European Union - English - EMA (European Medicines Agency)

les laboratoires servier - strontium ranelate - osteoporosis, postmenopausal - drugs for treatment of bone diseases - treatment of severe osteoporosis in postmenopausal women at high risk for fracture to reduce the risk of vertebral and hip fractures. treatment of severe osteoporosis in adult men at increased risk of fracture. the decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks.,

European Union - English - EMA (European Medicines Agency)

h. lundbeck a/s - nalmefene hydrochloride dihydrate - alcohol-related disorders - drugs used in alcohol dependence - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), without physical withdrawal symptoms and who do not require immediate detoxification.selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.selincro should be initiated only in patients who continue to have a high drinking-risk level two weeks after initial assessment.

European Union - English - EMA (European Medicines Agency)

vaia s.a. - pioglitazone hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - pioglitazone is indicated as second- or third-line treatment of type-2 diabetes mellitus as described below:as monotherapy:in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;as dual oral therapy in combination with:metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;as triple oral therapy in combination with:metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. pioglitazone is also indicated for combination with insulin in type-2-diabetes-mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).after initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in hba1c). in patients who fail to show an adequate response, pioglitazone should be discontinued. in light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - methylphenidate hydrochloride, quantity: 60 mg - capsule, modified release - excipient ingredients: purified talc; methacrylic acid copolymer; ammonio methacrylate copolymer; triethyl citrate; iron oxide yellow; gelatin; macrogol 6000; titanium dioxide; iron oxide black; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; ethanol absolute; potassium hydroxide; maize starch; sucrose - ritalin 10 tablets and ritalin la capsules are indicated for the treatment of adhd. ritalin 10 tablets are also indicated for the treatment of narcolepsy. attention-deficit hyperactivity disorder (adhd) adhd was previously known as attention-deficit disorder. other terms used to describe this behavioural syndrome include: minimal brain dysfunction in children, hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction and psycho-organic syndrome of children. ritalin 10 / ritalin la are indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. special diagnostic considerations for adhd in children: the aetiology of this syndrome is unknown and there is no single diagnostic test. adequate diagnosis requires the use, not only of medical, but also of psychological, educational and social resources. characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and an abnormal eeg. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. drug treatment is not indicated for all children with this syndrome. stimulants are not intended for use in children who exhibit symptoms secondary to environmental factors (e.g. child abuse in particular) or primary psychiatric disorders. appropriate educational placement is essential and psychosocial intervention is generally necessary. when remedial measures alone are insufficient, the decision to prescribe stimulant medicine will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. continuation of treatment in adolescent and special diagnostic considerations for adhd in adults: there is limited information to guide clinicians about how long older adolescents should continue to receive treatment with drugs for attention deficit hyperactivity disorder (adhd). the decision should be based on the extent to which symptoms of adhd and social functioning have improved to a point that medication is no longer needed. if older adolescents have been largely symptom-free for a year and are functioning well, a trial without medication is warranted. this should be undertaken at times of low stress such as during holidays or in a period when a school routine is well established. adhd needs to be considered in adults who present with longstanding symptoms suggestive of adhd (inattention, impulsivity, disorganisation) that appear to have started in childhood and are persisting into adult life. further, people with personality disorder and/or problems with drug use accompanied by a significant level of impulsivity and inattention should be referred for evaluation by a psychiatrist with the training and skills required to assess and treat adhd. this expertise is necessary due to the overlap of adhd symptoms with anxiety, mood and personality disorders. narcolepsy the symptoms include daytime sleepiness, inappropriate sleep episodes and rapidly occurring loss of voluntary muscle tone. ritalin 10 is effective for symptoms of sleepiness but not for loss of voluntary muscle tone.

Australia - English - Department of Health (Therapeutic Goods Administration)

boucher & muir pty ltd - flecainide acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: magnesium stearate; microcrystalline cellulose; pregelatinised maize starch; croscarmellose sodium; maize starch - 1. supraventricular arrhythmias: a) due to pre-excitation syndromes, e.g. wolff-parkinson-white and lown-ganong-levine syndromes. b) due to dual av nodal pathways in patients with debilitating symptoms. c) paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms.,although flecainide may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. in these patients, particularly in the presence of impaired left ventricular function, flecainide should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. life threatening ventricular arrhythmias not controlled by other drugs.,flecainide sandoz tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous therapy or conversion by other means.,prescribers should also consult the "precautions" section of this product information.

Australia - English - Department of Health (Therapeutic Goods Administration)

boucher & muir pty ltd - flecainide acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: pregelatinised maize starch; maize starch; microcrystalline cellulose; croscarmellose sodium; magnesium stearate - 1. supraventricular arrhythmias: a) due to pre-excitation syndromes, e.g. wolff-parkinson-white and lown-ganong-levine syndromes. b) due to dual av nodal pathways in patients with debilitating symptoms. c) paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms.,although flecainide may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. in these patients, particularly in the presence of impaired left ventricular function, flecainide should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. life threatening ventricular arrhythmias not controlled by other drugs.,flecainide sandoz tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous therapy or conversion by other means.,prescribers should also consult the "precautions" section of this product information.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - acarbose, quantity: 100 mg - tablet - excipient ingredients: colloidal anhydrous silica; pregelatinised maize starch; microcrystalline cellulose; magnesium stearate - as an adjunct to prescribed diet and exercise for the management of blood glucose concentrations in non-insulin dependent diabetic patients who are inadequately controlled by diet alone or by diet and oral hypoglycaemic agents.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - acarbose, quantity: 50 mg - tablet - excipient ingredients: magnesium stearate; pregelatinised maize starch; microcrystalline cellulose; colloidal anhydrous silica - as an adjunct to prescribed diet and exercise for the management of blood glucose concentrations in non-insulin dependent diabetic patients who are inadequately controlled by diet alone or by diet and oral hypoglycaemic agents.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - acarbose, quantity: 50 mg - tablet - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; pregelatinised maize starch - as an adjunct to prescribed diet and exercise for the management of blood glucose concentrations in non-insulin dependent diabetic patients who are inadequately controlled by diet alone or by diet and oral hypoglycaemic agents.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - acarbose, quantity: 100 mg - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; pregelatinised maize starch - as an adjunct to prescribed diet and exercise for the management of blood glucose concentrations in non-insulin dependent diabetic patients who are inadequately controlled by diet alone or by diet and oral hypoglycaemic agents.