Montelukast 10 Mg Film-Coated Tablets
Page 1
Sandoz Ltd
Montelukast 10 mg film-coated tablets
PL 04416/0946
Package leaflet: Information for the patient Montelukast 10mg 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 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 10 mg is and what it is used for
2. What you need to know before you take Montelukast 10 mg
3. How to take Montelukast 10 mg
4. Possible side effects
5. How to store Montelukast 10 mg
6. Contents of the pack and other information
1. What Montelukast 10 mg is and what it is used for
Montelukast 10 mg 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, Montelukast 10 mg 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 to treat asthma, preventing your asthma symptoms during the day and night.
• Montelukast 10 mg is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.
• Montelukast 10 mg also helps prevent the narrowing of airways triggered by exercise.
• In those asthmatic patients in whom Montelukast 10 mg is indicated in asthma, Montelukast 10 mg can also provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Montelukast 10 mg 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.
PIL.0946.007.05d" 1904/0140163 V02948GrCSP Update Montelukast MSIS_
FI/H/PSUR/0015/002SPC. Label &
PIL CDS safety update, in line with reference product + V027
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 10 mg Do not take Montelukast 10 mg
- if you are allergic (hypersensitive) to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Montelukast 10 mg:
• If your asthma or breathing gets worse, tell your doctor immediately.
• Oral Montelukast 10 mg 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. Montelukast 10 mg 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 lung (pulmonary) problems, and/or rash, you should consult your doctor.
| • You should not take acetylsalicylic acid (aspirin)aspirin or anti-inflammatory medicines (also known as non-steroidal antiinflammatory drugs or NSAIDs) if they make your asthma worse.
Other medicines and Montelukast 10 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Some medicines may affect how Montelukast 10 mg works, or Montelukast 10 mg may affect how other medicines work.
Tell your doctor if you are taking the following medicines before starting Montelukast 10 mg:
• 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 with food and drink
Montelukast 10 mg may be taken with or without food.
Pregnancy and breast-feeding
Use in pregnancy
Women who are pregnant or intend to become pregnant should consult their doctor before taking | Montelukast 10 mg. Your doctor will assess whether you can take Montelukast 10 mg_during this time.
Use in breast-feeding
PIL.0946.007.05d" 1904/0140163 V02948GrCSP Update Montelukast MSIS_
FI/H/PSUR/0015/002SPC. Label &
PIL CDS safety update, in line with reference product + V027
It is not known if Montelukast 10 mg appears in breast milk. You should consult your doctor before taking Montelukast 10 mg if you are breast-feeding or intend to breast-feed.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Montelukast 10 mg 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 Montelukast 10 mg may affect some patients’ ability to drive or operate machinery.
Montelukast 10 mg fllm-coated tablets contain lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Montelukast 10 mg
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• You should take only one tablet of Montelukast 10 mg 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 be taken by mouth.
The recommended dose is:
For adults and adolescents 15 years of age and older:
One 10 mg tablet to be taken daily in the evening. Montelukast 10 mg may be taken with or without food.
If you are taking Montelukast 10 mg, be sure that you do not take any other products that contain the same active ingredient, montelukast.
Montelukast 10mg should not be used in children below 15 years of age due to the high content of active substance.
Other dosage forms with appropriate strengths are available for younger children.
If you take more Montelukast 10 mg than you should
Contact your doctor immediately for advice.
There were no side effects reported in the majority of overdose reports. The most frequently occurring symptoms reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity.
If you forget to take Montelukast 10 mg
Try to take Montelukast 10 mg 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
Montelukast 10 mg can treat your asthma only if you continue to take it. It is important to continue taking Montelukast 10 mg 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.
Talk to a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Uncommon side effects (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 in breathing or swallowing
Very rare side effects (may affect up to 1 in 10,000 people):
■ suicidal thoughts and actions. Warning signs are e.g. talking about suicide, withdrawing from social contact and wanting to be left alone or feeling trapped or hopeless about a situation
■ yellowing of the skin and eyes, unusual tiredness or fever, dark coloured urine caused by inflammation of the liver (hepatitis)
■ 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 your child gets one or more of these symptoms.
■ severe skin reactions (erythema multiforme) that may occur without warning _
Formatted: English (U.K.)
In clinical studies with montelukast 4 mg oral granules, the most commonly reported side effects (may affect up to 1 in 10 people) thought to be related to montelukast were:
■ diarrhoea
■ hyperactivity
■ asthma
■ scaly and itchy skin
■ rash
Additionally, the following side effects were reported in clinical studies with either montelukast 10 mg film-coated tablets, 5 mg or 4 mg chewable tablets: :
• abdominal pain
• headache
• thirst
These were usually mild and occurred at a greater frequency in patients treated with montelukast than placebo (a pill containing no medication).
Additionally, while the drug has been on the market, the following have been reported:
Talk to a doctor straight away if you notice any of the following serious side effects—you may need urgent medical treatment:
| Uncommon side effects (may affect up to 1 in 100 people):
PIL.0946.007.05d 1901/01W/163 V02918G: CSP Update Montelukast MSIS
FI/H/PSUR/0015/002SPC, Label &
PIL CDS safety update, in line with reference product + V027
*—allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
Very rare side effects (may affect up to 1 in 10,000 people):
*—suicidal thoughts and actions. Warning signs are e.g. talking about suicide, withdrawing from social contact and wanting to be left alone or feeling trapped or hopeless about a situation *—yellowing of the skin and eyes, unusual tiredness or fever, dark coloured urine caused by inflammation of the liver (hepatitis)
*—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 your child gets one or more of these symptoms.
*—severe skin reactions (erythema multiforme) that may occur without warning
Other possible side effects
Very common side effects (may affect more than 1 in 10 people):
• upper respiratory infection
Common side effects (may affect up to 1 in 10 people):
• diarrhoea, nausea, vomiting
• abnormal liver function test results
• rash
• fever
Uncommon side effects (may affect up to 1 in 100 people):
• behaviour and mood related changes (dream abnormalities, including nightmares, trouble sleeping,
sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression)
• dizziness, drowsiness, pins and needles/numbness, seizure
• nosebleed
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• tiredness, feeling unwell. swelling
Rare side effects (may affect up to 1 in 1,000 people):
• increased bleeding tendency •_ tremor
• disturbance in attention, memory impairment
• palpitations
Very rare side effects (may affect up to 1 in 10,000 people):
•_ hallucinations, disorientation^
Formatted: English (U.S.)
swelling (inflammation) of the lungs
tender red lumps under the skin most commonly on your shins (erythema nodosum)
Formatted: Indent: Left: 0 cm, Hanging: 0.75 cm, Line spacing: single, Tab stops: Not at 1 cm
Formatted: English (U.K.)
Reporting 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.
PIL.0946.007.05d 1901/01W/163 V02918G: CSP Update Montelukast MSIS
FI/H/PSUR/0015/002SPC, Label &
PIL CDS safety update, in line with reference product + V027
You can also report side effects directly via the Yellow Card Scheme (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
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 container after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from light and moisture.
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 te-protect the environment.
6. Contents of the pack and other information
What Montelukast 10 mg contains
The active substance is montelukast.
One tablet contains 10 mg Montelukast sodium which corresponds to 10 mg of montelukast ( as montelukast sodium)..
The other ingredients are:
Core: Lactose monohydrate, hydroxypropylcellulose type EF, cellulose, microcrystalline, croscarmellose sodium, magnesium stearate
Coating: Hypromellose 6 cps, titanium dioxide (E 171), macrogol 400, ferric oxide, yellow (E 172), ferric oxide, red (E 172)
What Montelukast 10 mg looks like and contents of the pack
Beige, squared, biconvex, film-coated tablet, encoded 10 on one side
Packaged in
OPA/Al/PVC/Al blisters:
| 7, 10, 14, 20, 21, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, 200 tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, United Kingdom Manufacturers:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia or LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland or
LEK S.A, Ul. Podlipie 16 C, 95 010 Strykow, Poland or
S.C. Sandoz S.R.L, Str. Livezeni nr7A, 540472 Targu-Mures, Romania or
Sandoz N.V. Medialaan 40 - 1800 Vilvoorde, Belgium.
| This leaflet was last revised in 0140/20163
MSIS
PIL.0946.007.05d 1904/0140/163 V02948G: CSP Update Montelukast
FI/H/PSUR/0015/002SPC. Label &
PIL CDS safety update, in line with
reference product + V027