Atovaquone Glenmark 750 mg/5 ml oral suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
• This includes any possible side effects not listed in this leaflet. See section 4.

1. What Atovaquone Glenmark 750mg/5ml oral suspension is and what it is used for
2. What you need to know before you take Atovaquone Glenmark 750mg/5ml oral suspension
3. How to take Atovaquone Glenmark 750mg/5ml oral suspension
4. Possible side effects
5. How to store Atovaquone Glenmark 750mg/5ml oral suspension
6. Contents of the pack and other information

• if you are allergic to atovaquone or any of the other ingredients of this medicine (listed in Section 6).

Talk to your doctor or pharmacist before taking Atovaquone Glenmark 750mg/5ml oral suspension

Take special care with Atovaquone Glenmark 750mg/5ml oral suspension

Your doctor needs to know before you take Atovaquone Glenmark 750mg/5ml oral suspension:

• if you have kidney or liver disease.
• if you have diarrhoea, particularly when you start your treatment. Diarrhoea reduces the amount of Atovaquone Glenmark 750mg/5ml oral suspension your body absorbs, so the treatment may not be effective.
• if you are over 65 years of age.
• Tell your doctor if any of these applies to you. Your doctor may decide that Atovaquone Glenmark 750mg/5ml oral suspension isn’t suitable for you, or that you need extra check-ups while you’re taking it.

Tell your doctor or pharmacist if you’re taking, have recently taken any other medicines, including any herbal medicines or other medicines you’ve 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 Glenmark 750mg/5ml oral suspension isn’t suitable for you, or that you need extra check-ups while you’re taking it.

Remember to tell your doctor if you start taking any other medicine while you’re taking Atovaquone Glenmark 750mg/5ml oral suspension.

Always take Atovaquone Glenmark 750mg/5ml oral suspension with food - preferably foods that are high in fat. This will increase the amount of Atovaquone Glenmark 750mg/5ml oral suspension 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 Glenmark 750mg/5ml oral suspension with food, talk to your doctor about alternative treatments.

• If you are pregnant, do not take Atovaquone Glenmark 750mg/5ml oral suspension unless your doctor recommends it. If you become pregnant while you are taking Atovaquone Glenmark 750mg/5ml oral suspension, 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 Glenmark 750mg/5ml oral suspension. It is not known whether Atovaquone Glenmark 750mg/5ml oral suspension passes into breast milk; if it does it may harm your baby.

Your ability to drive or use machinery is not expected to be affected while you’re taking Atovaquone Glenmark 750mg/5ml oral suspension.

This medicine contains 50.00 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.

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 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”).

This medicine contains less than 1 mmol sodium (23 mg) in each 5 ml, that is to say essentially ‘sodium free’.

The recommended adult dose of Atovaquone Glenmark 750mg/5ml oral suspension is one 5 ml spoonful (containing 750 mg atovaquone), twice a day for 21 days.

Take one dose in the morning and one in the evening.

Contact your doctor or pharmacist for advice. If possible, show them the Atovaquone Glenmark 750mg/5ml oral suspension pack.

If you forget to take a dose of Atovaquone Glenmark 750mg/5ml oral suspension, 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 forgotten dose.

Don’t stop Atovaquone Glenmark 750mg/5ml oral suspension without advice.

Take Atovaquone Glenmark 750mg/5ml oral suspension for as long as your doctor recommends. Don’t 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.

Other side effects have occurred in a very small number of people but their exact frequency is unknown:

• 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)
• widespread rash with blisters and peeling skin, particularly occuring around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)

If you notice any of these symptoms contact a doctor urgently.

If you get any side effects, talk to your doctor or pharmacist. 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.

• Each 5 ml spoonful of Atovaquone Glenmark 750mg/5ml oral suspension suspension contains 750 mg of the active ingredient atovaquone (1 ml of Atovaquone Glenmark 750mg/5ml oral suspension contains 150 mg atovaquone).
• The other ingredients are benzyl alcohol, xanthan gum, poloxamer 188, saccharin sodium, purified water, tutti frutti flavouring, citric acid monohydrate, tri-sodium citrate dihydrate

Atovaquone Glenmark 750mg/5ml oral suspension oral suspension is a yellow liquid. The medicine is contained in a plastic bottle with child -resistant cap, containing 226 ml oral suspension.

A 5ml measuring spoon is included in each pack.

Marketing Authorisation Holder:

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Production site address:

Registered Address:

This medicinal product is authorised in the Member States of the EEA under the following names:

UK: Atovaquone Glenmark 750 mg/5 ml oral suspension

NL: Atovaquon Glenmark 750 mg/5 ml suspensie voor oraal gebruik

PT: Atovaquona Kabi

DE: Atovaquon Glenmark 750 mg/5 ml Suspension zum Einnehmen

DK: Atovaquone Glenmark

ES: Atovacuona Glenmark 750 mg/5 ml suspensión oral EFG

FI: Atovaquone Glenmark

SE: Atovaquone Glenmark

NO: Atovaquone Glenmark

FR: Atovaquone Biogaran 750 mg/5ml, suspension buvable

IT: Atovquone Glenmark