DARAPRIM 25MG TABLETS

Active substance: PYRIMETHAMINE

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6

Package Leaflet:
Information for the User

10000000100300

Read all of this leaflet
carefully before you start
taking this medicine.
• 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. Do not pass it
on to others. It may harm them,
even if their symptoms are the
same as yours.
• If any of the side effects get
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
In this leaflet:
1 What Daraprim is and what it is
used for
2 Before you take Daraprim
3 How to take Daraprim
4 Possible side effects
5 How to store Daraprim
6 Further information

1 What Daraprim is and
what it is used for

3 How to take Daraprim

• you have kidney or liver problems
• you have a blood problem called
anaemia

• Swallow your tablets with a glass
of water.

Daraprim is used:

• you have ever had fits (seizures).

• to prevent malaria in people
living in areas where the malaria
parasite (Plasmodium) is sensitive
to pyrimethamine (Daraprim). It is
important that you only take
Daraprim if it has been
recommended by your doctor,
pharmacist or travel clinic.
Daraprim is not suitable for all
malaria areas.

Taking other medicines

No medicine for malaria gives
complete protection. You should
also ensure you:

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

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

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

- brain (encephalitis) and other
parts of the body if your immune
system is poor. This can be due
to AIDS

• proguanil or quinine sulphate -
used for malaria/night cramps

- eyes, infection can lead to
problems with your eyesight

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

- unborn baby, when an infection
is passed on from the mother
during pregnancy.

2 Before you take
Daraprim tablets
Do not take Daraprim if:
• you are allergic (hypersensitive) to
pyrimethamine or any of the other
ingredients of Daraprim (see
Section 6: Further information)
• you are a woman in the first
trimester of pregnancy

pyrimethamine

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

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

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

Daraprim® 25 mg tablets

Take special care with Daraprim

• you are a woman who is
breast-feeding. Ask your doctor or
midwife for advice
• 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.

• zidovudine - used to treat HIV
infection/AIDS

• lorazepam - used to help you sleep
or relax
• warfarin - used to thin your blood
• antacids - used for heart-burn or
indigestion
• medicines for diarrhoea which
contain an ingredient called kaolin.
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.

• Cover exposed areas of skin
• Use insect repellents and mosquito
nets.
Malaria
To help prevent infection with
malaria the usual dose depends on
your age:
• Adults and children over
10 years - One tablet once a
week
• Children 5 to 10 years - Half a
tablet once a week
• Children under 5 years should
not take Daraprim
• Take your first tablet during the
week before you travel to the
malaria area
• Take a dose each week you are in
the area

• 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
- then between one and four
tablets each day for the rest of
the course.
• To treat infections of the eye, the
usual dose is:

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

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

What Daraprim contains

United Kingdom-GBR
Daraprim

If you have any of the following
side effects or symptoms, talk to
your doctor immediately:

• depression

• The active substance is
pyrimethamine. Each tablet contains
25 mg of the active substance.

• sore throat, an unexpected illness
or skin reaction such as a rash or
irritation or breathlessness.

• sudden onset of high fever, rapid
shallow breathing, chills and
sweating
• abdominal pain
• dry mouth

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

• mouth ulcers on the inside of the
cheek

• From week 13 of your pregnancy
onwards, the usual dose is: one or
two tablets each day.

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 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.

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.

Children under 5 years should
not take Daraprim.

Other side effects include:

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

Toxoplasmosis

If you forget to take Daraprim

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

• If you forget to take a dose, take it
as soon as you remember it.

Adults and children over 5 years.
To treat infections, caused by
Toxoplasma you usually:

• Do not take a double dose (two
doses at the same time) to make
up for a forgotten dose.

• If you need a further course, you
should wait for two weeks
between courses.

6 Further information

• abnormal bruising, tiredness,
weakness or giddiness

• Take a dose each week for a
further 4 weeks after you leave the
malaria area.

• Take the medicine for 3 to
6 weeks.

4 Possible side effects

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

In the unborn baby Daraprim may
stop toxoplasmosis from the mother
damaging the unborn baby.

• However, if it is time for the next
dose, skip the missed dose.

GSK-CAN-Mississauga-CAMIS

Very Rare (affects less than 1 in
10,000 people

Very common (affects more than
1 in 10 people)
• anaemia
• headache
• vomiting, feeling sick and diarrhoea

• dry throat

• red inflamed dry skin
• blood in the urine
• malaise
If you have been prescribed
Daraprim and you become
unwell during or after your visit
to the malaria area, tell your
doctor or pharmacist if you
cannot think of another reason
for feeling unwell.
If you have been prescribed
Daraprim for toxoplasmosis please
check the leaflet for the
sulphonamide antibiotic you should
also have been prescribed.
If any of the side effects get serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

Common (affects less than 1 in
10 people but more than 1 in
100 people)

5 How to store Daraprim

• tiredness, weakness, abnormal
bruising

• Keep out of reach and sight of
children.

• giddiness
• change in blood test results

• 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.

Uncommon (affects less than 1 in
100 people but more than 1 in
1000 people)

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

• fever

• 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.

• weakness

• abnormal skin pigmentation

1

• The other ingredients are lactose
monohydrate, maize starch,
hydrolysed starch, docusate
sodium and magnesium stearate.

K

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.

0002456

Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation holder:
GlaxoSmithKline UK, Stockley Park
West, Uxbridge, Middlesex UB11 1BT
Manufacturer:
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany
Other formats
To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:

Front
Page 1 of 2

0800 198 5000 (UK only).
Please be ready to give the following
information:
Product name: Daraprim 25 mg
tablets
Reference number: 00003/5026R
This is a service provided by the
Royal National Institute of Blind
People.
Leaflet date: April 2013
Daraprim is a registered trademark
of the GlaxoSmithKline group of
companies
© 2013 GlaxoSmithKline group of
companies

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

GSLFLT002

Replaces Item Code:

A093701

Component Basic Dimensions:

628.7 x 311.2

(in mm)

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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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