Tamsunorm SR 0.8 mg. 30 capsules

Trade Name:

Tamsunorm SR 0.8 mg

30 Hard gelatin capsules containing sustained release pellets

Composition:

Tamsulosin hydrochloride 800 mcg

Inactive ingredients:

Sugar spheres, ethyl cellulose, methacrylic acid copolymer, polyethylene glycol, Gelatin, sunset yellow, ponceau, titanium dioxide, brilliant blue, yellow iron oxide

Properties:

Pharmacodynamic properties Alpha1-adrenoceptor antagonist. Preparations for the exclusive treatment of prostatic disease. Tamsulosin binds selectively and competitively to postsynaptic alpha1-receptors, in particular to the subtype alpha1A, which bring about relaxation of the smooth muscle of the prostate, whereby tension is reduced.

Tamsunorm increases maximum urinary flow rate by reducing smooth muscle tension in prostate and urethra and thereby relieving obstruction. lt also improves the complex of irritative and obstructive symptoms in which bladder instability and tension of the smooth muscles of the lower urinary

tract play an important role. Alpha1-blockers can reduce blood pressure by lowering peripheral resistance. No reduction in blood pressure of any clinical significance was observed during studies with Tamsunorm.

Indications:

Treatment of functional symptoms of benign prostatic hyperplasia (BPH).

Dosage and administration:

-Male 45 to 75 years:

One capsule daily, to be taken after the same meal each day.

-The capsule should be swallowed whole and should not be crushed or chewed as this will interfere with the sustained release of the active ingredient.

Side effects:

-sleepiness or staying asleep, weakness -back pain

-diarrhea

-runny or stuffy nose 

-pain or pressure in the face 

-sore throat, cough, fever, chills, or other signs of infection 

-blurred vision 

-difficulty ejaculating 

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately: painful erection of the penis that lasts for hours, rash, itching, hives, swelling of the eyes, face, tongue, lips, throat, arms, hands, feet, ankles or lower legs

Contraindications:

-Hypersensitivity to tamsulosin hydrochloride, including drug-induced angioedema, or any other component of the product; 

-A history of orthostatic hypotension; severe hepatic insufficiency.

Warnings and precautions:

• As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsunorm, 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.

• The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract and glaucoma surgery in some patients on or previously treated with tamsulosin hydrochloride. IFIS may increase the risk of eye complications during and after the operation. Discontinuing tamsulosin hydrochloride 1-2 weeks prior to cataract or glaucoma surgery is 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 before the surgery. The initiation of therapy with tamsulosin hydrochloride 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 IFISs during surgery.

• Tamsulosin hydrochloride should be used with caution in combination with strong (e.g. ketoconazole) and moderate (e.g. erythromycin) inhibitors of CYP3A4.
• Tamsunorm should not be given to patents receiving antihypertensive medicines with significant alpha1-adrenoceptor antagonist achty (eg. doxazosin, indoramin, prazosin, terazosin, verapamil) without first consůting a đoctor.
• Tamsunorm should not be given to a man who experiences postural hypotension, uncontrolled diabetes and urinary incontinence.
• Tamsunorm should not be supplied to any man with heart, renal or liver disease, or to a man who has had prostate surgery.
• Tamsunorm should not be supplied to a man whose symptoms are of less than 3 months duration.
• Tamsunorm should not be given to any man who reports dysuria, haematuria, or cloudy urine, in the past 3 months or to ones suffering from a fever that might be related to a urinary tract infection
• Tamsunorm should not be used in those planning to have eye surgery for cataract or glaucoma, or who have recently experienced blurred or cloudy vision that has not been examined by a GP or optician.
• If urinary symptoms have not improved within 14 days of starting treatment with Tamsunorm, or are getting worse, the patient should stop taking Tamsunorm and be referred to the doctor. Medical review is required for the diagnosis of BPH. Patients must see their doctor within 6 weeks of starting treatment, for assessment of their symptoms and confirmation that they can continue to take Tamsunorm.

• Every 12 months, patients should be advised to consult a doctor for a clinical review.

• Interaction with other medicinal products:

-No interactions have been seen when Tamsunorm was given concomitantly with either atenolol, enalapril, or theophylline.

-Concomitant cimetidine brings about a rise in plasma levels of tamsulosin, and furosemide a fall, but as levels remain within the normal range, posology need not be changed neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin changes the free fraction of tamsulosin in human plasma. Neither does tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinon.

-There is a theoretical risk of enhanced hypotensive effects when given concurrently with drugs which may reduce blood pressure including anesthetic agents, other alpha1-adrenoceptor antagonists.

• Pregnancy and lactation:

Tamsunorm is not indicated for use in women.

• Ejaculation disorders have been ohsenved 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.

• Effects on ability to drive and use machines:

No data is available on whether Tamsunorm adversely affects the ability to drive or operate machines. However, in this respect patients should be aware

of the fact that drowsiness, blurred vision, dizziness and syncope can occur.

Storage:

Store in a dry place at temperature not exceeding 30 °C

Package:

Carton box contains  3 blisters each of 10 sustained release hard gelatin capsules and an insert leaflet.