MONTELUKAST - TRIMA 4 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

MONTELUKAST AS SODIUM SALT

Commercializzato da:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

Codice ATC:

R03DC03

Forma farmaceutica:

CHEWABLE TABLETS

Composizione:

MONTELUKAST AS SODIUM SALT 4 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Gruppo terapeutico:

MONTELUKAST

Area terapeutica:

MONTELUKAST

Indicazioni terapeutiche:

Montelukast - Trima is indicated in adult and pediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including prevention of daytime and nighttime symptoms, the treatment of aspirin-sensitive asthmatic patients, and the prevention of exercise-induced bronchoconstriction. Montelukast - Trima is effective alone or in combination with other agents used in the maintenance treatment of chronic asthma. Montelukast - Trima and inhaled corticosteroids may be used concomitantly with additive effects to control asthma or to reduce the inhaled corticosteroid dose while maintaining clinical stability. Montelukast - Trima is indicated for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.

Data dell'autorizzazione:

2016-10-31

Foglio illustrativo

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed with a doctor’s
prescription only
MONTELUKAST-TRIMA 4 MG
CHEWABLE TABLETS
Each chewable tablet contains montelukast 4 mg
(as sodium)
MONTELUKAST-TRIMA 5 MG
CHEWABLE TABLETS
Each chewable tablet contains montelukast 5 mg
(as sodium)
MONTELUKAST-TRIMA 10 MG
TABLETS
Each tablet contains montelukast 10 mg
(as sodium)
Inactive ingredients and allergens: See section 2
under “Important information about some of this
medicine’s ingredients” and section 6 “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE. This leaflet contains concise
information about the medicine. If you have any
further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if it
seems to you that their medical condition is similar
to yours.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD
KNOW ABOUT THE MEDICINE?
SERIOUS
MENTAL
HEALTH
PROBLEMS
HAVE
HAPPENED IN PEOPLE TAKING MONTELUKAST or
even
after
treatment
has
stopped.
This
can
happen
in
people
with
or
without
a
history
of
mental
health
problems.
Stop
taking
MONTELUKAST-TRIMA and tell your doctor right
away if you or your child have any unusual
changes in behavior or thinking, including any of
the following symptoms:
agitation,
including
aggressive
behavior
or
hostility, attention problems, bad or vivid dreams,
depression,
disorientation
(confusion),
feeling
anxious,
irritability,
hallucinations
(seeing
or
hearing things that are not really there), memory
problems,
obsessive-compulsive
symptoms,
restlessness, sleep walking, stuttering, suicidal
thoughts and actions (including suicide), tremor,
trouble sleeping, uncontrolled muscle movements.
1. WHAT IS THIS MEDICINE INTENDED FOR?
MONTELUKAST-TRIMA is indicated for prophylaxis and
treatment of chronic asthma, including prevention
of daytime and nighttime symptoms, treatment of
aspirin-sensitive as