Tamsulosin Alkem 0,4 mg Capsule

Tamsulosin Alkem is indicated for the treatment of functional symptoms of benign prostatic hyperplasia (BPH).

Posology: One capsule daily to be taken after breakfast or the first meal of the day.

Special populations

• Renal Impairment: No dose adjustment is warranted in renal impairment.
• Hepatic impairment: No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see section 4.3).

Method of administration: For oral use. The capsule should be swallowed whole and should not be crunched or chewed, as this will interfere with the sustained release property of the active ingredient.

Tamsulosin Alkem is contraindicated in:

• known hypersensitivity to tamsulosin hydrochloride, or to any of the excipients listed in section 6.1.
• a history of orthostatic hypotension.
• severe hepatic insufficiency.
• combination with strong inhibitors of CYP3A4, e.g. ketoconazole (see section 4.5)

Orthostatis: A reduction in blood pressure can occur during treatment with Tamsulosin Alkem, as a result of which, orthostatic hypotension and 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 Alkem is initiated, the patient should be examined 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 clearances of < 10 mL/ min) should be approached with caution, as these patients have not been studied.

Intraoperative Floppy Iris Syndrome (IFIS): The u201cIntraoperative Floppy Iris Syndromeu201d (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients previously treated with tamsulosin. IFIS may increase the risk of eye complications during and after the operation. Discontinuing tamsulosin 1 to 2 weeks prior to cataract 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 as in Tamsulosin Alkem for a longer period prior to cataract surgery. The initiation of therapy with tamsulosin in patients for whom cataract surgery is scheduled is not recommended. During pre-operative assessment cataract surgeons and ophthalmic teams should be consider whether patients scheduled for cataract 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 Alkem should not be given in combination with strong inhibitors of CYP3A4 (e.g. ketoconazole) in patients with poor metaboliser CYP2D6 phenotype. Tamsulosin Alkem should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g. erythromycin). Tamsulosin Alkem should be used with caution in combination with cimetidine, particularly at a dose higher than 0,4 mg. Tamsulosin Alkem should not be used in combination with other alpha adrenergic blockers. Caution is advised when alpha adrenergic blockers including Tamsulosin Alkem are co-administered with PDE5 inhibitors. Alpha adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two medicine classes can potentially cause symptomatic hypotension. Caution should be exercised with concomitant administration of warfarin and Tamsulosin Alkem (see section 4.5).

Priapism: Tamsulosin Alkem 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 (see section 4.8).

Screening for Prostate Cancer: Prostate cancer and BPH frequently co-exist; therefore, patients should be screened for the presence of prostate cancer prior to treatment with Tamsulosin Alkem and at regular intervals afterwards.

Sulfa Allergy: In patients with sulfa allergy, allergic reaction to Tamsulosin Alkem has been reported. If a patient reports a serious or life-threatening sulfa allergy, caution is warranted when taking Tamsulosin Alkem.

Tamsulosin Alkem is not indicated for use in women.

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.

No studies on the effects of Tamsulosin Alkem on the ability to drive and use of machines have been performed. However, dizziness has been reported and patients who experience these symptoms should be cautious while driving or operating machinery.

Summary of safety profile: Adverse reactions were usually mild and transient. The frequently observed adverse reactions are dizziness, drowsiness and lethargy.

Listed summary of adverse reactions: Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: Frequent, less frequent, frequency unknown.

Gastrointestinal disorders: Less frequent: Nausea, diarrhoea, vomiting and constipation Frequency unknown: Dry mouth

Endocrine disorders: Less frequent: Diaphoresis

Cardiac disorders: Less frequent: Palpitations and tachycardia

Vascular disorders: Less frequent: Orthostatic hypotension

Nervous system disorders: Frequent: Dizziness, drowsiness, and lethargic Less frequent: Headache, depression, nervousness, sleep disturbances, vertigo, hallucinations, paraesthesia, and syncope

Eye disorders: Less frequent: Intra-operative Floppy Iris Syndrome (IFIS) in cataract surgery, and reddened sclera Frequency unknown: Blurred vision and visual impairment

Ear and labyrinth disorders: Less frequent: Tinnitus

Respiratory, thoracic and mediastinal disorders: Less frequent: Nasal congestion, rhinitis, chest pain, dyspnoea, and epistaxis

Reproductive system disorders: Frequent: Ejaculation disorders including retrograde ejaculation and ejaculation failure Less frequent: Impotence and priapism

Renal and urinary disorders: Less frequent: Urinary frequency and incontinence

Skin and subcutaneous tissue disorders: Less frequent: Alopecia, arthralgia, skin rash, pruritus, urticaria, lichen planus, angioedema, and Stevens-Johnson syndrome Frequency unknown: erythema multiforme and dermatitis exfoliative

General disorder and administration site conditions: Less frequent: Asthenia

Hepatobiliary disorders: Less frequent: Pancreatitis

Investigations: Less frequent: Abnormal liver enzyme values.

Post-marketing experience: In addition to the adverse events listed above, atrial fibrillation, dysrhythmia, tachycardia and dyspnoea have been reported in association with use of tamsulosin as in Tamsulosin Alkem.

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. Healthcare professionals 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 Alternatively all adverse events can be reported to Alkem Laboratories via the e-mail: [email protected].

Symptoms: Overdosage with tamsulosin hydrochloride can potentially result in severe hypotensive effects (see section 4.8). 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, activated charcoal and an osmotic laxative, such as sodium sulfate, can be administered.