SINGULAIR 5 MG CHEWABLE TABLETS

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

MONTELUKAST AS SODIUM

可用日期:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC代码:

R03DC03

药物剂型:

CHEWABLE TABLETS

组成:

MONTELUKAST AS SODIUM 5 MG

给药途径:

PER OS

处方类型:

Required

厂商:

ORGANON LLC, USA

治疗组:

MONTELUKAST

治疗领域:

MONTELUKAST

疗效迹象:

Singulair 5 mg is indicated in adult and pediatric patients 6 years of age and older for the prophylaxis and chronic treatment of asthma including prevention of daytime and nighttime symptoms of the treatment of aspirin-sensitive asthmatic patients and the prevention of exercise-induced bronchoconstriction. Singulair is effective alone or in combination with other agents used in the maintenance treatment of chronic asthma. Singulair and inhaled corticosteroids may be used concomitantly with additive effects to control asthma or to reduce the inhaled corticosteroid dose while maintaining clinical stability. Singulair is indicated for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.Because the benefits of SINGULAIR may not outweigh the risk of neuropsychiatric symptoms in patients with seasonal rhinitis [see Warnings and Precautions (5.1)], reserve use for patients who have an intolerance to alternative therapies.

授权日期:

2023-03-31

资料单张

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine can be sold under doctor's prescription only
SINGULAIR
 4 MG
GRANULES FOR KIDDIES
Each sachet of granules contains:
Montelukast (as sodium) 4 mg
SINGULAIR
 4 MG
CHEWABLE TABLETS FOR
PRE-SCHOOL KIDS
Each chewable tablet contains:
Montelukast (as sodium) 4 mg
SINGULAIR
® 5 MG
CHEWABLE TABLETS
Each chewable tablet contains:
Montelukast (as sodium) 5 mg
SINGULAIR
® 10 MG
TABLETS
Each tablet contains:
Montelukast (as sodium) 10 mg
For a list of inactive ingredients please refer to section 6.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about SINGULAIR. 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 their
ailment seems similar to yours.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SINGULAIR?
•
SERIOUS MENTAL HEALTH PROBLEMS HAVE HAPPENED IN PEOPLE TAKING
SINGULAIR or even after treatment
has stopped. This can happen in people with or without a history of
mental health problems. Stop taking
SINGULAIR and tell your healthcare provider right away if you or your
child have any unusual changes in
behavior or thinking, including any of these 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 SINGULAIR IS AND WHAT IT IS USED FOR?
SINGULAIR is indicated for the prophylaxis and chronic treatment of
asthma, including prevention of daytime
and nighttime symptoms, the treatment of aspirin-sensitive asthmatic
patient

产品特点

1
[Organon] Confidential
[Organon] Confidential
SINGULAIR

4 MG
GRANULES FOR KIDDIES
Each sachet of granules contains:
Montelukast 4 mg (as sodium salt)
SINGULAIR

4 MG
CHEWABLE TABLETS FOR PRE-SCHOOL KIDS
Each chewable tablet contains:
Montelukast 4 mg (as sodium salt)
SINGULAIR
®
5 MG
CHEWABLE TABLETS
Each chewable tablet contains:
Montelukast 5 mg (as sodium salt)
SINGULAIR
®
10 MG
TABLETS
Each tablet contains:
Montelukast 10 mg (as sodium salt)
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS
SERIOUS NEUROPSYCHIATRIC (NP) EVENTS HAVE BEEN REPORTED WITH THE USE
OF SINGULAIR. THE TYPES
OF EVENTS REPORTED WERE HIGHLY VARIABLE, AND INCLUDED, BUT WERE NOT
LIMITED TO, AGITATION,
AGGRESSION, DEPRESSION, SLEEP DISTURBANCES, SUICIDAL THOUGHTS AND
BEHAVIOR (INCLUDING SUICIDE).
THE MECHANISMS UNDERLYING NP EVENTS ASSOCIATED WITH SINGULAIR USE ARE
CURRENTLY NOT WELL
UNDERSTOOD _[SEE WARNINGS AND PRECAUTIONS (5.1)]_.
BECAUSE OF THE RISK OF NP EVENTS, THE BENEFITS OF SINGULAIR MAY NOT
OUTWEIGH THE RISKS IN SOME
PATIENTS, PARTICULARLY WHEN THE SYMPTOMS OF DISEASE MAY BE MILD AND
ADEQUATELY TREATED WITH
ALTERNATIVE THERAPIES. RESERVE USE OF SINGULAIR FOR PATIENTS WITH
ALLERGIC RHINITIS WHO HAVE AN
INADEQUATE RESPONSE OR INTOLERANCE TO ALTERNATIVE THERAPIES _[SEE
INDICATIONS AND USAGE (1.3)]_. IN
PATIENTS WITH ASTHMA OR EXERCISE-INDUCED BRONCHOCONSTRICTION, CONSIDER
THE BENEFITS AND RISKS
BEFORE PRESCRIBING SINGULAIR.
DISCUSS THE BENEFITS AND RISKS OF SINGULAIR WITH PATIENTS AND
CAREGIVERS WHEN PRESCRIBING
SINGULAIR. ADVISE PATIENTS AND/OR CAREGIVERS TO BE ALERT FOR CHANGES
IN BEHAVIOR OR NEW NP
SYMPTOMS WHEN TAKING SINGULAIR. IF CHANGES IN BEHAVIOR ARE OBSERVED,
OR IF NEW NP SYMPTOMS
OR SUICIDAL THOUGHTS AND/OR BEHAVIOR OCCUR, ADVISE PATIENTS TO
DISCONTINUE SINGULAIR AND
CONTACT A HEALTHCARE PROVIDER IMMEDIATELY _[SEE WARNINGS AND
PRECAUTIONS (5.1)]_.
1
THERAPEUTIC INDICATIONS
SINGULAIR 4 MG GRANULES FOR KIDDIES
Is indicated in adult and pediatric patients 12 months of age and
older for the prophylaxis and chronic
treatment