| 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 and 4.5 below in bold.
4.4. Special warnings and precautions for use
As with other alpha adrenoreceptor antagonists, terazosin is not recommended in patients with a history of micturition syncope.
In clinical trials, the incidence of postural hypotension was greater in BPH patients than those with hypertension. In these cases, the incidence of postural hypotension events was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%).
If administration is discontinued for more than several days, therapy should be re-instituted using the initial dosing regimen.
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.
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. As IFIS may lead to increased procedural complications during cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.
4.5. Interactions with other medicinal products and other forms of interaction
In patients receiving terazosin plus ACE inhibitors or diuretics the proportion reporting dizziness or related side effects was greater than in the total population of terazosin treated patients from clinical trials.
Caution should be observed when terazosin is administered with other antihypertensive agents, to avoid the possibility of significant hypotension. When adding terazosin to a diuretic or other antihypertensive agent, dosage reduction and retitration may be necessary.
Terazosin has been given without interaction with analgesics/anti-inflammatories, cardiac glycosides, hypoglycemics, antiarrhythmics, anxiolytics/sedatives, antibacterials, hormones/steroids and drugs used for gout.
Phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) (see section 4.4).
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