Montelukast sandoz
Poland
Table of Contents
Package leaflet: Information for the patient
Montelukast Sandoz, 10 mg, film-coated tablets
Montelukastum
Please read the entire leaflet before taking this medicine, as it contains important information
for the patient.
- Keep this leaflet so that you can read it again if necessary.
- Consult your doctor or pharmacist if you have any further questions.
- This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
- If any of the adverse effects worsen or if any adverse effects occur that are not listed in this leaflet, inform your doctor or pharmacist (see section 4).
Table of contents:
- What Montelukast Sandoz is and what it is used for
- Important information before taking Montelukast Sandoz
- How to take Montelukast Sandoz
- Possible side effects
- How to store Montelukast Sandoz
- Contents of the pack and other information
1. What Montelukast Sandoz is and what it is used for
What is Montelukast Sandoz
Montelukast Sandoz is a leukotriene receptor antagonist that inhibits the activity of substances called leukotrienes.
How Montelukast Sandoz works
Leukotrienes cause narrowing and swelling of the airways and trigger allergy symptoms. By inhibiting leukotriene activity, Montelukast Sandoz relieves symptoms of bronchial asthma, helps control asthma, and alleviates symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
When to use Montelukast Sandoz
Your doctor prescribes Montelukast Sandoz for the treatment of bronchial asthma and for preventing asthma symptoms during the day and at night.
Montelukast Sandoz is used in the treatment of adults and adolescents aged 15 years and older whose asthma is not adequately controlled with previously used medications and who require additional therapy.
Montelukast Sandoz also helps prevent exercise-induced narrowing of the airways.
In patients with bronchial asthma for whom Montelukast Sandoz is indicated, the medicine may also relieve symptoms of seasonal allergic rhinitis.
Your doctor will determine how to use Montelukast Sandoz based on your symptoms and the severity of bronchial asthma.
What is bronchial asthma?
Asthma is a chronic disease.
The clinical picture of asthma includes:
- Breathing difficulties caused by narrowing of the airways. This narrowing worsens and subsides in response to various triggers;
- Increased sensitivity of the airways to various 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.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions to airborne pollen from trees, grasses, and weeds. Typical symptoms of seasonal allergies may include nasal congestion, watery nasal discharge, nasal itching, sneezing, tearing, and eye swelling, redness, and itching.
2. Information before using Montelukast Sandoz
Tell your doctor about any medical conditions or allergies you currently have or have had in the past.
When not to take Montelukast Sandoz
Do not take Montelukast Sandoz if you are allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting Montelukast Sandoz.
If your asthma or breathing worsens, inform your doctor immediately.
Oral Montelukast Sandoz is not intended for the treatment of acute asthma attacks.
If an asthma attack occurs, follow the instructions provided by your doctor. Always keep your inhaler medication for use during asthma attacks.
It is important that you (adult or child) continue taking all asthma medications prescribed by your doctor.
Do not replace other asthma medications prescribed by your doctor with Montelukast Sandoz.
All patients taking asthma medications should know that if they experience a combination of symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening of respiratory symptoms, and/or rash, they should consult their doctor.
Do not take acetylsalicylic acid preparations or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your 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 you experience such symptoms while taking montelukast, consult your doctor.
Children and adolescents
Montelukast Sandoz should not be used in children under 15 years of age.
For these patients, Montelukast Sandoz is available in other formulations suitable for different age groups.
Other medicines and Montelukast Sandoz
Tell your doctor or pharmacist about any other medicines you are currently taking, have recently taken, or plan to take, including medicines obtained without a prescription.
Some medicines may affect how Montelukast Sandoz works, or conversely, Montelukast Sandoz may affect how other medicines work.
Before starting Montelukast Sandoz, inform your doctor if you are taking any of the following medicines:
- phenobarbital (used to treat epilepsy)
- phenytoin (used to treat epilepsy)
- rifampicin (used to treat tuberculosis and certain other infections)
- gemfibrozil (a medicine used to lower high blood lipid levels)
Montelukast Sandoz with food and drink
Montelukast Sandoz can be taken regardless of meals.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Your doctor will assess whether it is safe to take Montelukast Sandoz during this period.
Breastfeeding
It is not known whether Montelukast Sandoz passes into human milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Montelukast Sandoz.
Driving and using machines
Montelukast Sandoz is not expected to affect the ability to drive or operate machinery. However, the effect of the medicine may vary between individuals. Some adverse effects reported during treatment with Montelukast Sandoz, such as dizziness and drowsiness, may affect the ability to drive or operate machinery in some patients.
Montelukast Sandoz contains lactose and sodium
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet; therefore, this medicine is considered "sodium-free."
3. How to use Montelukast Sandoz
This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
contact your doctor or pharmacist.
Take only one tablet of Montelukast Sandoz once daily, as prescribed by your doctor.
This medicine should be taken even when no symptoms are present and on days when an asthma attack occurs.
Adults and adolescents aged 15 years and older
The recommended dose is one tablet (10 mg) daily, taken in the evening.
If you are taking Montelukast Sandoz, make sure you are not taking any other medicine containing the same active substance—montelukast.
This medicine should be taken orally.
Montelukast Sandoz may be taken with or without food.
Montelukast Sandoz should not be used in children under 15 years of age due to the high content of the active substance.
Other dosage forms with appropriate strength are available for younger children.
Taking more Montelukast Sandoz than recommended
Contact your doctor immediately.
In most reports of overdose, no adverse effects were described. The most commonly reported symptoms associated with overdose in adults and children included abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.
If you forget to take a dose of Montelukast Sandoz
Make every effort to take Montelukast Sandoz as directed. If you miss a dose, return to your regular dosing schedule and take one tablet once daily.
Do not take a double dose to make up for a missed tablet.
Stopping Montelukast Sandoz
Montelukast Sandoz is effective in treating asthma only when taken regularly. It is important to continue taking Montelukast Sandoz for as long as your doctor has instructed.
This will help control asthma symptoms.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur,
seek immediate medical advice, as urgent medical attention may be required.
Uncommon adverse reactions (may occur in fewer than 1 in 100 people):
allergic reactions, including swelling of the face, lips, tongue, and (or) throat, which may cause
difficulty breathing or swallowing
changes in behaviour and mood: agitation, including aggressive behaviour or hostility, depression
seizures.
Rare adverse reactions (may occur in fewer than 1 in 1,000 people):
increased tendency to bleed
tremor
palpitations
Very rare adverse reactions (may occur in fewer than 1 in 10,000 people):
reduced platelet count (thrombocytopenia)
changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and behaviour. Warning signs include, for example, talking about suicide, withdrawal and desire to be left alone, or feelings of being trapped or helpless
yellowing of the skin and eyes, unusual tiredness or fever, dark urine due to liver inflammation
swelling (inflammation) of the lungs
a group of symptoms such as flu-like symptoms, tingling or numbness in the hands and feet, worsening of respiratory symptoms and (or) rash (Churg-Strauss syndrome). If a child develops one or more of these symptoms, a doctor should be informed immediately.
severe skin reactions (erythema multiforme), which may occur without warning.
The most commonly reported adverse reactions (may occur in fewer than 1 in 10 people)
associated with the use of montelukast and reported in clinical trials with the 4 mg oral granules, 4 mg or 5 mg chewable tablets, or 10 mg film-coated tablets were:
abdominal pain
headache
excessive thirst
diarrhoea
excessive physical activity
asthma
peeling and itching of the skin
rash.
These reactions were usually mild and occurred more frequently in patients treated with montelukast than in patients receiving placebo (tablets without active ingredient).
Additionally, the following adverse reactions have been reported during the post-marketing period:
Very common adverse reactions (may occur in more than 1 in 10 people):
upper respiratory tract infections
Common adverse reactions (may occur in fewer than 1 in 10 people):
diarrhoea, nausea, vomiting
increased liver enzyme activity
rash
fever
Uncommon adverse reactions (may occur in fewer than 1 in 100 people):
behavioural and mood-related changes (abnormal dreams, including nightmares, difficulty falling asleep, sleepwalking, irritability, feelings of anxiety, psychomotor agitation)
dizziness, drowsiness, tingling/numbness, nosebleeds
dry mouth, indigestion
bruising, itching, urticaria
joint or muscle pain, muscle cramps
nocturnal enuresis in children
weakness, feeling of fatigue, malaise, swelling
Rare adverse reactions (may occur in fewer than 1 in 1,000 people):
changes in behaviour and mood: attention disorders, memory impairment, uncontrolled muscle movements
Very rare adverse reactions (may occur in fewer than 1 in 10,000 people):
tender, red nodules under the skin, most commonly on the shins (erythema nodosum)
stuttering
obsessive-compulsive symptoms
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Montelukast Sandoz
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton after EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C. Store in the original packaging 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. Such measures help protect the environment.
6. Contents of the packaging and other information
What Montelukast Sandoz contains
The active substance is montelukast.
Each coated tablet contains montelukast sodium equivalent to 10 mg of montelukast.
The other ingredients are:
Tablet core: monohydrate lactose, hydroxypropylcellulose (type EF), microcrystalline cellulose,
sodium croscarmellose, magnesium stearate
Coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 400, talc, yellow iron oxide (E 172), red iron oxide (E 172).
What Montelukast Sandoz looks like and contents of the packaging
Beige, round, biconvex coated tablets, smooth on both sides.
Coated tablets are packed in blisters made of OPA/ALU/PVC/ALU foil and placed in a cardboard box.
Packaging contains 28, 30, 60 or 90 coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer/Importer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
S.C. Sandoz, S.R.L.
Str. Livezeni nr. 7A
540472 Targu-Mures, Romania
Lek S.A.
ul. Podlipie 16
95-010 Stryków
For more detailed information about the medicinal product and its names in the countries of the
European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00