Patient leaflet - Atovaquone 750 mg/5 ml oral suspension
1. What Atovaquone is and what it is used for
Atovaquone is used to treat a lung infection called Pneumocystis pneumonia (PCP) in people who cannot take the medicine co-trimoxazole.
This disease is caused by an organism called Pneumocystis jiroveci (which used to be called Pneumocystis carinii).
The active ingredient in atovaquone is atovaquone. Atovaquone belongs to a group of anti-parasitic medicines known as antiprotozoals.
2. What you need to know before you take Atovaquone
Do not take Atovaquone
if you are allergic to atovaquone or any of the other ingredients of this medicine
(listed in section 6)
if you have ever developed a severe skin rash or skin peeling, blistering and/or
mouth sores after taking atovaquone or other medicine with atovaquone.
Warnings and precautions
Talk to your doctor or pharmacist before taking Atovaquone:
- if you have kidney or liver disease
if you have diarrhoea, particularly when you start your treatment.
Diarrhoea reduces the amount of atovaquone your body absorbs, so the treatment may not be effective
- if you are over 65 years of age
This medicine can cause serious skin reactions. Stop using atovaquone and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Tell your doctor if any of these applies to you. Your doctor may decide that atovaquone is not suitable for you, or that you need extra check-ups while you are taking it.
Other medicines and Atovaquone
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines, including any herbal medicines or other medicines you have bought without a prescription.
Some medicines can reduce the effectiveness of atovaquone, or atovaquone itself can change the effect of other medicines taken at the same time. These include: · the antibiotics rifampicin and rifabutin
- the antibiotic tetracycline
- metoclopramide used to treat nausea and vomiting
indinavir, zidovudine or didanosine, used to treat HIV
- efavirenz or certain highly active protease-inhibitors used to treat HIV. · etoposide used to treat cancer
Tell your doctor if you are taking any of these. Your doctor may decide that atovaquone is not suitable for you, or that you need extra check-ups while you are taking it.
Remember to tell your doctor if you start taking any other medicine while you are taking atovaquone.
Atovaquone with food and drink
Always take atovaquone with food - preferably foods that are high in fat. This will increase the amount of atovaquone that your body can absorb, and make your treatment more effective.
Ask your doctor for advice about which foods are suitable.
If you have difficulty in taking atovaquone with food, talk to your doctor about alternative treatments.
Pregnancy, breast-feeding and fertility
If you are pregnant, do not take atovaquone unless your doctor recommends it.
If you become pregnant while you are taking atovaquone, ask your doctor for advice about whether you should continue the treatment. Ask your doctor or pharmacist for advice before taking this medicine while pregnant. · Do not breast-feed while taking atovaquone. It is not known whether atovaquone passes into breast milk; if it does it may harm your baby.
Driving and using machines
Your ability to drive or use machinery is not expected to be affected while you are taking atovaquone.
Atovaquone contains benzyl alcohol
This medicine contains 50 mg benzyl alcohol in each 5 ml.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.
Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor.
Intravenous administration of benzyl alcohol has been associated with serious adverse events and death in neonates (“gasping syndrome”). The minimum amount of benzyl alcohol at which toxicity may occur is not known.
Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist.
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding or if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Atovaquone contains sodium
This medicine contains less than 1 mmol sodium (23 mg) in each 5 ml, that is to say essentially 'sodium free'.
Atovaquone contains propylene glycol
This medicine contains 2.75 – 3.25 mg propylene glycol in each 5 ml.
Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.
If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
UK (Unit-III)
Atovaquone OS Leaflet
Version: 00
Dimension: 240 x 270 mm
Printing Colour: Black
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3. How to take Atovaquone
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Shake the bottle well before use.
Do not dilute Atovaquone.
Always take atovaquone with food - preferably foods which are high in fat. This will greatly increase the amount of atovaquone absorbed, and will make your treatment more effective.
How much to take
The recommended adult dose of atovaquone is one 5 ml spoonful (containing 750 mg atovaquone), twice a day for 21 days. Use the 5 ml spoon provided. Wash the spoon with clean water after taking every dose.
Take one dose in the morning and one in the evening.
If you take more Atovaquone than you should
Contact your doctor or pharmacist for advice. If possible, show them the atovaquone pack.
If you forget to take Atovaquone
If you forget to take a dose of atovaquone, take the next dose as soon as you remember (again with food), and then continue the treatment as before. Do not take a double dose to make up for a missed dose.
If you stop taking Atovaquone
Do not stop atovaquone without advice.
Take atovaquone for as long as your doctor recommends. Do not stop unless your doctor advises you to - even if you are feeling better. If you do not complete the full course of treatment, the infection may come back.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using atovaquone and seek medical attention immediately if you notice any of the following symptoms:
Not known (frequency cannot be estimated from the available data):
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). · widespread rash, high body temperature and enlarged lymph nodes
(DRESS syndrome or drug hypersensitivity syndrome)
skin rash, which may blister, and looks like small targets (central dark spot
surrounded by paler area and dark ring around the edge) (erythema multiforme)
Very common side effects
These may affect more than 1 in 10 people:
- feeling sick (nausea)
- rash
- itching skin
Common side effects
These may affect up to 1 in 10 people:
- diarrhoea
- being sick (vomiting)
- headache
- sleeping problems (insomnia)
high temperature (fever)
allergic reactions, occasionally severe. Signs of allergic reactions include:
sudden wheezing, tightness of the chest or throat, or difficulty breathing · swollen eyelids, face, lips, tongue or other part of the body
- hives (urticaria)
Other common side effects, which may show up in blood tests, are: · low levels of sodium in the blood (hyponatraemia)
- increases in liver enzymes
- reduced number of red blood cells (anaemia), which can cause tiredness, headaches and shortness of breath
- reduced number of some types of white blood cells (neutropenia) Uncommon side effects
These may affect up to 1 in 100 people:
- an increase in amylase, which may show up in a blood test (amylase is an enzyme produced in the pancreas)
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 Yellow Card Scheme website 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 Atovaquone
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 outer carton and bottle label. The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
After first opening, the suspension may be stored for up to 21 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 Atovaquone contains
The active substance is Atovaquone.
Each 5 ml of oral suspension contains 750 mg of atovaquone.
The other ingredients are:
Poloxamer, hypromellose, benzyl alcohol, xanthan gum, saccharin sodium, purified water and Strawberry flavour (containing flavouring ingredients, propylene glycol (E 1520) and water).
What Atovaquone looks like and contents of the pack
Yellow coloured suspension.
A 250 ml high density polyethylene container with child resistant plastic cap containing 226 ml of atovaquone oral suspension and 5ml double head polypropylene spoon with 1.25ml, 2.5ml and 5ml markings.
Marketing Authorisation Holder and Manufacturer
Amarox Limited
Congress House, 14 Lyon Road
Harrow, HA1 2EN
United Kingdom
To listen to or request a copy of this leaflet in Braille, large print or audio please call,
0203 972 0004 (UK only)
This leaflet was last revised in 05/2026.
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