Montelukast sandoz

Package leaflet: Information for the patient

Montelukast Sandoz, 5 mg, chewable tablets
Montelukastum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific child only. Do not share it with others. This medicine may harm other people, 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, inform your doctor or pharmacist (see section 4).

Leaflet contents:

1. What Montelukast Sandoz is and what it is 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 Montelukast Sandoz is and what it is 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 blocking the action of leukotrienes, Montelukast Sandoz relieves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast Sandoz for the treatment of asthma in the child and for preventing the occurrence of asthma symptoms during the day and at night.
Montelukast Sandoz 5 mg is used to treat patients aged 6 to 14 years who have not achieved adequate asthma control with previously used medications and require additional therapy.
Montelukast Sandoz 5 mg may also be used as an alternative to inhaled corticosteroids in children aged 6 to 14 years who have not recently taken oral corticosteroids and who are unable to use inhaled corticosteroids.
Montelukast Sandoz 5 mg also helps prevent exercise-induced narrowing of the airways.
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.
The condition of asthma includes:

• Breathing difficulties due to narrowing of the airways. This narrowing worsens or improves in response to various factors.
• Airway hypersensitivity, causing them to react to many triggers such as cigarette smoke, pollen, cold air, or physical exertion.
• 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 your doctor about 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 your doctor or pharmacist.
If the child's asthma symptoms worsen or if 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 strictly the instructions provided by the doctor. Always keep an inhaler medicine for use during asthma attacks.
It is important that the child takes all anti-asthma medicines prescribed by the doctor. Montelukast Sandoz must not be used instead of other anti-asthma medicines prescribed for the child.
Remember to consult your doctor if the child taking anti-asthma medicines 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 medicines (so-called non-steroidal anti-inflammatory drugs – NSAIDs) if they worsen asthma symptoms in the child.
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 6 years of age.
For children and adolescents under 18 years of age, this medicine 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 your doctor or pharmacist about all medicines currently or recently given to the child, as well as any medicines planned for use, 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 in the treatment of epilepsy)
phenytoin (a medicine used in the treatment of epilepsy)
rifampicin (a medicine used in the treatment of 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 the 5 mg strength of Montelukast Sandoz, as it is intended for children aged 6 to 14 years. However, the information below refers to the active substance of the medicine, montelukast.
Use during pregnancy
Women who are pregnant or planning pregnancy should consult their 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 human breast milk. Therefore, women who are breastfeeding or planning to breastfeed should consult their doctor before taking Montelukast Sandoz.
Driving and operating machinery
Montelukast Sandoz should not affect the ability to drive a car 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, the azo dye Allura red (E 129), sodium and sucrose.
This medicine contains 1.2 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 been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Montelukast Sandoz

The child should take only one tablet of Montelukast Sandoz once daily, as directed by the doctor.
The medicine should be taken even when the child has no symptoms, as well as on days when an asthma attack occurs.
Montelukast Sandoz should always be used in the child exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist again.

Recommended dose:
Children aged 6 to 14 years
One 5 mg chewable tablet once daily, taken in the evening. Montelukast Sandoz should not be taken with food, but administered at least 1 hour before or 2 hours after a meal. The tablet must be chewed before swallowing.

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 intended for oral use.
The 5 mg strength of Montelukast Sandoz is not recommended for children under 6 years of age.

• For children aged 2 to 5 years, 4 mg chewable tablets are available.
• For adults and adolescents aged 15 years and older, 10 mg film-coated tablets are available.

Accidental overdose of Montelukast Sandoz in a child
Contact the child's doctor immediately.
In most cases of overdose, no adverse effects have been observed. 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, return to the regular dosing schedule—giving one tablet once daily.
Do not give 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 directed by the doctor. This will help control the child's asthma symptoms.
If you have any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
If any of the following severe adverse effects occur, seek medical advice immediately,
as urgent medical care may be required.
Uncommon adverse effects (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 effects (may occur in less than 1 in 1000 people):
increased tendency to bleeding
tremor
palpitations
Very rare adverse effects (may occur in less than 1 in 10,000 people):
reduced number of platelets (thrombocytopenia)
changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and behaviours. Warning signs include, for example, talking about suicide, withdrawal from social contacts and desire to be left alone, or feelings of being trapped or helpless
yellowing of the skin and eyes, unusual tiredness or fever, dark-coloured urine due to liver inflammation
swelling (inflammation) of the lungs
a combination of symptoms such as flu-like symptoms, tingling or numbness in hands and feet, worsening of respiratory symptoms and (or) rash (Churg-Strauss syndrome). If a child develops one or more of these symptoms, inform the doctor immediately.
severe skin reactions (erythema multiforme), which may occur without warning.
The most commonly reported adverse effects (may occur in less than 1 in 10 people)
associated with montelukast use and reported in clinical trials with the 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
skin peeling and itching
rash
These effects were usually mild and occurred more frequently in patients treated with montelukast than in those receiving placebo (a tablet without active substance).
Additionally, the following adverse effects have been reported after marketing authorization:
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 (abnormal dreams, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, 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, swelling
Rare: may occur in less than 1 in 1000 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 occurring on the shins (erythema nodosum)
obsessive-compulsive symptoms
stuttering
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.
Adverse effects 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

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 stated month.
Keep 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. Such 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 5 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 tablets are pink or slightly mottled pink, round, and marked with the number "5" on one side.
The chewable tablets are packed in blisters made of OPA/ALU/PVC/ALU or OPA/ALU/PE/ALU foil and placed in a cardboard box.
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 more detailed information about the medicine and its trade names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00