Montelukast Teva

Package leaflet: Information for the user

Montelukast Teva 10 mg film-coated tablets

For adolescents and adults from the age of 15 years
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, because it could be harmful.
• If you experience any side effect, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet. See section 4.

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

1. What Montelukast Teva 10 mg film-coated tablets are and what they are used for

Montelukast Teva 10 mg film-coated tablets are a leukotriene receptor antagonist
that blocks substances called leukotrienes. Leukotrienes cause narrowing and
swelling of the airways in the lungs, also causing allergic symptoms. By blocking
leukotrienes, Montelukast Teva 10 mg film-coated tablets improve asthma symptoms, help control
asthma, and relieve symptoms of seasonal allergies (also known as hay fever or
seasonal allergic rhinitis).
Your doctor has prescribed Montelukast Teva 10 mg film-coated tablets for the treatment of
your asthma, to prevent asthma symptoms both during the day and at night.
Montelukast Teva 10 mg film-coated tablets are used to treat patients aged 15 years and older
whose asthma is not adequately controlled with their current asthma medications and who
require additional therapy.
For patients with both asthma and seasonal allergies, Montelukast Teva 10 mg film-coated tablets
can also provide relief from symptoms of seasonal allergic rhinitis.
Montelukast Teva 10 mg film-coated tablets, in patients aged 15 years and older, help prevent
exercise-induced asthma symptoms.

What is asthma?
Asthma is a long-term condition.
Asthma includes:

• Difficulty breathing due to narrowing of the airways. Airway narrowing worsens and improves in response to various triggers.
• Sensitive airways that react 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 known as hay fever or seasonal allergic rhinitis) are an allergic
response often caused by plant pollens carried in the air, as well as grasses and weeds.
Typical symptoms of seasonal allergies include: stuffy, runny, and itchy nose; sneezing; and
watery, swollen, red, and itchy eyes.

2. What you need to know before taking Montelukast Teva 10 mg film-coated tablets

Do not take Montelukast Teva 10 mg film-coated tablets

• if you are allergic to montelukast sodium 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 Teva 10 mg film-coated tablets.

• It is important that Montelukast Teva 10 mg film-coated tablets are taken daily in the evening as prescribed by your doctor, even when you do not have symptoms or an asthma attack.
• Montelukast Teva 10 mg film-coated tablets must not be used to treat acute asthma attacks. They will not help you in this situation and must not be used for this purpose. If you experience an asthma attack, follow your doctor’s instructions. It is very important to always have your rescue medication readily available. Always carry your emergency inhaled medication for asthma attacks with you.
• If you need inhaled beta-agonists more frequently than usual, contact your doctor as soon as possible.
• It is important that you continue taking all asthma medications prescribed by your doctor. Montelukast Teva 10 mg film-coated tablets must not be used instead of other corticosteroid medications (either oral or inhaled) that you are already taking.
• Patients with aspirin-sensitive asthma who are taking Montelukast Teva 10 mg film-coated tablets must continue to avoid taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you are taking asthma medications, including montelukast, and develop a combination of symptoms such as flu-like symptoms, increasing breathlessness, tingling or reduced sensation in the arms or legs, worsening of lung symptoms and/or skin redness, consult your doctor.

Patients should be aware that various neuropsychiatric events (e.g., changes in behaviour and mood) have been reported in adults, adolescents and children treated with montelukast (see section 4). If you or your child develop such symptoms during treatment with Montelukast Teva 10 mg, you must consult your doctor or your child’s doctor. Montelukast Teva 10 mg film-coated tablets are not recommended for children under 15 years of age.

Other medicines and Montelukast Teva 10 mg film-coated tablets
Montelukast Teva 10 mg film-coated tablets can be taken together with other medicines you may be using for asthma. However, some medicines may interfere with the action of Montelukast Teva 10 mg film-coated tablets, or Montelukast Teva 10 mg film-coated tablets may interfere with the action of other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is particularly important if the other medicines are:

• Phenobarbital (used to treat epilepsy)
• Phenytoin (used to treat epilepsy)
• Rifampicin (used to treat tuberculosis and certain other infections)

Montelukast Teva 10 mg film-coated tablets with food and drink
Montelukast Teva 10 mg film-coated tablets can be taken in the evening with or without food.

Pregnancy, breast-feeding and fertility
Pregnancy
Women who are pregnant, planning to become pregnant, or who might become pregnant should consult their doctor before taking Montelukast Teva 10 mg film-coated tablets.

Breast-feeding
It is not known whether montelukast passes into human milk. If you are breast-feeding or intend to breast-feed, you should consult your doctor before taking Montelukast Teva 10 mg film-coated tablets. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Montelukast Teva 10 mg film-coated tablets are not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary. Some side effects (such as dizziness and somnolence), which have been reported very rarely with montelukast, may affect the ability of some patients to drive or use machinery.

Montelukast Teva 10 mg film-coated tablets contain lactose
Montelukast Teva 10 mg film-coated tablets contain lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Montelukast Teva 10 mg film-coated tablets

Take this medicine exactly as directed by your doctor or pharmacist,
even when you have no symptoms, or during an asthma attack. If you have any doubts, consult your doctor or
pharmacist.
The recommended dose for adults and adolescents aged above 15 years is one 10 mg tablet to be taken once daily in the evening.
Montelukast Teva 10 mg film-coated tablets must not be taken together with other products
containing the same active substance, montelukast.
If you take more Montelukast Teva 10 mg film-coated tablets than you should
It is important not to take too many tablets. If you take too many tablets or think that a
child has taken an overdose, contact immediately the nearest hospital emergency department
or your doctor. Symptoms of overdose may include abdominal pain, drowsiness,
thirst, headache, vomiting and hyperactivity (involuntary movements). Take this leaflet and any remaining tablets with you and show them to the doctor.
If you forget to take Montelukast Teva 10 mg film-coated tablets
If you forget to take a tablet, continue taking the medicine as usual. Do not take a double
dose to make up for the forgotten tablet.
If you stop taking Montelukast Teva 10 mg film-coated tablets
It is important that you continue taking Montelukast Teva 10 mg film-coated tablets for as long as your doctor has prescribed, whether or not you have symptoms, as this will help you control your asthma. Treatment with Montelukast Teva 10 mg film-coated tablets
may only be effective against asthma if you continue taking it.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.
For children aged 2 to 5 years, 4 mg chewable tablets are available.
For children aged 2 to 5 years who have difficulty taking the chewable tablet, a 4 mg granule formulation is available.
For children aged 6 to 14 years, 5 mg chewable tablets are available.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
In clinical studies with montelukast, the most common side effects (which may affect 1 in 10 people),
that may be related to montelukast, were:

• abdominal pain
• headache

Additionally, since the drug has been on the market, the following side effects have been reported:

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
• fever
• rash
• increased levels of liver enzymes

Uncommon (may affect up to 1 in 100 people)

• allergic reactions including rash, swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing
• changes in behaviour and mood: abnormal dreams including nightmares, sleep disorders, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression
• dizziness, drowsiness, tingling/numbness, seizures
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• weakness, fatigue, malaise, swelling due to fluid retention

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

• increased tendency to bleed
• changes in behaviour and mood: tremor
• palpitations

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

• hallucinations, disorientation, suicidal thoughts and behaviour, stuttering
• hepatitis (inflammation of the liver)
• red, painful nodules under the skin, usually on the shins (erythema nodosum), severe skin reactions (erythema multiforme) which may occur without warning
• hepatic eosinophilic infiltration

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported.
You must inform your doctor immediately if you experience one or more of these symptoms.
Ask your doctor or pharmacist if you would like more information about side effects.

Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. 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 Teva 10 mg film-coated tablets

Keep Montelukast Teva out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging. The expiry date refers to the last day of the month.
This medicine requires no special storage conditions. Keep the blister in the outer packaging to protect the medicine from light.
Do not dispose of medicines 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 Teva 10 mg film-coated tablets contain

• The active substance is montelukast sodium, equivalent to 10 mg of montelukast.
• The other ingredients are:

Tablet core: sodium lauryl sulfate, monohydrate lactose, hydroxypropylcellulose, pregelatinized starch (from maize), sodium carboxymethylstarch type A (from maize), magnesium stearate
Coating: Opadry 20A23676 yellow containing hydroxypropylcellulose, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172)

Description of the appearance of Montelukast Teva 10 mg film-coated tablets and package contents
Montelukast Teva 10 mg film-coated tablets are beige, round, film-coated tablets marked with "93" on one side and "7426" on the other side.
Montelukast Teva 10 mg film-coated tablets are available in packs of: 7, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 120 tablets, and in calendar packs of 7, 14, 28, 56, and 98 tablets.
Aluminium/aluminium blister packs
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4 - 20123 Milan
Italy

Manufacturers
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen (Hungary)
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG (United Kingdom)
Pharmachemie B.V.
Swensweg 5, Haarlem, 2031 GA (Netherlands)
Teva Operations Poland Sp. z o.o.,
ul. Mogilska 80, 31-546 Kraków (Poland)
Merckle GmbH
Ludwig-Merckle-Str. 3, 89143 Blaubeuren (Germany)

This patient information leaflet was last approved on