Demelon Capsule 1.5mg

Product Information

DEMELON

Demelon®(Rivastigmine)

Presentation

Demelon-1.5 capsule: Yellow cap and yellow body, each capsule contains Rivastigmine hydrogen tartrate INN equivalent to

Rivastigmine 1.5 mg.

Demelon-3 capsule: Orange cap and orange body, each capsule contains Rivastigmine hydrogen tartrate INN equivalent to Rivastigmine

3 mg.

Indications

Symptomatic treatment of mild to moderately severe Alzheimer’s dementia. Symptomatic treatment of mild to moderately severe

dementia in patients with Idiopathic Parkinson’s disease.

Dosage & administration

Rivastigmine (Demelon capsule) should be administered twice a day, with morning and evening meals.

Initial dose : Rivastigmine 1.5 mg (Demelon-1.5 capsule) twice a day.

Dose titration: The starting dose is Rivastigmine 1.5 mg (Demelon-1.5 capsule) twice a day. If this dose is well tolerated after a

minimum of two weeks of treatment, the dose may be increased to Rivastigmine 3 mg (Demelon-3 capsule) twice a day.

Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be

considered after a minimum of two weeks of treatment at that dose level.

Maintenance dose: The effective dose is 3 mg (Demelon-3 one capsule) to 6 mg (Demelon-3 two capsules) twice a day; to achieve

maximum therapeutic benefit patients should be maintained on their highest well tolerated dose. The recommended maximum daily dose

is 6 mg (Demelon-3 two capsules) twice a day. Maintenance treatment can be continued for as long as a therapeutic benefit for the

patient exists. Re-initiation of therapy : If treatment is interrupted for more than several days, it should be re-initiated at

1.5 mg twice daily. Dose titration should then be carried out as described above.

Renal and hepatic impairment : Due to increased exposure in moderate renal and mild to moderate hepatic impairment, dosing

recommendations to titrate according to individual tolerability should be closely followed

Children : Rivastigmine is not recommended for use in children.

Contra-indications, warnings, etc.

The use of this medicinal product is contraindicated in patients with hypersensitivity to the

active substance or other carbamate derivatives.

Interaction with other medicinal product : As a cholinesterase inhibitor, Rivastigmine may exaggerate the effects of

succinylcholine-type muscle relaxants during anaesthesia. Caution is recommended when selecting anaesthetic agents. Possible dose

adjustments or temporarily stopping treatment can be considered if needed. In view of its pharmacodynamic effects, rivastigmine

should not be given concomitantly with other cholinomimetic substances and might interfere with the activity of

anticholinergic medicinal products. No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin,

diazepam or fluoxetine in studies in healthy volunteers. The increase in prothrombin time induced by warfarin is not affected by

administration of rivastigmine. No untoward effects on cardiac conduction were observed following concomitant administration of

digoxin and Rivastigmine.

Use in pregnancy and lactation : For Rivastigmine no clinical data are available. Rivastigmine should not be used during pregnancy

unless clearly necessary. In animals, rivastigmine is excreted into milk. It is not known if rivastigmine is excreted into

human milk. Therefore, women on rivastigmine should not breast-feed.

Side-effects : The most commonly reported adverse reactions are gastrointestinal, including nausea (38%) and vomiting (23%),

especially during titration. Female patients in clinical studies were found to be more susceptible than male patients

to gastrointestinal adverse reactions and weight loss.

Overdose : Most cases of accidental overdose have not been associated with any clinical signs or symptoms and almost all of the

patients concerned continued rivastigmine treatment. Where symptoms have occurred, they have included nausea, vomiting

and diarrhoea, hypertension or hallucinations. Due to the known vagotonic effect of cholinesterase inhibitors on heart rate,

bradycardia and/or syncope may also occur. Ingestion of 46 mg occurred in one case; following conservative management the

patient fully recovered within 24 hours. As rivastigmine has a plasma half-life of about 1 hour and a duration of

acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose no further dose of

rivastigmine should be administered for the next 24 hours. In overdose accompanied by severe nausea and vomiting, the use of

antiemetics should be considered. Symptomatic treatment for other adverse reactions should be given as necessary. In massive

overdose, atropine can be used. An initial dose of 0.03 mg/kg intravenous atropine sulphate is recommended, with subsequent doses

based on clinical response. Use of scopolamine as an antidote is not recommended.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Demelon-1.5 capsule: Each carton containing 4 x 7 capsules in blister.

Demelon-3 capsule: Each carton containing 2 x 7 capsules blister.