Skip to Content

UK Edition. Click here for US version.

REPRAPOG 62.5 MG/25 MG FILM-COATED TABLETS

Active substance(s): ATOVAQUONE / PROGUANIL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

SZ00000LT000

Reprapog 62.5 mg/25 mg Film-coated Tablets

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 give Reprapog
3. How to give Reprapog
4. Possible side effects
5. How to store Reprapog
6. Contents of the pack and other information

1

Other medicines and Reprapog
Tell your doctor or pharmacist if your child is taking, has recently taken
or might take any other medicine.

What Reprapog is and what it is used for

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:
• 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.

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 (for children and adults weighing between 11 kg
and 40 kg)
• to treat malaria (for children weighing between 5 kg and 11 kg).

Tell your doctor if your child is taking any of these. Your doctor may
decide that Reprapog isnʼt suitable for them, or that they need extra
check ups while taking it.

Although this medicine is usually used for children and teenagers, it can
be prescribed for adults weighing less than 40 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 if your child starts taking any other
medicines while theyʼre taking Reprapog.

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

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

If you or your child is pregnant, do not take this medicine unless your
doctor recommends it.

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.

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
This medicine is not expected to affect your ability to drive or use
machinery.

3

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

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.

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

See a doctor immediately if your child gets symptoms after returning
from abroad, such as high temperature, headache, shivering and
tiredness.

2

How to give Reprapog

To prevent malaria
The recommended dose depends on the body weight:
11-20 kg – 1 tablet once a day
21-30 kg – 2 tablets once a day (as a single dose)
31-40 kg – 3 tablets once a day (as a single dose).

What you need to know before you give
Reprapog

Do not give Reprapog:
• if your child is allergic to atovaquone, proguanil hydrochloride or to
any of the other ingredients of this medicine (listed in section 6)
• for preventing malaria, if your child has severe kidney problems.






Tell your doctor if either of these apply to your child.

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

For maximum protection your child must take the full course of
treatment.

Warnings and precautions
Talk to your doctor before giving Reprapog.

To treat malaria
The recommended dose to treat malaria in children weighing between
5 kg and 11 kg depends on your childʼs weight:
5-8 kg – 2 tablets once a day for 3 days
9-10 kg – 3 tablets once a day for 3 days.

If your child is sick (vomits):
If your child vomits within 1 hour of taking the tablet, give another dose
straight away.
• For preventing malaria:
- it is important to take the full course of Reprapog. If your child
has to take extra tablets due to sickness, you may need another
prescription.
- if your child has been vomiting, it is especially important to use
extra protection, such as repellents and bed nets. Reprapog may
not be as effective, as the amount absorbed will be reduced.
• For treating malaria:
- if your child has vomiting and diarrhoea tell your doctor. Your
child 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 their
blood.

If your child is sick (vomits)
If your child vomits within 1 hour of taking the tablet, give another dose
straight away.

Continued on the next page >>

Artwork Proof Box
Ref: Licence application
Proof no.
001.0

Date prepared:
31/05/2013

Colours:
Black
Black 20%
Dimensions: 150 x 300 mm

Font size:
7pt
Fonts:
Helvetica

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.

Method of administration
Give Reprapog with food or a milky drink, where possible.
The tablets should be swallowed whole. However, for children who find
it difficult to swallow, they may be crushed just before being taken and
mixed with food or a milky drink.
It is best to give Reprapog at the same time each day.

If you give your child more Reprapog than you should
Talk to a doctor or go to a pharmacist for advice. Take the medicine
pack with you.

If you forget to give Reprapog
It is very important that your child takes the full course of Reprapog. If
you forget to give your child a dose, donʼt worry. Just give the next dose
as soon as you remember. Then continue the treatment as before. Do
not give a double dose to make up for a forgotten dose.
If you stop giving Reprapog
• Use for prevention:
Keep giving Reprapog for 7 days after you return to a
malaria-free area. Stopping early puts your child at risk of getting
malaria, as it takes 7 days to ensure that any parasites that may be
in the blood following a bite from an infected mosquito are killed.
• Use for treatment:
Keep giving this medicine until your doctor tells you to stop. Do not
stop giving Reprapog just because your child feels better.

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

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.

5

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

4

Possible side effects

How to store Reprapog

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

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.

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

Reprapog does not require any special storage conditions.

Look out for the following severe reactions. They have occurred in a
small number of people, but their exact frequency is unknown.

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

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.

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

Contact a doctor immediately if your child gets any of these symptoms.
Stop taking Reprapog.

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).

Contents of the pack and other information

What Reprapog contains
• The active substances are atovaquone and proguanil hydrochloride.
Each tablet contains 62.5 mg of atovaquone and 25 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.

If you notice any of these symptoms contact a doctor urgently. Most of
the other side effects reported have been mild and have not lasted very
long.

What Reprapog looks like and contents of the pack
Pink, round, biconvex film-coated tablets debossed with 'I' on one side
and '11' on the other side.

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

Al/Al Blister or Transparent PVC-Al Blister: 3, 6, 9, 12, 18, 24, 36, 48
film-coated tablets.

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.

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.

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

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

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

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.

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

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

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

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

Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park, Paola PLA 3000, Malta.
This leaflet was last revised in 05/2013.
SZ00000LT000

Artwork Proof Box
Ref: Licence application
Proof no.
001.0

Date prepared:
31/05/2013

Colours:
Black
Black 20%
Dimensions: 150 x 300 mm

Font size:
7pt
Fonts:
Helvetica

Expand view ⇕

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.

Hide