Romilast

Package leaflet: Information for the user

Romilast, 10 mg, coated tablets
Montelukast
Please read 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 you personally. Do not give it 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.

Contents of the leaflet

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 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. Leukotrienes cause narrowing and swelling of the airways and allergy symptoms.
How Romilast works
By blocking the action of leukotrienes, Romilast relieves asthma symptoms and helps control asthma, as well as alleviating symptoms of seasonal allergies (also known as seasonal allergic rhinitis or hay fever).
When Romilast should be used
Your doctor has prescribed Romilast for the treatment of asthma to prevent daytime and nighttime asthma symptoms.

• Romilast is used in the treatment of adults and adolescents aged 15 years and older in whom adequate asthma control has not been achieved with previously used medications and additional therapy is required.
• Romilast also helps prevent airway narrowing caused by physical exercise.
• In patients with asthma for whom Romilast is indicated due to asthma, it may also relieve symptoms of seasonal allergic rhinitis.

Your doctor will determine how to take Romilast depending on your symptoms and the severity of your 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.
• Hyperreactivity 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: cough, wheezing, and chest tightness.
What is seasonal allergy?
Seasonal allergy (also known as hay fever or seasonal allergic rhinitis) is an allergic reaction to airborne pollen from trees, grasses, and weeds. Symptoms typically include: nasal congestion, watery nasal discharge, itchy nose, sneezing; and watery, swollen, red, itchy eyes.

2. Important information before using Romilast

You should inform your doctor about any current or past medical conditions and allergies.

When not to use 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 starting Romilast, discuss this with your doctor or pharmacist:

• If asthma symptoms worsen or breathing difficulties occur, seek medical advice immediately.
• Romilast tablets are not intended for the treatment of acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always keep a rescue inhaler available for immediate use in case of an asthma attack.
• It is important to continue taking all anti-asthma medications prescribed by your doctor. Romilast should not be used as a substitute for other anti-asthma medicines 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 of respiratory symptoms and/or rash, medical advice should be sought.
• Do not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs), if they worsen asthma symptoms.

Various neuropsychiatric events (e.g. changes in behavior and mood, depression, and suicidal tendencies) 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 15 years of age.
For children under 18 years of age, different formulations of this medicine are available, adapted to the patient's age.

Romilast with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to use, including over-the-counter medicines.

Some medicines may affect the action of Romilast, or Romilast may affect the action of other medicines.

Before starting Romilast, inform your doctor if the patient 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),
• gemfibrozil (used in the treatment of high plasma lipid levels).

Romilast with food and drink
Romilast may be taken with or without food.

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 decide whether it is safe to take this medicine during pregnancy.

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

Driving and operating machinery
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 contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Romilast

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

• Take only one tablet once daily, as directed by the physician.
• The medicine should be taken even when asthma symptoms are not present, as well as during acute asthma attacks.

Adults and adolescents aged 15 years and older:
The recommended dose is one 10 mg tablet once daily in the evening. Ensure that the patient
taking Romilast is not also taking other medicines containing the same active substance –
montelukast.
The medicine should be taken orally.
Romilast may be taken with or without food.
If more Romilast is taken than recommended
Contact a physician immediately.
In most cases of overdose, no adverse effects have been observed. Following overdose in children and adults, the most commonly observed symptoms include: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperkinesia.
If a dose of Romilast is missed
Continue taking the medicine as directed by the physician. If a dose has been missed, return to the regular dosing schedule – one tablet once daily.
Do not take a double dose to make up for the missed dose.
Stopping Romilast treatment
Romilast is effective in treating asthma only when taken regularly.
It is important to continue taking the medicine for as long as directed by the physician. This will help keep asthma under control.
If there are any further doubts regarding the use of this medicine, consult the physician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
In clinical trials using montelukast 10 mg film-coated tablets,
the most commonly reported side effects (may occur in up to 1 in 10 people),
considered to be related to the medicine, were:

• abdominal pain,
• headache. These symptoms were usually mild and occurred more frequently in patients taking Romilast than in patients taking placebo (a tablet containing no active medicine).

Serious side effects
Contact your doctor immediately if you experience any of the following side effects,
which may be serious and may require immediate medical attention.
Uncommon: may occur in 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 behaviour and mood: agitation, including aggressive behaviour or hostility, depression
• seizures

Rare: may occur in up to 1 in 1,000 people

• increased tendency to bleed
• tremor
• palpitations

Very rare: may occur in up to 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
• reduced platelet count
• changes in behaviour and mood: hallucinations, disorientation, stuttering, 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 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 up to 1 in 10 people

• diarrhoea, nausea, vomiting
• rash
• fever
• increased liver enzymes

Uncommon: may occur in up to 1 in 100 people

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty sleeping, 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 up to 1 in 1,000 people

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

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

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

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet,
tell 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.: 22 49-21-301, fax: 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 provide more information on the safety of this medicine.

5. How to store Romilast

• Keep this 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 first two digits indicate the month, the last four digits indicate the year. The expiry date refers to the last day of the specified 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 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 tablet contains 10 mg of montelukast in the form of montelukast sodium.
• Other components are: Tablet core: monohydrate lactose (89.0 mg), microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate. Coating: Opadry Yellow 03B52874: hypromellose 6 cP, titanium dioxide (E171), polyethylene glycol 400, iron oxide yellow (E172), iron oxide red (E172).

What Romilast looks like and contents of the pack
Beige to pale yellow, square, film-coated tablet with rounded edges, imprinted with the code "M10" on one side and plain on the other.
Blister packs in packages containing: 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Manufacturer:
Ranbaxy (Poland) Sp. z o.o. Sun Pharmaceutical Industries Europe B.V.
Idzikowskiego Street 16 Polarisavenue 87
00-710 Warsaw 2132JH Hoofddorp
Poland Netherlands
Tel. 22 642 07 75
Terapia SA
124 Fabricii Street
400 632 Cluj Napoca
Romania
For further information, please contact the Marketing Authorisation Holder's representative.