Montelukast 10 Mg Film-Coated Tablets
Out of date information, search anotherPACKAGE LEAFLET INFORMATION FOR THE USER
35 mm
Montelukast 10 mg film-coaled fabfsts monteluka I
Read ill ol this laadst canlully before you atari taking this medicine.
• Keep th leaflet Y u may need to read It again
• II you ha e any further questions, please ask your doctor or pharmacist
• This med cine has been prescribed lor you. Do not pass It on to others It may harm them even it their symptoms are the same as yours
oooooo
• 1 any I the side effects gets serious, or It you notice any side eltecls not stedmth leaflet please tell your doctor or pharmacist.
In this leaflet.
1 What Montelukast Is and what it Is used tor
2 Belore you lake Montelukast
3 How to take Montelukast
4 Possible side effects
5 How to store Montelukast
6 Further Inlormat n
Montelukast Is a leukotrtene receptor antagonist that blocks substances called leukotrienes Leukotrienes cause narrowing and swelling ot airways In lha lungs and also cause allergy symptoms By blocking leukotrienes Montelukast Improves asthma symptoms helps control asthma and improves seasonal al ergy symptoms (also known as hay lever or seasons allergic rhln I s)
Your doctor has prescribed Montelukast to prevent asthma sympl ms during the day and nlghl
• Montelukast Is used lor the prevention ol asthma ol patients who are not adequately controlled on their medication and need additional therapy
• Montelukast also helps prevent the narrowing ol airways triggered by exercise
• In those asthmatic patients In whom Monte ukast Is Imflcated In asthma. Monteiukast can also provide symptomatic rellel ol seasonal allergic rtmit
Yout doctor wil determ ne how Montelukast should be used depending on the sympt ms and severity ol your asthma
Whal Is asthma?
Asthma Is a long-term disease Asthma Includes
• diHIcuiiy breathing because ol narrowed airways Th s narrowing ol airways worsens and Improves In response to various conditions sensitive airways that react to many things such as cigarette smoke pollen, cold air or exercise.
• swelflng (inflammation) In the lining I the a lways
Symptoms ol asthma Include. Coughing wheeang and chest tightness What an seasonal allergies?
Seasona allerg es (also known as hay lever or seasonal allergic rhinitis are an allerg c response often caused by a rbome pollens trom trees, grasses and wee s The symptoms ol seasonal allergies typically may ndude study, runny itchy nose sneezing, watery swollen red Itchy eyes
Tell your doctor about any medical problems or allergies you have now or have had
Do not take Montelukast II you
• are allergic (hypersensitive) to montelukast or any ol the other ingredients ol Montelukast
(see 6 Further inlormation).
Take special care with Montelukast
• II your asthma or breathing gels worse, tell your doctor immed atefy
• Oral Montelukast is not meant to treat acute asthma attacks II an attack occurs, follow the Instructions your doctor has glveny u Always have your Inhaled rescue med dne lor asthma attacks with you
• It is Important that you or your child take all asthma med cations prescribed by your doctor Montelukast sh uld not be substituted lor other asthma medications your dodoi has prescribed lor you
• Any patient on anti-asthma medldoes should be aware that II you develop a combination ol symptoms such as a Hu-like Illness p ns and need es or numbness ol arms or legs, worsening ol pulmonary symptoms and/or rash, you should consult your dodor
■ You should not take acetyl salicylic acid (asp tin) or antl-lnllammalory medldnes (also known as non-steroidal ant inflammatory drugs or N SAID's) II they make you asthma woise
Use In children
For children 2 to 5 years old Montelukast Paediatric 4 mg chewable tablets are available
For ch Idren 6 to 14 years old Montelukast Paediatric 5 mg chewable tab ets are available
Taking other medicines
Some medicines may affect how Montelukast works, or Montelukast may ailed how other medldnes woik
Please tell your dodor or pharmacist il you are taking or have recently taken other medidnes indud ng those obtained without a prescript on
Tell your doctor II you are taking the following medicines before start ng Montelukast
• phenobarbital (used for treatment ol epilepsy)
• phenytoin (used lor treatment ol epilepsy)
• nlampldn (used to treat tuberculosis and some other Inledions)
Taking Montelukast with food and drink Montdukasl 10 mg may be taken with or without lood Pregnancy and braast-laedlng
Use iir pregnancy
Women who are pregnant or intend t become pregna t should consul! the r dodor before taking Montelukast Y u doctor wil assess whether you can take Montelukast during this lime
Use in breasl-leeding
II Is not known il Montelukast appears In breast m Ik You should consult your dodor before taking Montelukast II you are breast lead ng or intend t breast-leed
Orlvlng and using machlnas
Monlelukasl is not expected to affect your ability to drive a car or operate machinery However, Individual responses to medication may vary Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with Monlelukasl may affect some patients' ability to drive or operate machinery
important Information about some ol the ingredients of Montelukast
Montelukast 10 mg film-coated tablets contain lactose It you have been told by your doctor that you have an Intolerance to same sugars, contact your doctor before taking this medicinal product
3. How to lake Montelukast
• You should take only one tablet ol Montelukast once a day as prescribed by your doctor
• It should be taken even when you have no symptoms or have an acute asthma attack
• Always take Montelukast as your doctor has told you You should check with your doctor or pharmacist It you are not sure
• To be taken by mouth
For adults 1S years of age and older
One 10 mg tablet to be taken daily In the evening. Montelukast 10 mg may be taken with or without lood
It you are taking Montelukast be sure that you do not take any other products that contain the same active ingredient, montelukast
It you taka more Montelukast than you should
Contact your doctor Immediately lor advice.
There were no side effects reported In the maturity ol overdose reports. The most frequently occurring symptoms reported with overdose in adults and children Included abdominal pain, sleepiness, thirst, headache, vomiting and hyperactivity.
II you lorgel to take Monlalukast
Try to take Monlelukasl as prescribed However, il you miss a dose, just resume the usual schedule ol one tablet once dally.
Do not take a double dose to make up lor a forgotten dose
It you stop taking Monlelukasl
Montelukast can treat your asthma only It you continue to lake II.
It is Important to continue taking Montelukast lor as long as your doctor prescribes It will help control your asthma.
II you have any further questions on the use of this product, ask your doctor or pharmacist
. Possible side ellecls
Like ad medicines. Montelukast can cause side effects although not everybody gets them
Toll your doctor right away II you gat one or moro ol thasa symptoms:
• flu-Hke illness
■ pins and needles
• numbness ol arms and legs
• worsening ol pulmonary symptoms and/or rash (Churg-Strauss syndrome)
In clinical studies with Monlelukasl 10 mg film-coaled tablets, the most commonly reported side effects (occurring In at least 1 ol 100 patients and less than I ol 10 patients treated) thought to be related to Montelukast were
• abdominal pain
• headache
These were usually mild and occurred al a greater frequency in patients trealed with Montelukast than placebo (a pIB containing no medication)
Additionally, while the medicine has been on the market, the loBowing have been reported.
• upper respiratory Inlection
• Increased bleeding tendency
• allergic reactions induding rash, swelling ol the lace, lips, tongue, and/or throat which may cause difficulty In breathing or swallowing
• behaviour and mood related changes [dream abnormalities, Including nightmares, hallucinations. Irritability, feeing anxious, restlessness, agitation Including aggressive behaviour, tremor, depression, trouble sleeping, sleep walking, suicidal thoughts and actions (in very rare cases))
• dizziness, drowsiness, pins and needles/numbness, seizure
• palpitations
• nosebleed
• diarrhoea, dry mouth, indigestion, nausea, vomiting
• hepatitis
• bruising. Itching hives, tender red lumps under the skin most commonly on your shins (erythema nodosum).
• foinl or muscle pain, muscle cramps
• tiredness, teellng unwefl, swelling, lever
Ask your doctor or pharmacist lor more Information about side effects II
any ol the side effects gets serious, or il you notice any side effects not
listed In this leaflet, please left your doctor or pharmacist
5. Hew to store Montelukast
• Keep out of the reach and sight ol children
• Do not use this medicine alter the date shown by the six numbers following EXP on the blister. The (list two numbers Indicate Ihe month, the last lour numbers indicate the year. This medicine expires at the end of the month shown
• Store below 25*0 Store In the original package In order to protect lrom moisture
• Medicines should not be disposed ol via wastewater or household waste Ask your pharmacist how to dispose ol medicines no lunger required These measures will help to protect the environment
fi. Further inlamialion
Whal Montelukast contains
•The active substance Is montelukast Each tablet contains montelukast sodium equivalent to 10 mg ol montelukast
• The other Ingredients are
Cora Lactose anhydrous, microcrystalHne cellulose, croscarmellose sodium, silica colloidal anhydrous and magnesium stearate Coaling hypromellose. hydroxypropylcellulose. yellow and red iron oxide and titanium dioxide
What Monlalukast looks Ihe and eontenls ol Ihe pack
Montelukast 10 mg are beige, rounded square shaped, biconvex lilm-coated tablets with engraved "APO" on one side and "M10* on the other side
Blisters In packages ol 10 2B, 30,9B and 100 tablets.
Not all pack sizes may be maiketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Apotex Europe BV Darwlnweg 20,2333 OR Leiden, The Netherlands Manufacturer
Apotex Nederland BV, Archlmedesweg 2,2333 ON Leiden, The Netherlands
This leaflet was last approved In July 2014-