Amitriptyline 25mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Amitriptyline hydrochloride

Disponible des:

Genesis Pharmaceuticals Ltd

Codi ATC:

N06AA09

Designació comuna internacional (DCI):

Amitriptyline hydrochloride

Dosis:

25mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04030100; GTIN: 5060014441652

Informació per a l'usuari

MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Relonchem Limited,
Cheshire House,
Gorsey lane,
Widnes, WA8 0RP,
United Kingdom.
Date leaflet revised: October 2018
AMITRIPTYLINE 25MG TABLETS
Amitriptyline hydrochloride
PATIENT INFORMATION LEAFLET
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.
•
• 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:
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
DO NOT TAKE AMITRIPTYLINE TABLETS IF YOU:
•
Prolonged QT interval
A heart problem called "prolonged QT interval" (which is
shown
on
your
electrocardiogram,
ECG)
and
heart
rhythm disorders (rapid or irregular heart beat) have
been reported with Amitriptyline Tablets. Tell your
doctor if you:
Amitriptyline
belongs
to
a
group
of
medicines
called
tricyclic antidepressant drugs. These medicines alter the
levels of chemicals in the brain to relieve the symptoms of
depression. Amitriptyline 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
•
• have slow heart rate,
•
• are taking any other medication that may cause heart
problems, or
•
have a problem that gives you a low level of potassium
or magnesium, or a high level of potassium in your
blood.
•
• have an over active thyroid gland or receive thyroid
medication.
THOUGHTS
OF
SUICIDE
AND
WORSENING
OF
YOUR
DEPRESSION
You may be more likely to think like this:
• If you have previously had thoughts about killing or
harming yourself.
If you have thoug

Fitxa tècnica

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