MONTELUKAST TEVA 5 mg CHEWABLE TABLETS

2. What you need to know before you or your child take Montelukast Teva

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

Do not take Montelukast Teva chewable tablets

• 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 take Montelukast Teva 5 mg chewable tablets.

• If your asthma or breathing or your child's asthma or breathing worsen, inform your doctor or your child's 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 you or your child. Always have your child's or your rescue inhaler medication available for asthma attacks.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast Teva should not be used instead of other asthma medications that your doctor has prescribed for your child.
• • If you or your child are being treated with asthma medications, you should be aware that if you 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, you should consult your doctor or your child's 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.
  • If you or your child have phenylketonuria, you should know 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 you or your child develop these symptoms while taking Montelukast chewable tablets, you should contact your doctor or your child's doctor.

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.

Taking Montelukast Teva with other medicines

Tell your doctor, your child's doctor, or pharmacist if you or your child are taking, have 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.

Before taking Montelukast Teva, 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).
• gemfibrozil (used to treat hypertriglyceridemia, hyperlipidemia, and primary hypercholesterolemia).

Taking Montelukast Teva 5 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

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 unknown whether montelukast chewable tablets appear in breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking montelukast chewable tablets.

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 somnolence) that have been reported with montelukast may affect the patient's ability to drive or operate machines.

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 cases 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; it is essentially "sodium-free".

3. How to take Montelukast Teva

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

• You or your child should only take one montelukast chewable tablet 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 or your child 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 Teva, ensure that neither you nor your child take any other medicine that contains the same active ingredient, 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 you or your child take more Montelukast Teva than you should

Seek help from your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 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, somnolence, thirst, headache, vomiting, and hyperactivity.

If you or your child forget to take Montelukast Teva chewable tablets

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

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

If you or your child stop taking Montelukast Teva chewable tablets

Montelukast may only treat your asthma or your child's asthma if you or your child continue taking it. It is essential that you continue taking montelukast for the time your doctor or your child's doctor prescribes it. 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, your child's doctor, or pharmacist.

For pediatric patients from 2 to 5 years of age, Montelukast Teva 4 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 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 observe 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 may cause difficulty breathing or swallowing
• behavior and 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
• behavior and mood-related changes: hallucinations, disorientation, suicidal thoughts and actions
• inflammation (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that may 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)

• behavior and mood-related changes: sleep disturbances, including nightmares, sleepwalking, irritability, anxiety, stress, agitation
• dizziness, somnolence, tingling/numbness of the extremities
• nosebleeds,
• dry mouth, indigestion
• bruising, itching, urticaria
• muscle or joint pain, muscle cramps
• bedwetting (in children)
• weakness/fatigue, malaise, swelling

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

• behavior and mood-related changes: 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)
• behavior and mood-related changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects:

If you or your child experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: 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 that appears on the blister and on the carton after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C. Keep the blister in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. 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 Teva 5 mg chewable tablets

• The active ingredient is montelukast. Each chewable tablet contains 5.20 mg of montelukast sodium, equivalent to 5 mg of montelukast.
• The other ingredients are: mannitol (E421), sodium lauryl sulfate, hydroxypropyl cellulose, red iron oxide (E172), cherry flavor PHS-143671: maltodextrin (corn) and modified starch E1450, aspartame (E951), sodium carboxymethyl starch (corn) (Type A), and magnesium stearate.

Appearance and packaging of the product

The 5 mg chewable tablets are pink, square-shaped, and engraved with "93" on one side and "7425" on the other.

Montelukast Teva 5 mg chewable tablets are available in packs 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 5mg Kautabletten

Czech Republic: Montelukast Teva 5mg

Denmark: Montelukast Teva

Estonia: Montelukast Teva

Spain: Montelukast Teva 5 mg chewable tablets EFG

Finland: Montelukast ratiopharm 5mg, chewable tablets

Hungary: Montelukast Teva 5mg chewable tablets

Ireland: Montelukast Teva 5mg Chewable Tablets

Latvia: Montelukast Teva

Norway: Montelukast Teva 5mg, chewable tablets

Poland: Montelukast Teva, 5 mg, chewable tablets

Portugal: Montelucaste Teva 5 mg Chewable Tablets

Slovakia: Montelukast Teva 5mg

Date of the last revision of this package 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/