Amitriptyline 25mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Amitriptyline hydrochloride

Saatavilla:

Accord-UK Ltd

ATC-koodi:

N06AA09

INN (Kansainvälinen yleisnimi):

Amitriptyline hydrochloride

Annos:

25mg

Lääkemuoto:

Oral tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 04030100; GTIN: 5060149310199

Pakkausseloste

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Amitriptyline, Film-Coated Tabs,
10, 25, 50mg, 28 - UK
296x210 (Reel Fed)
51009451
Leaflet for Blisters
1731
RH
06-12-21
* Please note that ONLY Artwork Studio is permitted to make changes to
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approved for print/date
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DATE SENT:
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REVISION DATE:
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MIN BODY TEXT SIZE:
SUPPLIER:
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[e-mail]
AMITRIPTYLINE ALL STRENGTHS TABLET PIL - UK
Black
Profile
BBBB3435
M.Doak
08/12/2021
13/12/2021
M.Doak
296x210mm
7pt
Accord Barnstaple
N/A
N/A
3
Version 7
12.02.2020
German GTIN 14
(incorporating PZN):
N/A
Cartons and label leaflets only
(labels only when specified)
page 4
page 1
51009451 BBBB3435
AMITRIPTYLINE 10MG, 25MG
AND 50MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amitriptyline Tablets Bp 25mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg Amitriptyline Hydrochloride.
Excipient with known effect:
Each tablet contains 42.00mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, circular, biconvex, film-coated tablets, impressed “C” on
one face and
the identifying letters “AB” on the reverse.
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 incr