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Document: leaflet MAH GENERIC_PL 04569-1271 change

• leaflet MAH GENERIC_PL 04569-1271
• leaflet MAH GENERIC_PL 25258-0064

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ATOVAQUONE/PROGUANIL HYDROCHLORIDE 250 mg/100 mg FILM-COATED TABLETS

(atovaquone/proguanil hydrochloride)

What is in this leaflet:

1.    What Atovaquone/Proguanil Hydrochloride is and what it is used for.

2.    What you need to know before you take Atovaquone/ Proguanil Hydrochloride.

3.    How to take Atovaquone/Proguanil Hydrochloride

4.    Possible side effects.

5.    How to store Atovaquone/Proguanil Hydrochloride.

6.    Contents of the pack and other information.

1.    WHAT ATOVAQUONE/PROGUANIL HYDROCHLORIDE IS AND WHAT IT IS USED FOR

Atovaquone/Proguanil Hydrochloride belongs to a group of medicines called antimalarials.

It contains two active ingredients, atovaquone and proguanil hydrochloride.

Atovaquone/Proguanil Hydrochloride is used to:

•    Prevent malaria.

•    Treat malaria.

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

Protecting yourself from catching malaria

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

As well as taking Atovaquone/Proguanil Hydrochloride, 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.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATOVAQUONE/PROGUANIL HYDROCHLORIDE

Do not take Atovaquone/Proguanil Hydrochloride:

•    if you are allergic to atovaquone, proguanil hydrochloride or any of the other ingredients of this medicine (listed in section 6)

•    For preventing malaria, if you have severe kidney —disease

•    Tell your doctor if either of these applies to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Atovaquone/Proguanil Hydrochloride:

Children

Atovaquone/Proguanil Hydrochloride 250 mg/ 100 mg film-coated tablets should not be used in children or in adults who weigh less than 40 kg. There may be a different type of tablets available in your country for children, containing less atovaquone and proguanil hydrochloride.

Other medicines and Atovaquone/Proguanil Hydrochloride

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Some medicines can affect the way Atovaquone/Proguanil Hydrochloride works, or Atovaquone/Proguanil Hydrochloride 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 or certain 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 Atovaquone/Proguanil Hydrochloride is not suitable for you, or that you need extra check ups while you are taking it.

Remember to tell your doctor if you start taking any other medicines while you are taking Atovaquone/Proguanil Hydrochloride.

Atovaquone/Proguanil Hydrochloride with food and drink

Take Atovaquone/Proguanil Hydrochloride with food or a milky drink, where possible. This will increase the amount of Atovaquone/Proguanil Hydrochloride your body can absorb, and make your treatment more effective.

Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby, do not take Atovaquone/Proguanil Hydrochloride unless your doctor recommends it.

Ask your doctor or pharmacist for advice before taking this medicine.

Do not breast-feed while taking Atovaquone/Proguanil Hydrochloride, as the ingredients of Atovaquone/Proguanil Hydrochloride may pass into breast milk and may harm your baby.

Driving and using machines If you feel dizzy, do not drive.

Atovaquone/Proguanil Hydrochloride 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.

Atovaquone/Proguanil Hydrochloride contains lactose. If you

have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.

3. HOW TO TAKE ATOVAQUONE/PROGUANIL HYDROCHLORIDE

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

Take Atovaquone/Proguanil Hydrochloride with food or a milky drink, where possible.

It is best to take Atovaquone/Proguanil Hydrochloride at the same time each day.

To prevent malaria:

The recommended dose for adults and children weighing at least 40 kg is 1 tablet once a day, taken as below. Atovaquone/Proguanil Hydrochloride is not recommended for preventing malaria in children, or in adults or adolescents who weigh less than 40 kg:

•    start taking Atovaquone/Proguanil Hydrochloride 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.

To treat malaria:

The recommended dose for adults is 4 tablets once a day for 3 days.

For children weighing 11 kg or more 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 tablets available in your country for children, containing less atovaquone and proguanil hydrochloride.

If you take more Atovaquone/Proguanil Hydrochloride than you should

Contact a doctor or pharmacist for advice.

If possible show them the Atovaquone/Proguanil Hydrochloride pack.

If you forget to take Atovaquone/Proguanil Hydrochloride

It is very important that you take the full course of Atovaquone/Proguanil Hydrochloride.

If you forget to take a dose, do not worry. Just take your next dose 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 Atovaquone/Proguanil Hydrochloride

Do not stop taking Atovaquone/Proguanil Hydrochloride without advice.

Keep taking Atovaquone/Proguanil Hydrochloride for 7 days after you return to a malaria-free area. Take the full course of Atovaquone/Proguanil Hydrochloride for maximum protection. 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.

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

If you are sick (vomit):

For preventing malaria:

• If you are sick (vomit) within 1 hour of taking your

Date: 22 APR 2014

Atovaquone/Proguanil Hydrochloride film-coated tablet, take another dose straight away.

•    It is important to take the full course of Atovaquone/ Proguanil Hydrochloride. 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. Atovaquone/Proguanil Hydrochloride 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. Atovaquone/Proguanil Hydrochloride 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.

4. 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 or low blood pressure

•    swollen eyelids, face, lips, tongue or other part of the body.

Contact a doctor immediately if you get any of these symptoms and stop taking Atovaquone/Proguanil Hydrochloride.

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 in 10 people):

•    headache

•    feeling sick and being sick (nausea and vomiting)

•    stomach pain

•    diarrhoea.

Common side effects (may affect up to 1 in 10 people):

•    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 up to 1 in 100 people):

•    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).

Not known (frequency cannot be estimated from the available data)

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:

•    in people with severe kidney disease, 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:

UK

Yellow Card Scheme,

Website: www.mhra.gov.uk/yellowcard

Ireland

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE ATOVAQUONE/PROGUANIL HYDROCHLORIDE

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 the carton after 'EXP'.

The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

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.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Atovaquone/Proguanil Hydrochloride contains:

•    The active substances are atovaquone and proguanil hydrochloride. Each film-coated tablet contains 250 mg atovaquone and 100 mg proguanil hydrochloride.

•    The other ingredients are:

Tablet core: Cellulose, microcrystalline, Povidone (K-30), Crospovidone (Type A), Poloxamer 188, Magnesium stearate.

Film-coat: Titanium dioxide (E171), Lactose monohydrate, Macrogol 4000, Hypromellose 15cP (E464), Hypromellose 50cP (E464), Hypromellose 3cP (E464), Iron oxide red (E172), Iron oxide black (E172), Iron oxide yellow (E172).

What Atovaquone/Proguanil Hydrochloride looks like and contents of the pack

Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets are buff coloured, round, biconvex, film-coated tablets debossed with 'A-P' over '2' on one side and 'M' on the other side. They are supplied in PVC-Aluminium, OPA/Aluminium/PVC-Aluminium, PVC/PVdC-Aluminium blister packs containing 12, 24 tablets or 12 x 1, 24 x 1 tablets.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Generics [UK] Ltd., Potters Bar, Herts., EN6 1TL,

United Kingdom.

Manufacturers

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Generics [UK] Ltd., Potters Bar, Herts., EN6 1TL,

United Kingdom.

Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany    Malarex

250 mg/100 mg Filmtabletten Austria    Atovaquon/Proguanil

Arcana 250 mg/100 mg Filmtabletten Belgium    Atovaquone/Proguanil Mylan

250 mg/100 mg Filmomhulde tabletten

Denmark    Provaqomyl

Finland    Provaqomyl

France    Atovaquone/Proguanil

MYLAN, 250 mg/100 mg, comprime pellicule

Italy    Atovaquone e Proguanile Mylan

Generics

Ireland    Atovaquone/Proguanil Hydrochloride

250 mg/100 mg film-coated tablets Norway    Provaqomyl

Sweden    Provaqomyl

Spain    Atovacuona/Hidrocloruro

de proguanil

MYLAN 250 mg/100 mg comprimidos recubiertos con pelicula EFG The Netherlands Atovaquon/Proguanil HCl Mylan

250/100 mg, filmomhulde tabletten United Kingdom Atovaquone/Proguanil Hydrochloride

250 mg/100 mg film-coated tablets

This leaflet was last revised in January 2014.

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