Montelukast ratiopharm 5 mg, kauwtabletten

Respilukas 5mg Chewable Tablets is a leukotriene receptor antagonist that blocks substances called leukotrienes.Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Respilukas 5mg Chewable Tablets improves asthma symptoms and helps control asthma.

Your doctor has prescribed Respilukas 5mg Chewable Tablets to treat your child’s asthma, preventing asthma symptoms during day and night.

Respilukas 5mg Chewable Tablets are used for the treatment of patients 6 to14 years of age who are not adequately controlled on their asthma medications and need additional therapy.

Respilukas 5mg Chewable Tablets may also be used as an alternative treatment to inhaled corticosteroids for 6 to 14 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids.

Respilukas 5mg Chewable Tablets, in patients 6 to 14 years of age, also helps prevent asthma symptoms which are triggered by exercise.

Your doctor will determine how Respilukas 5mg Chewable Tablets should be used depending on the symptoms and severity of your child’s 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.

Do not use Respilukas 5mg Chewable Tablets:

- if your child is allergic (hypersensitive) to montelukast sodium or any of the other ingredients of Respilukas 5mg Chewable Tablets.

Take special care with Respilukas 5mg Chewable Tablets

• Oral Respilukas 5mg Chewable Tablets is NOT intended for the treatment of a sudden attack of breathlessness. It will not help your child 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 your child needs to use their beta-agonist inhaler more often than usual, you should consult your child’s doctor as soon as possible.
• It is important that your child uses all the asthma medication prescribed by the doctor as intended. Respilukas 5mg Chewable Tablets should not replace steroid medications (whether inhaled or taken by mouth) that your child may already be using.
• If your child has phenylketonuria you should note that Respilukas 5mg Chewable Tablets contain aspartame, which is a source of phenylalanine. The phenylalanine in the tablets may be harmful to people with phenylketonuria
• 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.
• Use in infants and toddlers: Respilukas 5mg Chewable Tablets are not recommended for use in children under two years of age.

Taking other medicines

Respilukas 5mg Chewable Tablets may be used together with other medicines your child may be taking for asthma. However, some medicines can interfere with Respilukas 5mg Chewable Tablets, or Respilukas 5mg Chewable Tablets may affect how your child’s other medicines work.

Please tell your doctor or pharmacist if your child is taking or has 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 Respilukas 5mg Chewable Tablets with food and drink

If Respilukas 5mg chewable tablets are taken together with food they should be taken in the evening 1 hour before or 2 hours after 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 Respilukas 5mg Chewable Tablets.

Breast feeding: It is not known whether Respilukas 5mg Chewable Tablets is present in human breast-milk. The doctor should be consulted before Respilukas 5mg Chewable Tablets are taken, if you are already breast feeding or intending to breast feed a baby.

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

Driving and using machines

In adults, Respilukas 5mg Chewable Tablets are not expected to affect their ability to drive a car or operate machinery. However, individual responses to medication may vary. Certain side effects that have been reported very rarely with Respilukas 5mg Chewable Tablets may affect some patients’ ability to drive or operate machinery.

Important information about some of the ingredients of Montelukast:

Montelukast contains aspartame, a source of phenylalanine. May be harmful for people with phenylketonuria

Ensure that your child always takes Respilukas 5mg Chewable Tablets as instructed by your doctor, even when your child has no symptoms, or if your child experiences an asthma attack. You should check with your doctor or pharmacist if you are not sure.

The usual dose for children aged 6 to 14 years is one Respilukas 5mg 5 mg Chewable Tablet daily in the evening.

If Respilukas 5mg Chewable Tablets use is associated with food, the tablets should be taken 1 hour before or two hours after food.

Respilukas 5mg Chewable Tablets should not be used together with other products that contain the same active ingredient, montelukast.

If you take more Respilukas 5mg Chewable Tablets than you should

If your child (or someone else) swallows a lot of the tablets all together, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause abdominal pain, sleepiness, thirst, headache, vomiting, and involuntary movement. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Respilukas 5mg Chewable Tablets

If your child misses a dose, just carry on with the next one as usual. Do not take or give a double dose to make up for a forgotten dose.

If your child stops taking Montelukast Chewable Tablets

It is important to continue taking Respilukas 5mg Chewable Tablets in the presence or absence of symptoms, for as long as your child’s doctor prescribes it, in order to help maintain control of your child’s asthma. Respilukas 5mg Chewable Tablets can help control your asthma only with continued use.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Respilukas 5mg Chewable Tablets can cause side effects, although not everybody gets them.

In clinical studies with Montelukast 5 mg chewable tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to montelukast were:

• headache

Additionally, the following side effects were reported in clinical studies with montelukast 4 mg chewable tablets and 10 mg film-coated tablets:

• abdominal pain
• thirst

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 (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 medicine has been on the market, the following has been reported:

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 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
• tremor
• palpitations
• swelling beneath the skin

Very rare (affects less than 1 user in 10,000)

• hallucinations, disorientation, suicidal thoughts and actions
• hepatitis (inflammation of the liver)
• tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erythema mutliforme) that may occur without warning.
• hepatic eosininophilic 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

Keep out of the reach and sight of children.

Do not store above 30ºC. Store in the original package in order to protect from light.

Do not use Respilukas 5mg Chewable Tablets after the expiry date that is stated on the blister and carton. The expiry date refers to the last day of that month

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.

What Respilukas 5mg Chewable Tablets contain:

• the active ingredient is montelukast sodium equivalent to 5 mg montelukast
• the other ingredients include: mannitol (E421), sodium laurilsulfate, hydroxypropyl cellulose, Red iron oxide (E172), Flav.cherry PHS-143671: (maltodextrins (maize) and starch modified E1450 (Waxy maize)), aspartame (E951), sodium starch glycolate Type A, magnesium stearate

What Respilukas 5mg Chewable Tablets looks like and contents of the pack

Respilukas 5 mg Chewable Tablets are mottled pink, square shaped tablet, debossed with "93" on one side and "7425" on the other side of the tablet.

Respilukas 5mg Chewable Tablets are available in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets

.

Aluminium – Aluminium blister packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

To be completed locally

This medicinal product is authorised in the member states of the EEA under the following names:

Denmark: Respilukas 5 mg tyggetabletter

France: Montelukast Ratio 5 mg, comprimé à croquer

Germany: MonteluBronch 5 mg Kautabletten

Netherlands: Montelukast ratiopharm 5 mg, kauwtabletten

Portugal Montelucaste ratiopharm

Spain : Montelukast Ratiopharm 5mg, comprimidos masticables EFG

This leaflet was last revised: October 2012

T HIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS

PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V