Amitriptyline 25mg Film-coated Tablets tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amitriptyline (amitriptyline hydrochloride)

Available from:

Accord Healthcare Limited

ATC code:

N06AA09

INN (International Name):

amitriptyline (amitriptyline hydrochloride)

Dosage:

25mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/2x14/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-12-17

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,pharmacist or nurse.
-
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 you doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
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 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 tablets are used in following conditions :
•
to treat the symptoms of depression.
•
for the relief of bed-wetting at night by children known as
nocturnal enuresis.
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 PATIENTS):
•
are allergic (hypersensitive) to amitriptyline, other tricyclic
antidepressants
or
any
of
the
other
ingredients
of
Amitriptyline Tablets (see section 6). The 25mg tablets
contain
sunset
yellow
(E110),
which
may
cause
allergic-type reactions including asthma. Allergy is more
common in people who are allergic to aspirin. An allergic
reaction can include a rash, itching or shortness of breath.
•
have heart disease such as irregular heartbeats, heart
block or failure, coronary artery disease or have recently
had a heart attack
•
suffer
from
periods
of
increased
and
exaggerated
behaviour (mania)
•
hav

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amitriptyline 25mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Amitriptyline HCl 25.00mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Yellow coloured, round, biconvex, film-coated tablet plain on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-Symptoms of depression (especially where sedation is required).
-Nocturnal enuresis where organic pathology is excluded.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
Initially
50-75mg
daily
in
divided
doses
or
as
a
single
dose
at
night,
increasing to 150-200mg daily according to clinical response.
Maintenance dose 50-100mg at night which should be continued for at
least three
months to lessen chances of relapse.
Adolescents and the elderly: 25-50mg daily in divided doses or as a
single dose at
night. Half the normal maintenance dose may be sufficient to produce a
satisfactory
clinical response.
Children: For nocturnal enuresis only. The maximum period of treatment
(including
gradual withdrawal) should not exceed three months. A further course
of treatment
should not be started until a full physical examination, including an
ECG, has been
made.
(11-16 years): 25-50mg daily.
(7-10 years): A more suitable dosage form should be used for this age
group.
(Under 7 years): Not recommended for this age group.
Method of Administration
For oral administration.
4.3.
CONTRAINDICATIONS
•
Hypersensitivity to tricyclic antidepressants or to any of the
ingredients in the tablets
•
Patients
who
are taking
mono-amine
oxidase
inhibitors (MAOIs)
or
who have
received them within the last 14 days ;
•
prior sensitisation to amitriptyline;
•
history of myocardial infarction; arrhythmias; particularly heart
block of any degree,
congestive heart failure, coronary artery insufficiency;
•
mania;
•
severe liver disease, porphyria,
•
children under 7 years.
•
Breast feeding (See also “Use in pregnancy”