Montelukast Aurovitas

Warnings and precautions

Before starting to take Montelukast Aurovitas, you should discuss it with your doctor or pharmacist.

• You should immediately inform your doctor if your asthma worsens or if you have difficulty breathing.
• Montelukast Aurovitas taken orally is not intended for the treatment of acute asthma attacks. In case of an asthma attack, 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 you take all asthma medications prescribed by your doctor. You should not use Montelukast Aurovitas instead of other asthma medications prescribed by your doctor.
• You should consult your doctor if you are taking asthma medications and experience symptoms such as: flu-like symptoms, tingling or numbness of the hands or feet, worsening of respiratory symptoms, and (or) rash.
• You should not take aspirin or anti-inflammatory drugs (so-called non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma symptoms.

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

montelukast, you should consult your doctor.

Use in children and adolescents

Do not give this medicine to children under 15 years of age.
There are different forms of the medicine available for pediatric patients under 18 years of age, depending on age.

Other medicines and Montelukast Aurovitas

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
Some medicines may affect the action of Montelukast Aurovitas, or Montelukast Aurovitas may affect the action of other medicines.
Before starting to take Montelukast Aurovitas, you should tell your doctor about 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 Aurovitas with food and drink

Montelukast Aurovitas 10 mg can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will decide whether you can take Montelukast Aurovitas during this period.
Breastfeeding
It is not known whether Montelukast Aurovitas passes into breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking Montelukast Aurovitas.

Driving and using machines

You should not expect Montelukast Aurovitas to affect your ability to drive or use machines. However, individual reactions to the medicine may vary. Some side effects (such as dizziness and drowsiness) that have been reported with Montelukast Aurovitas may affect some people's ability to drive or use machines.

Montelukast Aurovitas contains lactose

Montelukast Aurovitas 10 mg film-coated tablets contain lactose. If you have intolerance to some sugars, you should contact your doctor before taking the medicine.

Montelukast Aurovitas contains sodium

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

3. How to take Montelukast Aurovitas

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist or nurse. If you are unsure, you should consult your doctor or pharmacist or nurse.

• You should take only one tablet of Montelukast Aurovitas once a day, as directed by your doctor.
• You should take the medicine even if you do not have symptoms or if you have an acute asthma attack.

Use in children and adolescents aged 15 and older

The recommended dose is one 10 mg tablet once daily, in the evening.
If you are taking Montelukast Aurovitas, you should make sure that you are not taking other medicines that contain the same active substance, montelukast.
The medicine should be taken orally.
Montelukast Aurovitas 10 mg can be taken with or without food.

Taking a higher dose of Montelukast Aurovitas than recommended

You should consult your doctor immediately.
In most cases of overdose, no side effects have been observed. The most common side effects reported after overdose of Montelukast Aurovitas in adults and children were: abdominal pain, drowsiness, increased thirst, headache, vomiting, and increased activity.

Missing a dose of Montelukast Aurovitas

You should try to take Montelukast Aurovitas as directed. If you miss a dose, you should go back to your usual schedule of taking one tablet once a day.
You should not take a double dose to make up for a missed dose.

Stopping treatment with Montelukast Aurovitas

Montelukast Aurovitas is effective in treating asthma only if it is taken regularly. It is important to continue taking Montelukast Aurovitas for as long as your doctor has prescribed it. This will help control your asthma.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with montelukast 10 mg film-coated tablets, the most common side effects (which may affect up to 1 in 10 people but less than 1 in 100 people) that were probably related to montelukast were:

• abdominal pain,
• headache.

These symptoms were usually mild and occurred more often in patients treated with montelukast than in patients who received a placebo (a tablet that does not contain the medicine).

Severe side effects

You should contact your doctor immediatelyif you experience any of the following side effects, which may be severe and may 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 in 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 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 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
• inflammation (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• liver inflammation

Other side effects reported after the medicine was placed on the market

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: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling or numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• muscle or joint 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 movements

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

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

Reporting side effects

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

5. How to store Montelukast Aurovitas

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after the EXP date.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original package to protect from light and moisture.
Use within 30 days of opening the HDPE bottle.
Medicines should not be disposed of via wastewater or household waste. 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 Aurovitas contains

• The active substance of the medicine is montelukast. One film-coated tablet contains montelukast sodium, which corresponds to 10 mg of montelukast.
• The medicine also contains Core:lactose monohydrate, microcrystalline cellulose (E460), sodium carboxymethylcellulose, hydroxypropylcellulose (E463), magnesium stearate (E572).

Coating:hydroxypropylcellulose (E463), hypromellose 6cP (E464), titanium dioxide (E171), yellow iron oxide (E172), carnauba wax (E903), red iron oxide (E172).

What Montelukast Aurovitas looks like and contents of the pack

Film-coated tablets
Beige, square film-coated tablets with rounded edges, with the symbol "X" embossed on one side and "54" on the other.
Blister pack of polyamide/Aluminum/PVC/Aluminum in a cardboard box.
Pack sizes: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, and 200 tablets
HDPE bottles with PP closure and desiccant in a cardboard box:
Pack sizes: 30 tablets
Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

Manufacturer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France
Montelukast Arrow Lab 10 mg, film-coated tablet
Germany
Montelukast Aurobindo 10 mg film-coated tablets
Ireland
MONTELUKAST 10 mg Film-Coated Tablets
Italy
Montelukast Aurobindo 10mg film-coated tablets
Malta
Montelukast Aurobindo 10mg film-coated tablets
Netherlands
Montelukast Aurobindo 10 mg, film-coated tablets
Poland
Montelukast Aurovitas
Spain
Montelukast Aurovitas 10 mg film-coated tablets EFG

Date of last revision of the leaflet: 02.2024