Avarinex 2.5 mg/5 ml Syrup

The active substance is Desloratadine 2,5 mg per 5 ml syrup. AVARINEX SYRUP is an anti-allergy medicine. It helps control your or your child’s allergic reaction and its symptoms. AVARINEX SYRUP relieves symptoms associated with allergic rhinitis (e.g. hay fever), such as sneezing, runny or itchy nose and burning or itchy eyes. AVARINEX SYRUP may also be used to relieve the symptoms associated with chronic idiopathic urticaria (itching, redness and number and size of hives).

Do not take AVARINEX SYRUP:

• If you or your child is hypersensitive (allergic) to desloratadine or to any of the other ingredients of AVARINEX SYRUP (see section 6 “What this product contains”).
• Do not give AVARINEX SYRUP to your child if he/she is under two years of age.
• If you are pregnant or breastfeeding.
• If you or your child suffers from a disease called porphyria (a group of disorders that can cause nerve or skin problems).
• If you or your child are allergic to other antihistamines (check with your doctor if you are unsure).
• If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.

Talk to your doctor or pharmacist before taking AVARINEX SYRUP:

Take special care with AVARINEX SYRUP if you or your child:

• have liver or kidney problems.
• have a medical or family history of seizures
• have any other medical conditions.
• Are going to have a skin test for allergies done, AVARINEX SYRUP should not be consumed 48 hours before you do the test.

Other medicines and AVARINEX SYRUP:

Always tell your healthcare professional if you or your child are taking any other medicine. (This includes complementary or traditional medicine). Before you take AVARINEX SYRUP, make sure your doctor knows if you or your child are taking the following medicines:

• ketoconazole: an antifungal medicine used to treat certain kinds of fungal or yeast infections.
• erythromycin: an antibiotic medicine used to treat certain kinds of bacterial infections and often used for people who have an allergy to penicillins.
• azithromycin: an antibiotic medicine to treat certain kinds of bacterial infections (such as pneumonia and ear infections).
• antihistamines: a medicine commonly used to treat allergies.
• fluoxetine: a medicine used to treat depression.
• cimetidine: a medicine used treat stomach ulcers, acid reflux, or to prevent and treat symptoms of heartburn associated with acid, indigestion and sour stomach.

AVARINEX SYRUP with food, drink, and alcohol:

AVARINEX SYRUP may be taken with or without food.

Pregnancy and breastfeeding and fertility:

You should not use AVARINEX SYRUP if you are pregnant or breastfeeding your baby. If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other health care professional for advice before taking this medicine.

Driving and using machines:

Some people may experience sedation and if you do, you should not drive or perform complicated tasks.

AVARINEX SYRUP contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

AVARINEX SYRUP contains sorbitol

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

AVARINEX SYRUP contains propylene glycol

This medicine contains 500 mg propylene glycol in each 5 mL which is equivalent to 20-25 mg/kg body weight.

Always take AVARINEX SYRUP exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

• Children 2 to 5 years of age: 2.5 ml (1.25 mg) (1/2 a medicine measure) once a day,
• Children 6 to 11 years of age: 5 ml (2.5 mg) (1 medicine measure) once a day,
• Adults and adolescents (12 years of age and over): 10 ml (5 mg) (2 medicine measures) once a day.

Your doctor will determine the duration of your treatment. AVARINEX SYRUP should not be taken for longer than 4 weeks.

Method of administration

For oral use only. To be taken with or without meals.

If you take more AVARINEX SYRUP 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 a dose of AVARINEX SYRUP:

Try to take/give AVARINEX SYRUP as prescribed by your healthcare professional. However, if you or your child miss a dose, do not take/give a double dose to make up for forgotten individual doses.

AVARINEX SYRUP can have side effects. Not all side-effects reported for this medicine are included in this leaflet. Should your or your child’s general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking AVARINEX SYRUP and tell your doctor immediately or go to the nearest hospital immediately or go to the casualty department at your nearest hospital.

• Allergic reaction: if you or your child develop skin rash/ burning or prickling sensation, or fever. These are all very serious side effects. If you or your child have them, you or your child may have had a serious reaction to AVARINEX SYRUP. You or your child may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent:

• Headache
• Trouble sleeping (insomnia)
• Diarrhoea
• Dry mouth
• Tiredness (fatigue)
• Fever

Less Frequent:

• Hallucinations
• Dizziness
• Convulsions (seizures)
• Drowsiness
• Rapid heartbeat
• Palpitations (unpleasant sensation of irregular and/or forceful beating of the heart).
• Stomach pain
• Nausea
• Vomiting
• Indigestion
• Sensitivity to light
• Muscle pain
• Abnormal liver function tests
• Liver inflammation

Frequency Unknown:

• Increased appetite
• Aggression
• Jaundice (yellow colouration of skin)
• Physical weakness
• Weight gain

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

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. By reporting side effects, you can help provide more information on the safety of AVARINEX SYRUP.

• STORE ALL MEDICINE OUT OF REACH OF CHILDREN
• Store AVARINEX SYRUP at or below 30 °C in the original container.
• Do not use this medicine after the expiry date shown on the pack.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or the sewerage system (e.g. toilets).