DARAPRIM 25MG TABLETS

Active substance: 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
about your illness or your
medicine, 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
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 is used:
• to treat infections, caused by a
parasite called Toxoplasma
together with antibiotics called
sulphonamides. These infections
can affect the:
- 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
- unborn baby, when an infection
is passed on from the mother
during pregnancy.

1 What Daraprim is and what it is
used for

Ask your doctor if you need to have
these conditions explained to you.

2 What you need to know before
you take Daraprim

2 What you need to know
before you take Daraprim

3 How to take Daraprim
4 Possible side effects
5 How to store Daraprim
6 Contents of the pack and other
information

Do not take Daraprim :
• 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

Daraprim® 25 mg tablets

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

Warnings and Precautions
Check with your doctor or
pharmacist before taking this
medicine if:

• you have a blood problem called
anaemia

3 How to take Daraprim

If you take more Daraprim than
you should

• you have ever had fits (seizures).

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

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

• Swallow your tablets with a glass
of water.

If you forget to take Daraprim

Other medicines and Daraprim
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription. This includes herbal
medicines. This is because Daraprim
can affect the way some medicines
work. Also some other medicines
can affect the way Daraprim works.
In particular tell your doctor if you are
taking any of the following medicines:
• trimethoprim or co-trimoxazole –
used as antibiotics
• proguanil or quinine sulfate – used
for malaria/night cramps
• zidovudine – used to treat HIV
infection/AIDS
• medicines for cancer – such as
methotrexate, daunorubicin, or
cytosine
• lorazepam – used to help you
sleep or relax
• warfarin – used to thin your blood

Toxoplasmosis
Daraprim should always be given
with another antibiotic called a
sulphonamide and a folic acid
(vitamin) supplement.
Adults and children over 5 years.
To treat infections, caused by
Toxoplasma you usually:
• Take the medicine for 3 to
6 weeks.
• If you need a further course, you
should wait for two weeks
between courses.
• To treat infections of the brain
(encephalitis) and other organs in
people who have a poor immune
system or AIDS, the usual dose is:
- four to eight tablets each day for
the first 2 or 3 days

• antacids – used for heart-burn or
indigestion

- then between one and four
tablets each day for the rest of
the course.

• medicines for diarrhoea which
contain an ingredient called kaolin.

• To treat infections of the eye, the
usual dose is:

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.

- four tablets each day for the first
1 or 2 days
- then one or two tablets each day
for the rest of the course.
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: one or
two tablets each day.
• 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.
Children under 5 years should
not 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.

4 Possible side effects
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:
• sore throat, an unexpected illness
or skin reaction such as a rash or
irritation or breathlessness.

Common (may affect less than 1 in
10 people but more than 1 in
100 people)
• tiredness, weakness, abnormal
bruising
• giddiness
• weakness
• change in blood test results
Uncommon (may affect less than
1 in 100 people but more than 1 in
1000 people)

• headache
• vomiting, feeling sick and diarrhoea

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

This is a service provided by the
Royal National Institute of Blind
People.
This leaflet was last revised in:
September 2014
Daraprim is a registered trade mark
of the GSK group of companies

6 Contents of the pack &
other information

• sudden onset of high fever, rapid
shallow breathing, chills and
sweating
• abdominal pain
• mouth ulcers on the inside of the
cheek

If you have been prescribed
Daraprim for toxoplasmosis please
check the leaflet for the
sulphonamide antibiotic you should
also have been prescribed.

• anaemia

Product name: Daraprim 25 mg
tablets
Reference number: 00003/5026R

• change in blood test results,
sleepiness, contractions of body
muscles

• abnormal skin pigmentation

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.

Very common (may affect more
than 1 in 10 people)

• Keep out of sight and reach of
children.

Very Rare (may affect less than 1 in
10,000 people)

• fever

• red inflamed dry skin

Other side effects include:

Please be ready to give the following
information:

• 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.

• abnormal bruising, tiredness,
weakness or giddiness

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.

5 How to store Daraprim

• malaise

Reporting of side effects

©2014 GSK group of companies.
All rights reserved.

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
Daraprim tablets are white and
round with the marking ‘GS A3A’.
Your Daraprim tablets are in cartons
of 30 tablets.

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.

Marketing Authorisation Holder
and Manufacturer

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

Manufacturer:
Aspen Bad Oldesloe GmbH,
Industriestrasse 32-36,
23843 Bad Oldesloe, Germany.

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

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).

• you have kidney or liver problems

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Leading: 13pt
Horizontal Scale: 100%
Smallest text size: 10pt
Microtext: Y

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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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