Montelukast Sandoz GmbH

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Montelukast Sandoz GmbH 4 mg chewable tablets

Generic medicine
Please read this leaflet carefully before giving this medicine to your child
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 your child only. Do not give it to other people. This medicine could be harmful, even if their symptoms are the same as your child's.
• If your child experiences any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Montelukast Sandoz GmbH is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Sandoz GmbH improves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast Sandoz GmbH to treat your child's asthma and to prevent its symptoms during the day and night.

• Montelukast Sandoz GmbH 4 mg is used to treat patients aged 2 to 5 years who are not adequately controlled with their current medications and require additional therapy.
• Montelukast Sandoz GmbH 4 mg may also be used as an alternative to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids and who have been shown unable to use inhaled corticosteroids.
• Montelukast Sandoz GmbH 4 mg also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older. Your doctor will determine how to use Montelukast Sandoz GmbH based on your child's symptoms and the severity of their asthma.

What is asthma?
Asthma is a long-term condition.
Asthma involves:

• breathing difficulty caused by narrowing of the airways. This narrowing worsens and improves depending on various circumstances;
• sensitive airways that react to many stimuli, such as cigarette smoke, pollen, cold air, or physical exercise;
• swelling (inflammation) in the lining of the airways.

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

2. What you should know before taking Montelukast Sandoz GmbH

Inform your doctor of any illness or allergies your child currently has or has previously had.
Do not give Montelukast Sandoz GmbH to your child if

• he or she is allergic (hypersensitive) 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 GmbH.

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast Sandoz GmbH for oral use must not be used to treat acute asthma attacks. If an attack occurs, follow the instructions provided by your doctor for your child. Always keep emergency inhaled medications available for your child's asthma attacks.
• It is important that your child takes all anti-asthma medicines prescribed by the doctor. Montelukast Sandoz GmbH must not be used as a substitute for other anti-asthma medicines prescribed by the doctor.
• If your child is taking anti-asthma medicines, you should know that, if he or she develops a combination of symptoms such as flu-like symptoms, tingling or numbness in arms or legs, worsening of lung symptoms and/or skin rash, you must consult the doctor.
• Your child should avoid taking acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs, or NSAIDs), if these worsen his or her asthma.

Other medicines and Montelukast Sandoz GmbH
Some medicines may interfere with the way Montelukast Sandoz GmbH works, or Montelukast Sandoz GmbH may interfere with the way other medicines work.
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.
If your child is taking any of the following medicines, inform the doctor before administering Montelukast Sandoz GmbH:

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

Montelukast Sandoz GmbH with food and drinks
Montelukast Sandoz GmbH must not be taken at the same time as food; it should be taken at least one hour before or two hours after eating.
Pregnancy and breastfeeding
This section does not apply to Montelukast Sandoz GmbH, as it is intended for use in children aged 2 to 5 years. However, the following information refers to the active substance, montelukast.
Use during pregnancy
Women who are pregnant or planning to become pregnant should consult their doctor before taking Montelukast Sandoz GmbH. The doctor will decide whether or not Montelukast Sandoz GmbH should be taken during this period.
Use during breastfeeding
It is not known whether Montelukast Sandoz GmbH passes into breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking Montelukast Sandoz GmbH.
Driving and using machines
This section does not apply to Montelukast Sandoz GmbH 4 mg chewable tablets, as it is intended for use in children aged 2 to 5 years. However, the following information refers to the active substance, montelukast.
Montelukast Sandoz GmbH is not expected to affect your ability to drive or operate machinery. However, individual responses to medicines may vary. In some patients, certain very rare side effects (such as dizziness and drowsiness) reported with montelukast could impair the ability to drive or operate machinery.
Montelukast Sandoz GmbH contains aspartame, a source of phenylalanine. This substance may be harmful to patients with phenylketonuria (a rare inherited metabolic disorder).
Montelukast Sandoz GmbH contains the red colourant Allura Red (E129), which may cause allergic reactions.

3. How to take Montelukast Sandoz GmbH

• This medicine should be given to children under the supervision of an adult.
• Your child should take only one tablet of Montelukast Sandoz GmbH once daily, as prescribed by the doctor.
• The tablet should be taken even when the child has no symptoms and also during an acute asthma attack.
• Make sure your child always takes Montelukast Sandoz GmbH exactly as directed by the doctor. If you have any doubts, consult your child’s doctor or pharmacist.
• For oral use only.

Recommended dose:
For children aged 2 to 5 years
One 4 mg chewable tablet to be taken once daily in the evening. Montelukast Sandoz GmbH should not be taken together with food: it should be taken at least one hour before or two hours after eating. The tablets must be chewed before swallowing.
If your child is taking Montelukast Sandoz GmbH, make sure they do not take any other products containing the same active substance (montelukast).
Montelukast Sandoz GmbH is not recommended for children under 2 years of age.

• For children aged 2 to 5 years, 4 mg chewable tablets are available; and 4 mg granules (for children who have difficulty swallowing chewable tablets).
• For children aged 6 to 14 years, 5 mg chewable tablets are available.

If your child takes more Montelukast Sandoz GmbH than they should
Contact your child’s doctor immediately.
In most overdose reports, no adverse effects were observed. The most commonly reported symptoms in cases of overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to give Montelukast Sandoz GmbH to your child
Try to give Montelukast Sandoz GmbH as prescribed. However, if you forget to give a dose, simply continue with the normal dosing schedule of one tablet once daily.
Do not give your child a double dose to make up for a missed dose.

If your child stops taking Montelukast Sandoz GmbH
Montelukast Sandoz GmbH can only treat your child’s asthma if they continue taking it.
It is important that your child continues to take Montelukast Sandoz GmbH for the entire duration prescribed by the doctor. The medicine will help your child control their asthma.
If you have any questions about how to use this medicine, consult your child’s 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 serious side effects – you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

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

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

• increased tendency to bleed (unexplained bruising or bleeding has also been reported).

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, wanting to be alone, or feeling trapped or hopeless in a given situation.
• yellowing of the skin and eyes, unusual tiredness or fever, dark 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 reaction (erythema multiforme) which may appear suddenly.

Other side effects
In clinical studies with both 10 mg film-coated tablets and 5 mg or 4 mg chewable tablets, the following side effects have been reported:

• abdominal pain
• headache
• thirst

These side effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet without active ingredient).
In addition, after the medicine was placed on the market, the following side effects have been reported:

Very common (may affect more than 1 in 10 people):

• upper respiratory tract infection

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

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

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

• changes in behaviour and mood (dream abnormalities, including nightmares, sleep disorders, sleepwalking, irritability, feeling anxious, 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 (may affect up to 1 in 1,000 people):

• tremor
• attention disorders, memory problems
• palpitations

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

• hallucinations, disorientation
• lung inflammation
• soft red nodules under the skin, usually on the shins (erythema nodosum)

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 the following address:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Montelukast Sandoz GmbH

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 packaging after Exp.
The expiry date refers to the last day of the month.
Store in the original packaging to protect from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Montelukast Sandoz GmbH contains

• The active substance is montelukast.

Each tablet contains 4 mg of montelukast (as montelukast sodium).

• The other components are: mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose (E463), red iron oxide (E172), sodium croscarmellose, flavouring (cherry flavour AP0551, cherry Durarome TD0990B [containing allura red, E129]), aspartame (E951) and magnesium stearate.

Description of the appearance of Montelukast Sandoz GmbH and package contents

Montelukast Sandoz GmbH 4 mg chewable tablets are pink to pink mottled, oval-shaped tablets, marked with the number "4" on one side.

Montelukast Sandoz GmbH is available in packages containing:
7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, 200 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH – Biochemiestrasse 10 – 6250 Kundl (Austria)
Representative in Italy: Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturers responsible for batch release
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
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., Van Rooijen Pharma, Schietstandlaan 2 – 2300 Turnhout, Belgium

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria: Montelukast Sandoz 4 mg - Kautabletten
Belgium: Montelukast Sandoz 4 mg - Kauwtabletten
Czech Republic: Castispir 5 mg žvýkací tablety
Germany: Montelukast Sandoz 4 mg Kautabletten
Denmark: Montelukast Sandoz
Spain: Montelukast Sandoz 4 mg comprimidos masticables EFG
Finland: Montelukast Sandoz 4 mg purutabletti
France: Montelukast Sandoz 4 mg, comprimé à croquer
United Kingdom: Montelukast Sandoz 4 mg chewable tablets
Greece: Montelukast/Sandoz
Hungary: Montelukast Sandoz 4 mg rágótabletta
Italy: Montelukast Sandoz GmbH
Lithuania: Mofenstra 4 mg kramtomosios tabletės
Netherlands: Montelukast Sandoz kauwtablet 4 mg, kauwtabletten
Norway: Montelukast Sandoz 4 mg tyggetabletter
Poland: Montelukast Sandoz
Portugal: MONTELUCASTE SANDOZ
Romania: Astmasan 4 mg comprimate masticabile
Sweden: Montelukast Sandoz 4 mg tuggtabletter
Slovenia: Mofenstra 4 mg žvečljive tablete
Slovak Republic: ASTMASAN 4 mg žuvacie tablety

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE PATIENT

Montelukast Sandoz GmbH 5 mg chewable tablets

Generic medicine
Please read this leaflet carefully before giving this medicine to your child
because it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others. This medicine could be harmful, even if the symptoms are the same as those of your child.
• If your child experiences any side effects, including those not listed in this leaflet, consult your child’s doctor or pharmacist. See section 4.

Contents of this leaflet:

7. What Montelukast Sandoz GmbH is and what it is used for
8. What you need to know before taking Montelukast Sandoz GmbH
9. How to take Montelukast Sandoz GmbH
10. Possible side effects
11. How to store Montelukast Sandoz GmbH
12. Contents of the pack and other information

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

Montelukast Sandoz GmbH is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes cause the narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Sandoz GmbH improves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast Sandoz GmbH to treat your child's asthma and to prevent asthma symptoms during both day and night.

• Montelukast Sandoz GmbH 5 mg is used for the treatment of patients aged 6 to 14 years whose disease is not adequately controlled with their current medications and who require additional therapy.
• Montelukast Sandoz GmbH 5 mg may also be used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast Sandoz GmbH 5 mg also helps prevent exercise-induced narrowing of the airways. Your doctor will determine how to use Montelukast Sandoz GmbH based on your child's symptoms and the severity of their asthma.

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

• difficulty breathing, caused by narrowing of the airways. This narrowing worsens and improves depending on various circumstances;
• sensitive airways, which react to many stimuli such as cigarette smoke, pollen, cold air, or physical exercise;
• swelling (inflammation) in the lining of the airways.

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

2. What you need to know before taking Montelukast Sandoz GmbH

Inform your doctor of any illness or allergies your child has or has previously had.
Do not give Montelukast Sandoz GmbH to your child if

• he or she is allergic (hypersensitive) 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 GmbH.

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast Sandoz GmbH for oral use must not be used to treat acute asthma attacks. If an attack occurs, follow the instructions provided by your doctor for your child. Always keep your child's emergency inhaled asthma medications readily available.
• It is important that your child takes all asthma medications prescribed by the doctor. Montelukast Sandoz GmbH must not be used as a substitute for other asthma medications prescribed by the doctor.
• If your child takes asthma medications, you should know that if he or she develops a combination of symptoms such as flu-like symptoms, tingling or numbness in arms or legs, worsening of pulmonary symptoms and/or skin rash, you should consult the doctor.
• Your child should avoid taking acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs, or NSAIDs), if these worsen his or her asthma.

Other medicines and Montelukast Sandoz GmbH
Some medicines may interfere with the effectiveness of Montelukast Sandoz GmbH, or Montelukast Sandoz GmbH may interfere with the effectiveness of other medicines. Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription. If your child is taking any of the following medicines, inform your doctor before administering Montelukast Sandoz GmbH:

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

Montelukast Sandoz GmbH with food and drink
Montelukast Sandoz GmbH should not be taken at the same time as food; it should be taken at least one hour before or two hours after eating.
Pregnancy and breastfeeding
This section does not apply to Montelukast Sandoz GmbH, as it is intended for use in children aged 6 to 14 years. However, the following information refers to the active substance, montelukast.
Use during pregnancy
Women who are pregnant or planning to become pregnant should consult their doctor before taking Montelukast Sandoz GmbH. The doctor will decide whether or not it is appropriate to take Montelukast Sandoz GmbH during this period.
Use during breastfeeding
It is not known whether Montelukast Sandoz GmbH passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking Montelukast Sandoz GmbH.
Driving and using machines
Montelukast Sandoz GmbH is not expected to affect your ability to drive or operate machinery. However, individual responses to medicines may vary. In some patients, certain side effects (such as dizziness and drowsiness), which have been reported very rarely with montelukast, could impair the ability to drive or operate machinery.
Montelukast Sandoz GmbH contains aspartame, a source of phenylalanine. This substance may be harmful to patients with phenylketonuria (a rare inherited metabolic disorder).
Montelukast Sandoz GmbH contains the colour allura red (E129), which may cause allergic reactions.

3. How to take Montelukast Sandoz GmbH

• Your child must take only one tablet of Montelukast Sandoz GmbH once daily, as prescribed by the doctor.
• The tablet should be taken even when your child has no symptoms or during an acute asthma attack.
• Make sure your child always takes Montelukast Sandoz GmbH exactly as directed by the doctor. If you have any doubts, consult your child’s doctor or pharmacist.
• For oral use.

Recommended dose:
For children aged 6 to 14 years
One 5 mg chewable tablet to be taken once daily in the evening. Montelukast Sandoz GmbH should not be taken at the same time as food: it should be taken at least one hour before or two hours after eating. The tablets must be chewed before swallowing.
If your child is taking Montelukast Sandoz GmbH, ensure they do not take other products containing the same active substance (montelukast).
Montelukast Sandoz GmbH 5 mg is not recommended for children under 6 years of age.

• For children aged 2 to 5 years, 4 mg chewable tablets are available.
• For adults and adolescents aged 15 years and older, 10 mg tablets are available.

If your child takes more Montelukast Sandoz GmbH than they should
Contact your child’s doctor immediately.
In most overdose reports, no adverse effects were observed. The most frequently reported symptoms in cases of overdose in adults and children included abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to give your child Montelukast Sandoz GmbH
Try to give Montelukast Sandoz GmbH as prescribed. However, if you forget to give a dose, simply continue with the usual dosage of one tablet once daily.
Do not give your child a double dose to make up for the missed dose.

If your child stops taking Montelukast Sandoz GmbH
Montelukast Sandoz GmbH can only control your child’s asthma if taken regularly.
It is important that your child continues to take Montelukast Sandoz GmbH for the entire duration prescribed by the doctor. The medicine will help your child manage their asthma.
If you have any doubts about using this medicine, consult your child’s doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately if you notice any of the following serious 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 could cause difficulty breathing or swallowing.

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

• increased tendency to bleed (unexplained bruising or bleeding has also been reported).

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 contacts, wanting to be alone, or feeling trapped or 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 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 reaction (erythema multiforme) which may appear suddenly.

Other side effects
In clinical studies with both 10 mg film-coated tablets and 5 mg chewable tablets, the following side effects were reported:

• abdominal pain
• headache.

These effects were generally mild and occurred more frequently in patients treated with Montelukast Sandoz GmbH than in those treated with placebo (a tablet without active ingredient).
In addition, after the medicine was placed on the market, the following side effects have been reported:

Very common (may affect more than 1 in 10 people):

• upper respiratory tract infection

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

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

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

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

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

• tremor
• attention disorders, memory problems
• palpitations

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

• hallucinations, disorientation
• lung inflammation
• soft red lumps under the skin, usually on the shins (erythema nodosum)

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 the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Montelukast Sandoz GmbH

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 packaging after "Exp.".
The expiry date refers to the last day of the month.
Store in the original packaging to protect from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Montelukast Sandoz GmbH Contains

• The active substance is montelukast.

Each tablet contains 5 mg of montelukast (as montelukast sodium).

• The other components are: mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose (E463), red iron oxide (E172), croscarmellose sodium, flavouring (cherry flavour AP0551, cherry Durarome TD0990B [contains Allura Red, E129]), aspartame (E951) and magnesium stearate.

Description of the Appearance of Montelukast Sandoz GmbH and Pack Sizes
Montelukast Sandoz GmbH 5 mg chewable tablets are pink to pink speckled, round tablets, marked with the number "5" on one side.
Montelukast Sandoz GmbH is available in packs containing:
7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, 200 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH – Biochemiestrasse 10 – 6250 Kundl (Austria)
Representative in Italy: Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturers Responsible for Batch Release
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
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., Van Rooijen Pharma, Schietstandlaan 2 – 2300 Turnhout, Belgium

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Montelukast Sandoz 5 mg - Kautabletten
Belgium: Montelukast Sandoz 5 mg - Kauwtabletten
Czech Republic: Castispir 5 mg žvýkací tablety
Germany: Montelukast Sandoz 5 mg Kautabletten
Denmark: Montelukast Sandoz
Spain: Montelukast Sandoz 5 mg comprimidos masticables EFG
Finland: Montelukast Sandoz 5 mg purutabletti
France: Montelukast Sandoz 5 mg, comprimé à croquer
United Kingdom: Montelukast Sandoz 5 mg chewable tablets
Greece: Montelukast/Sandoz
Hungary: Montelukast Sandoz 5 mg rágótabletta
Italy: Montelukast Sandoz GmbH
Lithuania: Mofenstra 5 mg kramtomosios tabletės
Netherlands: Montelukast Sandoz kauwtablet 5 mg, kauwtabletten
Norway: Montelukast Sandoz 5 mg tyggetabletter
Poland: Montelukast Sandoz
Portugal: MONTELUCASTE SANDOZ
Romania: Astmasan 5 mg comprimate masticabile
Sweden: Montelukast Sandoz 5 mg tuggtabletter
Slovenia: Mofenstra 5 mg žvečljive tablete
Slovak Republic: ASTMASAN 5 mg žuvacie tablety