Updated on 12/05/2016 and displayed until Current
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Change to Section 4.8 – Undesirable effects - how to report a side effect
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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-Mar-2015 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 was updated with HPRA reporting information
Section 10 was updated with the date of revision
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Updated on 01/05/2014 and displayed until 12/05/2016
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Change to Section 4.8 – Undesirable effects - how to report a side effect
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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: 23-Apr-2014 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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| Update to section 4.8 to include the addition of reporting suspected adverse reactions information statement. This is a requirement of the latest QRD template.
Section 10 has consequently been updated due to these changes (now April 2014).
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Updated on 15/08/2013 and displayed until 01/05/2014
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Change to section 7 - Marketing authorisation holder
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Change to section 8 - MA number
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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: 09-Aug-2013 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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7. MARKETING AUTHORISATION HOLDER
Pfizer Healthcare Ireland,
9 Riverwalk, National Digital Park,
Citywest Business Campus, Dublin 24.
8. MARKETING AUTHORISATION NUMBER
PA 822/170/1
10. DATE OF REVISION OF THE TEXT
August 2013
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Updated on 04/03/2013 and displayed until 15/08/2013
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.4 - Special warnings and precautions for use
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| Date of revision of text on the SPC: 19-Feb-2013 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 100 mg guaifenesin
This product also contains ethanol (107mg per 5ml), maltitol (E965) and sorbitol (E420).
4.4. Special Warnings and Precautions for Use
This medicinal product contains 2.7% v/v ethanol (alcohol), up to 214 mg per dose, (equivalent to approx 2 ml wine per dose). Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.
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Updated on 20/11/2012 and displayed until 04/03/2013
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 15-Nov-2012 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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| Only typographical errors revised, no change to medical/pharmaceutical information.
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Updated on 08/09/2012 and displayed until 20/11/2012
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Change to section 6.3 - Shelf life
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| Date of revision of text on the SPC: 31-Aug-2012 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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| 6.3 Shelf Life reduction from 36 months to 27 months.
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Updated on 14/11/2011 and displayed until 08/09/2012
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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: 22-Sep-2011 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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6.5 Nature and Contents of Container
PET bottles containing 100ml with PET lined PP/HDPE screw caps.
A clear polypropylene measuring cap is also included.
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Updated on 11/05/2011 and displayed until 14/11/2011
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Change to section 4.1 - Therapeutic indications
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Change to section 4.4 - Special warnings and precautions for use
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Change to section 4.8 - Undesirable effects
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 30-Apr-2011 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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New Text as follows;
4.1 Therapeutic Indications
Expectorant used as an adjunct in the treatment of productive cough
4.4. Special Warnings and Precautions for Use
Caution should be exercised in patients with chronic cough as occurs with smoking or chronic lung disease such as asthma or emphysema.
A doctor or healthcare professional should be sought if cough lasts more than 5 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
4.8 Undesirable Effects
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Immune system disorders
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Hypersensitivity
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Gastrointestinal disorders
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Nausea, vomiting
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4.9 Overdose
In case of accidentally overdose, discontinue use and seek professional assistance immediately.
The following signs and symptoms may be associated with an overdose of Guaifenesin:
Gastrointestinal disorders
Nausea, vomiting
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Updated on 11/08/2010 and displayed until 11/05/2011
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Change to section 7 - Marketing authorisation holder
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| Date of revision of text on the SPC: 30-Jun-2010 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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7. MARKETING AUTHORISATION HOLDER
Pfizer Consumer Healthcare Ltd,
Ramsgate Road, Sandwich,
Kent, CT13 9NJ,
United Kingdom.
(formally Wyeth Consumer Healthcare)
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Updated on 04/03/2010 and displayed until 11/08/2010
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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| Date of revision of text on the SPC: 24-Nov-2009 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 the posology for children under 12 has been removed.
Section 4.3 the product is no longer recommended for children under 12 years of age.
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Updated on 05/05/2009 and displayed until 04/03/2010
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.4 - Special warnings and precautions for use
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Change to section 6.1 - List of excipients
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Change to section 6.3 - Shelf life
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Change to section 6.5 - Nature and contents of container
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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: 29-Oct-2008 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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Section 2 (Qualitative and Quantitive composition), now states the product contains ethanol (103mg/5ml), maltitol (E965) and sorbitol (E420).
Section 4.4 (Special Warnings and precautions for use) now states; Not more than 4 doses should be given in 24 hours. Do not exceed the stated dose. This product should not be taken with any other cough and cold medicine.
Section 6.1 (List of excipients) E numbers have been stated after Sodium benzoate (E211) and Maltitol (E965) and Sorbitol (E420).
Section 6.5 (Nature and content of container) removed, glass bottle. which had a shelf life of 5 years (Section 6.3). Not marketed in this type of container.
Section 10 (Revision of Date) states October 2008.
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Updated on 26/03/2008 and displayed until 05/05/2009
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Change to section 4.2 - Posology and method of administration
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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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| Date of revision of text on the SPC: 02/2008 |
| Legal Category: retail sale through pharmacy only |
Free-text change information supplied by the pharmaceutical company
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Section 4.2, Posology now states, that Patients should be advised to consult a pharmacist/doctor before using in children under 6 years of age.
Section 4.3, Contraindications now states, not recommended for children under 2 years of age.
Section 4.4, Special Warnings and Precautions states, if symptoms persist for more than 5 days consult a doctor.
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Updated on 16/04/2007 and displayed until 26/03/2008
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Change to section 6.1 - List of excipients
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: general sale |
Free-text change information supplied by the pharmaceutical company
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| Update 6.1 - Natural cherry flavourings - ethanol, propylene glycol and natural flavorings
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Updated on 23/08/2006 and displayed until 16/04/2007
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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: 08/2006 |
| Legal Category: general sale |
Free-text change information supplied by the pharmaceutical company
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| Section 10: Include revision date
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Updated on 30/03/2005 and displayed until 23/08/2006
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Change to section 6.3 - Shelf life
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Change to section 6.5 - Nature and contents of container
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Updated on 18/08/2004 and displayed until 30/03/2005
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Change to section 1 - Name of medicinal product
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Change to section 6.1 - List of excipients
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Updated on 11/06/2003 and displayed until 18/08/2004
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