10 mg film-coated tablets, for adults and adolescents from 15 years
montelukast
What Montelukast Teva is and what it is used for
Montelukast Teva is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Leukotrienes cause contraction and swelling of the airways in the lungs and also cause allergic symptoms. By blocking the leukotrienes, Montelukast Teva improves the symptoms of asthma, helps control asthma, and improves the symptoms of seasonal allergies (so-called hay fever or seasonal allergic rhinitis ).
Your doctor has prescribed Montelukast Teva to treat your asthma, thus preventing asthma symptoms during the day and night.
Montelukast Teva 10 mg film-coated tablets are used to treat patients 15 years of age or older who do not have adequate control over previous asthma medication and therefore need additional treatment. In patients with asthma and seasonal allergies, Montelukast Teva 10 mg film-coated tablets can also treat your allergic symptoms.
Montelukast Teva 10 mg film-coated tablets also prevent asthma symptoms associated with physical exertion in patients aged 15 years or older.
What is asthma?
Asthma is a chronic disease.
Asthma includes:
- difficulty breathing due to airway constriction. This contraction of the airways worsens and improves depending on various conditions.
- sensitive airways that react to various things such as cigarette smoke, pollen, cold air or exertion.
- swelling ( inflammation ) of the mucous membranes of the airways.
Symptoms of asthma include cough, wheezing, and tightness in the chest.
What is a seasonal allergy?
Seasonal allergy (also called hay fever or seasonal allergic rhinitis ) is an allergic reaction that is often caused by airborne pollen from trees, grass, or weeds. The symptoms of seasonal allergy are characterized by; stuffy, runny, and itchy nose; sneezing; watery, swollen, red, and itchy eyes.
Montelukast contained in Montelukast Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before taking Montelukast Teva
Do not take Montelukast Teva
- if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Montelukast Teva
- Even if you have no asthma symptoms or experience an asthma attack, you should take Montelukast Teva exactly as your doctor has told you.
- Montelukast Teva should not be used to treat acute asthma attacks. Montelukast Teva can not help you with acute asthma attacks and should never be used for this purpose. If an attack occurs, follow the instructions given by your doctor for this situation. It is very important to always have your inhaled bronchodilator asthma medication for acute asthma attacks easily accessible. Always carry your inhalable tracheal asthma medication for acute asthma attacks with you.
- If you need more than usual inhalation of your bronchodilator asthma medicine, contact your doctor as soon as possible.
- It is important that you take any other asthma medication prescribed by your doctor. Montelukast Teva is not intended to replace the steroids (those that are inhaled or swallowed) that your doctor has prescribed for concomitant treatment.
- If you know that asthma is aggravated by acetylsalicylic acid , do not take acetylsalicylic acid or other anti- inflammatory drugs (so-called NSAIDs ).
- If you are being treated with asthma medication, including Montelukast, you should know that if you experience a combination of the following symptoms, contact your doctor immediately: flu-like symptoms , worsening breathing symptoms, tingling or numbness in the arms or legs, and / or skin rash.
Patients should be aware that various neuropsychiatric events (eg, behavioral and mood-related changes) have been reported in adults, adolescents, and children with montelukast (see section 4). If you or your child develop such symptoms while using Montelukast Teva 10 mg film-coated tablets, you should consult your or your child’s doctor.
Montelukast Teva film-coated tablets should not be used by children and adolescents under 15 years of age
Other medicines and Montelukast Teva
Montelukast Teva can be used with other medicines that you take for asthma. Some medicines may affect the way Montelukast Teva works and Montelukast Teva may affect the way other medicines work.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This is especially important for the following medicines:
- phenobarbital (antiepileptic drugs )
- phenytoin (antiepileptic drugs )
- rifampicin (used to treat tuberculosis and other infections )
Montelukast Teva with food and drink
Montelukast Teva film-coated tablets should be taken in the evening with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using Montelukast Teva.
Pregnancy
Your doctor will decide if you can take Montelukast Teva during this time.
Breast-feeding
It is unknown whether montelukast passes into breast milk. Therefore, consult your doctor before using Montelukast Teva during breastfeeding or scheduled breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Montelukast Teva is not expected to affect your ability to drive or use machines. However, individual reactions to drugs may vary. In very rare cases, however, certain side effects (such as dizziness and drowsiness) have been reported that may affect some patients’ ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Montelukast Teva contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Montelukast Teva
Even if you have no asthma symptoms or experience an asthma attack, always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose for adults and adolescents over the age of 15 is one 10 mg tablet in the evening. This medicine should be swallowed.
Montelukast Teva should not be used with any other product that contains the same active ingredient, montelukast.
If you take more Montelukast Teva than you should
An excessive amount can probably cause stomach pain, drowsiness, thirst, headache, vomiting, and hyperactivity (involuntary movements). Take this leaflet, any remaining tablets, and the package with you to the hospital or doctor so that they know which tablets have been taken.
If you forget to take Montelukast Teva
If you have missed a dose, return to the usual schedule with one tablet a day. Do not take a double dose to make up for a forgotten dose.
If you stop taking Montelukast Teva
To control your asthma, you must take Montelukast Teva both when you have symptoms and when you are symptom-free for as long as your doctor prescribes it. Montelukast Teva can only treat your asthma if you continue to take it.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
For children 2 to 5 years, Montelukast Teva 4 mg chewable tablets are available.
For children 2 to 5 years who have difficulty taking chewable tablets, granules 4 mg are available.
For children 6 to 14 years, Montelukast Teva 5 mg chewable tablets are available.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical trials with montelukast, the most commonly reported adverse reactions (may affect up to 1 in 10 people) where a probable association exists:
- magont
- headache
These were usually mild and were more common in patients treated with Montelukast Teva than with placebo (a pill that does not contain any medicine).
Serious side effects are
Talk to your doctor immediately if you notice any of the following side effects that may be serious and where you may need urgent medical attention.
Uncommon (may affect up to 1 in 100 people)
- allergic reactions including rash, swelling of the face, lips, tongue and / or throat, which may cause breathing or swallowing difficulties
- behavioral and mood changes: anxiety / upset including aggressive behavior or hostility, depression
- epileptic seizure
Rare (may affect up to 1 in 1,000 people)
- increased tendency to bleed
- tremors
- palpitation
Very rare (may affect up to 1 in 10,000 people)
- combination of symptoms, such as flu-like symptoms , tingling or numbness in the arms and legs, aggravated respiratory symptoms and / or rash (Churg-Strauss syndrome)
- decreased platelet count
- Behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and acts
- swelling ( inflammation ) of the lungs
- severe skin reactions (erythema multiforme) that may occur without warning
- hepatitis _ _
Other side effects have been reported during the time the drug has been on the market
Very common (may affect more than 1 user in 10)
- upper respiratory tract infection
Common (may affect up to 1 in 10 people)
- diarrhea, nausea, vomiting
- fever
- rash
- elevated liver values
Uncommon (may affect up to 1 in 100 people)
- behavioral and mood changes, altered dream patterns including nightmares, insomnia, sleepwalking, irritability, anxiety, restlessness
- dizziness, drowsiness, numbness and tingling
- nosebleeds
- dry mouth , indigestion
- bruising, itching , hives
- joint or muscle aches, muscle cramps
- bedwetting in children
- weakness / fatigue, general malaise, swelling
Rare (may affect up to 1 in 1,000 people)
- Behavioral and Mood-Related Changes, Attention Deficit Hyperactivity Disorder, Involuntary Muscle Movement
Very rare (may affect up to 1 in 10,000 people)
- sore red lumps under the skin, preferably on the shins (erythema nodosum)
- behavioral and mood changes: obsessive-compulsive disorder, stuttering
How to store Montelukast Teva
Keep this medicine out of the sight and reach of children.
No special storage instructions. Store the blister cards in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is montelukast sodium equivalent to 10 mg montelukast.
- The other ingredients are sodium lauryl sulphate, lactose monohydrate , hydroxypropylcellulose, pregelatinized starch (maize), sodium starch glycolate (type A), magnesium stearate. The coating contains Opadry 20A23676 yellow which contains hydroxypropylcellulose, hypromellose, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).
What the medicine looks like and contents of the pack
Montelukast Teva 10 mg film-coated tablets: Beige, round, film-coated tablets, marked with “93” on one side and “7426” on the other side.
Montelukast Teva is available in packs of 7, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 120 tablets, as well as calendar packs of 7, 14, 28, 56 and 98 tablets.
Aluminum – aluminum blister cards.
Not all pack sizes may be marketed.