ECE Pharma
Full Prescribing Info
Tamsulosin hydrochloride.
Each enteric coated tablet contains: Tamsulosin Hydrochloride BP 200 mcg/400 mg.
Pharmacology: Pharmacokinetics: Tamsulosin is absorbed from the gastrointestinal tract and is almost completely bioavailable. The extent and rate of absorption ore reduced by food. After oral doses of an immediate-release preparation, peak plasma concentrations occur after 1 hour. Tamsulosin is about 99% bound to plasma proteins. It is metabolized slowly in the liver primarily by the cytochrome P450 isoenzymes CYP206 and CYP3A4, it is excreted mainly in the urine as metabolites and some unchanged drug. The plasma elimination half-life has been reported to be between 4 and 5.5 hours.
It is used benign prostatic hyperplasia to relieve symptoms of urinary obstruction.
Dosage/Direction for Use
In benign prostatic hyperplasia, tamsulosin hydrochloride is given by mouth in a modified- release formulation, in a dose of 200/400 micrograms once doily. Swallow whole tablet with glass of water, 30 mins after meal.
Use with caution in severely decreased kidney function.
Not to be used in history of drops in blood pressure when moving from sitting or lying position to standing, which causes dizziness (postural hypotension) severely decreased liver function. This medicine should not be used if the patient is allergic to one or any of its ingredients. Please inform the doctor or pharmacist if the patient has previously experienced such an allergy. If the patient experiences an allergic reaction, stop using this medicine and inform the doctor or pharmacist immediately.
Special Precautions
This medicine may cause dizziness, light-headedness, on rare occasions, fainting. Take care when moving from a lying down or sitting or standing particularly if waking up in the night, until the patient knows how this medicines affects him/her. If feeling dizzy or light headed at any time during treatment, sit or lie down until the symptoms pass.
This medicine may cause drowsiness, dizziness or blurred vision and so may affect the ability to drive or operate machinery safely.
Do not drive or operate machinery until the patient knows how this medicine affects him/her and if the patient is sure it won't affect his/her performance.
This medicine does not cause prostate cancer, but prostate cancer can be another cause of an enlarged prostate gland. For this reason, tests for prostate cancer should be carried out before the patient start treatment with this medicine, and at regular intervals thereafter. One test that can be carried out is a digital rectal examination (DRE). The other is to measure the level of prostate specific antigen (PSA) in the blood.
If the patient is scheduled to have eye surgery or cataract it is important to let an eye specialist know if the patient is or has been taking this medicine. This is because Tamsulosin can make the pupil dilate poorly and the iris (the coloured circular part of the eye) become floppy during the procedure. The specialist needs to know if the patient has been taking this medicine so they can take appropriate precautions with the medicines and techniques they use during the surgery. The patient may be asked to stop taking this medicine for a period of time before cataract surgery. Check with a doctor.
Adverse Reactions
Medicines and their possible side effects affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Simply because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Dizziness; headache; weakness or loss of strength (asthenia); abnormal ejaculation; a drop in blood pressure that occurs when going from lying down to sitting or standing, which results in dizziness and Lightheadedness (postural hypotension); fainting (syncope); awareness of the heartbeat (palpitations); disturbance of the gut such as diarrhoea, constipation, nausea or vomiting; inflammation of the lining of the nose (rhinitis) causing a blocked or runny nose; skin reactions such as rash and itch; drowsiness; blurred vision; dry mouth; swelling due to fluid retention (oedema); persistent painful erection of the penis (priapism).
Drug Interactions
It is important to tell a doctor or pharmacist what medicines the patient is already taking, including those bought without a prescription and herbal medicines, before starting treatment with this medicine. Similarly, check with the doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
If this medicine is taken with other medicines that can reduce blood pressure, this effect may be enhanced, with an increased chance of dizziness or fainting. Other medicines that may reduce blood pressure include the following: anaesthetics; medicines for high blood pressure; other alpha blockers; phosphodiesterase type 5 inhibitors for impotence, eg sildenafil, vardenafil, tadalafil.
MIMS Class
Drugs for Bladder & Prostate Disorders
ATC Classification
G04CA02 - tamsulosin ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.
Pimax EC tab 200 mcg
Pimax EC tab 400 mcg
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