Montelukast Alter

Package leaflet: Information for the patient

MONTELUKAST ALTER 10 mg film-coated tablets

Montelukast
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Montelukast Alter is and what it is used for
2. What you need to know before taking Montelukast Alter
3. How to take Montelukast Alter
4. Possible side effects
5. How to store Montelukast Alter
6. Contents of the pack and other information

1. What Montelukast Alter is and what it is used for

Montelukast Alter is a leukotriene receptor antagonist, meaning it blocks substances known as leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs and also trigger allergic symptoms. By blocking leukotrienes, Montelukast Alter improves asthma symptoms and helps control the condition, as well as improving symptoms of seasonal allergies (also known as hay fever and seasonal allergic rhinitis).
Your doctor has prescribed Montelukast Alter for the treatment of asthma, to prevent its symptoms both during the day and at night.

• Montelukast Alter is used to treat patients whose symptoms are not adequately controlled with their current medications and who require additional therapy.
• Montelukast Alter also prevents exercise-induced narrowing of the airways.
• In asthmatic patients for whom Montelukast Alter is indicated for asthma, it may also provide relief from symptoms of seasonal allergic rhinitis. Your doctor will determine how to use Montelukast Alter based on your symptoms and the severity of your asthma.

Montelukast Alter is indicated in adults aged 15 years and older.
What is asthma?
Asthma is a long-term condition characterized by:

• Difficulty breathing due to narrowing of the airways. This narrowing worsens and improves in response to various triggers;
• Airway hyperresponsiveness to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise;
• Swelling (inflammation) of the airways.

Asthma symptoms include coughing, shortness of breath, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also called hay fever or seasonal allergic rhinitis) are allergic reactions often caused by airborne pollen from trees, grass, and weeds. Typical symptoms of seasonal allergies may include nasal congestion, runny nose, nasal itching, sneezing, and red, swollen, itchy, and watery eyes.

2. What you need to know before taking Montelukast Alter

Inform your doctor of any current or past illnesses and of any allergies.
Do not take Montelukast Alter

• if you are allergic (hypersensitive) 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 taking Montelukast Alter

• If your asthma or breathing worsens, contact your doctor immediately. Montelukast Alter for oral use must not be used to treat acute asthma attacks. If you experience an attack, follow your doctor's instructions. Always keep your emergency inhaled medication for asthma attacks with you.
• It is important that you take all asthma medications prescribed by your doctor.
• Montelukast Alter must not be used instead of other asthma medications prescribed for you by your doctor.
• If you are taking asthma medications, you should know that if you experience a combination of symptoms such as flu-like symptoms, tingling or reduced sensation in the arms or legs, worsening of lung symptoms and/or skin redness or heart problems, you must consult your doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Various neuropsychiatric events (e.g. behavioural and mood changes, depression and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If you develop such symptoms while taking montelukast, you must contact your doctor.
Children and adolescents
This medicine is contraindicated in children and adolescents under 15 years of age.
For children aged 2 to 5 years, 4 mg chewable tablets and 4 mg granules are available.
For children aged 6 to 14 years, 5 mg chewable tablets are available.
Other medicines and Montelukast Alter
Some medicines may interfere with the action of Montelukast Alter, or Montelukast Alter may interfere with the action of other medicines you are taking.
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking the following medicines before starting Montelukast Alter:

• Phenobarbital (used to treat epilepsy)
• Phenytoin (used to treat epilepsy)
• Rifampicin (used to treat tuberculosis and certain other infections)
• Gemfibrozil (used to treat high levels of fats in the blood)

Montelukast Alter with food and drink
Montelukast Alter may be taken in the evening with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant or planning to become pregnant, you should consult your doctor before taking Montelukast Alter.
Your doctor will decide whether or not you may take Montelukast Alter under these circumstances.
Breastfeeding
It is not known whether Montelukast Alter passes into human milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Montelukast Alter.
Driving and using machines
No effects on the ability to drive or operate machinery are expected. However, individual responses to medicines may vary. Some adverse effects (such as dizziness and drowsiness), which have been reported very rarely with Montelukast Alter, may affect the ability to drive and operate machinery.
Montelukast Alter contains lactose
Montelukast Alter contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Montelukast Alter

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor will determine how to use Montelukast Alter depending on your symptoms and the severity of your asthma.
You must take only one tablet of Montelukast Alter per day, as prescribed by your doctor.
The tablet should be taken even if you do not have symptoms or are experiencing an acute asthma attack.
Take the tablet by mouth.

Use in adults from 15 years of age and older
One 10 mg tablet to be taken once daily in the evening.
Make sure you do not take other products containing the same active substance, montelukast.

If you take more Montelukast Alter than you should
Contact your doctor immediately.
In most reported cases of overdose, no adverse effects were observed.
The symptoms most frequently reported with overdose in adults and children include:

• abdominal pain
• drowsiness
• thirst
• headache
• vomiting
• hyperactivity.

If you forget to take Montelukast Alter
Try to take Montelukast Alter as prescribed. However, if you forget to take a tablet, continue taking the medicine as normally scheduled.
Do not take a double dose to make up for the missed tablet.

If you stop taking Montelukast Alter
Treatment with Montelukast Alter can only be effective against asthma if you continue taking it.
It is important to continue taking Montelukast Alter for as long as your doctor has prescribed it. It will help you control your asthma.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
In clinical studies with Montelukast Alter, the side effects considered related to the use of the medicine most commonly reported were:

• abdominal pain
• headache (cephalalgia)
  These side effects were generally mild.

Additionally, the following side effects may occur:
Very common (may affect more than 1 in 10 people)

• upper respiratory tract infection

Common (may affect up to 1 in 10 people)

• diarrhoea, nausea, vomiting
• rash
• fever
• elevated levels of certain blood substances known as serum transaminases (ALT, AST)

Uncommon (may affect up to 1 in 100 people)

• allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause breathing or swallowing difficulties
• changes in behaviour and mood such as dream abnormalities, including nightmares, insomnia, sleepwalking, irritability, feeling anxious, restlessness, agitation, including aggressive behaviour or hostility, depression
• dizziness, drowsiness, tingling sensations, seizures
• nosebleeds
• dry mouth, digestive disturbances
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• weakness/tiredness, malaise, swelling

Rare (may affect up to 1 in 1,000 people)

• increased tendency to bleed
• palpitations
• angioedema, facial swelling, especially around the eyes and mouth
• tremor

Very rare (may affect up to 1 in 10,000 people)

• hallucinations, disorientation, suicidal thoughts and actions

• hepatitis (liver inflammation), hepatic eosinophilic infiltration (liver problems)

• red, painful swellings of the subcutaneous tissue, most commonly on the front of the legs (erythema nodosum), severe skin reactions (erythema multiforme) which may occur without warning

• during treatment of asthmatic patients with montelukast, a combination of symptoms such as an influenza-like illness, tingling or numbness in the arms or legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) has been reported in very rare cases. Patients should inform their doctor immediately if one or more of these symptoms occur

• stuttering.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Montelukast Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Store this medicine in its original packaging to protect it from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Montelukast Alter contains

• The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
• The other components are:
  o Core: Microcrystalline cellulose, Monohydrate lactose, Sodium croscarmellose, Hydroxypropylcellulose (E 463), Magnesium stearate.
  o Coating (Opadry white 03B68903): Titanium dioxide (E 171), Hypromellose (E 464), Talc, Polyethylene glycol.

Description of the appearance of Montelukast Alter and pack sizes
Montelukast Alter 10 mg film-coated tablets are white, round, biconvex, with a diameter of 8 mm.
Blister packs in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer
Laboratori Alter S.r.l. – Via Egadi 7, 20144 Milan, Italy

Manufacturer
Laboratorios Alter, S.A. C/Mateo Inurria 30, 28036 - Madrid, Spain