Package Leaflet: Information for the User

Malarone 250 mg/100 mg – Film-coated Tablets

Atovaquone/Proguanil hydrochloride
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

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

1. What Malarone is and what it is used for
Malarone belongs to a group of medicines called antimalarials. It contains two active substances:
atovaquone and proguanil hydrochloride.

What Malarone is used for
Malarone is used in two ways:
for the prevention of malaria
for the treatment of malaria
See section 3, How to take Malarone.

Malaria is spread through the bite of an infected mosquito that transmits the malaria parasite
( Plasmodium falciparum ) into the bloodstream. Malarone prevents malaria by killing this parasite.
Malarone also kills these parasites in individuals already infected with malaria.

Protect yourself from contracting malaria.
People of all ages can contract malaria. It is a serious illness, but it can be prevented.
It is very important that, in addition to taking Malarone, you take precautions to avoid being bitten
by mosquitoes.

Use an insect repellent on exposed areas of 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 room protected by mosquito nets or sleep under an insecticide-impregnated mosquito net.
Close doors and windows at dusk if they are not fitted with mosquito nets.
Use an insecticide (tablets, sprays, plug-in devices) to eliminate insects from the room or to prevent mosquitoes from entering.

→ If you need further information, consult your doctor or pharmacist.
Despite these necessary precautions, it is still possible to contract malaria. Some types of
malaria infection may cause symptoms after a long delay; therefore, the disease may appear
days, weeks, or even months after returning from abroad.
→ Seek immediate medical attention if, after returning home, you experience symptoms such as high fever, headache, chills, and fatigue.

2. What you should know before taking Malarone

Do not take Malarone:

if you are allergic to atovaquone, proguanil hydrochloride, or any of the other ingredients of this medicine (listed in section 6)
for malaria prevention, if you have severe kidney disease.

→ Tell your doctor if either of these situations applies to you.
Warnings and precautions with Malarone
Talk to your doctor or pharmacist before taking Malarone if:

you have severe kidney disease
your child is being treated for malaria and weighs less than 11 kg. There is another tablet strength available for treating children weighing less than 11 kg (see section 3).
Tell your doctor or pharmacist if any of these situations apply to you.

Other medicines and Malarone
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Some medicines may affect the action of Malarone, or Malarone may increase or decrease 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 some potent protease inhibitors used to treat HIV
warfarin and other medicines that inhibit blood clotting
etoposide, used to treat cancer

→ Tell your doctor if you are taking any of these medicines. Your doctor may decide that Malarone is not suitable for you, or that you need additional monitoring while taking Malarone.
→ Remember to inform your doctor if you start taking any other medicines while also taking Malarone.
Malarone with food and drinks
Take Malarone with food or a milk-based drink, if possible. This way, your body will absorb more Malarone, making the treatment more effective.
Pregnancy and breastfeeding
If you are pregnant, do not take Malarone unless your doctor specifically recommends it.
→ Ask your doctor or pharmacist for advice before taking Malarone.
Do not breastfeed while taking Malarone, as its components may pass into breast milk and harm the baby.
Driving and using machines
If you feel dizzy, do not drive
Malarone may cause dizziness in some people. If this happens to you, do not drive, operate machinery, or engage in activities that could put yourself or others at risk.

3. HOW TO TAKE MALARONE

Take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, consult your doctor or pharmacist.
Take Malarone with food or a milk-based drink, if possible.
It is best to take Malarone at the same time each day.

If you vomit

For prevention of malaria:

if you vomit within 1 hour after taking Malarone, take another dose immediately
it is important to complete the full course of Malarone. If you need to take additional tablets due to vomiting, you may require another prescription.
if you have vomited, it is especially important that you use additional protective measures, such as repellents and mosquito nets. Due to reduced absorption, Malarone may not be fully effective.

For treatment of malaria:

if you vomit and have diarrhoea, inform your doctor; you will need regular blood tests. Malarone may not be fully effective due to reduced absorption. These tests will check whether the malaria parasite has been eliminated from your blood.

For prevention of malaria
The recommended dose in adults is 1 tablet once daily, taken as follows.
Not recommended for prevention of malaria in children, or in adults weighing less than
40 kg. Malarone Paediatric Tablets are recommended for prevention of malaria in adults or children
weighing less than 40 kg.
To prevent malaria in adults:

start taking Malarone 1 or 2 days before travelling to a malaria-risk area
continue taking Malarone every day throughout your stay
continue taking Malarone for a further 7 days after returning to a malaria-free area.

For treatment of malaria
The recommended dose in adults is 4 tablets once daily for 3 days.
For children, the dose depends on body weight:

11–20 kg – 1 tablet once daily for 3 days
21–30 kg – 2 tablets once daily for 3 days
31–40 kg – 3 tablets once daily for 3 days
over 40 kg – see adult dosage.

Not recommended for treatment of malaria in children weighing less than 11 kg.
For children weighing less than 11 kg, speak with your doctor. A different formulation of Malarone tablets may be available in your country.

If you take more Malarone than you should
Seek advice from your doctor or pharmacist. If possible, show them the Malarone packaging.

If you forget to take Malarone
It is very important to complete the full course of Malarone.
If you forget to take one dose, do not worry. Take the next dose as soon as you remember.
Then continue your treatment as before.
Do not take a double dose to make up for the forgotten dose. Take the next dose
at the usual time.

Do not stop treatment with Malarone without medical advice
Continue taking Malarone for 7 days after returning to a malaria-free area. Complete the full course of Malarone to ensure maximum protection. Stopping treatment early puts you at risk of contracting malaria, as it takes 7 days to ensure that any parasites that may have entered your blood following a bite from an infected mosquito have been killed.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Pay attention to the following serious reactions. These have occurred in a small number of people, but their
exact frequency is unknown.
Severe allergic reactions – symptoms include:
rash and itching
sudden wheezing, chest or throat tightness, or difficulty breathing
swelling of the eyelids, face, lips, tongue or other parts of the body
→ Contact a doctor immediately if you experience any of these symptoms. Stop taking Malarone
immediately.
Severe skin reactions
rash, which may include blisters and appear as small targets (dark spots in the centre, surrounded by a lighter area with a dark ring around the edge) ( erythema
multiforme )
severe widespread rash with blisters and skin peeling, particularly occurring around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome )
→ If you notice any of these effects, contact a doctor urgently.
Many of the other reported side effects have been mild and short-lived:
Very common side effects
These may occur in more than 1 in 10 people:
headache
feeling sick and being sick (nausea and vomiting)
stomach ache
diarrhoea.
Common side effects
These may occur in up to 1 in 10 people:
dizziness
sleep disturbances ( insomnia )
strange dreams
depression
loss of appetite
fever
rash which may be itchy
cough.
Common side effects that may be detected by blood tests include:

reduced number of red blood cells ( anaemia ) which may cause tiredness, headache and shortness of breath
reduced number of white blood cells ( neutropenia ) which may make you more susceptible to infections
low levels of sodium in the blood ( hyponatraemia )
increased liver enzymes.

Uncommon side effects
These may occur in up to 1 in 100 people:
anxiety
unusually aware of abnormal heartbeats (palpitations)
mouth swelling and redness
hair loss
Uncommon side effects that may be detected by blood tests:
an increase in amylase ( an enzyme produced by the pancreas )
Rare side effects
These may occur in up to 1 in 1,000 people:
seeing or hearing things that are not real ( hallucinations )
Other side effects
Other side effects have occurred in a small number of people, but their exact frequency remains
unknown.
inflammation of the liver (hepatitis)
blockage of the bile ducts (cholestasis)
increased heart rate (tachycardia)
inflammation of blood vessels ( vasculitis ) which may present as raised red or purple spots on the skin, but may also affect other parts of the body
seizures
panic attacks, crying
nightmares
formation of mouth ulcers
blisters
skin peeling
increased sensitivity of the skin to sunlight
serious mental health problem in which the person loses contact with reality and is unable to think and judge clearly
Other side effects that may be detected by blood tests:

decrease in all types of blood cells (pancytopenia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at the website: http://www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Malarone

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box.
Malarone does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Malarone contains
The active substances are: 250 mg atovaquone and 100 mg proguanil hydrochloride in each tablet.
The excipients are:
tablet core: poloxamer 188, microcrystalline cellulose, hydroxypropylcellulose, povidone K30,
sodium carboxymethylstarch (type A), magnesium stearate
tablet coating: hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 400
and polyethylene glycol 8000 (see section 2).
→ Tell your doctor without taking Malarone if you are allergic to any of these
components.
Description of Malarone tablets and pack contents
Malarone tablets are round, pink film-coated tablets with the imprint ‘GX CM3’ on one side.
They are supplied in blisters containing 12 tablets.
The Marketing Authorisation Holder is
GlaxoSmithKline S.p.A., via Alessandro Fleming n° 2, 37135 Verona, Italy
The manufacturer is
Aspen Bad Oldesloe GmbH - Bad Oldesloe, Germany
Glaxo Wellcome S.A. - Avenida de Extremadura, 3 - Aranda de Duero (Burgos), Spain

Package Leaflet: Information for the User

Malarone Children 62.5 mg/25 mg – Film-coated tablets

Atovaquone/Proguanil hydrochloride
Please read this entire leaflet carefully before taking this medicine or giving it to your child,
as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you (or your child) only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.

Contents of this leaflet:
1. What Malarone Children is and what it is used for
2. What you need to know before taking Malarone Children
3. How to take Malarone Children
4. Possible side effects
5. How to store Malarone Children
6. Package contents and other information

1. What Malarone Children is and what it is used for
Malarone Children belongs to a group of medicines called antimalarials. Each tablet contains two active substances: atovaquone and proguanil hydrochloride.

What Malarone Children is used for
Malarone Children is used in two situations:
for the prevention of malaria (in children weighing between 11 kg and 40 kg)
for the treatment of malaria (in children weighing between 5 kg and < 11 kg).
See section 3, How to take Malarone Children.

Although this medicine is usually used in children and adolescents, it may also be prescribed for adults weighing less than 40 kg.

Malaria is transmitted through the bite of an infected mosquito, which introduces the malaria parasite (Plasmodium falciparum) into the bloodstream. Malarone Children prevents malaria by killing this parasite. Malarone Children also kills these parasites in individuals already infected with malaria.

Protect your child from contracting malaria.
Individuals of all ages can contract malaria. It is a serious illness, but it can be prevented.
It is very important that, in addition to taking Malarone Children, precautions are taken to avoid mosquito bites.

Use an insect repellent on exposed skin.
Wear light-coloured clothing covering most of the body, especially after sunset, as this is the time when mosquitoes are most active.
Sleep in a room protected by mosquito nets, or sleep under an insecticide-impregnated mosquito net.
Close doors and windows at dusk, if they are not fitted with mosquito screens.
Use an insecticide (mats, sprays, plug-in devices) to eliminate insects from the room or to prevent mosquitoes from entering.

→ If you need further information, consult your doctor or pharmacist.
Despite these necessary precautions, it is still possible to contract malaria. Some types of malaria infection may cause symptoms after a long delay; therefore, the disease may appear several days, weeks, or even months after returning from abroad.
→ Seek immediate medical attention for your child if, after returning home, symptoms such as high fever, headache, chills, and fatigue occur.

2. What you should know before taking Malarone Paediatric

Do not take Malarone Paediatric:

if your child is allergic to atovaquone, proguanil hydrochloride, or any of the other ingredients of this medicine (listed in section 6)
for malaria prevention, if your child has severe kidney disease.

→ Tell your doctor if either of these applies to your child.
Warnings and precautions with Malarone Paediatric
Talk to your doctor or pharmacist before taking Malarone Paediatric if:

you/your child has severe kidney disease
your child is being treated for malaria and weighs less than 5 kg, or is taking Malarone Paediatric to prevent malaria and weighs less than 11 kg.
Tell your doctor or pharmacist if any of these situations apply to you or your child.

Other medicines and Malarone Paediatric
Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may affect how Malarone Paediatric works, or Malarone Paediatric may increase or decrease 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 some potent protease inhibitors used to treat HIV
warfarin and other medicines that prevent blood clotting
etoposide, used to treat cancer

→ Tell your doctor if your child is taking any of these medicines. Your doctor may decide that Malarone Paediatric is not suitable, or that your child needs further monitoring while taking Malarone Paediatric.
→ Remember to inform your doctor if your child starts taking any other medicines while taking Malarone Paediatric.
Malarone Paediatric with food and drink
Take Malarone Paediatric with food or a milk-based drink, if possible. This way, your body/your child's body will absorb more of the medicine, making the treatment more effective.
Pregnancy and breastfeeding
If you or the child is pregnant, do not take Malarone Paediatric unless recommended by your doctor.
Do not breastfeed while taking Malarone Paediatric, as the components of Malarone may pass into breast milk and harm the baby.
Driving and using machines
If you feel dizzy, do not drive
Malarone Paediatric may cause dizziness in some people. If this happens to you, do not drive, operate machinery, or take part in activities that could put you or others at risk.

3. How to take Malarone Paediatric

Take this medicine exactly as your doctor or pharmacist has told you. If
you are unsure, consult your doctor or pharmacist.
Take Malarone Paediatric with food or a milk-based drink, if possible. The tablets
should be swallowed whole. However, for children who have difficulty swallowing them, the tablets may be
crushed immediately before administration and mixed with food or a milk-based drink.
It is best to take Malarone Paediatric at the same time each day.
If your child vomits
For prevention of malaria:

if your child vomits within 1 hour after taking Malarone Paediatric, give another dose immediately
it is important to complete the full course of Malarone Paediatric. If your child needs to take additional tablets due to vomiting, you may require another prescription.
if your child has vomited, it is especially important to use additional protective measures, such as repellents and mosquito nets. Due to reduced absorption, Malarone Paediatric may not be fully effective.

For treatment of malaria:

if your child vomits and has diarrhoea, inform your doctor. Your child will need regular blood tests. Malarone Paediatric may not be fully effective due to reduced absorption. The tests will check whether the malaria parasite has been eliminated from the blood.

To prevent malaria
The recommended dose for preventing malaria depends on your child's weight.
11–20 kg – 1 tablet once daily
21–30 kg – 2 tablets once daily (as a single dose)
31–40 kg – 3 tablets once daily (as a single dose)
Start taking Malarone Paediatric 1 or 2 days before travelling to a malaria-risk area.
Continue taking Malarone Paediatric every day throughout the stay.
Continue taking Malarone Paediatric for a further 7 days after returning to a malaria-free area.
For maximum protection, your child must complete the entire course.
For treatment of malaria
The recommended dose for treatment of malaria depends on your child's weight.
5–8 kg – 2 tablets once daily for 3 days
9–10 kg – 3 tablets once daily for 3 days
If your child takes more Malarone Paediatric than prescribed
Seek advice from your doctor or pharmacist. If possible, show them the Malarone Paediatric pack.
If a dose is missed
It is very important that your child completes the full course of Malarone Paediatric.
If you forget to give your child one dose, do not worry. Give the next dose as soon as you remember. Then continue the treatment as before.
Do not take an extra dose to make up for a forgotten dose. Take the next
dose at the usual time.
Do not stop treatment with Malarone Paediatric without consulting your doctor.
Continue taking Malarone Paediatric for 7 days after returning to a malaria-free area.
Complete the full course of Malarone to ensure maximum protection. Stopping treatment early exposes your
child to the risk of contracting malaria, as it takes 7 days to ensure that any parasites present in the blood following a bite from an infected mosquito are killed.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Pay attention to the following serious reactions. These have occurred in a small number of people, but their exact frequency is unknown.

Severe allergic reactions – symptoms include:
skin rash and itching
sudden wheezing, tightness in the chest or throat, or difficulty breathing
swelling of the eyelids, face, lips, tongue, or other parts of the body
→ Contact a doctor immediately if your child experiences any of these symptoms.
Stop giving Malarone Children immediately.

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

Many of the other reported side effects have been mild and short-lived:

Very common side effects
These may occur in more than 1 out of 10 people:
headache
feeling sick and being sick (nausea and vomiting)
stomach ache
diarrhoea

Common side effects
These may occur in up to 1 out of 10 people:
dizziness
sleep disturbances (insomnia)
strange dreams
depression
loss of appetite
fever
rash, which may be itchy
cough

Common side effects that may be detected by blood tests include:

reduced number of red blood cells (anaemia) which may cause tiredness, headache, and shortness of breath
reduced number of white blood cells (neutropenia) which may make you more susceptible to infections
low levels of sodium in the blood (hyponatraemia)
increased liver enzymes

Uncommon side effects
These may occur in up to 1 out of 100 people:
anxiety
unusual awareness of irregular heartbeats (palpitations)
mouth inflammation and redness
hair loss

Uncommon side effects that may be detected by blood tests:
increased amylase (an enzyme produced by the pancreas)

Rare side effects
These may occur in up to 1 out of 1,000 people:
seeing or hearing things that are not there (hallucinations)

Other side effects
Other side effects have occurred in a small number of people, but their exact frequency remains unknown.
inflammation of the liver (hepatitis)
blockage of the bile ducts (cholestasis)
increased heart rate (tachycardia)
inflammation of blood vessels (vasculitis) which may appear as raised red or purple spots on the skin, but may also affect other parts of the body
seizures
panic attacks, crying
nightmares
severe mental health problem in which the person loses touch with reality and is unable to think and judge clearly
formation of mouth ulcers
blisters
skin peeling
increased sensitivity of the skin to sunlight

Other side effects that may be detected by blood tests:
decrease in all types of blood cells (pancytopenia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: http://www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Malarone Paediatric

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box.
Malarone Paediatric does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Malarone Paediatric contains
The active substances are: 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride in each tablet.
The excipients are:
tablet core: poloxamer 188, microcrystalline cellulose, hydroxypropylcellulose, povidone K30,
sodium starch glycolate (type A), magnesium stearate
tablet coating: hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 400
and polyethylene glycol 8000 (see section 2).
→ Inform your doctor before giving Malarone Paediatric to your child if he or she is allergic to any
of these ingredients.
Description of the appearance of Malarone Paediatric and contents of the pack
Malarone Paediatric tablets are round, pink, film-coated tablets. They are supplied in blisters
containing 12 tablets.
Marketing Authorisation Holder
GlaxoSmithKline S.p.A., via Alessandro Fleming n° 2, 37135 Verona, Italy
Manufacturer
Aspen Bad Oldesloe GmbH - Bad Oldesloe, Germany
Glaxo Wellcome S.A. - Avenida de Extremadura, 3 - Aranda de Duero (Burgos), Spain