10 mg film-coated tablets
montelukast
What Montelukast Sandoz is and what it is used for
What Montelukast Sandoz is
Montelukast Sandoz is a leukotriene receptor antagonist that blocks substances called leukotrienes .
How Montelukast Sandoz works
Leukotrienes cause contraction and swelling of the airways in the lungs and also cause allergic symptoms. By blocking the leukotrienes, Montelukast Sandoz improves the symptoms of asthma, helps control asthma, and improves the symptoms of seasonal allergies (so-called hay fever or seasonal allergic rhinitis ).
When to use Montelukast Sandoz
Your doctor has prescribed Montelukast Sandoz to treat asthma and thus prevent asthma symptoms during the day and night.
- Montelukast Sandoz is used for the treatment of adults and adolescents, 15 years and older who have not received adequate control of previous asthma medication and therefore need additional treatment.
- Montelukast Sandoz also prevents airway constriction in connection with physical exertion.
- Montelukast Sandoz can also be used for seasonal allergic rhinitis in those patients where Montelukast Sandoz is used to treat asthma .
Depending on your symptoms and the severity of your asthma, your doctor will decide how to use Montelukast Sandoz.
Montelukast contained in Montelukast Sandoz may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What is asthma?
Asthma is a chronic disease.
Asthma includes:
- difficulty breathing due to airway constriction. This contraction of the airways worsens and improves due to different 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 Sandoz may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Montelukast Sandoz
Do not use Montelukast Sandoz
- if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Tell your doctor about any medical or allergic problems you may have or have had.
Talk to your doctor or pharmacist before using Montelukast Sandoz:
- If asthma symptoms or breathing worsen, contact your doctor immediately.
- Montelukast Sandoz is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor for this situation. Always carry your inhaled bronchodilator asthma medication with you for acute asthma attacks.
- It is important that you or your child take any other asthma medication prescribed by your doctor. Montelukast Sandoz is not intended to replace other asthma medicines prescribed by your doctor for concomitant treatment.
- During treatment with asthma medication, you should know that if you get a combination of different symptoms, such as flu-like symptoms , tingling or numbness in the arms or legs, worsening respiratory symptoms and / or skin rash, a doctor should be consulted.
- If you know that asthma is aggravated by acetylsalicylic acid or other anti- inflammatory drugs ( NSAIDs ), then do not use these drugs.
Children and young people
Do not give this medicine to children under 15 years of age.
There are other dosage forms of this drug available to children and adolescents under 18 years of age depending on the age group.
Other medicines and Montelukast Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the way Montelukast Sandoz works and Montelukast Sandoz may affect the way other medicines work.
Tell your doctor if you are taking the following medicines before you start taking Montelukast Sandoz:
- phenobarbital (antiepileptic medicine )
- phenytoin ( antiepileptic medicine )
- rifampicin (medicine for tuberculosis and other infections )
- gemfibrozil (antihypertensive agent).
Montelukast Sandoz with food and drink
Montelukast Sandoz 10 mg can be taken with or without food.
Pregnancy and breastfeeding
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 taking this medicine.
Pregnancy
Your doctor will decide if you can take Montelukast Sandoz during this time.
Breast-feeding
It is unknown whether Montelukast Sandoz passes into breast milk. Therefore, consult your doctor before using Montelukast Sandoz during breastfeeding or scheduled breastfeeding.
Driving and using machines
Montelukast Sandoz is not expected to affect your ability to drive or use machines. However, individual reactions to drugs may vary. However, dizziness and drowsiness have been reported which 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 Sandoz 10 mg film-coated tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Montelukast Sandoz
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Take only one tablet of Montelukast Sandoz a day according to your doctor’s recommendation.
- It is important that you continue to take Montelukast Sandoz daily both during asymptomatic periods and during periods of worsening asthma .
Adults and adolescents, 15 years and older:
The recommended dose is one 10 mg tablet taken once daily in the evening.
Montelukast Sandoz should not be used with any other product containing the same active ingredient, montelukast.
This medicine should be taken by mouth.
Montelukast Sandoz 10 mg can be taken with or without food.
Montelukast Sandoz 10 mg should not be used in children under 15 years of age due to the high content of the active substance.
For younger children, other dosage forms in appropriate strengths are available.
If you take more Montelukast Sandoz than you should
In the majority of reports of overdose, no side effects have been reported. The most common symptoms reported with overdose in adults and children included stomach pain, drowsiness, thirst, headache, vomiting, and overactivity.
If you forget to take Montelukast Sandoz
Try to take Montelukast Sandoz as prescribed. 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 Sandoz
Montelukast Sandoz can only treat your asthma if you continue to take it. It is important to continue taking Montelukast Sandoz for as long as your doctor prescribes it. It helps you control your asthma.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you get any of the following serious side effects – 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
Very rare (may affect up to 1 in 10,000 people):
- suicidal thoughts and actions. Signs of this can be i.a. that the person talks about suicide, withdraws from social contacts, wants to be alone or has a feeling of hopelessness or of being in a trap
- yellowing of the skin and eyes, unusual tiredness or fever and darkening of the urine, which is caused by a hepatitis
- a combination of symptoms, such as flu-like symptoms , tingling or numbness in the arms or legs, aggravated respiratory symptoms and / or skin rash (Churg-Strauss syndrome) have been reported. Tell your doctor immediately if your child has one or more of these symptoms.
- severe skin reactions (erythema multiforme) that may occur without warning
In addition, the following adverse reactions were reported in clinical trials with either 10 mg film-coated tablets, 5 mg chewable tablets, or 4 mg chewable tablets (may affect up to 1 in 10 people):
- magont
- headache
- thirst
In clinical trials with 4 mg granules, the most commonly reported adverse reactions (may affect up to 1 in 10 people) where there is a probable association with montelukast is:
- diarrhea
- overactivity
- asthma
- scaly and itchy skin
- rash
These were usually mild and were more common in patients treated with montelukast than with placebo (a pill that does not contain any medicine).
During the time the drug has been on the market, the following side effects have been reported:
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
- abnormal liver function values
- rash
- fever
Uncommon (may affect up to 1 in 100 people):
- behavioral and mood changes (altered dream pattern including nightmares, insomnia, sleepwalking, irritability, anxiety, restlessness, anxiety / upset including aggressive behavior or hostility, depression)
- dizziness, drowsiness, tingling / numbness, seizures
- nosebleeds
- dry mouth , indigestion
- bruising, itching , hives
- joint or muscle aches, muscle cramps
- fatigue, general malaise, swelling
Rare (may affect up to 1 in 1,000 people):
- increased tendency to bleed
- tremors
- attention deficit disorder, impaired memory
- palpitation
Very rare (may affect up to 1 in 10,000 people):
- hallucinations, disorientation
- swelling ( inflammation ) of the lungs
- sore red lumps under the skin, preferably on the shins (erythema nodosum)
How to store Montelukast Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. or EXP. The expiration date is the last day of the specified month.
Store below 30 ° C.
Store in the original package. Sensitive to light. Moisture sensitive.
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 package and other information
Content declaration
- The active substance is montelukast.
One tablet contains 10 mg montelukast (as montelukast sodium).
- Other ingredients are:
Tablet core: Lactose monohydrate, hydroxypropyl cellulose type EF, cellulose, microcrystalline, croscarmellose sodium, magnesium stearate
Film coating: Hypromellose 6 cps, titanium dioxide (E171), macrogol 400, red and yellow iron oxide (E172)
What the medicine looks like and contents of the pack
Beige, square, biconvex, film-coated tablet with the designation “10” on one side.
Packaging
OPA / Al / PVC / Al-blister:
7, 10, 14, 20, 21, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, 200 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark.
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany
or
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia
or
Lek Pharmaceuticals dd Trimlini 2 D, 9220 Lendava, Slovenia
or
LEK SA, Ul. Podlipie 16 C, 95 010 Stryków, Poland
or
LEK SA, Ul. Domaniewska 50, 02-672 Warsaw, Poland
or
SC Sandoz SRL, Str. Livezeni 7A, 540472, Targu-Mures, Romania
or
Sandoz NV, Medialaan 40 – 1800 Vilvoorde, Belgium