Amitriptyline 10mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Amitriptyline hydrochloride

제공처:

Wockhardt UK Ltd

ATC 코드:

N06AA09

INN (국제 이름):

Amitriptyline hydrochloride

복용량:

10mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04030100; GTIN: 5012727904689

환자 정보 전단

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amend
READ ALL OF THIS LEAFLET
CAREFULLY BEFORE YOU
START TO TAKE 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 Amitriptyline Tablets are and what they are used for
2. What you need to know before you take Amitriptyline Tablets
3. How to take Amitriptyline Tablets
4. Possible side effects
5. How to store Amitriptyline Tablets
6. Contents of the pack and other information
1. WHAT AMITRIPTYLINE TABLETS ARE AND WHAT THEY ARE
USED FOR
Amitriptyline belongs to a group of medicines known as
tricyclic antidepressants.
This medicine is used to treat:
• Depression in adults (major depressive episodes)
• Neuropathic pain in adults
• Chronic tension type headache prophylaxis in adults
• Migraine prophylaxis in adults
• Bed-wetting at night in children aged 6 years and above,
only when organic causes, such as spina bifida and
related disorders, have been excluded and no response
has been achieved to all other non-drug and drug
treatments, including muscle relaxants and
desmopressin. This medicine should only be prescribed
by doctors with expertise in treating patients with
persistent bed-wetting.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AMITRIPTYLINE TABLETS
DO NOT TAKE AMITRIPTYLINE TABLETS:
• if you are allergic to amitriptyline or any of the other
ingredients of this medicine (listed in section 6)
• if you recently have had a heart attack (myocardial
infarction)
• if you have heart problems such as disturbances

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ELAVIL/Amitriptyline Tablets 10 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amitriptyline HCl BP 10.00 mg
3
PHARMACEUTICAL FORM
Film-coated Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptoms of depression (especially where sedation is required).
Amitriptyline is
indicated for the treatment of nocturnal enuresis in children aged 6
years and above
when organic pathology has been excluded and no response has been
achieved to all
other non


drug and drug treatments (used only as third line therapy).
Amitriptyline
should
only
be
prescribed
by
a
healthcare
professional
with
expertise
in
the
management of persistent enuresis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS:_
INITIAL DOSE:
Usually 75 mg daily in divided doses (or a single dose at night). This
may be
increased if necessary to a total of 150-200 mg a day, with the
additional doses being
given in the late afternoon and/or at bedtime.
The sedative effect is usually rapidly apparent, while antidepressant
activity may be
seen within three or four days or may take up to 30 days to develop
adequately.
MAINTENANCE DOSE:
The usual maintenance dosage is 50-100 mg daily. The total dosage may
be given in a
single dose preferably in the evening or at bedtime. When satisfactory
improvement
has been reached, dosage should be reduced to the lowest amount that
will maintain
relief of symptoms. Maintenance therapy should be continued for three
months or
longer to lessen chances of relapse.
_ELDERLY: _
In general lower dosages are recommended for these patients, as they
are more prone
to side effects, especially confusion, agitation and postural
hypotension. An initial
dosage of 10-25 mg three times daily is recommended, which should be
increased
slowly. A daily dosage of 50 mg may be satisfactory in elderly
patients who may not
tolerate higher dosages. The required dosage may be administered
either as divided
doses or a single dose preferably in the evening or at bedtime.
_CHILDREN: _
N