Country: Израел
Језик: Енглески
Извор: Ministry of Health
MONTELUKAST AS SODIUM
ORGANON PHARMA ISRAEL LTD., ISRAEL
R03DC03
TABLETS
MONTELUKAST AS SODIUM 10 MG
PER OS
Required
ORGANON LLC, USA
MONTELUKAST
MONTELUKAST
Singulair 10 mg is indicated in adult and adolescents 15 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.
2023-03-31
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 Прочитајте комплетан документ
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 Прочитајте комплетан документ