MONTELUKAST TEVA 4 mg CHEWABLE TABLETS

2. What you need to know before your child takes Montelukast Teva chewable tablets

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

Do not give Montelukast Teva 4 mg to your child:

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

Warnings and precautions

Consult your child's doctor or pharmacist before giving Montelukast Teva 4 mg chewable tablets to your child.

• If your child's asthma or breathing worsens, inform your doctor immediately.
• 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 available for asthma attacks.
• It is essential that your child uses all asthma medications prescribed by their doctor. Montelukast Teva should not replace other asthma medications prescribed by your doctor for your child.
• If your child is being treated with asthma medications, they 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.
• 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.
• If your child has phenylketonuria, they should be aware that Montelukast Teva chewable tablets contain aspartame, which is a source of phenylalanine. The phenylalanine in the tablets may be harmful to patients with phenylketonuria.

Several neuropsychiatric events (e.g., changes in behavior and mood-related events, depression, and suicidal tendencies)have been reported in patients of all ages treated with montelukast(see section 4). If your child develops these symptoms while taking Montelukast chewable tablets, they should contact their doctor.

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.

Taking Montelukast Teva 4 mg with other medicines

Tell your child's 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 Teva, 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 hypertriglyceridemia, hyperlipidemia, and primary hypercholesterolemia).

Taking Montelukast Teva 4 mg with food and drinks

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

Pregnancy, breastfeeding, and fertility

This subsection is not applicable to Montelukast Teva 4 mg chewable tablets as its use is indicated in children from 2 to 5 years of age.

Driving and using machines

This subsection is not applicable to Montelukast Teva chewable tablets, as its 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 the ability to drive a car or operate machinery in adults. 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 machinery.

Montelukast Teva contains aspartame

This medicine contains 0.5 mg of aspartame in each chewable tablet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Montelukast Teva contains sodium

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

3. How to take Montelukast Teva

Follow exactly the administration instructions of this medicine given by your child's doctor or pharmacist. If you are in 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 Montelukast Teva 4 mg chewable tablet daily, to be taken in the evening.

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

This medicine is taken orally.

The tablets should be chewed before swallowing.

Montelukast should not be taken with food; it should be taken at least 1 hour before or 2 hours after food.

If your child takes more Montelukast Teva than they should

Seek immediate help from your child's doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20.

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 you forget to give Montelukast Teva to your child

Try to give montelukast as prescribed. However, if your child forgets a dose, just resume the usual routine of one chewable tablet once a day. Do not give a double dose to your child to make up for missed doses.

If your child stops taking Montelukast Teva

Montelukast may only treat your child's asthma if they continue to take it. It is essential that your child continues to take 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.

For pediatric patients from 6 to 14 years of age, Montelukast Teva 5 mg chewable tablets are available.

For adult patients 15 years of age and older, Montelukast Teva 10 mg film-coated tablets are available.

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 reported most frequently (may affect up to 1 in 10 people) were:

• abdominal pain
• thirst

In addition, 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 tablet that does not contain any 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 events: excitement including aggressive or hostile behavior, depression
• seizures

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

• increased risk of bleeding
• tremors
• palpitations

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

• 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 events: 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, and vomiting,
• skin rash,
• fever,
• elevated liver enzymes.

Uncommon (may affect up to 1 in 100 people)

• mood-related events: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxiety, stress
• dizziness, drowsiness, tingling/numbness of the limbs
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• muscle or joint pain, muscle cramps
• bedwetting (in children)
• weakness/tiredness, malaise, swelling.

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

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

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

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

Reporting of side effects:

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

5. Storage of Montelukast Teva

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 blister and on the carton after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C. Store the blister in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and further information

Composition of Montelukast Teva 4 mg chewable tablets

• The active substance is montelukast. Each chewable tablet contains 4.16 mg of montelukast sodium, equivalent to 4 mg of montelukast.
• The other ingredients are: mannitol (E421), sodium lauryl sulfate, hydroxypropylcellulose, red iron oxide (E172), cherry flavor PHS-143671: maltodextrins (corn) and modified starch E1450, aspartame (E951), sodium carboxymethylcellulose (corn) (Type A), and magnesium stearate.

Appearance and package contents

The 4 mg chewable tablets are pink, speckled, triangular tablets, engraved with "93" on one side and "7424" on the other.

Montelukast Teva 4 mg chewable tablets are available in pack sizes of 7, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13 (Debrecen) - H-4042

Hungary

or

Pharmachemie B.V.

Swensweg, 5 2031 GA Haarlem

Netherlands

or

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80, 31-546 Krakow

Poland

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

Austria: Montelukast ratiopharm 4mg Kautabletten

Czech Republic: Montelukast Teva

Denmark: Montelukast Teva

Estonia: Montelukast Teva

Spain: Montelukast Teva 4 mg chewable tablets EFG

Finland: Montelukast ratiopharm 4mg, chewable tablets

Hungary: Montelukast Teva 4mg rágótabletta

Ireland: Montelukast Teva 4mg Chewable Tablets

Norway: Montelukast Teva 4mg, tyggetablett

Poland: Montelukast Teva, 4 mg, tablets for chewing and swallowing

Portugal: Montelucaste Teva 4 mg Chewable Tablets

Slovakia: Montelukast Teva 4mg

Date of last revision of this leaflet: August 2024

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