Montelukast Sandoz

Leaflet attached to the packaging: patient information

Montelukast Sandoz, 10 mg, film-coated tablets

Montelukast

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist (see section 4).

Table of contents of the leaflet:

• 1. What is Montelukast Sandoz and what is it used for
• 2. Important information before taking Montelukast Sandoz
• 3. How to take Montelukast Sandoz
• 4. Possible side effects
• 5. How to store Montelukast Sandoz
• 6. Contents of the pack and other information

1. What is Montelukast Sandoz and what is it used for

What is Montelukast Sandoz

Montelukast Sandoz is a leukotriene receptor antagonist, which inhibits the activity of substances called leukotrienes.

How Montelukast Sandoz works

Leukotrienes cause the airways to narrow and swell, and cause allergy symptoms. By inhibiting the activity of leukotrienes, Montelukast Sandoz relieves the symptoms of asthma, helps control it, and relieves the symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When to use Montelukast Sandoz

Your doctor has prescribed Montelukast Sandoz to treat asthma and prevent its symptoms from occurring during the day and night. Montelukast Sandoz is used in adults and adolescents aged 15 years and older, who have not achieved adequate control of asthma with their current medications and require additional treatment. Montelukast Sandoz also helps prevent narrowing of the airways caused by physical exertion. In patients with asthma, for whom Montelukast Sandoz is indicated, this medicine may also relieve the symptoms of seasonal allergic rhinitis. Your doctor will determine how to use Montelukast Sandoz based on the symptoms and severity of your asthma.

What is asthma?

Asthma is a chronic disease. The picture of asthma includes: difficulty breathing due to narrowing of the airways, which worsens and improves in response to various conditions; sensitivity of the airways to a number of factors, such as cigarette smoke, pollen, cold air, or physical exertion; swelling (inflammation) of the mucous membrane lining the airways. The symptoms of asthma include: coughing, wheezing, and chest tightness.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic reaction to pollen in the air from trees, grasses, and weeds. Typical symptoms of seasonal allergies may include: stuffy nose, runny nose, itchy nose, sneezing, tearing, swelling, redness, and itchy eyes.

2. Important information before taking Montelukast Sandoz

Tell your doctor about all diseases or allergies you have now or have had in the past.

When not to take Montelukast Sandoz

If you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Montelukast Sandoz, discuss it with your doctor or pharmacist. If your asthma worsens or your breathing gets worse, tell your doctor right away. The oral medicine Montelukast Sandoz is not intended for the treatment of acute asthma attacks. In case of an asthma attack, follow the instructions given by your doctor. Always carry your inhaler with you, which is intended for use in asthma attacks. It is important that you (adult or child) take all asthma medications prescribed by your doctor. Do not replace other asthma medications prescribed by your doctor with Montelukast Sandoz. Every patient taking asthma medications should know that if they experience a set of symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening of respiratory symptoms, and/or rash, they should consult a doctor. Do not take aspirin or other non-steroidal anti-inflammatory drugs (also known as NSAIDs) if they worsen your 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 you experience such symptoms while taking montelukast, consult your doctor.

While taking montelukast, if you experience such symptoms, consult your doctor.

Children and adolescents

The medicine should not be used in children under 15 years of age. For these patients (in different age categories), Montelukast Sandoz is available in other forms.

Other medicines and Montelukast Sandoz

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription. Some medicines may affect how Montelukast Sandoz works, or vice versa, Montelukast Sandoz may change the effect of other medicines. Before taking Montelukast Sandoz, tell your doctor about taking the following medicines: phenobarbital (used to treat epilepsy), phenytoin (used to treat epilepsy), rifampicin (used to treat tuberculosis and some other infections), gemfibrozil (a medicine used to lower high blood lipid levels).

Montelukast Sandoz with food and drink

Montelukast Sandoz 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 baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Your doctor will assess whether you can take Montelukast Sandoz during this period. Breastfeeding It is not known whether Montelukast Sandoz passes into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Montelukast Sandoz.

Driving and using machines

Montelukast Sandoz should not affect your ability to drive or use machines, however, the effect of the medicine may vary from person to person. Certain side effects reported during treatment with Montelukast Sandoz, such as dizziness and drowsiness, may affect the ability to drive or use machines in some patients.

Montelukast Sandoz contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially 'sodium-free'.

3. How to take Montelukast Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Take only one tablet of Montelukast Sandoz once daily, as recommended by your doctor. Take the medicine even when you have no symptoms and on days when you have an asthma attack.

Adults and adolescents 15 years and older

The recommended dose is one 10 mg tablet to be taken once daily in the evening. If you are taking Montelukast Sandoz, make sure you do not take any other medicine that contains the same active substance - montelukast. Take the medicine by mouth. The medicine can be taken with or without food. Do not take Montelukast Sandoz in children under 15 years of age due to the high content of the active substance. Other forms of the medicine are available for younger children.

Taking a higher dose of Montelukast Sandoz than recommended

Contact your doctor immediately. In most reports of overdose, no adverse effects were reported. The most common adverse effects reported in association with overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

Missing a dose of Montelukast Sandoz

Try to take Montelukast Sandoz as recommended. If you miss a dose, go back to your normal schedule and take one tablet once daily. Do not take a double dose to make up for a missed tablet.

Stopping treatment with Montelukast Sandoz

Montelukast Sandoz is effective in treating asthma only when taken regularly. It is important to take Montelukast Sandoz for as long as your doctor recommends. This will help control your asthma symptoms. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, contact your doctor immediately, as you may need urgent medical attention.

Rareside effects (may affect up to 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, and seizures. Very rareside effects (may affect up to 1 in 10,000 people): increased risk of bleeding; tremors; palpitations; Very rareside effects (may affect up to 1 in 10,000 people): decreased platelet count (thrombocytopenia); changes in behavior and mood: hallucinations, disorientation, suicidal thoughts and behaviors. Warning signs are, for example, talking about suicide, withdrawal, and wanting to be left alone, or feeling trapped or helpless; yellowing of the skin and eyes, unusual feeling of tiredness or fever, dark urine due to liver inflammation; swelling (inflammation) of the lungs; a set of symptoms such as flu-like symptoms, tingling or numbness of the hands and feet, worsening of respiratory symptoms, and/or rash (Churg-Strauss syndrome). If a child experiences one or more of these symptoms, contact your doctor immediately; severe skin reactions (erythema multiforme), which may occur without warning. The most commonly reported side effects (may affect up to 1 in 10 people) associated with montelukast and reported in clinical trials with the use of 4 mg oral granules, 4 mg or 5 mg chewable tablets, or 10 mg film-coated tablets were: abdominal pain; headache; thirst; diarrhea; hyperactivity; asthma; skin peeling and itching; rash. These side effects were usually mild and occurred more frequently in patients treated with montelukast than in patients receiving placebo (tablets without active substance). In addition, the following side effects have been reported during the post-marketing period: Very commonside effects (may affect more than 1 in 10 people): upper respiratory tract infections; Commonside effects (may affect up to 1 in 10 people): diarrhea, nausea, vomiting; abnormal liver function tests; rash; fever; Uncommonside effects (may affect up to 1 in 100 people): changes in behavior and mood (abnormal dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness); dizziness, drowsiness, feeling of tingling or numbness; nosebleeds; dry mouth, indigestion; bruising, itching, hives; joint or muscle pain, muscle cramps; bedwetting in children; feeling tired, unwell, swelling; Rareside effects (may affect up to 1 in 1,000 people): tremors; attention disorders, memory impairment; uncontrolled movements; Very rareside effects (may affect less than 1 in 10,000 people): tender, red lumps under the skin, most commonly on the shins (erythema nodosum); stuttering; obsessive-compulsive symptoms.

Reporting side effects

If you experience any side effects, including those not listed in this 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 medicine.

5. How to store Montelukast Sandoz

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. Store in the original package 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 Montelukast Sandoz contains

The active substance is montelukast. Each film-coated tablet contains montelukast sodium, which is equivalent to 10 mg of montelukast. The other ingredients are: Core: lactose monohydrate, hydroxypropylcellulose (type EF), microcrystalline cellulose, sodium croscarmellose, magnesium stearate; Coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 400, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Montelukast Sandoz looks like and contents of the pack

Beige, round, biconvex film-coated tablets, smooth on both sides. The film-coated tablets are packaged in blisters made of OPA/ALU/PVC/ALU foil and placed in a carton. The packs contain 28, 30, 60, or 90 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria Manufacturer/Importer Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben, Germany Lek S.A. ul. Domaniewska 50 C 02-672 Warsaw Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia Lek Pharmaceuticals d.d. Trimlini 2D 9220 Lendava, Slovenia S.C. Sandoz, S.R.L. Str. Livezeni nr. 7A 540472 Targu-Mures, Romania Lek S.A. ul. Podlipie 16 95-010 Stryków