Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
Prochlorperazine maleate
Aspen Pharmacare Australia Pty Ltd
Medicine Registered
NAUSETIL _Prochlorperazine maleate_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Nausetil. 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 or pharmacist has weighed the risks of you taking Nausetil against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NAUSETIL IS USED FOR Nausetil contains the active ingredient prochlorperazine maleate and is used to treat nausea associated with migraine (severe headache). Nausetil belongs to a group of medicines called phenothiazines, which help to correct chemical imbalances in the brain allowing it to function correctly. These chemicals may also affect the parts of the brain which control nausea. There is no evidence that it is addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE NAUSETIL IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO: • prochlorperazine maleate • the group of medicines called phenothiazines • any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include asthma, wheezing, shortness of breath, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, skin rash, itching or hives. DO NOT TAKE NAUSETIL IF YOU HAVE ANY OF THE FOLLOWING MEDICAL CONDITIONS: • shock • disease of the blood with a low number of blood cells • jaundice, yellowing of the skin and/or eyes. NAUSETIL MUST NOT BE GIVEN TO ANYONE WHO IS UNCONSCIOUS OR IN A COMA. DO NOT TAKE ANY MEDICINES THAT CAUSE DROWSINESS WHILE YOU ARE TAKING NAUSETIL. DO NOT GIVE NAUSETIL TO CHILDREN UNDER THE AGE OF TWO (2) YEARS OR UNDER 10 KG IN WEIGHT. DO NOT TAKE IT AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK. DO NOT TAKE IT IF THE PACKAGING IS TORN OR SHOWS SI Preberite celoten dokument
NAUSETIL PI –S3, marketed Page 1 of 9 PRODUCT INFORMATION NAUSETIL (Schedule 3 - prochlorperazine maleate) NAME OF THE MEDICINE NAUSETIL (prochlorperazine maleate). Chemical name: 2-chloro-10-[3-(4-methylpiperazin-1-yl)propyl]-10_H_-phenothiazine bis[hydrogen (Z)-butenedioate]. Structural formula: Chemical formula: C 20 H 24 ClN 3 S, 2C 4 H 4 O 4 Molecular weight: 606.2 CAS: 84-02-6 DESCRIPTION Prochlorperazine maleate is an odourless, nonhygroscopic, white or almost white, fine granular powder, which becomes coloured on exposure to light. It is very slightly soluble (about 0.1%) in water, ethanol or methanol and is insoluble in ether or chloroform. Prochlorperazine is a phenothiazine with a piperazine moiety in the side chain. It possesses strong antiemetic and antipsychotic activity with less sedative action than chlorpromazine. Each NAUSETIL tablet contains 5 mg of prochlorperazine maleate as the active ingredient. Excipients include starch–wheat, magnesium stearate, sodium lauryl sulfate, calcium hydrogen phosphate anhydrous and quinoline yellow. PHARMACOLOGY As with other phenothiazines, prochlorperazine has actions on several neurotransmitter systems as follows: NAUSETIL PI –S3, marketed Page 2 of 9 • Antidopamine action, which probably contributes to both the therapeutic effect and unwanted effects including extrapyramidal disorders and endocrine disturbances. • alpha-Adrenoreceptor antagonism, which contributes to cardiovascular side effects, e.g. orthostatic hypotension and reflex tachycardia. • Potentiation of noradrenaline by blocking its reuptake into nerve terminals. • Weak anticholinergic action. • Weak antihistamine action. • Weak serotonin antagonism. Prochlorperazine also has an effect on temperature control and blocks conditioned avoidance responses. Pharmacokinetics There are few publis Preberite celoten dokument