Package leaflet: Information for the patient

Montelukast Sandoz, 4 mg, chewable tablets
Montelukastum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific child only. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same as the child's.
If the child experiences any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Leaflet contents:

What Montelukast Sandoz is and what it is used for
Important information before taking Montelukast Sandoz
How to take Montelukast Sandoz
Possible side effects
How to store Montelukast Sandoz
Contents of the pack and other information

1. What Montelukast Sandoz is and what it is used for

Montelukast Sandoz is a leukotriene receptor antagonist that blocks the action of substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways. By blocking the action of leukotrienes, Montelukast Sandoz relieves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast Sandoz to treat asthma in the child and to prevent daytime and nighttime asthma symptoms.
Montelukast Sandoz 4 mg is used to treat patients aged 2 to 5 years who have not achieved adequate asthma control with previously used medications and who require additional therapy.
Montelukast Sandoz 4 mg may also be used as an alternative to inhaled corticosteroids in children aged 2 to 5 years who have not recently taken oral corticosteroids and who are unable to use inhaled corticosteroids.
Montelukast Sandoz 4 mg also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.
Your doctor will determine how to use Montelukast Sandoz based on the child's symptoms and severity of asthma.

What is asthma?
Asthma is a chronic disease.
Asthma is characterized by:

Breathing difficulties due to narrowing of the airways. This narrowing worsens or improves in response to various factors.
Airway hypersensitivity, causing the airways to react to many triggers such as cigarette smoke, pollen, cold air, or physical exercise.
Swelling (inflammation) of the mucosal lining of the airways.
Symptoms of asthma include coughing, wheezing, and a feeling of tightness in the chest.

2. Important information before using Montelukast Sandoz

Inform the doctor of any current or past health problems or allergies in the child.
When not to use Montelukast Sandoz

if the child is allergic (hypersensitive) to montelukast or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Montelukast Sandoz, discuss this with the doctor or pharmacist.
If the child's asthma symptoms worsen or breathing difficulties occur, inform the doctor immediately.
Montelukast Sandoz, taken orally, is not intended for the treatment of acute asthma attacks. In case of an asthma attack, follow the doctor's instructions strictly. Always have an inhaler available for use during asthma attacks.
It is important that the child takes all anti-asthma medications prescribed by the doctor. Montelukast Sandoz should not be used instead of other anti-asthma medications prescribed for the child.
Remember to consult the doctor if the child taking anti-asthma medications develops the following symptoms: flu-like symptoms, tingling or numbness in hands or feet, worsening of respiratory symptoms and/or rash.
Do not give the child acetylsalicylic acid or anti-inflammatory drugs (so-called non-steroidal anti-inflammatory drugs – NSAIDs) if they worsen the child's asthma symptoms.
Various neuropsychiatric events (for example, changes in behaviour and mood, depression and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur in a patient during treatment with montelukast, consult a doctor.
Children and adolescents
Do not give this medicine to children under 2 years of age.
For children and adolescents under 18 years of age, Montelukast Sandoz is available in other pharmaceutical forms appropriate for specific age groups.
Montelukast Sandoz and other medicines
Some medicines may affect the way Montelukast Sandoz works, or Montelukast Sandoz may alter the effect of other medicines taken by the child.
Tell the doctor or pharmacist about all medicines currently or recently given to the child, as well as any medicines planned for the child, including those available without a prescription.
Before starting Montelukast Sandoz, inform the doctor if the child is taking any of the following medicines:
phenobarbital (a medicine used to treat epilepsy)
phenytoin (a medicine used to treat epilepsy)
rifampicin (a medicine used to treat tuberculosis and certain other infections)
gemfibrozil (a medicine used to lower high levels of lipids in plasma).
Montelukast Sandoz with food and drink
Montelukast Sandoz should not be taken with food, but should be taken at least 1 hour before or 2 hours after a meal.
Pregnancy and breastfeeding
This section does not apply to Montelukast Sandoz 4 mg, as it is intended for children aged 2 to 5 years. However, the information below refers to the active substance of the medicine, montelukast.
Use during pregnancy
Women who are pregnant or planning to become pregnant should consult a doctor before taking Montelukast Sandoz. The doctor will assess whether it can be taken during this time.
Use during breastfeeding
It is not known whether montelukast passes into breast milk. Therefore, women who are breastfeeding or planning to breastfeed should consult a doctor before taking Montelukast Sandoz.
Driving and using machines
This section does not apply to Montelukast Sandoz 4 mg, as it is intended for children aged 2 to 5 years. However, the information below refers to the active substance of the medicine, montelukast.
Montelukast Sandoz is not expected to affect the ability to drive or operate machinery. However, the effect of the medicine may vary between individual patients. Very rarely, adverse reactions (such as dizziness and drowsiness) have been reported in some individuals, which may affect the ability to drive or operate machinery.
Montelukast Sandoz contains aspartame, azo dye Allura red (E 129), sodium and sucrose.
This medicine contains 0.96 mg of aspartame in each chewable tablet. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
This medicine contains the azo dye Allura red (E 129), which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, meaning the medicine is considered "sodium-free".
This medicine contains sucrose. If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to take Montelukast Sandoz

The child should take only one tablet of Montelukast Sandoz once daily, as directed by the doctor.
The child should continue taking the medicine even when no symptoms are present and on days when an acute asthma attack occurs.
Montelukast Sandoz should always be given to the child exactly as prescribed by the doctor. If in doubt, contact the doctor or pharmacist again.

Recommended dose:
Children aged 2 to 5 years
One 4 mg chewable tablet once daily, taken in the evening. Montelukast Sandoz should not be taken with food, but at least 1 hour before or 2 hours after a meal. The tablet must be chewed before swallowing.
The medicine should be administered under the supervision of an adult.
If the child is taking Montelukast Sandoz, ensure that they are not also receiving other medicines containing the same active substance, montelukast.
This medicine is for oral use only.
Use of Montelukast Sandoz is not recommended in children under 2 years of age.

For children aged 2 to 5 years, 4 mg chewable tablets and 4 mg granules (for children who have difficulty taking chewable tablets) are available.
For children aged 6 to 14 years, 5 mg chewable tablets are available.

Accidental overdose of Montelukast Sandoz in a child
Contact the child's doctor immediately.
In most cases, no adverse effects have been observed following overdose. The most commonly reported symptoms of overdose in adults and children include: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and increased motor activity.

Missed dose of Montelukast Sandoz
Try to give the child Montelukast Sandoz as prescribed by the doctor. However, if a dose is missed, resume the regular dosing schedule—take one tablet once daily.
Do not take a double dose to make up for a missed dose.

Stopping Montelukast Sandoz
Montelukast Sandoz is effective in treating asthma in children only when taken regularly. It is important that the child continues taking Montelukast Sandoz for as long as the doctor has recommended. This will help control the child's asthma symptoms.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the following serious adverse reactions occur, seek immediate medical advice, as urgent medical treatment may be required.
Uncommon adverse reactions (may occur in less than 1 in 100 people):
allergic reactions, including swelling of the face, lips, tongue and (or) throat, which may cause
difficulty in breathing or swallowing
changes in behaviour and mood: agitation, including aggressive behaviour or hostility, depression
seizures
Rare adverse reactions (may occur in less than 1 in 1,000 people):
increased tendency to bleed
tremor
palpitations
Very rare adverse reactions (may occur in less than 1 in 10,000 people):
decreased platelet count (thrombocytopenia)
changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and behaviour. Warning signs include, for example, talking about suicide, withdrawal from social interactions, desire to be left alone, or feelings of being trapped or helpless.
yellowing of the skin and eyes, unusual tiredness or fever, darkening of the urine due to liver inflammation
swelling (inflammation) of the lungs
a combination of symptoms such as flu-like symptoms, tingling or numbness in the hands and feet, worsening respiratory symptoms and (or) rash (Churg-Strauss syndrome). If your child develops one or more of these symptoms, inform your doctor immediately.
severe skin reactions (erythema multiforme), which may occur without warning.
The most commonly reported adverse reactions (may occur in less than 1 in 10 people)
associated with montelukast use and reported in clinical trials using 4 mg oral granules, 4 mg or 5 mg chewable tablets, or 10 mg film-coated tablets were:
abdominal pain
headache
increased thirst
excessive activity
diarrhoea
asthma
dry, itchy skin
rash
These reactions were usually mild and occurred more frequently in patients treated with montelukast than in those receiving placebo (an inactive tablet).
Additionally, the following adverse reactions have been reported since the medicine was marketed:
Very common: may occur in more than 1 in 10 people:
upper respiratory tract infection
Common: may occur in less than 1 in 10 people:
diarrhoea, nausea, vomiting
increased liver enzyme activity
rash
fever
Uncommon: may occur in less than 1 in 100 people:
changes in behaviour and mood (unusual dreams, including nightmares, difficulty falling asleep, sleepwalking, irritability, feelings of anxiety, psychomotor agitation)
dizziness, drowsiness, tingling and (or) numbness
nosebleeds
dry mouth, indigestion
bruising, itching, urticaria
joint or muscle pain, muscle cramps
bedwetting in children
weakness, feeling tired, malaise, oedema
Rare: may occur in less than 1 in 1,000 people:
changes in behaviour and mood: attention disorders, memory impairment, uncontrolled muscle movements
Very rare: may occur in less than 1 in 10,000 people:
tender, red nodules under the skin, most commonly on the shins (erythema nodosum)
obsessive-compulsive symptoms
stuttering
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, speak to your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Montelukast Sandoz

This medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the specified month.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

The active substance is montelukast.
Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.
The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, iron oxide red (E172), sodium croscarmellose, cherry flavour (Cherry Flavour AP0551, Cherry Duarome TD0990B [containing azo dye Allura red E129]), aspartame (E951) and magnesium stearate.
What Montelukast Sandoz looks like and contents of the pack
The chewable and dispersible tablets are pink or slightly mottled pink, oval-shaped, marked with the number "4" on one side.
The chewable and dispersible tablets are packed in blisters made of OPA/ALU/PVC/ALU or OPA/ALU/PE/ALU foil and placed in cardboard boxes.
The medicine is available in packs containing 28 or 30 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer/Importer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
S.C. Sandoz, S.R.L.
Livezeni Street no 7A
540472 Targu-Mures, Romania
Sandoz N.V.
Van Rooijen Pharma
Schietstandlaan 2 – 2300 Turnhout, Belgium
LEK S.A.
ul. Podlipie 16
95-010 Stryków, Poland
For further information about the medicine and its names in the countries of the European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00