Updated on 24/02/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 15-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 5.3 update for adult syrup in line with European guidelines
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Updated on 29/11/2010 and displayed until 24/02/2011
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 5.3 - Preclinical Safety Data
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 02-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3: Change is specific to the Paediatric syrup only, New text added to advise that 'Mucodyne Paediatric syrup is contraindicated for use in children less than 2 years of age.
Section 5.3: text ammended to the following- there are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.
Section 10 ammended:
Capsules 17th January 2010
Syrup; 1st feb 2010
Paediatric Syrup: 2nd September 2010
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Updated on 22/09/2010 and displayed until 29/11/2010
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 6. 3 - Shelf Life
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 30-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The following changes have been made to the combined SPC for Mucodyne- Capsules, syrup and Paediatric syrup:
Section 2: The following text has been added for Mucodyne Syrup:
Syrup: Each 5 ml of oral solution contains 250 mg of Carbocisteine. Also contains 2 g of sucrose, 70 mg of ethanol (1.6% v/v), 7.5 mg of methyl parahydroxybenzoate (E218) and 33 mg of sodium (1.4 mmol).
Section 3: text changed to the following:
Capsules: Yellow, size 1 capsules marked “MUCODYNE 375” in black and containing a white to off-white powder or friable plug.
Syrup: A clear amber coloured syrupy liquid
Paediatric Syrup: A rosy brown to red brown mobile liquid
Section 4.3: Contraindication added for all 3 formulation for hypersensitivity to the active substance or any of the excipients. Wording for Capsules and Syrup contraindication for active peptic ulcers cahnges to 'use in patients with active peptic ulceration'.
Section 4.4: following text added for special warning and precautions for use:
Capsules:
Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Syrup and Paediatric syrup:
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Section 6.3: shelf life for Paediatric syrup changed to 24 months from 36 months.
Section 10: Date of revision of text ammended accordingly: Capsules 30th July 2010, Syrup: December 09, Paediatric syrup: 22nd march 2010.
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Updated on 20/04/2009 and displayed until 22/09/2010
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Reasons for adding or updating:
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 8: Change of Marketing Authorisation Number for Mucodyne Capsules to PL04425/0203
Section 9: Renewal of Authorisation: 7 February 2009
Section 10: Date of revision of text: February 2009
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Updated on 29/01/2009 and displayed until 20/04/2009
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 08-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.5: Syrup and Paediatric Syrup - change from PVC to glass bottle.
Section 6.1: Syrup - change in excipients from
Nipagin in sodium BP, Sucrose (granulated sugar) BP, Caramel liquid (E150), Rum flavour A662, Cinnamon flavour no. 1 NA, Sodium hydroxide solution 32% w/v (E524), Hydrochloric acid (E507) BP, Deionised water.
to
Methyl parahydroxybenzoate (E218), Sucrose, Caramel powder (E150), Aromatic Elixir (containing ethyl alcohol, rum and aromatic rum flavour), Cinnamon oil, Sodium hydroxide, Purified water.
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Updated on 26/09/2008 and displayed until 29/01/2009
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 14-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 6.1 (list of excipients): distilled water changed to purified water for Mucodyne paediatric solution.
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Updated on 19/09/2008 and displayed until 26/09/2008
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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SPC Submitted in error
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| Date of revision of text on the SPC: 14-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 6.1 (list of excipients): distilled water changed to purified water for Mucodyne paediatric solution.
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Updated on 29/07/2008 and displayed until 19/09/2008
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Feb-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Following wording has been added to section 4.8;
Mucodyne Capsules, Syrup and Paediatric Syrup
Immune System Disorders:
There have been reports of anaphylactic reactions and fixed drug eruption.
Skin and subcutaneous tissue disorders:
There have been reports of skin rashes and allergic skin eruptions.
Mucodyne Capsules and Syrup
Gastrointestinal disorders:
There have been rare reports of gastrointestinal bleeding occurring during treatment with Mucodyne.
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Updated on 28/09/2007 and displayed until 29/07/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 (Marketing Authorisation Holder): change to sanofi-aventis.
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Updated on 15/08/2006 and displayed until 28/09/2007
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Variation to update the excipient specifications from BP to Ph Eur where relevant
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Updated on 03/01/2006 and displayed until 15/08/2006
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 20/09/2005 and displayed until 03/01/2006
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Reasons for adding or updating:
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Addition of joint SPC covering all presentations
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