HYTRIN Tablets 2mg
*Company:
ADVANZ PharmaStatus:
No Recent UpdateLegal 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 07 April 2023
File name
Hytrin 2 mg Tablets_PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 07 April 2023
File name
Hytrin 2 mg Tablets_SPC.pdf
Reasons for updating
- 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 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 December 2021
File name
Hytrin 2mg tablets_SPC_IE.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 December 2021
File name
Hytrin tablets_PIL_IE.pdf
Reasons for updating
- New PIL for new product
Updated on 15 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 January 2018
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.7 - Effects on ability to drive and use machines
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Updated on 15 January 2018
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.7 - Effects on ability to drive and use machines
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 14 February 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Section 4.6 Pregnancy and lactation
Section 4.8 Undesirable effects anf how to report Adverse event
Section 6.5 Nature and contents of container
Section 6.6 Special precautions for disposal and other handling
Section 10. DATE OF REVISION OF THE TEXT
Updated on 14 February 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 4.6 Pregnancy and lactation
Section 4.8 Undesirable effects anf how to report Adverse event
Section 6.5 Nature and contents of container
Section 6.6 Special precautions for disposal and other handling
Section 10. DATE OF REVISION OF THE TEXT
Updated on 28 July 2010
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Changes in bold below: Section 4.8 following PSUR submission and Section 10 to show current date.
4.8. Undesirable Effects
Post marketing experience:
Thrombocytopenia, priapism and angioedema have been reported. Atrial fibrillation has been reported: however, a cause and effect relationship has not been established.
10. Date of Revision of the Text
June 2010
Updated on 28 July 2010
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Changes in bold below: Section 4.8 following PSUR submission and Section 10 to show current date.
4.8. Undesirable Effects
Post marketing experience:
Thrombocytopenia, priapism and angioedema have been reported. Atrial fibrillation has been reported: however, a cause and effect relationship has not been established.
10. Date of Revision of the Text
June 2010
Updated on 18 May 2010
Reasons for updating
- 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 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
Implementation of warnings concerning additional hypotensive effects following co-administration of non-selective alpha-blockers and phosphodiesterase-5-inhibitors. Changes were made to sections 4.4, 4.5, and 10 below in bold.
4.4. Special warnings and precautions for use
Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in recommended dosage. There is no evidence that terazosin aggravates renal dysfunction.
There is as yet insufficient experience of use of terazosin in children under the age of 12 years.
An excessive hypotensive effect may occur in some patients following soon after the initial doses. This is usually self limiting and in most cases does not recur after the initial period of therapy or during subsequent dose titration. Please also see Section 4.7 Effects on Ability to Drive and Use Machines.
The usual half life of terazosin is 10-12 hours. This may be significantly prolonged in patients with congestive cardiac failure (by up to 7-8 hours), usually with reduction on clinical improvement.
In certain patients with left ventricular failure, the decrease in left ventricular filling consequent to vigorous therapy may result in a significant fall in cardiac output and systemic blood pressure after administration of terazosin. These effects should be kept in mind when introducing therapy and continuous titration of dose used.
Since the drug is metabolised in the liver it should only be used with care in patients with existing hepatic dysfunction.
As with other alpha-1-adrenoreceptor antagonists, terazosin is not recommended in patients with history of micturition syncope.
Laboratory Tests: Small but statistically significant decreases in haematocrit, haemoglobin, white blood cells, total protein and albumin were observed in controlled clinical trials. These laboratory findings suggest the possibility of haemodilution. Treatment with terazosin for up to 24 months had no significant effect on Prostate Specific Antigen (PSA) levels.
In clinical trials, the incidence of postural hypotension was greater in BPH patients than those with hypertension.
If administration is discontinued for more than several days, therapy should be re-instituted using the initial dosing regimen.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. An IFIS may lead to increased procedural complications during the cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.
Concomitant use of phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) and terazosin may lead to symptomatic hypotension in some patients. In order to minimise the risk for developing postural hypotension the patient should be stable on the alpha-blocker therapy before initiating use of phosphodiesterase-5-inhibitors.
4.5. Interactions with other medicinal products and other forms of interaction
Terazosin is highly protein bound. There is a theoretical potential for interaction with such drugs as anticoagulants and nonsteroidal anti-inflammatory drugs leading to higher plasma levels of drug.
Except for angiotension converting enzyme (ACE) inhibitors and diuretics, no clinically significant interactions have been observed with Hytrin in BPH. In BPH patients the adverse events profile of patients treated concurrently with non-steroidal anti-inflammatory drugs (NSAIDs), theophylline, antianginal agents, oral hypoglycaemic agents, ACE inhibitors or diuretics was compared to the profile in the general treated population.
In the small subset of patients who were treated with Hytrin and ACE inhibitors or diuretics, the percent reporting dizziness or other dizziness-related adverse events appears to be greater than in the total population of terazosin patients from double-blind placebo-controlled studies.
Caution should be observed when Hytrin is administered concomitantly with other antihypertensive agents (e.g. calcium antagonists) to avoid the possibility of significant hypotension. When adding Hytrin to a diuretic or other antihypertensive agent, dosing reduction and retitration of these agents may be necessary.
Phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) (see section 4.4).
10. Date of Revision of the Text
December 2009
Updated on 18 May 2010
Reasons for updating
- 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 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Implementation of warnings concerning additional hypotensive effects following co-administration of non-selective alpha-blockers and phosphodiesterase-5-inhibitors. Changes were made to sections 4.4, 4.5, and 10 below in bold.
4.4. Special warnings and precautions for use
Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in recommended dosage. There is no evidence that terazosin aggravates renal dysfunction.
There is as yet insufficient experience of use of terazosin in children under the age of 12 years.
An excessive hypotensive effect may occur in some patients following soon after the initial doses. This is usually self limiting and in most cases does not recur after the initial period of therapy or during subsequent dose titration. Please also see Section 4.7 Effects on Ability to Drive and Use Machines.
The usual half life of terazosin is 10-12 hours. This may be significantly prolonged in patients with congestive cardiac failure (by up to 7-8 hours), usually with reduction on clinical improvement.
In certain patients with left ventricular failure, the decrease in left ventricular filling consequent to vigorous therapy may result in a significant fall in cardiac output and systemic blood pressure after administration of terazosin. These effects should be kept in mind when introducing therapy and continuous titration of dose used.
Since the drug is metabolised in the liver it should only be used with care in patients with existing hepatic dysfunction.
As with other alpha-1-adrenoreceptor antagonists, terazosin is not recommended in patients with history of micturition syncope.
Laboratory Tests: Small but statistically significant decreases in haematocrit, haemoglobin, white blood cells, total protein and albumin were observed in controlled clinical trials. These laboratory findings suggest the possibility of haemodilution. Treatment with terazosin for up to 24 months had no significant effect on Prostate Specific Antigen (PSA) levels.
In clinical trials, the incidence of postural hypotension was greater in BPH patients than those with hypertension.
If administration is discontinued for more than several days, therapy should be re-instituted using the initial dosing regimen.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. An IFIS may lead to increased procedural complications during the cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.
Concomitant use of phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) and terazosin may lead to symptomatic hypotension in some patients. In order to minimise the risk for developing postural hypotension the patient should be stable on the alpha-blocker therapy before initiating use of phosphodiesterase-5-inhibitors.
4.5. Interactions with other medicinal products and other forms of interaction
Terazosin is highly protein bound. There is a theoretical potential for interaction with such drugs as anticoagulants and nonsteroidal anti-inflammatory drugs leading to higher plasma levels of drug.
Except for angiotension converting enzyme (ACE) inhibitors and diuretics, no clinically significant interactions have been observed with Hytrin in BPH. In BPH patients the adverse events profile of patients treated concurrently with non-steroidal anti-inflammatory drugs (NSAIDs), theophylline, antianginal agents, oral hypoglycaemic agents, ACE inhibitors or diuretics was compared to the profile in the general treated population.
In the small subset of patients who were treated with Hytrin and ACE inhibitors or diuretics, the percent reporting dizziness or other dizziness-related adverse events appears to be greater than in the total population of terazosin patients from double-blind placebo-controlled studies.
Caution should be observed when Hytrin is administered concomitantly with other antihypertensive agents (e.g. calcium antagonists) to avoid the possibility of significant hypotension. When adding Hytrin to a diuretic or other antihypertensive agent, dosing reduction and retitration of these agents may be necessary.
Phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) (see section 4.4).
10. Date of Revision of the Text
December 2009
Updated on 14 August 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 August 2008
Reasons for updating
- Correction of spelling/typing errors
Updated on 30 August 2007
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 August 2007
Reasons for updating
- New SPC for new product