REMINYL PRC 16 MG

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

GALANTAMINE AS HYDROBROMIDE

제공처:

J-C HEALTH CARE LTD

ATC 코드:

N06DA04

약제 형태:

CAPSULES PROLONGED RELEASE

구성:

GALANTAMINE AS HYDROBROMIDE 16 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

JANSSEN CILAG S.P.A., ITALY

치료 영역:

GALANTAMINE

치료 징후:

Reminyl is indicated for the smptomatic treatment of mild to moderately severe dementia of the Alzheimer type.

승인 날짜:

2011-12-31

환자 정보 전단

Reminyl SH 10/19
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
REMINYL
® CAPSULES PRC 8 MG
REMINYL
® CAPSULES PRC 16 MG
REMINYL
® CAPSULES PRC 24 MG
Active ingredient and its quantity:
GALANTAMINE (AS HYDROBROMIDE) 8 MG
GALANTAMINE (AS HYDROBROMIDE) 16 MG
GALANTAMINE (AS HYDROBROMIDE) 24 MG
INACTIVE AND ALLERGENIC INGREDIENTS IN THE
PREPARATION – SEE SECTION 2 “IMPORTANT INFORMATION
ABOUT SOME OF THE INGREDIENTS OF THE MEDICINE”,
SECTION 6 “FURTHER INFORMATION”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information
about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for the treatment of
your ailment. Do not pass it on to others. It may harm
them, even if it seems to you that their medical condition
is similar.
The medicine is not intended for children and
adolescents.
1. WHAT IS THE MEDICINE INTENDED FOR?
Reminyl is intended for the treatment of symptoms
(of mild to moderate severity) of dementia associated
with Alzheimer’s disease in adults. This disease affects
brain function and is manifested by symptoms including
gradual impairment of memory, increasing confusion
and behavioral changes that impair day-to-day
functioning.
Reminyl contains the active ingredient galantamine and
is a prolonged-release capsule. That is, the medicine
is released slowly.
THERAPEUTIC GROUP: Anti-dementia medicines
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
• You are sensitive (allergic) to the active ingredient
or to any of the other ingredients contained in the
medicine. For a list of the other ingredients, see
section 6 “Further Information”.
• If you suffer from severe liver or kidney disease.
• If you are breastfeeding.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
Talk to your doctor before taking Reminyl. This
medicine is used only in Alzheimer’s dis

제품 특성 요약

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Reminyl_PRC_SPC 09.19
1.
NAME
OF
THE
MEDICINAL
PRODUCT
REMINYL 8 mg prolonged-release capsules,
REMINYL 16 mg prolonged-release capsules,
REMINYL 24 mg prolonged-release capsules
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each 8 mg capsule contains 8 mg galantamine (as hydrobromide).
Each 16 mg capsule contains 16 mg galantamine (as hydrobromide).
Each 24 mg capsule contains 24 mg galantamine (as hydrobromide).
Excipients with known effect:
8 mg capsule: sucrose 59 mg
16 mg capsule: sucrose 117 mg
24 mg capsule: sucrose 176 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Prolonged-release capsule, hard
8 mg capsule: White opaque, size 4 hard capsules with the inscription
“G8”, containing white to
off-white pellets.
16 mg capsule: Pink opaque, size 2 hard capsules with the inscription
“G16”, containing white to
off-white pellets.
24 mg capsule: Caramel opaque, size 1 hard capsules with the
inscription “G24”, containing white to
off-white pellets.
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).
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Reminyl_PRC_SPC 09.19
_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