Amitriptyline 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amitriptyline hydrochloride

Available from:

Sigma Pharmaceuticals Plc

ATC code:

N06AA09

INN (International Name):

Amitriptyline hydrochloride

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100

Patient Information leaflet

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Amitriptyline Film-coated Tablets
10, 25, 50mg x 28 (UK)
296x210 (Reel Fed)
50979616
Leaflet for Blisters
1332
T. Hull
01/10/19
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approved for print/date
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FMD info
NA (not a carton)

No

Yes
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Details
AMITRIPTYLINE ALL STRENGTHS 28 TABLETS PIL - UK
Black
Profile
BBBA6642
RH
24-10-19
04-02-20
RH
296x210
7pt
Accord Barnstaple
n/a
n/a
04
Version 2
01.11.2017
page 4
page 1
50979616 BBBA6642
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 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 called tricyclic
antidepressant drugs. This medicine is used to treat:
• Depression in adults (major depres

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
AMITRIPTYLINE TABLETS BP 50mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg Amitriptyline Hydrochloride.
Excipient with known effect:
Each tablet contains 84.00 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tan film-coated tablets.
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 100mg – 150mg, divided into
two doses,
depending on individual patient response and tolerability.
Daily doses ab