Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Terazosin hydrochloride
A A H Pharmaceuticals Ltd
G04CA03
Terazosin hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050400; GTIN: 5037563003129
CHILDREN • Terazosin is not recommended for use in children. IF YOU TAKE MORE TERAZOSIN THAN YOU SHOULD • If you accidentally take more than 1 tablet in a day, you should contact your doctor immediately. • If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause very low blood pressure resulting in fainting, dizziness, and drowsiness. Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed. IF YOU FORGET TO TAKE TERAZOSIN • If you have forgotten to take a tablet of a new strength at bedtime, ask your doctor or pharmacist for advice before continuing. • If you forget to take a tablet at the normal time, take one as soon as you remember. DO NOT take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time. • If you have forgotten to take a tablet for several days, DO NOT continue using the same tablets. YOU MUST CONTACT YOUR DOCTOR FOR ADVICE BEFORE YOU START TAKING TERAZOSIN TABLETS AGAIN AS YOUR TREATMENT MAY HAVE TO BE RESTARTED AS IF YOU ARE TAKING IT FOR THE FIRST TIME. IF YOU STOP TAKING TERAZOSIN • You should continue to take your tablets unless your doctor tells you not to. DO NOT stop just because you feel better. If you have any further questions on the use of this product, ask your doctor or pharmacist. POSSIBLE SIDE EFFECTS Like all medicines, Terazosin can cause side effects, although not everybody gets them. If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital: • an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives). This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation. THE MOST COMMON S Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Terazosin Teva 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 11.87mg of terazosin hydrochloride dihydrate equivalent to 10 mg of terazosin. Excipient with known effect: Each 10 mg tablet contains 109.03 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Mottled blue, round, flat tablet with bevelled edges embossed with “93” on one-side and “763” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Terazosin Teva Tablets are indicated for: The treatment of mild to moderate hypertension. The symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. For the different dosage regimens suitable strengths are available. The dose of terazosin should be adjusted according to the patient's response. The following is a guide to administration: INITIAL DOSE The lowest single dose of 1 mg before bedtime for all patients which should not be exceeded. Strict compliance with this recommendation should be observed to minimise potential acute first-dose hypotensive episodes. SUBSEQUENT DOSES Treatment of mild to moderate hypertension. The single daily dosage may be increased by approximately doubling the dosage at weekly intervals to achieve the desired blood pressure response. The maintenance dose needs to be adjusted to the patient’s response. 2 mg/day may be sufficient with increases up to 10 mg if necessary (clinical studies support the use of 2 – 10 mg as maintenance dose). The maximum dose is 20 mg of terazosin per day and should not be exceeded. Use with thiazide diuretics and other antihypertensive agents in the treatment of hypertension When adding a thiazide diuretic or another antihypertensive agent to a patient's regimen the dose of terazosin should be reduced or discontinued and retitration carried out if necessary. Caution should be observed when terazo Διαβάστε το πλήρες έγγραφο