Montelukast teva

Package leaflet: Information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Montelukast Teva
10 mg, film-coated tablets
Montelukastum
Please read this leaflet carefully before taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
  Contents of the leaflet:

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

What Montelukast Teva is
Montelukast Teva, film-coated 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, film-coated tablets, relieves asthma symptoms and helps control asthma, as well as alleviates symptoms of seasonal allergies (also known as allergic rhinitis or hay fever).
When Montelukast Teva should be used
Your doctor has prescribed Montelukast Teva, film-coated tablets, for the treatment of asthma and for preventing daytime and nighttime asthma symptoms.

• Montelukast Teva is used in the treatment of adult patients and adolescents aged 15 years and older in whom adequate control has not been achieved with previously used medications and additional treatment is required.
• Montelukast Teva also helps prevent airway narrowing caused by physical exercise. In patients with asthma who are being treated with Montelukast Teva, the medicine may also relieve symptoms of seasonal allergic rhinitis.

Your doctor will determine how to use Montelukast Teva based on your symptoms and the severity of your asthma.
What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties caused by narrowing of the airways. Airway narrowing worsens and improves in response to various triggers.
• Increased sensitivity of the airways reacting 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 chest tightness.
What are seasonal allergies?
Seasonal allergies (also called hay fever or seasonal allergic rhinitis) are allergic reactions of the body, often triggered by airborne pollen from trees, grasses, or weeds. Symptoms of seasonal allergies may typically include: nasal congestion, runny nose, itchy nose, sneezing; watery, swollen, red, burning eyes.

2. Important information before using Montelukast Teva

Inform the physician about any current or past medical conditions and allergies the patient may have.

When not to use Montelukast Teva

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

Warnings and precautions

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

• If asthma symptoms worsen or breathing difficulties occur, contact your physician immediately.

• Orally administered Montelukast Teva is not intended for the treatment of acute asthma attacks. If an asthma attack occurs, follow your doctor's instructions. Always keep a rescue inhaler available for immediate use in case of an asthma attack.

• It is important that the patient continues to take all anti-asthma medications prescribed by the physician. Montelukast Teva should not be used as a substitute for other anti-asthma medications prescribed by the physician.

• Be aware that if the patient taking anti-asthma medications develops symptoms such as flu-like symptoms, tingling or numbness in hands or feet, worsening respiratory symptoms and/or rash, medical advice should be sought.

• The patient should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs) if they worsen asthma symptoms.

Patients should be informed that neuropsychiatric events (for example, changes in behavior and mood) have been reported in adults, adolescents, and children treated with Montelukast Teva (see section 4). If such symptoms occur in the patient (including a child) during treatment with Montelukast Teva, consult a physician (or pediatrician).

Children and adolescents

Do not use this medicine in children under 15 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.

Some medicines may affect the action of Montelukast Teva or Montelukast Teva may affect the action of other medicines the patient is taking.

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

• phenobarbital (used in the treatment of epilepsy),

• phenytoin (used in the treatment of epilepsy),

• rifampicin (used in the treatment of tuberculosis and certain other infections),

• gemfibrozil (used in the treatment of high plasma lipid levels).

Montelukast Teva with food and drink

Montelukast Teva coated tablets can be taken regardless of meals.

Pregnancy and breastfeeding

If the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, she should consult a doctor or pharmacist before using Montelukast Teva.

Pregnancy

The treating physician will assess whether the patient may take Montelukast Teva during this period.

Breastfeeding

It is unknown whether Montelukast Teva passes into the breast milk of nursing mothers.

If a woman is breastfeeding or plans to breastfeed, she should consult her doctor before using Montelukast Teva.

Driving and operating machinery

Montelukast is not expected to affect the patient's ability to drive or operate machinery. However, individual responses to the medicine may vary. Some adverse reactions (such as dizziness and drowsiness) reported during montelukast use may affect the ability to drive and operate machinery.

Montelukast Teva contains lactose.

If the patient has been diagnosed with an intolerance to certain sugars, he or she should consult the doctor before using this medicine.

Montelukast Teva contains sodium.

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

3. How to use Montelukast Teva

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

• Take only one tablet of Montelukast Teva 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 adults and adolescents aged 15 years and older
The recommended dose is one 10 mg tablet once daily in the evening.
Ensure that the patient taking Montelukast Teva is not also taking other medicines
containing the same active substance, montelukast.
This medicine is intended for oral use.
Montelukast Teva may be taken with or without food.

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

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
During clinical trials with the medicine Montelukast Teva in the form of film-coated tablets, 10 mg, the most frequently reported adverse reactions (which may occur in less than 1 in 10 people), considered to be related to the use of Montelukast Teva, were:

• abdominal pain
• headache

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

Serious adverse reactions
Contact a doctor immediately if any of the following adverse reactions occur, as they may be serious and the patient may require immediate medical attention.
Uncommon: may affect 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 behavior and mood: agitation, including aggressive behavior or hostility, depression
• seizures

Rare: may affect less than 1 in 1,000 people

• increased tendency to bleed
• tremor
• palpitations

Very rare: may affect less than 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 behavior and mood: hallucinations, disorientation, suicidal thoughts and attempts
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior warning signs
• hepatitis (inflammation of the liver)

Other adverse reactions reported after marketing of the medicine
Very common: may affect more than 1 in 10 people

• upper respiratory tract infection

Common: may affect up to 1 in 10 people

• diarrhoea, nausea, vomiting
• rash
• fever
• elevated 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, anxiety, restlessness
• dizziness, drowsiness, sensation of pricking and 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 affect up to 1 in 1,000 people

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

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

• changes in behavior and mood: obsessive-compulsive symptoms, stuttering
• tender red subcutaneous nodules, most commonly appearing on the shins (erythema nodosum)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Montelukast Teva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton after: EXP. The expiry date refers to the last day of the stated month.
No special temperature storage conditions are required. Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater. 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

What Montelukast Teva contains

• The active substance in this medicine is montelukast sodium, which is equivalent to 10 mg of montelukast.
• Other ingredients of the medicine are:
  Core: sodium lauryl sulfate, lactose monohydrate, hydroxypropylcellulose, pregelatinized corn starch, sodium carboxymethyl starch (type A), magnesium stearate;
  Coating: Opadry 20A23676 Yellow, consisting of: hydroxypropylcellulose, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Montelukast Teva tablets look like and contents of the pack
Montelukast Teva 10 mg film-coated tablets are beige, round, film-coated tablets, embossed on one side with the number "93" and on the other side with "7426".
Montelukast Teva 10 mg film-coated tablets are available in packs of 28 tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, the country of export:
Teva Pharmaceuticals CR, s.r.o.
Radlická 3185/1c
150 00 Prague 5
Czech Republic

Manufacturer:
Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Teva Operations Poland sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

Parallel importer:
ProCarePlus Pharma S.A.
ul. Bobrzyńskiego 14
30-348 Kraków
Poland

Repackaged in:
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland
Chemiczno-Farmaceutyczna Spółdzielnia Pracy "ESPEFA"
ul. Juliusza Lea 208
30-133 Kraków
Poland
MEDICOFARMA S.A.
ul. Sokołowska 9 lok. U19
01-142 Warszawa
Poland

Marketing Authorisation Number in the Czech Republic, the country of export: 14/420/08-C
Parallel Import Authorisation Number: 212/22

This medicinal product is authorised for sale in the member countries of the European Economic Area under the following names:
Austria: Montelukast ratiopharm 10 mg Filmtabletten
Czech Republic: Montelukast Teva 10mg
Denmark: Montelukast Teva 10 mg, filmovertrukne tabletter
Estonia: Montelukast Teva
Finland: Montelukast ratiopharm 10 mg kalvopäällysteiset tabletit
Hungary: Montelukast Teva 10mg filmtabletta
Ireland: Montelukast Teva 10mg Film-Coated Tablets
Norway: Montelukast Teva 10 mg, filmdrasjerte tabletter
Poland: Montelukast Teva
Portugal: Montelucaste Teva 10 mg
Slovakia: Montelukast Teva 10 mg
Spain: Montelukast Teva 10 mg comprimidos recubiertos con película EFG