name Decapeptyl 6 Month 22.5mg | Active Ingredients triptorelin pamoate |
| Medicine Name Dysport | Active Ingredients Clostridium botulinum type A toxin-haemagglutinin complex |
| Medicine Name INCRELEX | Active Ingredients Mecasermin |
| Medicine Name Mucodyne 375mg Capsules- Discontinued | Active Ingredients Carbocisteine |
| Medicine Name NutropinAq | Active Ingredients Somatropin |
| Medicine Name Somatuline Autogel 60 mg, 90 mg and 120 mg solution for injection in a pre-filled syringe | Active Ingredients Lanreotide acetate |
| Medicine Name Somatuline LA 30mg | Active Ingredients Lanreotide acetate |
| Medicine Name Xermelo 250 mg film-coated tablets | Active Ingredients Telotristat ethyl |
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 16 July 2020 SPC
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Data correction to sections 5.2 and 5.3 of SmPC
Updated on 3 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 3 January 2018 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)
Free text change information supplied by the pharmaceutical company
Updated on 20 December 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 20 December 2017 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
- Change of distributor details
Updated on 25 February 2016 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 18 February 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 15 February 2016 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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
Updated on 12 February 2016 PIL
Reasons for updating
- Change of trade or active ingredient name
- Change to date of revision
Updated on 2 October 2015 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Side effects include;
Gastrointestinal disorders
nausea, headache, gastrointestinal upset, vomiting,
Nervous system disorders
Headache
Skin and subcutaneous tissue disorders
Aallergic skin reactions and anaphylactic reactions, fixed drug eruption.
Isolated cases of dermatitis bullous such as Stevens-Johnson syndrome and erythema multiforme.
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Updated on 1 September 2015 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
4.8 Undesirable effects
(additional sideeffects) Side effects include;
Gastrointestinal disorders
vomiting,
Nervous system disorders
Headache
Skin and subcutaneous tissue disorders
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie
Section 6:
Date leaflet was last revised.
Updated on 27 August 2015 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 28 January 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to marketing authorisation holder
Updated on 21 May 2013 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 20 September 2012 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
Updated on 8 July 2009 PIL
Reasons for updating
- Change to improve clarity and readability
Updated on 20 May 2008 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 8 August 2007 PIL
Reasons for updating
- Improved electronic presentation
Updated on 19 December 2006 PIL
Reasons for updating
- Improved electronic presentation
Updated on 13 December 2006 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 7 - Marketing authorisation holder
- 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
Updated on 17 May 2005 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 6 April 2005 PIL
Reasons for updating
- Improved electronic presentation
Updated on 30 March 2005 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 19 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 18 August 2003 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 31 July 2003 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 17 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)