Montelukast Teva

PATIENT INFORMATION LEAFLET: USER INFORMATION

Montelukast Teva, 5 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific 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 your 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
• 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 relieves asthma symptoms and helps control asthma.

When to use Montelukast Teva

Your doctor has prescribed Montelukast Teva, chewable tablets to treat asthma and prevent asthma symptoms day and night.

• Montelukast Teva, chewable tablets is used to treat children and adolescents aged 6 to 14 years who have not achieved adequate control of asthma with their current medications and require additional treatment.
• Montelukast Teva may also be used instead of inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for asthma and are not able to use inhaled corticosteroids.
• Montelukast Teva also helps prevent narrowing of the airways caused by physical exertion.

Depending on the symptoms and severity of asthma in the patient, the doctor will decide how to use Montelukast Teva.

What is asthma?

Asthma is a chronic disease.

• difficulty 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 causes them to react to many factors, such as cigarette smoke, plant 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

Tell your doctor about any current or past illnesses or allergies.

When not to take Montelukast Teva

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

Warnings and precautions

Discuss with your doctor or pharmacist before starting Montelukast Teva.

• If asthma symptoms worsen or breathing difficulties occur, seek medical attention immediately.
• Orally taken Montelukast Teva is not intended for the treatment of acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always carry a rescue inhaler with you in case of an asthma attack.
• It is essential to take all asthma medications prescribed by your doctor. Do not take Montelukast Teva instead of other asthma medications prescribed by your doctor.
• Remember that if you are taking asthma medications and experience symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening respiratory symptoms, and (or) rash, seek medical attention.
• Do not take aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen your asthma symptoms.
• .
• If you have 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 (such as 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 6 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 your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.

• 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

Do not take Montelukast Teva, chewable tablets with food; take the medicine at least 1 hour before or 2 hours after food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will assess whether you can take Montelukast Teva during this period.

Breastfeeding

It is not known whether Montelukast Teva passes into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Montelukast Teva.

Driving and using machines

Do not expect Montelukast Teva to affect your ability to drive or use machines. However, individual reactions to the medicine may vary. Some side effects (such as dizziness and drowsiness) reported during montelukast treatment 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 impaired elimination.

Montelukast Teva contains sodium

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

3. How to take Montelukast Teva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• Take only one Montelukast Teva chewable tablet once daily, as recommended by your doctor.
• Take the medicine even when the patient does not have asthma symptoms, as well as in the event of an acute asthma attack.

Use in children aged 6 to 14 years:

The recommended dose is one 5 mg chewable tablet once daily, in the evening.

Make sure the patient taking Montelukast Teva does not take other medicines containing the same active substance, montelukast.

This medicine is intended for oral use.

Chew the tablet before swallowing.

Do not take Montelukast Teva, chewable tablets with food; take the medicine at least 1 hour before or 2 hours after food.

Taking a higher dose of Montelukast Teva than recommended

Contact your doctor immediately.

In most cases of overdose, no side effects were observed. In cases of overdose in children and adults, the following symptoms were most commonly observed:

abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missing a dose of Montelukast Teva

Take Montelukast Teva as recommended by your doctor. However, if you miss a dose, return to your usual dosing schedule - one chewable tablet once daily. Do not take a double dose to make up for the missed dose.

Stopping Montelukast Teva treatment

Montelukast Teva is effective in treating asthma only when taken regularly.

It is essential to continue taking Montelukast Teva as long as your doctor recommends. This will help keep the patient's asthma under control.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

Montelukast Teva, 4 mg, chewable tablets are available for children aged 2 to 5 years.

For patients aged 15 years and older, Montelukast Teva, 10 mg, film-coated tablets are available.

4. Possible side effects

Like all medicines, Montelukast Teva can cause side effects, although not everybody gets them.

During clinical trials with Montelukast Teva, 5 mg, chewable tablets, the most commonly reported side effect (which may occur in up to 1 in 10 people) considered related to Montelukast Teva was:

• headache
• Additionally, in clinical trials with Montelukast Teva, 10 mg, film-coated tablets, the following were reported:
• abdominal pain These symptoms were usually mild and occurred more frequently in patients taking Singulair than in patients taking placebo (a tablet that does not contain any medicine).

Severe side effects

Seek medical attention immediatelyif you experience any of the following severe side effects, which may require urgent medical attention.

Uncommon: may affect up to 1 in 100 people

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

Rare: may affect up to 1 in 1,000 people

• increased tendency to bleeding
• tremor
• palpitations

Very rare: may affect up to 1 in 10,000 people

• 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 (infection) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• liver inflammation

Other side effects reported after marketing

Very common: may affect more than 1 in 10 people

• upper respiratory tract infections

Common: may affect up to 1 in 10 people

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

Uncommon: may affect 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: may affect up to 1 in 1,000 people

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

Very rare: may affect 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 you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse.

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.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Montelukast Teva

Keep this 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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 5 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 starch E1450 (corn), aspartame (E951), sodium carboxymethyl cellulose type A, magnesium stearate.

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

Montelukast Teva, 5 mg, chewable tablets are pink, square, and have the number "93" embossed on one side and "7425" on the other.

Montelukast Teva, 5 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, Postbus 552, 2003 RN Haarlem, 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

Date of last revision of the leaflet:December 2021