Montelukast 10mg Film-Coated Tablets
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
Montelukast 10 mg Film-coated Tablets
montelukast
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 symptoms 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 10 mg Film-coated tablets is and what it is used for
2. What you need to know before you take Montelukast 10 mg Film-coated tablets
3. How to take Montelukast 10 mg Film-coated tablets
4. Possible side effects
5. How to store Montelukast 10 mg Film-coated tablets
6. Contents of the pack and other information
1. What Montelukast 10 mg Film-coated Tablets is and what it is used for
Montelukast 10 mg Film-coated Tablets is a Leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in your lungs and also cause allergy symptoms. By blocking Leukotrienes, improves asthma symptoms, helps control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Montelukast 10 mg Film-coated Tablets to treat asthma, preventing your asthma symptoms during the day and night.
• This medicine is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.
• This medicine also helps prevent the narrowing of airways triggered by exercise.
• In those asthmatic patients in whom this medicine is indicated in asthma, this medicine can also provide relief of seasonal allergic rhinitis.
Your doctor will determine how this medicine should be used depending on the symptoms and severity of your asthma.
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, cold air, or exercise.
• Swelling (inflammation) in the lining of the airways.
Symptoms of asthma include: Coughing, wheezing, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or season allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grasses and weeds. The symptopms of seasonal allergies typically may include: stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes.
2. Before you take Montelukast 10 mg Film-coated tablets
Tell your doctor about any medical problems or allergies you have now or have had.
Do not take Montelukast 10 mg Film-coated Tablets
- if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions- If your asthma or breathing gets worse, tell your doctor immediately.
- Oral Montelukast 10 mg Film-coated Tablets is not meant to treat acute asthma attacks. If an attack occurs,
follow the instructions your doctor has given you. Always have your inhaled rescue medicine for asthma attacks with you.
- It is important that you or your child take all asthma medications prescribed by your doctor. [Name to be completed nationally] should not be substituted for other asthma medications your doctor has prescribed for you.
- Any patient on anti-asthma medicines should be aware that if you develop a combination of symptoms
such as a flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash, you should consult your doctor.
- You should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDS) if they make your asthma worse.
Children and adolescents 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 10 mg Film-coated Tablets
Some medicines may affect how [Name to be completed nationally] works, or [Name to be completed nationally] may affect how other medicines work.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medicines before starting Montelukast 10 mg Film-coated Tablets:
- Phenobarbital ( used for treatment of epilepsy)
- Phenytoin (used for treatment of epilepsy)
- Rifampicin ( used to treat tuberculosis and some other infections)
- gemfibrozil (used for treatment of high lipid levels in plasma)
Montelukast 10 mg Film-coated Tablets with food and drink
This medicine may be taken with or without food.
Pregnancy and breast-feeding
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 any medicine.
Pregnancy
Women who are pregnant or intend to become pregnant should consult their doctor before taking this medicine. Your doctor will assess whether you can take this medicine during this time.
Lactation
It is not known if this medicine appears in breast milk. You should consult your doctor before taking this medicine if you are breast feeding or intend to breast feed.
Driving and using machines
This medicine is not expected to affect your ability to drive a car or operate machinery. However, individual responses to medication may vary. Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with this medicine may affect some patients ability to drive or operate machinary.
Montelukast 10 mg Film-coated Tablets contains lactose
This medicine contains lactose. If you have been told by your doctor that you have an
intolerance to some sugars, (Rare hereditary problems, galactose intolerance, the lapp lactose deficiency of
glucose-galactose malabsorption) you should contact your doctor before taking this medicine.
3. How to take Montelukast 10 mg Film-coated Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
- You should take only one tablet of this medicine once a day as prescribed by your doctor
- It should be taken even when you have no symptoms or have an acute asthma attack.
To by taken by mouth
For adults 15 years of age and older
One 10 mg tablet to be taken daily in the evening. This medicine may be taken with or without food.
If you are taking this medicine, be sure that you do not take any other products that contain the same active ingredient, montelukast.
If you take more Montelukast 10 mg Film-coated Tablets than you should
Contact your doctor Immediately for advice.
There were no side effects reported in the majority of overdose reports. The most frequently occuring symptoms reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomitting and hyperactivity.
If you forget to take Montelukast 10 mg Film-coated Tablets
Try to take this medicine as prescribed. However, if you miss a dose, just resume the usual schedule of one tablet once daily.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Montelukast 10 mg Film-coated Tablets
This medicine can treat your asthma only if you continue to take it. It is important to continue taking this medicine for as long as your doctor prescribes. It will help control your asthma.
If you have any further questions on 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 montelukast the most commonly reported side effects (occuring 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 greated 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 (affects at least 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Additionally, while the drug 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, disturbance in attention, memory impairment (Rare); hallucinations, disorientation, suicidal thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon), swelling (inflammation) of the lungs (very rare)
• 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 reactions (erythema multiforme) that may occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); weakness/tiredness, feeling unwell, swelling (Uncommon).
In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flulike 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 pharmacistor nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 10 mg film-coated tablets
Keep this medicine out of the sight and reach of children.
Do not used this medicine after the expiry date which is stated on the carton after EXP. The expiry date
refers to the last day of the month. Use within 30 days of opening. Once the pack has been opened write the date of opening on the space provided on the package label and also write the date by when the product should be used.
Store in the original package to protect from moisture. This medicinal product does not require any special temperature storage conditions.
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 to protect the environment
6. Contents of the pack and other information What Montelukast 10 mg Film-coated Tablets contains
- The active substance is Montelukast Sodium
- The other ingredients are:
Core:
Cellulose microcrystalline,
Lactose monohydrate,
Croscarmellose sodium,
Hydroxypropylcellulose (E463)
Magnesium stearate.
Film-coating:
Hypromellose (E464)
Hydroxypropylcellulose (E463)
Titanium dioxide (E171)
Iron Oxide yellow (E172)
Carnauba wax (E903)
Iron Oxide red (E172)
What Montelukast 10 mg Film-coated Tablets looks like and contents of the pack
10 mg tablets are beige, round, 8 mm biconvex, film-coated tablets, engraved with ‘G’ on one side and ‘392’on the other side.
Montelukast 10 mg Film-coated Tablets are available in HDPE containers in cardboard carton with polypropylene child resistant closures also contains a canister of silica gel desiccant.
Pack sizes: 20, 28, 30
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Glenmark Pharmaceuticals s.r.o.
City Tower, Hvezdova 1716/2b, 140 78 Prague 4,
Czech Republic
Manufacturer
Glenmark Pharmaceuticals s.r.o.
City Tower, Hvezdova 1716/2b, 140 78 Prague 4,
Czech Republic
Accord Healthcare Limited Sage House, 319 Pinner Road, Harrow, Middlesex, HA1 4HF, United Kingdom