Romilast

Package Leaflet: Information for the User

Romilast, 4 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 in the treatment of patients aged 2 to 5 years, in whom adequate control of asthma has not been achieved with existing medications and additional medication is necessary.
• Romilast may also be used as an alternative to inhaled glucocorticosteroids in children aged 2 to 5 years who have not recently taken oral glucocorticosteroids for asthma and who are unable to use inhaled glucocorticosteroids.
• Romilast also helps prevent bronchospasm caused by physical exertion in patients aged 2 years and older.

Your doctor will determine how to take Romilast based on the child'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, which worsens and improves in response to various factors.
• increased sensitivity 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 tightness in the chest.

2. Important information before taking Romilast

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

When not to give Romilast to a child

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

Warnings and precautions

Before starting Romilast, discuss it with your doctor or pharmacist.

• If the child's asthma symptoms worsen or if there are difficulties breathing, 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 have a rescue inhaler with you in case of an asthma attack in the child.
• It is essential that the child takes all asthma medications prescribed by the doctor.
• Romilast should not be used as a replacement for other asthma medications prescribed by the doctor.
• Remember that if the child taking asthma medications experiences symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening respiratory symptoms, and/or rash, seek medical attention.
• The child should not be given acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen the child's 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 the patient experiences such symptoms while taking montelukast, consult a doctor.

If the patient experiences such symptoms while taking montelukast, consult a doctor.

Children and adolescents

Romilast 4 mg should not be given to children under 2 years of age. Romilast 4 mg chewable tablets are intended for children aged 2 to 5 years. Romilast 5 mg chewable tablets are intended for children aged 6 to 14 years.

Romilast and other medicines

Tell your doctor or pharmacist about all medicines given to the child currently or recently, as well as any medicines that may be given to the child, including those available without a prescription. Some medicines may affect the action of Romilast or Romilast may affect the action of other medicines taken by the child. Before starting Romilast, inform your doctor if the child is taking:

• phenobarbital (used to treat epilepsy),
• phenytoin (used to treat epilepsy),
• rifampicin (used to treat tuberculosis and some other infections).

Romilast with food and drink

Romilast should not be taken during meals; the medicine should be taken at least 1 hour before meals or 2 hours after meals.

Pregnancy and breastfeeding

This section does not apply to Romilast, as it is intended for use in children aged 2 to 5 years.

Driving and using machines

This section does not apply to Romilast, as it is intended for use in children aged 2 to 5 years. However, the following information is relevant to the active substance, montelukast. It is not expected that Romilast will affect the ability to drive and use machines. However, individual responses to the medicine may vary. Some side effects (such as dizziness and drowsiness), which have been reported with Romilast, may affect the ability to drive and use machines.

Romilast 4 mg chewable tablets contain aspartame, sodium, and mannitol

This medicine contains 1.2 mg of aspartame in each 4 mg chewable tablet, equivalent to 0.674 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

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

• This medicine should be given to the child under adult supervision. For children who have problems taking the chewable tablet, a granule formulation is available.
• The child should be given only one 4 mg Romilast chewable tablet once daily, as prescribed by the doctor.
• The medicine should be taken even when the child does not have asthma symptoms, as well as when an acute asthma attack occurs.
• The medicine should be taken orally.

Children aged 2 to 5 years:

Take one 4 mg Romilast chewable tablet once daily, in the evening. The medicine should not be taken during meals; it should be taken at least 1 hour before meals or 2 hours after meals. Ensure that the child taking Romilast does not take other medicines containing the same active substance, montelukast. This medicine is intended for oral use. The tablet should be chewed before swallowing.

If the child takes more Romilast than they should

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

If the child misses a dose of Romilast

Give the medicine as prescribed by the doctor. If the child misses a dose, return to the usual dosing schedule - one chewable tablet once daily. Do not take a double dose to make up for the missed dose.

If the child stops taking Romilast

Romilast is effective in treating asthma in the child only if taken regularly. It is essential to continue taking the medicine as prescribed by the doctor to keep the child's asthma under control. If you have any further questions about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Romilast can cause side effects, although not everybody gets them. During clinical trials with montelukast chewable tablets 4 mg, the most commonly reported side effects (which may occur in less than 1 in 10 people) considered to be related to the medicine were:

• abdominal pain
• increased thirst
• Additionally, in clinical trials with montelukast film-coated tablets 10 mg and chewable tablets 5 mg, the following side effects were reported:
• headache

These symptoms usually had a mild intensity 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

Contact a doctor immediatelyif you experience any of the following severe side effects, which may require urgent 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
• tremors
• 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)
• decreased 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
• inflammation of the liver

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 activity

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 and 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 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

• painful, 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, 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.
• Store in the original packaging 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 that are no longer needed. 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 4 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 4 mg chewable tablets are pink to red, mottled, oval, biconvex tablets with "MT4" engraved on one side and smooth on the other. Blisters in packs of: 28 tablets.

Marketing authorization holder and manufacturer

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