REMINYL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GALANTAMINE HYDROBROMIDE

Available from:

Shire Pharmaceuticals Limited

ATC code:

N06DA04

INN (International Name):

GALANTAMINE HYDROBROMIDE

Dosage:

4 Mg/Ml

Pharmaceutical form:

Oral Solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

galantamine

Authorization status:

Marketed

Authorization date:

2000-09-15

Patient Information leaflet

Page 1 of 8
Package leaflet: Information for the user
REMINYL 4MG/ML ORAL SOLUTION
galantamine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Reminyl is and what it is used for
2.
What you need to know before you take Reminyl
3.
How to take Reminyl
4.
Possible side effects
5.
How to store Reminyl
6.
Contents of the pack and other information
1.
WHAT REMINYL IS AND WHAT IT IS USED FOR
Reminyl contains the active substance ‘galantamine’, an
antidementia medicine. It is used in
adults to treat the symptoms of mild to moderately severe
Alzheimer’s disease, a type of
dementia that alters brain function.
Alzheimer’s disease causes increasing memory loss, confusion and
behavioural changes
which make it increasingly difficult to carry out normal daily
activities. These effects are
thought to be caused by a lack of ‘acetylcholine’, a substance
responsible for sending
messages between brain cells. Reminyl increases the amount of
acetylcholine in the brain and
treats the signs of the disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE REMINYL
DO NOT TAKE REMINYL

If you are allergic to galantamine or to any of the other ingredients
of this medicine
(listed in section 6 )

If you have severe liver or severe kidney disease
Page 2 of 8
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Reminyl. This medicine
is only used in
Alzheimer’s disease and is not recommended for other types of memory
loss or confusion.
SERIOUS SIDE EFFECTS
Reminyl can cause serious skin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
REMINYL 4 mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml oral solution contains 4 mg galantamine (as hydrobromide).
Excipients with known effect: methyl parahydroxybenzoate and propyl
parahydroxybenzoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear and colourless oral solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reminyl is indicated for the symptomatic treatment of mild to
moderately severe dementia of the Alzheimer type.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults/Elderly
_Before start of treatment_
The diagnosis of probable Alzheimer type of dementia should be
adequately confirmed according to current clinical
guidelines (see section 4.4).
_Starting dose_
The recommended starting dose is 8 mg/day (4 mg twice a day) for 4
weeks.
_Maintenance dose_
The tolerance and dosing of galantamine should be reassessed on a
regular basis, preferably within 3 months after start
of treatment. Thereafter, the clinical benefit of galantamine and the
patient’s tolerance of treatment should be
reassessed on a regular basis according to current clinical
guidelines. Maintenance treatment can be continued for as
long as therapeutic benefit is favourable and the patient tolerates
treatment with galantamine.
Discontinuation of
galantamine should be considered when evidence of a therapeutic effect
is no longer present or if the patient does not
tolerate treatment.
The initial maintenance dose is 16 mg/day (8 mg twice a day) and
patients should be maintained on 16 mg/day for at
least 4 weeks.
An increases to the maintenance dose of 24 mg/day (12 mg twice a day)
should be considered on an individual basis
after appropriate assessment including evaluation of clinical benefit
and tolerability.
In individual patients not showing an increased response or not
tolerating 24 mg/day, a dose reduction to 16 mg/day
should be considered.
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