Montelukast Accord

PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast Accord 10 mg film-coated tablets

For adults and adolescents from 15 years of age
Equivalent 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, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Montelukast Accord 10 mg film-coated tablets are and what they are used for
2. What you need to know before taking Montelukast Accord 10 mg film-coated tablets
3. How to take Montelukast Accord 10 mg film-coated tablets
4. Possible side effects
5. How to store Montelukast Accord 10 mg film-coated tablets
6. Contents of the pack and other information

1. What Montelukast Accord 10 mg film-coated tablets is and what it is used for

What Montelukast Accord 10 mg film-coated tablets is
Montelukast Accord 10 mg film-coated tablets is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Montelukast Accord 10 mg film-coated tablets works
Leukotrienes cause narrowing and swelling of the airways in the lungs and also trigger allergy symptoms. By blocking leukotrienes, Montelukast Accord 10 mg film-coated tablets improves asthma symptoms, helps control asthma, and relieves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
When Montelukast Accord 10 mg film-coated tablets should be used
Your doctor has prescribed Montelukast Accord 10 mg film-coated tablets for the treatment of asthma, to prevent asthma symptoms during the day and at night.

• Montelukast Accord 10 mg film-coated tablets is used for the treatment of adult patients and adolescents aged 15 years and older whose asthma is not adequately controlled with their current medications and who require additional therapy.
• Montelukast Accord 10 mg film-coated tablets also helps prevent narrowing of the airways caused by physical exercise.
• In asthmatic patients for whom Montelukast Accord 10 mg film-coated tablets is indicated for asthma, it may also provide symptomatic relief of seasonal allergic rhinitis.

Your doctor will determine how Montelukast Accord 10 mg film-coated tablets should be used based on your symptoms and the severity of your asthma.
.
What is asthma?
Asthma is a long-term condition.
Asthma includes:

• Breathing difficulties due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various triggers.
• Sensitive airways that react to many factors, such as cigarette smoke, pollen, cold air, or physical exercise.
• Swelling (inflammation) of the lining 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 airborne pollen from trees, grass, and weeds. Symptoms of seasonal allergies may typically include: blocked or runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

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

Inform your doctor about any medical condition or allergy you currently have or have had in the past.
Do not take Montelukast Accord 10 mg film-coated tablets

• if you are allergic to montelukast or to any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Montelukast Accord 10 mg film-coated tablets.

• Inform your doctor immediately if your asthma or breathing worsens.
• Montelukast Accord 10 mg film-coated tablets for oral use are not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions provided by your doctor. Always carry your emergency inhaled asthma medication with you.
• It is important that you or your child take all asthma medications prescribed by your doctor. Montelukast Accord 10 mg film-coated tablets must not be used instead of other asthma medications prescribed by your doctor.
• If you are taking asthma medications, be aware that if you develop a combination of symptoms such as flu-like illness, tingling or numbness in the arms or legs, worsening of lung symptoms, and/or skin rash, you should consult your doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also called non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

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 Accord (see section 4). If you develop these symptoms while taking Montelukast Accord, you should consult your doctor.
Children and adolescents
Do not give this medicine to children under 15 years of age.
Different forms of this medicine are available for pediatric patients under 18 years of age, depending on age group.
Other medicines and Montelukast Accord 10 mg film-coated tablets
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.
Some medicines may affect how Montelukast Accord 10 mg film-coated tablets work, or Montelukast Accord 10 mg film-coated tablets may affect how other medicines work.
Before starting Montelukast Accord 10 mg film-coated tablets, inform your doctor if you are currently taking any of the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used to treat high levels of lipids in the plasma)

Montelukast Accord 10 mg film-coated tablets with food and drink
Montelukast Accord 10 mg film-coated tablets can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking Montelukast 10 mg film-coated tablets.
Pregnancy
Your doctor will assess whether you can take Montelukast Accord 10 mg film-coated tablets during this period.
Use during breastfeeding
It is not known whether Montelukast Accord 10 mg film-coated tablets are excreted in human milk. Consult your doctor before taking Montelukast Accord 10 mg film-coated tablets if you are breastfeeding or intend to breastfeed.
Driving and using machines
Montelukast Accord 10 mg film-coated tablets are not expected to affect the ability to drive or use machines. However, individual responses to the medicine may vary. Some adverse effects (such as dizziness and somnolence) reported with Montelukast Accord 10 mg film-coated tablets could affect the ability of some patients to drive or use machines.
Montelukast Accord 10 mg film-coated tablets contain lactose
Montelukast Accord 10 mg film-coated tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

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

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• You must take only one tablet of Montelukast Accord 10 mg film-coated tablets once daily as prescribed by your doctor.
• The tablet should be taken even when you do not have symptoms or during an acute asthma attack.

For adults and adolescents aged 15 years and older:
The recommended dose is one 10 mg tablet taken once daily in the evening.
If you are taking Montelukast Accord 10 mg film-coated tablets, make sure you do not take any other product containing the same active substance, montelukast.
This medicine is for oral use.
Montelukast Accord 10 mg film-coated tablets can be taken with or without food.

If you take more Montelukast Accord 10 mg film-coated tablets than you should
Contact your doctor immediately.
In most reported cases of overdose, no adverse effects were reported. The symptoms most commonly reported with overdose in adults and children included abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Montelukast Accord 10 mg film-coated tablets
Try to take Montelukast Accord 10 mg film-coated tablets as prescribed by your doctor. However, if you forget to take a dose, simply resume your regular dosing schedule of one tablet once daily. Do not take a double dose to make up for the missed dose.

If you stop taking Montelukast Accord 10 mg film-coated tablets
Montelukast Accord 10 mg film-coated tablets will only control your asthma if you continue taking the medicine.
It is important to continue taking Montelukast Accord 10 mg film-coated tablets for the period prescribed by your doctor. This will help control your asthma.
If you have any questions about the use of this medicine, consult 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 Accord 10 mg film-coated tablets, the side effects considered related to Montelukast most commonly reported (may affect up to 1 in 10 people) were:

• abdominal pain
• headache

These were usually mild and occurred more frequently in patients treated with Montelukast than in those treated with placebo (a tablet containing no active substance).

Serious side effects
Speak to your doctor immediately if you notice any of the following side effects, which may be serious and for which urgent medical treatment may be required.

Uncommon: the following may affect up to 1 in 100 people

• allergic reactions, including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing
• behavioural and mood-related changes: agitation including aggressive behaviour or hostility, depression
• seizures

Rare: the following may affect up to 1 in 1,000 people

• increased tendency to bleed
• tremor
• palpitations

Very rare: the following may affect up to 1 in 10,000 people

• a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count in the blood
• behavioural and mood-related changes: hallucinations, disorientation, suicidal thoughts and behaviour
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) which may occur without warning
• inflammation of the liver (hepatitis)

Other side effects reported during commercial use of the medicine

Very common: the following may affect more than 1 in 10 people

• upper respiratory tract infection

Common: the following may affect up to 1 in 10 people

• diarrhoea, nausea, vomiting
• rash
• fever
• elevated liver enzymes

Uncommon: the following may affect up to 1 in 100 people

• behavioural and mood-related changes: changes in dream activity, including nightmares, sleep disturbances, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting in children
• weakness/tiredness, feeling unwell, swelling

Rare: the following may affect up to 1 in 1,000 people

• behavioural and mood-related changes: attention disorders, memory impairment, involuntary muscle movements

Very rare: the following may affect up to 1 in 10,000 people

• red, swollen nodules under the skin, most commonly on the shins (erythema nodosum)
• 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:
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 Accord 10 mg film-coated tablets

• Keep this medicine out of the sight and reach of children.
• Do not use Montelukast Accord 10 mg film-coated tablets after the expiry date stated on the label or packaging after “Exp.”. The expiry date refers to the last day of that month.
• This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from light and moisture.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Montelukast Accord 10 mg film-coated tablets contain
The active substance is Montelukast. Each film-coated tablet contains 10 mg of
montelukast.
The other components are:
Tablet core: Lactose monohydrate, microcrystalline cellulose,
low-substituted hydroxypropylcellulose (LH-11) (E 463), sodium croscarmellose,
magnesium stearate.
Film coating: Hydroxypropylcellulose (LF) (E 463), hypromellose 6CPS (A), titanium
dioxide (E 171), macrogol 6000, yellow iron oxide and red iron oxide (E172) ( see
section 2: Important information about some components of Montelukast Accord 10 mg
film-coated tablets).
Description of the appearance of Montelukast Accord 10 mg film-coated tablets and
pack contents
Montelukast Accord 10 mg film-coated tablets are film-coated tablets, 7.9 x 7.9 mm in size, beige in colour, biconvex, square-shaped with rounded edges, marked with "M10" on one side and smooth on the other.
Montelukast Accord 10 mg film-coated tablets are available in OPA-Al-PVC/Al blister packs containing 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets.
(Not all pack sizes may be marketed.)
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,
95-200 Pabianice,
Poland
This medicinal product is authorised in the European Economic Area Member States
under the following names