Montelukast teva

Package leaflet: Information for the user

Montelukast Teva, 10 mg, film-coated tablets
Montelukastum
Please read all of 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 side effects, including any 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, relieve asthma symptoms and help control asthma, as well as alleviate 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 to treat adult patients and adolescents aged 15 years and older who have not achieved adequate control with previously used medications and who require additional treatment.
• 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 increases and decreases in response to various triggers.
• Airway hypersensitivity reacting 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.

What are seasonal allergies?
Seasonal allergies (also called hay fever or seasonal allergic rhinitis) are an allergic reaction of the body, often triggered by airborne pollen from trees, grasses, or weeds. Symptoms of seasonal allergies may typically include: blocked nose, runny nose, itchy nose, sneezing; watery, swollen, red, burning eyes.

2. Important information before using Montelukast Teva

Inform your doctor about any current or past medical conditions and allergies you may have.

When not to use Montelukast Teva

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Montelukast Teva.

• If asthma symptoms worsen or you experience difficulty breathing, contact your doctor immediately.
• Orally administered 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 on hand for immediate use in case of an asthma attack.
• It is important to continue taking all asthma medications prescribed by your doctor. Do not use Montelukast Teva as a substitute for other asthma medications prescribed by your doctor.
• Be aware that if you experience symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening respiratory symptoms, and/or rash while taking asthma medications, you should contact your doctor.
• Do not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen your asthma symptoms.

Various neuropsychiatric events (e.g. changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur while taking montelukast, consult your doctor.

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 with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan 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 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 high levels of lipids in plasma)

Montelukast Teva with food and drink
Montelukast Teva coated tablets can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Your doctor will decide whether you can take Montelukast Teva during pregnancy.

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

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

Montelukast Teva contains lactose.
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before using this medicine.

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

3. How to take Montelukast Teva

This medicine should always be taken exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

• Take only one Montelukast Teva 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 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 prescribed
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 include: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

If a dose of Montelukast Teva is missed
Montelukast Teva should be taken as prescribed by your doctor. However, if a dose is missed, resume the regular dosing schedule—one 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.
Montelukast Teva 5 mg chewable tablets are available for children aged 6 to 14 years.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
During clinical trials with Montelukast Teva 10 mg film-coated tablets, the most commonly reported adverse reactions (which may occur in up to 1 in 10 people), considered 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 drug).

Serious adverse reactions
Contact your 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 occur in 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 behaviour and mood: agitation, including aggressive behaviour or hostility, depression
• seizures

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

• increased tendency to bleed
• tremor
• palpitations

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

• a syndrome of symptoms such as flu-like symptoms, sensations of pricking, 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 (such as erythema multiforme), which may occur without prior warning symptoms
• hepatitis (inflammation of the liver)

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

• upper respiratory tract infection

Common: may occur in up to 1 in 10 people

• diarrhoea, nausea, vomiting
• rash
• fever
• elevated 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, anxiety, restlessness
• dizziness, somnolence, sensations 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 1,000 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

• changes in behaviour 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, pharmacist, or nurse.
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 Warszawa
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 authorisation holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

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 cardboard
package after: EXP. The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine. 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.
Following this advice helps protect the environment.

6. Contents of the pack and other information

What Montelukast Teva contains

• The active substance is montelukast. Each film-coated tablet contains 10.40 mg of montelukast sodium, equivalent to 10 mg of montelukast.
• Other ingredients are:
  Core: sodium lauryl sulfate, lactose monohydrate, hydroxypropylcellulose 75-150 cP, pregelatinized starch (corn), sodium carboxymethyl starch (corn) type A, magnesium stearate;
  Coating: Opadry 20A23676 Yellow, which contains: hydroxypropylcellulose 360-672 mPas, hypromellose 6 cP, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

What Montelukast Teva film-coated tablets look like and contents of the pack
Montelukast Teva 10 mg film-coated tablets are beige, round, film-coated tablets, embossed with the number "93" on one side and "7426" on the other.
Montelukast Teva 10 mg film-coated tablets 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, Haarlem, 2031 GA, 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 Member States 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