Montelukast teva

Montelukast Teva, 5 mg, chewable and chewable tablets
Montelukastum
Read the entire leaflet before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific child only. Do not give it to anyone else. This medicine may harm another child, even if their symptoms are the same.
• 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 Teva is and what it is used for
2. What you need to know before using Montelukast Teva
3. How to take Montelukast Teva
4. Possible side effects
5. How to store Montelukast Teva
6. Contents of the package and other information

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

What is Montelukast Teva
Montelukast Teva, chewable and chewable tablets is a leukotriene receptor antagonist, meaning 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 and chewable tablets helps relieve asthma symptoms and helps control asthma.

When Montelukast Teva should be used
Your doctor has prescribed Montelukast Teva, chewable and chewable tablets for the treatment of asthma and for preventing asthma symptoms during the day and night.

• Montelukast Teva, chewable and chewable tablets is used in the treatment of children and adolescents aged 6 to 14 years who have not achieved adequate asthma control with previously used medications and who require additional therapy.
• Montelukast Teva may also be used instead of inhaled corticosteroids in patients aged 6 to 14 years who have not recently received oral corticosteroids for asthma treatment and who are unable to use inhaled corticosteroids.
• Montelukast Teva also helps prevent exercise-induced narrowing of the airways.

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

What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties due to narrowing of the airways. Airway narrowing worsens or improves in response to various triggers.
• Airway hyperresponsiveness, causing them to react to many factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the mucous lining of the airways.

Asthma symptoms include coughing, wheezing, and a feeling of tightness in the chest.

2. Information before using Montelukast Teva

You should inform your doctor about any medical conditions and allergies you currently have or have had in the past.

When not to take Montelukast Teva

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

Warnings and precautions

Before starting Montelukast Teva, discuss it with your doctor or pharmacist.

• If asthma symptoms worsen or breathing difficulties occur, contact your doctor immediately.
• Oral Montelukast Teva is not intended for the treatment of acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always keep a reliever inhaler available for immediate use in case of an asthma attack.
• It is important that you use all asthma medications prescribed by your doctor. Do not use 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 in the hands or feet, worsening respiratory symptoms and/or rash, you should contact your doctor.
• You should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs) if they worsen your asthma symptoms.
• .
• If you have phenylketonuria, you should be aware that Montelukast Teva contains aspartame, which is a source of phenylalanine. The phenylalanine contained in the tablets may be harmful to people with phenylketonuria.

You should be informed that neuropsychiatric events (for example, changes in behaviour and mood) have been reported in adults, adolescents and children treated with montelukast (see section 4). If you (including a child) experience such symptoms while taking Montelukast Teva, consult your doctor (or paediatrician).

Children and adolescents

Do not use this medicine in children under 6 years of age.

Other formulations of this medicine, appropriate for the patient's age, are available for children and adolescents under 18 years of age.

Montelukast Teva and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take, including medicines available without a prescription.

Some medicines may affect the action of Montelukast Teva or Montelukast Teva may affect the action of other medicines you are taking.

Before starting Montelukast Teva, inform your doctor if you are taking any of the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and certain other infections)
• gemfibrozil (used to treat hypertriglyceridaemia, mixed hyperlipidaemia and primary hypercholesterolaemia)

Montelukast Teva with food and drink

Do not take Montelukast Teva chewable tablets with food; the medicine should be taken at least one hour before or two hours after a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist 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 human breast milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Montelukast Teva.

Driving and using machines

Montelukast Teva is not expected to affect the ability to drive or operate machinery. However, individual reactions to the medicine may vary. Some adverse effects (such as dizziness and drowsiness) reported during treatment with montelukast may affect patients' ability to drive or operate machinery.

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 impaired excretion.

Montelukast Teva contains sodium

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

3. How to use Montelukast Teva

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.

• Take only one Montelukast Teva chewable tablet once daily, as directed by your doctor.
• This medicine should be taken even when the patient does not have asthma symptoms, and also during 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.
Ensure that a patient taking Montelukast Teva does not take other medicines containing the same active substance, montelukast.
This medicine is intended for oral use.
The tablet must be chewed before swallowing.
Montelukast Teva chewable tablets should not be taken during meals; the medicine should be taken at least one hour before or two hours after a meal.

Taking more Montelukast Teva than recommended
Contact your doctor immediately.
In most cases of overdose, no adverse effects have been observed. However, in cases of overdose in children and adults, the following symptoms have most commonly occurred:
abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperkinesia.

If you miss a dose of Montelukast Teva
Montelukast Teva should be taken as directed by your doctor. However, if a dose is missed, resume the usual dosing schedule—one chewable tablet once daily. Do not take a double dose to make up for a missed dose.

Stopping Montelukast Teva
Montelukast Teva is effective in treating asthma only when taken regularly.
It is important to continue taking Montelukast Teva for as long as your doctor has instructed. This will help keep the patient's asthma under control.

If you have any further questions about the use of this medicine, consult 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, this medicine 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 to be related to the use of Montelukast Teva 5 mg chewable tablets, was:

• Headache

Additionally, in clinical trials with Montelukast Teva 10 mg film-coated tablets, the following side effect was reported:

• Abdominal pain

These symptoms were usually mild and occurred more frequently in patients taking Singulair than in those taking placebo (a tablet containing no active ingredient).

Serious side effects
Contact your doctor immediately if any of the following side effects occur, as they may be severe and the patient may require immediate medical attention.

Uncommon: may occur in up to 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: may occur in up to 1 in 1000 people

• Increased tendency to bleed
• Tremor
• Palpitations

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

• A group of symptoms such as flu-like symptoms, sensation of pricking and tingling or numbness in hands and feet, worsening of respiratory symptoms and (or) rash (Churg-Strauss syndrome) (see section 2)
• Low platelet count
• Changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and attempts
• Swelling (inflammation) of the lungs
• Severe skin reactions (erythema multiforme), which may occur without prior warning symptoms
• Hepatitis (inflammation of the liver)

Other side effects reported after the medicine was marketed

Very common: may occur in more than 1 in 10 people

• Upper respiratory tract infections

Common: may occur in up to 1 in 10 people

• Diarrhoea, nausea, vomiting
• Rash
• Fever
• Increased liver enzyme levels

Uncommon: may occur in up to 1 in 100 people

• Changes in behaviour and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness
• Dizziness, drowsiness, sensation of pricking, tingling or numbness
• Nosebleeds
• Dry mouth, dyspepsia
• Bruising, itching, urticaria
• Joint or muscle pain, muscle cramps
• Nocturnal enuresis in children
• Weakness and (or) fatigue, malaise, oedema

Rare: may occur in up to 1 in 1000 people

• Changes in behaviour and mood: attention disorders, memory disturbances, uncontrolled muscle movements

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

• Tender red subcutaneous nodules, most commonly appearing on the shins (erythema nodosum), severe skin reactions (erythema multiforme)
• Changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Reporting side effects helps to 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. Keep the blister in the outer carton to protect from light.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Montelukast Teva contains

• The active substance is montelukast sodium, equivalent to 5 mg of montelukast.
• Other ingredients are: mannitol (E421), sodium lauryl sulfate, hydroxypropylcellulose, iron oxide red (E172), cherry flavour PHS-143671: maltodextrins (corn), modified starch E1450 (corn), aspartame (E951), sodium carboxymethylstarch type A, magnesium stearate.

What Montelukast Teva chewable tablets look like and contents of the pack
Montelukast Teva chewable tablets, 5 mg, are square, pink speckled tablets, embossed with "93" on one side and "7425" on the other.
Montelukast Teva chewable tablets 5 mg are available in packs of 14 and 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Tel.: (22) 345 93 00

Manufacturer

1. Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, The 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 authorised in the European Economic Area countries under the following names:
Poland: Montelukast Teva