Reminyl

Reminyl

galantamine

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Full Prescribing Info
Contents
Galantamine HBr.
Description
Each prolonged-release capsule also contains the following excipients: Gelatin, diethyl phthalate, ethylcellulose, hypromellose, polyethylene glycol, titanium dioxide (E171), sugar (57 mg) and maize starch.
Action
Dementia of the Alzheimer type is believed to be due to a lack of acetylcholine, a substance responsible for the transmission of messages between brain cells. Reminyl increases the amount of acetylcholine, exerting a beneficial effect on the symptoms.
Indications/Uses
Treatment of mild to moderately severe dementia of Alzheimer type, a disease that alters brain function.
The symptoms include progressive memory loss, increasing confusion and behavioural changes, as a result of which it becomes more and more difficult to carry out daily living activities.
Dosage/Direction for Use
Reminyl is started at a low dose and then is slowly increased to the most suitable dose.
One cap once daily in the morning, preferably with meal.
Switching from Tablet to Prolonged-Released Capsule: Take the last dose of Reminyl tablet in the evening. In the following morning, take the first dose of Reminyl prolonged-release capsule. Do not take more than 1 capsule daily. While taking once-daily Reminyl prolonged-release capsule, do not take Reminyl tablets twice daily.
Administration: Reminyl is taken orally with plenty of liquid to ensure hydration.
Missed Dose: If a dose of Reminyl has been missed, that dose should be skipped and the treatment should be continued as usual at the next scheduled intake. If multiple doses have been skipped, consult the physician immediately.
Overdosage
Symptoms: In case of overdosage, one or more of the following may occur: Severe nausea, vomiting, muscle weakness, abdominal cramps, leakage of urine and faeces, increased saliva, watering eyes, sweating, rapid heart rate, serious heart rhythm disorder, slow heartbeat, low blood pressure, breathing difficulties, fainting, seizures or collapse.
Treatment: As in any case of overdosage, general supportive measures should be used.
In severe cases, anticholinergics eg, atropine may be used as a general antidote for cholinomimetics. An initial dose of 0.5-1 mg IV is recommended, with subsequent doses based on the clinical response.
Because strategies for the management of overdosage are continually evolving, it is advisable to contact a poison control centre to determine the latest recommendations for the management of an overdosage.
Contraindications
Known hypersensitivity to galantamine or to any of the excipients of Reminyl. Severe hepatic or renal disease.
Special Precautions
Heart disorders; stomach ulcer or history of ulcer; acute abdominal pain; some disorders of the nervous systeme (eg, epilepsy); respiratory diseases that interfere with breathing (eg, asthma); recent operation on the gut or bladder, or difficulties in passing urine; concomitant use with aspirin or aspirin-like drugs; medical operation with general anaesthetic; since patients with Alzheimer's disease and while on Reminyl therapy often lose weight, regular monitoring of weight is needed.
Renal and Hepatic Impairment: Depending on the seriousness of the problem, the physician decides whether treatment with Reminyl is appropriate or the dose needs to be adapted.
Effects on the Ability to Drive or Operate Machinery: Reminyl, as well as the disease itself, can negatively affect the ability to drive or operate machinery.
Use in children: Not recommended for use in children.
Use In Pregnancy & Lactation
Use in pregnancy: Reproduction studies conducted in pregnant rat showed a nonsignificant increase in the incidence of minor skeletal abnormalities in rats.
There is no evidence from laboratory investigations that galantamine may harm either pregnant women or unborn babies. Nevertheless, in case of pregnancy or possible pregnancy, it should be discussed with a physician whether it is advisable to use Reminyl.
Use in lactation: It is not known whether galantamine passes into human milk. Therefore, women on Reminyl should not breastfeed.
Adverse Reactions
Like all medicines, Reminyl can cause side effects, although not everybody experiences them.
The most commonly reported side effects (occurring in >1 in every 10 people who have taken Reminyl) are nausea and vomiting.
Common side effects (occurring in <1 in every 10 people who have taken Reminyl) are: Decreased appetite, loss of appetite; feeling sad (depression); seeing, feeling or hearing things that are not real; dizziness, headache, trembling, feeling faint, abnormally tired, drowsiness; slow heart beat; high blood pressure; diarrhea, abdominal pain, upper abdominal pain, indigestion, stomach discomfort, abdominal discomfort; increased sweating; muscle spasms; feeling tired, general feeling of discomfort, feeling weak; weight loss; falling.
Uncommon side effects (occurring in <1 in every 100 people who have taken Reminyl) are: Excessive water loss in the body; change in the sense of taste; excessive sleepiness; tingling, pricking or numbness of the skin; blurred vision; ringing noise in the ears; disturbance in the mechanism of conducting impulses in the heart, sensation of abnormal heart beats (palpitations), possible skipped heart beat; reddening of the face, low blood pressure; feeling the need to vomit; muscle weakness; increased liver enzymes in the blood on laboratory tests.
Rare side effect (occurring in <1 in every 1000 people who have taken Reminyl) is inflammation of the liver (hepatitis).
Drug Interactions
Reminyl should not be combined with other medicines that act through similar mechanisms in the body.
Drugs for diarrhea, Parkinson's disease, airway spasms, certain heart disorders or high blood pressure (eg, digoxin or β-blockers). If antidepressants (eg, paroxetine, fluoxetine, amitriptyline or fluvoxamine), quinidine (used for heart rhythm disorders) or the antifungal ketoconazole are used in the same period as Reminyl, a smaller amount of Reminyl may be needed.
ATC Classification
N06DA04 - galantamine ; Belongs to the class of anticholinesterases. Used in the management of dementia.
Presentation/Packing
PR cap 8 mg (white, opaque, marked with G8) x 4 x 7's.
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