Montelukast Medreg

Leaflet attached to the packaging: patient information

Montelukast Medreg, 10 mg, film-coated tablets

Montelukast

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Montelukast Medreg is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause the airways in the lungs to narrow and swell, as well as cause allergy symptoms. By blocking the action of leukotrienes, Montelukast Medreg reduces the symptoms of asthma and relieves the symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
Montelukast Medreg has been prescribed by your doctor to treat asthma and to prevent asthma symptoms from occurring during the day and night.

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

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

What is asthma?

Asthma is a chronic disease.
Asthma is:

• difficulty breathing caused by narrowing of the airways. The airways narrow or widen in response to various factors.
• sensitivity of the airways that react to many factors, such as cigarette smoke, pollen, cold air, or physical exertion.
• inflammation (swelling) of the lining of the airways.

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

What is seasonal allergy?

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

2. Important information before taking Montelukast Medreg

Tell your doctor about any current or past illnesses and allergies.

When not to take Montelukast Medreg

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

Warnings and precautions

Before starting to take Montelukast Medreg, discuss it with your doctor or pharmacist.

• If your asthma symptoms worsen or if you experience shortness of breath, seek medical attention immediately.
• Montelukast Medreg is not intended for the treatment of acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always carry a rescue inhaler with you.
• It is essential to take all asthma medications prescribed by your doctor. Montelukast Medreg should not be used as a replacement for other asthma medications prescribed by your doctor.
• Remember that every adult or child taking asthma medications should see their doctor if they experience symptoms such as flu-like illness, tingling or numbness in the limbs, worsening shortness of breath, and/or rash.
• Patients who experience worsening asthma symptoms after taking acetylsalicylic acid (aspirin) should not take medications containing this substance or other anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs, NSAIDs).

Various neuropsychiatric events (such as changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages taking montelukast (see section 4). If you experience such symptoms while taking

montelukast, consult your doctor.

Children and adolescents

The medicine should not be used in children under 15 years of age. Other forms of the medicine are available for patients under 15 and under 18 years of age.

Montelukast Medreg and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.
Some medicines may affect the action of Montelukast Medreg or Montelukast Medreg may affect the action of other medicines.
Before starting to take Montelukast Medreg, tell your doctor if you are taking:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used to treat high levels of fats in the blood).

Montelukast Medreg with food and drink

Montelukast Medreg can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor should decide whether to use Montelukast Medreg during pregnancy.
Breastfeeding
It is not known whether montelukast passes into breast milk. Before taking Montelukast Medreg, consult your doctor if you are breastfeeding or plan to breastfeed.

Driving and using machines

Do not expect Montelukast Medreg to affect your ability to drive or use machines. However, individual reactions to the medicine may vary.
In very rare cases, during treatment with Montelukast Medreg, side effects such as dizziness and drowsiness have been reported, which may affect the ability to drive or use machines.

Montelukast Medreg contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

Montelukast Medreg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Montelukast Medreg

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

• Take one tablet of Montelukast Medreg once daily, as recommended by your doctor.
• Take the medicine even when you do not have asthma symptoms, as well as during an acute asthma attack.

Use in adults and adolescents over 15 years of age

Take 1 tablet of 10 mg once daily, in the evening.
Make sure that the patient taking Montelukast Medreg does not take other medicines that contain the same active substance, montelukast.
Take the medicine orally.
Montelukast Medreg can be taken with or without food.

Taking a higher dose of Montelukast Medreg than recommended

Consult your doctor immediately.
In most cases of overdose, no side effects have been observed.
In cases of overdose in children and adults, the most common symptoms observed were stomach pain, drowsiness, increased thirst, headache, vomiting, and increased restlessness.

Missing a dose of Montelukast Medreg

Try to give Montelukast Medreg as recommended by your doctor. However, if a dose is missed, return to your usual dosing schedule – one tablet once daily. Do not take a double dose to make up for a missed dose.

Stopping treatment with Montelukast Medreg

Montelukast Medreg is effective in treating asthma only if taken regularly. It is essential to continue taking Montelukast Medreg for as long as your doctor recommends. This will help keep your asthma symptoms under control.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Montelukast Medreg can cause side effects, although not everybody gets them.
During clinical trials with Montelukast Medreg, 10 mg, film-coated tablets, the most common side effects (occurring in at least 1 in 10 treated patients) considered to be related to montelukast were:

• stomach pain
• headache

These symptoms were usually mild and occurred more frequently in patients taking Montelukast Medreg than in patients taking a placebo (a tablet that does not contain any medicine).

Severe side effects

Seek medical attention immediatelyif 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 behavior or hostility, depression
• seizures

Rare(may affect up to 1 in 1,000 people)

• increased tendency to bleed
• 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 in 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 (swelling) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• liver inflammation.

Other side effects reported after the medicine was marketed:

Very common(may affect more than 1 in 10 people)

• upper respiratory tract infections

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• changes in behavior and mood (sleep disturbances, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, restlessness)
• dizziness, drowsiness, tingling or numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• joint and muscle pain, muscle spasms
• 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 disturbances, memory disturbances, uncontrolled movements

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

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Montelukast Medreg

Keep the medicine out of the 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 month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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:

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

What Montelukast Medreg looks like and contents of the pack

Montelukast Medreg, 10 mg, are light yellow-brown (beige), oval, film-coated tablets. The tablets have the inscription "I" on one side and "114" on the other side.
The tablets are packaged in Aluminum/PVC/Aluminum/OPA blisters, in a cardboard box, and are available in packs 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 authorization holder and manufacturer

Marketing authorization 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
Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

This medicine is authorized 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 film-coated tablets
Slovakia:
Montelukast Medreg 10 mg

Date of last revision of the leaflet: