Romilast

Package leaflet: Information for the user

Romilast, 4 mg, chewable tablets
Montelukastum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Romilast is and what it is 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 package and other information

1. What Romilast is and what it is used for

What is Romilast
Romilast is a leukotriene receptor antagonist that 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 recommended Romilast for the treatment of asthma in your child to prevent
asthma symptoms during the day and at night.

• Romilast is used in the treatment of patients aged 2 to 5 years who have not achieved adequate asthma control with previously used medications and require additional therapy.
• Romilast may also be used instead of inhaled glucocorticosteroids in children aged 2 to 5 years who have not recently received oral glucocorticosteroids for asthma treatment and who are unable to use inhaled glucocorticosteroids.
• Romilast also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Your doctor will determine how to use Romilast based on your child's symptoms and the severity of asthma.
What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

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

Asthma symptoms include: coughing, wheezing, and chest tightness.

2. Important information before using Romilast

Inform the doctor about any medical conditions and allergies currently present or previously experienced by the child.

When Romilast must not be used in children

• if the child 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 Romilast, discuss this with the doctor or pharmacist:

• If the child's asthma symptoms worsen or if breathing difficulties occur, seek medical advice immediately.
• Romilast, taken orally, is not intended for the treatment of acute asthma attacks. If such an attack occurs, follow the doctor's instructions. Always keep a reliever inhaler available for immediate use in case of an asthma attack.
• It is important that the child continues to take all anti-asthma medications prescribed by the doctor.
• Romilast should not be used instead of other anti-asthma medications prescribed by the doctor.
• Remember that if a child taking anti-asthma medications develops symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening respiratory symptoms and/or rash, medical advice should be sought.
• Do not give the child acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen the child's asthma symptoms.

Various neuropsychiatric events (for example, changes in behaviour and mood, depression and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur while taking montelukast, consult a doctor.

Children and adolescents
Romilast 4 mg must not be used in 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 with other medicines
Tell the doctor or pharmacist about all medicines currently or recently given to the child, as well as any medicines that may be given in the future, 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 the doctor if the child is taking any of the following medicines:

• 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).

Romilast with food and drink
Romilast should not be taken during meals; it should be taken at least 1 hour before a meal or 2 hours after a meal.

Pregnancy and breastfeeding
This section does not apply to Romilast, as this medicine is intended for use in children aged 2 to 5 years.

Driving and operating machinery
This section does not apply to Romilast, as this medicine is intended for use in children aged 2 to 5 years. However, the following information is relevant regarding the active substance – montelukast.
Romilast is not expected to affect the ability to drive or operate machinery.
Nevertheless, individual responses to the medicine may vary. Some adverse reactions (such as dizziness and drowsiness) reported during treatment with Romilast may affect the ability to drive or operate machinery.

Romilast 4 mg chewable tablets contain aspartame, sodium and mannitol
This medicine contains 1.2 mg of aspartame per 4 mg chewable tablet, equivalent to 0.674 mg of phenylalanine. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, meaning the medicine is considered "sodium-free".
Mannitol may have a mild laxative effect.

3. How to use Romilast

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

• This medicine should be administered to a child under the supervision of an adult. For children who have difficulty taking the chewable tablet, granules are available.
• The child should be given only one Romilast 4 mg chewable tablet once daily, as directed by the doctor.
• The medicine should be taken even when the child has no asthma symptoms, as well as during an acute asthma attack.
• The medicine should be taken orally.

Children aged 2 to 5 years:
One Romilast 4 mg chewable tablet should be taken once daily in the evening.
The medicine should not be taken during meals; it should be taken at least one hour before a meal or two hours after a meal.
Ensure that a child taking Romilast is not also taking other medicines containing the same active substance – montelukast.
This medicine is intended for oral use.
The tablet must be chewed before it is swallowed.

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

Missed dose of Romilast in a child
The medicine should be taken as directed by the doctor. If the child forgets to take a dose, resume the regular dosing schedule – one chewable tablet once daily. Do not give a double dose to make up for a missed dose.

Stopping treatment with Romilast
Romilast is effective in treating asthma in children only when taken regularly. It is important to continue giving the medicine to the child for as long as the doctor has instructed. This will help keep the child's asthma under control.

If there are any further questions about the use of this medicine in children, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
During clinical studies using montelukast in the form of chewable and dispersible tablets 4 mg,
the most commonly reported side effects (may occur in less than 1 in 10 people), considered to be related to the use of this medicine, were:

• abdominal pain
• excessive thirst

Additionally, in clinical studies using montelukast in the form of 10 mg coated tablets and 5 mg chewable and dispersible tablets, the following have been reported:

• headache

These symptoms were usually mild in severity and occurred more frequently in patients taking montelukast than in patients taking placebo (a tablet containing no active ingredient).

Serious side effects
Contact a doctor immediately if any of the following side effects occur, as they may be serious and may require immediate 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 in breathing or swallowing
• changes in behaviour and mood: agitation, including aggressive behaviour or hostility, depression
• seizures

Rare: may occur in less than 1 in 1000 people

• increased tendency to bleed
• tremor
• palpitations

Very rare: may occur in less than 1 in 10,000 people

• a group of symptoms such as flu-like symptoms, tingling or numbness in hands and feet, worsening of respiratory symptoms and (or) rash (Churg-Strauss syndrome) (see section 2)
• decreased platelet count
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and attempts
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior warning symptoms
• hepatitis (inflammation of the liver)

Other side effects reported after marketing of the medicine
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

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

Uncommon: may occur in less than 1 in 100 people

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

Rare: may occur in less than 1 in 1000 people

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

Very rare: may occur in less than 1 in 10,000 people

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

Reporting of side effects
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions 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 authorisation holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store the medicine 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 stated month.
• Store in the original packaging to protect from light and moisture.
• Medicines must 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 packaging and other information

What Romilast contains

• The active substance is montelukast. Each chewable tablet contains 4 mg of montelukast in the form of montelukast sodium.
• The other ingredients are: mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, iron oxide red (E172), sodium croscarmellose, cherry flavour, aspartame (E951), magnesium stearate.

What Romilast looks like and contents of the pack
Romilast 4 mg chewable tablets are pink to red, marbled, oval, biconvex tablets, embossed with the code "MT4" on one side and smooth on the other.
Blister packs in packages containing: 28 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warszawa
Poland
Tel. 22 642 07 75

Manufacturer:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands

Terapia SA
124 Fabricii Street
400 632 Cluj Napoca
Romania

For further information, please contact the Marketing Authorisation Holder.