Montelukast Sandoz

Package leaflet: Information for the patient

Montelukast Sandoz 10 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist (see section 4).

Contents of this leaflet:

1. What Montelukast Sandoz is and what it is used for
2. What you need to know 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 Montelukast Sandoz is and what it is used for

What Montelukast Sandoz is
Montelukast Sandoz is a leukotriene receptor antagonist that blocks certain substances called leukotrienes.

How Montelukast Sandoz works
Leukotrienes cause narrowing and swelling of the airways in the lungs and also trigger allergic symptoms. By blocking leukotrienes, Montelukast Sandoz improves asthma symptoms, helps control asthma, and relieves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When Montelukast Sandoz should be used
Your doctor has prescribed Montelukast Sandoz to treat your asthma and to prevent asthma symptoms during both day and night.

• Montelukast Sandoz is used for the treatment of adults and adolescents over 15 years of age whose asthma is not adequately controlled with their current medications and who require additional therapy.
• Montelukast Sandoz also helps prevent exercise-induced narrowing of the airways.
• In asthmatic patients for whom the medicine is indicated for asthma, Montelukast Sandoz may also provide symptomatic relief of seasonal allergic rhinitis. Your doctor will determine how Montelukast Sandoz should be used based on your symptoms and the severity of your asthma.

What asthma is
Asthma is a long-term condition.
Asthma includes:

• Breathing difficulties caused by narrowing of the airways. This narrowing worsens and improves in response to various triggers;
• Sensitive airways that react to many stimuli, such as cigarette smoke, pollen, cold air, or physical exercise;
• Swelling (inflammation) of the lining of the airways.

Asthma symptoms include: coughing, shortness of breath, and chest tightness.

What seasonal allergies are
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions often caused by airborne pollen from trees, grasses, and weeds. Symptoms of seasonal allergies typically include: stuffy, runny, and/or itchy nose; sneezing; and watery, swollen, red, and/or itchy eyes.

2. What you need to know before taking Montelukast Sandoz

Talk to your doctor about any medical conditions and allergies you have or have had.
Do not take Montelukast Sandoz

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Montelukast Sandoz.

• If your asthma or breathing worsens, inform your doctor immediately.
• Montelukast Sandoz oral tablets must not be used to treat acute asthma attacks. If an asthma attack occurs, follow your doctor's instructions. Always keep your emergency inhaled asthma medication available.
• It is important that you or your child take all anti-asthma medicines prescribed by your doctor. Montelukast Sandoz must not be used instead of other anti-asthma medicines prescribed by your doctor.
• Every patient taking anti-asthma medicines should be aware that, if they develop a combination of symptoms such as flu-like symptoms, tingling or numbness in arms or legs, worsening of lung symptoms and/or skin rash, they must consult their doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs, or NSAIDs) if these worsen your asthma.
• Patients should be aware that various neuropsychiatric events (e.g., changes in behaviour and mood) have been reported in adults, adolescents and children treated with Montelukast Sandoz (see section 4). If you or your child develops these symptoms while taking Montelukast Sandoz, you must consult your child's doctor.

Children and adolescents
Do not give this medicine to children under 15 years of age.
Different pharmaceutical forms of this medicine are available for paediatric patients under 18 years of age, depending on age.

Other medicines and Montelukast Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interfere with the action of Montelukast Sandoz, or Montelukast Sandoz may interfere with the action of other medicines.
If you are taking any of the following medicines, inform your doctor before taking Montelukast Sandoz:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and certain other infections)
• gemfibrozil (used to treat high lipid levels in plasma).

Montelukast Sandoz with food and drinks
Montelukast Sandoz may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, please consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will decide whether Montelukast Sandoz can be taken during pregnancy.
Breastfeeding
It is not known whether Montelukast Sandoz passes into breast milk. If you are breastfeeding or intend to breastfeed, you must consult your doctor before taking Montelukast Sandoz.
Driving and using machines
Montelukast Sandoz is not expected to affect your ability to drive or operate machinery.
However, individual responses to medicines may vary. Some adverse effects (such as dizziness and drowsiness) reported with Montelukast Sandoz could impair the ability to drive or operate machinery in some patients.
Montelukast Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.

3. How to take Montelukast Sandoz

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Take one tablet of Montelukast Sandoz once daily, as prescribed by your doctor.
• You must continue taking the medicine even when you have no symptoms or during an acute asthma attack.

For adults and adolescents aged 15 years and older
The recommended dose is one 10 mg tablet taken once daily in the evening.
If you are taking Montelukast Sandoz, make sure you do not take other products containing the same active substance (montelukast).
This medicine is for oral use.
You may take Montelukast Sandoz with or without food.
Due to its high active substance content, Montelukast Sandoz must not be used in children under 15 years of age.
Other formulations with lower dosages are available and are more suitable for younger children.

If you take more Montelukast Sandoz than you should
Contact your doctor immediately.
In most overdose cases, no adverse effects have been reported. The most commonly reported symptoms of overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Montelukast Sandoz
Try to take Montelukast Sandoz as prescribed. However, if you miss a dose, simply resume your regular dosing schedule of one tablet once daily.
Do not take a double dose to make up for the missed dose.

If you stop taking Montelukast Sandoz
Montelukast Sandoz can only control your asthma if you continue taking it. It is important that you keep taking Montelukast Sandoz for the entire duration prescribed by your doctor. Montelukast Sandoz will help control your asthma.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you experience any of the following side effects – you may need
urgent medical treatment:
Uncommon (may affect up to 1 in 100 people)

• allergic reactions, including rash, swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing

Very rare (may affect up to 1 in 10,000 people):

• suicidal thoughts and actions. Warning signs include, for example, talking about suicide, withdrawing from social contact and wanting to be alone, or feeling trapped and hopeless in a particular situation
• yellowing of the skin and eyes, unusual tiredness or fever, dark-coloured urine caused by inflammation of the liver (hepatitis)
• a combination of flu-like symptoms, tingling or numbness in arms and legs, worsening of lung symptoms and/or skin rash has been reported (Churg-Strauss syndrome). You must contact your doctor immediately if your child experiences one or more of these symptoms.
• severe skin reactions (erythema multiforme) which may occur without warning

In addition, the following side effects have been reported during clinical trials with both montelukast 10 mg film-coated tablets and 5 mg or 4 mg chewable tablets (occur in up to 1 in 10 people):

• abdominal pain
• headache
• thirst

During clinical trials with montelukast 4 mg oral granules, the most commonly reported side effects (occurring in up to 1 in 10 people) considered related to montelukast were:

• diarrhoea
• hyperactivity
• asthma
• scaly and itchy skin
• rash

These were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a pill containing no active ingredient).
After the medicine was marketed, the following side effects have also been reported:
Very common side effects (may affect more than 1 in 10 people):

• upper respiratory tract infection

Common side effects (may affect up to 1 in 10 people):

• diarrhoea, nausea, vomiting
• abnormal liver function test results
• rash
• fever

Uncommon side effects (may affect up to 1 in 100 people):

• changes in behaviour and mood (abnormal dreams, including nightmares, sleep disorders, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression)
• dizziness, drowsiness, tingling/numbness, seizures
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• fatigue, feeling unwell, swelling

Rare side effects (may affect up to 1 in 1,000 people):

• increased tendency to bleed
• tremor
• attention disorders, memory problems
• palpitations

Very rare side effects (may affect up to 1 in 10,000 people):

• hallucinations, disorientation
• swelling (inflammation) of the lungs
• painful red lumps under the skin, usually on the shins (erythema nodosum)
• stuttering

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
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 stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging, to protect from light and moisture.
Do not dispose of medicines 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 Sandoz contains

• The active substance is montelukast. Each tablet contains 10 mg of montelukast (as montelukast sodium).
• The other components are: Core: monohydrate lactose, hydroxypropylcellulose type EF, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. Coating: hypromellose 6 cps, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172), red iron oxide (E 172).

Description of the appearance of Montelukast Sandoz and package contents
Beige, square-shaped, biconvex film-coated tablets, marked with the number "10" on one side.
Available in OPA/Al/PVC/Al blisters containing:
7, 10, 14, 20, 21, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz SpA, Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturers
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d, Verovskova 57, 1526 Ljubljana, Slovenia
LEK S.A., Ul. Podlipie 16 C, 95 010 Strykow, Poland
Lek Pharmaceuticals d.d, Trimlini 2 D, 9220 Lendava, Slovenia
LEK S.A., Ul. Domaniewska 50, 02-672 Warszawa, Poland
S.C. Sandoz S.R.L., Str. Livezeni nr. 7A, 540472 Targu-Mures, Romania
Sandoz N.V., Medialaan 40 – 1800 Vilvoorde, Belgium

This medicinal product is authorized in the European Economic Area countries under the following names:

Austria: Montelukast Sandoz 10 mg - Filmtabletten
Belgium: Montelukast Sandoz 10 mg filmomhulde tabletten
Czech Republic: Castispir 10 mg
Denmark: Montelukast "Sandoz"
Finland: Montelukast Sandoz 10 mg tabletti, kalvopäällysteinen
France: MONTELUKAST SANDOZ 10 mg, comprimé pelliculé
Greece: MONTELUKAST/SANDOZ
Italy: MONTELUKAST SANDOZ
Lithuania: Mofenstra 10 mg plėvele dengtos tabletės
Norway: Montelukast Sandoz 10 mg tabletter, filmdrasjerte
Netherlands: MONTELUKAST SANDOZ 10 MG, FILMOMHULDE TABLETTEN
Poland: MONTELUKAST SANDOZ, 10 MG, TABLETKI POWLEKANE
Portugal: MONTELUCASTE SANDOZ
United Kingdom: Montelukast 10 mg film-coated tablets
Romania: ASTMASAN 10 mg comprimate filmate
Slovakia: ASTMASAN 10 mg filmom obalené tablety
Slovenia: Mofenstra 10 mg filmsko obložene tablete
Spain: Montelukast Sandoz 10 mg comprimidos recubiertos con película EFG
Hungary: Montelukast Sandoz 10 mg filmtabletta