Summary of Product Characteristics
last updated on the eMC:
15/08/2008
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 15/08/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 18-Jul-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.5 Interaction with other Medicinal products and other forms of Interaction
The following sentence has been added -
No other medicines, food or drink, in particular antacids, milk, fruit or fruit juices, should be consumed within half an hour before or after a dose of De-Nol as they may influence its effect.
4.8 Undesirable Effects
The original paragraph has been deleted and the following table has been added.
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Immune system disorders
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anaphylactic reaction
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Gastrointestinal disorders
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blackening of the stool
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nausea, vomiting, constipation, diarrhoea
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Skin and subcutaneous tissue disorders
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rash, pruritus
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Updated on 09/07/2007 and displayed until 15/08/2008
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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 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 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: 07/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.3 Contraindications
The following sentence has been added:
Hypersensitivity to the active substance(s) or to any of the excipients.
4.4 Special warnings and special precautions for use
The following has been added:
Prolonged use of high doses of bismuth compounds is not recommended because this has occasionally led to reversible encephalopathy. It is, not advisable to take other bismuth-containing drugs concomitantly.
Contains approximately 2 mmol (approximately 40 mg) potassium per tablet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
4.8 Undesirable effects
This has been added to and now reads
Blackening of the stool usually occurs; nausea, vomiting, constipation, diarrhoea, anaphylaxis, rash and pruritis have been reported.
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Updated on 06/01/2006 and displayed until 09/07/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 22/07/2004 and displayed until 06/01/2006
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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 6.1 - List of Excipients
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Updated on 30/12/2003 and displayed until 22/07/2004
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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 6.1 - List of Excipients
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Change to section 10 (date of (partial) revision of the text
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Updated on 25/07/2002 and displayed until 30/12/2003
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 4.3 - Contra-indications
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Change to section 6. 4 - Special Precautions for Storage
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Addition of Legal Category
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Updated on 07/08/2001 and displayed until 25/07/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 28/01/2000 and displayed until 07/08/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 28/01/2000
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Reasons for adding or updating:
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