Farlosin SR

Each sustained release tablet contains tamsulosin hydrochloride 0.4 mg.

Pharmacotherapeutic group: α1-adrenoceptor antagonist.
Pharmacology: Pharmacodynamics: 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: Farlosin SR 0.4 mg 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 catheterization is significantly delayed.
A1-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 0.4 mg.
Pharmacokinetics: The pharmacokinetics parameters of 30 subjects (34 subjects were included in the study, 4 subjects were dropped out/were withdrawn from study) were calculated and results were statistically analyzed to demonstrate bioequivalence in a randomized, balanced, open label, two-sequence, two-treatment, two-period, two-way crossover design study. After oral administration of single dose of Tamsulosin 0.4 mg (test product) in the fasted state, the mean of the maximum plasma concentration (C_max) (rate of absorption) was 2.34 ng/mL, the median T_max was 3.07 h. The extent of absorption is expressed in Area Under the Curve (AUC)_0-72 and AUC_0-inf, the mean values were 110.59 ng.h/mL and 114.74 ng.h/mL respectively. The mean elimination half-life (T_½) of Tamsulosin 0.4 mg was 0.063 h.
The ratios and confidence intervals between test and reference product were as follows: for C_max the ratio was 105.4% (93.52%-118.89%). For AUC_0-72 the ratio was 107.2% (95.98%-119.79%). The results of the study showed that the ratios and confidence intervals are within the acceptance range for bioequivalence, therefore it can be concluded that the test product, Tamsulosin 0.4 mg sustained release tablets, is bioequivalence with the reference product.

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

One tablet daily.
FARLOSIN SR 0.4 mg can be taken independently of food.
The tablets must be swallowed whole and not be crunched or chewed as this interferes with the sustained release of the active substances.
Pediatric population: There is no relevant indication for use of Farlosin SR 0.4 mg in children.
The safety and efficacy of tamsulosin in children <18 years have not been established.

Symptoms: Overdosage 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 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. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.

Hypersensitivity to tamsulosin hydrochloride including drug-induced angioedema or to any of the excipients.
A history of orthostatic hypotension.
Severe hepatic insufficiency.

As with other alpha1-adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin sustained release tablet 0.4 mg, 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 sustained release tablet 0.4 mg is initiated, the patients should be examined in order to exclude the presence of other conditions, which can cause the same symptoms as benign prostatic hyperplasia. Digital rectum 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 and glaucoma surgery in some patients or on previously treated with tamsulosin hydrochloride. IFIS may increase the risk of eye complications during and after operation. Discontinuing tamsulosin hydrochloride 1-2 week prior to cataract or glaucoma surgery is anecdotally considered helpful, but the benefit of treatment discontinuation has not been established. IFIS has also been reported in patients who had discontinued tamsulosin for a longer period prior to the surgery.
The initiation of therapy with tamsulosin in patients for whom cataract or glaucoma surgery is scheduled is not recommended. During pre-operative assessment, 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.
Cases of allergic reactions to tamsulosin in patients with a past history of sulfonamide allergy have been reported. If a patient reports a previously experienced sulfa allergy, caution is warranted when administrating tamsulosin hydrochloride.
It is possible that a remnant of the tablet is observed in the faeces.
Effect on Ability to Drive and Use Machines: 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, drowsiness, blurred vision and syncope can occur.

Not applicable, as Tamsulosin 0.4 mg is intended for male patients only.

(See table.)


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Respiratory, thoracic and mediastinal disorders: Incidence unknown: Epistaxis.
Gastrointestinal disorders: Incidence unknown: Dry mouth.
Skin and subcutaneous tissue disorder: Incidence unknown: Erythema multiforme, Dermatitis exfoliative.
Eye disorder: Incidence unknown: Vision blurred, Visual impairment.
During cataract and glaucoma surgery a small pupil situation, known as Intraoperative Floppy Iris Syndrome (IFIS), has been reported during post-marketing surveillance. As with other alpha-blockers drowsiness can occur.
Post-marketing experience: In addition to the adverse events listed previously, atrial fibrillation, arrhythmia, tachycardia and dyspnoea have been reported in association with tamsulosin use. Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events and the role of tamsulosin in their causation cannot be reliably determined.

Interaction studies have only been performed in adults.
No interactions have been seen when tamsulosin hydrochloride was given concomitantly with either atenolol, enalapril or theophylline.
Concomitant cimetidine brings about a rise in plasma levels of tamsulosin, while 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.
No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative if the cytochrome P450-linked drug metabolizing enzyme system), involving amitriptyline, salbutamol, glibenclamide and finasteride.
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 C_max of tamsulosin hydrochloride.
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 C_max and AUC of tamsulosin that had increased, but these increases are not considered clinically relevant.
Concurrent administration of other α1-adrenoceptor antagonists could lead to hypotensive effects.

Store at temperatures below 30°C.

Drugs for Bladder & Prostate Disorders

G04CA02 - tamsulosin ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.

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