Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
metoclopramide hydrochloride, Quantity: 10 mg
Arrotex Pharmaceuticals Pty Ltd
metoclopramide hydrochloride
Tablet, film coated
Excipient Ingredients: purified talc; stearic acid; macrogol 6000; pregelatinised maize starch; hypromellose; titanium dioxide; colloidal anhydrous silica; maize starch; microcrystalline cellulose
Oral
60, 10, 100, 150, 50, 30, 25, 125, 20
(S4) Prescription Only Medicine
In Adults (20 years and over): As an adjunct to X-ray examination of the stomach and duodenum. To assist in intestinal intubation. To control nausea and vomiting associated with the following conditions: intolerance to essential drugs possessing emetic properties; uraemia; radiation sickness; malignant disease; postoperative vomiting; labour; infectious diseases. There is no clear benefit in motion sickness or other labyrinth disturbances. Metoclopramide hydrochloride has been found useful in the management of gastric retention after gastric surgery. Metoclopramide hydrochloride may be useful in the treatment of diabetic gastroparesis of mild to moderate severity. Once control of diabetes has been established by diet and/or insulin, metoclopramide hydrochloride should be discontinued.,Young Adults: The use of metoclopramide hydrochloride in patients under 20 years should be restricted to the following situations: Severe intractable vomiting of known cause. Vomiting associated with radiotherapy and intolerance to cytotoxic drugs. As an aid to gastrointestinal intubation
Visual Identification: White to off-white, circular, biconvex film-coated tablets with breakline on both sides.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-12-17
Emexlon Page 1 of 7 EMEXLON _metoclopramide hydrochloride (as monohydrate) _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Emexlon. 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 Emexlon 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 EMEXLON IS USED FOR In adults over 20 years this medicine is used: • to treat nausea and vomiting caused by infectious diseases, migraine, kidney disease, child birth, other medications, cancer, or following surgery, chemotherapy or radiation treatment. • to activate stomach contractions in conditions where there is a need to encourage normal passage of food through the stomach and intestines. • with X-rays to help diagnose problems of the stomach and/or intestines. • to help with passing tubes into the intestine. In young adults between 15 to 20 years of age this medicine is used to: • treat severe vomiting of known cause or following chemotherapy or radiation treatment. • help with passing tubes into the intestine. This medicine works by blocking the action of a chemical in the brain which causes nausea and vomiting. It also acts in the stomach and upper intestine to increase muscle contractions. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU OR YOUR CHILD. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE EMEXLON _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE EMEXLON IF YOU HAVE AN ALLERGY TO: • any medicine containing Metoclopramide hydrochloride (as monohydrate) • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: Emexlon Page 2 of 7 • shortness of breath Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – EMEXLON (METOCLOPRAMIDE HYDROCHLORIDE (AS MONOHYDRATE)) FILM COATED TABLETS 1 NAME OF THE MEDICINE Metoclopramide hydrochloride monohydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Emexlon film coated tablets come in two strengths and contain either 5 mg or 10 mg of Metoclopramide hydrochloride (as monohydrate). For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Emexlon film coated tablets containing metoclopramide hydrochloride (as monohydrate) 10 mg are white to off-white, circular, biconvex film-coated tablets with breakline on both sides. Emexlon film coated tablets containing metoclopramide hydrochloride (as monohydrate) 5 mg are white to off-white, circular, biconvex film-coated tablets plain on both sides. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS _Adults (20 years and over): _As an adjunct to X-ray examination of the stomach and duodenum. To assist in intestinal intubation. To control nausea and vomiting associated with the following conditions: intolerance to essential drugs possessing emetic properties; uraemia; radiation sickness; malignant disease; postoperative vomiting; labour; infectious diseases. There is no clear benefit in motion sickness or other labyrinth disturbances. Metoclopramide hydrochloride (as monohydrate) has been found useful in the management of gastric retention after gastric surgery. Metoclopramide hydrochloride (as monohydrate) may be useful in the treatment of diabetic gastroparesis of mild to moderate severity. Once control of diabetes has been established by diet and/or insulin, metoclopramide hydrochloride (as monohydrate) should be discontinued. 2 _Young Adults and Children over 1 year of age: _ The use of metoclopramide hydrochloride (as monohydrate) in patients under 20 years should be restricted to the following situations and only used as second line therapy: Severe intractable vomiting of known cause. Vomiting associated with radiotherapy and intolerance to cytotoxic drugs. As an a Read the complete document