MONTELUKAST STADA 4 mg CHEWABLE TABLETS

2. What you need to know before taking Montelukast Stada

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

DO NOT give Montelukast Stada to your child

• If he/she is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before giving montelukast to your child

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor for your child. 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 your doctor for your child.
• 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 give this medicine to children under 2 years of age.

For pediatric patients under 18 years of age, other formulations of this medicine are available based on the age range.

Other medicines and Montelukast Stada

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.

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

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)

Taking Montelukast Stada with food and drinks

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

Pregnancy and breastfeeding

This subsection is not applicable to montelukast 4 mg chewable tablets, as their use is indicated in children from 2 to 5 years of age.

Driving and using machines

This subsection is not applicable to montelukast 4 mg chewable tablets, as their use is indicated in children from 2 to 5 years of age. However, the following information is important for the active substance, montelukast.

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

Montelukast Stada contains aspartame (E951)

This medicine contains 4.8 mg of aspartame in each chewable tablet. Aspartame is a source of phenylalanine that may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Montelukast Stada contains sodium

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

3. How to take Montelukast Stada

Follow exactly the administration instructions of this medicine given 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.
• For children who have problems taking a chewable tablet, an oral granule formulation is available.
• Your child should only take one montelukast chewable 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.

For children from 2 to 5 years of age:

The recommended dose is one 4 mg chewable tablet daily in the evening.

If your child is taking Montelukast Stada, ensure they do not take any other medicine that contains the same active ingredient, montelukast.

This medicine is taken orally.

The tablets should be chewed before swallowing.

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

If your child takes more Montelukast Stada than they should

Seek help from your child's doctor immediately.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 5620420, indicating the medicine and the amount taken.

If you forget to give Montelukast Stada to your child

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

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

If your child stops taking Montelukast Stada

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 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.

In clinical trials conducted with montelukast 4 mg chewable tablets, the side effects related to the administration of the medicine and most frequently reported (may affect up to 1 in 10 people) were:

• abdominal pain
• thirst

Additionally, the following side effects were reported in clinical trials with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• headache

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

Serious side effects

Consult your doctor immediatelyif you observe any of the following side effects in your child, which may be serious and your child may need urgent medical treatment.

Uncommon: may affect up to 1 in 100 people

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

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

• increased risk of bleeding
• tremor
• palpitations

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

• 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) (see section 2)
• low platelet count
• mood-related changes: hallucinations, disorientation, suicidal thoughts and actions
• inflammation (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that can occur without warning

• inflammation of the liver (hepatitis)

Other side effects reported during the marketing of the medicine

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
• skin rash
• fever
• elevated liver enzymes

Uncommon: may affect up to 1 in 100 people

• mood-related changes: sleep disturbances, including nightmares, sleep problems, 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)
• weakness/tiredness, malaise, swelling

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

• mood-related changes: attention disturbance, memory disturbance, uncontrolled muscle movements

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)
• mood-related changes: 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 leaflet. You can also report side effects directly via the Spanish Medicines and Health Products Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Stada

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 carton, after EXP. The expiry date is the last day of the month stated.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Montelukast Stada

• The active substance is montelukast (as montelukast sodium).

Each chewable tablet contains montelukast sodium, equivalent to 4 mg of montelukast.

• The other ingredients are: microcrystalline cellulose, mannitol, crospovidone type B, red iron oxide (E172), hydroxypropylcellulose, disodium edetate, cherry flavor, aspartame (E951), talc, and magnesium stearate.

Appearance of the product and contents of the pack

Montelukast Stada 4 mg chewable tablets are pink, oval, biconvex, with "M4" engraved on one side.

Montelukast Stada is available in the following packs:

Nylon/Alu/PVC-Aluminum blisters:

• Blisters (without calendar): 10, 20, 30, 50, 60, 90, 100, and 250 tablets.
• Blisters (without calendar): 7, 14, 28, 56, 98, 126, and 154 tablets.

HDPE bottles:

10, 20, 30, 50, 60, 90, 100, and 250 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 – Sant Just Desvern (Barcelona) Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastraße 2 – 18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

LAMP SANPROSPERO S.p.A.

Via della Pace, 25/A

41030 San Prospero (Modena)

Italy

or

Eurogenerics NV/SA

Heizel Esplanade b22

1020 Brussel

Belgium

or

STADA Arzneimittel GmbH

Stada Arzneimittel GmbH Muthgasse 36

1190 Vienna

Austria

or

SANECA PHARMACEUTICALS, A.S.

Nitranska 100 - Hlohovec - 920 27

Slovakia

or

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin

Slovakia

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

Austria: Montelukast STADA 4 mg Kautabletten

Belgium: Montelukast Eurogenerics 4 mg kauwtabletten

Czech Republic: Montelukast STADA 4 mg žvýkací tablety

Denmark: Montelukast Stada

Spain: Montelukast Stada 4 mg comprimidos masticables EFG

Ireland: Montelair 4 mg chewable tablets

Luxembourg: Montelukast Eurogenerics 4 mg comprimés à croquer

Portugal: Montelucaste Ciclum

Sweden: Montelukast STADA, 4 mg tuggtablett

Date of last revision of this leaflet:March 2024

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