4 mg for children aged 2 to 5 years
What Montelukast Actavis is and what it is used for
Montelukast Actavis is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Leukotriene causes contraction and swelling of the airways in the lungs. By blocking the leukotrienes, Montelukast Actavis improves the symptoms of asthma and helps control asthma.
Your child’s doctor has prescribed Montelukast Actavis to treat your child’s asthma and thus prevent asthma symptoms during the day and night.
- Montelukast Actavis is used for treating patients aged 2 to 5 years who have not had adequate control of previous asthma medication and therefore need additional treatment.
- Montelukast Actavis may also be a treatment alternative to inhaled cortisone in patients aged 2 to 5 years who have not recently been treated with oral cortisone preparations and who have not been able to use inhaled cortisone
- Montelukast Actavis also prevents airway constriction in connection with physical exertion in patients aged 2 years or older.
Depending on the symptoms and severity of your child’s asthma, your child’s doctor will decide how to use Montelukast Actavis.
Montelukast contained in Montelukast Actavis may also be authorized 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 your child takes Montelukast Actavis
Tell your child’s doctor about any medical or allergic problems your child has or has had.
Do not use Montelukast Actavis
- if your child is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using your child Montelukast Actavis
- If your child’s asthma symptoms or breathing worsen, contact your child’s doctor immediately.
- Montelukast Actavis taken by mouth is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your child’s doctor for this situation. Always carry your child’s bronchodilator asthma medication for inhalation with you for acute asthma attacks.
- It is important that your child takes all other asthma medications prescribed by your doctor. Montelukast Actavis is not intended to replace other asthma medications prescribed by your child’s doctor.
- If your child is being treated with asthma medication and has 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, contact your child’s doctor.
- If you know that your child’s asthma is exacerbated by acetylsalicylic acid , do not give your child acetylsalicylic acid or other non-cortisone-type anti- inflammatory drugs ( NSAIDs ).
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 your child develops such symptoms while using Montelukast Actavis, you should consult your child’s doctor.
Other medicines and Montelukast Actavis
Some medicines may affect the way Montelukast Actavis works and Montelukast Actavis may affect the way your child’s other medicines work.
Tell your child’s doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Tell your child’s doctor if your child is taking the following medicines before starting treatment with Montelukast Actavis:
- phenobarbital (antiepileptic drugs )
- phenytoin (antiepileptic drugs )
- rifampicin (remedy for tuberculosis and certain other infections )
- gemfibrozil (antihypertensive agent)
Montelukast Actavis with food and drink
Montelukast Actavis 4 mg chewable tablet should not be taken with food; intake should be 1 hour before or 2 hours after a meal.
Pregnancy and breastfeeding
This subheading does not apply to Montelukast Actavis 4 mg chewable tablets as they are intended for the treatment of children aged 2 to 5 years. However, the following information applies to the active substance, montelukast.
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding
It is unknown whether Montelukast Actavis passes into breast milk. Therefore, consult a physician before using Montelukast Actavis during breastfeeding or scheduled breastfeeding. Your doctor will decide if you can take Montelukast Actavis during this time.
Driving and using machines
This subheading does not apply to Montelukast Actavis 4 mg chewable tablets as they are intended for the treatment of children aged 2 to 5 years. However, the following information applies to the active substance, montelukast.
Montelukast Actavis 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.
Montelukast Actavis contains aspartame
This medicine contains 1.20 mg of aspartame per chewable tablet.
Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
Montelukast Actavis contains lactose
If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicine to your child.
Montelukast Actavis contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per chewable tablet, ie essentially ‘sodium-free’.
Montelukast Actavis contains sulfites
The flavors in this medicine contain less than 0.001% sulfites per chewable tablet. May in rare cases cause severe hypersensitivity reactions and convulsions in the trachea.
How you or your child take Montelukast Actavis
- Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your child’s doctor or pharmacist.
- This medicine should be given to children under the supervision of an adult.
- The recommended dose is one Montelukast Actavis tablet once a day as prescribed by your child’s doctor .
- Your child should take the tablet both during asymptomatic periods and during periods of worsening asthma .
- To be taken by mouth.
For children aged 2 to 5 years:
One Montelukast Actavis 4 mg chewable tablet is taken once daily in the evening. Montelukast Actavis 4 mg chewable tablet should not be taken with food; intake should be 1 hour before or 2 hours after a meal.
Montelukast Actavis should not be used with any other product containing the same active ingredient, montelukast.
Other age group r:
For other age groups, other strengths and drug formulations of montelukast may be available.
Montelukast Actavis 4 mg chewable tablet is not recommended for children under 2 years of age.
If your child has taken too much Montelukast Actavis
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 give your child Montelukast Actavis
Try to give Montelukast Actavis as prescribed. If your child has missed a dose, return to the usual schedule with one tablet a day.
Do not give a double dose to make up for a forgotten dose.
If your child stops taking Montelukast Actavis
Montelukast Actavis can only treat your child’s asthma if your child continues to take it.
Your child must continue to take Montelukast Actavis for as long as your doctor prescribes it. It helps control your baby’s asthma.
If you have any further questions on the use of this product, ask your doctor or your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects reported during treatment with montelukast, stop giving your child Montelukast Actavis and contact your doctor immediately:
- Sudden wheezing, swelling of the lips, tongue and throat or in the body, rash, fainting or difficulty swallowing (severe allergic reaction ). This side effect is less common (may affect up to 1 in 100 people).
- Flu-like symptoms , tingling or numbness in the arms or legs, worsening of respiratory symptoms and / or rash (Churg-Strauss syndrome). This side effect is very rare (may affect up to 1 in 10,000 people).
- Suicidal thoughts and actions. This side effect is very rare (may affect up to 1 in 10,000 people).
- Severe skin reactions (erythema multiforme) that may occur without warning. This side effect is very rare (may affect up to 1 in 10,000 people).
The following side effects have also been reported with montelukast:
Very common: may affect more than 1 in 10 people
- colds (upper respiratory tract infection)
Common: may affect up to 1 in 10 people
- headache
- magont
- thirst
- diarrhea, nausea, vomiting
- rash
- fever
- asthma
- hyperactivity
- reddening, itchy skin ( eczema )
- increase of certain substances in the blood ( transaminases )
Uncommon: may affect up to 1 in 100 people
- behavioral and mood changes (altered dream patterns including nightmares, difficulty sleeping, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behavior or hostility, depression)
- dizziness, drowsiness, numbness and tingling, 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
- tremors, attention deficit disorder, impaired memory
- increased tendency to bleed
- shaking
- palpitations ( palpitation )
- swelling of the skin
Very rare: may affect up to 1 in 10,000 people
- hallucinations, confusion, stuttering
- hepatitis (hepatitis), hepatic impairment ( hepatic eosinophil infiltration)
- sore red bumps under the skin, mainly on the narrow legs (erythema nodosum)
How to store Montelukast Actavis
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 and blister after EXP. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light. Moisture sensitive.
Do not store above 30 ° C.
Medicines should not be disposed of via wastewater. 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 chewable tablet contains montelukast sodium equivalent to 4 mg montelukast.
- The other ingredients (excipients) are: microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, lactose monohydrate , red iron oxide (E172), mannitol, silage, cherry flavor (nature identical flavors, flavorings, natural flavors, maltodextrin (acacia) (acodeia414) (E1518), ethyl maltol, maltol, alpha-tocopherol (E307)), aspartame (E951), magnesium stearate.
What the medicine looks like and contents of the pack
Montelukast Actavis 4 mg chewable tablets are pink, marbled, oval, biconvex tablets marked with M4 on one side.
Blisters in packaging if:
10, 14, 20, 28, 30, 50, 56, 100 chewable tablets are
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland