Mylatrip 2.5mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Frovatriptan succinate monohydrate

Disponível em:

Viatris UK Healthcare Ltd

Código ATC:

N02CC07

DCI (Denominação Comum Internacional):

Frovatriptan succinate monohydrate

Dosagem:

2.5mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 04070401; GTIN: 5016695006789

Folheto informativo - Bula

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYLATRIP 2.5 MG FILM-COATED TABLETS
frovatriptan
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 Mylatrip is and what it is used for
2.
What you need to know before you take Mylatrip
3.
How to take Mylatrip
4.
Possible side effects
5.
How to store Mylatrip
6.
Contents of the pack and other information
1.
WHAT MYLATRIP IS AND WHAT IT IS USED FOR
Mylatrip contains the active ingredient frovatriptan which belongs to
a group of medicines called triptans.
Mylatrip is used to treat migraine headache in adults.

Migraine symptoms may be caused by the widening of blood vessels in
the head. Mylatrip is
thought to reduce the widening of these blood vessels. This helps to
take away the headache and
other symptoms of a migraine attack, such as feeling or being sick
(nausea or vomiting) and being
sensitive to light and sound.

Mylatrip works only when a migraine headache has started. You should
not take Mylatrip to prevent
migraines occuring.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYLATRIP
DO NOT TAKE MYLATRIP
-
if you are allergic to frovatriptan or any of the other ingredients of
this medicine (listed in section 6).
-
if you have moderately high or very high blood pressure or mild high
blood pressure that is not being
treated.
-
if you have or have had heart disease, a heart attack, angina (chest
pain as a result of lack of oxygen in
the heart muscle) or other signs of coronary heart disease such as
breathlessness, extreme tiredness or

Características técnicas

OBJECT 1
MYLATRIP 2.5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 25-Sep-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Mylatrip 2.5 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 2.5 mg frovatriptan as frovatriptan
succinate monohydrate.
Excipient with known effect:
Each film-coated tablet contains 107.09 mg lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
White to off white, film-coated, round, biconvex tablet debossed with
“M” on one side of the tablet “FR”
over “2.5” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Acute treatment of the headache phase of migraine attacks with or
without aura.
Frovatriptan is indicated in adults.
4.2 Posology and method of administration
Posology
Frovatriptan should be taken as early as possible after the onset of a
migraine attack but it is also effective
when taken at a later stage. Frovatriptan should not be used
prophylactically.
If a patient does not respond to the first dose of frovatriptan, a
second dose should not be taken for the
same attack, since no benefit has been shown. Frovatriptan may be used
for subsequent migraine attacks.
_Adults (18 to 65 years of age)_
The recommended dose of frovatriptan is 2.5 mg.
If the migraine recurs after initial relief, a second dose may be
taken, providing there is an interval of at
least 2 hours between the two doses.
The total daily dose should not exceed 5 mg per day.
_Paediatric population_ (under 18 years)
The safety and efficacy of frovatriptan in children and adolescents
below the age of 18 years have not
been established. Therefore, its use in this age group is not
recommended. No data are available.
_Older people (over 65 years)_
Frovatriptan data in patients over 65 years remain limited. Therefore,
its use in this category of patients is
not recommended.
_Renal impairment_
No dosage adjustment is required in patients with renal impairment
(see sect