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WELLVONE 750 MG/ 5ML ORAL SUSPENSION

Active substance(s): ATOVAQUONE

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3
10000000132812

1 What Wellvone is and
what it is used for

Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
This medicine has been
prescribed for you only. Don’t
pass it on to others. It may harm
them, even if their signs of illness
are the same as yours.
Keep this leaflet. You may need
to read it again.
If you have any further questions,
ask your doctor or pharmacist.
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.

Wellvone 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 Wellvone
is atovaquone. Wellvone belongs
to a group of anti-parasitic
medicines known as
antiprotozoals.

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

2 What you need to know

before you take
Wellvone
Don’t take Wellvone

• If you’re allergic to atovaquone
or any of the other ingredients
of this medicine (listed in
Section 6).
➔➔Talk to 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,
particularly when you start your
treatment. Diarrhoea reduces
the amount of Wellvone 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 Wellvone isn’t
suitable for you, or that you
need extra check-ups while
you’re 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 you are taking
Wellvone, 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 Wellvone. It is not
known whether Wellvone
passes into breast milk; if it
does it may harm your baby.

Other medicines and Wellvone
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 Wellvone, or
Wellvone 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 Wellvone 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
Wellvone.

Wellvone with food and
drink
Always take Wellvone with
food - preferably foods that are
high in fat. This will increase the
amount of Wellvone 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
Wellvone with food, talk to your
doctor about alternative
treatments.

GSK-CAN-Mississauga-CAMIS
United Kingdom-GBR
Wellvone
N/A
A153314L

N/A
N/A
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Driving and using machines
Your ability to drive or use
machinery is not expected to be
affected while you’re taking
Wellvone.

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Mississauga - Additional Artwork Information Panel
Specification Number:
(Does NOT include Specification version number)

GSLFLT015

Replaces Item Code:

A105599

Component Basic Dimensions:

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3 How to take Wellvone
Always take this medicine exactly
as your doctor or pharmacist has
told you. Check with your doctor
or pharmacist if you’re not sure.
Shake the bottle well before use.
Do not dilute Wellvone.
Always take Wellvone with
food - preferably foods which are
high in fat. This will greatly
increase the amount of Wellvone
absorbed, and will make your
treatment more effective.

How much to take
The recommended adult dose of
Wellvone 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.

If you take too much
Wellvone
Contact your doctor or pharmacist
for advice. If possible, show them
the Wellvone pack.

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
the treatment as before.
Don’t take a double dose to
make up for a missed dose.

Don’t stop Wellvone without
advice.

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

- 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).

Very common side effects

Uncommon side effects

Take Wellvone 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.
If you have any further questions
on the use of this medicine, ask
your doctor or pharmacist.

4 Possible 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

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).

Other side effects
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.

Reporting of side effects
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. 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.
Don’t use this medicine after the
expiry date shown on the label of
the bottle. Once opened use
within 21 days.
Don’t store above 25°C and don’t
freeze.
Do not throw away any
medicines via wastewater or
household waste. Ask your
pharmacist how to throw away
medicines you no longer use. This
will help protect the
environment.

6 Contents of the pack

and other information
What Wellvone contains
Each 5 ml spoonful of Wellvone
suspension contains 750 mg of
the active ingredient atovaquone
(1 ml of Wellvone contains
150 mg atovaquone). The other
ingredients are benzyl alcohol,
xanthan gum, poloxamer 188,
saccharin sodium, purified water,
tutti frutti flavouring (sweet
orange oil, concentrated orange
oil, propylene glycol, benzyl
alcohol, vanillin, acetic aldehyde,
amyl acetate and ethyl butyrate)
(see section 2).
If you think you might be allergic
to any of these ingredients:
➔➔ Tell your doctor and don’t take
Wellvone.

What Wellvone looks like and
contents of the pack
Wellvone oral suspension is a
yellow liquid. The medicine is
contained in a 240 ml plastic
bottle with child-resistant cap.
A 5 ml measuring spoon is
included in each pack.

Marketing Authorisation
Holder and Manufacturer
Marketing Authorisation
Holder

10000000132812
Manufacturer

Aspen Bad Oldesloe GmbH,
Industriestrasse 32-36,
23843 Bad Oldesloe, Germany

GSK-CAN-Mississauga-CAMIS

Other formats:

To listen to or request a copy of
this leaflet in Braille, large print
or audio, please call, free of
charge:

0800 198 5000 (UK Only)

Please be ready to give the
following information:
Product name
Wellvone
Reference number 10949/0271
This is a service provided by the
Royal National Institute of Blind
People.
This leaflet was last revised in
January 2015.
Wellvone is a registered trade
mark of the GSK group of
companies.
© 2015 GSK group of companies.
All rights reserved.

United Kingdom-GBR
Wellvone
N/A
A153314L

N/A
N/A
1
K

0

Glaxo Wellcome UK Ltd, Stockley
Park West, Uxbridge, Middlesex
UB11 1BT

0

Mississauga - Additional Artwork Information Panel
Specification Number:
(Does NOT include Specification version number)

GSLFLT015

Replaces Item Code:

A105599

Component Basic Dimensions:

153 x 314

(in mm)

8.0pt
9.0pt
100%
8.0pt
Y

Page 2 of 2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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