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REPRAPOG 250 MG/100 MG FILM-COATED TABLETS

Active substance(s): ATOVAQUONE / PROGUANIL HYDROCHLORIDE

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Package leaflet: Information for the user

Reprapog 250 mg/100 mg Film-coated Tablets

SZ00000LT000

atovaquone/proguanil hydrochloride

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

1

Some medicines can affect the way Reprapog works, or Reprapog itself
can strengthen or weaken the effectiveness of other medicines taken at
the same time. These include:

What Reprapog is and what it is used for

metoclopramide, used to treat nausea and vomiting
the antibiotics, tetracycline, rifampicin and rifabutin
efavirenz, indinavir or certain other highly active
protease-inhibitors used to treat HIV
• warfarin and other medicines that stop blood clotting
• etoposide used to treat cancer.
Tell your doctor if you are taking any of these. Your doctor may decide
that Reprapog isnʼt suitable for you, or that you need extra check ups
while youʼre taking it.




Reprapog belongs to a group of medicines called antimalarials. It
contains two active ingredients, atovaquone and proguanil
hydrochloride.

Reprapog has two uses:
• to prevent malaria in adults and children who weigh at least 40 kg
• to treat malaria in adults and children who weigh at least 11 kg.

Malaria is spread by the bite of an infected mosquito, which passes the
malaria parasite (Plasmodium falciparum) into the bloodstream.
Reprapog prevents malaria by killing this parasite. For people who are
already infected with malaria, Reprapog also kills these parasites.

Remember to tell your doctor before you start taking any other
medicines while youʼre taking Reprapog.
Pregnancy, breast-feeding and fertility

Protect yourself from catching malaria
People of any age can get malaria. It is a serious disease, but is
preventable.

If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking this
medicine.

As well as taking Reprapog, it is very important that you also take steps
to avoid being bitten by mosquitoes.
• Use insect repellent on exposed areas of the skin
• Wear light coloured clothing that covers most of the body, especially
after sunset as this is the time when mosquitoes are most active
• Sleep in a screened room or under a mosquito net impregnated with
insecticide
• Close windows and doors at sunset, if they are not screened
• Consider using an insecticide (mats, spray, plug-ins) to clear a room
of insects or to deter mosquitoes from entering the room.

If you are pregnant, do not take this medicine unless your doctor
recommends it.

Do not breast-feed while taking Reprapog, as the ingredients may pass
into breast milk and may harm your baby.

In animal studies the active ingredients atovaquone and proguanil have
shown no effects on fertility.
Driving and using machines
If you feel dizzy, do not drive. This medicine makes some people feel
dizzy. If this happens to you, do not drive, use machines or take part in
activities where you may put yourself or others at risk.

If you need further advice, talk to your doctor or pharmacist.

3

It is still possible to get malaria after taking the necessary precautions.
Some types of malaria infection take a long time to cause symptoms, so
the illness may not start until several days, weeks or even months after
returning from abroad.

See a doctor immediately if you get symptoms such as high
temperature, headache, shivering and tiredness after returning home.

2

How to take Reprapog

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

What you need to know before you take
Reprapog

To prevent malaria
The recommended dose for adults and children weighing at least 40 kg
is 1 tablet once a day, taken as below.

Do not take Reprapog:
• if you are allergic to atovaquone, proguanil hydrochloride or to any of
the other ingredients of this medicine (listed in section 6).
• for preventing malaria, if you have severe kidney problems.






Tell your doctor if either of these apply to you.

Start taking Reprapog 1 to 2 days before travelling to an area which
has malaria
Continue taking it every day during your stay
Continue taking it for another 7 days after your return to a
malaria-free area.

Use in children and adolescents
Not recommended for preventing malaria in children, or in adults
who weigh less than 40 kg.
There may be a different type of atovaquone/proguanil tablet available
for children in your country.

Warnings and precautions
Talk to your doctor before taking Reprapog.

If you are sick (vomit):
If you vomit within 1 hour of taking your tablet, take another dose
straight away.
• For preventing malaria:
- it is important to take the full course of Reprapog. If you have to
take extra tablets due to sickness, you may need another
prescription.
- if you have been vomiting, it is especially important to use extra
protection, such as repellents and bednets. Reprapog may not be
as effective, as the amount absorbed will be reduced.
• For treating malaria:
- if you have vomiting and diarrhoea tell your doctor, you will need
regular blood tests. Reprapog will not be as effective, as the
amount absorbed will be reduced. The tests will check whether
the malaria parasite is being cleared from your blood.

To treat malaria
The recommended dose for adults weighing at least 40 kg is 4 tablets
once a day for 3 days.

Use in children and adolescents
For children weighing at least 11 kg the dose depends on their
bodyweight:
• 11-20 kg – 1 tablet once a day for 3 days
• 21-30 kg – 2 tablets once a day for 3 days
• 31-40 kg – 3 tablets once a day for 3 days
• over 40 kg – dose as for adults.

Not recommended for treating malaria in children who weigh less than
11 kg.
For children who weigh less than 11 kg talk to your doctor. There may
be a different type of atovaquone/proguanil tablet available in your
country.

Other medicines and Reprapog
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicine.

If you are sick (vomit)
If you vomit within 1 hour of taking your tablet, take another dose
straight away.
Continued on the next page >>

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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
(www.mhra.gov.uk/yellowcard). By reporting side effects you can help
provide more information on the safety of this medicine.

Method of administration
Take Reprapog with food or a milky drink, where possible.
It is best to take Reprapog at the same time each day.

If you take more Reprapog than you should
If you take more than you should, talk to a doctor or go to a
pharmacist for advice. Take the medicine pack with you.

5

If you forget to take Reprapog
It is very important that you take the full course of Reprapog. If
you forget to take a dose, do not worry. Just take it as soon as you
remember. Then continue your treatment as before. Do not take a
double dose to make up for a forgotten dose.

Keep this medicine out of the sight and reach of children.

If you stop taking Reprapog
• Use for prevetion:
Keep taking Reprapog for 7 days after you return to a
malaria-free area. Stopping early puts you at risk of getting malaria,
as it takes 7 days to ensure that any parasites that may be in your
blood following a bite from an infected mosquito are killed.
• Use for treatment:
Keep taking this medicine until your doctor tells you to stop. Do not
stop taking Reprapog just because you feel better.

Do not use this medicine after the expiry date which is stated on the
blister and carton after EXP (month,year). The expiry date refers to the
last day of that month.
Reprapog does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6

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

4

How to store Reprapog

Possible side effects

Contents of the pack and other information

What Reprapog contains:
• The active substances are atovaquone and proguanil hydrochloride.
Each tablet contains 250 mg of atovaquone and 100 mg of proguanil
hydrochloride.
• The other ingredients are: poloxamer, microcrystalline cellulose,
povidone K30, sodium starch glycolate (Type A), magnesium
stearate, hypromellose, low-substituted hydroxypropyl cellulose,
silica colloidal anhydrous, titanium dioxide (E171), red iron oxide
(E172) and macrogol.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Look out for the following severe reactions. They have occurred in a
small number of people, but their exact frequency is unknown.

Severe allergic reactions - signs include:
• rash and itching
• sudden wheezing, tightness of the chest or throat, or difficulty
breathing
• swollen eyelids, face, lips, tongue or other parts of the body.
Contact a doctor immediately if you get any of these symptoms. Stop
taking Reprapog.

What Reprapog looks like and contents of the pack
Pink, round, biconvex film-coated tablets debossed with 'H' on one side
and '175' on the other side.
Al/Al Blister or Transparent PVC-Al Blister: 3, 6, 9, 12, 18, 24, 36, 48
film-coated tablets.

Severe skin reactions
• skin rash, which may blister and looks like small targets (central dark
spots, surrounded by paler area with a dark ring around the edge)
(erythema multiforme)
• severe widespread rash with blisters and peeling skin, particularly
occurring around the mouth, nose, eyes and genitals
(Stevens-Johnson syndrome).
If you notice any of these symptoms contact a doctor urgently.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Most of the other side effects reported have been mild and have not
lasted very long.

Manufacturer
Lek Pharmaceuticals d.d.,
Verovškova 57,
1526 Ljubljana,
Slovenia

Very common side effects, may affect more than 1 per 10 users
• headache
• feeling sick and being sick (nausea and vomiting)
• stomach pain
• diarrhoea.

Or

Common side effects, may affect 1 to 10 per 100 users
• dizziness
• sleeping problems (insomnia)
• strange dreams
• depression
• loss of appetite
• fever
• rash which may be itchy
• cough.

Lek Pharmaceuticals d.d.,
Trimlini 2D,
9220 Lendava,
Slovenia
Or

LEK S.A.,
ul. Domaniewska 50 C,
02-672 Warsaw,
Poland

Common side effects, which may show up in your blood tests are:
• reduced numbers of red blood cells (anaemia) which can cause
tiredness, headaches and shortness of breath
• reduced numbers of white blood cells (neutropenia) which may make
you more likely to catch infections
• low levels of sodium in the blood (hyponatraemia)
• an increase in liver enzymes.

Or

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany

Uncommon side effects, may affect 1 to 10 per 1,000 users
• anxiety
• an unusual awareness of abnormal beating of the heart (palpitations)
• swelling and redness of the mouth
• hair loss.

Or

S.C. Sandoz, S.R.L.,
Str. Livezeni nr. 7A,
RO-540472 Targu-Mures,
Romania

Uncommon side effects that may show up in your blood tests:
• an increase in amylase (an enzyme produced in the pancreas).

Or

Other side effects
Other side effects have occurred in a small number of people but their
exact frequency is unknown.
• inflammation of the liver (hepatitis)
• blockage of the bile ducts (cholestasis)
• increase in heart rate (tachycardia)
• inflammation of the blood vessels (vasculitis) which may be visible
as red or purple raised spots on the skin but can affect other parts of
the body
• fits (seizures)
• panic attacks, crying
• seeing or hearing things that are not there (hallucinations)
• nightmares
• mouth ulcers
• blisters
• peeling skin
• increased sensitivity of the skin to sunlight.

Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta.
This leaflet was last revised in 05/2013.

Other side effects that may show up in your blood tests:
• A decrease in all types of blood cells (pancytopenia).

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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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