Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
moclobemide, Quantity: 150 mg
Arrotex Pharmaceuticals Pty Ltd
Moclobemide
Tablet, film coated
Excipient Ingredients: pregelatinised maize starch; lactose monohydrate; sodium starch glycollate; povidone; magnesium stearate; hypromellose; microcrystalline cellulose; PEG-8 stearate; titanium dioxide; propylene glycol; purified water; iron oxide yellow
Oral
60 tablets
(S4) Prescription Only Medicine
Treatment of major depression.
Visual Identification: Yellow, round, biconvex film-coated tablet, scored on one side. Diameter 10mm; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2012-04-19
Clobemix tablets – Consumer Medicine Information Doc ID: 77.AN.M.2.0 Page 1 CLOBEMIX tablets Moclobemide Consumer Medicine Information What is in this leaflet This leaflet answers some common questions about Clobemix tablets. 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 Clobemix tablets 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 Clobemix is used for The name of your medicine is Clobemix tablets. Clobemix tablets belongs to a group of medicines called antidepressants. It contains the active ingredient called moclobemide. Clobemix tablets is available in two strengths: 150 mg and 300 mg tablets. Antidepressants are used to treat depression and work on the central nervous system. They are thought to work by their action on brain chemicals called amines, which are involved in controlling mood. There are many different types of medicines used to treat depression. Clobemix tablets belongs to a group of medicines called reversible inhibitors of monoamine oxidase A (RIMA). Your doctor, however, may have prescribed Clobemix tablets for another purpose. Ask your doctor if you have any questions about why Clobemix tablets has been prescribed for you. This medicine is available only with a doctor's prescription. Before You Take Clobemix Do not take Clobemix tablets if: You have ever had an allergic reaction to Clobemix tablets or any of the ingredients listed at the end of this leaflet You are suffering from severe confusion Do not take CLOBEMIX if you are taking: • clomipramine • selegiline • bupropion • triptans (a family of medicines commonly used to treat migraines e.g. zolmitriptan) • pethidine • tramadol • dextromethorphan (often found in cough and cold medicines) • Lestu allt skjalið
Clobemix PI P a g e | 1 AUSTRALIAN PI CLOBEMIX (MOCLOBEMIDE) FILM COATED TABLETS 1 NAME OF THE MEDICINE Moclobemide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CLOBEMIX tablets contain 150 mg or 300 mg moclobemide. Excipients with known effect: Contains sugars as lactose. Moclobemide is a white crystalline powder. It contains no crystal water and is not hygroscopic. It is soluble in water at 0.4 g / 100 mL. The pKa is approximately 6.2. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM CLOBEMIX 150 mg tablets are yellow, round, biconvex, film coated tablet, scored on one side with a diameter of 10 mm. CLOBEMIX 300 mg tablets are a white to yellowish-white, oblong, biconvex, film coated tablet, scored on one side with the following dimensions 17 mm x 8.2 mm. 4 CLINICAL PARTICULARS T HERAPEUTIC INDICATIONS CLOBEMIX is indicated in the treatment of major depression. D OSE AND METHOD OF ADMINISTRATION Adults: CLOBEMIX therapy should be initiated in two divided daily doses. The recommended initial daily dose is 300 mg or 450 mg. The recommended dose range is 300 - 600 mg/day. CLOBEMIX should be taken after meals. Dosage in the elderly: No dosage adjustments are necessary in elderly patients. Dosage in patients with impaired renal function: Single dose pharmacokinetic data suggest that no dosage adjustment may be required in patients with reduced renal function. However multiple dose studies with moclobemide have not been performed in patients with renal dysfunction; therefore, CLOBEMIX should be use with caution in this patient population. In normal volunteers, the absolute bioavailability almost doubles following multiple dosing as compared to a single dose. Clobemix PI P a g e | 2 Dosage in patients with impaired hepatic function: In patients with severely impaired hepatic metabolism, the daily dose of CLOBEMIX should be reduced to half or one third of the dose to reach the usual plasma level. C ONTRAINDICATIONS • Known hypersensitivity to the drug. • Acute confusional sta Lestu allt skjalið