Lotprosin XL 16mg capsules
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-11-2018
Summary of Product characteristics
(SPC)
27-12-2018
Active ingredient:
Galantamine hydrobromide
Available from:
Accord-UK Ltd
ATC code:
N06DA04
INN (International Name):
Galantamine hydrobromide
Dosage:
16mg
Pharmaceutical form:
Modified-release capsule
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04110000; GTIN: 5012617022189
Patient Information leaflet
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BBBA3313
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Details
GALANTAMINE LOTPROSTIN XL 8MG, 16MG & 24MG PROLONGED-RELEASE HARD
CAPSULES PIL - UK
Black
BBBA3313
S.Anson
01.11.18
07.11.18
S.Anson
170 x390
7pt
Pharmathen
01.11.18
06.11.18
2
Version 2
01.11.2017
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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,
pharmacist or nurse.
• 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.
• The full name of this medicine is Lotprosin XL
8mg, 16mg and 24mg Prolonged-release Capsules,
hard but within the leaflet it will be referred to as
Lotprosin XL capsules.
WHAT IS IN THIS LEAFLET:
1 WHAT LOTPROSIN XL CAPSULES ARE AND WHAT
THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LOTPROSIN XL CAPSULES
3 HOW TO TAKE LOTPROSIN XL CAPSULES
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE LOTPROSIN XL CAPSULES
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT LOTPROSIN XL CAPSULES ARE AND WHAT
THEY ARE USED FOR
Lotprosin XL capsules contains the active substance
‘galantamine’, an antidementia medicine. It is used in
adults to treat the symptoms of mild to moderately
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lotprosin XL 16mg Prolonged release Capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 16mg capsule contains 16 mg galantamine (as hydrobromide).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged release capsule, hard
16mg: Opaque, flesh size 2 hard gelatine capsules containing two round
biconvex tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lotprosin XL 16mg Prolonged release Capsule 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 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 and patients should be
maintained
on 16 mg/day for at least 4 weeks.
• An increase to the maintenance dose of 24 mg/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.
_ _
_Treatment withdrawal _
• There is no reboun
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