MONTELUKAST SANDOZ 10 mg FILM-COATED TABLETS

2. What you need to know before taking Montelukast Sandoz

Tell your doctor about any allergies or medical problems you have now or have had.

Do not take Montelukast Sandoz:

• if you are allergic to montelukast or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take montelukast tablets:

• If your asthma or breathing worsens, inform your doctor immediately.

• Montelukast oral tablets are not indicated for the treatment of acute asthma attacks. In case of an attack, follow the instructions provided by your doctor. Always carry your rescue inhaler medication with you in case of an asthma attack.

• It is essential that you or your child take all asthma medications prescribed by your doctor. Montelukast tablets should not be substituted for other asthma medications prescribed by your doctor.

• Patients taking asthma medications should be aware that if they develop a combination of symptoms such as pseudo-flu-like illness, tingling or numbness in the arms or legs, worsening pulmonary symptoms, and/or rash, they should consult their doctor.

• You should not take aspirin or non-steroidal anti-inflammatory drugs (also known as NSAIDs) if they worsen your asthma.

Children and Adolescents

Do not give this medication to children under 15 years of age.

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

Other Medications and Montelukast Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications, including those obtained without a prescription.

Some medications may affect the functioning of montelukast tablets or montelukast tablets may affect the functioning of other medications.

Tell your doctor if you are taking the following medications before starting to take montelukast tablets:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and other infections)
• gemfibrozil (used to treat high plasma lipid levels)

Taking Montelukast Sandoz with Food and Drinks

Montelukast tablets can be taken with or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will indicate if you can take montelukast tablets during this period.

Breastfeeding

It is not known if montelukast tablets are excreted in breast milk. You should consult your doctor before taking montelukast tablets if you are breastfeeding or plan to breastfeed.

Driving and Using Machines

Montelukast tablets are not expected to affect your ability to drive or use machines. However, individual responses to medication may vary. Some side effects (such as dizziness and drowsiness) reported with Montelukast Sandoz 10 mg that may affect some patients' ability to drive or use machines.

Montelukast Sandoz Tablets Contain Lactose and Sodium.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medication.

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

3. How to Take Montelukast Sandoz

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• You should only take one 10 mg montelukast tablet once a day as prescribed by your doctor.
• You should take it even if you do not have symptoms or have an acute asthma attack.

For Adults and Adolescents 15 Years of Age and Older:

The recommended dose is one 10 mg tablet per day in the evening

If you are taking montelukast, make sure you do not take any other medication that contains the same active ingredient, montelukast.

This medication is for oral use.

You can take montelukast with or without food.

Montelukast should not be used in children under 15 years of age due to the high content of the active ingredient.

There are other formulations with suitable concentrations for younger children.

If You Take More Montelukast Sandoz Than You Should

Consult your doctor immediately.

No side effects were reported in most cases of overdose. The most frequent symptoms associated with overdose in adults and children included abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you have taken more Montelukast Sandoz than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If You Forget to Take Montelukast Sandoz

Try to take montelukast as prescribed. However, if you forget a dose, simply resume your usual schedule of one tablet once a day.

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

If You Stop Taking Montelukast Sandoz

Montelukast can only treat your asthma if you continue taking it. It is essential to continue taking montelukast for the entire time prescribed by your doctor. It will help control your asthma.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Consult your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

Side effects are 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,
• changes in behavior and mood: restlessness including aggressive behavior and hostility, depression,
• seizures.

Side effects are rare(may affect up to 1 in 1,000 people):

• increased tendency to bleed,
• tremors,
• seizures.

Side effects are very rare(may affect up to 1 in 10,000 people):

• reduction in blood platelets (thrombocytopenia),
• changes in behavior and mood: hallucinations, disorientation, suicidal thoughts and actions. Warning signs are, for example, talking about suicide, withdrawing from social contact, and wanting to be alone or feeling trapped or desperate about a situation,
• yellowing of the skin and eyes, unusual fatigue or fever, dark urine caused by liver inflammation (hepatitis),
• swelling (inflammation) of the lungs,
• a combination of symptoms with pseudo-flu-like illness, tingling or numbness in the arms and legs, worsening pulmonary symptoms, and/or rash (Churg-Strauss syndrome). You should inform your doctor immediately if your child presents one or more of these symptoms,
• severe skin reactions (erythema multiforme) that can occur without warning.

• In clinical studies with montelukast 4 mg oral granules, 4 mg chewable tablets, 5 mg chewable tablets, or 10 mg film-coated tablets, the side effects that were reported very frequently (may affect up to 1 in 10 people) that could be related to montelukast were: abdominal pain,
• headache,
• thirst.
• diarrhea,
• hyperactivity,
• asthma,
• scaly skin and itching,
• rash.

They were generally mild and occurred more frequently in patients treated with montelukast than in those who received placebo (a pill without medication).

In addition, during the marketing of the medication, the following have been reported:

Side effects are very common(may affect more than 1 in 10 people):

• upper respiratory tract infection.

Side effects are common(may affect up to 1 in 10 people):

• diarrhea, nausea, vomiting,
• abnormalities in liver function tests,
• skin rash,
• fever.

Side effects are uncommon(may affect up to 1 in 100 people):

• changes related to behavior and mood (sleep disturbances, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious),
• dizziness, drowsiness, tingling/numbness,
• nosebleeds,
• dry mouth, indigestion,
• bruising, itching, hives,
• joint or muscle pain, muscle cramps,
• bedwetting in children,
• fatigue, feeling unwell, swelling.

Side effects are rare(may affect up to 1 in 1,000 people):

• tremors,
• attention disorders, memory disorders
• uncontrolled muscle movements.

Side effects are very rare(may affect up to 1 in 10,000 people):

• painful red lumps under the skin, most often on the shins (erythema nodosum),
• stuttering,
• obsessive-compulsive symptoms.

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 Surveillance System for Human Use: https://notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Montelukast Sandoz

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the blister pack and carton after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Keep in the original package to protect from light and moisture.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Collection Point in your pharmacy. If in doubt, ask your doctor or pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Montelukast Sandoz

• The active ingredient is montelukast.

Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.

• The other ingredients are:

Core:lactose monohydrate, hydroxypropylcellulose type EF, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Coating:polyvinyl alcohol, titanium dioxide (E 171), macrogol 400, talc, yellow iron oxide (E 172), and red iron oxide (E 172).

Appearance of the Product and Package Contents

Film-coated tablet, beige, round, biconvex, and smooth on both sides.

The tablets are packaged in OPA/Al/PVC/Al blisters inserted into a carton.

Package sizes: 7, 10, 14, 20, 21, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, 200 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

c/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek S.A.

Ul. Domaniewska 50C

02-672 Warszawa

Poland

or

Lek S.A.

Ul. Podlipie 16

95-010 Strykow

Poland

or

S.C. Sandoz S.R.L.

Str. Livezeni nr. 7A

540472 Targu-Mures Jud. Mures

Romania

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Trimlini 2D,

9220 Lendava

Slovenia

or

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

Date of the Last Revision of this Package Leaflet:May 2024

Other Sources of Information:

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