10 mg film-coated tablets For adults and adolescents from 15 years
montelukast
What Montelukast Accord is and what it is used for
What the Montelukast Accord is
Montelukast Accord is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Montelukast Accord works
Leukotriene causes contraction and swelling of the airways in the lungs as well as allergic symptoms. By blocking the leukotrienes, Montelukast Accord improves asthma symptoms, helps control asthma, and improves the symptoms of seasonal allergies (so-called hay fever or seasonal allergic rhinitis ).
When to use Montelukast Accord
Your doctor has prescribed Montelukast Accord to treat asthma and prevent asthma symptoms at all hours of the day.
- Montelukast Accord is used for the treatment of adults and adolescents, 15 years and older who have not received adequate control of previous medication and therefore need additional treatment.
- Montelukast Accord also helps prevent contraction of the airways caused by exertion.
- In asthmatic patients where Montelukast Accord is indicated for asthma , Montelukast Accord may also provide symptomatic relief in seasonal allergic rhinitis .
Your doctor will decide how to use Montelukast Accord depending on your symptoms and the severity of your asthma.
Montelukast contained in the Montelukast Accord 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 is asthma?
Asthma is a chronic disease.
Asthma means:
- respiratory distress 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.
What you need to know before taking Montelukast Accord
Tell your doctor about any medical or allergic problems you may have or have had.
Do not take Montelukast Accord
- 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 Accord
- If asthma symptoms or breathing become difficult, contact your doctor immediately.
- Montelukast Accord tablets are 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 medicine with you.
- It is important that you or your child take all asthma medications prescribed by your doctor. Montelukast Accord is not intended to replace other asthma medicines prescribed by your doctor.
- If you are being treated 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.
- Do not take acetylsalicylic acid or other anti- inflammatory drugs ( NSAIDs ) if your asthma worsens.
Patients should be aware that various neuropsychiatric events (eg, behavioral and mood-related changes) have been reported in adults, adolescents, and children with the Montelukast Accord (see section 4). If you develop such symptoms while using Montelukast Accord, 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 Accord
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 Accord works and Montelukast Accord may affect the way other medicines work.
Tell your doctor if you are taking the following medicines before you start taking Montelukast Accord 10 mg film-coated tablets:
- phenobarbital (antiepileptic medicine )
- phenytoin ( antiepileptic medicine )
- rifampicin (medicine for tuberculosis and other infections )
- gemfibrozil (medicine for high blood fat levels)
Montelukast Accord with food and drink
Montelukast Accord 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 before taking Montelukast 10 mg film-coated tablets.
Pregnancy
Your doctor will decide if you can take Montelukast Accord during this period.
Breast-feeding
It is unknown whether montelukast is excreted in human milk. Therefore, consult a physician before using Montelukast Accord during breast-feeding or scheduled breast-feeding.
Driving and using machines
Montelukast Accord 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 with Montelukast Accord, 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 Accord contains lactose
Montelukast Accord 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.
3. How to take Montelukast Accord
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 of Montelukast Accord a day as prescribed by your doctor .
- You should take the tablet both during asymptomatic periods and during periods of worsening asthma .
Adults and adolescents over 15 years:
The recommended dose is a 10 mg tablet taken once daily in the evening.
Montelukast Accord should not be used with any other product containing the same active substance, montelukast.
This medicine is for oral use.
Montelukast Accord can be taken with or without food.
If you have ingested too much Montelukast Accord
In the majority of reports of overdoses, 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 Accord
Try to take Montelukast Accord exactly as your doctor has told you. 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 Accord
Montelukast Accord can only treat your asthma if you continue to take it.
You must continue to take Montelukast Accord 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, Montelukast Accord 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.
The side effects 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, these may be serious and 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 actions
- swelling ( inflammation ) of the lungs
- severe skin reactions (erythema multiforme) that may occur without warning
- hepatitis . _
Other side effects 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 disorder, impaired memory, involuntary muscle movements.
Very rare: may affect up to 1 in 10,000 people
- sore red bumps under the skin, usually on the shins (erythema nodosum)
- behavioral and mood changes: obsessive-compulsive disorder, stuttering.
How to store Montelukast Accord
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiration date is the last day of the specified month.
- No special temperature instructions. Store in the original package. Moisture sensitive. 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. One film-coated tablet contains 10 mg montelukast.
Other ingredients are:
Tablet core: Lactose monohydrate, microcrystalline cellulose, low substituted hydroxypropyl cellulose ( LH- 11) (E 463), croscarmellose sodium, magnesium stearate.
Film coating: Hydroxypropylcellulose (LF) (E 463), hypromellose 6CPS (A), titanium dioxide (E 171), macrogol 6000, yellow iron oxide, and red iron oxide (E172) ( see section 2: Important information about some of the ingredients of Montelukast Accord ).
What the medicine looks like and contents of the pack
Montelukast Accord 10 mg film-coated tablet is 7.9 x 7.9 mm beige, rounded square, film-coated, with the designation M10 on one side.
Blister pack of polyamide / PVC / aluminum of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319, Pinner Road
North Harrow
Middlesex, HA1 4HF
UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50, 95-200 Pabianice, Poland