Midon 5 mg Tablets
- Name:
Midon 5 mg Tablets
- Company:
Takeda Products Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/05/20

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Takeda Products Ireland Ltd

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 7 May 2020 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
In Section 6 (Marketing Authorisation Holder), the address has been updated to:
6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland.
This is the legally registered office.
Also, the local representative/’trading as’ address has been added:
5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
The date of revision is: February 2020
Updated on 7 May 2020 SPC
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
In Section 7 (Marketing Authorisation Holder), the address has been updated to:
6th Floor
South Bank House
Barrow Street
Dublin 4
Ireland
This is the legally registered office.
The date of revision is: 15th April 2020
Updated on 19 November 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 19 November 2018 SPC
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.
The concomitant use of midodrine with vasoconstrictor, sympathomimetic pressor agents e.g. decongestants, some appetite suppressants and other drugs which cause hypertension such as
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 SPC
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.
The concomitant use of midodrine with vasoconstrictor, sympathomimetic pressor agents e.g. decongestants, some appetite suppressants and other drugs which cause hypertension such as
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 SPC
Reasons for updating
- New SPC 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
Updated on 13 October 2010 SPC
Reasons for updating
- SPC submitted in error
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)