Montelukast medreg

Package leaflet: Information for the patient

Montelukast Medreg, 10 mg, film-coated tablets
Montelukastum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

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

Table of contents of the leaflet:

1. What Montelukast Medreg is and what it is used for
2. Important information before taking Montelukast Medreg
3. How to take Montelukast Medreg
4. Possible side effects
5. How to store Montelukast Medreg
6. Contents of the pack and other information

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

Montelukast Medreg is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs, as well as trigger allergy symptoms. By blocking the action of leukotrienes, Montelukast Medreg reduces symptoms of bronchial asthma and relieves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

Montelukast Medreg has been prescribed by your doctor for the treatment of bronchial asthma and for preventing asthma symptoms during the day and night.

• Montelukast Medreg is used in the treatment of adult patients and adolescents aged 15 years and older whose asthma is not adequately controlled with previously used medications and who require additional therapy.
• Montelukast Medreg also helps prevent narrowing of the airways caused by physical exercise.
• In patients with bronchial asthma, Montelukast Medreg used for asthma treatment may also relieve symptoms of seasonal allergic rhinitis.

Your doctor will determine how to use Montelukast Medreg based on your symptoms and the severity of your asthma.

What is asthma?
Asthma is a chronic disease.
Asthma involves:

• Breathing difficulties caused by narrowing of the airways. Airways may narrow or widen in response to various triggers.
• Hypersensitivity of the airways reacting to many factors, such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the mucosal lining of the airways.

Symptoms of asthma include: coughing, wheezing, and a feeling of tightness in the chest.

What is seasonal allergy?
Seasonal allergy (also known as hay fever or seasonal allergic rhinitis) is an allergic reaction often triggered by pollen from trees, grasses, and weeds. Symptoms of seasonal allergy usually include: runny nose, nasal congestion, itching of the nose, sneezing, excessive tearing, swelling, redness, and itching of the eyes.

2. Important information before using Montelukast Medreg

Inform the treating physician about any current or past medical conditions and allergies
in the child.

When not to use Montelukast Medreg

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

Warnings and precautions
Before starting treatment with Montelukast Medreg in a child, discuss this with the physician or
pharmacist.

• If asthma symptoms worsen or shortness of breath occurs, contact the treating physician immediately.
• Oral Montelukast Medreg is not intended for the treatment of acute asthma attacks. If such an attack occurs, follow the physician's instructions. Always have a rescue inhaled medication available to relieve acute asthma attacks.
• It is important to take all anti-asthma medications prescribed by the treating physician. Montelukast Medreg must not be used as a substitute for other anti-asthma medications prescribed by the treating physician.
• Remember that any adult patient or child taking anti-asthma medications should consult the treating physician if experiencing symptoms such as flu-like illness, tingling or numbness in the extremities, worsening shortness of breath, and/or rash.
• Patients whose asthma symptoms worsen after taking acetylsalicylic acid (aspirin) must not take medications containing this substance or other anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs, NSAIDs).

Various neuropsychiatric events (e.g. changes in behaviour and mood, depression, and suicidal
ideation) have been reported in patients of all ages treated with montelukast (see section 4). If such
symptoms occur in a patient during treatment with montelukast, consult a physician.

Children and adolescents
Montelukast Medreg must not be used in children under 15 years of age. Alternative formulations of the medicine are available for patients under 15 years of age and under 18 years of age.

Montelukast Medreg and other medicines
Inform the physician or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

Some medicines may affect the action of Montelukast Medreg, or Montelukast Medreg may affect the action of other medicines.

Before starting Montelukast Medreg, inform the physician if the patient is taking:

• 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 levels of fats in plasma).

Montelukast Medreg with food and drink
Montelukast Medreg may be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her physician or pharmacist before using this medicine.

Pregnancy
The physician should decide whether the use of Montelukast Medreg during pregnancy is absolutely necessary.

Breastfeeding
It is not known whether montelukast passes into human milk. The patient should consult her physician about the use of Montelukast Medreg before using it if she is breastfeeding or intends to breastfeed.

Driving and operating machinery
Montelukast Medreg is not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary.
In very rare cases, adverse reactions (such as dizziness and drowsiness) have been reported during treatment with Montelukast Medreg, which may affect the ability to drive and operate machinery.

Montelukast Medreg contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should contact the physician before taking this medicine.

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

3. How to use Montelukast Medreg

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

• Take one tablet of Montelukast Medreg once daily, as directed by the doctor.
• This medicine should be taken even when there are no asthma symptoms, and also during an acute asthma attack.

Use in adults and adolescents aged above 15 years
Take 1 tablet of 10 mg once daily in the evening.
Ensure that the patient taking Montelukast Medreg is not using other medicines containing the same active substance, montelukast.
The medicine should be taken orally.
Montelukast Medreg may be taken during meals or independently of meals.

Taking more Montelukast Medreg than recommended
Contact the treating 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 were abdominal pain, drowsiness, increased thirst, headache, vomiting, and increased motor activity.

If a dose of Montelukast Medreg is missed
Try to administer Montelukast Medreg as prescribed by the 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 Medreg
Montelukast Medreg is effective in treating asthma only when taken regularly. It is important to continue taking Montelukast Medreg for as long as directed by the treating doctor. This will help keep asthma symptoms under control.

If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

During clinical studies with Montelukast Medreg 10 mg film-coated tablets, the most commonly reported adverse reactions (occurring in at least 1 in 10 treated patients), considered related to montelukast intake, were:

• abdominal pain
• headache

These symptoms were usually mild in severity and occurred more frequently in patients taking Montelukast Medreg 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 fewer than 1 in 100 patients):

• 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 fewer than 1 in 1,000 patients):

• increased tendency to bleed
• tremor
• palpitations

Very rare (may occur in fewer than 1 in 10,000 patients):

• a syndrome characterised by 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 suicide attempts
• swelling (inflammation) of the lungs
• severe skin reactions (e.g. 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 patients):

• upper respiratory tract infections

Common (may occur in fewer than 1 in 10 patients):

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

Uncommon (may occur in fewer than 1 in 100 patients):

• changes in behaviour and mood (sleep disturbances, including nightmares, difficulty falling asleep, sleepwalking, irritability, restlessness, akathisia)
• dizziness, drowsiness, pricking, tingling or numbness
• nosebleeds
• dry mouth, dyspepsia
• bruising, itching, urticaria
• joint and muscle pain, muscle cramps
• nocturnal enuresis in children
• weakness and/or fatigue, malaise, oedema

Rare (may occur in fewer than 1 in 1,000 patients):

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

Very rare (may occur in fewer than 1 in 10,000 patients):

• tender, red nodules under the skin, usually appearing on the shins (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

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

5. How to store Montelukast Medreg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Montelukast Medreg contains
The active substance is montelukast. Each tablet contains montelukast sodium equivalent to
10 mg of montelukast.
The other ingredients are:

• Tablet core: lactose monohydrate, mannitol, sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate.
• Tablet coating: Opadry yellow 20A520007/Instacoat universal yellow A05G13837 (hypromellose, titanium dioxide (E 171), hydroxypropylcellulose, carnauba wax, yellow iron oxide (E 172), red iron oxide (E 172)).

What Montelukast Medreg looks like and contents of the pack
Montelukast Medreg 10 mg are light yellow-brown (beige), film-coated oval tablets (tablets). The tablets are embossed with the code "I" on one side and "114" on the other side.
The tablets are packed in aluminium/PVC/aluminium/OPA blisters, placed in a cardboard box, and available in pack sizes of 7, 10, 14, 20, 28, 30, 40, 49, 50, 56, 60, 70, 80, 84, 90, 98, 100, 120, 140 and 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

Manufacturer/Importer:
Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic: Montelukast Medreg
Poland: Montelukast Medreg
Romania: Montelukast Gemax Pharma 10 mg comprimate filmate
Slovakia: Montelukast Medreg 10 mg