Summary of Product Characteristics
last updated on the eMC:
11/05/2012
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 11/05/2012 and displayed until Current
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Reasons for adding or updating:
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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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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 04-May-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Product information updated in line with PSUR WS procedure
Section 4.2
Addition of following text after Nasal Polyps table
The patient should be informed that the full effect of Rhinocort is not achieved until after a few days treatment. Treatment of seasonal rhinitis should, if possible, start before exposure to allergens.
Section 4.3
Contraindications amended to:
Hypersensitivity to budesonide or to any of the excipients.
Section 4.4
Paragraph 2
Word ”lung” replaced with ”active or quiescent pulmonary”.
Paragraph 3
Following text removed
The patient should be informed that the full effect of Rhinocort is not achieved until after a few days treatment. Treatment of seasonal rhinitis should, if possible, start before exposure to the allergens
Following text added to paragraph 3.
”of seasonal rhinitis.”
Paragraph 4 – new text added
Reduced liver function affects the elimination of corticosteroids, causing lower elimination rate and higher systemic exposure. Be aware of possible systemic side effects.
Paragraph 5
Update to paragraph detailing systemic effects experienced whilst using nasal corticorsteroids.
Update to paragraph on Paediatric population
Section 4.5
Interaction with other medicinal products and other forms of interaction updated.
Section 4.6
New text added relating to Pregnancy and lactation
Section 4.8
Immune system disorders – not known amended to Very rare
Addition to Undesirable effects of Endocrine disorders - rare
Eye Disorders changed to Unknown. Addition of Cataract to column 3.
New paragraph - Paediatric Population added.
Section 4.9
Overdose information updated
Section 10
Date of revision of the text amended to 4 May 2012
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Updated on 23/04/2012 and displayed until 11/05/2012
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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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: 16-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4
Addition of risk of psychiatric adverse drug reactions to inhaled and intranasal corticosteroids and risk of non-psychiatric systemic adverse drug reactions to intranasal corticosteroids.
Section 10
Date of Revision updated to 16th April 2012
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Updated on 05/05/2009 and displayed until 23/04/2012
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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: 08-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Text in Section 4.8 revised to:
Adverse reactions, which have been associated with budesonide, are given below, listed by system organ class and frequency. Frequency is defined as: very common (³1/10), common (³1/100 and <1/10), uncommon (³1/1000 and <1/100), rare (³1/10 000 and <1/1000), very rare (<1/10 000) and not known (reported spontaneously and cannot be estimated from available post marketing data).
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Immune system disorders
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Uncommon
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Immediate and delayed hypersensitivity reactions including urticaria, rash, dermatitis angioedema and pruritus
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Not Known
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Anaphylactic reaction
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Eye disorders
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Rare
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Raised intraocular pressure or glaucoma
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Respiratory, thoracic and mediastinal disorders
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Common
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Haemorrhagic secretion and epistaxis
Nasal Irritation (sneezing, stinging and dryness)
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Very rare
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Nasal septum perforation
Ulceration of mucus membrane
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Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods (see section 4.4).
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Updated on 27/08/2008 and displayed until 05/05/2009
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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: 20-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 5.3
Text added as correction, text was previously omitted:
In animal reproduction studies, corticosteroids such as budesonide have been shown to induce malformations (cleft plate, skeletal malformations). However these animal experimental results do not appear to be relevant in humans at the recommended doses.
Animal studies have also identified an involvement of excess prenatal glucocorticosteroids in increased risk for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range.
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Updated on 25/06/2008 and displayed until 27/08/2008
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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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Change to section 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 20-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 10
Date changed to 20th May 2008
Section 4.6
There is no information regarding the passage of budesonide into breast milk. Use in lactation requires that the therapeutic benefit to the mother be weighed against any potential risk to the neonate.Budesonide is excreted in breast milk. However, at therapeutic doses of Rhinocort no effects on the breast fed child are anticipated. Rhinocort can be used during breastfeeding.
Section 4.8
Clinical trials, literature reports and post-marketing experience suggest that the following adverse drug reactions may occur:
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Common
(³1/100 to <1/10)
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- Haemorrhagic secretion and epistaxis
- Nasal Irritation (sneezing, stinging and dryness)
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Uncommon
(1/1,000 to <1/100)
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- Immediate and delayed hypersensitivity reactions including urticaria, rash, dermatitis angioedema and pruritus
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Rare
(³1/10,000 to <1/1,000)
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- Raised intraocular pressure or glaucoma
Nasal septum perforation
Ulceration of mucus membrane
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Very Rare
(<1/10,000)
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Ulceration of mucus membrane
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Occasionally sneezing, nasal stinging and dryness may follow immediately after the use of the spray. Slight haemorrhagic secretion/epistaxis may occur.
Hypersensitivity reactions including skin rashes and angioedema may occur in rare cases.
Rhinocort contains potassium sorbate (E202), an irritant which may cause dermatitis.
Ulceration of mucous membrane and nasal septal perforation has been reported following the use of intranasal aerosol corticosteroids, but these are extremely rare.
General - Rare cases of raised intraocular pressure or glaucoma have been reported following the use of intranasal steroid formulations.
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Updated on 18/01/2006 and displayed until 25/06/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 05/05/2004 and displayed until 18/01/2006
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Reasons for adding or updating:
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