Montelukast Sandoz

Leaflet attached to the packaging: patient information

Montelukast Sandoz, 4 mg, granules

Montelukast

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this child. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as the child's.
• If the child experiences any side effects, including any side effects not listed in this leaflet, tell the doctor or pharmacist (see section 4).

Table of contents of the leaflet:

• 1. What is Montelukast Sandoz and what is it used for
• 2. Important information before taking Montelukast Sandoz
• 3. How to take Montelukast Sandoz
• 4. Possible side effects
• 5. How to store Montelukast Sandoz
• 6. Contents of the pack and other information

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

Montelukast Sandoz is a leukotriene receptor antagonist that inhibits the activity of compounds called leukotrienes. Leukotrienes cause narrowing and swelling of the airways. By inhibiting the action of leukotrienes, Montelukast Sandoz relieves asthma symptoms and helps control its course.
The doctor has prescribed Montelukast Sandoz to treat asthma in the child and prevent its symptoms from occurring during the day and at night.
Montelukast Sandoz is used to treat patients from 6 months to 5 years of age who have not achieved adequate asthma control with their current medications and require additional medications.
Montelukast Sandoz can also be used instead of inhaled corticosteroids in children aged 2 to 5 years who have not recently taken oral corticosteroids and are unable to use inhaled corticosteroids.
Montelukast Sandoz also helps prevent narrowing of the airways caused by physical exertion in patients over 2 years of age.
The doctor will determine how to take Montelukast Sandoz based on the child's symptoms and the severity of the asthma.

What is asthma?

Asthma is a chronic disease.
Asthma causes:
difficulty breathing due to narrowing of the airways. This narrowing worsens or improves in response to various factors.
airway hypersensitivity, causing them to react to many factors, such as cigarette smoke, plant pollen, cold air, or physical exertion.
inflammation (inflammation) of the lining of the airways.
Asthma symptoms include: coughing, wheezing, and a feeling of pressure in the chest.

2. Important information before taking Montelukast Sandoz

Tell the doctor about any current or past health problems or allergies in the child.

When not to take Montelukast Sandoz

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

Warnings and precautions

Before starting Montelukast Sandoz, discuss it with your doctor or pharmacist.
If the child's asthma symptoms worsen or shortness of breath occurs, tell 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. Always carry an inhaled medication for use in asthma attacks.
It is essential that the child takes all asthma medications prescribed by the doctor. Montelukast Sandoz should not be used instead of other asthma medications prescribed by the doctor for the child.
Remember to consult a doctor if the child taking asthma medications experiences the following symptoms: flu-like symptoms, tingling or numbness of the hands or feet, worsening of respiratory symptoms, and (or) rash.
The child should not be given 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 (such as changes in behavior 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 the patient while taking montelukast, consult a doctor.

During treatment with montelukast, consult a doctor if such symptoms occur.

Children and adolescents

Do not give this medicine to children under 6 months of age.
For children and adolescents under 18 years of age, this medicine is available in other pharmaceutical forms suitable for the respective age groups.

Montelukast Sandoz and other medicines

Some medicines may affect the way Montelukast Sandoz works or Montelukast Sandoz may change the effect of other medicines taken by the child.
Tell the doctor or pharmacist about all medicines the child is taking, has recently taken, or is planned to be taken, including those available without a prescription.
Before starting Montelukast Sandoz, tell the doctor about the child taking 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 some other infections),
gemfibrozil (a medicine used to lower high blood lipid levels).

Montelukast Sandoz with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

This subsection does not apply to Montelukast Sandoz, as the medicine is intended for children from 6 months to 5 years of age, but the following information applies to the active substance of the medicine, montelukast.
Use during pregnancy
Pregnant or breastfeeding women should consult a doctor before taking Montelukast Sandoz. The doctor will assess whether they can take it at that time.
Use during breastfeeding
It is not known whether Montelukast Sandoz passes into breast milk. Therefore, breastfeeding women or those planning to breastfeed should consult a doctor before taking it.

Driving and using machines

This subsection does not apply to Montelukast Sandoz, as the medicine is intended for children from 6 months to 5 years of age, but the following information applies to the active substance of the medicine, montelukast.
Montelukast should not affect the ability to drive or use machines, but the effect of the medicine may vary from patient to patient. Certain side effects (such as dizziness and drowsiness), which have been very rarely reported with Montelukast Sandoz, may affect some patients' ability to drive or use machines.
Montelukast Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".

3. How to take Montelukast Sandoz

This medicine should be given to the child under adult supervision. The child should take Montelukast Sandoz every evening.
The medicine should be given even when the child has no symptoms and on days when an asthma attack has occurred.
This medicine should always be used in the child as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
The medicine should be taken orally.

The usual dose is:

Children from 6 months to 5 years of age

One sachet of Montelukast Sandoz 4 mg granules per day, taken orally, in the evening.
If the child is taking Montelukast Sandoz, ensure they do not receive other medicines containing the same active substance, montelukast.
For children from 2 to 5 years of age, Montelukast Sandoz is available in the form of chewable tablets of 4 mg and granules. The use of 4 mg Montelukast Sandoz granules is not recommended in children under 6 months of age.

How to give Montelukast Sandoz to the child?

The sachet should be opened immediately before administration.
Montelukast Sandoz can be given:

• directly into the child's mouth OR
• after mixing with a spoonful of cold or room temperature soft food (e.g., apple sauce, ice cream, carrot with rice). If Montelukast Sandoz is mixed with a spoonful of soft food (cold or room temperature), ensure the entire dose of the medicine is mixed with the food.

Also, ensure the child takes the full spoonful of granules (or a mixture of granules and food) immediately (within 15 minutes). NOTE: Never store the mixture of granules and food for later.
Montelukast Sandoz is not intended to be dissolved in a liquid. However, a liquid can be given to the child to drink after taking Montelukast Sandoz.
Montelukast Sandoz can be taken with or without food.

If the child takes more Montelukast Sandoz than recommended

Consult the child's doctor immediately.
In most cases of overdose, no side effects have been observed. The most common symptoms of overdose in adults and children are: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and increased restlessness.

Missing a dose of Montelukast Sandoz

Try to give the child Montelukast Sandoz as directed by the doctor. However, if a dose is missed, return to the usual dosing schedule - one sachet per day.
Do not take a double dose to make up for the missed dose.

Stopping Montelukast Sandoz

Montelukast Sandoz is effective in treating asthma in the child only if taken regularly. It is essential that the child takes Montelukast Sandoz for as long as the doctor recommends. This will help control the child's asthma symptoms.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following serious side effects occur, consult a doctor immediately, as urgent medical attention may be required.

Rareside effects (may occur in less than 1 in 100 people):
allergic reactions, including swelling of the face, lips, tongue, and (or) throat, which can cause difficulty breathing or swallowing.
changes in behavior and mood: agitation, including aggressive or hostile behavior, depression
seizures
Very rareside effects (may occur in less than 1 in 1000 people):
increased tendency to bleed
tremors
palpitations
Very rareside effects (may occur in less than 1 in 10,000 people):
decreased platelet count (thrombocytopenia)
changes in behavior and mood: hallucinations, disorientation, suicidal thoughts and behaviors. Warning signs are, for example, talking about suicide, withdrawal, and wanting to be left alone or feeling trapped or helpless
yellowing of the skin and eyes, unusual tiredness or fever, dark urine due to liver inflammation
inflammation (inflammation) of the lungs
a syndrome of symptoms such as flu-like symptoms, tingling or numbness of the hands and feet, worsening of respiratory symptoms, and (or) rash (Churg-Strauss syndrome). If the child experiences one or more of these symptoms, tell the doctor immediately.
severe skin reactions (erythema multiforme), which can occur without warning.
The most commonly reported side effects (may occur in less than 1 in 10 people) associated with montelukast and reported in clinical trials with the use of 4 mg oral granules, 4 mg or 5 mg chewable tablets, or 10 mg film-coated tablets were:
headache
abdominal pain
increased thirst
diarrhea
excessive activity
asthma
dryness and itching of the skin
rash
These side effects were usually mild and occurred more frequently in patients treated with montelukast than in those receiving a placebo (a medicine that does not contain an active substance).
Additionally, the following side effects have been reported after the medicine was placed on the market:
Very commonside effects (may occur in more than 1 in 10 people):
upper respiratory tract infection
Commonside effects (may occur in less than 1 in 10 people):
diarrhea, nausea, vomiting
abnormal liver function test results
rash
fever
Rareside effects (may occur in less than 1 in 100 people):
changes in behavior and mood (abnormal dreams, including nightmares, sleep disturbances, sleepwalking, irritability, restlessness, anxiety)
dizziness, drowsiness, tingling, and (or) numbness,
nosebleeds
dry mouth, indigestion
bruising, itching, hives
joint or muscle pain, muscle cramps
bedwetting in children
feeling tired, unwell, swelling
Very rareside effects (may occur in less than 1 in 10,000 people):
attention disorders
memory impairment
tremors
uncontrolled muscle movements
Very rareside effects (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 side effects

If side effects occur, including any side effects not listed in the leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Montelukast Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet after "EXP". The expiry date refers to the last day of the month.
Do not store above 25 °C.
Store in the original package to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Montelukast Sandoz contains

The active substance is montelukast. Each sachet of granules contains montelukast sodium equivalent to 4 mg of montelukast.
The other ingredients are: mannitol, hydroxypropylcellulose, and magnesium stearate.

What Montelukast Sandoz looks like and contents of the pack

White or almost white granules.
The granules are packed in PET/Aluminum/PE sachets placed in a cardboard box.
Pack sizes:
28 or 30 sachets.

Marketing authorization holder and manufacturer

Marketing authorization 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
S.C. Sandoz, S.R.L.
Livezeni Street no 7A
540472 Targu-Mures, Romania
Lek S.A.
ul. Podlipie 16
95-010 Stryków

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:05/2024
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