Midon 5 mg Tablets

  • Name:

    Midon 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

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 19/11/2018

Click on this link to Download PDF directly

Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Actos tablets Active Ingredients pioglitazone hydrochloride
Medicine Name Adcetris 50 mg powder for concentrate for solution for infusion Active Ingredients Brentuximab vedotin
Medicine Name Alofisel 5 million cells/mL suspension for injection Active Ingredients Human Allogeneic Mesenchymal Adult Stem Cells
Medicine Name Alunbrig Active Ingredients Brigatinib
Medicine Name Blopress Plus Tablets Active Ingredients Candesartan Cilexetil, Hydrochlorothiazide
Medicine Name Blopress tablets Active Ingredients Candesartan Cilexetil
Medicine Name Calcichew 500mg Chewable Tablets Active Ingredients Calcium Carbonate
Medicine Name Calcichew-D3 Forte Chewable Tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Calcichew-D3 Forte Double Strength 1000 mg/800 IU chewable tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Competact 15 mg/850 mg film-coated Tablets Active Ingredients Metformin Hydrochloride, pioglitazone hydrochloride
Medicine Name Condyline Cutaneous Solution 5 mg/ml Active Ingredients Podophyllotoxin
Medicine Name Edarbi Tablets Active Ingredients Azilsartan medoxomil potassium
Medicine Name Entyvio 300 mg powder for concentrate for solution for infusion Active Ingredients Vedolizumab
Medicine Name Instanyl 50, 100 and 200 mcg nasal spray, solution in single-dose container Active Ingredients fentanyl citrate
Medicine Name Matrifen Transdermal patch Active Ingredients Fentanyl
Medicine Name Mepact 4mg powder for suspension for infusion Active Ingredients Mifamurtide
Medicine Name Midon 2.5 mg Tablets Active Ingredients Midodrine Hydrochloride
Medicine Name Midon 5 mg Tablets Active Ingredients Midodrine Hydrochloride
Medicine Name NINLARO 2.3 mg, 3 mg, 4 mg hard capsules Active Ingredients Ixazomib Citrate
Medicine Name Prostap 3 DCS Active Ingredients Leuprorelin Acetate
Medicine Name Prostap 6 DCS Active Ingredients Leuprorelin Acetate
Medicine Name Prostap SR DCS Active Ingredients Leuprorelin Acetate
Medicine Name Protium 20mg Active Ingredients Pantoprazole sodium sesquihydrate
Medicine Name Protium 40mg Active Ingredients Pantoprazole sodium sesquihydrate
Medicine Name Protium 40mg iv Active Ingredients Pantoprazole sodium sesquihydrate
1 - 0 of 26 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 19 November 2018 PIL

Reasons for updating

  • New PIL for new product

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 25 March 2015 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

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 25 March 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

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 25 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 13 October 2010 PIL

Reasons for updating

  • SPC submitted in error
  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Updated on 13 October 2010 SmPC

Reasons for updating

  • SPC submitted in error
  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided