MONTELUKAST STADA 5 mg CHEWABLE TABLETS

2. What you need to know before taking Montelukast Stada

Tell your doctor about any allergy or medical problem that you or your child have now or have had.

DO NOT take Montelukast Stada

• If you or your child are 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 you or your child start taking montelukast

• If your asthma or breathing or your child's worsens, inform your doctor immediately.
• Montelukast oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor for you or your child. Always have your asthma rescue medication.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast should not be used instead of other asthma medications that your doctor has prescribed for you or your child.
• Any patient being treated with asthma medications should 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.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they worsen your asthma.

Children and Adolescents

Do not give this medicine to children under 6 years of age.

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

Other Medicines and Montelukast Stada

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or may take any other medicine, including those obtained without a prescription.

Some medicines may affect the way montelukast works, or montelukast may affect the way other medicines work that you are using.

Before taking montelukast, tell your doctor if you or your child are 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 5 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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will assess whether you can take montelukast during this period.

Breastfeeding

It is not known whether montelukast appears in breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking montelukast.

Driving and Using Machines

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

Montelukast Stada contains Aspartame (E951)

This medicine contains 6 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; it is essentially "sodium-free".

3. How to take Montelukast Stada

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• You or your child should only take one chewable tablet of montelukast once a day, as prescribed by your doctor.
• It should be taken even when you or your child do not have symptoms or when you have an acute asthma attack.

For children from 6 to 14 years of age:

The recommended dose is one 5 mg chewable tablet daily in the evening.

If you or your child are taking montelukast, ensure that neither your child nor you take any other medicine that contains the same active ingredient, montelukast.

This medicine is taken orally.

The tablets should be chewed before swallowing.

Montelukast 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

If you or your child take more Montelukast Stada than you should

Seek help from your doctor immediately.

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.

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 ingested.

If you or your child forget to take Montelukast Stada

Try to take montelukast as prescribed. However, if you or your child forget a dose, just resume your usual schedule of one chewable tablet once a day.

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

If you or your child stop taking Montelukast Stada

Montelukast may only treat your asthma or your child's asthma if you or your child continue to take it.

It is essential that you continue taking montelukast for the time your doctor prescribes.

It will help control your asthma or your child's asthma.

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

4. Possible Side Effects

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

In clinical trials with montelukast 5 mg chewable tablets, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• headache

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

• abdominal pain

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 notice any of the following side effects, which may be serious and you or 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 package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their 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 stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light.

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

6. Package Contents and Additional Information

Composition of Montelukast Stada

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

Each chewable tablet contains montelukast sodium, equivalent to 5 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 Package Contents

Montelukast Stada 5 mg chewable tablets are pink, round, biconvex, with "M5" engraved on one face.

Montelukast Stada is available in the following packages:

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 SAN PROSPERO 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

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin

Slovakia

or

SANECA PHARMACEUTICALS, A.S.

Nitranska 100 - Hlohovec - 920 27

Slovakia

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

Austria: Montelukast STADA 5 mg Kautabletten

Belgium: Montelukast Eurogenerics 5 mg kauwtabletten

Czech Republic: Montelukast STADA 5 mg žvýkací tablety

Denmark: Montelukast Stada

Spain: Montelukast Stada 5 mg comprimidos masticables EFG

France: Montelukast EG 5 mg comprimé à croquer

Ireland: Montelair 5 mg chewable tablets

Luxembourg: Montelukast Eurogenerics 5 mg comprimés à croquer

Portugal: Montelucaste Ciclum

Sweden: Montelukast STADA, 5 mg tuggtablett

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

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