Sintrine® Film-Coated Tablets

SINTRINE 10 is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How SINTRINE 10 works

Leukotriene’s cause narrowing and swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, SINTRINE 10 improves asthma symptoms, helps control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

When SINTRINE 10 should be used

Your doctor has prescribed SINTRINE 10 to treat asthma, preventing your asthma symptoms during the day and night.

• SINTRINE 10 is used for the treatment of adults and adolescents 15 years of age and older who are not adequately controlled on their medication and need additional therapy.
• SINTRINE 10 also helps prevent the narrowing of airways triggered by exercise.
• In those asthmatic patients in whom SINTRINE 10 is indicated in asthma, SINTRINE 10 can also provide symptomatic relief of seasonal allergic rhinitis.

Your doctor will determine how SINTRINE 10 should be used depending on the symptoms and severity of your asthma.

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 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.

Tell your doctor about any medical problems or allergies you have now or have had.

Do not take SINTRINE 10 if:

• You are allergic (hypersensitive) to montelukast or any other inactive ingredients (see “WHAT SINTRINE 10 CONTAINS”).
• You are pregnant or breast feeding your baby.
• Safety and efficacy have not been established with SINTRINE 10 in children under the age of 15 years.

Take special care with SINTRINE 10:

Talk to your doctor or pharmacist before taking SINTRINE 10.

• If your asthma or breathing gets worse, tell your doctor immediately.
• It is important that you or your child take all asthma medications prescribed by your doctor. SINTRINE 10 should not be substituted for other asthma medications your doctor has prescribed for you.
• Any patient on antiasthma medicines should be aware that if you develop a combination of symptoms such as a flulike illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash, you should consult your doctor.
• Oral SINTRINE 10 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.
• Do not decrease the dose or stop taking any other anti-asthma medications unless instructed to do so by your doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
• Seek medical attention if, while using SINTRINE 10, 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 exacerbations of asthma after exercise, continue to use the usual dose of inhaled beta-antagonists as prophylaxis unless otherwise instructed by your doctor.

Various neuropsychiatric events (for example behaviour and mood-related changes, depression and suicidality) have been reported in patients of all ages treated with montelukast (see section 4). If you or your child develop such symptoms while taking montelukast, you should contact your doctor.

Children and adolescents

Do not give this medicine to children less than 15 years of age. There are different form(s) of this medicine available for paediatric patients under 18 years of age based on age range.

Using other medicines with SINTRINE 10:

• Always tell your doctor or healthcare professional if you are taking any other medicine. (This included complementary or traditional medicines.)
• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking this medicine.
• Some medicines may affect how SINTRINE 10 works, or SINTRINE 10 may affect how other medicines work. It is important to consult your doctor about all medicines that you are using or planning to use.
• Tell your doctor if you or your child is using any of the following medicines, before taking SINTRINE 10:
• Phenobarbital (used for the treatment of epilepsy).
• Phenytoin (used for the treatment of epilepsy).
• Rifampicin (used for the treatment of certain infections such as tuberculosis (TB)).
• Gemfibrozil (used for treatment of high lipid levels in plasma)

Important information about some of the ingredients of SINTRINE 10: SINTRINE 10 contains lactose monohydrate which may have an effect on the control of your blood sugar if you have diabetes mellitus. Patients with the rare hereditary conditions of lactose/fructose or galactose intolerance should not take SINTRINE 10.

SINTRINE 10 with food and drink

SINTRINE 10 can be taken with or without food.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking SINTRINE 10.

Driving and using machinery:

SINTRINE 10 may make you drowsy which may impair your ability to drive and use machinery. Take care if you feel dizzy, tired or drowsy while using SINTRINE 10.

Do not share medicines prescribed for you with any other person.

Always take SINTRINE 10 exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

The recommended dosage of SINTRINE 10 is one tablet a day in the evening with or without food for the prevention and treatment of asthma.

If you have the impression that the effect of SINTRINE 10 is too strong or too weak, talk to your doctor or pharmacist.

It is important to continue taking SINTRINE 10 for as long as your doctor prescribes it in order to maintain control of your asthma. SINTRINE 10 can treat your asthma only if it is taken continuously.

If you have any questions about the proper dose or usage of SINTRINE 10, ask your doctor or pharmacist.

If you take more SINTRINE 10 than you should:

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

If you forget to take SINTRINE 10

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

If you stop taking SINTRINE 10

SINTRINE 10 can treat your asthma only if you continue to take it. It is important to continue taking SINTRINE 10 for as long as your doctor prescribes. It will help control your asthma.

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

SINTRINE 10 can have side effects. Not all side effects reported for SINTRINE 10 are included in this leaflet. Should your general health worsen of if you experience any untoward effects while taking SINTRINE 10, 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
• 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
• behaviour and mood related changes: hallucinations, disorientation, suicidal thoughts and actions
• 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
• headache
• Upper respiratory tract infections
• diarrhoea, nausea, vomiting
• rash
• fever
• elevated liver enzymes

Less Frequent:

• Stuffy- nose, coughing
• Heartburn
• toothache
• behaviour and mood related changes: disturbance in attention, memory impairment, uncontrolled muscle movements
• tender red lumps under the skin, most commonly on your shins (erythema nodosum)
• behaviour and mood related changes: obsessive-compulsive symptoms, stuttering
• joint or muscle pain, muscle cramps
• bedwetting in children
• weakness/tiredness, feeling unwell, swelling
• behaviour and mood related changes: disturbance in attention, memory impairment, uncontrolled muscle movements
• tender red lumps under the skin, most commonly on your shins (erythema nodosum)
• behaviour and mood related changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects

If you get side effects, talk to your doctor, or pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of SINTRINE ® 10. Suspected side-effects can also be reported directly to the Holder of Certificate of Registration (HCR) via the website: https://pvi1j.solutions.iqvia.com or the e-mail address, [email protected].

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Store at or below 25 °C. Store in the original package. The product is sensitive to light and moisture.
• Container: Keep the bottle 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).