Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)

Oral use.
One capsule daily, to be taken after breakfast or the first meal of the day.
The capsule must be swallowed whole and must not be crunched or chewed, as this interferes with
the modified release of the 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 Contraindications).
Paediatric population
There is no relevant indication for use of tamsulosine in children.
The safety and efficacy of tamsulosine in children < 18 years have not been established. Currently
available data are described in section 5.1.

As with other α1-adrenoceptor antagonists, a reduction in blood pressure can occur in individual
cases during treatment with tamsulosin as a result of which, rarely, syncope can occur. At the first
signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the
symptoms have disappeared.
Before therapy with tamsulosin is initiated, the patient should be examined in order to exclude the
presence of other conditions, which can cause the same symptoms as benign prostatic hyperplasia.
Digital rectal examination and, when necessary, determination of prostate specific antigen (PSA)
should be performed before treatment and at regular intervals afterwards.
The treatment of patients with severe renal impairment (creatinine clearance of < 10 ml/min) should
be approached with caution, as these patients have not been studied.
The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been
observed during cataract or glaucoma surgery in some patients on or previously treated with
tamsulosin. IFIS may increase the risk of eye complications during and after the operation.
Discontinuing tamsulosin 1-2 weeks prior to cataract or glaucoma surgery is anecdotally considered
helpful, but the benefit of treatment discontinuation has not yet been established. IFIS has also been
reported in patients who had discontinued tamsulosin for a longer period prior to cataract surgery.
The initiation of therapy with tamsulosin in patients for whom cataract or glaucoma surgery is
scheduled is not recommended. During pre-operative assessment, cataract surgeons and ophthalmic
teams should consider whether patients scheduled for cataract or glaucoma surgery are being or have
been treated with tamsulosin in order to ensure that appropriate measures will be in place to manage
the IFIS during surgery.
Tamsulosin hydrochloride should not be given in combination with strong inhibitors of CYP3A4 in
patients with poor metaboliser CYP2D6 phenotype.
Tamsulosin hydrochloride should be used with caution in combination with strong and moderate
inhibitors of CYP3A4. (see section 4.5)

studies have only been performed in adults.
No interactions have been seen when tamsulosin was given concomitantly with either atenolol,
enalapril or theophylline.
Concomitant cimetidine brings about a rise in plasma levels of tamsulosin, whereas furosemide a
fall, but as levels remain within the normal range posology need not be adjusted.

In vitro, neither diazepam nor propranolol, trichlormethiazide, chlormadinone, 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.
Diclofenac and warfarin, however, may increase the elimination rate of tamsulosin.
Concomitant administration of tamsulosin hydrochloride with strong inhibitors of CYP3A4 may lead
to increased exposure to tamsulosin hydrochloride. Concomitant administration with ketoconazole
(a known strong CYP3A4 inhibitor) resulted in an increase in AUC and Cmax of tamsulosin
hydrochloride by a factor of 2.8 and 2.2, respectively. Tamsulosin hydrochloride should not be given
in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6
phenotype.
Tamsulosin hydrochloride should be used with caution in combination with strong and moderate
inhibitors of CYP3A4.
Concomitant administration of tamsulosin hydrochloride with paroxetine, a strong inhibitor of
CYP2D6, resulted in a Cmax and AUC of tamsulosin that had increased by a factor of 1.3 and 1.6,
respectively, but these increases are not considered clinically relevant.
Concurrent administration of other α1-adrenoceptor antagonists could lead to hypotensive effects.

Tamsulosin Aurobindo is not indicated for use in women Ejaculation disorders have been observed in short and long term clinical studies with tamsulosin.

Events of ejaculation disorder, retrograde ejaculation and ejaculation failure have been reported in the post authorization phase.

No studies on the effects on the ability to drive and use machines have been performed.

However, patients should be aware of the fact that dizziness can occur.

Common (may affect up to 1 in 10 people):
• Dizziness, particularly when going to sit or stand up.
• Abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.

Uncommon (may affect up to 1 in 100 people):
• headache
• palpitations (the heart beats more rapidly than normal and it is also noticeable)
• reduced blood pressure e.g. when getting up quickly from a seating or lying position sometimes associated with dizziness
• runny or blocked nose (rhinitis)
• constipation
• diarrhoea
• feeling sick and vomiting
• weakness (asthenia)
• rashes
• itching and hives (urticaria).

Rare (may affect up to 1 in 1,000 people):
• faintness and sudden local swelling of the soft tissues of the body (e.g. the throat or tongue)
• difficult breathing and/or itching and rash, often as an allergic reaction (angioedema)

Very rare (may affect up to 1 in 10,000 people):
• priapism (painful prolonged unwanted erection for which immediate medical treatment is required)
• Rash, inflammation and blistering of the skin and/ or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens- Johnson syndrome)

Not known (frequency cannot be estimated from the available data):
• blurred vision
• impaired vision
• Nose bleeding (epistaxis)
• serious skin rashes (erythema multiform, dermatitis exfoliative)
• Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing (dyspnoea).
• If you are undergoing eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma) and are already taking or have previously taken Od-Tam, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.
• Dry mouth

Symptoms:
Overdose with tamsulosin hydrochloride can potentially result in severe hypotensive effects.
Severe hypotensive effects have been observed at different levels of overdosing.
Treatment:
In case of acute hypotension occurring after overdose 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. When large quantities are involved,
gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium
sulphate, can be administered.

Pharmacotherapeutic group: α 1-adrenoceptor antagonist, ATC code: GO4C AO2. Preparations for
the exclusive treatment of prostatic disease.
Mechanism of action:
Tamsulosin binds selectively and competitively to the postsynaptic α1-adrenoceptors, in particular
to subtypes α1A and α1D. It brings about relaxation of prostatic and urethral smooth muscle.
Pharmacodynamic effects:
Tamsulosin increases the maximum urinary flow rate. It relieves obstruction by relaxing smooth
muscle in prostate and urethra thereby improving voiding symptoms.
It also improves the storage symptoms in which bladder instability plays an important role.
These effects on storage and voiding symptoms are maintained during long-term therapy. The need
for surgery or catheterisation is significantly delayed.
α1-adrenoceptor antagonists can reduce blood pressure by lowering peripheral resistance. No
reduction in blood pressure of any clinical significance was observed during studies with tamsulosin.
Paediatric population
A double-blind, randomized, placebo-controlled, dose ranging study was performed in children with
neuropathic bladder. A total of 161 children (with an age of 2 to 16 years) were randomized and
treated at 1 of 3 dose levels of tamsulosin (low [0.001 to 0.002 mg/kg], medium [0.002 to 0.004
mg/kg], and high [0.004 to 0.008 mg/kg]), or placebo. The primary endpoint was number of patients
who decreased their detrusor leak point pressure (LPP) to <40 cm H2O based upon two evaluations
on the same day. Secondary endpoints were: Actual and percent change from baseline in detrusor
leak point pressure, improvement or stabilization of hydronephrosis and hydroureter and change in
urine volumes obtained by catheterisation and number of times wet at time of catheterisation as
recorded in catheterization diaries. No statistically significant difference was found between the
placebo group and any of the 3 tamsulosin dose groups for either the primary or any secondary
endpoints. No dose response was observed for any dose level.

Absorption:

Tamsulosin is rapidly absorbed from the intestines and its bioavailability is almost complete.
Absorption is slowed down if a meal has been eaten before taking the medicinal product.
Uniformity of absorption can be assured by always taking tamsulosin after breakfast.
Tamsulosin shows linear kinetics.
Peak plasma levels are achieved at approximately six hours after a single dose of tamsulosin taken
after a full meal. The steady state is reached by day five of multiple dosing, when Cmax in patients
is about two-thirds higher than that reached after a single dose. Although this has been demonstrated
only in the elderly, the same result would also be expected in younger patients. There are huge interpatient
variations in plasma levels of tamsulosin, both after single as well as multiple dosing.

Distribution:
In humans, Tamsulosin is about 99 % bound to plasma proteins and volume of distribution is small(about 0.2 l/kg).
Biotransformation:
Tamsulosin has a low first pass metabolic effect. Most tamsulosin is found unaltered in plasma. The
substance is metabolised in the liver.
In studies on rats, tamsulosin was found to cause only a slight induction of microsomal liver enzymes.

In vitro Results suggest that CYP3A4 and CYP2D6 are involved in metabolism, with possible minor contribution of other CYP isoenzymes in the metabolism of tamsulosin
hydrochloride. Inhibition of CYP3A4 and CYP2D6 enzymes that metabolize drugs may lead to
increased exposure to tamsulosin hydrochloride (see sections 4.4 and 4.5).
The metabolites are not as effective and toxic as the active medicinal product itself.
Excretion:
Tamsulosin and its metabolites are mainly excreted in the urine with about 9% of the dose being
present in unchanged form.
The elimination half-life of tamsulosin in patients is approximately 10 hours (when taken after a meal) and 13 hours in the steady state.

Toxicity after a single dose and multiple dosing has been investigated in mice, rats and dogs.
Reproductive toxicity has also been investigated in rats, carcinogenicity in mice and rats, and
genotoxicity in vivo and in vitro.
The common toxicity profile found with large doses of tamsulosin is equivalent to the
pharmacological effect associated with alpha adrenergic antagonists. Changes in ECG readings were
found with very large doses in dogs.
This is not, however, assumed to be of any clinical significance. Tamsulosin has not been found to
have any significant genotoxic properties.
Greater proliferative changes in the mammary glands of female rats and mice have been discovered
on exposure to tamsulosin. These findings, which are probably indirectly linked to
hyperprolactinaemia and only occur as a result of large doses having been taken, are considered
clinically insignificant.

Cellulose Microcrystalline, Methacrylic Acid-Ethyl acrylate copolymer (1:1) Dispersion 30 percent,
Talc, Triacetin, Calcium Stearate

Not applicable.

Store below 30ºC.

Blister pack of 30’s (10’s blister x 3)

other handling
No special requirements.