Arrow - Amitriptyline

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Amitriptyline hydrochloride 50mg;  ;  ;  ; Amitriptyline hydrochloride 50mg

Dostępny od:

Teva Pharma (New Zealand) Limited

INN (International Nazwa):

Amitriptyline hydrochloride 50 mg

Dawkowanie:

50 mg

Forma farmaceutyczna:

Film coated tablet

Skład:

Active: Amitriptyline hydrochloride 50mg       Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Iron oxide red Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Microcrystalline cellulose Purified talc   Quinoline yellow Titanium dioxide Active: Amitriptyline hydrochloride 50mg Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Indigo carmine aluminium lake Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Microcrystalline cellulose Purified talc   Sunset yellow FCF Titanium dioxide

Sztuk w opakowaniu:

Blister pack, PVC/Aluminium, 30 tablets

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

Vasudha Pharma Chem Limited

Wskazania:

For the treatment of depression.

Podsumowanie produktu:

Package - Contents - Shelf Life: Blister pack, PVC/Aluminium - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/Aluminium - 50 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/Aluminium - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture

Data autoryzacji:

2011-09-27

Ulotka dla pacjenta

CONSUMER MEDICINE INFORMATION
ARROW - AMITRIPTYLINE
Amitriptyline hydrochloride 10 mg, 25 mg and 50 mg film-coated tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ARROW -
AMITRIPTYLINE. It does not contain all the information available on
this
medicine. It does not take the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of using ARROW – AMITRIPTYLINE
against the benefits expected it will have for you. If you have any
concerns
about using this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may want to read it again.
WHAT ARROW - AMITRIPTYLINE IS USED FOR
Your ARROW - AMITRIPTYLINE tablets contain amitriptyline
hydrochloride. It
belongs to a group of medicines known as tricyclic antidepressants
(TCAs).
ARROW - AMITRIPTYLINE is used to treat depression. Depression involves
emotional and physical symptoms such as feeling low in spirit, loss of
interest
in activities, being unable to enjoy life, poor appetite or
overeating, disturbed
sleep, often waking up early, loss of sex drive, lack of energy and
feeling
guilty over nothing.
Your doctor may, however, prescribe ARROW - AMITRIPTYLINE for another
reason. Ask your doctor if you have any questions about why ARROW -
AMITRIPTYLINE has been prescribed for you.
ARROW - AMITRIPTYLINE IS NOT RECOMMENDED FOR USE IN CHILDREN 12
YEARS OF AGE AND UNDER. ARROW - AMITRIPTYLINE IS NOT RECOMMENDED
FOR USE IN ADOLESCENTS (13-18 YEARS OF AGE) FOR THE TREATMENT OF
DEPRESSION, UNLESS UNDER THE SUPERVISION OF A SPECIALIST.
ARROW - AMITRIPTYLINE is available on prescription from your doctor.
BEFORE YOU TAKE ARROW - AMITRIPTYLINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ARROW - AMITRIPTYLINE IF:
•
You are allergic to amitriptyline, other tricyclic antidepressants or
any other
ingredients listed at the end of this leaflet
•
YOU ARE TAKING ANOTHER MEDICINE FOR DEPRESSION CALLED A MONOAMINE
OXIDASE INHIBITOR (MAOI) OR HAVE BEEN TAKING A MAOI WITHIN THE LAST
14 DAYS.

Charakterystyka produktu

Version 1.3
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Arrow-Amitriptyline
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg, 25 mg or 50 mg of amitriptyline
hydrochloride.
Excipient with known effect:
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Arrow-Amitriptyline 10mg tablets are blue coloured, circular biconvex
film-coated tablets with
“IA” embossed on one side and plain on the other side
10
Arrow-Amitriptyline 25mg tablets are yellow coloured, circular
biconvex film-coated tablets with
“IA” embossed on one side and plain on the other side.
25
Arrow-Amitriptyline 50mg tablets are brown coloured, circular biconvex
film-coated tablets with
“IA” embossed on one side and plain on the other side.
50
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Arrow-Amitriptyline is recommended for the treatment of depression.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
DEPRESSION
Dosage should be initiated at a low level and increased gradually,
noting carefully the clinical
response and any evidence of intolerance.
ADULTS
_Outpatients _
Initially, 75mg of amitriptyline a day in divided doses is usually
satisfactory. If necessary, this may be
increased to a total of 150mg a day. Increases are made preferably in
the late afternoon and/or
bedtime doses. The sedative effect is usually rapidly apparent. The
antidepressant activity may be
evident within 3 or 4 days or may take up to 30 days to develop
adequately.
Alternate methods of initiating therapy in outpatients are to begin
therapy with 50 to 100mg
amitriptyline preferably in the evening or at bedtime; this may be
increased by 25 to 50mg as
necessary to a total of 150mg per day. Initiate therapy with one 75mg
capsule or tablet preferably in
the evening or at bedtime and increase, if necessary, to two, or one
in the morning and one in the
evening.
_Hospitalised Patients _
100mg a day may be required initially. This can be increased gradually
to 200mg a day if necessary.
A small number of hospitalised patien