Amitriptyline 25mg 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:

25mg

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

PATIENT INFORMATION LEAFLET
AMITRIPTYLINE 25 MG TABLETS
AMITRIPTYLINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
IT CONTAINS IMPORTANT INFORMATION.
•
Keep this leaflet. You may want to read it again.
•
If you have any other questions, or if there is something you do not
understand, please ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Never give it to
someone else. It may not be the right medicine for 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 is and what it is 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 IS AND WHAT IT IS USED FOR
:
•
Amitriptyline belongs to a group of drugs called tricyclic
antidepressants (TCADs). It prolongs the effect of noradrenaline and
serotonin levels (substances which transmit nerve impulses) in the
brain
to relieve the symptoms of depression.
•
Amitriptyline is used to treat depression. It is also used to treat
night
bedwetting in children aged 6 years and above as third line therapy
only.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMITRIPTYLINE
TABLETS
DO NOT TAKE THIS MEDICINE IF YOU:
•
have previously suffered an ALLERGIC REACTION to a medicine containing
Amitriptyline or other anti-depressant medicines
•
are allergic to any of the other ingredients of this tablet (See
section 6
further information)
•
suffer from any severe LIVER DISEASE
•
or the patient is under 6 years of age
•
suffer from HEART PROBLEMS (e.g. abnormal heart beats, coronary artery
disease)
•
have suffered a HEART ATTACK within the last three months
•
are taking or have you recently taken (within the last 14 days) an

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