MONTELUKAST RATIOPHARM 4 mg CHEWABLE TABLETS

2. What you need to know before your child takes Montelukast ratiopharm 4 mg Chewable Tablets

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

Do not give Montelukast ratiopharm 4 mg Chewable Tablets to your child:

• If they 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 giving Montelukast ratiopharm 4 mg Chewable Tablets to your child.

• If your child's asthma or breathing worsens, inform their doctor immediately.
• Montelukast ratiopharm 4 mg Chewable Tablets is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your child's 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 ratiopharm should not be used instead of other asthma medications prescribed by your child's doctor.
• 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 make their asthma worse.

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 ratiopharm 4 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 need to take/use any other medicine, including those obtained without a prescription.

Some medicines may affect the functioning of Montelukast ratiopharm Chewable Tablets or montelukast may affect the functioning of other medicines your child is using.

Before taking Montelukast ratiopharm Chewable Tablets, 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 ratiopharm 4 mg Chewable Tablets with food and drinks

Montelukast ratiopharm 4 mg Chewable Tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after food.

Pregnancy, breastfeeding, and fertility

This subsection is not applicable to Montelukast ratiopharm 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 ratiopharm 4 mg 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 ratiopharm 4 mg Chewable Tablets 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 very rarely 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 1 mmol of sodium (23 mg) per chewable tablet; this is, essentially "sodium-free".

3. How to take Montelukast ratiopharm 4 mg Chewable Tablets

Follow exactly the administration instructions of this medicine indicated by your child's doctor or pharmacist. 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 chewable tablet of montelukast 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 ratiopharm, 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 ratiopharm 4 mg Chewable Tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after food.

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

For children from 6 to 14 years of age, 5 mg chewable tablets are available.

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

If your child takes more Montelukast ratiopharm 4 mg Chewable Tablets than they should

Seek help from your child's doctor immediately.

In most cases of overdose, no side effects were reported. The symptoms that occurred most frequently reported in overdose in adults and children were

abdominal pain, drowsiness, 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 forget to give Montelukast ratiopharm 4 mg Chewable Tablets to your child

Try to give Montelukast ratiopharm Chewable Tablets 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 forgotten doses.

If your child stops taking Montelukast ratiopharm 4 mg Chewable Tablets

Montelukast ratiopharm 4 mg Chewable Tablets may only treat your child's asthma with continued use.

It is essential that your child continues to take montelukast for as long as 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.

4. Possible side effects

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

In clinical trials with montelukast 4 mg chewable tablets, the adverse reactions 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 tablet 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 that include 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 likelihood 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 infections

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• mood-related changes: 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, fatigue, feeling unwell, 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 patients)

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: 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 4 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. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. 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 ratiopharm 4 mg Chewable Tablets

• The active ingredient 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 glycolate starch Type A (derived from potato) and magnesium stearate.

Appearance of the Product and Package Contents

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

Montelukast ratiopharm 4 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 and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

or

TEVA PHARMA S.L.U.

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

Spain

or

Teva Operations Poland Sp.z.o.o.

Ul. Mogilska 80, Krakow- 31-546 -

Poland

or

Merckle GmbH

Ludwig-Merckle-Str. 3, 89143 Blaubeuren

Germany

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

Portugal: Montelucaste ratiopharm

Spain: Montelukast ratiopharm 4 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/