10 mg film-coated tablets – For adults and adolescents from 15 years
montelukast
What Montelukast Stada is and what it is used for
What Montelukast Stada is
Montelukast Stada is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Montelukast Stada works Leukotriene causes contraction and swelling of the airways in the lungs and also causes allergic symptoms. By blocking the leukotrienes, Montelukast Stada 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 Stada
Your doctor has prescribed Montelukast Stada to treat asthma and thus prevent asthma symptoms during the day and night.
- Montelukast Stada 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 Stada also prevents airway constriction in connection with physical exertion.
- Montelukast Stada can also be used for seasonal allergic rhinitis in patients where Montelukast Stada is used to treat asthma .
Depending on your symptoms and the severity of your asthma, your doctor will decide how to use Montelukast Stada.
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 Stada may also be approved for the treatment of other diseases not mentioned in this product information. 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 Stada
Do not use Montelukast Stada
Tell your doctor about any medical or allergic problems you may have or have had.
Do not take Montelukast Stada
- 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 Stada.
- If asthma symptoms or breathing worsen, contact your doctor immediately.
- Montelukast Stada 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 Stada is not intended to replace other asthma medications 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 (see section 4). If you develop such symptoms while using Montelukast Stada, you should consult your doctor.
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 for children and adolescents under 18 years of age based on age group.
Other medicines and Montelukast Stada
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 Stada works and Montelukast Stada may affect how your child’s other medicines work.
Tell your doctor if you are taking the following medicines before starting Montelukast Stada:
- phenobarbital (antiepileptic drugs )
- phenytoin (antiepileptic drugs )
- rifampicin (remedy for tuberculosis and other infections )
- gemfibrozil (antihypertensive agent).
Montelukast Stada with food, drink and alcohol
Montelukast Stada 10 mg can be taken 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 Stada.
Pregnancy
Your doctor will decide if you can take Montelukast Stada during this time.
Breast-feeding
It is unknown whether montelukast passes into breast milk. Therefore, consult a physician before using this medicine during breastfeeding or scheduled breastfeeding.
Driving and using machines
Montelukast Stada is not expected to affect your ability to drive or use machines. However, individual reactions to drugs may vary. In very rare cases, 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 Stada contains lactose and sodium
Montelukast Stada 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.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. next to “sodium-free”.
How to use Montelukast Stada
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 Stada a day according to the doctor’s recommendation.
- It is important that you continue to take Montelukast Stada 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 Stada should not be used with any other product containing the same active ingredient, montelukast.
This medicine should be taken by mouth.
You can take Montelukast 10 mg with or without food.
If you take more Montelukast STADA 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 overactivity.
If you forget to take Montelukast STADA
Try to take Montelukast Stada 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 STADA
Montelukast Stada can only treat your asthma if you continue to take it. It is important to continue taking Montelukast Stada 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 were (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 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
- itching
- fever
- elevated liver enzyme values.
Uncommon: may affect up to 1 in 100 people
- behavioral and mood-related 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
- fatigue, a general feeling of illness, swelling.
Rare: may affect up to 1 in 1,000 users
- Behavioral and mood changes: Attention Deficit Hyperactivity Disorder, involuntary muscle movements.
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 Stada
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 blister and the outer carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 (like montelukast sodium).
One tablet contains montelukast sodium equivalent to 10 mg montelukast.
Other ingredients are:
Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, disodium edetate, magnesium stearate.
Film coating:
Hypromellose, hydroxypropyl cellulose, titanium dioxide (E171), red and yellow iron oxide (E172).
What the medicine looks like and contents of the pack
10 mg Montelukast Stada tablet is a beige, round, biconvex film-coated tablet.
Nylon / Alu / PVC – Aluminum / blister:
Blister (without weekday marking): 10, 20, 30, 50, 60, 90, 100 and 250 tablets.
Blister (with weekday marking): 7, 14, 28, 56, 98, 126, and 154 tablets.
HDPE cans:
10, 20, 30, 50, 60, 90, 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers:
Centrafarm Services BV, Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands.
Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, Ireland.
LAMP SANPROSPERO SPA, Via della Pace, 25 / A, 41030 San Prospero (Modena), Italy.
Eurogenerics NV / SA, Heizel Esplanade b22, 1020 Brussels, Belgium.
STADA Arzneimittel GmbH, Muthgasse 36, 1190 Vienna, Austria.
HBM Pharma sro, Sklabinská 30, 036 80 Martin, Slovakia.
Saneca Pharmaceutical as, Nitrianska 100, 920 27 Hlohovec, Slovakia.
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark