10 mg film-coated tablets
montelukast
What Montelukast Krka is and what it is used for
What Montelukast Krka is
Montelukast Krka is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Montelukast Krka works
Leukotrienes cause contraction and swelling of the airways in the lungs and also cause allergic symptoms. By blocking the leukotrienes, Montelukast Krka 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 Krka
Your doctor has prescribed Montelukast Krka to treat asthma and thus prevent asthma symptoms during the day and night.
- Montelukast Krka 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 Krka also prevents contraction of the airways in connection with physical exertion.
- In the asthmatic patients where Montelukast Krka is used for asthma , Montelukast Krka can also provide relief in seasonal allergic rhinitis .
Depending on your symptoms and the severity of your asthma, your doctor will decide how to use Montelukast Krka.
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 Krka may also be approved for the treatment of other diseases 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 using Montelukast Krka
Tell your doctor about any medical or allergic problems you may have or have had.
Do not use Montelukast Krka
- 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 Krka.
- If asthma symptoms or breathing worsen, contact your doctor immediately.
- Montelukast Krka taken by mouth is not intended 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 all other asthma medications prescribed by your doctor. Montelukast Krka 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.
- Patients should be aware that various neuropsychiatric events (eg, behavioral and mood-related changes) have been reported in adults, adolescents, and children with Montelukast Krka (see section 4). If you or your child develop such symptoms while using Montelukast Krka, you should contact your or your child’s doctor.
Children
Do not give this medicine to children under 15 years of age.
There are other dosage forms of this drug available for children and adolescents under 18 years of age based on age group.
Other medicines and Montelukast Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Some medicines may affect the way Montelukast Krka works and Montelukast Krka may affect the way other medicines work.
Tell your doctor if you are taking the following medicines before you start taking Montelukast Krka:
- phenobarbital (antiepileptic medicine )
- phenytoin ( antiepileptic medicine )
- rifampicin (medicine for tuberculosis and certain other infections )
- gemfibrozil (medicine for high blood fat levels).
Montelukast Krka with food
Montelukast Krka 10 mg film-coated tablets 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 Krka during this time.
Breast-feeding
It is unknown whether montelukast passes into breast milk. Therefore, consult a physician before using Montelukast Krka during breastfeeding or scheduled breastfeeding.
Driving and using machines
Montelukast Krka is not expected to affect your ability to drive or use machines. However, individual reactions to medication 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 Krka contains lactose and sodium
Montelukast Krka contains lactose . 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 film-coated tablet, ie essentially ‘ sodium-free. is next to “sodium-free”.
How to use Montelukast Krka
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Take only one tablet Montelukast Krka a day according to your doctor’s prescription.
- It should be taken 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 Krka should not be used with any other product that contains the same active ingredient, montelukast.
This medicine should be taken by mouth.
Montelukast Krka 10 mg can be taken with or without food.
If you use more Montelukast Krka than you should
Contact a doctor immediately for advice.
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 hyperactivity.
If you forget to use Montelukast Krka
Try to take Montelukast Krka 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 using Montelukast Krka
Montelukast Krka can only treat your asthma if you continue to take it. It is important to continue taking Montelukast Krka 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.
In clinical trials with montelukast 10 mg film-coated tablets, the most commonly reported adverse reactions (may affect up to 1 in 10 people) where a probable association with montelukast is found:
- magont
- headache
These were usually mild and were more common in patients treated with montelukast 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 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
- seizures
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) (see section 2)
- 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 users
- diarrhea, nausea, vomiting
- rash
- fever
- elevated liver enzymes
Uncommon: may affect up to 1 in 100 people
- Behavioral and Mood Changes: Changed Dream Patterns Including Nightmares, Insomnia, Sleepwalking, Irritability, Anxiety, Restlessness
- dizziness, drowsiness, numbness and tingling
- nosebleeds
- dry mouth , indigestion
- bruising, itching , hives
- joint or muscle pain, muscle cramps
- bedwetting in children
- weakness / fatigue, general malaise, swelling
Rare: may affect up to 1 in 1,000 people
- Behavioral and mood changes: Attention Deficit Hyperactivity Disorder, involuntary muscle movements.
Very rare: may affect up to 1 in 10,000 people
- sore red bumps under the skin, preferably on the shins (erythema nodosum)
- behavioral and mood changes: obsessive-compulsive disorder
- stuttering
How to store Montelukast Krka
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: The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light.
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. Each film-coated tablet contains 10 mg montelukast (as montelukast sodium).
- The other ingredients are lactose monohydrate , cellulose powder, microcrystalline cellulose, croscarmellose sodium and magnesium stearate in the tablet core as well as hypromellose, titanium dioxide (E171), talc, propylene glycol, red iron oxide (E172) and yellow iron oxide (E172) in the film coating.See section 2 “Montelukast Krka contains lactose and sodium”.
What the medicine looks like and contents of the pack
The film-coated tablets are apricot-colored, round, slightly biconvex tablets with beveled edges.
Carton of 7 , 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140 or 200 film-coated tablets in blister packs.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA Polska Sp. zoo, ul. Równoległa 5, Warsaw, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany