Amitriptyline 10mg 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:

10mg

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
ELAVIL
Amitriptyline Hydrochloride
PLEASE READ THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE
_WHAT IS IN YOUR MEDICINE? _
The name of this medicine is ELAVIL. It is available in tablets
containing 10 mg and 25 mg of Amitriptyline Hydrochloride,
together with the following ingredients: Lactose, calcium
hydrogen phosphate, maize starch, micro crystalline cellulose,
colloidal anhydrous silica, stearic acid, magnesium stearate,
hydroxymethylpropylcellulose, ethylcellulose, diethyl phthalate
hydroxypropylcellulose (E463) titanium dioxide (E171).
The 10 mg tablet also contains indigo carmine (E132).
The 25 mg tablet also contains quinoline yellow (E104) and
sunset yellow (E110).
ELAVIL 10 mg tablets are round, blue, film-coated tablets,
engraved DDSA. ELAVIL 25 mg tablets are round, yellow, film-
coated tablets engraved DDSA.
Both strengths are available in packs of 100 and 500 tablets.
The manufacturer of ELAVIL tablets is:
DDSA Pharmaceuticals Ltd.,
Chatfield Road, off York Road, London SW11 3SE.
The product licence holder of ELAVIL tablets is:
Chelonia Healthcare Limited,
Boumpoulinas 11, 3rd Floor,
Nicosia, Cyprus, P.C.1060, Cyprus
_WHAT ARE ELAVIL TABLETS FOR? _
ELAVIL belongs to a group of medicines known as the anti-
depressants and is used in the treatment of the symptoms of
depression, especially where sedation is required.
ELAVIL is also effective in treating bedwetting in children (aged
6 years and above), known as nocturnal enuresis.
_CHECK BEFORE YOU TAKE ELAVIL _
Before taking this medicine, tell your doctor if you have ever
had any unusual or allergic reactions to Amitriptyline, or to any
of the other ingredients of ELAVIL.
If your doctor has told you that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
Sunset yellow E110 may cause allergic reactions.
Also tell your doctor if you are pregnant, likely to become
pregnant, or are breast-feeding a baby.
AMITRIPTYLINE SHOULD NOT BE GIVEN TO CHILDREN BELOW 6
YEARS.
Bec

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ELAVIL/Amitriptyline Tablets 10 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amitriptyline HCl BP 10.00 mg
3
PHARMACEUTICAL FORM
Film-coated Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptoms of depression (especially where sedation is required).
Amitriptyline is
indicated for the treatment of 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 (used only as third line therapy).
Amitriptyline
should
only
be
prescribed
by
a
healthcare
professional
with
expertise
in
the
management of persistent enuresis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS:_
INITIAL DOSE:
Usually 75 mg daily in divided doses (or a single dose at night). This
may be
increased if necessary to a total of 150-200 mg a day, with the
additional doses being
given in the late afternoon and/or at bedtime.
The sedative effect is usually rapidly apparent, while antidepressant
activity may be
seen within three or four days or may take up to 30 days to develop
adequately.
MAINTENANCE DOSE:
The usual maintenance dosage is 50-100 mg daily. The total dosage may
be given in a
single dose preferably in the evening or at bedtime. When satisfactory
improvement
has been reached, dosage should be reduced to the lowest amount that
will maintain
relief of symptoms. Maintenance therapy should be continued for three
months or
longer to lessen chances of relapse.
_ELDERLY: _
In general lower dosages are recommended for these patients, as they
are more prone
to side effects, especially confusion, agitation and postural
hypotension. An initial
dosage of 10-25 mg three times daily is recommended, which should be
increased
slowly. A daily dosage of 50 mg may be satisfactory in elderly
patients who may not
tolerate higher dosages. The required dosage may be administered
either as divided
doses or a single dose preferably in the evening or at bedtime.
_CHILDREN: _
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