Montelukast Biotech Film-Coated Tablets

MONTELUKAST BIOTECH is used for the treatment of asthma, including preventing your asthma symptoms. In adult asthmatic patients in whom MONTELUKAST BIOTECH is used for asthma, it may also provide some relief of the symptoms of seasonal allergies.

Do not take MONTELUKAST BIOTECH tablets:

• If you are allergic to montelukast or any of the other ingredients of MONTELUKAST BIOTECH (listed in section 6).
• If you are pregnant or breastfeeding.

Do not give your child MONTELUKAST BIOTECH to take:

• If he / she is allergic to montelukast or any of the other inactive ingredients included in the tablets.
• If he / she is under the age of 2 years as the safety and efficacy of the 4 mg tablets have not been demonstrated.
• If he / she is under the age of 6 years as the safety and efficacy of 5 mg tablets have not yet been demonstrated.
• If he / she is under the age of 15 years as the safety and efficacy of 10 mg tablets have not been demonstrated.
• MONTELUKAST BIOTECH 10 contains soya oil. If you are allergic to peanut or soya, do not use MONTELUKAST BIOTECH 10.

Warnings and precautions

Take special care with MONTELUKAST BIOTECH:

• MONTELUKAST BIOTECH should not be used for the treatment of an acute asthma attack as the effectiveness has not been demonstrated. You should or your child however continue to use it during worsening of asthma symptoms. You should have appropriate inhalation medication available to treat worsening of asthma.
• MONTELUKAST BIOTECH can unmask a vascular disorder named Churg - Strauss. If you or your child experience any of the following seek medical advice immediately: any type of rash, worsening of asthma symptoms, increased heartbeat, chest pain, together with headache, fever, muscle pains and weight loss.
• MONTELUKAST BIOTECH can cause certain neuropsychiatric events. If you or your child experience any of the following seek medical advice: aggression, anxiousness, abnormal dreams or hallucinations, depression, difficulty sleeping (insomnia), irritability, restlessness, suicidal thoughts and behaviour. See “Possible Side Effects”.
• MONTELUKAST BIOTECH should be used every day even when you or your child experiences no asthma symptoms.
• You should contact your doctor if your asthma is not well controlled.
• You should use MONTELUKAST BIOTECH together with other medication your doctor might have prescribed for you or your child to use before exercise.
• You should always have the inhaled rescue medication for acute asthma attacks with you and available to use in an emergency situation.
• If you or your child’s asthma symptoms get worse, or if you must increase the use of you or your child’s inhaled rescue medicine for asthma attacks in a 24-hour period, you should contact your doctor immediately.
• If aspirin normally makes your asthma worse, do not take aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen.
• If you or your child have liver problems, tell your doctor.
• If your asthma worsens during exercise, you should use your usual inhalation medication as prescribed for prevention of an asthma attack.
• You should not decrease the dose or stop any medication prescribed for the treatment of asthma, unless instructed by your doctor.
• If you or your child is also using inhaled or oral corticosteroids, you should never suddenly stop using that and replace it with MONTELUKAST BIOTECH therapy. Your doctor will advise how to gradually stop using the corticosteroids and when to introduce MONTELUKAST BIOTECH therapy.

What should you tell your doctor before you use MONTELUKAST BIOTECH? You need to tell your doctor about any medical problems or allergies that you or your child have now or had in the past.

Children and adolescents

MONTELUKAST CHEW BIOTECH 4 chewable tablets are for use in children from 2 to 5 years old. MONTELUKAST CHEW BIOTECH 5 chewable tablets are for use in children from 6 to 14 years old.

Other medicines and MONTELUKAST BIOTECH

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) MONTELUKAST BIOTECH does not generally interfere with other medicine that you or your child may be taking. However, some medicine may affect how MONTELUKAST BIOTECH works or how it is excreted from the body, or MONTELUKAST BIOTECH may affect how your other medicine work or how it is excreted from the body. It is therefore very important to tell your doctor about all medicine that you or your child are using or planning to use in the future, including those obtained without a prescription.

Do not share medicines prescribed for you with any other person. MONTELUKAST BIOTECH should always be taken exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure about how or when to take MONTELUKAST BIOTECH.

Take MONTELUKAST BIOTECH once daily in the evening, with or without food, as your doctor has prescribed.

• The dosage for paediatric patients 2 to 5 years of age is one 4 mg chewable tablet daily.
• The dosage for paediatric patients 6 to 14 years of age is one 5 mg chewable tablet daily.
• The dosage for adults 15 years of age and older is one 10 mg film-coated tablet daily. The 10 mg film-coated tablet should be swallowed whole.

Talk to your doctor or pharmacist if you have the impression that the effect of MONTELUKAST BIOTECH is too strong or too weak.

If you take more MONTELUKAST BIOTECH than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take MONTELUKAST BIOTECH

If you or your child missed a dose, just resume the original schedule of one tablet once daily. Do not take a double dose to make up for the forgotten individual doses.

If you stop taking MONTELUKAST BIOTECH

It is important to continue taking MONTELUKAST BIOTECH for as long as your doctor prescribes it, even when you or your child is symptom free, in order to maintain control of you or your child’s asthma.

MONTELUKAST BIOTECH can have side effects. Not all side effects reported for MONTELUKAST BIOTECH are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MONTELUKAST BIOTECH, please consult your healthcare provider for advice.

If any of the following happens, stop taking MONTELUKAST BIOTECH and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious reaction to MONTELUKAST BIOTECH. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to your nearest hospital if you notice any of the following:

• seizure
• heartbeat being more noticeable and faster
• chest pain
• suicidal thoughts and behaviour
• aggressive behaviour, anxiousness, depression, irritability, restlessness
• abnormal dreams (including nightmares) and hallucinations
• yellowing of the skin and eyes, clay-coloured stools, dark urine, breath odour – an indication of liver disease
• inflammation of the liver (hepatitis), with symptoms such as fatigue, loss of appetite and muscle or joint ache

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• upper respiratory tract infections (bronchitis, coughing)
• headache
• dizziness
• abdominal pain, diarrhoea
• gastroenteritis, dental pain
• indigestion, thirst
• skin rash
• feeling weak or tired, emotional stress (trauma)
• feeling unbalanced / spinning head

Less frequent side effects:

• an increased tendency of bleeding
• very low white blood cells, leaving the body vulnerable to serious infections
• low platelets in your blood causing bleeding into the tissues, bruising and slow blood clotting
• inflamed blood vessels leading to symptoms like asthma, sinus problems and organ damage
• porphyria (severe stomach pain, pain in your back and legs)
• insomnia (having difficulty sleeping), sleepwalking
• problems concentrating, memory loss, disorientation
• sudden, small, uncontrollable movement, esp. of the face, speech disorder such as stuttering
• excessive thoughts (obsessions) that lead to repetitive behaviour (compulsions)
• drowsiness
• tingling or numbness in the hands and/or feet
• eye problems (abnormal contraction of the eyelid muscles, dilated pupils)
• cold or flu symptoms (blocked nose, coughing)
• nose bleeds
• inflammation of the lungs from an increase in eosinophils
• nausea, vomiting
• dry mouth, excessive production of saliva, flatulence
• skin disorders (e.g., itching, bruising, red lesions)
• skin condition that causes red, target-like lesions, often triggered by infections or certain medications. It can lead to mild to moderate symptoms, including rash, fever, and discomfort. In severe cases, it may affect the mucous membranes, causing blistering and ulceration
• hives
• joint and/or muscle pain (including muscle cramps)
• bed-wetting usually in children
• increased sweating
• swelling in any part of the body, fever.
• changes in blood counts (picked up in blood tests).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications:

https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of MONTELUKAST BIOTECH.

Store all medicine out of reach of children.

For how long should I keep my medicine? Do not use this medicine after the month and year following the expiry date printed on the outer carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets)

How and where should I store my medicine? Store at room temperature at or below 25 °C, protected from moisture and light. Keep blister in outer carton until required for use. Tablets should not be removed from blisters until required for use, to protect it from moisture.