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Product

Therapeutic Category

tajdearob

Montelukast

Montelukast 10 mg film-coated tablets is a leukotriene receptor antagonist that blocks substances called leukotrienes.


Generic Name

Montelukast


Packing

30


Therapeutic Category

Respiratory/Antiasmatic


Storage

Store in the original package in order to protect from light and moisture.


adobe-pdf-logoProduct Insert(PIL)

adobe-pdf-logoPrescribing Information(SPC)


Product Description

Product Overview


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 the lungs and also
cause allergy symptoms. By blocking leukotrienes, Montelukast 10 mg film-coated tablets
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.

• Montelukast 10 mg film-coated tablets is used for the treatment of patients who are not
adequately controlled on their medication and need additional therapy.
• Montelukast 10 mg film-coated tablets also helps prevent the narrowing of airways triggered by
exercise.
• In those asthmatic patients in whom Montelukast 10 mg film-coated tablets is indicated in
asthma, Montelukast 10 mg film-coated tablets can also provide symptomatic relief of seasonal
allergic rhinitis.

Your doctor will determine how Montelukast 10 mg film-coated tablets should be used depending
on the symptoms and severity of your asthma.

Montelukast 10 mg film-coated tablets are indicated for patients 15 years of age and older.

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 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.

What you need 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 (hypersensitive) to montelukast or any of the other ingredients of Montelukast 10 mg film-coated tablets (see section 6.).

Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Montelukast 10 mg film-coated tablets
• 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.
Montelukast 10 mg film-coated tablets 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
Montelukast 10 mg film-coated tablets are not recommended for use in children and adolescents
under the age of 15.
For children 2 to 5 years old, Montelukast Paediatric 4 mg chewable tablets are available.
For children and adolescents 6 to 14 years old, Montelukast Paediatric 5 mg chewable tablets are
available.

Other medicines and Montelukast 10 mg film-coated tablets

Some medicines may affect how Montelukast 10 mg film-coated tablets works or Montelukast 10
mg film-coated tablets 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 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, drink and alcohol
Montelukast 10 mg film-coated tablets 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 film-coated tablets. Your doctor will assess whether you can take
Montelukast 10 mg film-coated tablets during this time.

Use in breast-feeding
It is unknown whether montelukast is excreted in human milk. You should consult your doctor
before taking Montelukast 10 mg film-coated tablets if you are breast-feeding or intend to breastfeed.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Montelukast 10 mg film-coated tablets has minor or moderate influence on the ability to drive
and use machines. Montelukast 10 mg film-coated tablets 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 film-coated tablets may affect some patients’ ability to drive or operate
machinery

Montelukast 10 mg film-coated tablets contains lactose
Montelukast 10 mg film-coated tablets contains 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.

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 Montelukast 10 mg film-coated tablets once a day as
prescribed by your doctor.
• It should be taken even when you have no symptoms or have an acute asthma attack.
• Always take Montelukast 10 mg film-coated tablets as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
• To be taken by mouth.

For adults and adolescents 15 years of age and older:
One 10 mg tablet to be taken daily in the evening. Montelukast 10 mg film-coated tablets may be
taken with or without food.

If you are taking Montelukast 10 mg film-coated tablets, 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
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 film-coated tablets
Try to take Montelukast 10 mg film-coated tablets 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
Montelukast 10 mg film-coated tablets can treat your asthma only if you continue to take it.

It is important to continue taking Montelukast 10 mg film-coated tablets 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.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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.

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 10 mg film-coated tablets were:
• abdominal pain
• headache

These were usually mild and occurred at a greater frequency in patients treated with Montelukast
10 mg film-coated tablets than placebo (a pill containing no medication).

If any of the following happens, stop taking Montelukast 10 mg and contact a doctor or go to the
nearest hospital straight away, as you may need urgent medical attention:
• allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may
cause difficulty in breathing or swallowing
• tender red lumps under the skin most commonly on your shins (erythema nodosum), severe
skin reactions (erythema multiforme) that may occur without warning

Additionally, while the medicine has been on the market, the following have been reported:
Very common: may affect more than 1 in 10 people
• upper respiratory infection

Common: may affect up to 1 in 10 people
• diarrhoea, nausea, vomiting
• rash
• fever

Uncommon: 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
• weakness/tiredness, feeling unwell, swelling
• tremor

Rare: may affect up to 1 in 1,000 people
• increased bleeding tendency
• disturbance in attention, memory impairment
• palpitations

Very rare: may affect up to 1 in 10,000 people
• hallucinations, disorientation, suicidal thoughts and actions
• hepatitis (inflammation of the liver)

Reporting of side effects
If you get any side effects, talk to your doctor , pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed (To be completed nationally). By reporting side effects you can help provide more information on the safety of this medicine

How to store Montelukast 10 mg film-coated tablets

• Keep this medicine out of the sight and reach of children.
• Do not use Montelukast 10 mg film-coated tablets after the expiry date which is stated on the
label or 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 and moisture.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

Contents of the pack and other information

What Montelukast 10 mg film-coated tablets contains
The active substance is Montelukast. Each film-coated tablet contains 10 mg of montelukast.

The other ingredients are:
Tablet core: Lactose monohydrate, cellulose microcrystalline, low substituted
hydroxypropylcellulose (LH-11) (E 463), croscarmellose sodium, magnesium stearate.
Film coat: Hydroxypropylcellulose (LF) (E 463), hypromellose 6CPS (A), titanium dioxide (E
171), macrogol 6000, iron oxide yellow and iron oxide red (E172) (see section 2 for Important
information about some of the ingredients of ).

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Taj Dearob Pharmaceuticals is an Ghana based pharmaceutical company that markets a broad range of innovative therapeutic medicines including UK Generics, high-end Oncology products, more info.