Montelukast Sandoz

Leaflet attached to the packaging: patient information

Montelukast Sandoz, 4 mg, chewable tablets

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 not mentioned 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. Package contents 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 substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways. By inhibiting the action of leukotrienes, Montelukast Sandoz alleviates asthma symptoms and helps control asthma.

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 4 mg is used to treat patients aged 2 to 5 years who have not achieved adequate asthma control with their current medications and require additional medication.

Montelukast Sandoz 4 mg may 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 4 mg also helps prevent bronchospasm caused by physical exertion in patients aged 2 years and older.

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 consists of:

difficulty breathing due to airway narrowing, which 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 (hypersensitive) to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Discuss the use of Montelukast Sandoz with a doctor or pharmacist before starting treatment.

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 exactly. Always carry a rescue inhaler with you.

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.

Consult a doctor if the child taking asthma medications experiences any of the following symptoms: flu-like symptoms, tingling or numbness of the 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 (e.g., 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.

Do not give this medicine to children under 2 years 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 or has recently taken, as well as any planned medications, including those available without a prescription.

Before starting Montelukast Sandoz, inform the doctor about the child 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 some other infections)

gemfibrozil (a medicine used to lower high lipid levels in the blood).

Montelukast Sandoz with food and drink

Do not take Montelukast Sandoz with a meal, but take it at least 1 hour before eating or 2 hours after eating.

Pregnancy and breastfeeding

This section does not apply to Montelukast Sandoz 4 mg, as it is intended for children aged 2 to 5 years, 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 passes into breast milk. Therefore, breastfeeding women or those 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, but the following information applies to the active substance of the medicine, montelukast.

Montelukast Sandoz should not affect the ability to drive or use machines, but the effect of the medicine may vary from person to person. Very rarely, side effects such as dizziness and drowsiness have been reported, which may affect the ability to drive or use machines.

Montelukast Sandoz contains aspartame, the colorant 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 to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

This medicine contains the azo colorant Allura red (E 129), which may cause allergic reactions.

This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, which means the medicine is considered "sodium-free".

This medicine contains sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

3. How to take Montelukast Sandoz

The child should take only one tablet of Montelukast Sandoz once a day, as directed by the doctor.

The child should also take the medicine when they do not have any symptoms and on days when they have had an acute asthma attack.

Montelukast Sandoz should always be taken by the child as directed by the doctor. In case of doubts, consult the doctor or pharmacist again.

The medicine should be taken orally.

Recommended dose:

Children aged 2 to 5 years

One 4 mg chewable tablet per day, taken in the evening. Montelukast Sandoz should not be taken with a meal, but taken at least 1 hour before eating or 2 hours after eating. The tablet should be chewed before swallowing.

The medicine should be given to the child under adult supervision.

If the child is taking Montelukast Sandoz, ensure they do not also take other medicines containing the same active substance, montelukast.

The 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 with problems taking chewable tablets) are available.
• For children aged 6 to 14 years, 5 mg chewable tablets are available.

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.

If a dose of Montelukast Sandoz is missed

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 tablet once a day.

Do not take a double dose to make up for a 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.

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Montelukast Sandoz 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 necessary.

Uncommon side effects (may occur in less than 1 in 100 people):

allergic reactions, including face, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing

behavioral and mood changes: agitation, including aggressive or hostile behavior, depression, seizures

Rare side effects (may occur in less than 1 in 1,000 people):

increased tendency to bleed

tremors

palpitations

Very rare side effects (may occur in less than 1 in 10,000 people):

decreased platelet count (thrombocytopenia)

behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and behaviors. Warning signs include talking about suicide, withdrawal from social contacts, and a desire to be left alone or feelings of being trapped or helpless.

yellowing of the skin and eyes, unusual tiredness or fever, dark urine due to liver inflammation

lung inflammation (pneumonitis)

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 may 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:

abdominal pain

headache

increased thirst

increased activity

diarrhea

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 tablet that does not contain the active substance).

Additionally, the following side effects have been reported after the medicine was placed on the market:

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):

diarrhea, nausea, vomiting

abnormal liver function test results

rash

fever

Uncommon (may occur in less than 1 in 100 people):

behavioral and mood changes (unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness)

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

Rare (may occur in less than 1 in 1,000 people):

tremors

attention disorders, memory impairment

uncontrolled muscle movements

Very rare (may occur in less than 1 in 10,000 people):

tender, red lumps under the skin, most often on the shins (erythema nodosum)

obsessive-compulsive symptoms

stuttering

Reporting side effects

If any side effects occur, including any possible side effects not mentioned in this leaflet, consult a doctor or pharmacist.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 the sight and reach 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 month stated.

Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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, hydroxypropyl cellulose, iron oxide red (E172), sodium croscarmellose, cherry flavor (Cherry Flavour AP0551, Cherry Duarome TD0990B [contains the azo colorant Allura red E129]), aspartame (E951), and magnesium stearate.

What Montelukast Sandoz looks like and what the package contains

The chewable tablets are pink or slightly speckled pink, oval, marked with the number "4" on one side.

The chewable tablets are packaged in blisters of OPA/ALU/PVC/ALU or OPA/ALU/PE/ALU foil and placed in a cardboard box.

The medicine is available in packs of 28 or 30 tablets.

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

Sandoz N.V.

Van Rooijen Pharma

Schietstandlaan 2 – 2300 Turnhout, Belgium

LEK S.A.

ul. Podlipie 16

95-010 Stryków

To obtain more detailed information about 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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