Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
bromocriptine mesilate, Quantity: 2.87 mg (Equivalent: bromocriptine, Qty 2.5 mg)
Sandoz Pty Ltd
Tablet, uncoated
Excipient Ingredients: maize starch; lactose monohydrate; disodium edetate; colloidal anhydrous silica; maleic acid; magnesium stearate
Oral
60 tablets
(S4) Prescription Only Medicine
Prevention of onset of lactation in the puerperium for clearly defined medical reasons. Therapy should be continued for 14 days to prevent rebound lactation. Parlodel should not be used to suppress established lactation. Treatment of hyperprolactinaemia where surgery and/or radiotherapy are not indicated or have already been used with incomplete resolution. Precautions should be taken to ensure that the hyperprolactinaemia is not due to severe primary hypothyroidism. Where the cause of hyperprolactinaemia is a prolactin-secreting microadenoma or macroadenoma, Parlodel is indicated for conservative treatment; prior to surgery in order to reduce tumour size and to facilitate removal; after surgery if prolactin level is still elevated. Adjunctive therapy in the management of acromegaly when: (1) The patient refuses surgery and/or radiotherapy; (2) Surgery and/or radiotherapy has been unsuccessful or full effects are not expected for some months; (3) A manifestation of the acromegaly needs to be brought under con
Visual Identification: White tablet, 7mm diameter, coded XC with breakline on one side, Sandoz on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
1991-08-21
PARLODEL® 1 PARLODEL ® _bromocriptine mesilate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Parlodel. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Parlodel against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PARLODEL IS USED FOR Parlodel has several uses. It can be used for the following medical conditions: 1. Prevention/suppression of breast milk production (lactation) in women who cannot/do not breast- feed for medical reasons. If breast milk production has already begun, your doctor can advise you about other methods of stopping lactation. 2. Treatment of people who have high blood levels of a hormone called prolactin. This condition is sometimes caused by a type of tumour called a prolactinoma. 3. Treatment of acromegaly, a disease in which the body produces too much growth hormone. Parlodel treats this disease by reducing the level of growth hormone in the blood. 4. To relieve symptoms, such as shaking of the limbs, stiffness and slowness of movement, in people with Parkinson's disease. Parlodel is often used in combination with other medicines such as levodopa. Parlodel contains the active ingredient, bromocriptine. It belongs to a group of medicines known as the ergot alkaloids, derived from a type of fungus. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE Prečítajte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION PARLODEL ® (BROMOCRIPTINE MESILATE ) TABLET AND HARD CAPSULE 1 NAME OF THE MEDICINE Bromocriptine mesilate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION • Parlodel tablets and capsules contain bromocriptine mesilate • Oral tablets: ➢ 2.5 mg bromocriptine (present as 2.9 mg mesilate). • Oral capsules: ➢ 10 mg bromocriptine (present as 11.5 mg mesilate). ➢ 5 mg bromocriptine (present at 5.735 mg mesilate). • List of excipients with known effect: lactose and sugars. • For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Oral tablets: • White, coded XC with breakline on one side, SANDOZ on the other side. Oral capsules: • 5 mg: opaque white and opaque blue, marked PS • 10 mg: opaque white 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS • Prevention of onset of lactation in the puerperium for clearly defined medical reasons. Therapy should be continued for 14 days to prevent rebound lactation. Parlodel should not be used to suppress established lactation. • Treatment of hyperprolactinaemia where surgery and/or radiotherapy are not indicated or have already been used with incomplete resolution. Precautions should be taken to ensure that the hyperprolactinaemia is not due to severe primary hypothyroidism. Where the cause of hyperprolactinaemia is a prolactin-secreting microadenoma or macroadenoma, Parlodel is indicated for conservative treatment; prior to surgery in order to reduce tumour size and to facilitate removal; after surgery if prolactin level is still elevated. • Adjunctive therapy in the management of acromegaly when: (1) The patient refuses surgery and/or radiotherapy (2) Surgery and/or radiotherapy has been unsuccessful or full effects are not expected for some months (3) A manifestation of the acromegaly needs to be brought under control pending surgery and/or radiotherapy. 2 • Idiopathic or post-encephalitic Parkinson's disease. It should be noted that data are not yet sufficient to evaluate the role of Prečítajte si celý dokument