Detrunorm XL 30 mg modified-release capsules
- Name:
Detrunorm XL 30 mg modified-release capsules
- Company:
ADVANZ Pharma
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
ADVANZ Pharma
Company Products
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 13 December 2017 PIL
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 13 December 2017
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 13 December 2017 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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 13 December 2016 PIL
Reasons for updating
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 13 December 2016 SPC
Reasons for updating
- 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 13 April 2015 PIL
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Free text change information supplied by the pharmaceutical company
Updated on 13 April 2015 SPC
Reasons for updating
- 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
Updated on 15 June 2012 PIL
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 2, the quantity of excipient lactose was rounded up from 5.667mg to 5.7mg.
In section 4.2 (Posology and method of administration) the word ‘children’ was replaced with ‘paediatric population’. Dose recommendations were added under the heading ‘Patients receiving concomitant treatment with drugs that are potent inhibitors of CYP 3A4 combined with methimazole’.
In section 4.3 (Contraindications) the statement ‘women who are pregnant or breast-feeding an infant’ was removed.
In section 4.4 (Special warnings and precautions for use) the statement ‘moderate or severe hepatic impairment’ was removed. Also in this section the statement ‘Due to a lack of data Detrunorm XL® 30mg capsules should not be used in children.
In section 4.6 (renamed Fertility, pregnancy and lactation) the statement concerning animal studies has been removed. This has been replaced with the statement ‘There are no adequate data from the use of propiverine hydrochloride in pregnant woman. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.’
In section 4.7 (Effects on ability to drive and use machinery) the following statement has been added: No studies on the effects on the ability to drive and use machines have been performed.
In section 5.2 (Pharmacokinetic properties) the statement ‘This was shown in two placebo-controlled studies with Detrunorm® 15mg Coated Tablets t.i.d over 7 days’ has been added to the paragraph entitled “Patients with glaucoma”.
In section 6.5 (Nature and contents of container) the section has been updated to reflect pack sizes manufactured.
In section 10 (Date of revision of the text) the date has been updated to July 2011.
Updated on 15 June 2012 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.2 - Pharmacokinetic properties
- 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)
Free text change information supplied by the pharmaceutical company
In section 2, the quantity of excipient lactose was rounded up from 5.667mg to 5.7mg.
In section 4.2 (Posology and method of administration) the word ‘children’ was replaced with ‘paediatric population’. Dose recommendations were added under the heading ‘Patients receiving concomitant treatment with drugs that are potent inhibitors of CYP 3A4 combined with methimazole’.
In section 4.3 (Contraindications) the statement ‘women who are pregnant or breast-feeding an infant’ was removed.
In section 4.4 (Special warnings and precautions for use) the statement ‘moderate or severe hepatic impairment’ was removed. Also in this section the statement ‘Due to a lack of data Detrunorm XL® 30mg capsules should not be used in children.
In section 4.6 (renamed Fertility, pregnancy and lactation) the statement concerning animal studies has been removed. This has been replaced with the statement ‘There are no adequate data from the use of propiverine hydrochloride in pregnant woman. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.’
In section 4.7 (Effects on ability to drive and use machinery) the following statement has been added: No studies on the effects on the ability to drive and use machines have been performed.
In section 5.2 (Pharmacokinetic properties) the statement ‘This was shown in two placebo-controlled studies with Detrunorm® 15mg Coated Tablets t.i.d over 7 days’ has been added to the paragraph entitled “Patients with glaucoma”.
In section 6.5 (Nature and contents of container) the section has been updated to reflect pack sizes manufactured.
In section 10 (Date of revision of the text) the date has been updated to July 2011.
Updated on 20 August 2008 PIL
Reasons for updating
- New SPC for new product
Updated on 20 August 2008 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)