ALMOTRIPTAN

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

ALMOTRIPTAN MALATE

Pieejams no:

Chanelle Medical

ATĶ kods:

N02CC05

SNN (starptautisko nepatentēto nosaukumu):

ALMOTRIPTAN MALATE

Deva:

12.5 Milligram

Zāļu forma:

Film Coated Tablet

Receptes veids:

Product subject to prescription which may be renewed (B)

Ārstniecības joma:

almotriptan

Autorizācija statuss:

Not Marketed

Autorizācija datums:

2013-11-15

Lietošanas instrukcija

ID:PL170M – { ES/H/0232/001/DC }
VERSION: 06
REVIEWED DATE: 27/04/2018
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALMOTRIPTAN 12.5MG FILM-COATED TABLETS
Almotriptan
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 Almotriptan 12.5 mg Film-coated tablets is and what it is used
for
2.
What you need to know before you take Almotriptan 12.5 mg Film-coated
tablets
3.
How to take Almotriptan 12.5 mg Film-coated tablets
4.
Possible side effects
5.
How to store Almotriptan 12.5 mg Film-coated tablets
6.
Contents of the pack and other information
1.
WHAT ALMOTRIPTAN 12.5 MG FILM-COATED TABLETS IS AND WHAT IT IS USED
FOR
Almotriptan 12.5 mg Film-coated tablets is an antimigraine agent which
belongs to a class of
compounds known as selective serotonin receptor agonists. Almotriptan
12.5 mg Film-coated tablets
is believed to reduce the inflammatory response associated with
migraines by binding to the serotonin
receptors in the brain (cranial) blood vessels and causing them to
narrow.
Almotriptan 12.5 mg Film-coated tablets is used to relieve headaches
associated with migraine attacks
with or without aura
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALMOTRIPTAN 12.5 MG FILM-COATED
TABLETS
DO NOT TAKEALMOTRIPTAN 12.5 MG FILM-COATED TABLETS
— if you are allergic to almotriptan or any of the ingredients of
this medicine (listed in section 6)
— if you have or have ever suffered from diseases that restrict the
blood supply to the heart such as:

heart attack

chest pain or discomfort that normally occurs

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Almotriptan 12.5mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablets contains 12.5 mg almotriptan as almotriptan
malate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white coloured, round, biconvex, film coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute treatment of the headache phase of migraine attacks with or
without aura.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Almotriptan 12.5mg Film-coated tablets should be taken with liquids as
early as possible after the onset of migraine-
associated headache but it is also effective when taken at a later
stage.
Almotriptan should not be used for migraine prophylaxis.
_Adults (18-65 years of age)_
The recommended dose is one tablet containing 12.5 mg of almotriptan.
A second dose may be taken if the symptoms
reappear within 24 hours. This second dose may be taken provided that
there is a minimum interval of two hours
between the two doses.
The efficacy of a second dose for the treatment of the same attack
when an initial dose is ineffective has not been
examined in controlled trials. Therefore if a patient does not respond
to the first dose, a second dose should not be
taken for the same attack.
The maximum recommended dose is two doses in 24 hours.
_Paediatric population_
_Children and adolescents (under 18 years of age)_
There are no data concerning the use of almotriptan in children and
adolescents, therefore its use in this age group is
not recommended.
_Elderly (over 65 years of age)_
No dosage adjustment is required in the elderly. The safety and
effectiveness of almotriptan in patients older than 65
years has not been systematically evaluated.
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