Wellvone

Patient Information Leaflet: Information for the User

Wellvone 750 mg/5 ml oral suspension

atovaquone
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Wellvone is and what it is used for

Wellvone 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 (formerly known as Pneumocystis carinii).
The active substance in Wellvone is atovaquone. Wellvone belongs to a group of antiparasitic medicines known as antiprotozoals.

2. What you need to know before taking Wellvone

Do not take Wellvone

• If you are allergic to atovaquone or to any of the other ingredients of this medicine (listed in section 6). Consult your doctor or pharmacist before taking Wellvone.

Take special care with Wellvone
Your doctor needs to know before you take Wellvone:
if you have kidney or liver disease
if you have diarrhoea, especially when starting treatment. Diarrhoea reduces the amount of Wellvone
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 situations apply to you. Your doctor may decide that
Wellvone is not suitable for you or that you need additional monitoring while taking it.

Pregnancy, breast-feeding and fertility
If you are pregnant, do not take Wellvone unless your doctor recommends it. If you become pregnant
while taking Wellvone, consult your doctor for advice on whether you should continue treatment.
Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant.
Do not breast-feed while taking Wellvone. It is not known whether Wellvone passes into breast milk;
if it does, it may have negative effects on the infant.

Other medicines and Wellvone
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,
including herbal remedies or other medicines purchased without a prescription.
Some medicines may reduce the effectiveness of Wellvone or Wellvone 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 to treat HIV
efavirenz or some very potent protease inhibitors, used to treat HIV
etoposide, used to treat cancer.
Tell your doctor if you are taking any of these medicines. Your doctor may decide that Wellvone is not
suitable for you or that you need additional monitoring while taking it.
Remember to inform your doctor if you start taking any other medicine while being treated with
Wellvone.

Taking Wellvone with food and drink
Always take Wellvone with food – especially food high in fat. This will increase the amount of Wellvone
absorbed by your body and make the treatment more effective.
Ask your doctor for advice on which foods are suitable.
If you have difficulty taking Wellvone with food, consult your doctor for an alternative treatment.

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

Wellvone contains benzyl alcohol
This medicine contains 50.66 mg of benzyl alcohol in each 5 ml.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with a risk of serious adverse effects, including breathing problems
(agitated breathing syndrome), in young children.
Do not administer to neonates (up to 4 weeks of age) unless otherwise recommended by a doctor.
Do not use for more than one week in young children (under 3 years of age) unless otherwise
recommended by a doctor or pharmacist.
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding, or if you have liver or
kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause
adverse effects (such as metabolic acidosis).

Wellvone contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium in each 5 ml, i.e. essentially ‘sodium-free’.

3. How to take Wellvone

Take this medicine exactly as directed by your doctor or pharmacist. If you
have
any doubts, consult your doctor or pharmacist.
Shake the bottle well before use.
Do not dilute Wellvone.
Always take Wellvone with food – especially food high in fat. This will increase
the amount of Wellvone absorbed and make the treatment more effective.
Dosage
The recommended dose of Wellvone in adults is one 5 ml spoonful (containing 750 mg of
atovaquone), twice daily for 21 days. Use the 5 ml spoon provided. Wash the spoon
with clean water after each dose.
Take one dose in the morning and one dose in the evening.
If you take more Wellvone than you should
Contact your doctor or pharmacist for advice; if possible, show them the Wellvone packaging.
If you forget to take Wellvone
If you forget to take a dose of Wellvone, take the next dose as soon as you remember (again with food), and then continue your treatment as before. Do not take a double dose to make up for a missed dose.
Do not stop taking Wellvone without medical advice.
Take Wellvone 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 doubts 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 patients:
nausea
rash
itching
Common side effects
These may affect up to 1 in 10 patients:
diarrhoea
vomiting
headache
sleep disturbances (insomnia)
raised temperature (fever)
allergic reactions, sometimes severe. Signs of allergic reactions include:
sudden breathlessness, tightness in the chest or throat, or difficulty breathing
swelling of the eyelids, face, lips, tongue or other parts of the body
hives.
Other common side effects that may be detected by blood tests are:
low levels of sodium in the blood (hyponatraemia)
increased liver enzymes
reduction in the number of red blood cells (anaemia), which may cause tiredness, headache and shortness of breath
reduction in the number of certain types of white blood cells (neutropenia).
Uncommon side effects
These may affect up to 1 in 100 patients:
an increase in amylase that may be detected by blood test (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 which may appear as blister-like lesions resembling small targets (a dark spot in the centre surrounded by a pale area with a dark 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: 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 Wellvone

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label. Use within 21 days after opening.
Do not store above 25°C and do not 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 Wellvone contains
Each 5 ml spoonful of Wellvone suspension contains 750 mg of the active substance atovaquone (1 ml of
Wellvone contains 150 mg of atovaquone). The other components are: benzyl alcohol (E1519), xanthan gum,
poloxamer 188, sodium saccharin, purified water, tutti-frutti flavour (sweet orange oil, concentrated orange oil, propylene glycol (E1520), benzyl alcohol (E1519), vanillin, acetaldehyde, amyl acetate, ethyl butyrate). See section 2 for further information on benzyl alcohol and sodium contained in Wellvone.
If you think you are allergic to any of these components:
consult your doctor and do not take Wellvone.
Description of the appearance of Wellvone and package contents
Wellvone oral suspension is a yellow-coloured liquid. The medicine is supplied in a 240 ml plastic bottle with child-resistant closure, containing 226 ml of oral suspension. Each package includes a dosing spoon (5 ml).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline Trading Services Limited
12 Riverwalk,
Citywest Business Campus
Dublin 24,
Ireland
Local representative: GlaxoSmithKline S.p.A. - Viale dell’Agricoltura, 7 - 37135 Verona - Italy
Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk,
Citywest Business Campus
Dublin 24,
Ireland
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