Sintrine Tablets

What SINTRINE is

SINTRINE is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How SINTRINE works

Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, SINTRINE improves asthma symptoms and helps control asthma.

When SINTRINE should be used

Your doctor has prescribed SINTRINE to treat your child’s asthma, preventing asthma symptoms during the day and night. SINTRINE 4 is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy. SINTRINE 5 is used for the treatment of paediatric patients 6 to 14 years of age who are not adequately controlled on their medication and need additional therapy. SINTRINE 4 may also be used as an alternative treatment to inhaled corticosteroids for 2 to 5 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids. SINTRINE 5 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. SINTRINE 4 also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older. SINTRINE 5 also helps prevent the narrowing of airways triggered by exercise. Your doctor will determine how SINTRINE should be used depending on the symptoms and severity of your child's asthma.

Tell your doctor about any medical problems or allergies your child has now or has had.

Do not take SINTRINE if:

• You are allergic (hypersensitive) to montelukast or any other inactive ingredients (see ‟ WHAT SINTRINE CONTAINS”).
• You are pregnant or breastfeeding your baby. Please consult your doctor before use.

Safety and efficacy have not been established with SINTRINE 4 in children under the age of 2 years. Safety and efficacy have not been established with SINTRINE 5 in children under the age of 6 years.

Take special care with SINTRINE:

• Talk to your doctor or pharmacist before you give SINTRINE to your child.
• If your child’s asthma or breathing gets worse, tell your doctor immediately.
• It is important that your child take all asthma medications prescribed by your doctor. SINTRINE should not be used instead of other asthma medications your doctor has prescribed for your child.
• If your child is on anti-asthma medicines, be aware that if he/she develops a combination of symptoms such as flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash, you should consult your doctor.
• Oral SINTRINE is not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always have your child’s inhaled rescue medicine for asthma attacks with you.
• Your child should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.
• Do not decrease the dose or stop taking any other anti-asthma medications unless instructed to do so by your doctor.
• Seek medical attention if, while using SINTRINE, short-acting inhaled bronchodilators are needed more often than usual, or if more than the maximum number of inhalations of short-acting bronchodilator treatment prescribed for a 24-hour period is needed.
• If you have a worsening of asthma after exercise, continue to use the usual dose of inhaled beta-antagonists as prophylaxis unless otherwise instructed by your doctor.

Important information about some of the ingredients of SINTRINE: SINTRINE chewable tablets contain aspartame, which is a source of phenylalanine (an essential amino acid of the body). Caution should be used if you or your child has a disorder called phenylketonuria, which is a genetic disorder that is characterised by the inability of the body to utilise phenylalanine.

The recommended dosage of SINTRINE is once a day in the evening with or without food as prescribed by your doctor.

• The dose for children from 2 to 5 years old is one 4 mg chewable tablet daily.
• The dose for children from 6 years old is one 5 mg chewable tablet daily.

If you have the impression that the effect of SINTRINE is too strong or too weak, talk to your doctor or pharmacist.

It is important to continue taking SINTRINE for as long as your doctor prescribes it in order to maintain control of your child’s asthma. SINTRINE can treat your child’s asthma only if it is taken continuously. Do not share SINTRINE with any other person, even if their symptoms are the same as your child’s.

If you take more SINTRINE than you should: In case of an accidental or intentional overdose contact your doctor or pharmacist as soon as possible. If neither is available, seek help at the nearest hospital or poison control centre.

If your child forgets to take SINTRINE: Give your child the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and give the medicine at the next regularly scheduled time. Do not give a double dose to make up the missed dose.

If you stop taking SINTRINE: SINTRINE can treat your child’s asthma only if he/she continues taking it. It is important for your child to continue taking SINTRINE for as long as your doctor prescribes. It will help control your child’s asthma. If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist.

SINTRINE can have side effects.

Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist, or other healthcare professional for advice.

Serious side effects

Talk with your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment.

• Less frequent:
• allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, hives
• behaviour and mood related changes: agitation including aggressive behaviour or hostility, depression, hallucinations, disorientation, suicidal thoughts and actions
• seizure
• increased bleeding tendency
• tremor
• racing or pounding heart (palpitations)
• 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) (see section 2)
• low blood platelet count
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that may occur without warning
• yellowing of the skin and whites of the eyes, inflammation of the liver (hepatitis)

Other side effects while the medicine has been on the market

• Frequent:
• Sleeplessness
• Abdominal (stomach) pain
• thirst
• headache
• Upper respiratory tract infections
• diarrhoea, nausea, vomiting
• rash
• fever
• elevated liver enzymes
• Less Frequent:
• Stuffy nose, coughing
• Heartburn, stomach flu.
• toothache
• behaviour and mood related changes: dream abnormalities, including nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, pins and needles/numbness
• nosebleed
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting in children
• weakness/tiredness, feeling unwell, swelling

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 SINTRINE. Suspected side effects can also be reported directly to the HCR via [email protected].

• Store in the original package. The product is sensitive to light and moisture. Store at or below 25 °C.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Keep the container tightly closed.

• Do not use after the expiry date printed on the label or carton.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).