Galantamine Pharmathen 8mg prolonged-release capsules hard

国: アルメニア

言語: 英語

ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有効成分:

galantamine (galantamine hydrobromide)

から入手可能:

Pharmaten International S.A. Industrial Park Sapes

INN（国際名）:

galantamine (galantamine hydrobromide)

投薬量:

8mg

医薬品形態:

capsules prolonged-release, hard

処方タイプ:

Prescription

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
GALANTAMINE PHARMATHEN 8MG PROLONGED-RELEASE
CAPSULES, HARD
GALANTAMINE PHARMATHEN 16MG PROLONGED-RELEASE
CAPSULES, HARD
Galantamine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
• 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. Do not pass
it on to others. It may harm them, even if their symptoms
are the same as yours.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1. What Galantamine Pharmathen is and what it is used
for
2. Before you take Galantamine Pharmathen
3. How to take Galantamine Pharmathen
4. Possible side effects
5. How to store Galantamine Pharmathen
6. Further information
1. WHAT GALANTAMINE PHARMATHEN IS AND
WHAT IT IS USED FOR
Galantamine Pharmathen is an antidementia medicine
used to treat the symptoms of mild to moderately severe
dementia of the Alzheimer type, a disease that alters brain
function.
The symptoms of Alzheimer’s disease include increasing
memory loss, confusion and
behavioral changes. As a result, it becomes more and
more difficult to carry out normal
daily activities.
These symptoms are believed to be due to a lack of
acetylcholine, a substance responsible for
sending messages between brain cells. Galantamine
Pharmathen increases the amount of acetylcholine in the
brain and so could improve the symptoms of the disease.
2. BEFORE YOU TAKE GALANTAMINE PHARMA-
THEN
DO NOT TAKE GALANTAMINE PHARMATHEN
• If you are allergic (hypersensitive) to galantamine or to
any of the other ingredients listed in section 6 of this
leaflet
• If you have severe liver and/or severe kidney disease.
TAKE SPECIAL CARE WITH GALANTAMINE PHARMATHEN
Galantamine Pharmathen should be used in Alzheimer’s
disease and not other forms of memory loss or confusion.
Medicines are not always suitable for every

製品の特徴

1
1. NAME OF THE MEDICINAL PRODUCT
Galantamine Pharmathen 8 mg prolonged release capsules, hard
Galantamine Pharmathen 16 mg prolonged release capsules, hard
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).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Prolonged release capsule, hard
8mg: Opaque white size 2 hard gelatine capsules containing one round
biconvex tablet
16mg: Opaque, flesh size 2 hard gelatine capsules containing two round
biconvex tablets
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Galantamine Pharmathen is indicated for the symptomatic treatment of
mild to moderately severe
dementia of the Alzheimer type.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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
three months after start of treatment. Thereafter, the clinical
benefit of galantamine and the patient's
2
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 no