Aldomet Tablets 250 mg

  • Name:

    Aldomet Tablets 250 mg

  • Company:
    info
  • Active Ingredients:

    Methyldopa

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/06/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 24/8/2016
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Aspen

Aspen

Company Products

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Medicine Name Aldomet Tablets 250 mg Active Ingredients Methyldopa
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1 - 0 of 63 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 13 June 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 August 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 August 2016 SmPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Text in red = new text
Text strikethrough = deleted text



4.8       Undesirable effects


Skin and subcutaneous tissue disorders

Rash (eczema, lichenoid eruption), toxic epidermal necrolysis, angioedema,  urticaria

Not known


6.1       List of excipients


Tablet Coating

 

 Propylene glycol

Anhydrous citric acid

Hypromellose

Quinoline yellow aluminium lake (E104)

Red iron oxide (E172)

 Talc

Titanium dioxide

Carnabua Carnauba wax

 

6.6       Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product



1.               DATE OF REVISION OF THE TEXT

 

August 2016 July 2015

Updated on 24 August 2016 PIL

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Text in red = new text
Text strikethrough = deleted text



4.8       Undesirable effects


Skin and subcutaneous tissue disorders

Rash (eczema, lichenoid eruption), toxic epidermal necrolysis, angioedema,  urticaria

Not known


6.1       List of excipients


Tablet Coating

 

 Propylene glycol

Anhydrous citric acid

Hypromellose

Quinoline yellow aluminium lake (E104)

Red iron oxide (E172)

 Talc

Titanium dioxide

Carnabua Carnauba wax

 

6.6       Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product



1.               DATE OF REVISION OF THE TEXT

 

August 2016 July 2015

Updated on 11 August 2015 PIL

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 4.5 - 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Text in red = new text
Text strikethrough = deleted text

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

For a full list of excipients, see section 6.1.

4.2 Posology and method of administration

Posology

Use in adults:
iInitial

Withdrawal of ‘Aldomet’ is followed by return of hypertension, usually within 48 hours. This is not complicated generally by an overshoot of blood pressure.

General considerations Patients with renal impairment:

 

 

Withdrawal of ‘Aldomet’ is followed by return of hypertension, usually within 48 hours. This is not complicated generally by an overshoot of blood pressure

 

Other antihypertensives:

 

Use in children Paediatric population:

 

Use in elderly people Older people

 

Method of administration

 

Oral.

 

 

4.3       Contraindications

 

‘Aldomet’ is contra-indicated in patients:

 

·       with hypersensitivity to the active substance (including hepatic disorders associated with previous methyldopa therapy), or to any  component of these products of the excipients listed in section 6.1

·       with a catecholamine-secreting tumour such as phaeochromocytoma or paraganglioma

·       with porphyria

 

Aldomet’ is not recommended for the treatment of phaeochromocytoma (see section 4.4 ‘Special warnings and precautions for use’

 

4.4 Special warnings and precautions for use

 

Aldomet should be discontinued

 

Reversible leukopenia, with primary effect on granulocytes has been reported rarely.

 

Occasionally, fever has occurred within the first three weeks of therapy, sometimes associated with eosinophilia or abnormalities in liver-function tests.  Jaundice, with or without fever, also may may also occur. 

 

 

Rarely, involuntary choreoathetotic movements have been observed during therapy with methyldopa in patients with severe bilateral  cerbrovascular cerebrovascular disease. 

 

As methyldopa fluoresces at the same wavelengths as catecholamines, spuriously high amounts of urinary catecholamines may be reported interfering with a diagnosis of catecholamine-secreting tumours such as phaeochromocytoma or paraganglioma.

 

 

Methyldopa does not interfere with measurements of VMA (vanillylmandelic acid) by those methods which convert VMA to vanillin. Methyldopa is not recommended contraindicated for the treatment of patients with catecholamine-secreting tumours such as phaeochromocytoma or paraganglioma.

 

Iron

 

4.6 Fertility, pregnancy and lactation

 

Use in Pregnancy Pregnancy

 

There was no clinical evidence that ‘Aldomet’ caused foetal abnormalities or affected the neonate.

 

Methyldopa does not crosses the placental barrier and appears in cord blood.

 

Breast feeding mothers

 

4.8 Undesirable effects

 

The following convention has been utilised for the classification of frequency: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥

1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).

The following reactions have been reported:

 

 

 

System Organ Class

Adverse event term

Frequency

Infections and infestations

Sialoadenitis

Not known

Blood and lymphatic system disorders

Haemolytic anaemia, bone-marrow failure, leukopenia, granulocytopenia, thrombocytopenia, eosinophilia

Not known

Endocrine disorders

Hyperprolactinaemia

Not known

Psychiatric disorders

Psychic disturbances including nightmares, reversible mild psychoses or depression, decreased libido

Not known

Nervous system disorders

Sedation (usually transient), headache, paraesthesia, Parkinsonism, VIIth nerve paralysis, choreoathetosis, mental impairment, carotid sinus syndrome, dizziness, symptoms of cerebrovascular insufficiency (may be due to lowering of blood pressure)

Not known

Cardiac disorders

Bradycardia, angina pectoris, myocarditis, pericarditis, atrioventricular block

Not known

Vascular disorders

Orthostatic hypotension (decrease daily dosage)

Not known

Respiratory, thoracic and mediastinal disorders

Nasal congestion       

Not known

Gastrointestinal disorders

Nausea, vomiting, abdominal distension, constipation, flatulence, diarrhoea, colitis, dry mouth, glossodynia, tongue discolouration, pancreatitis

Not known

Hepatobiliary disorders

Liver disorders including hepatitis, jaundice

Not known

Skin and subcutaneous tissue disorders

Rash (eczema, lichenoid eruption), toxic epidermal necrolysis

Not known

Musculoskeletal and connective tissue disorders

Lupus-like syndrome, mild arthralgia with or without joint swelling, myalgia

Not known

Reproductive system and breast disorders

Breast enlargement, gynaecomastia, amenorrhoea, lactation disorder, erectile dysfunction, ejaculation failure

Not known

General disorder and administration site conditions

Asthenia, oedema (and weigh gain) usually relieved by use of a diuretic. (Discontinue methyldopa if oedema progresses or signs of heart failure appear). Pyrexia

Not known

Investigations

Positive Coombs test, positive tests for antinuclear antibody, LE cells, and rheumatoid factor, abnormal liver-function tests, increased blood urea      

Not known

 

Cardiovascular disorders:  Bradycardia, aggravation of angina pectoris, myocarditis, pericarditis, orthostatic hypotension (decrease daily dosage).

 

Blood and lymphatic system disorders:   Haemolytic anaemia, bone-marrow depression, leucopenia, granulocytopenia, thrombocytopenia, eosinophilia.

 

Nervous system disorders:  Sedation (usually transient), headache, paraesthesia, Parkinsonism, Bells palsy, involuntary choreoathetotic movements, impaired mental    acuity,    prolonged    carotid    sinus    hypersensitivity.        Dizziness, light-headedness, and symptoms of cerebrovascular insufficiency (may be due to lowering of blood pressure).

 

Respiratory, thoracic and mediastinal disorders: Nasal stuffiness

Gastrointestinal disorders:  Nausea, vomiting, distension, constipation, flatus, diarrhoea, colitis, mild dryness of mouth, sore or black’ tongue, pancreatitis.

 

Skin and subcutaneous tissue disorders Rash as in eczema or lichenoid eruption, toxic epidermal necrolysis.

 

Musculoskeletal and connective tissue disorders:  Lupus-like syndrome, mild arthralgia with or without joint swelling, myalgia.

 

Endocrine disorders: Hyperprolactinaemia.

 

Infections and infestations: Sialadenitis.

General disorders and administrative site conditions:     Asthenia or weakness, oedema (and weight gain) usually relieved by use of a diuretic.  (Discontinue methyldopa if oedema progresses or signs of heart failure appear.), drug-related fever.

 

Hepatobiliary disorders: Liver disorders including hepatitis, jaundice.

 

Reproductive system and breast disorders:  Breast enlargement, gynaecomastia, amenorrhoea, lactation, impotence, failure of ejaculation.

 

Psychiatric disorders:  Psychic disturbances including nightmares, reversible mild psychoses or depression, decreased libido.

 

Investigations:  Positive Coombs test, positive tests for antinuclear antibody, LE cells, and rheumatoid factor, abnormal liver-function tests, rise in blood urea.

 

United Kingdom: Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

 

5.1       Pharmacodynamic properties

 

Pharmacotherapeutic group: antiadrenergic agents; ATC code C02AB

 

Mechanism of action

 

Pharmacodynamic effects

 

5.2       Pharmacokinetic properties

 

Absorption

 

Distribution

 

 

Biotransformation

 

Elimination

 

10. DATE OF REVISION OF THE TEXT

 

July 2015 January 2015

 

Updated on 11 August 2015 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 4.5 - 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Text in red = new text
Text strikethrough = deleted text

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

For a full list of excipients, see section 6.1.

4.2 Posology and method of administration

Posology

Use in adults:
iInitial

Withdrawal of ‘Aldomet’ is followed by return of hypertension, usually within 48 hours. This is not complicated generally by an overshoot of blood pressure.

General considerations Patients with renal impairment:

 

 

Withdrawal of ‘Aldomet’ is followed by return of hypertension, usually within 48 hours. This is not complicated generally by an overshoot of blood pressure

 

Other antihypertensives:

 

Use in children Paediatric population:

 

Use in elderly people Older people

 

Method of administration

 

Oral.

 

 

4.3       Contraindications

 

‘Aldomet’ is contra-indicated in patients:

 

·       with hypersensitivity to the active substance (including hepatic disorders associated with previous methyldopa therapy), or to any  component of these products of the excipients listed in section 6.1

·       with a catecholamine-secreting tumour such as phaeochromocytoma or paraganglioma

·       with porphyria

 

Aldomet’ is not recommended for the treatment of phaeochromocytoma (see section 4.4 ‘Special warnings and precautions for use’

 

4.4 Special warnings and precautions for use

 

Aldomet should be discontinued

 

Reversible leukopenia, with primary effect on granulocytes has been reported rarely.

 

Occasionally, fever has occurred within the first three weeks of therapy, sometimes associated with eosinophilia or abnormalities in liver-function tests.  Jaundice, with or without fever, also may may also occur. 

 

 

Rarely, involuntary choreoathetotic movements have been observed during therapy with methyldopa in patients with severe bilateral  cerbrovascular cerebrovascular disease. 

 

As methyldopa fluoresces at the same wavelengths as catecholamines, spuriously high amounts of urinary catecholamines may be reported interfering with a diagnosis of catecholamine-secreting tumours such as phaeochromocytoma or paraganglioma.

 

 

Methyldopa does not interfere with measurements of VMA (vanillylmandelic acid) by those methods which convert VMA to vanillin. Methyldopa is not recommended contraindicated for the treatment of patients with catecholamine-secreting tumours such as phaeochromocytoma or paraganglioma.

 

Iron

 

4.6 Fertility, pregnancy and lactation

 

Use in Pregnancy Pregnancy

 

There was no clinical evidence that ‘Aldomet’ caused foetal abnormalities or affected the neonate.

 

Methyldopa does not crosses the placental barrier and appears in cord blood.

 

Breast feeding mothers

 

4.8 Undesirable effects

 

The following convention has been utilised for the classification of frequency: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥

1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).

The following reactions have been reported:

 

 

 

System Organ Class

Adverse event term

Frequency

Infections and infestations

Sialoadenitis

Not known

Blood and lymphatic system disorders

Haemolytic anaemia, bone-marrow failure, leukopenia, granulocytopenia, thrombocytopenia, eosinophilia

Not known

Endocrine disorders

Hyperprolactinaemia

Not known

Psychiatric disorders

Psychic disturbances including nightmares, reversible mild psychoses or depression, decreased libido

Not known

Nervous system disorders

Sedation (usually transient), headache, paraesthesia, Parkinsonism, VIIth nerve paralysis, choreoathetosis, mental impairment, carotid sinus syndrome, dizziness, symptoms of cerebrovascular insufficiency (may be due to lowering of blood pressure)

Not known

Cardiac disorders

Bradycardia, angina pectoris, myocarditis, pericarditis, atrioventricular block

Not known

Vascular disorders

Orthostatic hypotension (decrease daily dosage)

Not known

Respiratory, thoracic and mediastinal disorders

Nasal congestion       

Not known

Gastrointestinal disorders

Nausea, vomiting, abdominal distension, constipation, flatulence, diarrhoea, colitis, dry mouth, glossodynia, tongue discolouration, pancreatitis

Not known

Hepatobiliary disorders

Liver disorders including hepatitis, jaundice

Not known

Skin and subcutaneous tissue disorders

Rash (eczema, lichenoid eruption), toxic epidermal necrolysis

Not known

Musculoskeletal and connective tissue disorders

Lupus-like syndrome, mild arthralgia with or without joint swelling, myalgia

Not known

Reproductive system and breast disorders

Breast enlargement, gynaecomastia, amenorrhoea, lactation disorder, erectile dysfunction, ejaculation failure

Not known

General disorder and administration site conditions

Asthenia, oedema (and weigh gain) usually relieved by use of a diuretic. (Discontinue methyldopa if oedema progresses or signs of heart failure appear). Pyrexia

Not known

Investigations

Positive Coombs test, positive tests for antinuclear antibody, LE cells, and rheumatoid factor, abnormal liver-function tests, increased blood urea      

Not known

 

Cardiovascular disorders:  Bradycardia, aggravation of angina pectoris, myocarditis, pericarditis, orthostatic hypotension (decrease daily dosage).

 

Blood and lymphatic system disorders:   Haemolytic anaemia, bone-marrow depression, leucopenia, granulocytopenia, thrombocytopenia, eosinophilia.

 

Nervous system disorders:  Sedation (usually transient), headache, paraesthesia, Parkinsonism, Bells palsy, involuntary choreoathetotic movements, impaired mental    acuity,    prolonged    carotid    sinus    hypersensitivity.        Dizziness, light-headedness, and symptoms of cerebrovascular insufficiency (may be due to lowering of blood pressure).

 

Respiratory, thoracic and mediastinal disorders: Nasal stuffiness

Gastrointestinal disorders:  Nausea, vomiting, distension, constipation, flatus, diarrhoea, colitis, mild dryness of mouth, sore or black’ tongue, pancreatitis.

 

Skin and subcutaneous tissue disorders Rash as in eczema or lichenoid eruption, toxic epidermal necrolysis.

 

Musculoskeletal and connective tissue disorders:  Lupus-like syndrome, mild arthralgia with or without joint swelling, myalgia.

 

Endocrine disorders: Hyperprolactinaemia.

 

Infections and infestations: Sialadenitis.

General disorders and administrative site conditions:     Asthenia or weakness, oedema (and weight gain) usually relieved by use of a diuretic.  (Discontinue methyldopa if oedema progresses or signs of heart failure appear.), drug-related fever.

 

Hepatobiliary disorders: Liver disorders including hepatitis, jaundice.

 

Reproductive system and breast disorders:  Breast enlargement, gynaecomastia, amenorrhoea, lactation, impotence, failure of ejaculation.

 

Psychiatric disorders:  Psychic disturbances including nightmares, reversible mild psychoses or depression, decreased libido.

 

Investigations:  Positive Coombs test, positive tests for antinuclear antibody, LE cells, and rheumatoid factor, abnormal liver-function tests, rise in blood urea.

 

United Kingdom: Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

 

5.1       Pharmacodynamic properties

 

Pharmacotherapeutic group: antiadrenergic agents; ATC code C02AB

 

Mechanism of action

 

Pharmacodynamic effects

 

5.2       Pharmacokinetic properties

 

Absorption

 

Distribution

 

 

Biotransformation

 

Elimination

 

10. DATE OF REVISION OF THE TEXT

 

July 2015 January 2015

 

Updated on 16 March 2015 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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

 

Please find attached the approved SmPC (Tracked text unavailable).  

 

The sections updated were; 4.3, 4.8, 4.9, 6.5.

Updated on 16 March 2015 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

 

Please find attached the approved SmPC (Tracked text unavailable).  

 

The sections updated were; 4.3, 4.8, 4.9, 6.5.

Updated on 21 January 2014 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Text in red = new text
Text strikethrough = deleted text


7 MARKETING AUTHORISATION HOLDER

 

Aspen Pharma Trading Limited

12/13 Exchange Place

Custom House Docks,

I.F.S.C.

Dublin 1

3016 Lake Drive

Citywest Business Campus

Dublin 24

Ireland



10 DATE OF REVISION OF THE TEXT

 

September 2013December 2013

Updated on 21 January 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

Text in red = new text
Text strikethrough = deleted text


7 MARKETING AUTHORISATION HOLDER

 

Aspen Pharma Trading Limited

12/13 Exchange Place

Custom House Docks,

I.F.S.C.

Dublin 1

3016 Lake Drive

Citywest Business Campus

Dublin 24

Ireland



10 DATE OF REVISION OF THE TEXT

 

September 2013December 2013

Updated on 7 June 2011 PIL

Reasons for updating

  • New SPC for medicines.ie
  • SPC retired pending re-submission

Free text change information supplied by the pharmaceutical company

None provided

Updated on 7 June 2011 SmPC

Reasons for updating

  • New SPC for medicines.ie
  • SPC retired pending re-submission

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

Free text change information supplied by the pharmaceutical company

None provided