Almogran 12.5mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Almotriptan hydrogen malate

Tilgjengelig fra:

Almirall Ltd

ATC-kode:

N02CC05

INN (International Name):

Almotriptan hydrogen malate

Dosering :

12.5mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04070401; GTIN: 5050768010242 5050768010259 5050768010266

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALMOGRAN
® 12.5MG TABLETS
almotriptan (as almotriptan D, L- hydrogen malate)
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 your doctor, pharmacist
or nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
The name of your medicine is Almogran 12.5mg Tablets but
will be referred to as Almogran throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Almogran is and what it is used for
2.
What you need to know before you take Almogran
3.
How to take Almogran
4.
Possible side effects
5.
How to store Almogran
6.
Contents of the pack and other information
1. WHAT ALMOGRAN IS AND WHAT IT IS USED FOR
Almogran is an anti-migraine agent which belongs to a class
of compounds known as selective serotonin receptor
agonists. Almogran 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.
Almogran is used to relieve headaches associated with
migraine attacks with or without aura.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ALMOGRAN
DO NOT TAKE ALMOGRAN
−
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 with
activity or stress
•
heart problems without pain
•
chest pain that occurs when you are resting
•
severe hypertension (severe high blood pressure)
•
uncontrolled mild or moderate high blood pressure.
−
i

Preparatomtale

OBJECT 1
ALMOGRAN 12.5 MG FILM-COATED TABLET
Summary of Product Characteristics Updated 20-Jul-2015 | Almirall
Limited
1. Name of the medicinal product
Almogran/Amignul/Almotrex 12.5 mg Film-coated tablet.
2. Qualitative and quantitative composition
Each tablet contains almotriptan 12.5 mg as almotriptan D,L-hydrogen
malate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White, circular, biconvex film-coated tablet with an "A" engraved on
one side.
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
Almogran/Amignul/Almotrex 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.
The tablets can be taken with or without food.
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.
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.
Renal Impairment
Dosage adjustment is not required in patients with mild or moderate
renal impairment. Patients with
seve