Description

Product Overview

What Azithromycin is and what it is used for

Azithromycin belongs to a group of medicines called macrolide antibiotics. Antibiotics are used to treat infections caused by microorganisms like bacteria.
Azithromycin is used for the treatment of certain infections caused by bacteria that are sensitive to it, such as:
•Chest, throat or nasal infections (such as bronchitis, pneumonia, tonsillitis, sore throat (pharyngitis) and sinusitis)
•Ear infections
•Skin and soft tissue infections, with exception of infected burn wounds e.g. – infection of the tube that carries urine from the bladder (urethra) or the neck of the womb (cervix) caused by Chlamidia trachomatis (bacteria).

What you need to know before you take Azithromycin

Do not take Azithromycin if:
•You are allergic to azithromycin dihydrate, erythromycin or any macrolide or ketolide antibiotic
•You are allergic to any of the other ingredients of this medicine.

Warnings and precautions

Talk with your doctor or pharmacist before taking Azithromycin if:
•You have severe liver or kidney problems
•You have severe heart problems or problems with your heart beat such as long QT syndrome (shown on an electro-cardiogram or ECG machine)
•Your blood levels of potassium or magnesium are too low
•You develop signs of another infection
•You are taking any ergot derivatives such as ergotamine (to treat migraine) as these medicines should not be taken together with azithromycin (see section “Taking other medicines”)
•You have a certain type of muscle weakness called myasthenia gravis
•You have nervous (neurological) or mental (psychiatric) problems.

Other medicines and Azithromycin
•Tell your doctor if you are taking, have recently taken or might take any other medicines.
•Tell your doctor or pharmacist if you are taking any of the following medicines:
•Antacids – used for heartburn and indigestion. Azithromycin should be taken at least 1 hour before or 2 hours after the antacid
•ergotamine – (used for migraine) should not be taken at the same time as serious side effects may develop (with numbness or tingling sensations in the limbs, muscle cramps, headaches, convulsions, abdominal or chest pain)
•cholesterol lowering medicines (statins)
•Warfare or similar medicines – used to thin the blood. Azithromycin can thin the blood even more

Azithromycin with food and drink
This medicine can be taken with or without food.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is insufficient information available about the use of azithromycin during pregnancy. Therefore you should not use Azithromycin during pregnancy, unless explicitly advised by your doctor.
Azithromycin is partially passed through the mother’s milk; therefore Azithromycin should not be used if you are breastfeeding.

Driving and using machines
There are no data available about the influence of azithromycin on the ability to drive or operate machines. However azithromycin tablets may cause dizziness and seizures so make sure you are not affected before driving or operating machinery.

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

How to take Azithromycin

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

For adults and young people with a body weight of 45kg or over
500mg once daily during three days with a total dose of 1500mg. Your doctor may decide to prescribe the total dose of 1500mg during a period of 5 days, with 500mg the first day and 250mg on days 2 to 5.

For infections of the neck of the womb and urethra caused by Chlamydia trachomatis
One dose of 1000mg, to be taken one time.

Children and adolescents under 45kg
The tablets are not recommended. Young people with a body weight of less than 45kg should use other forms of this medicine.

Patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal dose.

Dosage for elderly
For elderly the same dosage as for adults applies.

Administration
The tablets should be taken with ½ glass of water.

If you take more Azithromycin than you should
If you have taken too much Azithromycin, contact your doctor, pharmacist or go to your nearest hospital at once.
Symptoms of overdose are loss of hearing, feeling sick or being sick and diarrhoea. In case of over dosage admission into hospital may be necessary.

If you forget to take Azithromycin
If you forget to take Azithromycin, take your dose as soon as possible. If it is almost time for the next dose, just skip that dose and take the next one when it is due. If in doubt, please contact your doctor or pharmacist. If you have to skip a dose, still take all of your tablets. This means that you will finish your course a day later.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Azithromycin
Never stop the treatment with Azithromycin on your own, but first discuss this with your doctor. If the prescribed treatment is not completely finished, the infection may come back again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have any of the following symptoms of a severe allergic reaction stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital
•Sudden difficulty in breathing, speaking and swallowing
•Swelling of the lips, tongue, face and neck
•Extreme dizziness or collapse
•Severe or itchy skin rash, especially if this shows blistering and there is soreness of the eyes, mouth or genital organs.

If you experience any of the following side effects contact your doctor as soon as possible

•Diarrhoea that is serious lasts a long time or has blood in it, with stomach pain or fever. This can be a sign of a serious bowel inflammation. This is something that can rarely happen after taking antibiotics
•Yellowing of the skin or whites of the eyes caused by liver problems
•Inflammation of the pancreas, which causes severe pain in the abdomen and back
•Increased or reduced urine output, or traces of blood in your urine
•Skin rash caused by sensitivity to sunlight
•Unusual bruising or bleeding

These are all serious side effects. You may need urgent medical attention. Serious side effects are uncommon (may affect up to 1 in 100 people) or the frequency cannot be estimated from the available data.

Other side effects include

Very common (may affect more than 1 in 10 people)
•Diarrhoea
•Abdominal pain
•Feeling sick (nausea)
•Loose wind (flatulence).

Common (may affect up to 1 in 10 people)
•Lack of appetite (anorexia)
•Feeling dizzy
•Headache
•Sensation of pins and needles or numbness (par aesthesia)
•Changes in your sense of taste
•Visual impairment

Uncommon (may affect up to 1 in 100 people)
•Thrush (candidiasis) – a fungal infection
•Fungal infection
•Bacterial infection
•Inflammation of the throat (pharyngitis)
•Breathlessness, chest pain, wheeze and cough (respiratory disorder)
•Inflammation of the mucous membrane inside the nose (rhinitis)

Rare (may affect up to 1 in 1,000 people)
•Feeling agitated, feeling of unreality to the self and own feeling
•Abnormal hepatic function
•Allergic skin reactions
•Swelling of the hands, feet, lips, genitals or throat (angioneurotic oedema)
•Kidney problems.

Not known (frequency cannot be estimated from the available data)
•Gut (colon) infection (pseudomembranous colitis)
•Reduced number of red blood cells due to destruction (haemolytic anaemia); reduction in number of platelets (thrombocytopenia)
•Anaphylactic reaction
•Feeling angry, aggressive
•Anxiety
•Confusion

The following side effects have been reported in prophylactic treatment against Mycobacterium Avium complex (MAC):

Very common (may affect more than 1 in 10 people)
•Diarrhoea
•Abdominal pain
•Feeling sick (nausea)
•Loose wind (flatulence)
•Abdominal discomfort
•Loose stools

Common (may affect up to 1 in 10 people):
•Lack of appetite (anorexia)
•Feeling dizzy
•Headache
•Sensation of pins and needles or numbness (paraesthesia)
•Changes in your sense of taste
•Visual impairment

Uncommon (may affect up to 1 in 100 people):
•Reduced sense of touch (hypoaesthesia)
•Hearing loss or ringing in your ears
•Palpitations
•Liver problems such as hepatitis
•Severe form of skin flushing
•Allergic skin reactions such as being sensitive to sunlight, red, flaking and swollen skin

How to store Azithromycin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of that month.
PVC/Alu blister: Store below 25°C. Store in the original packaging to protect from moisture.
OPA-PVC-Alu/Alu blister: This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.