Amitriptyline 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amitriptyline hydrochloride

Available from:

Bristol Laboratories Ltd

ATC code:

N06AA09

INN (International Name):

Amitriptyline hydrochloride

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100; GTIN: 5060013944963

Patient Information leaflet

1. WHAT AMITRIPTYLINE TABLET IS AND WHAT IT IS
USED FOR
Amitriptyline belongs to a group of drugs called tricyclic
antidepressants (TCADs). It prolongs the effects of
noradrenaline and serotonin (substance which transmit nerve
impulses).
Amitriptyline is used:
• To treat the symptoms of depression
• For the relief of bed-wetting at night by children known as
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AMITRIPTYLINE TABLETS
DO NOT TAKE Amitriptyline tablets and TELL your doctor if you or
your child (if they are the patient):
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Amitriptyline
• Are allergic (hypersensitive) to Amitriptyline, other tricyclic
antidepressants or any of the other ingredients (see Section 6)
• The tablet contain sunset yellow aluminium lake, which may
cause allergic-type reaction
• Suffer from any liver or heart problems (e.g. abnormal heart
rhythm)
• Have HEART DISEASE such as heart block or failure, coronary
artery disease or have recently had a heart attack
• Are taking monoamine oxidase inhibitors (MAOI) or you have
taken MAOIs within the previous 14 days for depression.
• Are you pregnant, trying to become pregnant, or
breastfeeding
• If the CHILD IS UNDER 7 years old.
• Suffer from periods of increased and exaggerated behavior
(mania)
THOUGHTS OF SUICIDE AND WORSENING OF YOUR DEPRESSION OR
ANXIETY DISORDER
If you are depressed and/or have anxiety disorders you can
sometimes have thoughts of harming or killing yourself. These
may be increased when first starting antidepressants, since
these medicines all take time to work, usually about two weeks,
but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing or harming
yourself.
• If you are a young adult. Information from clinical trials has
shown an increased risk o

Summary of Product characteristics

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