Amantadine 100mg capsules

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Amantadine hydrochloride

Tersedia dari:

Alliance Healthcare (Distribution) Ltd

Kode ATC:

N04BB01

INN (Nama Internasional):

Amantadine hydrochloride

Dosis:

100mg

Bentuk farmasi:

Oral capsule

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 04090100

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
Amantadine
Hydrochloride
100mg Capsules
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 Amantadine Capsules are and what they are
used for
2. What you need to know before you take
Amantadine Capsules
3. How to take Amantadine Capsules
4. Possible side effects
5. How to store Amantadine Capsules
6. Contents of the pack and other information
1. What Amantadine Capsules are and what
they are used for
Amantadine is a dopaminergic drug which means it
can increase the levels of certain chemicals which
transmit impulses in the nervous system, including
the brain.
Amantadine hydrochloride 100mg capsules are used:
•
to treat Parkinson’s disease by improving muscle
control and reducing stiffness, shakiness and
shuffling,
2. What you need to know before you take
Amantadine Capsules
Do not take Amantadine Capsules if:
•
you are allergic to amantadine hydrochloride or
any of the other ingredients of this medicine (listed
in section 6),
•
you have/had fits (convulsions), for example
epilepsy,
•
you have ever had an ulcer in your stomach or
small intestine,
•
you have/had any serious kidney disease,
•
you are pregnant or trying to become pregnant
(see Section ‘Pregnancy and breast-feeding’),
•
you are breast-feeding (see Section ‘Pregnancy
and breast-feeding’).
•
you have increased pressure in the eyes
(glaucoma).
Do not take Amantadine Capsules if any of the
above applies to you. If you are not sure, talk to
your doctor or pharmacist

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amantadine Hydrochloride 100mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
hard
gelatin
capsule
contains
100mg
amantadine
hydrochloride
corresponding
to
80.6mg of amantadine.
Excipient with known effect
Each hard gelatin capsule contains 45 mg of lactose (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Brownish-red, size 3 (approximately 15.8 mm in length and 5.85 mm in
diameter), hard
gelatin capsule imprinted AM100 in white on both cap and body.
4.1
THERAPEUTIC INDICATIONS
_PARKINSON'S DISEASE. _
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
_ _
PARKINSON'S DISEASE:
Initially 100mg daily for the first week, increasing to 100mg twice
daily. The dose can be
titrated against signs and symptoms. Doses exceeding 200mg daily may
provide some
additional relief but may also be associated with increasing toxicity.
A dose of 400mg/day
should not be exceeded. The dose should be increased gradually, at
intervals of not less than 1
week.
Since
patients
over
65
years
of
age
tend
to
show
lower
renal
clearance
and
consequently higher plasma concentrations, the lowest effective dose
should be used.
Amantadine acts within a few days but may appear to lose efficacy
within a few months of
continuous treatment. Its effectiveness may be prolonged by withdrawal
for three to four
weeks,
which
seems
to
restore
activity.
During
this
time,
existing
concomitant
antiparkinsonian therapy should be continued, or low dose L-dopa
treatment initiated if
clinically necessary.
Amantadine withdrawal should be gradual, e.g. half the dose at weekly
intervals. Abrupt
discontinuation may exacerbate Parkinsonism, regardless of the
patient’s response to therapy
(see Section 4.4, “Special warnings and precautions for use”).
Combined treatment: any
antiparkinson drug already in use should be continued during initial
Amantadine treatment. It
may then be possible to reduce the other drug gradually. If incr