Azi-Once™ is one of a group of antibiotics called macrolides. It is used to treat
infections caused by certain bacteria and other micro-organisms which include:
• chest, throat or nasal infections (such as bronchitis, pneumonia, tonsillitis, sore
throat (pharyngitis) and sinusitis).
• ear infections.
• skin and soft tissue infections (such as an abscess or boil).
• sexually-transmitted diseases caused by an organism called chlamydia.

Do not take Azi-Once™ if you/your child:
• are allergic to Azi-Once™ or any other macrolide antibiotic such as erythromycin or
clarithromycin or any of the ingredients listed in section 6. An allergic reaction may
cause skin rash or wheezing.
• you are taking any ergot derivatives such as ergotamine (used to treat migraine) as
these medicines should not be taken together with Azi-Once™.
Take special care with Azi-Once™
Your doctor needs to know before you take Azi-Once™ if you/your child have or
have had any of the following:
• kidney problems. • heart conditions. • diabetes .
• liver problems: your doctor may need to monitor your liver function or stop the
treatment.
• and if you are taking any ergot derivatives such as ergotamine (used to treat
migraine) as these medicines should not be taken together with Azi-Once™.
Tell your doctor immediately if you feel your heart beating in your chest or have an
abnormal heartbeat, or get dizzy or faint or suffer from any muscle weakness when
taking Azi-Once™.
Prolonged cardiac repolarization and QT interval, imparting a risk of developing
cardiac arrhythmia and torsades de pointes, have been seen in treatment with
macrolides, including azithromycin. Cases of torsades de pointes have been
spontaneously reported during postmarketing surveillance in patients receiving
azithromycin.
Providers should consider the risk of QT prolongation which can be fatal when
weighing the risks and benefits of azithromycin for at-risk groups including:
• patients with known prolongation of the QT interval, a history of torsades de
pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart
failure.
• patients on drugs known to prolong the QT interval.
• patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or
hypomagnesemia, clinically significant bradycardia, and in patients receiving Class
IA (quinidine, procainamide) or Class III (dofetilide, aminodarone, sotalol)
antiarrhythmic agents.
Elderly patients may be more susceptible to drug-associated effects on the QT
interval.
If you develop diarrhoea or loose stools during or after treatment, tell your doctor at
once. Do not take any medicine to treat your diarrhoea without first checking with
your doctor. If your diarrhoea continues, please inform your doctor.
Talk to your doctor before taking azithromycin if you:
• have been diagnosed with a neurological disease, which is a disease of the brain or
nervous system.
• have mental, emotional or behavioural problems.
• have a condition known as myasthenia gravis, with fatigue and exhaustion of the
muscles: azithromycin may worsen or cause symptoms of myasthenia.
• Azithromycin is not recommended for patients under 6 months of age.
In patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide,
aminodarone, sotalol) antiarrhythmic agents (used to treat abnormal heart
rhythms), cisapride (used to treat stomach problems) or terfenadine (an antihistamine
that is used to treat allergies): azithromycin is not recommended.
Taking other medicines
Tell your doctor before taking or giving Azi-Once™ if you/your child are taking any
of the medicines listed below:
• ergot or ergotamine, see ‘Take special care’ section.
• warfarin or any similar medicine to prevent blood clots.
• ciclosporin (used to suppress the immune system to prevent and treat rejection of a
transplanted organ or bone marrow).
• antacids (for indigestion).
• digoxin (used to treat heart failure).
• Zidovudine, nelfinavir (used in the treatment of HIV).
• Statins (such as atorvastatin, used to lower lipids in blood).
• Rifabutin (used in the treatment bacterial infections including tuberculosis).
• Cisapride (used to treat stomach problems).
• Astemizole, terfenadine (antihistamines used to treat allergic reactions).
• Alfentanil (a painkiller).
• Fluconazole (for fungal infections).
• colchicine (used for gout and familial Mediterranean fever).
You should always tell your doctor if you/your child are taking or have recently taken
any other medicines including those obtained without a prescription.
Taking Azi-Once™ with food and drink
Azi-Once™ is not affected by food or drink.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or are breast-feeding you should not
take Azi-Once™ without discussing it with your doctor first.
Driving and using machines
Azi-Once™ is not expected to affect your ability to drive or use machines.
Important information about some of the ingredients of Azi-Once™
This medicine contains sucrose, a type of sugar (3.69g in 5ml).
If you have been told by your doctor that you have an intolerance to some sugars
contact your doctor before taking Azi-Once™.
If you are diabetic, you may need to take this into account in your diet.

Always take or give Azi-Once™ exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Azi-Once™ suspension is generally used for children 6 months and above. It may
also be used in adults and older children who have difficulty swallowing capsules.
Children under 45kg
The usual dose in children is 10mg for each kg of body weight, given as a single daily
dose for 3 days.
Adults and children over 45kg
The usual dose in adults and in children over 45kg is 500mg taken as a single dose,
for 3 days.
You should tell your doctor if you/your child have kidney or liver problems as your
doctor may need to alter the normal dose.
Doctors sometimes prescribe different doses to these. The label on the pack will tell
you which dose you/your child should take. If you are still not sure, ask your doctor
or pharmacist.
Always continue with the course of treatment even if you/your child feel better. If
your infection gets worse or you do not start to feel better within a few days or a new
infection develops, go back and see your doctor.
How to give Azi-Once™ Suspension in children less than 3 years of age
If your child is under three years of age or weighs up to 15kg in body weight, you
should measure the dose as clearly as possible using the 10ml oral dosing syringe
provided. The syringe is graduated in 0.25 ml divisions, providing 10mg of
azithromycin (the active ingredient) in every graduation.
Instructions for the syringe
1. Add the water provided in the pack to the powder in the bottle
(in the first use only).
2. Shake it very well to obtain a homogeneous suspension.
3. Use the syringe to draw the required volume after removal of its cover.
4. Deliver the dose smoothly by syringe inside your child mouth.
5. Wash the syringe, cover it and return it to the pack for the next dose.
How to give Azi-Once™ Suspension in children between 3 and 14 years of age

Warning: if giving this medicine to a child, ensure that while receiving the medicine he/she is supported in an upright position to avoid the risk of choking. If you/your child takes more Azi-Once™ than they should If you/your child take too much Azi-Once™ they may feel unwell. Tell your doctor or contact your nearest hospital casualty department immediately. Take any remaining medicine with you. If you forget to take or give Azi-Once™ If you forget to take Azi-Once™ take it as soon as you can. Take your next dose at the right time. Do not take a double dose to make up for a forgotten dose. If you stop taking Azi-Once™ If you/your child stop taking Azi-Once™ too soon, the infection may return.  Take Azi-Once™ for the full time of treatment, even when you/your child begin to feel better. If you have any further questions about the use of this product, ask your doctor or pharmacist for advice. 

Like all medicines Azi-Once™ can cause side effects although not everybody gets them. Tell your doctor immediately if you experience any of the following symptoms after taking this medicine as the symptoms can be severe.  • sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash          or itching (especially affecting the whole body) • severe or prolonged diarrhoea, which may have blood or mucus in it, during or          after treatment with Azi-Once™ as this may be a sign of serious bowel inflammation • severe skin rash causing redness and flaking • rapid or irregular heartbeat  • low blood pressure• Serious skin reactions: - blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome (SJS)) - blistering of the skin, severe skin reaction (Toxic Epidermal Necrosis (TEN)) - skin rash accompanied by other symptoms such as fever, swollen glands and an increase of eosinophils (a type of white blood cell). A rash appears as small, itchy red bumps (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)) - skin eruption that is characterised by the rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid) (Acute Generalized Exanthematous Pustulosis (AGEP)). Stop taking azithromycin if you develop these skin symptoms and contact your doctor or seek medical attention immediately.The most common side effects that occur when taking Azi-Once™ are listed below. These may go away during treatment as your body adjusts to the medicine. Tell your doctor if any of these side effects continue to bother you: Very common side effects (occurring in at least 1 in 10 people taking Azi-OnceTM): • stomach cramps, feeling sick, diarrhoea, wind Common side effects (likely to occur in less than 1 in 10 people) dizziness, headache, numbness or pins and needles, being sick, indigestion, loss of appetite, taste disturbance, visual disturbances, deafness, skin rash and /or itching, joint pain, low numbers of lymphocytes (type of white blood cells), higher number of eosinophils (type of white blood cells), low blood bicarbonate and tiredness or weakness

Uncommon side effects that occur in less than 1 in 100 people taking Azi-Once™ are: yeast infections of the mouth and vagina (thrush), low numbers of leukocytes (type of white blood cells), low number of neutrophils (type of white blood cells), allergic reactions of various severity, blistering of the skin, mouth, eyes and genitals, skin more sensitive to sunlight than normal, feeling nervous, reduced sense of touch or sensation (hypoesthesia), sleepness or sleeplessness (insomnia), poor hearing or ringing in the ears, heart palpitations, chest pain, constipation, stomach pain associated with diarrhoea and fever, inflammation of the liver (hepatitis), changes in liver enzymes, general loss of strength, swelling, general discomfort and abnormal laboratory test values (e.g. blood or liver tests). Rare side effects that occur in less than 1 in 1,000 people taking Azi-OnceTM are: agitation, vertigo and changes in liver function Other side effects that have been reported, but it is not known how frequently they occur: fits or fainting, aggression or anxiety, feeling hyperactive, localised muscle weakness, loss of smell or altered sense of smell, loss of taste, tongue discolouration, inflammation of the pancreas (pancreatitis), inflammation of the kidney or kidney failure, yellowing of the skin or eyes (jaundice) or liver failure (rarely life-threatening), bruising or prolonged bleeding after injury, abnormal electrocardio-gram (ECG) and reduction in red blood cells which can make the skin pale and cause weakness or breathlessness. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 

Keep all medicines out of the sight and reach of children.Store dry powder at temperature not exceeding 30 ºC, and after reconstitution store at temperature not exceeding 30 ºC. Discard any unused portion after 5 days of reconstitution.Do not take or give this medicine after the expiry date which is stated on the bottle. 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.