Atovaquone Glenmark

Package leaflet: Information for the user

Atovaquone Glenmark 750 mg/5 ml oral suspension

Atovaquone
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

1. What Atovaquone Glenmark is and what it is used for

Atovaquone Glenmark is used to treat a lung infection called Pneumocystis pneumonia (PCP) in patients who cannot take co-trimoxazole.
This disease is caused by an organism called Pneumocystis jiroveci (previously known as Pneumocystis carinii).
The active substance in Atovaquone Glenmark is atovaquone. Atovaquone Glenmark belongs to a group of antiparasitic medicines known as antiprotozoals.

2. What you need to know before taking Atovaquone Glenmark

Do not take Atovaquone Glenmark:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Atovaquone Glenmark.
Be especially careful with Atovaquone Glenmark.
Your doctor needs to know before you take Atovaquone Glenmark:

• if you have kidney or liver disease;
• if you have diarrhoea, especially when starting treatment. Diarrhoea reduces the amount of Atovaquone Glenmark absorbed by your body, which may make the treatment ineffective;
• if you are over 65 years of age.

Inform your doctor if any of these conditions apply to you. Your doctor may decide that Atovaquone Glenmark is not suitable for you or that you require additional monitoring while taking it.

Other medicines and Atovaquone Glenmark
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines or medicines purchased without a prescription.
Some medicines may reduce the effectiveness of Atovaquone Glenmark, or Atovaquone Glenmark may alter the effects 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 in the treatment of HIV;
• efavirenz or certain potent protease inhibitors used in the treatment of HIV;
• etoposide, used in the treatment of cancer.

Inform your doctor if you are taking any of these medicines. Your doctor may decide that Atovaquone Glenmark is not suitable for you or that you require additional monitoring while taking it.
Remember to inform your doctor if you start taking any other medicine while being treated with Atovaquone Glenmark.

Atovaquone Glenmark with food and drink
Always take Atovaquone Glenmark with food – especially high-fat meals.
This increases the amount of Atovaquone Glenmark absorbed by your body and makes the treatment more effective.
Ask your doctor for advice on which foods are suitable.
If you have difficulty taking Atovaquone Glenmark with food, consult your doctor for an alternative treatment.

Pregnancy, breastfeeding and fertility

• If you are pregnant, do not take Atovaquone Glenmark unless recommended by your doctor. If you become pregnant while taking Atovaquone Glenmark, consult your doctor to discuss whether you should continue treatment. Ask your doctor or pharmacist for advice before taking this medicine during pregnancy.
• Do not breastfeed while taking Atovaquone Glenmark. It is not known whether Atovaquone Glenmark passes into breast milk; if it does, it may have harmful effects on the infant.

Driving and using machines
Atovaquone Glenmark is not expected to affect your ability to drive or operate machinery.

3. How to use Atovaquone Glenmark

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Shake the bottle well before use.
Do not dilute Atovaquone Glenmark.
Always take Atovaquone Glenmark with food – especially food high in fat.
This will maximize the amount of Atovaquone Glenmark absorbed and make the
treatment more effective.

Dosage
The recommended dose of Atovaquone Glenmark in adults is one 5 ml spoonful (containing 750
mg of atovaquone) twice daily for 21 days.
Take one dose in the morning and one dose in the evening.

If you take more Atovaquone Glenmark than you should
Consult your doctor or pharmacist. If possible, show them the Atovaquone Glenmark packaging.

If you forget to take Atovaquone Glenmark
If you forget to take a dose of Atovaquone Glenmark, take the next dose as soon as you remember (again with food), then continue your treatment as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Atovaquone Glenmark
Do not stop taking Atovaquone Glenmark without medical advice.
Continue taking Atovaquone Glenmark for the full duration recommended by your doctor.
Do not stop taking it unless your doctor advises you to do so, even if you feel better. If the full course of treatment is not completed, the infection may return.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects
These may affect more than 1 in 10 people:

• nausea
• rash
• skin itching

Common side effects
These may affect up to 1 in 10 people:

• diarrhoea
• vomiting
• headache
• sleep disturbances (insomnia)
• high temperature (fever)
• allergic reactions, sometimes severe. Signs of allergic reactions include:
  • sudden shortness of breath, chest tightness or throat tightness, or difficulty breathing
  • swelling of the eyelids, face, lips, tongue or other body parts
  • hives

Other common side effects that may be detected by blood tests include:

• low levels of sodium in the blood (hyponatraemia)
• increased liver enzymes
• reduced number of red blood cells (anaemia), which may cause fatigue, headache and breathlessness
• reduced number of certain types of white blood cells (neutropenia)

Uncommon side effects
These may affect up to 1 in 100 people:

• increased amylase levels detectable in blood tests (amylase is an enzyme produced by the pancreas)

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

• skin rash that may appear as blister-like spots resembling small targets (a dark spot in the centre surrounded by a light area with a black ring around the edge) (erythema multiforme)
• widespread rash with blisters and peeling of the skin, occurring mainly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)

If you notice any of these symptoms, contact your doctor urgently.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly to the Agenzia del Farmaco (Italian Medicines Agency) via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atovaquone Glenmark

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle. Use within 21 days of opening.
This medicine does not require any special storage conditions. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Atovaquone Glenmark contains:

• Each 5 ml spoonful of Atovaquone Glenmark suspension contains 750 mg of the active substance atovaquone (1 ml of Atovaquone Glenmark contains 150 mg of atovaquone).
• The other components are: benzyl alcohol; xanthan gum; poloxamer 188; sodium saccharin; purified water; tutti frutti flavour, citric acid monohydrate, trisodium citrate dihydrate.

Description of the appearance of Atovaquone Glenmark and contents of the pack
Atovaquone Glenmark oral suspension is a yellow liquid. The medicine is contained in a 250 ml plastic bottle with a child-resistant closure. A 5 ml dosing spoon is included with the pack.
Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o, Hvezdova 1716/2b, Prague 4, 140 78, Czech Republic
Manufacturer
Glenmark Pharmaceuticals s.r.o, Fibichova 143, 566 17 Vysoke Myto, Czech Republic
Glenmark Pharmaceuticals Europe Limited, Building 2, Croxley Green Business Park, Croxley Green, Watford WD18 8YA, United Kingdom
This medicinal product is authorised in the Member States of the European Economic Area
under the following names:
[To be completed with national data]
Member State Name
NL Atovaquon Glenmark 750mg/5ml suspensie voor oraal gebruik
UK Atovaquone Glenmark 750mg/5ml oral suspension
DE Atovaquon Glenmark 750mg/5ml Suspension zum Einnehmen
ES Atovaquone Glenmark 750mg/5ml Suspensión oral
SE Atovaquone Glenmark
NO Atovaquone Glenmark
DK Atovaquone Glenmark
FI Atovaquone Glenmark
PT Atovaquone Glenmark 750 mg/5ml suspensão oral
FR Atovaquone Biogaran 750 mg/5ml suspension buvable
IT Atovaquone Glenmark
[To be completed with national data]