Romilast

Package Leaflet: Information for the User

Romilast, 5 mg, Chewable Tablets

Montelukast

Read the package leaflet carefully before taking the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Romilast and what is it used for

What is Romilast

Romilast is a leukotriene receptor antagonist, which blocks the action of substances called
leukotrienes.

How Romilast works

Leukotrienes cause narrowing and swelling of the airways. By blocking the action of
leukotrienes, Romilast relieves asthma symptoms and helps control asthma.

When to use Romilast

Your doctor has prescribed Romilast for the treatment of asthma in a child, to prevent
asthma symptoms from occurring during the day and at night.

• Romilast is used to treat patients aged 6 to 14 years who have not achieved adequate asthma control with their current medications and require additional treatment.
• Romilast may also be used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for asthma and are unable to use inhaled corticosteroids.
• Romilast also helps prevent narrowing of the airways caused by physical exertion in patients aged 6 to 14 years.

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

What is asthma?

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

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

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

2. Important information before taking Romilast

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

When not to take Romilast

• 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 Romilast, discuss with your doctor or pharmacist

• If asthma symptoms worsen or breathing difficulties occur, seek medical attention immediately.
• Romilast taken orally is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the doctor's instructions. Always carry a rescue inhaler with you in case of an asthma attack.
• It is essential to take all asthma medications prescribed by your doctor.
• Do not take Romilast instead of other asthma medications prescribed by your doctor.
• Remember that if you are taking asthma medications and experience symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening respiratory symptoms, and (or) rash, you should see a doctor.
• Do not take aspirin or non-steroidal anti-inflammatory drugs (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 taking montelukast (see section 4). If you experience such symptoms while taking montelukast, consult your doctor.

Consult your doctor if you experience any of these symptoms while taking montelukast.

Children and adolescents

Do not give this medicine to children under 6 years of age.
For children and adolescents under 18 years of age, different forms of this medicine are available, suitable for the patient's age.

Romilast 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 Romilast or Romilast may affect the action of other medicines you are taking.
Before taking Romilast, inform 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).

Taking Romilast with food and drink

Do not take Romilast during meals; take it at least 1 hour before a meal or 2 hours after a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Use during pregnancy
Your doctor will assess whether you can take this medicine during pregnancy.
Use during breastfeeding
It is not known whether Romilast passes into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking this medicine.

Driving and using machines

Do not expect Romilast 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) reported during treatment with Romilast may affect your ability to drive or use machines.

Romilast 5 mg, chewable tablets contain aspartame, sodium, and mannitol

This medicine contains 1.5 mg of aspartame in each 5 mg chewable tablet, equivalent to 0.842 mg of phenylalanine. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.
This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, which means it is essentially 'sodium-free'.
Mannitol may have a mild laxative effect.

3. How to take Romilast

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

• Take only one 5 mg chewable tablet of Romilast once daily, as advised by your doctor.
• Take the medicine even when you do not have asthma symptoms, and also when you have an acute asthma attack.
• Take the medicine orally.

Children and adolescents aged 6 to 14 years:

Take one 5 mg chewable tablet of Romilast once daily, in the evening. Do not take the medicine during meals; take it at least 1 hour before a meal or 2 hours after a meal. This medicine is intended for oral use. Chew the tablet before swallowing.
Make sure the patient taking Romilast does not take other medicines containing the same active substance - montelukast.

Taking more than the recommended dose of Romilast

Contact your doctor immediately.
In most cases of overdose, no side effects were observed. After overdose in children and adults, the following symptoms were most commonly reported: stomach pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missing a dose of Romilast

Take the medicine as advised by your doctor. If you forget to take a dose, return to your normal dosing schedule - one chewable tablet once daily.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Romilast

Romilast is effective in treating asthma only when taken regularly.
It is essential to continue taking the medicine for as long as your doctor has prescribed. This will help keep your asthma under control.
If you have any further questions about taking this medicine, ask 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 5 mg chewable tablets, the most commonly reported side effect (which may occur in less than 1 in 10 people) considered to be related to the medicine was:

• headache. Additionally, in clinical trials with montelukast 10 mg film-coated tablets, the following were reported:
• stomach pain. These symptoms were usually mild and occurred more frequently in patients taking Romilast than in those taking a placebo (a tablet that does not contain any medicine).

Severe side effects

Seek medical attention immediatelyif you experience any of the following severe side effects, which may require urgent medical attention.
Uncommon: may occur in less than 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 occur in less than 1 in 1000 people
• increased tendency to bleed
• tremors
• palpitations

Very rare: may occur in less than 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
• 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 marketed

Very common: may occur in more than 1 in 10 people

• upper respiratory tract infections Common: may occur in less than 1 in 10 people
• diarrhea, nausea, vomiting
• rash
• fever
• increased liver enzyme activity

Uncommon: may occur in less than 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 spasms
• bedwetting in children
• weakness and (or) fatigue, malaise, swelling

Rare: may occur in less than 1 in 1000 people

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

Very rare: may occur in less than 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 this leaflet, 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.: 22 49-21-301, fax: 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 Romilast

• Keep the medicine out of the sight and reach of children.
• Do not use Romilast after the expiry date stated on the outer packaging and blister.
  The expiry date refers to the last day of the month stated.
• Store in the original package to protect from light and moisture.
• 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 Romilast contains

• The active substance is montelukast. Each chewable tablet contains 5 mg of montelukast as montelukast sodium.
• The other ingredients are: mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose, red iron oxide (E172), sodium croscarmellose, cherry flavor, aspartame (E951), magnesium stearate.

What Romilast looks like and contents of the pack

Romilast 5 mg chewable tablets are pink to red, mottled, round, biconvex tablets with "MT5" engraved on one side and smooth on the other.
Blisters in packs of: 28, 30, or 50 tablets.

Marketing authorization holder and manufacturer

Manufacturer:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
Netherlands
Terapia SA
124 Fabricii Street
400 632 Cluj Napoca
Romania
To obtain more detailed information, contact the representative of the marketing authorization holder.
Date of last revision of the leaflet:22.02.2024
Marketing authorization holder:
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
Poland
Tel. 22 642 07 75