Monkasta

Package Leaflet: Information for the Patient

Monkasta, 10 mg, Film-Coated Tablets

For Adults and Adolescents 15 Years and Older

Montelukast

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication 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 Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Monkasta and What is it Used For
• 2. Important Information Before Taking Monkasta
• 3. How to Take Monkasta
• 4. Possible Side Effects
• 5. How to Store Monkasta
• 6. Package Contents and Other Information

1. What is Monkasta and What is it Used For

What is Monkasta

Monkasta is a Leukotriene Receptor Antagonist, Which Blocks the Action of Substances Called Leukotrienes.

How Monkasta Works

Leukotrienes Cause the Airways to Narrow and Swell, and Cause Allergy Symptoms. By Inhibiting the Activity of Leukotrienes, Monkasta Relieves Asthma Symptoms, Helps Control Asthma, and Relieves Seasonal Allergy Symptoms (Also Known as Hay Fever or Seasonal Allergic Rhinitis).

When to Use Monkasta

Your Doctor Has Prescribed Monkasta for the Treatment of Asthma, to Prevent Asthma Symptoms from Occurring During the Day and Night.

• Monkasta is Used in the Treatment of Adults and Adolescents 15 Years and Older, Who Have Not Achieved Adequate Control with Their Current Medications and Require Additional Treatment.
• Monkasta Also Helps Prevent Exercise-Induced Narrowing of the Airways.
• In Patients with Asthma, for Whom Monkasta is Indicated for the Treatment of Asthma, it May Also Relieve Symptoms of Seasonal Allergic Rhinitis.

Your Doctor Will Determine the Dosage of Monkasta Based on Your Symptoms and the Severity of Your Asthma.

What is Asthma?

Asthma is a Chronic Disease. In Asthma, There Are:

• Difficulty Breathing Due to Narrowing of the Airways, Which Worsens and Improves in Response to Various Factors.
• Sensitivity of the Airways, Which React to Many Factors, Such as Cigarette Smoke, Pollen, Cold Air, or Physical Exercise.
• Inflammation (Swelling) of the Lining of the Airways.

Asthma Symptoms Include: Coughing, Wheezing, and a Feeling of Tightness in the Chest.

What are Seasonal Allergies?

Seasonal Allergies (Also Known as Hay Fever or Seasonal Allergic Rhinitis) are an Allergic Reaction Often Caused by Pollen in the Air from Trees, Grasses, and Weeds. Seasonal Allergy Symptoms May Typically Include: Stuffy Nose, Runny Nose, Itching of the Nose, Sneezing; Watery, Swollen, Red, Itchy Eyes.

2. Important Information Before Taking Monkasta

Tell Your Doctor About Any Health Problems and Allergies You Have Now or Have Had in the Past.

When Not to Take Monkasta

• If You are Allergic to Montelukast or Any of the Other Ingredients of this Medication (Listed in Section 6).

Warnings and Precautions

Tell Your Doctor or Pharmacist Before Taking Monkasta.

• If Your Asthma or Breathing Gets Worse, Tell Your Doctor Right Away.
• Monkasta Taken Orally is Not Intended for the Treatment of Acute Asthma Attacks. If an Attack Occurs, Follow the Instructions Given by Your Doctor. You Should Always Carry Your Inhaler with You for Asthma Attacks.
• It is Important to Take All Your Asthma Medications as Directed by Your Doctor. Do Not Replace Other Asthma Medications Prescribed by Your Doctor with Monkasta.
• Any Patient Taking Asthma Medications Should Know That if They Experience Symptoms Such as: Flu-Like Symptoms, Tingling or Numbness of the Hands and Feet, Worsening of Respiratory Symptoms, and (or) Rash, They Should Consult Their Doctor.
• Do Not Take Aspirin or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) if They Make Your Asthma Worse.

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 You Experience Such Symptoms While Taking Montelukast, Consult Your Doctor.

If You Experience Such Symptoms While Taking Montelukast, Consult Your Doctor.

Children

Do Not Give this Medication to Children Under 15 Years of Age. Different Forms of this Medication are Available for Children Under 18 Years of Age, Depending on Their Age.

Other Medications and Monkasta

Tell Your Doctor or Pharmacist About All Medications You are Currently Taking or Have Recently Taken, as Well as Any Medications Available Without a Prescription. Some Medications May Affect the Action of Monkasta or Monkasta May Affect the Action of Other Medications. Before Taking Monkasta, Tell Your Doctor About the Following Medications:

• Phenobarbital (Used to Treat Epilepsy),
• Phenytoin (Used to Treat Epilepsy),
• Rifampicin (Used to Treat Tuberculosis and Some Other Infections),
• Gemfibrozil (Used to Treat High Blood Lipid Levels).

Monkasta with Food and Drink

Monkasta 10 mg Can be Taken with or Without Food.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, Consult Your Doctor or Pharmacist Before Taking this Medication. PregnancyYour Doctor Will Decide if You Can Take Monkasta During this Period. BreastfeedingIt is Not Known if Montelukast Passes into Breast Milk. If You are Breastfeeding or Plan to Breastfeed, Consult Your Doctor Before Taking Monkasta.

Driving and Using Machines

Do Not Expect Monkasta to Affect Your Ability to Drive or Use Machines. However, Individual Responses to the Medication May Vary. Some Side Effects (Such as Dizziness and Drowsiness) Reported with Montelukast May Affect Your Ability to Drive or Use Machines in Some Patients.

Monkasta Contains Lactose and Sodium

If You Have Been Diagnosed with an Intolerance to Some Sugars, Contact Your Doctor Before Taking this Medication. This Medication Contains Less Than 1 mmol (23 mg) of Sodium per Film-Coated Tablet, Which Means it is Essentially Sodium-Free.

3. How to Take Monkasta

Always Take this Medication Exactly as Your Doctor Has Told You. If You are Not Sure, Ask Your Doctor or Pharmacist.

• Take Only One Tablet of Monkasta Once a Day as Directed by Your Doctor.
• Take the Medication Even if You Do Not Have Any Symptoms or if You are Having an Acute Asthma Attack.

Adults and Adolescents 15 Years and Older:

The Recommended Dose is One 10 mg Tablet, to be Taken Every Evening. When Taking Monkasta, Make Sure You are Not Taking Any Other Medications Containing the Same Active Ingredient, Montelukast. This Medication is for Oral Use. Monkasta 10 mg Can be Taken with or Without Food.

Taking More Than the Recommended Dose of Monkasta

Seek Advice from Your Doctor Immediately. In Most Cases, No Side Effects Have Been Observed. The Most Commonly Reported Symptoms in Adults and Children Were: Abdominal Pain, Drowsiness, Thirst, Headache, Vomiting, and Hyperactivity.

Missing a Dose of Monkasta

Take Monkasta as Directed by Your Doctor. If You Miss a Dose, Continue with Your Normal Dosing Schedule - One Tablet Once a Day. Do Not Take a Double Dose to Make Up for a Missed Dose.

Stopping Treatment with Monkasta

Monkasta is Only Effective in the Treatment of Asthma if Taken Regularly. It is Important to Continue Taking Monkasta as Long as Your Doctor Recommends. This Will Help Keep Your Asthma Under Control. If You Have Any Further Questions on the Use of this Medication, Ask Your Doctor.

4. Possible Side Effects

Like All Medications, Monkasta Can Cause Side Effects, Although Not Everybody Gets Them. During Clinical Trials with Montelukast 10 mg Film-Coated Tablets, the Most Commonly Reported Side Effects (Which May Occur in More Than 1 in 10 People) That Were Considered to be Related to Montelukast Were:

• Abdominal Pain,
• Headache.

These Symptoms Were Usually Mild and Occurred More Frequently in Patients Treated with Montelukast Than in Patients Taking a Placebo (a Tablet Containing No Medication).

Severe Side Effects

Seek Medical Attention Immediatelyif You Experience Any of the Following Side Effects, Which May be Severe and Require Immediate Medical Attention.
Uncommon: May Occur in More 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 Behavior and Mood: Agitation, Including Aggressive Behavior or Hostility, Depression,
• Seizures.

Rare: May Occur in More Than 1 in 1,000 People

• Increased Risk of Bleeding,
• Tremors,
• Palpitations.

Very Rare: May Occur in More Than 1 in 10,000 People

• Symptoms Such as Flu-Like Symptoms, Tingling or Numbness of the Hands and Feet, Worsening of 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 (Swelling) of the Lungs,
• Severe Skin Reactions (Erythema Multiforme), Which May Occur Without Prior Symptoms,
• Hepatitis.

Other Side Effects Reported After the Medication Was Marketed

Very Common: May Occur in More Than 1 in 10 People

• Upper Respiratory Tract Infections.

Common: May Occur in More Than 1 in 100 People

• Diarrhea, Nausea, Vomiting,
• Rash,
• Fever,
• Increased Liver Enzyme Levels.

Uncommon: May Occur in More Than 1 in 1,000 People

• Changes in Behavior and Mood: Unusual Dreams, Including Nightmares, Difficulty Falling Asleep, Sleepwalking, Irritability, Feeling Anxious, Restlessness,
• Dizziness, Drowsiness, Tingling and Numbness,
• Nosebleeds,
• Dry Mouth, Indigestion,
• Bruising, Itching, Hives,
• Muscle or Joint Pain, Muscle Cramps,
• Nocturnal Enuresis in Children,
• Weakness and (or) Fatigue, Malaise, Swelling.

Rare: May Occur in More Than 1 in 10,000 People

• Changes in Behavior and Mood: Attention Deficit, Memory Impairment, Uncontrolled Muscle Movements.

Very Rare: May Occur in More Than 1 in 100,000 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 Package Leaflet, Tell Your Doctor or Pharmacist. You Can Report Side Effects Directly to the Department of Drug Safety Monitoring 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. You Can Also Report Side Effects to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide More Information on the Safety of this Medication.

5. How to Store Monkasta

Keep the Medication Out of Sight and Reach of Children. Do Not Use this Medication After the Expiration Date Stated on the Blister Pack and Carton After EXP. The Expiration Date Refers to the Last Day of the Month. Store in the Original Package to Protect from Light. Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Required. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Monkasta Contains

• The Active Substance is Montelukast. Each Film-Coated Tablet Contains 10 mg of Montelukast (as Montelukast Sodium).
• The Other Ingredients are: Cellulose (Lactose Monohydrate, Cellulose, Powder), Microcrystalline Cellulose, Sodium Carboxymethylcellulose, and Magnesium Stearate in the Tablet Core, and Hypromellose 6 cP (E 464), Titanium Dioxide (E 171), Talc, Propylene Glycol, Iron Oxide Red (E 172), and Iron Oxide Yellow (E 172) in the Tablet Coating (Opadry Orange 03H32599). See Section 2 "Monkasta Contains Lactose and Sodium".

What Monkasta Looks Like and Contents of the Package

The Film-Coated Tablets are Apricot-Colored, Round, Slightly Biconvex with Beveled Edges. Package: 28 and 90 Film-Coated Tablets in Blister Packs, in a Carton.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
To Obtain More Detailed Information on the Names of the Medication in Other EU Member States and the UK (Northern Ireland), Contact the Local Representative of the Marketing Authorization Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500
Date of Last Revision of the Package Leaflet:07.02.2024