MONTELUKAST 4 mg Tablets

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
2. Montelukast Teva, 4 mg, chewable tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Montelukast Teva and what is it used for
   1. What is Montelukast Teva
   2. How Montelukast Teva works
   3. When to use Montelukast Teva
   4. What is asthma?
4. Important information before taking Montelukast Teva in children
   1. When not to give Montelukast Teva to a child
   2. Warnings and precautions
   3. Children and adolescents
   4. Montelukast Teva and other medicines
   5. Montelukast Teva with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Montelukast Teva contains aspartame
   9. Montelukast Teva contains sodium
5. How to take Montelukast Teva
   1. Children aged 2 to 5 years:
   2. If the child takes more Montelukast Teva than they should
   3. If the child misses a dose of Montelukast Teva
   4. If the child stops taking Montelukast Teva
6. Possible side effects
   1. Severe side effects
   2. Other side effects reported after the medicine was marketed
   3. Reporting side effects
7. How to store Montelukast Teva
8. Contents of the pack and other information
   1. What Montelukast Teva contains
   2. What Montelukast Teva chewable tablets look like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Montelukast Teva, 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 child, even if their symptoms are the same.
• 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 Teva and what is it used for
• 2. Important information before taking Montelukast Teva in children
• 3. How to take Montelukast Teva
• 4. Possible side effects
• 5. How to store Montelukast Teva
• 6. Contents of the pack and other information

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

What is Montelukast Teva

Montelukast Teva, chewable tablets is a leukotriene receptor antagonist, i.e. it blocks the action of substances called leukotrienes.

How Montelukast Teva works

Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking the action of leukotrienes, Montelukast Teva, chewable tablets relieve asthma symptoms and help control asthma.

When to use Montelukast Teva

The doctor has prescribed Montelukast Teva, chewable tablets to treat asthma and prevent asthma symptoms in the child, day and night.

• Montelukast Teva, chewable tablets are used to treat patients aged 2 to 5 years who have not achieved adequate asthma control with their current medications and require additional treatment.
• Montelukast Teva may also be used as an alternative to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for asthma and are unable to use inhaled corticosteroids.
• Montelukast Teva also helps prevent exercise-induced bronchospasm in patients aged 2 years and older.

The doctor will determine how to take Montelukast Teva based on the child's symptoms and the severity of their asthma.

What is asthma?

Asthma is a chronic disease. In asthma, there are: difficulties in breathing due to narrowing of the airways. The narrowing of the airways worsens or improves in response to various factors. sensitivity of the airways, which react to many factors, such as cigarette smoke, pollen, cold air, or physical exertion. swelling (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 Teva in children

Tell the doctor about any current or past illnesses or allergies in the patient.

When not to give Montelukast Teva to a child

• 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 to give Montelukast Teva to a child, discuss it with a doctor or pharmacist.

• In case of worsening asthma symptoms or breathing difficulties, consult a doctor immediately.
• Orally administered Montelukast Teva is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the doctor's instructions. Always carry a rescue inhaler with you in case of an asthma attack.
• It is essential that the child takes all asthma medications prescribed by the doctor. Montelukast Teva should not be used instead of other asthma medications prescribed by the doctor.
• Remember that if the child taking asthma medications experiences symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening respiratory symptoms, and/or rash, consult a doctor.
• Do not give the child aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen the child's asthma symptoms.
• If the child has phenylketonuria, consider that Montelukast Teva contains aspartame, which is a source of phenylalanine. The phenylalanine in the tablets may be harmful to people with phenylketonuria.

Tell the patient that in adults, adolescents, and children treated with montelukast, various neuropsychiatric events (e.g., changes in behavior and mood) have occurred (see section 4). If the patient (including children) experiences such symptoms while taking Montelukast Teva, consult a doctor (or pediatrician).

Children and adolescents

Do not use this medicine in children under 2 years of age. For children and adolescents under 18 years of age, other forms of this medicine are available, suitable for the patient's age.

Montelukast Teva and other medicines

Tell the doctor or pharmacist about all medicines the child is taking, has recently taken, or may take, including those obtained without a prescription. Some medicines may affect the action of Montelukast Teva or Montelukast Teva may affect the action of other medicines taken by the child. Before starting to give Montelukast Teva, tell the doctor if the child is taking:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used to treat hypertriglyceridemia, mixed hyperlipidemia, and primary hypercholesterolemia)

Montelukast Teva with food and drink

Montelukast Teva, chewable tablets should not be taken with food; the medicine should be taken at least 1 hour before or 2 hours after a meal.

Pregnancy and breastfeeding

This section does not apply to Montelukast Teva, 4 mg, chewable tablets, as this medicine is intended for use in children aged 2 to 5 years.

Driving and using machines

This section does not apply to Montelukast Teva, chewable tablets, as this medicine is intended for use in children aged 2 to 5 years. However, the following information is relevant to the active substance, montelukast. It is unlikely that Montelukast Teva will affect the ability to drive or use machines. However, individual reactions to the medicine may vary. Some side effects (such as dizziness and drowsiness) reported during the use of montelukast may affect the patient's ability to drive or use machines.

Montelukast Teva contains aspartame

This medicine contains 0.5 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 elimination.

Montelukast Teva contains sodium

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

3. How to take Montelukast Teva

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

• This medicine should be given to the child under adult supervision. For children who have problems taking the chewable tablet, a granule formulation is available.
• The child should be given only one Montelukast Teva, 4 mg, chewable tablet per day, as directed by the doctor.
• The medicine should be taken even when the child does not experience asthma symptoms, as well as in case of an acute asthma attack.

Children aged 2 to 5 years:

The recommended dose is one 4 mg chewable tablet per day, in the evening. Ensure that the child taking Montelukast Teva does not take other medicines containing the same active substance, montelukast. This medicine is intended for oral use. The tablet should be chewed before swallowing. Montelukast Teva, chewable tablets should not be taken with food; the medicine should be taken at least 1 hour before or 2 hours after a meal.

If the child takes more Montelukast Teva than they should

Consult a doctor immediately. In most cases of overdose, no side effects have been observed. In cases of overdose in children and adults, the following symptoms have been most commonly reported: abdominal pain, thirst, headache, vomiting, and hyperactivity.

If the child misses a dose of Montelukast Teva

Montelukast Teva should be taken as directed by the doctor. However, if the child misses a dose, return to the usual dosing schedule – one chewable tablet per day. Do not take a double dose to make up for the missed dose.

If the child stops taking Montelukast Teva

Montelukast Teva is effective in treating asthma only when taken regularly. It is essential to continue taking Montelukast Teva as long as the doctor recommends. This will help keep the child's asthma under control. In case of further doubts about the use of this medicine, consult a doctor or pharmacist. Montelukast Teva, 5 mg, chewable tablets are available for children aged 6 to 14 years. For patients aged 15 years and older, Montelukast Teva, 10 mg, film-coated tablets are available.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. During clinical trials with Montelukast Teva, 4 mg, chewable tablets, the most commonly reported side effects (which may occur in up to 1 in 10 people) considered to be related to Montelukast Teva were:

• abdominal pain
• thirst

Severe side effects

Consult a doctor immediatelyif the child experiences any of the following severe side effects, which may require immediate medical attention.

• allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing
• changes in behavior and mood: agitation, including aggressive behavior or hostility, depression
• seizures

Rare side effects (may occur in up to 1 in 1,000 people):

• increased tendency to bleeding
• tremor
• palpitations

Very rare side effects (may occur in up to 1 in 10,000 people):

• a syndrome of symptoms such as flu-like symptoms, tingling or numbness of the hands and feet, worsening respiratory symptoms, and/or rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• changes in behavior and mood: hallucinations, disorientation, suicidal thoughts and attempts
• inflammation (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• hepatitis

Other side effects reported after the medicine was marketed

Very common side effects (may occur in more than 1 in 10 people):

• upper respiratory tract infections

Common side effects (may occur in up to 1 in 10 people):

• diarrhea, nausea, vomiting
• rash
• fever
• increased liver enzyme levels

Uncommon side effects (may occur in up to 1 in 100 people):

• changes in behavior and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling or numbness
• nosebleeds
• dry mouth, indigestion
• bruises, itching, hives
• joint or muscle pain, muscle spasms
• bedwetting in children
• weakness and/or fatigue, malaise, swelling

Rare side effects (may occur in up to 1 in 1,000 people):

• changes in behavior and mood: attention disorders, memory disorders, uncontrolled muscle movements

Very rare side effects (may occur in up to 1 in 10,000 people):

• tender red lumps under the skin, most commonly on the shins (erythema nodosum), severe skin reactions (erythema multiforme)
• changes in behavior and mood: obsessive-compulsive symptoms, stuttering

Reporting side effects

If the child experiences any side effects, including any side effects not listed in this leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Montelukast Teva

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Store the blister in the carton to protect from light. 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 Teva contains

• The active substance is montelukast sodium, which is equivalent to 4 mg of montelukast.
• The other ingredients are: mannitol (E421), sodium lauryl sulfate, hydroxypropyl cellulose, iron oxide red (E172), cherry flavor PHS-143671: maltodextrins (corn) and modified cornstarch E1450, aspartame (E951), carboxymethylcellulose sodium, magnesium stearate.

What Montelukast Teva chewable tablets look like and contents of the pack

Montelukast Teva, 4 mg, chewable tablets are pink, arc-shaped tablets with the number "93" embossed on one side and "7424" on the other. Montelukast Teva, 4 mg, chewable tablets are available in packs of 14 and 28 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands, tel.: (22) 345 93 00

Manufacturer

• 1. Pharmachemie B.V., Swensweg 5, Haarlem, 2031 GA, Netherlands
• 2. Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
• 3. Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland: Montelukast Teva