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DARAPRIM 25MG TABLETS

Active substance(s): PYRIMETHAMINE

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Package Leaflet:
Information for the User

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 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.
In this leaflet:
1 What Daraprim is and what it is
used for
2 What you need to know before
you take Daraprim
3 How to take Daraprim
4 Possible side effects

1 What Daraprim is and
what it is used for

• you have a blood problem called
anaemia

Daraprim contains a medicine called
pyrimethamine. This belongs to a
group of medicines called
antiprotozoals. They treat infections
of the blood caused by parasites.

Daraprim should always be given
with a folic acid (vitamin)
supplement.

Daraprim is used:
• to treat infections, caused by a
parasite called Toxoplasma,
together with antibiotics called
sulphonamides. These infections
can affect the:

Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
In particular tell your doctor if you
are taking any of the following
medicines:

- brain (encephalitis) and other
parts of the body if your immune
system is poor. This can be due
to AIDS
- eyes, infection can lead to
problems with your eyesight

• zidovudine – used to treat HIV
infection/AIDS

- unborn baby, when an infection
is passed on from the mother
during pregnancy.
Ask your doctor if you need to have
these conditions explained to you.

2 What you need to know
before you take Daraprim

5 How to store Daraprim

Do not take Daraprim:

6 Contents of the pack and other
information

• if you are allergic (hypersensitive)
to pyrimethamine or any of the
other ingredients of Daraprim (see
Section 6: Contents of the pack &
other information)

• if you are a woman who is
breast-feeding. Ask your doctor or
midwife for advice.
• if you are a child under 5 years of
age.
Do not take if any of the above apply
to you. If you are not sure, talk to
your doctor or pharmacist before
taking Daraprim.

pyrimethamine

Other medicines and Daraprim

• trimethoprim or cotrimoxazole –
used as antibiotics

• if you are a woman in the first
trimester of pregnancy

Daraprim 25 mg tablets

• you have ever had fits (seizures).

Warnings and Precautions
Talk to your doctor before taking
Daraprim if:
• you have kidney or liver problems

• proguanil or quinine sulfate – used
for malaria/night cramps

Driving and using machines
No studies on the effects on the
ability to drive and use machines
have been performed. Dizziness and
seizures have been reported by
patients taking Daraprim. If you
experience these, caution should be
exercised in driving and using
machinery.
Daraprim contains lactose
Daraprim contains lactose (a type of
sugar). If you have been told by your
doctor that you cannot tolerate or
digest some sugars (have an
intolerance to some sugars), talk to
your doctor before using this
medicine.

3. P
 ush out the tablet: gently push
one end of the tablet through the
foil layer.

Toxoplasmosis

Children under 5 years should
not take Daraprim.

Adults and children over 6 years.

If you take more Daraprim than you
should, talk to a doctor or go to
hospital straight away. Take this
medicine pack with you.

• To treat infections caused by
Toxoplasma, the usual dose is:

• medicines for cancer – such as
methotrexate, daunorubicin, or
cytosine

Always take this medicine exactly as
your doctor has told you. You should
check with your doctor or pharmacist
if you are not sure.

- then one or two tablets each day
for the rest of the course.

• lorazepam – used to help you sleep
or relax

• Swallow your tablets with a glass
of water.

• warfarin – used to thin your blood

Taking out a tablet

• antacids – used for heart-burn or
indigestion

These tablets come in special
packaging to prevent children
removing them.

If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Daraprim.
Pregnancy and breast-feeding
Do not take Daraprim if you
are 12 weeks pregnant or less. It can
harm your baby.
If you are more than 12 weeks
pregnant, or might become pregnant,
talk to your doctor before taking
Daraprim.
Do not breast-feed if you are taking
Daraprim. Ask your doctor or
midwife for advice.

In the unborn baby Daraprim may
stop toxoplasmosis from the mother
damaging the unborn baby.
• From week 13 of your pregnancy
onwards, the usual dose is:

If you take more Daraprim than
you should

If you forget to take Daraprim
• If you forget to take a dose, take it
as soon as you remember it.
• However, if it is time for the next
dose, skip the missed dose.
• Do not take a double dose
(two doses at the same time) to
make up for a forgotten dose.

- two tablets, twice a day, for the
first 2 days

4 Possible side effects

- then two tablets each day for the
rest of the course.

Like all medicines, Daraprim can
cause side effects, although not
everybody gets them.
If you have any of the following
side effects or symptoms, talk to
your doctor immediately:

• Daraprim may cause harm to
the baby in the first 12 weeks
of your pregnancy. A different
medicine should be used until
the 13th week of pregnancy.
Adults and adolescents who have
a poor immune system or AIDS.

2. P
 eel back the outer layer:
starting at the corner, lift and peel
over the pocket.

- then 1 mg/kg bodyweight
(maximum of one tablet) each
day for the rest of the course.

Daraprim should always be given
with another antibiotic, for example
a sulphonamide, and a folic acid
(vitamin) supplement.

- four tablets each day for the first
1 or 2 days

1. Separate one tablet: tear along
the cutting lines to separate one
“pocket” from the strip.

• To treat infections caused by
Toxoplasma, the usual dose is
based on body weight:
- 2 mg/kg bodyweight (maximum
of two tablets) on the first day

3 How to take Daraprim

• medicines for diarrhoea which
contain an ingredient called kaolin.

Children from 5 to 6 years.

• To treat infections caused by
Toxoplasma, the usual dose is
based on body weight:
• Less than 60 kg:
- eight tablets on the first day
- then two tablets each day for the
rest of the course.
• 60 kg or more:
- eight tablets on the first day
- then three tablets each day for
the rest of the course.

• sore throat, an unexpected illness
or skin reaction such as a rash or
irritation or breathlessness.
• abnormal bruising, tiredness,
weakness or dizziness
These symptoms may mean that
you are suffering from a drop in
the number of your blood cells. This
increases your risk of bleeding,
bruising and makes you less able to
fight infections. Your doctor will be
able to confirm this by carrying out
a blood test, and if necessary, will
give you appropriate treatment.
Daraprim may bring on fits (seizures)
in patients who are prone to
epilepsy. If you have epilepsy talk to
your doctor or pharmacist before
taking this medicine.

Other side effects include:
Very common (may affect more
than 1 in 10 people)
• decrease in the number of red
blood cells (anaemia). You may feel
tired or weak
• headache
• vomiting, feeling sick and diarrhoea
• rash
Common (may affect less than 1 in
10 people but more than 1 in
100 people)
• decrease in the number of blood
platelets (cells that help blood to clot).
The blood may take longer to clot
than normal. You may notice this if
you have a nosebleed or cut yourself
• dizziness
• decrease in the number of white
blood cells. This may affect your
ability to fight infections
Uncommon (may affect less than
1 in 100 people but more than 1 in
1000 people)
• fever
• abnormal skin pigmentation
Very Rare (may affect less than 1 in
10,000 people)
• decrease in the number of all types
of blood cells. Symptoms can include:
tiredness, weakness, rashes or
bruising easily, pale skin, rapid heart
rate, shortness of breath, bleeding
problems such as bleeding of the
gums or nosebleeds, infections
• contractions of body muscles
• sudden onset of high fever, rapid
shallow breathing, chills and
sweating
• abdominal pain
• mouth ulcers on the inside of the
cheek
• red inflamed dry skin
If you have been prescribed Daraprim
for toxoplasmosis please check the
leaflet for the sulphonamide
antibiotic you should also have been
prescribed.

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 the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or by
searching for MHRA Yellow Card in
the Google Play or Apple App Store.

1
62000000018010
GSK-CAN-Mississauga-CAMIS

By reporting side effects you can
help provide more information on the
safety of this medicine.

United Kingdom-GBR
Daraprim

5 How to store Daraprim
• Keep out of sight and reach of
children.

N/A
0002456

• Do not use Daraprim after the ‘use
by’ date which is stated on the
pack. The date refers to the last
day of the month.

N/A

• Store these tablets below 30°C and
inside the original packaging to
protect them from light.

N/A
1

• Medicines should not be disposed
of via wastewater or household
waste. Ask your pharmacist how to
dispose of medicines no longer
required. These measures will help
protect the environment.

K

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6 Contents of the pack &
other information

0

What Daraprim contains
• The active substance is
pyrimethamine. Each tablet
contains 25 mg of the active
substance.
• The other ingredients are lactose
monohydrate, maize starch,
hydrolysed starch, docusate sodium
and magnesium stearate.
What Daraprim looks like and
contents of the pack

12.0pt
13.0pt

Daraprim tablets are white and
round with the marking ‘GS A3A’.
They are packaged in blister packs
enclosed in a carton. Available in
packs of 30 tablets.

100%
10.0pt
Yes

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

GSLFLT002

Replaces Item Code:

A014911

Component Basic Dimensions:

311.15 x 628.65

(in mm)

Page 1 of 2

Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder:
The Wellcome Foundation Ltd,
Stockley Park West, Uxbridge,
Middlesex UB11 1BT

1

Manufacturer:
Glaxo Operations UK Limited (trading
as Glaxo Wellcome Operations),
Harmire Road, Barnard Castle,
Durham, DL12 8DT, United Kingdom.

62000000018010
GSK-CAN-Mississauga-CAMIS

Other formats

United Kingdom-GBR

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

Daraprim

0800 198 5000 (UK only).

N/A

Please be ready to give the following
information:

0002456

Product name: Daraprim 25 mg
tablets

N/A

Reference number: 00003/5026R
This is a service provided by the
Royal National Institute of Blind
People.

N/A
1

This leaflet was last revised in:
July 2017.

K

Trade marks are owned by or licensed
to the GSK group of companies

0

©2017 GSK group of companies or
its licensor.
0

12.0pt
13.0pt
100%
10.0pt
Yes

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

GSLFLT002

Replaces Item Code:

A014911

Component Basic Dimensions:

311.15 x 628.65

(in mm)

Page 2 of 2

+ Expand Transcript

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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