Montelukast 10 Mg Film-Coated Tablets
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Ref: 231-30-70026-C LEA MONTELUKAST 10mg TAB TUK Version: 1 6 February 2013 | |
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PL Number(s), PL 00289/1119. TEVA UK Limited Licence. MA Holder & Packer: Packed at Teva UK Limited, Eastbourne. Packing Line TBC. | |
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TEVA UK LIMITED | |
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Reason for revision: C Revision: Update to cutter guide. (10 mm around all edges). | |
Colours:
(PANTONE® is a registered trademark of Pantone, Inc.)
PANTONE® GREEN C
BLACK
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D imensions : L: 323 mm W: 200 mm |
Pharma Code (top to bottom on the front face when reading the text design right way up): 356 (01100101) |
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F o nts: Variants of Univers. Base Font Size: 9 Pt | |
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IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier. We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted. | |
Please refer to the latest version of the full base material specification: 92655
PAGE 1: FRONT FACE (INSIDE OF REEL)
Pharma code 356
First bar is 105mm from topedge.
MONTELUKAST 10 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking
this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Montelukast 10 mg Film-coated Tablets are and what they are used for
2. 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. Further information
OWHAT MONTELUKAST 10 mg FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Montelukast 10 mg Film-coated Tablets are 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 improve asthma symptoms, help control asthma and improve seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Montelukast 10 mg Film-coated Tablets to treat your asthma, preventing your asthma symptoms during the day and night.
Montelukast 10 mg Film-coated Tablets are used for the treatment of patients 15 years of age and older who are not adequately controlled on their asthma medications and need additional therapy.
For patients with asthma and seasonal allergies, Montelukast 10 mg Film-coated Tablets also treat your seasonal allergy symptoms.
Montelukast 10 mg Film-coated Tablets, in patients 15 years of age and older, help prevent asthma symptoms 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.
©BEFORE YOU TAKE MONTELUKAST 10 mg FILM-COATED TABLETS
Do not take Montelukast 10 mg Film-coated Tablets:
• if you are allergic (hypersensitive) to the active substance or any of the other ingredients of Montelukast 10 mg Film-coated Tablets.
Take special care with Montelukast 10 mg Film-coated Tablets
• It is important that Montelukast 10 mg Film-coated Tablets are taken daily in the evening as prescribed by your doctor even when you have no symptoms, or if you experience an asthma attack
• Oral Montelukast 10 mg Film-coated Tablets are NOT intended for the treatment of a sudden attack of breathlessness. They 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 more often than usual, you should consult your doctor as soon as possible
• It is important that you use all the asthma medication prescribed by the doctor as intended. Montelukast
10 mg Film-coated Tablets should not replace steroid medications (whether inhaled or taken by mouth) that you may be already using.
• Patients with aspirin-sensitive asthma taking Montelukast 10 mg Film-coatedTablets 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. If you experience a combination of any of the following symptoms, particularly if they are persistent and worsening, seek medical attention immediately: flu-like illness, increasing breathlessness, pins and needles or numbness of limbs, and/or rash.
• Montelukast 10 mg Film-coatedTablets are not recommended for use in children and adolescents under the age of 15.
Taking other medicines
Montelukast 10 mg Film-coated Tablets may be used together with other medicines you may be taking for asthma. However, some medicines can interfere with Montelukast 10 mg Film-coated Tablets, or Montelukast 10 mg Film-coated Tablets may affect how other medicines work.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those medicines obtained without a prescription. This is particularly important if the other medicine is:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections).
Taking Montelukast 10 mg Film-coated Tablets with food and drink
Montelukast 10 mg Film-coated Tablets may be taken in the evening with or without food.
Pregnancy and breast-feeding
Pregnancy: Female patients who are pregnant, intend to become pregnant or think they might be pregnant should consult their doctor before taking Montelukast 10 mg Film-coated Tablets.
Breast-feeding: It is not known whether Montelukast 10 mg Film-coated Tablets is present in human breast-milk. The doctor should be consulted before Montelukast 10 mg Film-coated Tablets are taken, if a female patient is breast-feeding or intending to breastfeed a baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Montelukast 10 mg Film-coated Tablets are not expected to affect your ability to drive a car or operate machinery. However, individual responses to medication may vary. Certain side effects that may affect some patients' ability to drive or operate machinery have been reported very rarely for Montelukast 10 mg Film-coated Tablets.
Top of page cut-off to middle of registration mark: 44 mm.
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Ref: 231-30-70026-C LEA MONTELUKAST 10mg TAB TUK Version: 1 6 February 2013 | |
|
hr^'/il | |
|
PL Number(s), PL 00289/1119. TEVA UK Limited Licence. MA Holder & Packer: Packed at Teva UK Limited, Eastbourne. Packing Line TBC. | |
|
TEVA UK LIMITED | |
|
Reason for revision: C Revision: Update to cutter guide. (10 mm around all edges). | |
Colours:
(PANTONE® is a registered trademark of Pantone, Inc.)
PANTONE® GREEN C
BLACK
|
D imensions : L: 323 mm W: 200 mm |
Pharma Code (top to bottom on the front face when reading the text design right way up): 356 (01100101) |
|
F o nts: Variants of Univers. Base Font Size: 9 Pt | |
|
IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier. We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted. | |
Please refer to the latest version of the full base material specification: 92655
PAGE 2: REAR FACE (OUTSIDE OF REEL)
70026-C
TEVA UK LIMITED
Important information about some of the ingredients of Montelukast 10 mg Film-coated Tablets
Montelukast 10 mg Film-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.
©HOW TO TAKE MONTELUKAST 10 mg FILM-COATED TABLETS
Always take Montelukast 10 mg Film-coated Tablets as instructed by your doctor, even when you have no symptoms, or if you experience an asthma attack. You should check with your doctor or pharmacist if you are not sure.
The usual dose for adults and adolescents aged 15 years upwards is one 10 mg tablet daily in the evening.
Montelukast 10 mg Film-coated Tablets should not be used together with other products that contain the same active ingredient, montelukast.
If you take more Montelukast 10 mg Film-coated Tablets than you should
It is important not to take too many tablets. Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have swallowed too many tablets or if you think a child has swallowed any. Symptoms of overdose include abdominal pain, sleepiness, thirst, headache, vomiting, and involuntary movement.
Take this leaflet and any of the remaining tablets with you to show the doctor.
If you forget to take Montelukast 10 mg Film-coated Tablets
If you forget to take a tablet, just carry on with the next one as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking Montelukast 10 mg Film-coated Tablets
It is important to continue taking Montelukast 10 mg Film-coatedTablets in the presence or absence of symptoms, for as long as your doctor prescribes them, in order to help maintain control of your asthma. Montelukast 10 mg Film-coated Tablets can treat asthma only with continued use.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Montelukast 10 mg Film-coated Tablets can cause side effects, although not everybody gets them.
The most common side effects, reported in between 1 in 10 and 1 in 100 people include:
Abdominal pain and headache.
The other side effects that have been experienced by some patients taking montelukast are:
Very common (affects at least 1 user in 10)
• upper respiratory infection
Common (affects 1 to 10 users in 100)
• diarrhoea, nausea, vomiting
• fever
• rash
• elevated liver enzymes
Uncommon (affects 1 to 10 users in 1,000)
• allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
• 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 (affects 1 to 10 users in 10,000)
• increased bleeding tendency
• behaviour and mood related changes: tremor
• palpitations
• swelling beneath the skin
Very rare (affects less than 1 user in 10,000)
• behaviour and mood related changes: hallucinations, disorientation, suicidal thoughts and action
• hepatitis (inflammation of the liver)
• tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning
• hepatic eosinophilic infiltration.
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.
Ask your doctor or pharmacist for more information about side effects.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
©HOW TO STORE MONTELUKAST 10 mg FILM-COATED TABLETS
Keep out of the reach and sight of children.
Do not use Montelukast 10 mg Film-coatedTablets after the expiry date that is stated on the blister and carton. The expiry date refers to the last day of that month.
No special storage conditions. Keep blister in outer carton in order to protect from light.
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.
FURTHER INFORMATION
What Montelukast 10 mg Film-coated Tablets contain:
• the active ingredient is montelukast sodium equivalent to 10 mg montelukast
• the other ingredients are:
tablet core: sodium laurilsulfate, lactose monohydrate, hydroxypropyl cellulose, pregelatinized starch (maize), sodium starch glycolate (maize) Type A, magnesium stearate,
tablet coating: Opadry 20A23676Yellow containing hydroxypropyl cellulose, hypromellose, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).
What Montelukast 10 mg Film-coated Tablets looks like and contents of the pack
Montelukast 10 mg Film-coated Tablets are beige, round, film-coated tablets, debossed with "93" on one side and "7426" on the other side of the tablet
Montelukast 10 mg Film-coated Tablets are available in packs of 7, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets and calendar packs of 7, 14, 28, 56 and 98 tablets.
Aluminium - Aluminium blister packs
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom.
This leaflet was last revised in 11/2012
PL 00289/1119 ‘iZHZD