MONTELUKAST RATIOPHARM 5 mg CHEWABLE TABLETS

2. What you need to know before you or your child take Montelukast ratiopharm 5 mg Chewable Tablets

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

Do not take/give Montelukast ratiopharm 5 mg 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 child's doctor or pharmacist before you or your child take Montelukast ratiopharm 5 mg Chewable Tablets.

• If your or your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast ratiopharm 5 mg Chewable Tablets are 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 rescue inhaler medication available for asthma attacks.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast ratiopharm should not be used in place of other asthma medications that your doctor has prescribed for your child.
• Some patients 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 aspirin or non-steroidal anti-inflammatory drugs (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they worsen your or your child's asthma.

Several neuropsychiatric events (e.g., changes in behavior and mood-related, 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 ratiopharm 5 mg, you should consult your 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 ratiopharm 5 mg Chewable Tablets with other medicines

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

Some medicines may affect the way Montelukast ratiopharm 5 mg Chewable Tablets work, or montelukast may affect the way other medicines work.

Before taking Montelukast ratiopharm 5 mg Chewable Tablets, 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 ratiopharm 5 mg Chewable Tablets with food and drinks

If Montelukast ratiopharm 5 mg Chewable Tablets should not be taken immediately with meals, they should be taken in the evening, 1 hour before or 2 hours after food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 ratiopharm.

Driving and using machines

Montelukast ratiopharm 5 mg is not expected to affect your ability to drive a car or operate machinery. 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 machinery.

Montelukast ratiopharm contains aspartame

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

Aspartame is a source of phenylalanine, which 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 ratiopharm 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 ratiopharm 5 mg Chewable Tablets

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist for you or your child. In case of doubt, 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 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, which should be taken in the evening.

If you or your child are taking Montelukast ratiopharm 5 mg Chewable Tablets, make sure that neither you nor your child take any other product that contains the same active ingredient, montelukast.

This medicine is taken orally.

The tablets should be chewed before swallowing.

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

For children from 2 to 5 years of age, 4 mg chewable tablets are available.

For children from 2 to 5 years of age, with difficulty taking the chewable tablet, a 4 mg granule formulation is available.

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

If you or your child take more Montelukast ratiopharm 5 mg Chewable Tablets than you should

Seek immediate medical attention from your doctor.

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.

Bring this package leaflet, the remaining tablets, and the packaging to the hospital or doctor so they know how many tablets were consumed.

You can also immediately consult your pharmacist or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you or your child forget to take Montelukast ratiopharm 5 mg 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 ratiopharm 5 mg Chewable Tablets

Montelukast ratiopharm 5 mg Chewable Tablets can only treat your or your child's asthma if you or your child continue taking it. It is essential that you or your child continue taking this medicine for as long as your doctor or your child's doctor prescribes it. It will help control your 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 adverse reactions related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• headache
• abdominal pain
• thirst

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

Severe side effects

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

Uncommon (may affect up to 1 in 100 people):

• allergic reactions that include swelling of the face, lips, tongue, and/or throat that can 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, uncontrolled muscle movements
• 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 infections

Common (may affect up to 1 in 10 people)

• diarrhea, nausea, and vomiting
• fever
• skin rash
• increase in liver enzyme levels

Uncommon (may affect up to 1 in 100 people)

• behavior and mood-related changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxiety, agitation
• dizziness, somnolence, tingling/numbness of the extremities
• nosebleeds, dry mouth
• indigestion
• bruising, itching, hives
• muscle or joint pain, muscle cramps
• weakness, fatigue, feeling of general 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 patients)

• red, painful lumps under the skin, which most frequently appear on the shins (erythema nodosum)
• behavior and mood-related changes: attention disturbance, memory disturbance, uncontrolled muscle movements

Reporting of side effects

If you or your child experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast ratiopharm 5 mg Chewable Tablets

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 blister after CAD or EXP. The expiry date is the last day of the month indicated.

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

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Montelukast ratiopharm 5 mg Chewable Tablets

• The active ingredient is montelukast. Each chewable tablet contains 5.20 mg of montelukast sodium, which is equivalent to 5 mg of montelukast.
• The other components are: mannitol (E421), sodium lauryl sulfate, hydroxypropylcellulose, red iron oxide (E172), cherry flavor PHS-143671: maltodextrins (corn) and modified starch E1450, aspartame (E951), sodium glycolate starch Type A (derived from potato) and magnesium stearate.

Appearance of the Product and Packaging Contents

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

Montelukast ratiopharm 5 mg chewable tablets are available in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets.

Aluminum-Aluminum blister packs.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Operations Poland Sp.z.o.o.

Mogilska 80, Krakow- 31-546 -

Poland

or

Merckle GmbH

Ludwig-Merckle-Str. 3, 89143 Blaubeuren

Germany

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

TEVA PHARMA S.L.U.

C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza

Spain

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

Portugal: Montelucaste ratiopharm

Spain: Montelukast ratiopharm 5 mg chewable tablets EFG

Date of the last revision of this leaflet: August 2024

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