Montash Film-Coated Tablets

MONTASH blocks the substances responsible for narrowing and swelling of the lungs, called leukotrienes. When montelukast blocks leukotrienes, it helps control asthma and improves the symptoms associated with asthma. MONTASH has been prescribed to treat you or your child’s asthma, which may be worsened by allergies as well as preventing asthma symptoms. MONTASH CHEW 4 is used in children from ages 2 – 5 years old. MONTASH CHEW 5 is used in children from ages 6 – 14 years old. MONTASH 10 is used in adults and children over the age of 15 years old. MONTASH 10 may also assist with in relieving the symptoms associated with seasonal allergies, in adults with asthma.

Do NOT take MONTASH:

• If you are hypersensitive (allergic) to montelukast or any of the other ingredients of MONTASH (listed in section 6).
• MONTASH CHEW 4 should not be given to your child if he/she is under the age of 2 years old.
• MONTASH CHEW 5 should not be given to your child if he/she is under the age of 6 years old.
• MONTASH 10 should not be given to your child if he/she is under the age of 15 years old.

Warnings and precautions:

Special care should be taken with MONTASH:

• If you have sudden asthma attacks, MONTASH does not relieve asthma symptoms immediately. Always keep your inhaler with you for acute attacks. Please consult your doctor if more inhalations are needed than usual.
• If you have other medicines prescribed for you/your child. MONTASH is not a substitute for other asthma medicines such as inhaled or oral corticosteroids (used to relief inflammation).
• If you have medicines used to treat asthma, including MONTASH, may cause a reaction. Contact your doctor immediately if you experience rash, difficulty breathing, heart pain or pins and needles or weakness/numbness in your hands, feet, arms or legs.
• If you are sensitive to aspirin and other steroidal anti-inflammatories, MONTASH does not change the need for asthma patients to avoid these medicines.

Children and adolescents

MONTASH CHEW 4 is used in children from ages 2 – 5 years old. MONTASH CHEW 5 is used in children from ages 6 - 14 years old. MONTASH 10 is used in adults and children over the age of 15 years old.

Other medicines and MONTASH

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.) Please discuss the use of the following medicines or substances in combination with MONTASH with your doctor or pharmacist:

• Phenytoin and phenobartital (medicine used to treat epilepsy).
• Rifampicin (a medicine used to treat TB and other infections).
• Gemfibrozil (a medicine used to treat high blood cholesterol levels).

MONTASH with food and drink:

MONTASH can be taken with or without a meal.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

Pregnancy:

The safety of MONTASH in pregnant women has not been established.

Breastfeeding:

Do not take MONTASH if you are breastfeeding or intend to breastfeed your baby.

Driving or using machinery:

You may experience drowsiness and dizziness when taking MONTASH. It is not always possible to predict to what extent MONTASH may interfere you’re your daily activities. Therefore, you should not drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether MONTASH affects your ability to perform such activities.

MONTASH contains aspartame (an artificial sweetener), a source of phenylalanine (amino acid). This should be taken into account if you have been diagnosed with phenylketonuria (a birth defect that causes amino acid to build up in your body).

• Each chewable tablet of MONTASH CHEW 4 contains 0,6 mg aspartame.
• Each chewable tablet of MONTASH CHEW 5 contains 0,743 mg aspartame.
• Each tablet of MONTASH 10 contains 1,5 mg aspartame.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Do not share medicines prescribed for you with any other person. Always take MONTASH exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Oral. MONTASH CHEW 4 and MONTASH CHEW 5 must be chewed before swallowing. The usual dose is one tablet at night. Your doctor will determine how MONTASH should be used depending on the symptoms and severity of your or your child’s asthma. MONTASH CHEW 4 is used in children from ages 2 – 5 years old. MONTASH CHEW 5 is used in children from ages 6 - 14 years old. MONTASH 10 is used in adults and children over the age of 15 years old. Your doctor may add MONTASH to your existing asthma medicines. Do not stop taking MONTASH if your asthma is under control. If you or child’s asthma or breathing gets worse, tell your doctor immediately. Do not exceed the recommended daily dosage.

If you take more MONTASH 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. Signs and symptoms of overdose include stomach pain, headache, feeling restless or hyperactive, drowsiness, thirst and vomiting.

Always take MONTASH as prescribed (see “HOW TO TAKE MONTASH”). If you forget to take MONTASH:

Always take MONTASH as prescribed (see “HOW TO TAKE MONTASH”). If you have missed a dose, take it as soon as you remember. Do not take a double dose of MONTASH to make up for forgotten individual doses.

If you stop taking MONTASH:

DO NOT stop taking MONTASH without discussing this with your doctor, even if you feel better. If your doctor thinks that you should stop using MONTASH, he/she will reduce your dose gradually over at least 2 weeks and then stop treatment completely.

MONTASH can have side effects. Not all side-effects reported for MONTASH 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 provider for advice. If any of the following happens, stop taking / using MONTASH 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
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to MONTASH. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Having suicidal thoughts
• Changes in the way your heart beats, for example, if you notice it beating faster
• Worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) (see Warnings and precautions)
• Yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems.

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:

• Stomach pain, headache and thirst
• Chest infections
• Diarrhoea, nausea and vomiting
• Increase in liver enzymes
• Increase in body temperature.

Less frequent side effects:

• Increased bleeding tendency, low number of platelets in the blood
• Abnormal dreams (including nightmares), sleeplessness, sleepwalking, feeling anxious, agitated (including aggressive behaviour or being hostile), or depressed; mood disorders (including feeling irritable, restless or having seizure), disturbance in attention, loss of memory, sudden uncontrolled body movements, hallucinating (seeing things/objects not there), feeling disoriented, obsessive compulsive disorders, stuttering
• Dizziness, drowsiness, “pins and needles” sensation, loss or decrease in sensation, fits
• Nose bleeds
• Dry mouth, indigestion
• Inflammation of the liver
• Swellling under the skin, bruising, lesions on the skin, bumps under the skin
• Joint pain, muscle pain and muscle cramps
• Bedwetting in children
• Weakness and tiredness, a general feeling of illness, swelling.

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 or, 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. Report all side effects to Unicorn Pharmaceuticals (Pty) Ltd to [email protected]. By reporting side effects, you can help provide more information on the safety of MONTASH.

Store at or below 25 ºC. Store in the original packaging. Do not take after the expiry date stated on the package. Return all unused MONTASH to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). KEEP OUT OF REACH OF CHILDREN.