Nolus

Package leaflet: Information for the user

Nolus 10 mg film-coated tablets

Montelukast
Generic medicine
For adults
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 effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this package leaflet:

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

1. What Nolus is and what it is used for

Nolus is a leukotriene receptor antagonist that blocks substances called
leucotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs
and also cause allergy symptoms. By blocking leukotrienes, Nolus improves asthma symptoms
and helps control asthma and also improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Nolus to treat your asthma and to prevent asthma symptoms both during the
day and at night.

• Nolus is used to treat patients whose disease is not adequately controlled with their current medications and who require additional therapy.
• Nolus also helps prevent narrowing of the airways caused by physical exercise.
• In asthmatic patients for whom Nolus is indicated for asthma, Nolus may also provide symptomatic relief of seasonal allergic rhinitis.

Your doctor will determine how Nolus should be used based on your symptoms and the severity of
your asthma.
What is asthma?
Asthma is a long-term condition.
Asthma involves:

• Difficulty breathing due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various triggers.

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• Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or physical exercise.
• Swelling (inflammation) of the 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 an allergic
reaction often caused by airborne plant pollens, grasses, and weeds.
Typical seasonal allergy symptoms include: blocked or runny and itchy nose; sneezing;
watery, swollen, red, and itchy eyes.

2. What you need to know before taking Nolus

Inform your doctor of any illness or allergy you currently have or have had in the past.
Do not take Nolus if you

• are allergic to montelukast, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• If your asthma or breathing worsens, contact your doctor immediately.
• Nolus oral is not to be used for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you. Always carry your inhaled emergency medication for asthma attacks.
• It is important that you or your child take all asthma medications prescribed by your doctor. Nolus must not be used instead of other asthma medications prescribed by your doctor.
• Every patient being treated with asthma medications should be aware that if a combination of symptoms such as flu-like symptoms, tingling or numbness in arms or legs, worsening of lung symptoms and/or skin rash occurs, medical advice must be sought.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.
• If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Various neuropsychiatric events (for example, 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
Nolus 10 mg film-coated tablets are not recommended for use in children and adolescents under 15 years of age.
For children aged 2 to 5 years, Montelukast 4 mg chewable tablets are available.
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For children aged 6 to 14 years, Montelukast 5 mg chewable tablets are available.
Other medicines and Nolus
Some medicines may interfere with the action of Nolus, or Nolus may interfere with the action of other medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking the following medicines before starting to take Nolus:

• 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 lipids in plasma)

Taking Nolus with food and drinks
Nolus 10 mg may be taken with or without food.
Pregnancy and breastfeeding
Use during pregnancy
Women who are pregnant, suspect they may be pregnant, are planning a pregnancy, or are breastfeeding should consult their doctor before taking this medicine. Your doctor will decide whether you can take Nolus under these circumstances.
Use during breastfeeding
It is not known whether Nolus is excreted in human breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Nolus.
Driving and using machines
No effects on the ability to drive or operate machinery are expected. However, individual responses to medicines may vary. Some side effects (such as dizziness and drowsiness), which have been reported very rarely with Nolus, may affect the ability to drive or use machinery in some patients.
Nolus 10 mg film-coated tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.
Nolus contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take Nolus

• You should take only one Nolus tablet once daily as prescribed by your doctor.
• The tablet must be taken even if you have no symptoms or are experiencing an acute asthma attack.
• Always take Nolus exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
• To be taken by mouth.

For adults and adolescents over 15 years of age
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One 10 mg tablet to be taken in the evening. Nolus 10 mg may be taken with or without food.
If you are taking Nolus, make sure you do not take other products containing the same active substance, montelukast.
If you take more Nolus than you should
Contact your doctor immediately.
In most overdose reports, no adverse effects were observed. The most frequently reported symptoms in cases of overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.
If you forget to take Nolus
Try to take Nolus as prescribed. However, if you forget to take a tablet, continue with your usual schedule of one tablet per day.
Do not take a double dose to make up for the missed dose.
If you stop taking Nolus
Nolus can only control your asthma if you continue taking it.
It is important to keep taking Nolus for the entire duration prescribed by your doctor. This will help you control your asthma.
If you have any questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with Nolus 10 mg film-coated tablets, the most commonly reported side effects (in more than 1 in 100 patients but less than 1 in 10 treated patients) considered to be related to the medicine were:

• abdominal pain
• headache

These side effects were generally mild and occurred more frequently in patients treated with Nolus than in those treated with placebo (a tablet containing no active drug).
Additionally, the following side effects have been reported during post-marketing use of the medicine:

Very common (affects at least 1 in 10 people)

• upper respiratory tract infection

Common (affects 1 to 10 in 100 people)

• diarrhoea, nausea, vomiting
• rash
• fever

Uncommon (affects 1 to 10 in 1,000 people)

• allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing

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• changes in behaviour or mood [abnormal dreams, including nightmares, sleep disorders, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression]
• dizziness, somnolence, tingling/numbness, seizures
• nosebleeds
• bruising, itching, urticaria
• dry mouth, indigestion
• muscle or joint pain, muscle cramps
• weakness/tiredness, malaise, swelling

Rare (affects 1 to 10 in 10,000 people)

• increased tendency to bleed
• tremor
• palpitations

Very rare (affects less than 1 in 10,000 people)

• hepatitis (inflammation of the liver)
• red lumps under the skin, most commonly on the legs (erythema nodosum), severe skin reactions (erythema multiforme) which may occur without warning
• hallucinations, disorientation, suicidal thoughts and actions
• stuttering

In asthmatic patients treated with montelukast, a combination of symptoms has been reported very rarely, including flu-like symptoms, tingling or numbness in the arms or legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome). You should contact your doctor immediately if you experience one or more of these symptoms.

Reporting of side effects
If you experience any side effects, 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 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 Nolus

• Keep out of the sight and reach of children.
• Do not use the medicine after the expiry date stated as six digits on the blister after the wording “Expiry”. The first two digits indicate the month and the last four the year. This medicine expires at the end of the indicated month.
• Store in the original packaging to protect from light and moisture.
• 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 Nolus contains
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• The active substance is: montelukast. The 10 mg tablet contains 10.4 mg of montelukast sodium, equivalent to 10 mg of montelukast.
• The other ingredients (excipients) are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, croscarmellose sodium, hydroxypropylcellulose, and magnesium stearate.
  Film coating: polyvinyl alcohol, titanium dioxide, talc, red iron oxide, black iron oxide, yellow iron oxide, lecithin, and xanthan gum.

Description of the appearance of Nolus and pack sizes
Nolus 10 mg tablets are beige, round, biconvex, film-coated tablets.
Pack sizes: 14 and 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Lanova Farmaceutici S.r.l., Via Conca D’oro, 212 – 00141 Rome, Italy

Manufacturer:
Pharmathen S.A.
Dervenakion 6
Pallini 15351, Attiki
Greece
Tel.: +30 210 6664300
Fax: +30 210 6666749
E-mail: [email protected]

Alternative manufacturer for secondary packaging (including batch release without testing):
La.Fa.Re. S.r.l.
Via Sacerdote Benedetto Cozzolino 77
80056 Ercolano (NA) – Italy

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Italy: Nolus

This Patient Information Leaflet was last approved on
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