MONTELUKAST SANDOZ 4 mg GRANULES

2. What you need to know before taking Montelukast Sandoz

Tell your doctor about any allergy or medical problem your child has now or has had.

Do not give Montelukast Sandoz to your child:

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Montelukast Sandoz.

• Montelukast oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given your child. Always keep your child's rescue inhaler medication with them in case of an asthma attack,
• 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 your child's 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 make their asthma worse.
• Patients should be aware that several neuropsychiatric events have been reported with montelukast (e.g., changes in behavior and mood-related) in adults, adolescents, and children (see section 4). If your child develops these symptoms while taking montelukast, they should consult their doctor.

Children and Adolescents

Do not give this medicine to children and adolescents under 6 months.

Other formats of this medicine are available for children under 18 years of age, based on the age range.

Taking Montelukast Sandoz with other medicines

Some medicines may affect the way montelukast works, or montelukast may affect the way other medicines work that your child is taking.

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.

Before taking montelukast, tell your doctor if your child is taking the following medicines:

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

Taking Montelukast Sandoz with food and drinks

Montelukast can be taken with or without food.

Pregnancy and Breastfeeding

This subsection is not applicable to Montelukast Sandoz 4 mg granules for oral suspension, as its use is indicated in children between 6 months and 5 years of age. However, the following information is important for the active substance, montelukast.

Use during pregnancy

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

Use during breastfeeding

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

Driving and using machines

This subsection is not applicable to Montelukast Sandoz 4 mg granules for oral suspension, as its use is indicated in children between 6 months and 5 years of age. However, the following information is important for the active substance, montelukast.

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

Montelukast Sandoz contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per dose; this is essentially "sodium-free".

3. How to take Montelukast Sandoz

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist for your child. In case of doubt, consult your child's doctor or pharmacist again.

• This medicine should be administered to children under adult supervision. Your child should take montelukast every night.
• 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 as their doctor has indicated. Consult your child's doctor or pharmacist if you are unsure.
• It should be taken orally.

The usual dose is:

For children from 6 months to 5 years of age

One sachet of montelukast 4 mg granules for oral suspension should be taken orally every night.

If your child is taking montelukast, make sure they do not take any other medicine that contains the same active substance, montelukast.

For children from 2 to 5 years of age, Montelukast Sandoz 4 mg chewable tablets are available. The formulation of Montelukast Sandoz 4 mg granules for oral suspension is not recommended in children under 6 months of age.

How should I give Montelukast Sandoz to my child?

• Do not open the sachet until the time of use.

• Montelukast can be administered:
• directly into the mouth;
• or mixed with a spoonful of soft cold or at room temperature food (e.g., apple sauce, ice cream, carrots, and rice).
• Mix the entire contents of Montelukast Sandoz in a spoonful of soft cold or at room temperature food, carefully observing that the complete dose is mixed with the food.
• Make sure to administer the entire spoonful of the food/granule mixture to the child immediately (before 15 minutes). IMPORTANT: Never save any leftover food/granule mixture for later use.
• Montelukast granules are not intended to be dissolved in liquids. However, your child can drink liquids after taking the medicine.
• Montelukast can be taken with or without food.

If your child takes more Montelukast Sandoz than they should

If they have taken more Montelukast Sandoz than they should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91562 04 20, indicating the medicine and the amount used.

In most cases of overdose, no side 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 you forget to give Montelukast Sandoz to your child

Try to give montelukast as prescribed. However, if your child misses a dose, just resume the regular schedule of one sachet once a day.

Do not give a double dose to make up for missed 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 the time their doctor prescribes it. It will help control your child's asthma.

If you have any further questions about the use of this medicine, ask your child's doctor or pharmacist.

4. Possible side effects

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

Tell your doctor immediately if your child experiences any of the following serious side effects, as they may need urgent medical attention.

Side effects are uncommon(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,
• mood changes and behavioral changes: restlessness, including aggressive or hostile behavior, depression,
• seizures.

Side effects are rare(may affect up to 1 in 1,000 people):

• increased tendency to bleed,
• tremors,
• palpitations.

Side effects are very rare(may affect up to 1 in 10,000 people):

• reduction of blood platelets (thrombocytopenia),
• behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and actions. Warning signs are, for example, talking about suicide, social withdrawal, desire to be alone, or feeling trapped or desperate about a situation,
• yellowing of the skin and eyes, unusual tiredness, or fever, dark urine color caused by liver inflammation (hepatitis),
• swelling (inflammation) of the lungs,
• a combination of symptoms similar to the flu, tingling or numbness in the arms and legs, worsening of lung symptoms, and/or skin rash (Churg-Strauss syndrome). Tell your doctor immediately if your child experiences one or some of these symptoms,
• severe allergic reactions (erythema multiforme) that can appear without warning.

Clinical trials conducted with montelukast 4 mg granules for oral suspension, 4 mg chewable tablets, 5 mg chewable tablets, or 10 mg tablets, the most frequently reported side effects related to montelukast were:

• headache,
• abdominal pain,
• thirst,

• diarrhea,
• hyperactivity,
• asthma,
• dry and itchy skin,
• skin rash.

These were usually mild and occurred more frequently in patients treated with montelukast than with placebo (a tablet that does not contain medication).

Additionally, while the medicine is on the market, the following side effects have been reported:

Side effects are very common(may affect more than 1 in 10 people):

• upper respiratory tract infection.

Side effects are common(may affect up to 1 in 10 people):

• diarrhea, nausea, and vomiting,
• altered liver test results,
• erythema,
• fever.

Side effects are uncommon(may affect up to 1 in 100 people):

• behavioral and mood changes (sleep disturbances, including nightmares, sleepwalking, irritability, feeling anxious, restlessness,),
• dizziness, drowsiness, tingling/numbness,
• nosebleeds,
• dry mouth, indigestion,
• bruising, itching, urticaria,
• joint or muscle pain, muscle cramps,
• bedwetting in children,
• fatigue, malaise, swelling.

Side effects are rare(may affect up to 1 in 1,000 people):

• loss of attention,
• loss of memory,
• tremors,
• uncontrolled muscle movements.

Side effects are very rare(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 of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 and sachet after EXP. The expiry date is the last day of the month stated.

Store below 25°C.

Keep the medicine in its original packaging to protect it from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Montelukast Sandoz

• The active substance is: montelukast. Each sachet of granules contains montelukast sodium equivalent to 4 mg of montelukast.
• The other ingredients are: mannitol, hydroxypropylcellulose, and magnesium stearate.

Appearance and packaging of the product

White or almost white granules.

Montelukast Sandoz 4 mg granules for oral suspension are packaged in PET/Alu/PE sachets and included in a cardboard box.

Package sizes:

7, 10, 14, 20, 28, 30, and 100 sachets.

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

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek S.A.

Ul. Domaniewska 50C,

02-672 Warszawa

Poland

or

Lek Pharmaceuticals d.d.

Trimlini 2d,

9220 Lendava

Slovenia

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A,

540472 Targu-Mures jud. mures

Romania

or

Lek S.A.

Ul. Podlipie Str.16

95-010 Strykow

Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Montelukast Sandoz 4 mg - Granulat

Slovenia: Mofenstra 4 mg zrnca

Finland: Montelukast Sandoz 4 mg rakeet

Hungary: Montelukast Sandoz 4 mg granulátum

Poland: Montelukast Sandoz

Portugal: Montelucaste Sandoz

United Kingdom: Montelukast Sodium 4 mg Oral Granules

Sweden: Montelukast Sandoz 4 mg granulat

This package leaflet was approved in April 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/