MONTELUKAST SANDOZ 5 mg CHEWABLE TABLETS

2. What you need to know before taking Montelukast Sandoz

Tell your doctor about any allergies or medical problems your child has now or has had.

Do not give Montelukast Sandoz to your child if

• They are allergic (hypersensitive) to montelukast or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before taking Montelukast Sandoz:

• If your child's asthma or breathing worsens, inform their doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your child's doctor. Always have your child's rescue inhaler medication for asthma attacks.
• It is essential that your child uses all asthma medications prescribed by their doctor. Montelukast should not be used instead of other asthma medications prescribed by their doctor.
• If your child is being treated with asthma medications, be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness of arms or legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen their asthma.

Children and Adolescents

Do not administer this medication to children under 2 years of age.

Other forms of this medication are available for pediatric patients under 18 years of age based on age ranges.

Other Medications and Montelukast Sandoz

Some medications may affect the functioning of Montelukast Sandoz, or Montelukast Sandoz may affect the functioning of other medications your child is using.

Tell your doctor or pharmacist if your child is taking, has recently taken, or may need to take any other medication, including those obtained without a prescription.

Before taking Montelukast Sandoz, tell your doctor if your child is taking 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 plasma lipid levels)

Taking Montelukast Sandoz with Food and Drinks

Montelukast Sandoz 4 mg chewable tablets should not be taken with meals; they should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and Breastfeeding

This subsection is not applicable to Montelukast Sandoz 4 mg chewable tablets, as its use is indicated in children. However, the following information is important for the active ingredient, montelukast.

Use in Pregnancy

Women who are pregnant or plan to become pregnant should consult their doctor before taking montelukast. Their doctor will evaluate whether they can take montelukast during this period.

Use in Breastfeeding

It is unknown whether montelukast appears in breast milk. If breastfeeding or planning to breastfeed, consult your doctor before taking montelukast.

Driving and Using Machines

This subsection is not applicable to Montelukast Sandoz 4 mg chewable tablets, as its use is indicated in children. However, the following information is important for the active ingredient, montelukast.

Montelukast is not expected to affect the ability to drive or operate machinery. However, individual responses to the medication may vary. Certain side effects (such as dizziness and drowsiness) that have been rarely reported with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast Sandoz contains aspartame, azoic red dye (E129), sodium, and sucrose.

This medication contains 1.2 mg of aspartame per chewable tablet. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medication contains azoic dye because it contains red allura. It may cause allergic reactions.

This medication contains less than 1 mmol of sodium (23 mg), which is essentially "sodium-free".

This medication contains sucrose. If your doctor has told you that your child has an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

3. How to Take Montelukast Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• Your child should only take one Montelukast Sandoz tablet once a day, as prescribed by their doctor.
• It should be taken even when your child does not have symptoms or when they have an acute asthma attack.
• Make sure your child always takes Montelukast Sandoz as their doctor has indicated. Consult your child's doctor or pharmacist if you have any doubts.
• It should be taken orally.

The recommended dose is:

For children between 6 and 14 years of age:

One 5 mg chewable tablet should be taken daily in the evening. Montelukast Sandoz 5 mg chewable tablets should not be taken with meals; they should be taken at least 1 hour before or 2 hours after meals. The tablets should be chewed before swallowing.

If your child is taking Montelukast Sandoz, ensure they do not take any other medication containing the same active ingredient.

Montelukast Sandoz 5 mg chewable tablets are not recommended for children under 6 years of age.

• For children between 2 and 5 years, 4 mg chewable tablet and 4 mg granule formulations are available.
• For adolescents over 15 years and adults, 10 mg tablets are available.

If your child takes more Montelukast Sandoz than they should

Contact your child's doctor immediately for help.

In most cases of overdose, no adverse effects were reported. The symptoms that occurred most frequently in overdose in adults and children were: abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If your child has taken more Montelukast Sandoz than they should, consult their doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to give Montelukast Sandoz to your child

Try to give Montelukast Sandoz 5 mg chewable tablets as prescribed. However, if your child forgets a dose, simply resume the usual dosage schedule of one tablet once a day.

Do not give a double dose to make up for forgotten doses.

If your child stops taking Montelukast Sandoz

Montelukast can only treat your child's asthma if they continue taking it.

It is essential that your child continues taking montelukast for as long as their doctor prescribes it. It will help control your child's asthma.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Tell your doctor immediately if you notice any of the following side effects in your child; they may need urgent medical treatment.

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

• allergic reactions, including swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing.
• behavior and mood-related changes: agitation, including aggressive or hostile behavior, depression,
• seizures.

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

• increased risk of bleeding,
• tremors,
• palpitations.

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

• reduction in blood platelets (thrombocytopenia),
• behavior and mood-related changes: hallucinations, disorientation, suicidal thoughts and actions. For example, talking about suicide, withdrawing from social contact and preferring solitude, or feeling trapped and hopeless in a given situation,
• yellowing of the skin and eyes, unusual tiredness or fever, dark urine due to liver inflammation (hepatitis),
• swelling (inflammation) of the lungs,
• cases of a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of lung symptoms, and/or skin rash (Churg-Strauss syndrome) have been reported. You should immediately inform your doctor if your child has one or more of these symptoms.
• severe skin reactions that can occur without warning (erythema multiforme)

In clinical studies with 10 mg film-coated tablets and 4 mg or 5 mg chewable tablets of montelukast, the most frequently reported side effects related to montelukast were:

• abdominal pain
• headache
• thirst
• hyperactivity,
• diarrhea,
• asthma,
• itching and dryness of the skin,
• rash.

These side effects were generally mild and occurred with a higher frequency in patients treated with montelukast than with placebo (a tablet that does not contain medication).

Additionally, since montelukast has been marketed, 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

• diarrhea, nausea, vomiting,
• abnormal liver function test results,
• skin rash,
• fever,

Uncommon: may affect up to 1 in 100 people

• behavior and mood-related changes (sleep disturbances, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, restlessness),
• dizziness, drowsiness, tingling/numbness,
• nosebleeds,
• dry mouth, indigestion,
• bruising, itching, hives,
• joint or muscle pain, muscle cramps,
• bedwetting in children,
• fatigue, malaise, swelling

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

• tremors,
• attention and memory disturbances,
• uncontrolled muscle movements.

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

• painful red lumps under the skin that most frequently appear on the shins (erythema nodosum),
• obsessive-compulsive symptoms,
• stuttering

Reporting Side Effects

If your child experiences any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Montelukast Sandoz

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Montelukast Sandoz

• The active ingredient is montelukast.

Each tablet contains montelukast sodium equivalent to 5 mg of montelukast.

• The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose (E463), red iron oxide (E172), sodium croscarmellose, flavoring (cherry flavor AP0551, cherry aroma TD0990B [contains the azoic dye red allura, E129]), aspartame (E951), and magnesium stearate.

Appearance of the Product and Package Contents

Montelukast Sandoz are pink, round, and engraved with "5" on one side.

The chewable tablets are packaged in OPA/ALU/PVC/ALU or OPA/ALU/PE/ALU blisters and placed in a cardboard box.

Montelukast Sandoz is available in packages of: 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140, 200 chewable tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovškova 57,

1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2 D, 9220

Lendava

Slovenia

or

Lek S.A.

Ul. Domaniewska 50 C,

02-672 Warszawa

Poland

or

Sandoz S.R.L.

Str. Livezeni nr. 7A,

540472 Targu-Mures

Romania

or

Lek, S.A.

Ul Podlipie, 16

95-010 Strykow

Poland

Date of the Last Revision of this Package Leaflet:May 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/