Amitriptyline 50mg 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:

50mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04030100; GTIN: 5012727904771

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
Amitriptyline 50mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMITRIPTYLINE HYDROCHLORIDE 50MG.
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Amitriptyline 50mg Tablets BP are buff film coated circular biconvex
tablets
with A on one face and 50 on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amitriptyline is indicated for:
•
the treatment of major depressive disorder in adults
•
the treatment of neuropathic pain in adults
•
the prophylactic treatment of chronic tension type headache (CTTH) in
adults
•
the prophylactic treatment of migraine in adults
•
the treatment of nocturnal enuresis in children aged 6 years and above
when
organic pathology, including spina bifida and related disorders, have
been excluded
and no response has been achieved to all other non-drug and drug
treatments,
including antispasmodics and vasopressin-related products. This
medicinal product
should only be prescribed by a healthcare professional with expertise
in the
management of persistent enuresis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Not all dosage schemes can be achieved with all the pharmaceutical
forms/strengths.
The appropriate formulation/strength should be selected for the
starting doses and any
subsequent dose increments.
_Major depressive disorder_
Dosage should be initiated at a low level and increased gradually,
noting carefully the
clinical response and any evidence of intolerability.
_Adults_
Initially 25 mg 2 times daily (50 mg daily). If necessary, the dose
can be increased by 25
mg every other day up to 150 mg daily divided into two doses.
The maintenance dose is the lowest effective dose.
_Elderly patients over 65 years of age and patients with
cardiovascular disease_
Initially 10 mg – 25 mg daily.
The daily dose may be increased up to 100 mg – 150 mg divided into
two doses,
depending on individual patient response and tolerability.
Doses above 10