Patient leaflet - Zithromax 200 mg in 5 ml suspension
1. What Zithromax is and what it is used for
Zithromax contains the active substance azithromycin. Azithromycin is an antibiotic that belongs to a group of antibiotics known as macrolides, which block the growth of susceptible bacteria.
Zithromax is taken for the treatment of the following infections:
Children aged 6 months and older weighing less than 45 kg
- Bacterial sinus infections (sinusitis)
- Bacterial infections of the middle ear (otitis media)
- Pneumonia (community-acquired pneumonia, not contracted in a hospital)
- Bacterial infections of the skin and underlying tissues. Children aged 2 years and older weighing less than 45 kg
Infections of the tonsils (tonsillitis) or throat (pharyngitis) caused by
streptococcal bacteria.
Adults (18 years of age and above) and adolescents (12 - 17 years of age) weighing at least 45 kg who have difficulty in swallowing:
In addition to the infections listed above, Zithromax can also be taken for the treatment of the following infections:
- Infections of urethra and cervix caused by Chlamydia trachomatis bacteria
Infections of urethra and cervix caused by Neisseria gonorrhoeae bacteria.
Zithromax should be used in combination with another antibiotic that is selected by your doctor or pharmacist.
Adults aged 18 years and older only, who have difficulty in swallowing:
- Long-term inflammation of the lungs (chronic bronchitis).
2. What you need to know before you take Zithromax
Do not take Zithromax
if you are allergic to azithromycin, erythromycin, any macrolide or ketolide
antibiotic, or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions
Talk to your doctor or pharmacist before taking Zithromax if you have or have had any of the following conditions:
heart problems (e.g. problems with your heart rhythm or cardiac
insufficiency) or low levels of potassium or magnesium in your blood: these conditions may contribute to serious cardiac side effects of azithromycin
liver problems: your doctor may need to monitor your liver function or stop
the treatment
- severe diarrhoea after administration of any other antibiotics
localised muscle weakness (myasthenia gravis), as the symptoms of this
disease may worsen during treatment
or if you are taking any ergot derivatives such as ergotamine (used to
treat migraine) as these medicines should not be taken together with Zithromax.
Stop taking this medicine and contact your doctor immediately (see also “Serious side effects” in section 4):
if you feel you are having an allergic reaction (e.g. difficulty in breathing,
swelling of the face or throat, rash, blistering)
if you notice any of the symptoms as described in section 4 related
to serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis
(AGEP), which have been reported in association with azithromycin treatment
- if you feel you have an abnormal heartbeat or palpitations, get dizzy or faint when taking Zithromax
- if you develop signs of liver problems (e.g. dark urine, loss of appetite or yellowing of the skin or whites of the eyes)
- if you develop severe diarrhoea during or after treatment. Do not take any medicine to treat your diarrhoea without first checking with your doctor. If your diarrhoea continues or reappears within the first weeks after treatment, please also inform your doctor.
Superinfection
Your doctor may observe you for signs of additional bacterial or fungal infections that cannot be treated with Zithromax (superinfection).
Sexually transmitted infections
Your doctor may test for and exclude a potential infection with syphilis, a sexually transmitted disease that may otherwise progress undetected and be diagnosed with a delay. Furthermore, in any case of sexually transmitted bacterial infections your doctor will initiate laboratory follow-up tests to monitor the success of therapy. Children and adolescents
Ask your doctor or pharmacist if your child is under 6 months of age, as the efficacy and safety of this medicinal product have not demonstrated in these children. Infantile hypertrophic pyloric stenosis (IHPS)
If your child is less than 6 months of age and your doctor recommended treatment with azithromycin, stop administering this medicine to him or her and contact your doctor immediately if she or he presents with projectile vomiting or becomes irritable when fed or shortly after it.
Other medicines and Zithromax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking Zithromax at the same time as some other medicines may result in side effects. Therefore, it is particularly important that you tell your doctor if you are using any of the following medicines:
- Atorvastatin and other medicines from the statins group (to lower blood cholesterol and prevent heart disease, including heart attacks and strokes)
- Ciclosporin (to prevent rejection of organ transplants by the body)
- Colchicine (to treat gout and familial Mediterranean fever)
- Dabigatran (to prevent and treat blood clot formation (anticoagulant))
- Digoxin (to treat heart diseases)
- Warfarin or similar medicines used to thin the blood (anticoagulants)
Medicines that may cause the heart muscle to take longer to contract and relax than usual (QT prolongation), such as the following:
- Quinidine, procainamide, dofetilide, amiodarone and sotalol (to treat an irregular heartbeat, including a too fast or too slow heartbeat – cardiac arrhythmia)
- Pimozide (to treat mental illness)
- Citalopram (to treat depression)
- Moxifloxacin and levofloxacin (antibiotics)
- Cisapride (to treat disorders in the gastrointestinal tract)
Hydroxychloroquine or chloroquine (to treat autoimmune diseases including rheumatoid arthritis, or to treat or prevent malaria) Pregnancy and breast-feeding
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. Pregnancy
Your doctor will decide if you should take this medicine during pregnancy, only after making sure that the benefits outweigh the potential risks.
Breast-feeding
Zithromax passes into breast milk. Your doctor will decide therefore whether you should stop breast-feeding or should avoid treatment with Zithromax taking into account both the benefit of breast-feeding for your child and the benefit of therapy for you.
Driving and using machines
Zithromax has a moderate influence on the ability to drive and use machines. Zithromax has been reported to cause dizziness, drowsiness and seizures, as well as problems with seeing and hearing in some people. These possible side effects may have an influence on your ability to drive and use machines.
Zithromax suspension contains sucrose, glucose, benzyl alcohol and sodium
This medicine contains sucrose and glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains 0.35 microgram benzyl alcohol per 5 ml (200 mg) oral suspension, which following preparation of the suspension is equivalent to 0.07 microgram/ml of benzyl alcohol. Benzyl alcohol may cause allergic reactions. This medicine contains less than 1 mmol sodium (23 mg) per 5 ml oral suspension, that is to say essentially ‘sodium-free’.
Package leaflet: Information for the patient
Zithromax® 200 mg in 5 ml Suspension
azithromycin
3. How to take Zithromax
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended doses and duration of treatment are as follows. Children aged 6 month and older weighing less than 45 kg
| Infection | Treatment course with azithromycin |
Bacterial sinus infections (sinusitis) Pneumonia (community-acquired pneumonia, not contracted in a hospital) Bacterial infections of the skin and underlying tissues | There is a 3-day or a 5-day treatment course for these infections 3‑day treatment course 10 mg/kg/day for 3 days 5‑day treatment course 10 mg/kg taken on the first day of treatment and then 5 mg/kg taken once daily for the following 4 days |
| Bacterial infections of the middle ear (otitis media) | There is a 1-day, a 3-day or a 5-day treatment course for this infection 1‑day treatment course single dose of 30 mg/kg 3‑day treatment course 10 mg/kg/day for 3 days 5‑day treatment course 10 mg/kg taken on the first day of treatment and then 5 mg/kg taken once daily for the following 4 days |
Children aged 2 years and older weighing less than 45 kg
| Infection | Treatment course with azithromycin |
| Infections of the tonsils (tonsillitis) or throat (pharyngitis) caused by streptococcal bacteria | There is a 3-day or a 5-day treatment course for these infections 3‑day treatment course 20 mg/kg/day for 3 days 5‑day treatment course 12 mg/kg/day for 5 days |
It is important to make sure that you use the amount of Zithromax indicated in the table below according to the body weight of the patient, the infection being treated and the specific treatment course (1-day, 3-day or 5-day) that your doctor or pharmacist has instructed you to follow.
| Body weight (kg) | Azithromycin maximum dose per day 40 mg/ml oral suspension in bottle after reconstitution (15 ml, 22.5 ml, 30 ml, 37.5 ml)^ | ||||
| 5 mg/kg+ | 10 mg/kg | 12 mg/kg++ | 20 mg/kg | 30 mg/kg | |
| 7 | 1.00 ml (40 mg) | 1.75 ml (70 mg) | 2.25 ml (90 mg) | 3.50 ml (140 mg) | 5.25 ml (210 mg) |
| 8 | 1.00 ml (40 mg) | 2.00 ml (80 mg) | 2.50 ml (100 mg) | 4.00 ml (160 mg) | 6.00 ml (240 mg) |
| 9 | 1.25 ml (50 mg) | 2.25 ml (90 mg) | 2.75 ml (110 mg) | 4.50 ml (180 mg) | 6.75 ml (270 mg) |
| 10 | 1.25 ml (50 mg) | 2.50 ml (100 mg) | 3.00 ml (120 mg) | 5.00 ml (200 mg) | 7.50 ml (300 mg) |
| 11 | 1.50 ml (60 mg) | 2.75 ml (110 mg) | 3.25 ml (130 mg) | 5.50 ml (220 mg) | 8.25 ml (330 mg) |
| 12 | 1.50 ml (60 mg) | 3.00 ml (120 mg) | 3.75 ml (150 mg) | 6.00 ml (240 mg) | 9.00 ml (360 mg) |
| 13 | 1.75 ml (70 mg) | 3.25 ml (130 mg) | 4.00 ml (160 mg) | 6.50 ml (260 mg) | 9.75 ml (390 mg) |
| 14 | 1.75 ml (70 mg) | 3.50 ml (140 mg) | 4.25 ml (170 mg) | 7.00 ml (280 mg) | 10.50 ml (420 mg) |
| 15 | 2.00 ml (80 mg) | 3.75 ml (150 mg) | 4.50 ml (180 mg) | 7.50 ml (300 mg) | 11.25 ml (450 mg) |
| 16 - 25 | 2.50 ml (100 mg) | 5.00 ml (200 mg) | 6.25 ml (250 mg) | 10.00 ml (400 mg) | 15.00 ml (600 mg) |
| 26 - 35 | 3.75 ml (150 mg) | 7.50 ml (300 mg) | 8.75 ml (350 mg) | 12.50 ml (500 mg)# | 22.50 ml (900 mg) |
| 36 - < 45 | 5.00 ml (200 mg) | 10.00 ml (400 mg) | 11.25 ml (450 mg) | 12.50 ml (500 mg)# | 30.00 ml (1200 mg) |
^ after reconstitution, the concentration of the oral suspension is 40 mg/ml and the total volume of suspension in the bottle is (15 ml, 22.5 ml, 30 ml, 37.5 ml). + Doses have been rounded to obtain an appropriate dose to be administered. ++ Doses have been rounded to obtain an appropriate dose to be administered. # not to exceed the adult daily dose of 500 mg
Adult and adolescent patients weighing at least 45 kg who have difficulty in swallowing
| Infection | Treatment course with azithromycin |
Infections of the tonsils (tonsillitis) or throat (pharyngitis) caused by streptococcal bacteria Bacterial sinus infections (sinusitis) Bacterial infections of the middle ear (otitis media) Bacterial infections in patients with long-term inflammation of the lungs (chronic bronchitis)* Pneumonia (community-acquired pneumonia, not contracted in a hospital)# Bacterial infections of the skin and underlying tissues | There is a 3-day or a 5-day treatment course for these infections, and the amount of Zithromax to take each day is described for these treatment courses below. 3‑day treatment course 12.5 ml (500 mg) taken once daily for 3 days 5‑day treatment course 12.5 ml (500 mg) taken on the first day of treatment and then 6.25 ml (250 mg) taken once daily for the following 4 days |
| Infections of urethra and cervix caused by Chlamydia trachomatis bacteria | 25 ml (1000 mg) taken as a single dose |
| Infections of urethra and cervix caused by Neisseria gonorrhoeae bacteria. Zithromax should be used in combination with another antibiotic that is selected by your doctor or pharmacist. | 25 ml (1000 mg) or 50 ml* (2000 mg) taken as a single dose |
* only for adult patients
# for adult patients oral treatment may follow an initial intravenous treatment Use in children and adolescents
The safety and efficacy of azithromycin have not been established in children under 6 months of age for any of the indications listed in section 1.
Method of administration
For oral use after reconstitution.
Zithromax should be taken by mouth as a single daily dose. The oral suspension may be taken with or without food. Taking this medicine just before a meal may help make it easier on your stomach.
If the bottle of Zithromax you received from your doctor or pharmacist contains only powder and no liquid then you need to add a specific volume of water to the bottle before it is ready for use. If the powder was already dissolved for you by your doctor or pharmacist then you can proceed directly to the “Instructions for taking each daily dose of Zithromax oral suspension” section below.
Instructions for preparing Zithromax powder for oral suspension before first use
Each carton of Zithromax contains:
- 1 bottle of Zithromax
- 1 push-in bottle adapter
1 10-ml oral dosing syringe graduated in 0.25 ml divisions providing
10 mg of azithromycin in every graduation
Step 1. Shake the bottle thoroughly to loosen the powder before adding any water. Prefill a cup with water and place it next to the bottle.
Step 2 Separate the push-in bottle adapter from the end of oral dosing syringe and keep it in the carton.
Step 3. Open the bottle by pressing down on the child-proof cap and turning it anticlockwise at the same time.
Step 4. Add water to the bottle using the oral dosing syringe to draw it from the cup and add it to the bottle. The volume of water required depends on the size of the bottle that has been provided.
- 15 ml bottle: add 9 ml of water.
- 22.5 ml bottle: add 12 ml (measure 10 ml + 2 ml) of water.
- 30 ml bottle: add 15 ml (measure 10 ml + 5 ml) of water.
- 37.5 ml bottle: add 19 ml (measure 10 ml + 9 ml) of water.
If air bubbles can be seen in the oral dosing syringe, fully push the plunger in to empty the water back into the cup. Then repeat the step to withdraw the water without air bubbles. While adding the water, the bottle should be kept inclined so that most of the powder is not at the bottom of the bottle, otherwise it might get stuck to the bottom.
Step 5. Take the push-in bottle adapter and push it downwards in the mouth of the bottle to firmly secure it. Screw the cap back on the bottle.
Step 6. Shake the bottle thoroughly until all the powder mixes properly with the water.
The oral suspension is now ready for use.
Store the oral dosing syringe in the carton, as it will be required for taking each daily dose of Zithromax oral suspension.
Instructions for taking each daily dose of Zithromax oral suspension Step 1. Shake the bottle thoroughly each time just before taking a dose of the oral suspension.
Step 2. Open the bottle and insert the tip of the oral dosing syringe into the opening of the push-in bottle adapter after checking that it is still firmly inserted in the mouth of the bottle.
Make sure the plunger of the dosing syringe is pushed in completely and the bottle is standing upright on a flat surface.
Step 3. Turn the bottle upside down with the dosing syringe in place and slowly pull back the plunger until the top of plunger is at the dosing syringe division that matches the volume (in ml) of Zithromax that your doctor told you to take.
The oral dosing syringe has a total volume of 10 ml and is graduated in 0.25 ml divisions. Depending on the total volume (in ml) of Zithromax oral suspension you need to take, it may be necessary to use the oral dosing syringe more than once to take your full dose.
If air bubbles can be seen in the oral dosing syringe, fully push in the plunger to empty the oral suspension back into the bottle. Then repeat this step to withdraw the oral suspension without air bubbles.
Step 4. Remove oral dosing syringe from the push-in bottle adapter by carefully pulling it upwards and after turning the bottle upright and place it on a flat surface.
Step 5. Take the dose of Zithromax
Ensure your child is an upright position and put the tip of the oral dosing syringe into his/her mouth. Point the dosing syringe at the inside of the cheek and slowly push down the plunger of the dosing syringe to release the suspension into the mouth. It may be necessary to use the oral dosing syringe more than once to take the amount of oral suspension your child have been told to take.
Step 6 Close the bottle and wash the oral dosing syringe
Place the screw cap back on the bottle, leaving the push-in bottle adapter still inserted in the mouth of the bottle.
Pull the plunger out of the dosing syringe and wash both parts of the dosing syringe with water. Dry the two parts. Push the plunger back into the dosing syringe. Store the dosing syringe in the carton, as it will be required for taking each daily dose of Zithromax oral suspension.
Repeat these steps for each day of the treatment course.
If you take more Zithromax than you should
If you take more Zithromax than you should then you may feel unwell. Typical signs of an overdose are vomiting, diarrhoea, abdominal pain and nausea.Tell your doctor or contact your nearest hospital emergency department immediately. If you forget to take Zithromax
If you forget to take Zithromax take it as soon as you can, as long as this is at least 12 hours before the next dose is due. If it is less than 12 hours left to your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Zithromax
If you stop taking Zithromax too soon, the infection may return. Take Zithromax for the full time of treatment, even when you begin to feel better.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
Serious side effects
Stop using Zithromax and seek medical attention immediately if you notice any of the following symptoms:
- sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching especially affecting the whole body (anaphylactic reaction, frequency not known)
rapid or irregular heartbeat (cardiac arrhythmia or torsades de pointes,
tachycardia, frequency not known)
dark urine, loss of appetite or yellowing of the skin or whites of the eyes,
which are signs of liver disorders (hepatic failure or hepatic necrosis (frequency not known)
severe diarrhoea with abdominal cramps, bloody stools and/or fever
may mean that you have an infection of the large intestine (antibiotic‑associated colitis, frequency not known). Do not take medicines against diarrhoea that inhibit the bowel movements (antiperistaltics).
reddish non-elevated, target-like or circular patches on the trunk, often
with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens‑Johnson syndrome# or toxic epidermal necrolysis, frequency not known).
widespread rash, high body temperature and enlarged lymph nodes
(DRESS syndrome or drug hypersensitivity syndrome, rare (may affect up to 1 in 1 000 people))
a red, scaly widespread rash with bumps under the skin and blisters
accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis, rare (may affect up to 1 in 1 000 people)).
Other side effects
Very common (may affect more than 1 in 10 people)
- diarrhoea
Common (may affect up to 1 in 10 people)
- headache
- being sick (vomiting), stomach pain, feeling sick (nausea)
changes in blood test results (lymphocyte count decreased, eosinophil
count increased, basophil count increased, monocyte count increased, neutrophil count increased, blood bicarbonate decreased) Uncommon (may affect up to 1 in 100 people)
thrush (candidiasis) - a fungal infection of the mouth and/or vagina, and
other fungal infections
pneumonia, bacterial infection of the throat, inflammation of the
gastrointestinal tract, respiratory disorder, inflammation of the mucous membrane inside the nose, vaginal infection
changes in the number of white blood cells (leukopenia, neutropenia,
eosinophilia)
- platelet count increased
reduction in the proportion of all blood cells in the total blood volume
(hematocrit decreased)
- allergic reactions, swelling of the hands, feet and face (angiooedema)
- lack of appetite
- nervousness, difficulty sleeping (insomnia)
feeling dizzy, feeling drowsy (somnolence), change in your sense of taste
(dysgeusia), sensation of pins and needles or numbness (paraesthesia)
- impaired vision
- ear disorder
- spinning sensation (vertigo)
- feeling your heartbeat (palpitations)
- hot flush
- sudden wheeziness, bleeding from the nose
constipation, wind, impaired digestion (dyspepsia), inflammation of the
lining of the stomach (gastritis), difficulty in swallowing (dysphagia), swollen belly, dry mouth, belching (eructation), mouth ulceration, increased salivation
rash, itching, hives (urticaria), dermatitis, dry skin, abnormally increased
sweating (hyperhidrosis)
swelling and pain in the joints (osteoarthritis), muscle pain, back pain,
neck pain
- painful urination (dysuria), kidney pain
- menstrual bleeding at irregular intervals (metrorrhagia), testicular disorder
swelling due to fluid retention, especially of the face, ankles and feet
(oedema, face oedema, peripheral oedema)
- weakness, tiredness, general feeling of being unwell, fever
- chest pain, pain
- abnormal laboratory test results (e.g. blood or liver tests)
- post procedural complication
Rare (may affect up to 1 in 1 000 people)
- feeling irritated
- liver problems, yellowing of the skin or eyes
- increased sensitivity to sunlight
Not known (frequency cannot be estimated from the available data)
reduced number of red blood cells due to increased cell breakdown which
can cause tiredness and pale skin (haemolytic anaemia)
reduction in number of platelets which can lead to bleeding and bruising
(thrombocytopenia)
feeling angry, aggressive, feeling of fear and concern (anxiety), acute
confusional state (delirium)
- hallucination
- fainting (syncope)
fits (seizures)
- reduced sensation to touch, pain and temperature (hypoaesthesia)
- feeling hyperactive
- change in your sense of smell (anosmia, parosmia)
- total loss of your sense of taste (ageusia)
- muscle weakness (myasthenia gravis)
- abnormal electrocardiogramm (ECG) heart tracing (QT prolongation)
- deafness, reduced hearing or ringing in your ears (tinnitus)
- low blood pressure
inflammation of the pancreas causing severe pain in the belly and back
(pancreatitis)
- your tongue changes colour
- joint pain (arthralgia)
- kidney inflammation (interstitial nephritis) and kidney failure Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zithromax
Keep this medicine out of the sight and reach of children.
Do not take or give this medicine after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Any unused medicine should be discarded after 5 days.
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.
6. Contents of the pack and other information
What Zithromax contains
The active substance is azithromycin (200 mg in 5 ml).
The other ingredients are sucrose (3.87 g per 5 ml, see section 2, Zithromax contains sucrose) hydroxypropylcellulose, sodium phosphate tribasic anhydrous, xanthan gum and flavourings: banana flavour (contains benzyl alcohol, see section 2, Zithromax contains benzyl alcohol), vanilla flavour and cherry flavour (contains benzyl alcohol, see section 2, Zithromax contains benzyl alcohol).
What Zithromax looks like and contents of the pack
Zithromax suspension is a dry powder which reconstitutes with water to give a cherry/banana flavoured suspension with a slight vanilla odour and comes in the following sizes: 15 ml (600 mg), 22.5 ml (900 mg), 30 ml (1200 mg) and 37.5 ml (1500 mg) bottles.
Each pack contains an oral dosing syringe.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
Manufacturer
Haupt Pharma Latina S.r.l.
SS 156 Km 47,600
04100, Borgo San Michele
Latina
Italy
Company Contact Address
For further information on this medicine, please contact Medical Information at Pfizer Limited, Walton Oaks, Tadworth, Surrey. Tel: 01304 616161
This leaflet was last revised in 09/2026.
Ref: ZX POS 26_0
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