Romilast

Package Leaflet: Information for the User

Romilast, 10 mg, Film-Coated Tablets

Montelukast

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for one person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their 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 Package and Other Information

1. What is Romilast and What is it Used For

What is Romilast

Romilast is a leukotriene receptor antagonist that blocks the action of substances called leukotrienes. Leukotrienes cause the airways to narrow and swell, and cause allergy symptoms.

How Romilast Works

By blocking the action of leukotrienes, Romilast relieves the symptoms of asthma and helps control asthma, as well as relieving the symptoms of seasonal allergies (also known as seasonal allergic rhinitis or hay fever).

When to Use Romilast

The doctor has prescribed Romilast for the treatment of asthma, to prevent the occurrence of asthma symptoms during the day and at night.

• Romilast is used in the treatment of adults and adolescents aged 15 years and older who have not achieved adequate control of asthma with their current medications and require additional treatment.
• Romilast also helps prevent bronchospasm caused by physical exertion.
• In patients with asthma, for whom Romilast is indicated for asthma, it may also relieve the symptoms of seasonal allergic rhinitis.

The doctor will determine how to use 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.
• inflammation (swelling) of the lining of the airways.

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

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 usually include: a stuffy nose, runny nose, itchy nose, sneezing; watery, swollen, red, itchy eyes.

2. Important Information Before Taking Romilast

Inform the 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 medication (listed in section 6).

Warnings and Precautions

Before starting to take Romilast, discuss it with the doctor or pharmacist.

• In case of worsening asthma symptoms or difficulty 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 carry a rescue inhaler with you in case of an asthma attack.
• It is essential to take all asthma medications prescribed by the doctor. Do not take Romilast instead of other asthma medications prescribed by the doctor.
• Remember that if a patient taking asthma medications experiences symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening respiratory symptoms, and (or) rash, they should consult a doctor.
• Do not take aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen 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, they should Consult a Doctor.

Children and Adolescents

Do not use this medication in children under 15 years of age. For children under 18 years of age, different forms of this medication are available, tailored to the patient's age.

Romilast and Other Medications

Inform the doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications they plan to take, including those available without a prescription. Some medications may affect the action of Romilast or Romilast may affect the action of other medications. Before starting to take Romilast, inform the doctor if the patient is taking:

• phenobarbital (used to treat epilepsy),
• phenytoin (used to treat epilepsy),
• rifampicin (used to treat tuberculosis and some other infections),
• gemfibrozil (used to treat high lipid levels in the blood).

Romilast with Food and Drink

Romilast can be taken with or without food.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medication. PregnancyThe doctor will assess whether it is possible to take this medication during pregnancy. BreastfeedingIt is not known whether Romilast passes into breast milk. If a woman is breastfeeding or plans to breastfeed, she should consult a doctor before taking the medication.

Driving and Operating Machines

It should not be expected that Romilast will affect the ability to drive or operate machines. However, individual reactions to the medication may vary. Some side effects (such as dizziness and drowsiness) reported during treatment with Romilast may affect the ability to drive or operate machines.

Romilast Contains Lactose and Sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medication. The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Romilast

This medication should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, consult a doctor or pharmacist.

• Take only one tablet of Romilast once a day, as instructed by the doctor.
• The medication should be taken even when asthma symptoms are not present, as well as when an acute asthma attack occurs.

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 does not take other medications containing the same active substance - montelukast. The medication should be taken orally. The medication can be taken with or without food.

Taking a Higher Dose of Romilast than Recommended

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

Missing a Dose of Romilast

Take the medication as instructed by the doctor. If the patient forgets to take a dose, they should return to their regular dosing schedule - one tablet once daily. Do not take a double dose to make up for the missed dose.

Stopping Treatment with Romilast

Romilast is effective in treating asthma only when taken regularly. It is essential to continue taking the medication as long as the doctor has prescribed. This will help keep the asthma under control. In case of any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, Romilast can cause side effects, although not everybody gets them. During clinical trials with montelukast 10 mg film-coated tablets, the most common side effects (which may occur in up to 1 in 10 people) considered to be related to the medication were:

• abdominal pain,
• headache. These symptoms were usually mild and occurred more frequently in patients taking Romilast than in patients taking a placebo (a tablet that does not contain any medication).

Severe Side Effects

Consult a Doctor Immediatelyif any of the following side effects occur, which may be severe and 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 behavior and mood: agitation, including aggressive or hostile behavior, 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 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, stuttering
• inflammation (infection) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• liver inflammation

Other Side Effects Reported After the Medication was Placed on the Market

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

• diarrhea, nausea, vomiting
• rash
• fever
• increased liver enzyme levels

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

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

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

Very Rare:may occur in up to 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 any side effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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, more information can be collected on the safety of the medication.

5. How to Store Romilast

• Store the medication out of 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.
• Medications should not be disposed of in wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the Package and Other Information

What Romilast Contains

• The active substance of the medication is montelukast. Each tablet contains 10 mg of montelukast in the form of montelukast sodium.
• Other ingredients are: Tablet core:lactose monohydrate (89.0 mg), microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, magnesium stearate. Coating:Opadry Yellow 03B52874:hypromellose 6 cP, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), red iron oxide (E172).

What Romilast Looks Like and What the Package Contains

Beige to light yellow, square, film-coated tablet with rounded edges, with the inscription "M10" on one side and smooth on the other. Blister packs 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 more detailed information, please contact the representative of the marketing authorization holder. Date of Last Revision of the Leaflet:14.03.2024.