Montelukast Teva

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Montelukast Teva

10 mg, coated tablets

Montelukastum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if you need to.

In case of any doubts, you should consult a doctor or pharmacist.

This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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, coated 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, coated tablets relieves the symptoms of asthma and helps control asthma and relieves the symptoms of seasonal allergies (also known as allergic rhinitis or hay fever).

When to use Montelukast Teva

The doctor has prescribed Montelukast Teva, coated tablets to treat asthma, prevent asthma symptoms during the day and at night.

• Montelukast Teva is used to treat adult and adolescent patients aged 15 years and older, who have not achieved adequate control with their current medications and require additional treatment.
• Montelukast Teva also helps prevent narrowing of the airways caused by physical exertion. In patients with asthma, who are taking Montelukast Teva to treat asthma, Montelukast Teva may also relieve symptoms of seasonal allergic rhinitis.

The doctor will determine how to take Montelukast Teva, depending on the patient's symptoms and the severity of asthma.

What is asthma?

Asthma is a chronic disease.
In asthma, there are:

• breathing difficulties caused by narrowing of the airways. The narrowing of the airways worsens and improves in response to various factors.
• airway hypersensitivity reacting to many factors, such as cigarette smoke, pollen, cold air, or physical exertion.
• swelling (inflammation) of the lining of the airways.

The symptoms of asthma include: coughing, wheezing, and a feeling of pressure in the chest.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic reaction of the body, often caused by airborne pollen from trees, grasses, or weeds. The symptoms of seasonal allergies may typically include: a stuffy nose, runny nose, itching of the nose, sneezing; watery, swollen, red, itchy eyes.

2. Important information before taking Montelukast Teva

You should inform your doctor about any current or past illnesses and allergies.

When not to take 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 taking Montelukast Teva, you should discuss it with your doctor, pharmacist, or nurse.

In case of worsening asthma symptoms or breathing difficulties, you should immediately consult your doctor.

Orally taken Montelukast Teva is not intended for the treatment of acute asthma attacks. If such an attack occurs, you should follow your doctor's instructions. You should always carry a rescue inhaler with you in case of an asthma attack.

It is important that the patient takes all asthma medications prescribed by their doctor.

Montelukast Teva should not be used instead of other asthma medications prescribed by the doctor.

You should remember that if the patient taking asthma medications experiences symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening respiratory symptoms, and (or) rash, they should consult their doctor.

The patient should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen the patient's asthma symptoms.
You should inform the patient that in adults, adolescents, and children treated with Montelukast Teva, 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, they should consult their doctor (or pediatrician).

Children and adolescents

Do not give this medicine to children under 15 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

You should tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might 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 patient.
Before taking Montelukast Teva, you should inform your doctor if the patient is taking the following medicines:

phenobarbital (used to treat epilepsy),

phenytoin (used to treat epilepsy),

rifampicin (used to treat tuberculosis and some other infections),

gemfibrozil (used to treat high lipid levels in the blood).

Montelukast Teva with food and drink

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking Montelukast Teva.
Pregnancy
The doctor will assess whether the patient can take Montelukast Teva during this period.
Breastfeeding
It is not known whether Montelukast Teva passes into breast milk.
If a woman is breastfeeding or plans to breastfeed, she should consult her doctor before taking Montelukast Teva.

Driving and using machines

Montelukast should not affect the patient's ability to drive or use machines. However, individual responses to the medicine may vary. Some side effects (such as dizziness and drowsiness), which have been reported with montelukast, may affect the ability to drive or use machines.

Montelukast Teva contains lactose.

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

Montelukast Teva contains sodium.

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

3. How to take Montelukast Teva

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

• You should take only one tablet of Montelukast Teva once daily, as prescribed by your doctor.
• The medicine should be taken even when the patient does not experience asthma symptoms, as well as in the event of 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.
You should ensure that the patient taking Montelukast Teva does not take other medicines that contain the same active substance, montelukast.
This medicine is intended for oral use.
Montelukast Teva can be taken with or without food.

Taking a higher dose of Montelukast Teva than recommended

You should immediately consult your doctor.
In most cases of overdose, no side effects have been observed.
In cases of overdose in children and adults, the most commonly observed symptoms were: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missing a dose of Montelukast Teva

Montelukast Teva should be taken as prescribed by your doctor. However, if the patient forgets to take a dose, they should return to their usual dosing schedule - one tablet once daily.
You should not take a double dose to make up for a missed dose.

Stopping treatment with 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 prescribed by your doctor.
This will help keep the patient's asthma under control.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During clinical trials with Montelukast Teva in the form of 10 mg coated tablets, the most commonly reported side effects (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 and occurred more frequently in patients taking montelukast than in patients taking a placebo (a tablet that does not contain any medicine).

Severe side effects

You should immediately consult your doctorif you experience any of the following side effects, which may be severe and require immediate 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

• 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: may affect more than 1 in 10 people

• upper respiratory tract infection

Common: may affect up to 1 in 10 people

• diarrhea, nausea, vomiting
• rash
• fever
• elevated liver enzymes

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, tingling or numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• 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

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

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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
Phone: +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 or parallel importer.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Montelukast Teva

The medicine should be stored out of sight and reach of children.
You should not use this medicine after the expiry date stated on the blister pack and carton after: EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storage temperature. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Montelukast Teva contains

The active substance of the medicine is montelukast sodium, which is equivalent to 10 mg of montelukast.

The other ingredients of the medicine are:
Core: sodium lauryl sulfate, lactose monohydrate, hydroxypropyl cellulose, corn starch, sodium carboxymethyl cellulose (type A), magnesium stearate;
Coating: Opadry 20A23676 Yellow with the composition: hydroxypropyl cellulose, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Montelukast Teva looks like and what the pack contains

Montelukast Teva, 10 mg, coated tablets are beige, round, coated tablets with the number "93" embossed on one side and "7426" on the other.
Montelukast Teva, 10 mg, coated tablets are available in packs of 28 tablets.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization 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, Netherlands

Parallel importer:

ProCarePlus Pharma S.A.
ul. Bobrzyńskiego 14
30-348 Kraków

Repackaged by:

CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Chemiczno-Farmaceutyczna Spółdzielnia Pracy "ESPEFA"
ul. Juliusza Lea 208
30-133 Kraków
MEDICOFARMA S.A.
ul. Sokołowska 9 lok. U19
01-142 Warsaw
Marketing authorization number in the Czech Republic, the country of export:14/420/08-C

Parallel import authorization number: 212/22

This medicinal product is authorized 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, film-coated tablets
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
Date of leaflet approval: 18.05.2022
[Information about the trademark]