Praxilene

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/11/18

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Summary of Product Characteristics last updated on medicines.ie: 1/11/2018

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Merck

Merck

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Medicine Name Praxilene Active Ingredients Naftidrofuryl Hydrogen Oxalate
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1 - 0 of 32 items.Total: Infinity pages

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 1 November 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 1 November 2018 SmPC

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 3 July 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 3 July 2015 SmPC

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

4.8 Undesirable effects

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 2 July 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 July 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 24 March 2014 PIL

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 SmPC

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

The text in red has been deleted.

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects

Updated on 10 January 2013 SmPC

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

 

17 December 2012

Updated on 3 December 2012 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 June 2012 SmPC

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 SmPC

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

See below for updated sections:

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 SmPC

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

Change of Name and Address of MA Holder
 

7.         Marketing Authorisation Holder

 

Merck Serono Ltd

Bedfont Cross

Stanwell Road

Feltham

Middlesex

TW14 8NX, UK

Updated on 14 March 2007 SmPC

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

Change in date of renewal.
 
Editorial changes only to sections 6.2, 6.6 and 7 (no changes in content or meaning).

Updated on 2 August 2004 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)