Romilast

Patient Information Leaflet

Romilast, 5 mg, chewable tablets
Montelukastum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 a specific individual. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents

1. What Romilast is and what it is used for
2. What you need to know 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 Romilast is and what it is used for

What Romilast is
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 Romilast should be used
Your doctor has prescribed Romilast for the treatment of asthma in a child, to prevent asthma symptoms during the day and at night.

• Romilast is used in the treatment of patients aged 6 to 14 years who have not achieved adequate asthma control with previously used medications and require additional therapy.
• Romilast may also be used instead of inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for asthma treatment and who are unable to use inhaled corticosteroids.
• Romilast also helps prevent exercise-induced narrowing of the airways in patients aged 6 to 14 years.

Your doctor will determine how to use Romilast based on the symptoms and severity of asthma in the patient.
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.
• Hyper-responsiveness 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 chest tightness.

2. Important information before using Romilast

Tell your doctor about any medical conditions and allergies currently present or experienced in the past by the patient.

When not to use Romilast

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

Warnings and precautions
Before starting to take Romilast, discuss this with your doctor or pharmacist:

• If asthma symptoms worsen or if breathing difficulties occur, contact your doctor immediately.
• Orally administered Romilast is not intended for the treatment of acute asthma attacks. If such an attack occurs, follow your doctor's instructions. Always keep a reliever inhaler available for immediate use in case of an asthma attack.
• It is important to take all asthma medications prescribed by your doctor.
• Do not use Romilast as a substitute for other asthma medications prescribed by your doctor.
• Be aware that if a patient taking asthma medications develops symptoms such as flu-like symptoms, tingling or numbness in hands or feet, worsening respiratory symptoms and/or rash, contact your doctor.
• The patient should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs), if they worsen asthma symptoms.

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

Children and adolescents
Do not use this medicine in children under 6 years of age.
Different formulations of this medicine are available for children and adolescents under 18 years of age, appropriate for the patient's age.

Romilast and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, 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 patient.
Before starting Romilast, inform your doctor if the patient is taking any of the following medicines:

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

Taking Romilast with food and drink
Do not take Romilast during meals; take the medicine at least 1 hour before or 2 hours after a meal.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Your doctor will assess whether the patient can take this medicine during pregnancy.

Breastfeeding
It is not known whether Romilast passes into human milk. If a woman is breastfeeding or intends to breastfeed, she should consult her doctor before using this medicine.

Driving and using machines
Romilast is not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary. Some adverse effects (such as dizziness and drowsiness) reported during treatment with Romilast may affect the ability to drive or operate machinery.

Romilast 5 mg chewable tablets contain aspartame, sodium, and mannitol
This medicine contains 1.5 mg of aspartame per 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 impaired 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 exactly as directed by the doctor or pharmacist. If in
doubt, consult the doctor or pharmacist.

• Take only one Romilast 5 mg chewable tablet once daily, as directed by the doctor.
• The medicine should be taken even when the patient does not have asthma symptoms, and also during an acute asthma attack.
• The medicine should be taken orally.

Children and adolescents aged 6 to 14 years:
Take 1 Romilast 5 mg chewable tablet 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. This medicine is intended for oral use. The tablet must be chewed before swallowing.
Ensure that the patient taking Romilast is not also taking other medicines containing the same active substance – montelukast.

Taking more Romilast than recommended
Contact the doctor immediately.
In most cases of overdose, no adverse effects were observed. Following overdose in children and adults, the most commonly reported symptoms were abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

If a dose of Romilast is missed
Take the medicine as directed by the doctor. If a dose is missed, return to the usual dosing schedule – one chewable tablet once daily.
Do not take a double dose to make up for the missed dose.

Stopping Romilast
Romilast is effective in treating asthma only when taken regularly.
It is important to continue taking the medicine for as long as the doctor has instructed. This will help keep asthma under control.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
In clinical trials using montelukast in the form of 5 mg chewable tablets, the most commonly reported adverse reaction (which may occur in fewer than 1 in 10 people) considered to be related to the medicine was:

• headache. Additionally, in clinical trials using montelukast 10 mg film-coated tablets, the following were reported:
• abdominal pain. These symptoms were usually mild and occurred more frequently in patients taking Romilast than in patients taking placebo (a tablet containing no active ingredient).

Serious adverse reactions
Contact a doctor immediately if any of the following adverse reactions occur, as they may be serious and may require immediate medical attention.
Uncommon: may occur in fewer 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 behaviour and mood: agitation, including aggressive behaviour or hostility, depression
• seizures

Rare: may occur in fewer than 1 in 1,000 people

• increased tendency to bleed
• tremor
• palpitations

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

• a syndrome of symptoms such as flu-like symptoms, sensation of pricking and tingling or numbness in hands and feet, worsening of respiratory symptoms and (or) rash (Churg-Strauss syndrome) (see section 2)
• low 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 symptoms
• hepatitis (inflammation of the liver)

Other adverse reactions 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 fewer than 1 in 10 people

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

Uncommon: may occur in fewer than 1 in 100 people

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

Rare: may occur in fewer than 1 in 1,000 people

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

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

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

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

5. How to store Romilast

• Keep this medicine out of 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 specified 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 pack and other information

What Romilast contains

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

What Romilast looks like and contents of the pack
Romilast 5 mg chewable tablets are pink to red, marbled, round, biconvex tablets, embossed with the code "MT5" on one side and smooth on the other.
Blister packs containing: 28, 30 or 50 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
The Netherlands

Terapia SA
124 Fabricii Street
400 632 Cluj-Napoca
Romania

For further information, please contact the representative of the Marketing Authorisation Holder.