Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
labetalol hydrochloride, Quantity: 200 mg
Alphapharm Pty Ltd
Tablet, film coated
Excipient Ingredients: sodium starch glycollate; pregelatinised maize starch; silicon dioxide; microcrystalline cellulose; sucrose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; sunset yellow FCF; macrogol 4000
Oral
100
(S4) Prescription Only Medicine
Treatment of all grades of hypertension.
Visual Identification: 10.5mm normal convex orange film coated tablet marked LL 200, G on reverse.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
1996-07-19
PRESOLOL _labetalol hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PRESOLOL. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking PRESOLOL against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT PRESOLOL IS USED FOR PRESOLOL contains the active ingredient labetalol hydrochloride and is used to lower high blood pressure, also called hypertension. Everyone has blood pressure. This pressure helps to circulate your blood all around your body. Your blood pressure may be different during different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than normal, even when you are calm and relaxed. There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. You may feel fine and have no symptoms, but if high blood pressure is not treated it can lead to serious health problems. This medicine belongs to a group of medicines called beta-blockers. These medicines work by changing the body's response to some nerve impulses. As a result, it widens blood vessels in the body causing blood pressure to fall. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed PRESOLOL for another reason. There is not enough information to recommend the use of this medicine in children. Safety and effectiveness have not been established in this age group. This medicine is available only with a doctor's prescription. There is no evidence that PRESOLOL is addictive. BEFORE YOU TAKE PRESOLOL _WHEN YOU MUST NOT TAKE I Olvassa el a teljes dokumentumot
AUSTRALIAN PRODUCT INFORMATION PRESOLOL _labetalol hydrochloride film coated tablet _ 1 NAME OF THE MEDICINE Labetalol hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 100 mg or 200 mg of labetalol hydrochloride as the active ingredient. Excipients of known effect: lactose monohydrate, sugars and sulfites. For the full list of excipients, see section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM PRESOLOL 100: orange film coated tablet, marked 100 _LL_ on one side, G on reverse. PRESOLOL 200: orange film coated tablet, marked 200 _LL_ on one side, G on reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of all grades of hypertension. 4.2 DOSE AND METHOD OF ADMINISTRATION PRESOLOL tablets are to be taken orally, preferably after meals. For all patients, the dosage of PRESOLOL must be titrated against blood pressure response. The recommended starting dose for all patients is 100 mg to 200 mg twice daily. The dosage should then be increased at weekly intervals until satisfactory control of blood pressure is attained. It is important to follow these dosage instructions and to increase the dosage gradually, in order to minimise side effects. Effective daily doses vary between 200 mg and 2.4 g. In those patients on high doses, a regimen of three to four doses a day may be necessary. Hypertension may be controlled by PRESOLOL alone. If PRESOLOL tablets are prescribed with diuretics, or other antihypertensive agents, an additive effect can be expected. When transferring patients from other treatment regimens, PRESOLOL should be introduced in the manner described above and the dosage of other treatments should be reduced gradually. 4.3 CONTRAINDICATIONS Beta-blockers are usually contraindicated in a variety of conditions and as labetalol has not yet been fully investigated for its effect on these conditions, they should be treated as contraindications until further information is available. 1. Bronchospasm. Beta-adrenergic blockade of the smooth muscle of bronchi a Olvassa el a teljes dokumentumot