MALARONE Tabletki powlekane

Treść ulotki

1. Malarone 250 mg/100 mg – Film-coated tablets
   1. What you need to know before taking Malarone
   2. HOW TO TAKE MALARONE
   3. Possible side effects
   4. How to store Malarone
   5. Contents of the pack and other information
2. Malarone Bambini 62,5 mg/25 mg – Film-coated tablets
   1. What you need to know before taking Malarone Children
   2. How to take Malarone Bambini
   3. Possible side effects
   4. How to store Malarone Bambini
   5. Contents of the pack and other information

Malarone 250 mg/100 mg – Film-coated tablets

Atovaquone/Proguanil hydrochloride

Read this leaflet carefully before taking this medicine 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 only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What is Malarone and what it is used for

2. What you need to know before you take 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 is Malarone and what it is used for

Malarone belongs to a group of medicines called antimalarials. It contains two active ingredients,
atovaquone and proguanil hydrochloride.

What is Malarone used for
Malarone is used in two cases:
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 people who are already infected with malaria.

Protect yourself from malaria infection.
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 repellenton exposed skin.
• Wear light-colored clothing that covers most of the body,especially after sunset as this is when mosquitoes are most active.
• Sleep in a room protected by mosquito netsor sleep under a mosquito net impregnated with insecticide.
• Close doors and windows at sunsetif they are not equipped with mosquito nets.
• Use an insecticide(plugs, sprays, plug-in devices) to clear the room of insects or prevent mosquitoes from entering.

→If you need more information,ask your doctor or pharmacist.

Despite these necessary precautions, it is still possible to contract malaria.Some types of
malaria infections cause symptoms after a long period of time, so the disease may manifest
many days, weeks or even months after returning from abroad.
→ See your doctor immediately upon your return home if you experience symptomssuch as high fever, headache, chills and fatigue.

2. What you need to know before taking Malarone

Do not take Malarone:

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

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

• you have serious kidney disease
• your child is being treated for Malaria and weighs less than 11 kg. There is another tablet dosage to treat children who weigh less than 11 kg (see section 3).
• Tell your doctor or pharmacistif any of these applies 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 available without a prescription.
Some medicines can affect the action of Malarone, or Malarone itself can increase or decrease
the effectiveness of other medicines taken at the same time. These include:

• metoclopramide,used for the treatment of nausea and vomiting
• the antibiotics tetracycline, rifampicinand rifabutin
• efavirenzor some potent protease inhibitorsused to treat HIV
• warfarinand other medicines that block blood clotting
• etoposideused for the treatment of cancer

→ Tell your doctorif you are taking any of these medicines. Your doctor may decide that
Malarone is not suitable for you, or that you need to undergo further examinations while taking
Malarone.
→ Remember to tell your doctorif you start taking other medicines while taking
Malarone

Malarone with food and drink
Take Malarone with food or a milk-containing drink, if possible. This way your
body will absorb a greater amount of Malarone and the treatment will be more effective.

Pregnancy and breastfeeding
If you are pregnant, do not take Malaroneunless your doctor recommends it.
→ Ask your doctor or pharmacist for advice before taking Malarone.

Do not breastfeed while taking Malaroneas the components of Malarone can pass into breast
milk and harm the baby.

Driving and operating machinery
If you feel dizzy, do not drive vehicles
Malarone causes dizziness in some people. If this happens to you, do not drive vehicles, use machinery,
or take part in activities that could put yourself or others at risk.

3. HOW TO TAKE MALARONE

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

If you vomit
For malaria prevention:

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

For malaria treatment:

• if you vomit and have diarrheainform your doctor, you will need to undergo regular blood tests. Malarone will not be fully effective due to the reduced amount absorbed. The tests will verify if the malaria parasite has been eliminated from your blood.

To prevent malaria
The recommended dose in adultsis 1 tablet once a day, taken as follows.

Not recommended for malaria prevention in children,or in adults with a weight less than
40 kg. Malarone Children tablets is recommended for malaria prevention 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 area
• continue taking Malarone every day throughout the duration of your stay
• continue taking Malarone for another 7 days after your return to a malaria-free area.

For malaria treatment
The recommended dose in adultsis 4 tablets once a day for 3 days.

For childrenthe dose depends on body weight:

• 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 - see the dosage for adults.

Not recommended for the treatmentof malaria in children weighing less than 11 kg.
For children weighing less than 11 kg, talk to your doctor. In your country, a
different formulation of Malarone tablets may be available.

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

If you forget to take Malarone
It is very important to complete the entire course with Malarone.
If you forget to take 1 dose, do not worry. Take the next dose as soon as you remember.
Then continue the treatment as before.

Do not take a double dose to make up for a missed dose. Take the next dose
at the usual time.
Do not stop the treatment with Malarone without advice
Continue taking Malarone for 7 days after your return to a malaria-free area.Follow
the entire course with Malarone for maximum protection. Stopping it early exposes you to the risk
of contracting malaria, as it takes 7 days to be sure that any parasites present in your
blood following a bite from an infected mosquito have been killed.
If you have any questions about using this medicine, ask 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.

Serious allergic reactions -symptoms include:
skin rash and itching
sudden wheezing, oppression of the chest or throat or difficulty breathing
swelling of the eyelids, face, lips, tongue or other parts of the body
→ Contact a doctor immediatelyif you experience any of these symptoms. Stop
taking Malarone immediately.
Serious skin reactions
skin rash, which may blister and appear as small targets (dark central
spots, surrounded by an area of lighter color with a dark ring around the edge) ( erythema

multiforme)
severe widespread rash with blisters and peeling of the skin, which occurs particularly
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 side effects reported 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 pain
diarrhoea.
Common side effects
These may occur in up to 1 in 10 people:
dizziness
sleep disorders ( insomnia)
strange dreams
depression
loss of appetite
fever
skin rash that may be itchy
cough .
Common side effects that can be detected by blood tests are:

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

Uncommon side effects
These may occur in up to 1 in 100 people:
anxiety
an unusual awareness of abnormal heartbeats (palpitations)
swelling and redness of the mouth
hair loss
Uncommon side effects that can 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 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)
obstruction of the bile ducts (cholestasis)
increased heart rate (tachycardia)
inflammation of the blood vessels ( vasculitis) which can manifest with raised red or purple
spots on the skin, but which can also affect other parts of the body
convulsions
panic attacks, crying
nightmares
formation of ulcers in the mouth
blisters
peeling of the skin
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 can be detected by blood tests:

• Decrease in all types of blood cells (pancytopenia)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the Italian
Medicines Agency, 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 datewhich is stated on the cardboard box.

Malarone does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment..0

6. Contents of the pack and other information

What Malarone contains
The active ingredients are:250 mg of atovaquone and 100 mg of proguanil hydrochloride in each tablet.

The excipients are:

tablet core:poloxamer 188, microcrystalline cellulose, hydroxypropylcellulose, povidone K30,
sodium carboxymethylcellulose (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 Malaroneif you are allergic to any of these
components.

Description of the appearance of Malarone and contents of the pack
Malarone tablets are round, film-coated, pink, with the inscription ‘GX CM3’ on one side.
They are packaged in blisters containing 12 tablets.

The marketing authorisation holderis
GlaxoSmithKline S.p.A. via Alessandro Fleming n° 2, 37135 Verona, Italy

The manufactureris
Aspen Bad Oldesloe GmbH - Bad Oldesloe, Germany
Glaxo Wellcome S.A. - Avenida de Extremadura, 3 - Aranda de Duero (Burgos), Spain

Malarone Bambini 62,5 mg/25 mg – Film-coated tablets

Atovaquone/Proguanile hydrochloride

Read this leaflet carefully before you take this medicine or give it to your child
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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4 .

Contents of this leaflet:

1. What is Malarone Bambini and what it is used for

2. What you need to know before you take Malarone Bambini

3. How to take Malarone Bambini

4. Possible side effects

5. How to store Malarone Bambini

6. Contents of the pack and other information

1. What is Malarone Bambini and what it is used for

Malarone Bambini belongs to a group of medicines called antimalarials. Each tablet
contains two active ingredients, atovaquone and proguanile hydrochloride.

What is Malarone Bambini used for
Malarone Bambini is used in two cases:
for the prevention of malaria(for children weighing between 11 kg and 40 kg)

for the treatment of malaria(for children weighing between 5 kg - < 11 kg).
See section 3, How to take MalaroneBambini.
Although this medicine is usually used in children and adolescents, it can also be prescribed for
adults weighing less than 40 kg.
Malaria is spread through the bite of an infected mosquito that transmits the malaria parasite
( Plasmodium falciparum) into the bloodstream. Malarone Bambini prevents malaria by killing this
parasite. Malarone Bambini also kills these parasites in people who are already infected with malaria.

Protect your child from malaria infection.
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 Bambini, precautions are taken to avoid being
bitten by mosquitoes.

• Use an insect repellent on exposed 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 netsor sleep under a mosquito net impregnated with insecticide.
• Close doorsand windows at sunsetif they are not equipped with mosquito nets.
• Use an insecticide(mats, sprays, plug-in devices) to rid the room of insects or prevent mosquitoes from entering.

→If you need more information,ask your doctor or pharmacist.

Despite these necessary precautions, it is still possible to contract malaria.Some types of
malarial infections cause symptoms after a long period of time, so the illness may manifest
many days, weeks or even months after returning from abroad.
→ Have your child seen by a doctor immediately if, upon returning home, they present symptoms
such as high fever, headache, chills and fatigue.

2. What you need to know before taking Malarone Children

Do not take Malarone Children:

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

→ Tell your doctor if either case applies to your child.
Warnings and precautions with Malarone Children
Talk to your doctor or pharmacist before taking Malarone Children 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 Children to prevent Malaria and weighs less than 11 kg.
• Tell your doctor or pharmacistif either case applies to you.

Other medicines and Malarone Children
Tell your doctor or pharmacist if your child is taking,has recently taken, or might
take any other medicines, including those available without a prescription.
Some medicines can affect the action of Malarone Children, or Malarone Children itself can
increase or decrease the effectiveness of other medicines taken at the same time. These include:

• metoclopramide,used for the treatment of nausea and vomiting
• the antibiotics tetracycline, rifampicinand rifabutin
• efavirenzor some potent protease inhibitorsused to treat HIV,
• warfarinand other medicines that block blood clotting
• etoposideused for the treatment of cancer

→ Tell your doctorif your child is taking any of these medicines. Your doctor may
decide that Malarone Children is not suitable for him/her, or that he/she needs to have further tests during
taking Malarone Children.
→ Remember to tell your doctorif your child starts taking other medicines in
conjunction with Malarone Children.

Malarone Children with food and drink
Take Malarone Children with food or with a milk-based drink, if possible. This way
your body/your child's body will absorb a greater amount of Malarone and the treatment will be more
effective.

Pregnancy and breastfeeding
If you or the child is pregnant, do not take Malarone Childrenunless your
doctor recommends it.

Do not breastfeed while taking Malarone Childrenas the components of Malarone can pass
into breast milk and harm the baby.

Driving and using machines
If you feel dizzy, do not drive vehicles
Malarone Children causes dizziness in some people. If this happens to you, do not drive vehicles, do not use
machines, do not take part in activities that could put you or others at risk.

3. How to take Malarone Bambini

Always take this medicine exactly as your doctor or pharmacist has told you.If
you have any doubts, ask your doctor or pharmacist.
Take Malarone Bambini with food or with a milk-based drink, if possible. The tablets
should be swallowed whole. However, for children who have difficulty swallowing them, they can be
crushed immediately before being taken and mixed with food or a milk-based drink.
It is best to take Malarone Bambini every day at the same time.

If your child vomits
For malaria prevention:

• if your child vomits within 1 hour of taking Malarone Bambini,give them another dose immediately
• it is important to complete the full course with Malarone Bambini.If, due to vomiting, your child needs to take additional tablets, they may need another prescription.
• if your child has vomited,it is particularly important to use additional protective measures, such as repellents and mosquito nets. Due to the reduced amount absorbed, Malarone Bambini may not be fully effective.

For malaria treatment:

• if your child vomits and has diarrheainform your doctor. Your child will need to undergo regular blood tests. Malarone Bambini may not be fully effective due to the reduced amount absorbed. The tests will check if the malaria parasite has been eliminated from their blood.

To prevent malaria
The recommended dose to prevent malariadepends on your child's 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)
start taking Malarone Bambini 1 or 2 days before travelling to a malaria area
continue taking Malarone Bambini every day throughout the duration of your stay
continue taking Malarone Bambini for another 7 days after returning to a malaria-free area.

For maximum protectionyour child must follow the treatment in full.

For malaria treatment
The recommended dose for malaria treatmentdepends 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 takes more Malarone Bambini than they should
Ask your doctor or pharmacist for advice. If possible, show them the Malarone Bambini packaging.

If you forget to take Malarone Bambini
It is very important that your child completes the full course with Malarone Bambini.
If you forget to give your child 1 dose, do not worry. Give them the next dose as soon as you
remember. Then continue the treatment as before.

Do not take a double dose to make up for a missed dose. Take the next
dose at the usual time.
Do not stop the treatment with Malarone Bambini without your doctor's advice
Continue to take Malarone Bambini for 7 days after returning to a malaria-free area.
Complete the full course with Malarone to have maximum protection. Stopping it early exposes your
child to the risk of contracting malaria, as it takes 7 days to be sure that any parasites present in the blood following an infected mosquito bite have been killed.
If you have any further questions, ask your doctor or pharmacist.

4. Possible side effects

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

Serious 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
→ Seek immediate medical attentionif your child shows any of these symptoms.

Stop giving Malarone Bambini immediately.
Serious skin reactions
rash, which may blister and appear as small targets (dark central spots, surrounded by a lighter-colored area with a dark ring around the edge) (erythema

multiforme)
severe widespread rash with blisters and peeling skin, which occurs particularly 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 side effects reported have been mild and short-lived:

Very common side effects
These may affect more than 1 in 10 people:
headache
feeling sick and being sick (nausea and vomiting)
stomach pain
diarrhoea.
Common side effects
These may affect up to 1 in 10 people:
dizziness
sleep problems (insomnia)
strange dreams
depression
loss of appetite
fever
skin rash that may be itchy
cough
Common side effects that can be detected by blood tests are:

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

Uncommon side effects
These may affect up to 1 in 100 people:
anxiety
an unusual awareness of abnormal heartbeats (palpitations)
swelling and redness of the mouth
hair loss
Uncommon side effects that can be detected by blood tests:
an increase in amylase (an enzyme produced by the pancreas)

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

Other side effects
Other side effects have been reported 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 the blood vessels (vasculitis) which can manifest with red or purple spots in
relief on the skin, but which can also affect other parts of the body
convulsions
panic attacks, crying
nightmares
serious mental health problem in which the person loses contact with reality and is unable to
think and judge clearly
formation of ulcers in the mouth
blisters
peeling skin
increased sensitivity of the skin to sunlight
Other side effects that can be detected by blood tests:
Decrease in all types of blood cells (pancytopenia)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the Italian Medicines Agency,
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 Bambini

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry datewhich is stated on the cardboard box.

Malarone Bambini does not require any special storage conditions.
Do not dispose of any medicine in waste water 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 Bambini contains
The active ingredients 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).
→ Tell your doctor before giving MalaroneBambinito your child if they are allergic to any
of these ingredients.

Description of the appearance of Malarone Bambini and contents of the pack
Malarone Bambini tablets are round, film-coated, pink. They are packaged in blisters
containing 12 tablets.

The marketing authorisation holderis
GlaxoSmithKline S.p.A. via Alessandro Fleming n° 2, 37135 Verona, Italy

The manufactureris
Aspen Bad Oldesloe GmbH - Bad Oldesloe, Germany
Glaxo Wellcome S.A. - Avenida de Extremadura, 3 - Aranda de Duero (Burgos), Spain