Falcimar

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Falcimar(Malaway)

250 mg + 100 mg, coated tablets

Atovaquone + Proguanil hydrochloride
Falcimar and Malaway are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Falcimar and what is it used for
• 2. Important information before taking Falcimar
• 3. How to take Falcimar
• 4. Possible side effects
• 5. How to store Falcimar
• 6. Contents of the packaging and other information

1. What is Falcimar and what is it used for

Falcimar belongs to a group of medicines called antimalarial medicines .This medicine contains two
active substances - atovaquone and proguanil hydrochloride.
Falcimar is used:

• to prevent malaria in adults and children weighing over 40 kg
• to treat malaria in adults and children weighing more than 11 kg.

Malaria is spread through the bite of an infected mosquito, which transmits the malaria parasite
(Plasmodium falciparum)into the bloodstream. Falcimar prevents malaria by killing this parasite.
It also kills the parasites in people already infected with malaria.

You should protect yourself against malaria infection.

Malaria can be contracted at any age. It is a serious disease, but it can be prevented.
Apart from taking Falcimar, it is essential to take measures to prevent mosquito bites.

• You should use an insect repellent on exposed skin areas.
• You should wear light-colored clothing that covers most of the body surface,especially after sunset, when mosquitoes are most active .
• You should sleep in a closed roomor under a mosquito net impregnated with an insecticide .
• You should close windows and doors at sunset,if they are not protected by a screen.
• You should consider using insecticides(pads, aerosols, mosquito plugs) to clear the room of insects or prevent mosquitoes from entering the room.

In case of further doubtsyou should contact a doctor or pharmacist.
Malaria can be contracted even if the necessary precautions are taken.
Some symptoms of malaria infection may appear only after a longer period, so the disease may become apparent after a few days, weeks, or even months after returning from a malaria-endemic area.
If symptoms such as high fever, headache, chills, and fatigue occur after returning home, you should contact a doctor immediately.

2. Important information before taking Falcimar

When not to take Falcimar:

• If the patient is allergic to atovaquone or proguanil hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• In the prevention of malaria, if the patient has chronic kidney disease .

Warnings and precautions

Malaria prevention:

• If the patient is sick (vomiting) within 1 hour of taking a Falcimar tablet, they should take another dose of the medicine immediately.
• It is essential to take the entire prescribed treatment cycle with Falcimar. If it is necessary to take more tablets due to illness, the patient will likely need another prescription.
• If the patient vomits, it is particularly important to use additional protective measures, such as insect repellents or mosquito nets. Falcimar may not be as effective, as the amount absorbed by the body will be lower.

Malaria treatment:

• If the patient vomits and diarrhea occurs, they should inform their doctor, as regular blood tests will be necessary. Falcimar may not be as effective, as the amount absorbed by the body will be lower. The tests will check if the malaria parasite has been removed from the patient's bloodstream.
• If the patient has chronic kidney disease, the doctor may prescribe a different medicine.
• If a specific infection symptom occurs during treatment with Falcimar, the doctor may prescribe a different medicine instead.
• If malaria is being treated, but there have been multiple recurrences or if the malaria is caused by a specific type of parasite, the doctor may recommend taking another medicine in addition to Falcimar.

Falcimar and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking
currently or recently, as well as any medicines they plan to take.
Some medicines may affect the action of Falcimar, or Falcimar may enhance or reduce the
effectiveness of other medicines taken at the same time.
These medicines include:

• metoclopramide used to treat nausea and vomiting,
• antibiotics such as tetracycline, rifampicin, and rifabutin,
• efavirenz or certain highly active protease inhibitors used to treat HIV,
• indinavir used to treat HIV,
• warfarin and other medicines that inhibit blood clotting,
• etoposide used to treat cancer.

The patient should inform their doctor if they are taking any of these medicines. The doctor may
decide that Falcimar is not a suitable medicine for the patient or that additional monitoring tests are
needed during treatment.
THE PATIENT SHOULD REMEMBER to inform their doctor about taking any other medicines
while taking Falcimar.

Taking Falcimar with food and drink

If possible, Falcimar should be taken with food or dairy drinks. This will allow the patient's body to
absorb more of the Falcimar medicine, making the treatment more effective.
It is not recommended to crush the tablets.

Pregnancy and breastfeeding

If the patient is pregnant or plans to become pregnant, they should not take Falcimar unless their doctor
recommends it.
Before taking Falcimar, the patient should consult their doctor or pharmacist.
The patient should not breastfeed while taking Falcimar, as the medicine's ingredients may pass into
the breast milk and harm the baby.

Driving and operating machinery

The patient should not drive vehicles if they have dizziness. Falcimar can cause dizziness in some
people. In such cases, the patient should not drive vehicles, operate machinery, or perform tasks that
may put themselves or others at risk.

3. How to take Falcimar

This medicine should always be taken exactly as described in the patient leaflet or as directed by the
doctor. In case of doubts, the patient should consult their doctor or pharmacist.
If possible, Falcimar should be taken with food or dairy drinks.
It is best to take Falcimar at the same time every day.

Malaria prevention

The usual dose for adults and adolescents weighing over 40 kg is one tablet per day, taken as described
below.
In the case of children, the patient should consult their doctor.
Falcimar is not recommended for the prevention of malaria in children or in adults and adolescents weighing
less than 40 kg.
In some countries, Falcimar for children may also be available in other pharmaceutical forms.
Malaria prevention in adults:

• the patient should start taking Falcimar 1 or 2 days before traveling to an area where malaria is present,
• the patient should take the medicine every day during their stay and for 7 days after returning to an area where malaria is not present,
• to ensure the patient has maximum protection, they should complete the entire treatment cycle with Falcimar. Since it takes 7 days to ensure that all parasites introduced by the mosquito are killed, stopping the treatment early increases the risk of infection.

Malaria treatment

For adults, the usual dose is 4 tablets taken once a day for 3 days.
For children weighing 11 kg or more:

• from 11 to 20 kg - 1 tablet per day for 3 days
• from 21 to 30 kg - 2 tablets per day for 3 days
• from 31 to 40 kg - 3 tablets per day for 3 days
• over 40 kg - the same dose as for adults.

Falcimar is not recommended for the treatment of malaria in children weighing less than 11 kg.
In the case of children weighing less than 11 kg, the patient should consult their doctor. In some countries,
Falcimar may also be available in other pharmaceutical forms.

Taking a higher dose of Falcimar than recommended

The patient should consult their doctor or pharmacist for advice. If possible, they should show the
packaging of Falcimar.

Missing a dose of Falcimar

It is very important to complete the entire treatment cycle with Falcimar. If the patient misses a dose,
they should not worry. They should take the next dose as soon as possible. Then, they should continue
the treatment as before. The patient should not take a double dose to make up for the missed dose.

Stopping Falcimar treatment

Falcimar should be taken for 7 days after the patient returns to an area

where malaria is not present.To ensure the patient has maximum protection, they should complete
the entire prescribed treatment cycle with Falcimar. Since it takes 7 days to ensure that all parasites
introduced by the mosquito are killed, stopping the treatment early puts the patient at risk of further
infection.
In case of any questions, the patient should consult their doctor or pharmacist.
If the patient has any further doubts about taking this medicine, they should consult their doctor or
pharmacist.

4. Possible side effects

Like all medicines, Falcimar can cause side effects, although not everybody gets them.
The patient should pay attention to the serious reactions listed below, which may be caused by
the medicine. They occurred in a small number of people, but the exact frequency is not known.
Severe allergic reactions - symptoms include:

• rash and itching,
• wheezing, chest tightness or throat tightness, or difficulty breathing,
• swelling of the eyelids, face, lips, tongue, or other parts of the body.

If the patient experiences any of these symptoms, they should contact their doctor immediately and stop taking the medicine.

Severe skin reactions:

• skin rash, which can cause blisters and look like small targets (black spots in the center surrounded by lighter, darker rings - erythema multiforme),
• severe and widespread rash with blisters, peeling skin - especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).

If the patient notices any of the above symptoms, they should contact their doctor immediately.

Most other side effects are mild and do not last long.
Very common: affects more than 1 in 10 patients

• headache
• nausea and vomiting
• abdominal pain
• diarrhea.

Common: affects 1 to 10 in 100 patients

• dizziness
• sleep problems (insomnia)
• vivid dreams
• depression
• loss of appetite
• fever
• rash
• cough
• allergic reactions
• itching ( pruritus).

Common side effects that may appear in the patient's blood tests:

• decrease in red blood cell count (anemia) ,which may cause fatigue, headaches, and shortness of breath
• decrease in white blood cell count (neutropenia), which increases the risk of serious infection
• low sodium levels in the blood (hyponatremia)
• increased liver enzyme activity.

Uncommon: affects 1 to 10 in 1000 patients
May occur in 1 in 100 people:

• anxiety
• awareness of an abnormal heartbeat (palpitations)
• swelling and redness of the mouth
• red blisters on the skin (hives)
• hair loss.

Uncommon side effects that may appear in blood tests:

• increased amylase activity (an enzyme produced in the pancreas) .

Rare: affects 1 to 10 in 10,000 patients

• seeing or hearing things that do not exist (hallucinations).

Other side effects: They occurred in a small number of people, but the exact frequency is not known.

• hepatitis (hepatitis)
• bile duct obstruction (cholestasis)
• rapid heartbeat (tachycardia)
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, and may also affect other parts of the body
• seizures (convulsions)
• panic attacks, crying
• nightmares
• severe mental problems, resulting in people losing contact with reality and being unable to think clearly and make judgments
• mouth ulcers
• blisters
• peeling skin
• increased skin sensitivity to sunlight
• affecting stomach function (food intolerance).

Other side effects that may appear in blood tests:

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

If any side effect gets worse or if the patient experiences any side effects not listed in the leaflet,
they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should
tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of
Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices,
and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Falcimar

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date
refers to the last day of the month.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their
pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Falcimar contains

• The active substances of Falcimar are atovaquone and proguanil hydrochloride. Each tablet contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride.
• The other ingredients of Falcimar are: Tablet core:microcrystalline cellulose, low-substituted hydroxypropylcellulose, sodium carboxymethylcellulose (type A), poloxamer 188, povidone K 30, anhydrous colloidal silica, magnesium stearate. Tablet coating:hypromellose, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), macrogol 8000.

What Falcimar looks like and what the packaging contains

The tablets are pink-brown to brown, round, biconvex, and film-coated, with the inscription "404" on one side and the inscription "G" on the other.
Falcimar tablets are supplied in PVC/PVDC/Aluminum blisters, in a cardboard box.
Pack sizes: 12, 24, 36, 60 tablets.
For more detailed information on the medicine, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Spain, the country of export:712700.0

Parallel import authorization number: 371/24

This medicinal product is authorized in the Member States under the following names:

Approval date of the leaflet: 22.10.2024

[Information about the trademark]