When a pharmaceutical company changes an SPC or PIL, 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.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 400 micrograms of tamsulosin hydrochloride. For a full list of excipients, see section 6.1. 4.2 Posology and method of administration One capsule a day after breakfast or the first meal of the day. The capsule is swallowed whole with a glass of water while standing or sitting (not lying down). The capsule should not be broken or pulled apart as this may have an effect on the release of the long-acting active ingredient. No dose adjustment is warranted in renal impairment. No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also 4.3 Contraindications). There is no relevant indication for use of Tamsulosin 0.4 mg capsules in children. 4.5 Interaction with other medicinal products and other forms of interaction No interactions have been observed when tamsulosin has been given concomitantly with atenolol, enalapril, or theophylline. Concomitant cimetidine raises, and concomitant furosemide lowers, plasma concentrations of tamsulosin but, as the concentration of tamsulosin remains within the normal range, posology need not be altered. In vitro, neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin change the free fraction of tamsulosin in human plasma. Neither does tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone. Tamsulosin has not been found to interact with amitriptyline, salbutamol, glibenclamide or finasteride during in vitro studies with liver microsomal fractions (representing the cytochrome P450-linked metabolising enzyme system). Diclofenac and Warfarin may increase the elimination rate of tamsulosin. Concurrent administration with another α1-adrenoreceptor antagonist may lower blood pressure. 4.9 Overdose No cases of acute overdosage have been reported.However, acute hypotension could theoretically occur after overdosage in which case cardiovascular support should be given. Acute overdose with 5 mg tamsulosin hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed, which were treated with fluid replacement and the patient could be discharged the same day. In case of acute hypotension occurring after overdosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders and, when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption If large quantities of the medicinal product are involved, gastric lavage may be performed and activated charcoal and an osmotic laxative, such as sodium sulphate, may be given. 5.1 Pharmacodynamic properties Pharmacotherapeutic group: α1A adrenoreceptor antagonist, ATC code: G04CA02
4.2 Posology and method of administration
One capsule a day after breakfast or the first meal of the day. The capsule is swallowed whole with a glass of water while standing or sitting (not lying down). The capsule should not be broken or pulled apart as this may have an effect on the release of the long-acting active ingredient.
No dose adjustment is warranted in renal impairment. No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also 4.3 Contraindications).
There is no relevant indication for use of Tamsulosin 0.4 mg capsules in children. 4.5 Interaction with other medicinal products and other forms of interaction No interactions have been observed when tamsulosin has been given concomitantly with atenolol, enalapril, or theophylline. Concomitant cimetidine raises, and concomitant furosemide lowers, plasma concentrations of tamsulosin but, as the concentration of tamsulosin remains within the normal range, posology need not be altered. In vitro, neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin change the free fraction of tamsulosin in human plasma. Neither does tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone. Tamsulosin has not been found to interact with amitriptyline, salbutamol, glibenclamide or finasteride during in vitro studies with liver microsomal fractions (representing the cytochrome P450-linked metabolising enzyme system). Diclofenac and Warfarin may increase the elimination rate of tamsulosin. Concurrent administration with another α1-adrenoreceptor antagonist may lower blood pressure. 4.9 Overdose No cases of acute overdosage have been reported.However, acute hypotension could theoretically occur after overdosage in which case cardiovascular support should be given. Acute overdose with 5 mg tamsulosin hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed, which were treated with fluid replacement and the patient could be discharged the same day. In case of acute hypotension occurring after overdosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders and, when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption If large quantities of the medicinal product are involved, gastric lavage may be performed and activated charcoal and an osmotic laxative, such as sodium sulphate, may be given. 5.1 Pharmacodynamic properties Pharmacotherapeutic group: α1A adrenoreceptor antagonist, ATC code: G04CA02
4.5 Interaction with other medicinal products and other forms of interaction
No interactions have been observed when tamsulosin has been given concomitantly with atenolol, enalapril, or theophylline. Concomitant cimetidine raises, and concomitant furosemide lowers, plasma concentrations of tamsulosin but, as the concentration of tamsulosin remains within the normal range, posology need not be altered.
In vitro, neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin change the free fraction of tamsulosin in human plasma. Neither does tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone.
Tamsulosin has not been found to interact with amitriptyline, salbutamol, glibenclamide or finasteride during in vitro studies with liver microsomal fractions (representing the cytochrome P450-linked metabolising enzyme system). Diclofenac and Warfarin may increase the elimination rate of tamsulosin.
Concurrent administration with another α1-adrenoreceptor antagonist may lower blood pressure. 4.9 Overdose No cases of acute overdosage have been reported.However, acute hypotension could theoretically occur after overdosage in which case cardiovascular support should be given. Acute overdose with 5 mg tamsulosin hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed, which were treated with fluid replacement and the patient could be discharged the same day. In case of acute hypotension occurring after overdosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders and, when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption If large quantities of the medicinal product are involved, gastric lavage may be performed and activated charcoal and an osmotic laxative, such as sodium sulphate, may be given. 5.1 Pharmacodynamic properties Pharmacotherapeutic group: α1A adrenoreceptor antagonist, ATC code: G04CA02
4.9 Overdose
No cases of acute overdosage have been reported.However, acute hypotension could theoretically occur after overdosage in which case cardiovascular support should be given. Acute overdose with 5 mg tamsulosin hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed, which were treated with fluid replacement and the patient could be discharged the same day. In case of acute hypotension occurring after overdosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders and, when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as tamsulosin is very highly bound to plasma proteins.
Measures, such as emesis, can be taken to impede absorption
If large quantities of the medicinal product are involved, gastric lavage may be performed and activated charcoal and an osmotic laxative, such as sodium sulphate, may be given. 5.1 Pharmacodynamic properties Pharmacotherapeutic group: α1A adrenoreceptor antagonist, ATC code: G04CA02
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: α1A adrenoreceptor antagonist, ATC code: G04CA02
No interactions have been observed when tamsulosin has been given concomitantly with atenolol, enalapril, nifedipine or theophylline. Concomitant cimetidine raises, and concomitant furosemide lowers, plasma concentrations of tamsulosin but, as the concentration of tamsulosin remains within the normal range, posology need not be altered.
4.8 Undesirable effects
Common
(>1/100, <1/10)
Uncommon
(>1/1 000, <1/100)
Rare
(>1/10 000, <1/1 000)
Very rare
(<1/10 000)
Nervous system disorders
Dizziness
Headache
Syncope
Cardiac disorders
Tachycardia
Vascular disorders
Orthostatic hypotension
Respiratory, thoracic and mediastinum-related disorders
Rhinitis
Gastrointestinal disorders
Constipation, diarrhoea, nausea, vomiting
Skin and subcutaneous tissue disorders
Rash, itching, urticaria
Angio-oedema
Stevens-Johnson syndrome
Reproductive systems and breast disorders
Ejaculation disorders
Abnormal ejaculation
Priapism
General disorders and administration site conditions
Asthenia
During cataract surgery a small pupil situation, known as Intraoperative Floppy Iris Syndrome (IFIS), has been associated with therapy of tamsulosin during post-marketing surveillance (See also section 4.4).
Post-marketing experience: In addition to the adverse events listed above, atrial fibrillation, arrhythmia, tachycardia and dyspnoea have been reported in
Section 6.1: the capsule ink was updated to ' Shellac, Black iron oxide (E 172) and Propylene glycol'.
Section 6.3: the shelf-life was increased from 30 months to 36 months.