SINGULAIR 5 mg CHEWABLE TABLETS

2. What you need to know before you take Singulair

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

Do not take Singulair

• 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 Singulair.

• If your asthma or breathing or your child's asthma or breathing worsen, tell your doctor immediately.
• Singulair 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 rescue inhaler medication for asthma attacks.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Singulair 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.

Neuropsychiatric events

Consult your doctor immediatelyif you or your child develop any of the following symptoms: changes in behavior and mood, depression, and suicidal tendencies (see section 4).

Children and adolescents

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

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

Other medicines and Singulair

Tell your 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 Singulair works, or Singulair may affect the way other medicines work.

Before taking Singulair, 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 Singulair with food and drinks

Singulair 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 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 Singulair during this period.

Breastfeeding

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

Driving and using machines

Singulair 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 drowsiness) that have been reported with Singulair may affect the patient's ability to drive or operate machinery.

Singulair 5mg chewable tablets contain aspartame, sodium, and benzyl alcohol

This medicine contains 1.5 mg of aspartame in each 5 mg chewable tablet, equivalent to 0.842 mg of phenylalanine. Aspartame contains a source of phenylalanine that may be harmful if you or your child have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

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

This medicine contains up to 0.45 mg of benzyl alcohol in each tablet. Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Consult your doctor or pharmacist if you or your child have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause side effects (metabolic acidosis).

3. How to take Singulair

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

• You or your child should only take one Singulair 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 14years of age:

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

If you or your child are taking Singulair, make sure that neither you nor your child take any other product containing the same active ingredient, montelukast.

This medicine is taken orally.

The tablets should be chewed before swallowing.

Singulair 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 Singulair 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, drowsiness, thirst, headache, vomiting, and hyperactivity.

Immediately consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91.562.04.20, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you or your child forget to take Singulair

Try to take Singulair as prescribed. However, if you or your child forget a dose, just resume your usual routine 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 Singulair

Singulair can only treat your asthma or your child's asthma if you or your child continue to take it. It is essential that you continue to take Singulair for as long as your 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 or pharmacist.

4. Possible side effects

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

In clinical trials with Singulair 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 Singulair 10 mg film-coated tablets:

• abdominal pain

These side effects were generally mild and occurred with a higher frequency in patients treated with Singulair than with placebo (a pill that does not contain medicine).

Serious side effects

Consult your doctor immediatelyif you or your child experience any of the following side effects, which may be serious and require urgent medical attention.

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
• behavior and mood 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):

• 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 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 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):

• behavior and mood changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruises, 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):

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

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 leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Singulair

• 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 after EXP. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month indicated.
• Store in the original package to protect from light and moisture.
• 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. Contents of the pack and other information

Composition of Singulair

• The active substance is montelukast. Each chewable tablet contains montelukast sodium equivalent to 5 mg of montelukast.
• The other ingredients are:

mannitol (E-421), microcrystalline cellulose, hypromellose (E-463), red iron oxide (E-172), sodium croscarmellose, cherry flavor that contains benzyl alcohol (E-1519), aspartame (E-951), and magnesium stearate.

Appearance of the product and contents of the pack

Singulair 5 mg chewable tablets are pink, round, biconvex, with SINGULAIR engraved on one side and MSD 275 on the other.

Blister packs in packs of: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140, and 200 tablets.

Blister packs (unit dose) in packs of: 49x1, 50x1, and 56x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Health, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Merck Sharp & Dohme, B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

or

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

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

Austria, Belgium, Denmark, Finland, France, Greece, Spain, Sweden, Germany, Ireland, Italy, Luxembourg, Netherlands, Portugal

Singulair

Date of last revision of this leaflet:04/2023.

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