Package leaflet: Information for the user

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Reprapog 250 mg/100 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 take Reprapog

3.    How to take Reprapog

4.    Possible side effects

5.    How to store Reprapog

6.    Contents of the pack and other information

A SANDOZ

1

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 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.

Protectyourself 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.

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.

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 you are taking any of these. Your doctor may decide that Reprapog isn't suitable for you, or that you need extra check ups while you're taking it.

Remember to tell your doctor before you start taking any other medicines while you're taking Reprapog.

Pregnancy, breast-feeding and fertility

Ifyou 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.

Ifyou 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

Ifyou feel dizzy, do not drive. This medicine makes some people feel dizzy. Ifthis happens to you, do not drive, use machines or take part in activities where you may put yourself or others at risk.

How to take Reprapog

What you need to know before you take Reprapog

Do nottake Reprapog:

•    if you are allergic to atovaquone, proguanil hydrochloride or to any of

the other ingredients ofthis medicine (listed in section 6).

•    for preventing malaria, if you have severe kidney problems.

Tell your doctor if either of these apply to you.

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.

Other medicines and Reprapog

Tell your doctor or pharmacist if you are taking, have recently taken or

might take any other medicine.

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

To prevent malaria

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

•    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.

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.

If you are sick (vomit)

If you vomit within 1 hour of taking your tablet, take another dose straight away.

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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 packwith you.

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.

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.

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

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

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.

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.

4

Possible side effects

6

Contents of the pack and other information

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 ifyou get any ofthese 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).

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.

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

•    A decrease in all types of blood cells (pancytopenia).

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 (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 'H' on one side and '175' 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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