Singulair mini

Package leaflet: Information for the user

Singulair Mini, 4 mg, granules
Montelukastum
Please read this leaflet carefully before giving this medicine to your child, because it
contains important information.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If your child experiences any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Singulair Mini is and what it is used for
2. What you need to know before giving Singulair Mini to your child
3. How to take Singulair Mini
4. Possible side effects
5. How to store Singulair Mini
6. Contents of the pack and other information

1. What Singulair Mini is and what it is used for

What Singulair Mini is
Singulair Mini is a leukotriene receptor antagonist that blocks the action of substances called leukotrienes.
How Singulair Mini works
Leukotrienes cause narrowing and swelling of the airways. By blocking the action of leukotrienes, Singulair Mini relieves asthma symptoms and helps control asthma.
When to use Singulair Mini
Your doctor has prescribed Singulair Mini for the treatment of asthma in your child to prevent asthma symptoms during the day and at night.

• Singulair Mini is used in patients aged 6 months to 5 years whose asthma is not adequately controlled with current medications and who require additional therapy.
• Singulair Mini may also be used instead of inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for asthma and who are unable to use inhaled corticosteroids.
• Singulair Mini also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Your doctor will determine how to use Singulair Mini based on your child's symptoms and the severity of asthma.
What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties caused by narrowing of the airways. This narrowing worsens and improves in response to various triggers.
• Airway sensitivity, in which the airways react to many factors, such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the mucous lining of the airways.

Asthma symptoms include coughing, wheezing, and chest tightness.

2. Important information before giving Singulair Mini to a child

You should inform the doctor about any medical conditions and allergies currently present or experienced in the past by the child.

When not to give Singulair Mini to a child

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

Warnings and precautions

Before starting to give Singulair Mini to a child, you should discuss this with the doctor or pharmacist.

• If the child's asthma symptoms worsen or if breathing difficulties occur, contact the doctor immediately.
• The oral medicine Singulair Mini is not intended for the treatment of acute asthma attacks. If such an attack occurs, follow the doctor's instructions. Always keep a reliever inhaler available for immediate use in case of an asthma attack in the child.
• It is important that the child takes all asthma medications prescribed by the doctor. Singulair Mini should not be used instead of other asthma medicines prescribed for the child by the doctor.
• Remember that if the child experiences any of the following symptoms while taking asthma medications—flu-like symptoms, tingling or numbness in the hands or feet, worsening respiratory symptoms and/or rash—contact the doctor.
• Do not give the child acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs), if they worsen the child's asthma symptoms.

Various neuropsychiatric events (for example, changes in behaviour and mood, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur in a patient while taking montelukast, consult a doctor.

Children and adolescents

Do not use this medicine in children under 6 months of age.

Other formulations of this medicine, appropriate for the patient's age, are available for children and adolescents under 18 years of age.

Singulair Mini and other medicines

Tell the doctor or pharmacist about all medicines currently or recently given to the child, as well as any medicines that may be given in the future, including those available without a prescription.

Some medicines may affect the action of Singulair Mini, or Singulair Mini may affect the action of other medicines taken by the child.

Before starting Singulair Mini, inform the doctor if the child is taking any of the following medicines:

• phenobarbital (used in the treatment of epilepsy)
• phenytoin (used in the treatment of epilepsy)
• rifampicin (used in the treatment of tuberculosis and certain other infections)

Singulair Mini with food and drink

Singulair Mini granules can be taken independently of meal times.

Pregnancy and breastfeeding

This section does not apply to Singulair Mini 4 mg granules, as this medicine is intended for use in children aged 6 months to 5 years.

Driving and operating machinery

This section does not apply to Singulair Mini 4 mg granules, as this medicine is intended for use in children aged 6 months to 5 years. However, the following information is relevant regarding the active substance—montelukast.

Singulair Mini is not expected to affect the ability to drive or operate machinery. Nevertheless, individual responses to the medicine may vary. Some adverse effects (such as dizziness and drowsiness) reported during the use of Singulair Mini may affect the ability to drive or operate machinery.

Singulair Mini contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per sachet; therefore, the medicine is considered "sodium-free".

3. How to use Singulair Mini

This medicine should always be given to the child according to the doctor's or pharmacist's instructions. If in doubt, consult the child's doctor or pharmacist.

• This medicine should be administered under the supervision of an adult. Singulair Mini should be given to the child once daily in the evening.
• This medicine should be taken even when the child does not have asthma symptoms, and also during an acute asthma attack.

Use in children aged 6 months to 5 years:
The recommended dose is one 4 mg sachet of Singulair Mini granules taken orally once daily in the evening.
Ensure that the child taking Singulair Mini is not also taking other medicines containing the same active substance, montelukast.

How should Singulair Mini granules be administered to a child?
This medicine is intended for oral use.

• Open the sachet immediately before administration.
• Singulair Mini granules may be given:
  • directly by mouth;
  • OR mixed with one spoonful of soft food (such as apple puree, ice cream, carrots with rice), cold or at room temperature.
• Mix the entire contents of the Singulair Mini granules with one spoonful of soft food, cold or at room temperature, ensuring that the full dose is thoroughly mixed with the food. After mixing the granules with food, the entire dose should be administered immediately (within 15 minutes). IMPORTANT: Do not store the granules mixed with food for later use.
• Singulair Mini granules are not intended to be dissolved in liquid. However, the granules may be followed by a drink of liquid.
• Singulair Mini granules may be taken regardless of meal times.

Accidentally taking more Singulair Mini than recommended
Contact the doctor immediately.
In most cases of overdose, no adverse effects have been observed.
In cases of overdose in children and adults, the most commonly observed symptoms include: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

If a dose of Singulair Mini is missed
Singulair Mini should be taken as directed by the doctor. However, if the child misses a dose, resume the regular dosing schedule—once daily, one sachet.
Do not give a double dose to make up for the missed dose.

Stopping Singulair Mini treatment
Singulair Mini is effective in treating asthma in children only when taken regularly. It is important to continue giving Singulair Mini to the child for as long as the doctor has recommended. This will help keep the child's asthma under control.

If you have any further questions about the use of this medicine in children, consult the 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 Mini granules 4 mg, the most commonly reported side effects (which may occur in less than 1 in 10 people), considered to be related to taking Singulair Mini, were:

• diarrhoea
• hyperkinesia (increased motor activity)
• asthma
• skin peeling and itching
• rash

Additionally, in clinical trials with Singulair 10 mg film-coated tablets and 5 mg or 4 mg chewable tablets, the following side effects were reported:

• abdominal pain
• headache
• excessive thirst

These symptoms were usually mild in severity and occurred more frequently in patients taking Singulair than in patients taking placebo (a tablet containing no active medicine).

Serious side effects
Contact a doctor immediately if your child experiences any of the following side effects, which may be serious and may require immediate medical attention.

Uncommon: may occur in less than 1 in 100 people

• allergic reactions, including swelling of the face, lips, tongue and (or) throat, which may cause difficulty in breathing or swallowing
• changes in behaviour and mood: agitation, including aggressive behaviour or hostility, depression
• seizures

Rare: may occur in less than 1 in 1 000 people

• increased tendency to bleed
• tremor
• palpitations

Very rare: may occur in less than 1 in 10 000 people

• a syndrome characterised by symptoms such as flu-like symptoms, tingling or numbness in hands and feet, worsening of respiratory symptoms and (or) rash (Churg-Strauss syndrome) (see section 2)
• decrease in platelet count
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and suicide attempts
• swelling (inflammation) of the lungs
• severe skin reactions (such as erythema multiforme), which may occur without prior symptoms
• hepatitis (inflammation of the liver)

Other side effects reported after the medicine was placed on the market
Very common: may occur in more than 1 in 10 people

• upper respiratory tract infections

Common: may occur in less than 1 in 10 people

• diarrhoea, nausea, vomiting
• rash
• fever
• increased liver enzymes

Uncommon: may occur in less than 1 in 100 people

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling and numbness
• nosebleeds
• dry mouth, dyspepsia (indigestion)
• bruising, itching, urticaria (hives)
• muscle or joint pain, muscle cramps
• nocturnal enuresis (bedwetting) in children
• weakness and (or) fatigue, malaise, oedema (swelling)

Rare: may occur in less than 1 in 1 000 people

• changes in behaviour and mood: attention disorders, memory impairment, uncontrolled muscle movements

Very rare: may occur in less than 1 in 10 000 people

• tender, red nodules under the skin, usually appearing on the shins (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of side effects
If your child experiences any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Singulair Mini medicine

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the sachet after: EXP. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the stated month.
• Do not store above 25°C. Store in the original packaging to protect from light and moisture.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This practice helps protect the environment.

6. Contents of the pack and other information

What Singulair Mini contains

• The active substance is montelukast. Each sachet of granules contains 4 mg of montelukast as montelukast sodium.
• Other ingredients are: mannitol (E 421), hydroxypropylcellulose (E 463) and magnesium stearate.

What Singulair Mini looks like and contents of the pack
Singulair Mini 4 mg granules are white granules.
Packs contain 7, 20, 28 and 30 sachets.
In Poland, the following pack sizes are authorised: 7, 28 and 30 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Manufacturer
Organon Polska Sp. z o.o. Merck Sharp & Dohme B.V.
ul. Marszałkowska 126/134 PO Box 581, Waarderweg 39
00-008 Warsaw 2031 BN Haarlem
Tel.: + 48 22 105 50 01 The Netherlands
e-mail: [email protected]
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania,
Slovenia, Slovakia, Spain, Sweden
Singulair