Package leaflet: Information for the user

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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

A SANDOZ

What Reprapog is and what it is used for

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).

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.

Protectyour child from catching malaria

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

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 need further advice, talk to your doctor or pharmacist.

Other medicines and Reprapog

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

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 totreat HIV

•    warfarin and other medicines that stop blood clotting

•    etoposide used to treat cancer.

Tell your doctor if your child is taking any of these. Your doctor may decide that Reprapog isn't suitable for them, or that they need extra check ups while taking it.

Remember to tell your doctor if your child starts taking any other medicines while they're taking Reprapog.

Pregnancy, breast-feeding and fertility

Ifyou 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.

Ifyou or your child is 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

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

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.

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How to give Reprapog

See a doctor immediately if your child gets symptoms after returning    Always give this medicine exactly as your doctor has told you. Check

from abroad, such as high temperature, headache, shivering and    with your doctor or pharmacist if you are not sure.

tiredness.

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 ofthis 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.

Warnings and precautions

Talk to your doctor before giving Reprapog.

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.

•    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.

To treat malaria

The recommended dose to treat malaria in children weighing between 5 kg and 11 kg depends on your child's 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.

Continued on the next page >>

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, don't 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.

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

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 ofthe skin to sunlight.

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.

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How to store Reprapog

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Possible side effects

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 ifyour 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).

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.

Very common side effects, may affect more than 1 per 10 users

•    headache

•    feeling sick and being sick (nausea and vomiting)

•    stomach pain

•    diarrhoea.

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.

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.

Uncommon side effects, may affect 1 to 10per 1,000 users

•    anxiety

•    an unusual awareness of abnormal beating of the heart (palpitations)

•    swelling and redness of the mouth

•    hair loss.

Uncommon side effects that may show up in your blood tests:

•    an increase in amylase (an enzyme produced in the pancreas).

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.

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.

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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 (TypeA), magnesium stearate, hypromellose, low-substituted hydroxypropyl cellulose, silica colloidal anhydrous,titanium dioxide (E171), red iron oxide (E172) and macrogol.

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.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

MarketingAuthorisation Holder Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Lek Pharmaceuticals d.d.,

Verovskova 57, 1526 Ljubljana, Slovenia

Or

Lek Pharmaceuticals d.d.,

Trimlini 2D, 9220 Lendava, Slovenia

Or

LEK S.A.,

ul. Domaniewska 50 C, 02-672 Warsaw, Poland

Or

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.

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