1- WHAT DEFONASE IS AND WHAT IT IS USED FOR
DEFONASE is fruit-flavored Loratadine/ pseudoephedrine syrup.
Loratadine is used as non-sedating long-acting antihistamine and pseudoephedrine is a natural occuring alkaloid of Ephedra that is used as vasoconstrictor and decongestant.
DEFONASE is indicated for the relief of symptoms associated with allergic rhinitis and common cold such as sneezing, nasal discharge (rhinorrhea), lacrimation, pruritis and itching.
Version No. AI0009-05

2- BEFORE YOU TAKE DEFONASE
A-Do not take DEFONASE:
• Do not use this medication if you are allergic to Loratadine, pseudoephedrine, adrenergic agents, or other drugs of similar chemical structures or any of defonase excipients.
• If you suffer from any of the following diseases; narrow-angle glaucoma,
urinary retention, severe hypertension or severe coronary artery disease.
• If you are treated with monoamine oxidase (MAO) inhibitor therapy or within 2 weeks of its stopping.
• This medicine should not be used for children below 6 years of age.
B-Take special care with DEFONASE
Check with your physician or pharmacist before using this medicine if:
• You have any of the following diseases: cardiovascular diseases, diabetes mellitus, increased intraocular pressure, renal impairment, prostatic hypertrophy and hyperthyrodism.
• You are more than 60 years old.
• Defonase may cause CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension.
C-Taking other medicines, herbal or dietary supplements
DEFONASE is contraindicated in patients taking MAO inhibitor and for 2 weeks after stopping it. The antihypertensive effects of beta blockers may be reduced by sympathomimetics. Increased ectopic pacemaker activity can occur when DEFONASE is used concomitantly with digitalis. Please tell your
physician or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
D-Taking DEFONASE with food and drink
DEFONASE can be taken by mouth with or without food.
E-Pregnancy
Loratadine/ pseudoephedrine are classified as class B so DEFONASE should be used if the expected benefits weigh the potential risks.
Ask your physician or pharmacist for advice before taking any medicine.
F-Breastfeeding
Loratadine & pseudoephedrine would not be expected to cause any adverse effects in breastfeed infants however pseudoephedrine may cause occasional irritability.
Loratadine & pseudoephedrine might have a negative effect on lactation .
Mothers with newborns whose lactation is not yet well established or mothers who are having difficulties producing sufficient milk should not use DEFONASE
Ask your physician or pharmacist for advice before taking any medicine.
G- Driving and using machines
Drowsiness may occur which may affect on the ability to drive or using machine.
H- Important information about some of the ingredients of DEFONASE:
DEFONASE syrup contains :
E420 which may have a mild laxative effect.
E211 which may increase the risk of jaundice in newborn babies.
 

3- HOW TO TAKE DEFONASE
Always take DEFONASE syrup exactly as your physician has told you.
You should check with your physician or pharmacist if you are not sure.
Dosage
Your physician will determine what dose is appropriate for you.
Doses in allergic rhinitis and common cold:
Children 6-12 years (body weight < 30 kg) : 2.5 ml twice daily.
Children 6-12 years (body weight > 30 kg) and Adults : 5 ml twice daily.
Or as prescribed by the physician
If you take more DEFONASE than you should:
Call your physician or go to the nearest hospital emergency unit immediately.
Overdosage manifestations:
CNS depressions (sedation, apnea, diminished mental alertness, cyanosis, coma, cardiovascular collapse) or CNS stimulation (insomnia, hallucination, tremors or convulsions). Other signs may be euphoria, excitement, tachycardia, palpitations, thirst, perspiration, nausea, tinnitus, ataxia, blurred vision and hypertension or hypotension. In the event of overdosage, treatment which should be started immediately is symptomatic and supportive.
If you forget to take DEFONASE:
if you forget to take a dose, take the missed dose as soon as you remember it.
However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.
Do not take a double dose to make up for a missed one.
If you stop taking DEFONASE SYRUP:
Do not stop taking DEFONASE unless your physician tells you to. If you have any
further questions on the use of this product, ask your physician or pharmacist.
 

4- POSSIBLE SIDE EFFECTS
Like all medicines, DEFONASE can cause side effects, although not everybody gets them.
Tell your physician immediately if you experience any of the following symptoms:
The common side effects are insomnia and dry mouth .
Rare side effects are: Nervousness, dizziness, fatigue, nausea, abdominal distress, anorexia, thirst, tachycardia, pharyngitis, rhinitis, acne, pruritus, rash, urticaria, arthralgia, confusion, dysphonia, hyperkinesia, hypoesthesia, decreased libido, paraesthesia, tremor, vertigo, flushing, postural hypotension, increased sweating, eye disorders, earache, tinnitus, taste abnormality, agitation, apathy, depression, euphoria, paroniria, increased appetite, change in bowel habits, dyspepsia, eructation, hemorrhoids, tongue discolouration, tongue disorder, vomiting, transient abnormal hepatic function, dehydration, increased weight, hypertension, palpitation, migraine, bronchospasm, coughing, dyspnea, epistaxis, nasal congestion, sneezing, nasal irritation, dysuria, micturition disorder, nocturia, polyuria, urinary retention, asthenia, back pain, leg cramps and malaise.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your physician or pharmacist.
 

5- HOW TO STORE DEFONASE
Store below 30° C.
Keep out of reach of children
To be used within one month after first opening.
Store in the original container.
Do not use DEFONASE after the expiry date which is stated on the box.
The expiry date refers to the last day of that month.
Do not use DEFONASE if you notice any visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.