Trilasym 50mg/5ml Oral Solution

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

AMANTADINE HYDROCHLORIDE

זמין מ:

Fontus Health Ltd 70 Northumberland Road Ballsbridge Dublin 4 D04VH66, Ireland

קוד ATC:

N04BB01

INN (שם בינלאומי):

AMANTADINE HYDROCHLORIDE 50 mg/5ml

טופס פרצבטיות:

ORAL SOLUTION

הרכב:

AMANTADINE HYDROCHLORIDE 50 mg/5ml

סוג מרשם:

POM

איזור תרפויטי:

ANTI-PARKINSON DRUGS

מצב אישור:

Withdrawn

תאריך אישור:

2019-05-02

עלון מידע

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRILASYM 50MG/ 5ML ORAL SOLUTION
amantadine 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.
The full name of this medicine is Trilasym 50mg/5ml Oral Solution but
is referred to as Trilasym
Solution within this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Trilasym solution is and what it is used for
2.
What you need to know before you take Trilasym solution
3.
How to take Trilasym solution
4.
Possible side effects
5.
How to store Trilasym solution
6.
Contents of the pack and other information
1.
WHAT TRILASYM SOLUTION IS AND WHAT IT IS USED FOR
Trilasym Solution contains the active substance amantadine. This is a
dopaminergic drug, meaning
that it can increase the levels of certain chemicals that transmit
impulses in the nervous system,
including the brain. It is also an antiviral medicine, which works
against influenza A infections by
stopping the virus from reproducing.
Trilasym Solution can be used:
-
to treat Parkinson’s disease by improving muscle control and
reducing stiffness, shakiness and
shuffling
-
to prevent, or treat the signs and symptoms of, certain influenza
(‘flu) infections (type A)
-
to reduce the pain caused by shingles (herpes zoster), a blistering
skin rash caused by the same
virus that causes chickenpox (the varicella zoster virus)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRILASYM SOLUTION
DO NOT TAKE TRILASYM SOLUTION IF:
-
you are allergic to amantadine hydrochloride or any of the other
ingredients of this medicine
(listed in section

מאפייני מוצר

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trilasym 50 mg/5 ml Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of Oral Solution contains 50 mg of amantadine hydrochloride.
Excipient(s) with known effect:
Each 5 ml also contains:
3250 mg of sorbitol (E420)
10 mg of sodium benzoate (E211)
6.5 mg raspberry flavour containing ethanol, propylene glycol (E 1520)
and benzyl alcohol
For the full list of excipients, see section 6.1
.
3
PHARMACEUTICAL FORM
Oral Solution
Clear, colourless, raspberry-flavoured liquid
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_PROPHYLAXIS AND TREATMENT OF SIGNS AND SYMPTOMS OF INFECTION CAUSED
BY INFLUENZA A VIRUS_
Trilasym is indicated in patients suffering from clinical influenza in
which complications
might be expected to occur.
Additionally, amantadine is recommended prophylactically in cases
particularly at risk,
including:
-
those with chronic respiratory disease or debilitating conditions;
-
the elderly;
-
those living in crowded conditions;
-
individuals in families where influenza has already been diagnosed,
for control of
institutional outbreaks or for those in essential services who are
unvaccinated or when
vaccination is unavailable or contra-indicated.
Trilasym does not completely prevent the host immune response to
influenza A infection, so
individuals who take this drug still develop immune responses to the
natural disease or
vaccination and may be protected when later exposed to antigenically
related viruses.
Trilasym is also indicated in post-exposure prophylaxis in conjunction
with inactivated
vaccine during an outbreak until protective antibodies develop, or in
patients who are not
expected to have a substantial antibody response (immunosuppression).
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_PARKINSON'S DISEASE _
_HERPES ZOSTER _
Trilasym is indicated in elderly or debilitated patients in whom the
physician suspects that a
severe and painful rash could occur. Trilasym can significantly reduce
the proportion of
patients experiencing pain