Aldomet Tablets 250 mg * Pharmacy Only: Prescription
Company:
AspenStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 08 August 2022
File name
62f11139b5b2b.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 August 2022
File name
62ed266e18a6f.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
- Change to product name
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 August 2022
File name
62ed25ce69fb2.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to name of medicinal product
- Improved presentation of PIL
Updated on 13 June 2019
File name
Meth_Tab_IE_P_Combined_v4_1560425705.pdf
Reasons for updating
- New PIL for new product
Updated on 24 August 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 August 2016
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
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
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, Bell’s 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
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, Bell’s 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
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
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
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 21 January 2014
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 07 June 2011
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
Updated on 07 June 2011
Reasons for updating
- New SPC for medicines.ie
- SPC retired pending re-submission