Midon 2.5 mg Tablets

  • Name:

    Midon 2.5 mg Tablets

  • Company:
    info
  • Active Ingredients:

    Midodrine Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/11/18

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Summary of Product Characteristics last updated on medicines.ie: 19/11/2018

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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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 19 November 2018

Updated on 19 November 2018 SmPC

Reasons for updating

  • Change to MA holder contact details

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

Updated on 24 March 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 March 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 March 2015 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Free text change information supplied by the pharmaceutical company

Change to section

Details of change

4.1. Therapeutic Indications

Changed:

‘‘For use in the treatment of idiopathic orthostatic hypotension (Shy-Drager and Bradbury-Eggleston Syndromes).’’

 

to

 

‘’ For use in the treatment of severe orthostatic hypotension due to dysfunction of the autonomic nervous system when corrective factors have been ruled out.’’

 

4.2. Posology and Method of Administration

Changed:

‘’Adults and adolescents:’’

 

to

 

‘’Adults:’’

 

 

‘’Children:’’

 

to

 

‘’Paediatric population:’’

 

 

Added:

Patients with renal impairment:

No specific studies have been performed addressing a possible dose-reduction in patients with renal impairment. Midodrine is contraindicated in patients with acute renal disease and severe renal impairment (see 4.3).

 

Patients with hepatic impairment:

No specific studies have been performed in this patient population.

 

4.3. Contraindications

Added:

•Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

 

•Hypertrophy of the prostate gland with residual urine volume increased

 

•Proliferative diabetic retinopathy

 

•Obliterative or spastic vessel disease (e.g. cerebrovascular occlusions and spasms)

 

Deleted:

•Any urinary outflow obstructive disorder or known hypersensitivity to any component of the product.  It is also contraindicated in patients with

 

4.5.  Interaction with other medicinal products and other forms of interaction

 

Formatting/ Change:

Interaction with other medicinal products and other forms of interaction

 

to

 

Interactions with Other medicaments and Other Forms of Interaction

 

Added:

Midodrine is an inhibitor of Cytochrome P450 CYP2D6 and may therefore affect the metabolism of other drugs metabolised by this isoenzyme (e.g. perphenazine, amiodaorone, metoclopramide). This may lead to increased systemic exposure and increased effects of these drugs.

 

Deleted/ Added:

The concomitant use of midodrine with vasoconstrictor, sympathomimetic pressor agents e.g. decongestants, some appetite suppressants and other drugs which cause hypertension such as reserpine, guanethidine, methyldopa, tricyclic antidepressants, antihistamines, thyroid hormones, MAO-inhibitors including over-the-counter remedies should be avoided as this may cause excessive hypertension.

 

Deleted:

Atropine

Midodrine may enhance or potentiate the blood-pressure raising effect of atropine.

 

4.6. Pregnancy and Lactation

Changed:

Pregnancy

There is no evidence of safety of midodrine hydrochloride in human pregnancy nor is there evidence from animal work that it is free from hazard. Avoid in pregnancy unless the possible clinical benefits clearly outweigh the potential hazards.

 

to

 

Pregnancy

There are no data from the use of midodrine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Midon is not recommended during pregnancy and in women of childbearing potential not using contraception. Any woman becoming pregnant during treatment should be withdrawn from the treatment immediately upon established pregnancy.

 

 

4.8. Undesirable Effects

Added:

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); Not known (cannot be estimated from the available data).

Deleted:

Side effects include:

Added:

Psychiatric disorders

Uncommon:  Sleep disorders, insomnia.

Not known: Anxiety, confusional state

Eye disorders

Rare: Visual disturbance

Not known: Increased tear production.

Gastrointestinal disorders

Common: Nausea, dyspepsia, vomiting, stomatitis.

Uncommon: Abdominal pain.

Not known: Diarrhoea

Skin and subcutaneous tissue disorders

Very common: Piloerection.

Common:  Chills, skin rash, pruritus (mainly of the scalp), flushing.

Deleted:

[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)]

Other reported symptoms include increased tear production.

Added:

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.

4.9. Overdose

Added:

Overdosage of midodrine produces piloerection, sensation of coldness, an urgent desire to empty the bladder, hypertension and bradycardia. 

These effects can be counteracted by induced emesis and administration of alpha -sympatholytic drugs. 

10. DATE OF REVISION OF THE TEXT

 

Changed to:

11th March 2015

Updated on 24 March 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 13 October 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 13 October 2014 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

SECTION 7. MARKETING AUTHORISATION HOLDER

 

Takeda UK Limited

Building 3

Glory Park

Glory Park Avenue

Wooburn Green

BUCKS

HP10 0DF

 

SECTION 10. DATE OF REVISION OF THE TEXT

 

26th September 2014

Updated on 15 April 2013 PIL

Reasons for updating

  • Change of manufacturer
  • Change of licence holder

Updated on 12 April 2013 SmPC

Reasons for updating

  • Change to MA holder contact details

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

 

Takeda UK Limited

Takeda House

Mercury Park

Wycombe Lane

Wooburn Green

High Wycombe

Buckinghamshire

HP10 0HH

United Kingdom

Updated on 7 January 2011 PIL

Reasons for updating

  • Change of licence holder

Updated on 15 October 2010 SmPC

Reasons for updating

  • Change to marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Midon 2.5 mg Tablets were transferred from Monmouth Pharmaceuticals Ltd to Nycomed UK Ltd on the 1st October 2010.

Updated on 27 May 2010 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Update from renewal process - date of change of text and minor typo corrections

Updated on 16 August 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • PIL retired pending re-submission

Updated on 31 May 2006 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

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

Updated on 8 August 2005 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients

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

Updated on 23 February 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 May 2004 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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)

Updated on 27 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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