Tamsulosin 0,4 Biotech 0,4 mg Sustained release capsules

TAMSULOSIN 0,4 BIOTECH is indicated for the treatment of functional symptoms of benign prostatic hyperplasia (BPH) in adult males. Efficacy in children with neurogenic bladder has not been demonstrated.

Posology
One TAMSULOSIN 0,4 BIOTECH sustained release capsule to be taken daily after breakfast.
Method of administration
Oral administration
TAMSULOSIN 0,4 BIOTECH should be swallowed whole with water (about 150 ml) in the standing or sitting position. TAMSULOSIN 0,4 BIOTECH should not be crunched or chewed, as this will interfere with the sustained release property of the active ingredient.

TAMSULOSIN 0,4 BIOTECH is contra-indicated in the following conditions:
u2022 In patients hypersensitive to tamsulosin hydrochloride or to any of the excipients of TAMSULOSIN 0,4 BIOTECH, listed in section 6.1.
u2022 A history of orthostatic hypotension.
u2022 Hepatic insufficiency.
u2022 TAMSULOSIN 0,4 BIOTECH should not be used in combination with strong inhibitors of CYP3A4, e.g., ketoconazole (see section 4.5).

A decrease in blood pressure with orthostatic hypotension and syncope may occur during treatment with TAMSULOSIN 0,4 BIOTECH. 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 0,4 BIOTECH 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.
Rarely (probably less than one in fifty thousand patients), TAMSULOSIN 0,4 BIOTECH, like other alpha 1 antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients must be advised about the seriousness of the condition.
The u201cIntraoperative Floppy Iris Syndromeu201d (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with TAMSULOSIN 0,4 BIOTECH. IFIS may lead to increased procedural complications during the operation. The initiation of therapy with TAMSULOSIN 0,4 BIOTECH in patients for whom cataract surgery is scheduled is not recommended. Discontinuing TAMSULOSIN 0,4 BIOTECH, 1 to 2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of requirement of stopping the therapy prior to cataract surgery has not yet been established. During pre-operative assessment, cataract surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with TAMSULOSIN 0,4 BIOTECH in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.
Special precautions : TAMSULOSIN 0,4 BIOTECH should not be given in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6 phenotype. TAMSULOSIN 0,4 BIOTECH should be used with caution in combination with strong and moderate (e.g., erythromycin) inhibitors of CYP3A4 (see section 4.5). TAMSULOSIN 0,4 BIOTECH is intended for adult male patients only.

No interactions have been seen when TAMSULOSIN 0,4 BIOTECH was given concomitantly with atenolol, enalapril, nifedipine or theophylline. Concomitant administration with cimetidine increases plasma levels of TAMSULOSIN 0,4 BIOTECH and concomitant administration with furosemide decreases the plasma levels of TAMSULOSIN 0,4 BIOTECH, but as levels remain within the normal range, dosage need not be changed. Diazepam, propranolol, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the free fraction of tamsulosin in human plasma, in vitro. Neither does tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone. No interactions at the level of hepatic metabolism have been observed during in vitro studies with liver microsomal fractions (representative of the cytochrome P450- linked drug metabolising enzyme system), involving amitriptyline, salbutamol, glibenclamide and finasteride.
Diclofenac and warfarin, however, may increase the elimination rate of TAMSULOSIN 0,4 BIOTECH. Concomitant administration of TAMSULOSIN 0,4 BIOTECH with strong inhibitors of CYP3A4 may lead to increased exposure to tamsulosin. Concomitant administration with ketoconazole (a known strong CYP3A4 inhibitor) resulted in an increase in AUC and C max of tamsulosin hydrochloride by a factor of 2,8 and 2,2 respectively. TAMSULOSIN 0,4 BIOTECH should not be given in combination with strong inhibitors of CYP3A4 (see section 4.3) in patients with poor metaboliser CYP2S6 phenotype. TAMSULOSIN 0,4 BIOTECH should be used with caution in combination with moderate (e.g., erythromycin) inhibitors of CYP3A4. Concomitant administration of TAMSULOSIN 0,4 BIOTECH with paroxetine, a strong inhibitor of CYP2D6, resulted in a C max 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 alpha 1 -adrenoceptor antagonists and anaesthetic medicines could lead to hypotensive effects.

TAMSULOSIN 0,4 BIOTECH should not be used in females.
Fertility
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 authorisation phase.

No data is available on whether TAMSULOSIN 0,4 BIOTECH adversely affects the ability to drive or operate machines. Patients should be aware of the fact that drowsiness, blurred vision, dizziness and syncope can occur.

Tabulated summary of adverse reactions
MedDRA System Organ Class
Nervous system disorders
Frequent: Dizziness
Less frequent: Headache, syncope
Eye disorders
Frequency unknown: Vision blurred*, visual impairment*
Cardiac disorders
Less frequent: Palpitations
Vascular disorders
Less frequent: Orthostatic hypotension
Respiratory, thoracic and mediastinal disorder
Less frequent: Rhinitis
Frequency unknown: Epistaxis*
Gastrointestinal disorders
Less frequent: Constipation, diarrhoea, nausea, vomiting
Frequency unknown: Dry mouth*
Skin and subcutaneous tissue disorders
Less frequent: Rash, pruritus, urticaria, angioedema, Stevens-Johnson syndrome
Frequency unknown: Erythema multiforme *, dermatitis exfoliative*
Reproductive systems and breast disorders
Frequent: Ejaculation disorders, including retrograde ejaculation and ejaculation failure
Less frequent: Priapism
General disorders and administration site disorders
Less frequent: Asthenia
* Observed post-marketing
Drowsiness, blurred vision or oedema can occur. During cataract surgery a small pupil situation, known as Intraoperative Floppy Iris Syndrome (IFIS), has been associated with therapy of TAMSULOSIN 0,4 BIOTECH during post-marketing surveillance (see section 4.4). In addition to the adverse events listed above, atrial fibrillation, dysrhythmia, tachycardia and dyspnoea have been reported in association with TAMSULOSIN 0,4 BIOTECH use.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

Symptoms
No cases of acute overdosage have been reported. However, acute hypotension could theoretically occur after overdosage in which case cardiovascular support should be given. Severe hypotensive effects have been observed at different levels of overdosing.
Treatment
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 0,4 BIOTECH is very highly bound to proteins. Measures such as emesis, can be taken to impede absorption. When large quantities are involved, activated charcoal and an osmotic laxative, such as sodium sulphate can be administered.