COMPOSITION :

Each capsule contains : Tamsulosin Hydrochloride 0.4 mg (as modified release pellets).

DESCRIPTION :

Tamsiflow (Tamsulosin Hydrochloride) is a new potent and long acting alpha-1 receptors

antagonist. It inhibits alpha-1 receptors selectively and competetivly. Blockade of these

adrenoreceptors can cause smooth muscle in the bladder neck and prostate to relax,

resulting in improvement in urine flow rate and reduction in symptoms of benign prostatic

hyperplasia (BPH). Tamsulosin is not intended for use as antihypertensive drug. The plasma

concentration of unchanged drug reached a peak at 7 to 8 hours after single oral

administration of 0.1 to 0.6 mg Tamsulosin hydrochloride to healthy male adults. The half life

is 9.0 to 11.6 hours. The excretion rate of unchanged drug in the urine up to 30 hours after

administration remained almost constant at 12-14%. No significant changes in the excretion

rate after repeated administration were observed.

INDICATIONS :

Tamsiflow is intended for treatment of the signs and symptoms of benign prostatic

hyperplasia (BPH).

DOSAGE & ADMINISTRATION :

• Adult : The usual dose is 0.4mg of Tamsiflow once daily after meals.

• Elderly : Elderly patients often have renal hypofunction. In case of patients

can not tolerate this dosage , other appropriate measures must be taken.

RESTRICTIONS ON USE :

Contraindications

Tamsulosin is contraindicated in the following cases :

- Patients with a history of hypersensitivity reactions to the drug.

- Patients with impaired renal functions (an excessive increase in plasma drug

concentration may be induced).

Precautions

- Carcinoma of the prostate and BPH cause many of the same symptoms. These two

diseases frequently co-exist. Patients should be evaluated prior to the start

treatment with Tamsulosin to rule out the presence of carcinoma of the prostate.

- Use Tamsulosin HCl with caution concerning dosage and administration since

overdosage may cause a decrease in blood pressure.

- Patients must be watched for any changes in blood pressure occurring with

postural change.

- The drug does not eliminate the cause of the disease, but gives symptomatic

relief. If the expected response does not appear, surgical therapy or other

alternative procedures may be considered.

Effect on the capacity to drive vehicles and operate machines

Patients should be cautioned against engaging in potentially hazardous activities requiring

alertness, such as working at heights, driving cars or operating machines.

DRUG INTERACTIONS :

- Before the start of treatment, patients should be asked whether they are taking any

antihypertensive drugs.If such drugs are used, blood pressure during treatment should

be monitored. If a decrease in blood pressure is observed, the treatment discontinued

or other appropriate measures taken.

- Tamsulosin should be used with caution in combination with cimetidine particularly

at doses higher than 0.4 mg.

- Caution should be exercised with concomitant administration of Tamsulosin and

warfarin.

ADVERSE EFFECTS :

- Psychoneurological : Dizziness, dizziness on standing up or wooziness may occur

infrequently.

- Cardiovascular : Hypotension or tachycardia may occur infrequently.

- Hypersensitivity : such as rash, administration should be discontinued if such symptoms

occur.

- Gastrointestinal : Nausea, vomiting, stomach discomfort and heaviness, stomachache,

decrease appetite or diarrhoea may occur infrequently.

- Hepatic : Elevations of serum GOT, GPT or LDH may occur.

- Others : Nasal obstruction, edema, difficulty in swallowing, burning

sensation in the throat.

OVERDOSAGE :

Overdosage of Tamsulosin leads to hypotension, support of the cardiovascular system is

very important. Restoration of blood pressure and normalization of heart rate may be

accomplished by keeping the patient in the supine position. If this measure is inadeqate,

then administration of intravenous fluids should be considered. If necessary, vasopressor

should then be used and renal function should be monitored. Dialysis is unlikely to be

benefit because Tamsulosin is highly bound to plasma protein.

STORAGE INSTRUCTIONS :

Store below 25°C in a dry place, protect from light.

PRESENTATIONS :

Tamsiflow Capsules : Pack of 30 capsules and hospital packs of different sizes.