Praxilene
*Company:
MerckStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 07 October 2021
File name
Praxilene PIl IE - TW 2474218 - 2021.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
update to report the symptom of “confusion” under section 3.
Our ref: 2474218
Updated on 07 October 2021
File name
Praxilene_IESPC_TW2474218_Current_V8.0.pdf
Reasons for updating
- Change to section 4.9 - Overdose
- 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
update to report the symptom of “confusion” under section 4.9.
Our ref: 2474218
Updated on 17 July 2020
File name
Praxilene_IE_TW2350569_Current_V7.0.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
6.5 - Delete 500 pack size presentation.
Updated on 17 July 2020
File name
IE-Praxilene PIL-Mfg Name Change + Del 500pck size - 13.07.2020.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 01 November 2018
File name
Brexit MA transfer PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 01 November 2018
File name
Praxilene_IE_TW1735731_Current_V6.0.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 July 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 July 2015
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
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
Updated on 02 July 2015
File name
PIL_15570_761.pdf
Reasons for updating
- New PIL for new product
Updated on 02 July 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 24 March 2014
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to instructions about missed dose
- Change to information about pregnancy or lactation
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 17 October 2013
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- 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
4.1 Therapeutic indications
In the treatment of:
Cerebral vascular disease - Praxilene has been shown to increase cerebral blood flow but this may not necessarily be accompanied by an improvement in clinical signs and symptoms,
Peripheral vascular disease with such symptoms as intermittent claudication and cold extremities. As with all such drugs, Praxilene capsules are not suitable for the treatment of advanced disease symptoms, such as pain at rest.
The text in blue has been added.
4.4 Special warnings and precautions for use
When Praxilene is used concomitantly with anti-hypertensive drugs, adjustment of dosage of the latter may be necessary.
The product should be used with caution in patients with renal or hepatic insufficiency.
Cases of liver damage have been reported. In the event of symptoms suggesting liver damage, Praxilene must be discontinued.
In view of the oxalate content of each capsule, a sufficient amount of liquid should be taken during treatment to maintain an adequate level of diuresis and avoid the development of calcium oxalate kidney stones.
The administration of Praxilene without liquid before going to bed may cause local oesophagitis. Therefore, it is essential to always take the capsule with a sufficient amount of water.
10.DATE OF THE REVISION OF THE TEXT
10/2013
Updated on 14 March 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
Updated on 10 January 2013
Reasons for updating
- 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 4.8 - Undesirable effects
- 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
4.2 Posology and method of administration
The usual dose is 100-200mg (1-2 capsules) three times a day (t.i.d).
Administration:
For oral administration. The capsules should be swallowed whole during meals with a sufficient amount of water (minimum of one glass).
Paediatric population
This drug is not indicated for use in children
4.3 Contraindications
Praxilene is contraindicated in
- hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Patients with a history of hyperoxaluria or recurrent calcium-containing stones.
4.4 Special warnings and precautions
When Praxilene is used concomitantly with anti-hypertensive drugs, adjustment of dosage of the latter may be necessary.
The product should be used with caution in patients with renal or hepatic insufficiency.
In view of the oxalate content of each capsule, a sufficient amount of liquid should be taken during treatment to maintain an adequate level of diuresis and avoid the development of calcium oxalate kidney stones.
The administration of Praxilene without liquid before going to bed may cause local oesophagitis. Therefore, it is essential to always take the capsule with a sufficient amount of water.
4.6 Fertility, pregnancy and lactation
Pregnancy
In the absence of any relevant clinical data, the use of Praxilene is not advisable during pregnancy.
Lactation
In the absence of specific data concerning the
excretion of the drug in human milk, Praxilene
should not be used by breast-feeding women.
4.8 Undesirable effects
According to information collected during clinical trials and spontaneous reports since marketing authorisation, the following undesirable effects may occur under treatment with Praxilene.
The following definitions apply to the frequency terminology used hereafter:
very common ≥1/10
common ≥1/100, <1/10
uncommon ≥1/1,000, <1/100
rare ≥1/10,000, <1/1,000
very rare <1/10,000
frequency not known: cannot be estimated from the available data
Gastro-intestinal disorders:
Uncommon: Diarrhoea, nausea, vomiting and epigastric pain.
Frequency not known: In some patients who took the medicinal product without liquid before going to bed, the capsule being stuck in the throat led to local oesophagitis.
Renal and urinary disorders:
Very rare: Calcium oxalate kidney stones (see section 4.4).
Skin and subcutaneous tissue disorders:
Uncommon: Skin rash.
Hepatobiliary disorders:
Rare: Liver damage
10. Date of Revision of the Text
Updated on 03 December 2012
Reasons for updating
- New PIL for medicines.ie
Updated on 26 June 2012
Reasons for updating
- 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
6.4 Special precautions for storage
Do not store above 25°C
Store in the original package in order to protect from light and moisture
10. Date of Revision of the Text
19 June 2012
Updated on 22 September 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- 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
2. Qualitative and quantitative composition
Each capsule contains 100 mg naftidrofuryl
hydrogen oxalate
For
a full list of excipients, see 6.1.
3. Pharmaceutical form
Capsule, hard
(capsule)
6.5 Nature and contents of container
High density polyethylene tablet containers or polypropylene tubs with tamper evident polyethylene closures, containing 100 or 500 capsules.
Not all pack sizes may be marketed.
9. Date of First Authorisation/Renewal of Authorisation
Date of first authorisation: 1st April 1980
Date of last renewal: 1st April 2010
10. Date of revision of the text
September 2011
Updated on 20 May 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
7. Marketing Authorisation Holder
Merck Serono Ltd
Bedfont Cross
Feltham
Middlesex
TW14 8NX,
Updated on 14 March 2007
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 02 August 2004
Reasons for updating
- Change to marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)