Montelukast Teva

Package Leaflet: Information for the User

Montelukast Teva, 10 mg, Coated Tablets

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. 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 the Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

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

1. What is Montelukast Teva and What is it Used for

What is Montelukast Teva

Montelukast Teva, Coated Tablets is a Leukotriene Receptor Antagonist, Which Means it Blocks the Action of Substances Called Leukotrienes.

How Montelukast Teva Works

Leukotrienes Cause the Airways in the Lungs to Narrow and Become Inflamed. By Blocking the Action of Leukotrienes, Montelukast Teva, Coated Tablets Relieves Asthma Symptoms and Helps Control Asthma and Relieves Symptoms of Seasonal Allergies (Also Known as Allergic Rhinitis or Hay Fever).

When to Use Montelukast Teva

Your Doctor Has Prescribed Montelukast Teva, Coated Tablets to Treat Asthma, to Prevent Asthma Symptoms During the Day and at Night.

• Montelukast Teva is Used to Treat Patients Aged 15 Years and Older Who Have Not Achieved Adequate Control with Their Current Medications and Require Additional Treatment.
• Montelukast Teva Also Helps Prevent Narrowing of the Airways Caused by Exercise. In Patients with Asthma, Who are Taking Montelukast Teva to Treat Asthma, Montelukast Teva May Also Relieve Symptoms of Seasonal Allergic Rhinitis.

Your Doctor Will Decide How to Take Montelukast Teva, Depending on the Symptoms and Severity of Asthma.

What is Asthma?

Asthma is a Chronic Disease.

• Difficulty Breathing Caused by Narrowing of the Airways. The Narrowing of the Airways Gets Worse and Better in Response to Various Factors.
• Sensitivity of the Airways Reacting to Many Factors, Such as Cigarette Smoke, Pollen, Cold Air, or Exercise.
• Inflammation (Swelling) of the Lining of the Airways.

Asthma Symptoms Include: Coughing, Wheezing, and 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 of the Body Often Caused by Pollen in the Air. Symptoms of Seasonal Allergies May Typically Include: Stuffy Nose, Runny Nose, Itching of the Nose, Sneezing; Tearful, Swollen, Red, and Burning Eyes.

2. Important Information Before Taking Montelukast Teva

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

When Not to Take Montelukast Teva

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

Warnings and Precautions

Before Taking Montelukast Teva, Discuss it with Your Doctor, Pharmacist, or Nurse.

• If Your Asthma Symptoms Get Worse or You Have Difficulty Breathing, See Your Doctor Immediately.
• Montelukast Teva Taken by Mouth is Not Intended for the Treatment of Acute Asthma Attacks. If an Attack Occurs, Follow Your Doctor's Instructions. Always Carry a Rescue Inhaler with You in Case of an Asthma Attack.
• It is Important that You Take All Your Asthma Medications as Prescribed by Your Doctor. Do Not Take Montelukast Teva Instead of Your Other Asthma Medications Prescribed by Your Doctor.
• Remember that if You are Taking Asthma Medications and Experience Symptoms Such as Flu-Like Symptoms, Tingling or Numbness of the Hands or Feet, Worsening of Respiratory Symptoms, and (or) Rash, You Should See Your Doctor.
• You Should Not Take Aspirin or Other Non-Steroidal Anti-Inflammatory Medications (Also Known as NSAIDs) if They Make Your Asthma Symptoms Worse.

Various Neuropsychiatric Events (Such as Changes in Behavior and Mood, Depression, and Suicidal Thoughts) Have Been Reported in Patients of All Ages Taking Montelukast (See Section 4). If You Experience Such Symptoms While Taking Montelukast, Consult Your Doctor.

Children and Adolescents

Do Not Give this Medication to Children Under 15 Years of Age.

For Children and Adolescents Under 18 Years of Age, Other Forms of this Medication are Available, Suitable for the Patient's Age.

Montelukast Teva and Other Medications

Tell Your Doctor or Pharmacist About All Medications You are Currently Taking, or Have Recently Taken, and Those You Plan to Take, Including Those Obtained Without a Prescription.

• 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)

Montelukast Teva with Food and Drink

Montelukast Teva, Coated Tablets can be Taken with or Without Food.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or are Planning to Have a Baby, Ask Your Doctor or Pharmacist for Advice Before Taking this Medication.

Pregnancy

Your Doctor Will Decide Whether You Can Take Montelukast Teva During this Time.

Breastfeeding

It is Not Known Whether Montelukast Teva Passes into Breast Milk.

If You are Breastfeeding or Plan to Breastfeed, Consult Your Doctor Before Taking Montelukast Teva.

Driving and Using Machines

Montelukast is Unlikely to Affect Your Ability to Drive or Use Machines. However, Individual Responses to Medication May Vary. Some Side Effects (Such as Dizziness and Drowsiness), Which Have Been Reported with Montelukast, May Affect Your Ability to Drive or Use Machines.

Montelukast Teva Contains Lactose

If You Have Been Told by Your Doctor that You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking this Medication.

Montelukast Teva Contains Sodium

This Medication Contains Less than 1 mmol (23 mg) of Sodium per Coated Tablet, Which Means it is Essentially Sodium-Free.

3. How to Take Montelukast Teva

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

• Take Only One Montelukast Teva Tablet Once a Day, as Advised by Your Doctor.
• Take the Medication Even if You Do Not Have Asthma Symptoms, and in Case of an Acute Asthma Attack.

Use in Adults and Adolescents Aged 15 Years and Older

The Recommended Dose is One 10 mg Tablet Once Daily, in the Evening.

Make Sure that You are Not Taking Other Medications that Contain the Same Active Ingredient, Montelukast.

This Medication is for Oral Use.

Montelukast Teva can be Taken with or Without Food.

Overdose of Montelukast Teva

Contact Your Doctor Immediately.

In Most Cases of Overdose, No Adverse Effects Have Been Observed.

In Cases of Overdose in Children and Adults, the Most Commonly Observed Symptoms Were: Abdominal Pain, Drowsiness, Increased Thirst, Headache, Vomiting, and Hyperactivity.

Missed Dose of Montelukast Teva

Take Montelukast Teva as Advised by Your Doctor. However, if You Miss a Dose, Return to Your Normal Dosing Schedule - One Tablet Once a Day. Do Not Take a Double Dose to Make Up for the Missed Dose.

Stopping Montelukast Teva

Montelukast Teva is Only Effective in Treating Asthma if Taken Regularly.

It is Important to Continue Taking Montelukast Teva for as Long as Your Doctor Recommends.

This Will Help Keep Your Asthma Under Control.

If You Have Any Further Questions About the Use of this Medication, Ask Your Doctor or Pharmacist.

Montelukast Teva, 4 mg, Chewable Tablets are Available for Children Aged 2 to 5 Years.

Montelukast Teva, 5 mg, Chewable Tablets are Available for Children Aged 6 to 14 Years.

4. Possible Side Effects

Like All Medications, Montelukast Teva can Cause Side Effects, Although Not Everybody Gets Them.

During Clinical Trials with Montelukast Teva 10 mg Coated Tablets, the Most Commonly Reported Side Effects (Which May Occur in More than 1 in 10 People) Considered to be Related to Montelukast Teva Were:

• Abdominal Pain
• Headache. These Symptoms Were Usually Mild and Occurred More Frequently in Patients Taking 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)
• Low Platelet Count
• Changes in Behavior and Mood: Hallucinations, Disorientation, Suicidal Thoughts and Attempts
• Inflammation of the Lungs (Pneumonia)
• Severe Skin Reactions (Erythema Multiforme), Which May Occur Without Warning
• Liver Inflammation (Hepatitis)

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 Infection

Common: May Occur in More than 1 in 100 People

• Diarrhea, Nausea, Vomiting
• Rash
• Fever
• Increased Liver Enzymes

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, Anxiety, Restlessness
• Dizziness, Drowsiness, Tingling or Numbness
• Nosebleeds
• Dry Mouth, Indigestion
• Bruising, Itching, Hives
• Joint or Muscle Pain, Muscle Cramps
• Bedwetting in Children
• Weakness and (or) Fatigue, Feeling Unwell, Swelling

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

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

Very Rare: May Occur in Less than 1 in 10,000 People

• Changes in Behavior and Mood: Obsessive-Compulsive Symptoms, Stuttering
• Painful Red Lumps Under the Skin, Usually on the Shins (Erythema Nodosum)

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in the Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse.

Side Effects can be Reported Directly to the Department of Drug Safety Monitoring 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 Authorization Holder.

By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medication.

5. How to Store Montelukast Teva

Keep this Medication Out of the Sight and Reach of Children.

Do Not Take 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 Stated.

No Special Precautions for Storage Temperature are Required. Store in the Original Package to Protect from Light.

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. Package Contents and Other Information

What Montelukast Teva Contains

• The Active Ingredient is Montelukast. Each Coated Tablet Contains 10.40 mg of Montelukast Sodium, Which is Equivalent to 10 mg of Montelukast.
• The Other Ingredients are: Core: Sodium Lauryl Sulfate, Lactose Monohydrate, Hydroxypropyl Cellulose 75-150 cP, Maize Starch, Sodium Carboxymethylcellulose (Maize) Type A, Magnesium Stearate; Coating: Opadry 20A23676 Yellow Consisting of Hydroxypropyl Cellulose 360-672 mPas, Hypromellose 6 cP, Titanium Dioxide (E171), Yellow Iron Oxide (E172), Red Iron Oxide (E172).

What Montelukast Teva Looks Like and Contents of the Package

Montelukast Teva, 10 mg, Coated Tablets are Beige, Round, Coated Tablets with "93" Engraved on One Side and "7426" on the Other.

Montelukast Teva, 10 mg, Coated Tablets are Available in Packs of 14 and 28 Tablets.

Not All Pack Sizes May be Available in Your Country.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Tel.: (22) 345 93 00

Manufacturer

• 1. Pharmachemie B.V., Swensweg 5, Haarlem, 2031 GA, The Netherlands
• 2. Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
• 3. Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

Austria:

Montelukast ratiopharm 10 mg Film-Coated Tablets

Czech Republic: Montelukast Teva 10mg

Denmark:

Montelukast Teva 10 mg, Film-Coated Tablets

Estonia:

Montelukast Teva

Finland:

Montelukast ratiopharm 10 mg, Film-Coated Tablets

Hungary:

Montelukast Teva 10mg, Film-Coated Tablets

Ireland:

Montelukast Teva 10mg, Film-Coated Tablets

Norway: Montelukast Teva 10 mg, Film-Coated Tablets

Poland:

Montelukast Teva

Portugal: Montelucaste Teva 10 mg

Slovakia:

Montelukast Teva 10 mg

Spain: Montelukast Teva 10 mg, Film-Coated Tablets EFG

Date of Last Revision of the Package Leaflet: August 2024