Montelukast 10mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Montelukast 10 mg film-coated tablets
For adults and adolescents from 15 years
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Montelukast is and what it is used for
2. What you need to know before you take Montelukast
3. How to take Montelukast
4. Possible side effects
5. How to store Montelukast
6. Contents of the pack and other information
1. WHAT MoNTELuKAsT Is And WHAT IT IS USED FOR
The active ingredient in Montelukast 10 mg tablets is montelukast, which is a leukotriene receptor antagonist. It blocks naturally occurring chemicals in the lungs called leukotrienes which cause narrowing of the airways and inflammation in the lungs, which can lead to asthma symptoms. Leukotrienes also contribute to the symptoms of allergy. Blocking leukotrienes reduces the symptoms of seasonal allergy (also known as seasonal allergic rhinitis or hay fever).
Montelukast is used for the treatment of adult patients and adolescents, aged 15 years and older with asthma, who are not adequately controlled on their asthma medications and need additional therapy. For patients with asthma and seasonal allergies, Montelukast also treats your seasonal allergy symptoms.
Montelukast also helps prevent asthma symptoms in adult patients and adolescents, aged 15 years and older, which are triggered by exercise.
What is asthma?
Asthma is a long-term disease.
Asthma includes:
• difficulty breathing because of narrowed airways. This narrowing of airways worsens and improves in response to various conditions.
• sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
• swelling (inflammation) in the lining of airways. Symptoms of asthma include: Coughing, wheezing, 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 pollens from trees, grasses and weeds. The symptoms of seasonal allergies typically may include: stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes.
2. WHAT YOU NEED TO Know BEFORE
you take montelukast
Tell your doctor about any medical problems or allergies you have now or have had.
Do not take Montelukast:
• if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
It is important that you take the medicine as prescribed by the doctor, even if you have no symptoms or if you experience an asthma attack.
Oral Montelukast is NOT intended for the treatment of a sudden attack of breathlessness. It will not help you in this situation and should never be used for this purpose. If an attack occurs, the instructions that the doctor has given should be followed exactly. It is very important to have the medication needed for such an attack readily accessible at all times.
If you need to use your beta-agonist inhaler (also known as a bronchodilator or reliever inhaler) more often than usual, you should consult your doctor as soon as possible.
Montelukast should not replace steroid medications (whether inhaled or taken by mouth) that you may be already using.
Patients with aspirin-sensitive asthma taking Montelukast must continue to avoid taking aspirin or other non-steroidal anti-inflammatory drugs.
A rare condition has been seen in a very small number of patients taking asthma medications, including montelukast, although montelukast has not been shown to cause it. Seek medical attention immediately if you experience a combination of any of the following symptoms, particularly if they are persistent or worsening:
• flu-like illness,
• increasing breathlessness,
• pins and needles or numbness of limbs, and/or
• rash.
Children
For children 2 to 5 years old, Montelukast 4 mg chewable tablets are available.
For children 6 to 14 years old, Montelukast 5 mg chewable tablets are available.
Other medicines and Montelukast
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking phenobarbital or phenytoin (used for treatment of epilepsy), rifampicin (used to treat tuberculosis and some other infections) or gemfibrozil (used for treatment of high lipid levels in plasma) because they may affect the efficacy of Montelukast.
Montelukast may be used together with other medicines that you may be taking for asthma.
Taking Montelukast with food
You may take the medicine with or without food.
Pregnancy and breast-feeding
Pregnancy
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding
It is not known whether montelukast is present in human breast-milk. You should consult your doctor before taking Montelukast if you are breast-feeding a baby, or intend to breast-feed.
Driving and using machines
Montelukast is not expected to affect your ability to drive a car or operate machinery. However, individual responses to medication may vary. Certain side
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effects that have been reported very rarely with Montelukast may affect some patients' ability to drive or operate machinery.
Montelukast contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE MONTELUKAST
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Take Montelukast once a day by mouth in the evening, with or without food, as instructed by your doctor.
The usual dose for adults and adolescents aged 15 years upwards is one 10 mg tablet daily.
It is important to continue taking Montelukast in the presence or absence of symptoms, for as long as your doctor prescribes it, in order to help maintain control of your asthma. Montelukast can treat asthma only with continued use.
Montelukast tablets should not be used together with other products that contain the same active ingredient, montelukast.
Use in children
Montelukast 10 mg tablets are not recommended for use in children under 15 years of age.
If you take more Montelukast than you should
If you have taken more Montelukast than you should, contact your doctor or pharmacist immediately.
In most cases, no side effects have been reported.
The most common symptoms that were reported included the following: thirst, sleepiness, headache, hyperactivity and abdominal pain.
If you forget to take Montelukast
If you forget to take a tablet, just carry on with the next one as usual. Do not take an extra tablet to make up, just resume the usual schedule of one tablet, once daily.
If you stop taking Montelukast
Montelukast can treat your asthma only if you continue to take it.
It is important to continue taking Montelukast for as long as your doctor prescribes. It will help control your asthma.
If you have any further questions on the use of this medicine, 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 montelukast 10 mg film-coated tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 patients treated) thought to be related to montelukast were:
• abdominal pain
• headache
These were usually mild and occurred at a greater frequency in patients treated with Montelukast than placebo (a pill containing no medication).
The frequency of possible side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people Rare: may affect up to 1 in 1,000 people Very rare: may affect up to 1 in 10,000 people
Additionally, while the medicine has been on the market, the following have been reported:
• upper respiratory infection (very common)
• increased bleeding tendency (rare)
• allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing (uncommon)
• behaviour and mood related changes [dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression (Uncommon); tremor (Rare); hallucination, disorientation, suicidal thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• rash (Common); bruising, itching, hives (Uncommon); tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reaction (erythema multiforme), which may occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); tiredness, feeling unwell, swelling (Uncommon).
In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg Strauss syndrome) have been reported. You must tell your doctor right away if you get one or more of these symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra. gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store montelukast
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. FURTHER INFoRMATioN
What Montelukast contains
• The active substance is montelukast. Each film-coated tablet contains 10 mg montelukast (as montelukast sodium).
• The other ingredients are lactose monohydrate, powdered cellulose, microcrystalline cellulose, croscarmellose sodium and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E171), talc, propylene glycol, red iron oxide (E172) and yellow iron oxide (E172) in the film coating.
What Montelukast looks like and contents of the pack
The film-coated tablets are apricot-coloured, round, slightly biconvex, with bevelled edges.
Boxes of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90,
98, 100, 140 or 200 film-coated tablets in blisters are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
KRKA Polska Sp. z o.o., ul. Rownolegta 5, 02-235 Warsaw, Poland
TAD Pharma GmbH, Heinz-Lohmann-StraBe 5,
27472 Cuxhaven, Germany
Distributed by:
Consilient Health (UK) Ltd, No,1 Church Road,
Richmond upon Thames, Surrey, TW9 2QE.
This leaflet was last revised 08/2014