AZOLID 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 trachomatis and Neisseria gonorrhea.

Do not take AZOLID to you or your child:

• Are allergic to AZOLID or any other macrolide antibiotics such as erythromycin or clarithromycin or any of the ingredients listed in section 6. An allergic reaction may cause a skin rash or wheezing.
• Are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines should not be taken together with AZOLID.
• Are patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
• patients with known prolongation of 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, amiodarone, sotalol) antiarrhythmic agents.

Take special care with AZOLID

Your doctor needs to know before you take AZOLID if you/your child have or have had any of the following conditions:

• Kidney problems.
• Heart conditions.
• Diabetes.
• If you are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines should not be taken together with AZOLID.
• Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure.

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 AZOLID.

If you/your child develop diarrhea or loose stools during or after treatment, tell your doctor at once. Do not take any medicine to treat your diarrhea without first checking with your doctor. If your diarrhea continues, please inform your doctor.

Taking other medicines

Tell your doctor before taking AZOLID, if you/your child are taking any of the medicines listed below:

• Ergot or ergotamine – see ‘Do not take AZOLID’ 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).
• Terfenadine (for hay fever or a skin allergy).
• Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents – see ‘Do not take AZOLID’ section.

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 AZOLID with food and drink

You should take AZOLID tablets either 1 hour before a meal or 2 hours after a meal.

Pregnancy and breast-feeding

If you are pregnant, trying to get pregnant, or are breastfeeding you should not take AZOLID without discussing it with your doctor first.

Driving and using machines

AZOLID is not expected to affect your ability to drive or use machines.

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

AZOLID tablets:

The usual dose in adults and children over (45 kg) is 500mg taken together, once a day, for 3 days.

For some diseases such as Chlamydia, the dose is 1g taken all together on one day only. For gonorrhea, the recommended dose is 1 g or 2 g of azithromycin in combination with 250 mg or 500 mg of ceftriaxone.

AZOLID tablets should not be taken by children weighing less than 45kg.

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. If you are still not sure, ask your doctor or pharmacist.

Always continue with the course even if you/your child feels 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.

If you/your child take more AZOLID than you should

If you take too much AZOLID you may feel unwell. Tell your doctor or contact your nearest hospital casualty department immediately.

If you forget to take or give AZOLID

If you forget to take AZOLID 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 AZOLID

If you/your child stops taking AZOLID too soon, the infection may return. Take AZOLID for the full time of treatment, even when you 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, AZOLID 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 diarrhea, which may have blood or mucus in it, during or after treatment with AZOLID as this may be a sign of serious bowel inflammation.
• Severe skin rash causing redness and flaking.
• Rapid or irregular heartbeat.
• Low blood pressure.

The most common side effects that occur when taking AZOLID 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 AZOLID):

• Stomach cramps, feeling sick, diarrhea, 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), a higher number of eosinophils (type of white blood cells).
• Low blood bicarbonate.
• Tiredness or weakness.

Uncommon side effects that occur in less than 1 in 100 people taking AZOLID 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 severities.
• blistering of the skin, mouth, eyes, and genitals.
• Skin more sensitive to sunlight than normal.
• Feeling nervous.
• Reduced sense of touch or sensation (hypoesthesia).
• Sleepiness or sleeplessness (insomnia).
• Poor hearing or ringing in the ears.
• Heart palpitations, chest pain.
• Constipation, stomach pain associated with diarrhea, and fever.
• Inflammation of the liver (hepatitis), changes in liver enzymes.
• General loss of strength.
• Swelling.
• General discomfort.
• Abnormal laboratory test values (e.g. blood or liver tests).

Rare side effects that occur in less than 1 in 1,000 people taking AZOLID are:

• Agitation.
• Vertigo.
• 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.
• localized muscle weakness.
• Loss of smell or altered sense of smell, loss of taste.
• Tongue discoloration.
• 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 an injury.
• Blistering of the skin, severe skin reaction.
• Abnormal electrocardiogram (EEG).  Prolongation of the QT interval: Cases of torsades de points have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Although the absolute risk is unknown, it appears to be low with azithromycin likely due to the lack of appreciable drug interactions, and the observation that it is rarely reported as a postmarketing adverse event. However, it would be prudent to avoid use in patients with known prolongation of 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, amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.
• Reduction in red blood cells 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.

Store below 30°C.

Keep out of the reach of children.