Amirol 25 Tablets

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

AMITRIPTYLINE HYDROCHLORIDE

Доступна с:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

код АТС:

N06AA09

ИНН (Международная Имя):

AMITRIPTYLINE HYDROCHLORIDE 25 mg

Фармацевтическая форма:

FILM-COATED TABLET

состав:

AMITRIPTYLINE HYDROCHLORIDE 25 mg

Тип рецепта:

POM

Терапевтические области:

PSYCHOANALEPTICS

Статус Авторизация:

Authorised

Дата Авторизация:

2007-02-28

тонкая брошюра

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1 OF 11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMIROL 10 MG FILM-COATED TABLETS
AMIROL 25 MG FILM-COATED TABLETS
Amitriptyline hydrochloride
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.
-
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 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 Amirol is and what it is used for
2.
What you need to know before you take Amirol
3.
How to take Amirol
4.
Possible side effects
5.
How to store Amirol
6.
Contents of the pack and other information
1.
WHAT AMIROL IS AND WHAT IT IS USED FOR
Amirol belongs to a group of medicines known as tricyclic
antidepressants.
This medicine 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.
•
bed-wetting at night in children aged 6 years and above, only when
organic causes, such
as spina bifida and related disorders, have been excluded and no
response has been
achieved to all other non-drug and drug treatments, including muscle
relaxants and
desmopressin. This medicine should only be prescribed by doctors with
expertise in
treating patients with persistent bed-wetting.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMIROL
DO NOT TAKE AMIROL:
•
if you are allergic to amitriptyline or any of the other ingredients
of this medicine (listed
in section 6).
•
if you recently have had a heart attack (myocardial infarction).
•
if you have heart problems such as disturbances in heart rhythm which
are seen on an
electrocardiogram (ECG), heart block, or co

Характеристики продукта

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amirol 10 mg film-coated tablets
Amirol 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amirol 10 mg film-coated tablets: Each film-coated tablet contains
Amitriptyline
Hydrochloride 10mg.
Amirol 25 mg film-coated tablets: Each film-coated tablet contains
Amitriptyline
Hydrochloride 25mg
Excipient with known effect
Amirol 10 mg film-coated tablets: Each film-coated tablet contains
58,4 mg of lactose
monohydrate.
Amirol 25 mg film-coated tablets: Each film-coated tablet contains
96,6 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Amirol 10 mg film-coated tablets: Light blue, round, film-coated
tablets.
Amirol 25 mg film-coated tablets: Yellow, round, film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amirol 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
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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