Falcimar

Leaflet accompanying the packaging: information for the user

Falcimar, 250 mg + 100 mg, film-coated tablets

Atovaquone + Proguanil hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 pack and other information

1. What is Falcimar and what is it used for

Falcimar belongs to a group of medicines called antimalarials. The medicine contains two active substances - atovaquone and proguanil hydrochloride. Falcimar is used to: prevent malaria in adults and children over 40 kg, treat malaria in adults and children over 11 kg. Malaria is spread through the bite of an infected mosquito that carries 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.

Protect yourself from malaria infection.

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

• Use an insect repellent on exposed skin areas.
• Wear light-colored clothing that covers most of the body's surface,especially after sunset, when mosquitoes are most active .
• Sleep in an enclosed roomor under a mosquito net impregnated with an insecticide .
• Close windows and doors at sunset,if they are not screened.
• Consider using insecticides(mats, aerosols, mosquito plugs) to clear the room of insects or prevent mosquitoes from entering the room.

If you have any further questions, consult your doctor or pharmacist .
Malaria can still be contracted even with the necessary precautions. Some symptoms of malaria infection may appear only after a longer period, so the disease may become apparent after several 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 your 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, another dose of the medicine should be taken immediately. It is essential to complete the prescribed treatment cycle with Falcimar. If more tablets need to be taken 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 repellents or mosquito nets. Falcimar may not be as effective because the amount absorbed by the body will be lower. Malaria treatment: If the patient vomits and diarrhea occurs, the doctor should be informed, as regular blood tests will need to be performed. Falcimar may not be as effective because 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 it has recurred multiple times, or if malaria is caused by a specific type of parasite, the doctor may recommend taking another medicine in addition to Falcimar.

Falcimar and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Some medicines may affect the action of Falcimar or may increase or decrease the effectiveness of other medicines taken at the same time. These 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. Inform your doctor if you are taking any of these medicines. Your doctor may decide that Falcimar is not suitable for you or that additional monitoring tests are needed while taking the medicine. Remember to inform your doctor about taking any other medicines while taking Falcimar.

Taking Falcimar with food and drink

If possible, take Falcimar with food or dairy products. This will allow the body to absorb more of the medicine, making the treatment more effective. It is not recommended to crush the tablets.

Pregnancy and breastfeeding

If you are pregnant or plan to become pregnant, do not take Falcimar unless your doctor advises you to. Consult your doctor or pharmacist before taking Falcimar. Do not breastfeed while taking Falcimar, as the medicine's ingredients may pass into breast milk and harm the baby.

Driving and using machines

Do not drive if you experience dizziness. Falcimar can cause dizziness in some people. In such cases, do not drive, operate machinery, or perform tasks that may put you or others at risk.

3. How to take Falcimar

Always take this medicine exactly as described in the patient leaflet or as advised by your doctor. If you are unsure, consult your doctor or pharmacist. If possible, take Falcimar with food or dairy products. It is best to take Falcimar at the same time every day.

Malaria prevention:

The usual dose for adults and adolescents over 40 kg is one tablet per day, taken as described below. For use in children, consult your doctor. Falcimar is not recommended for malaria prevention in children or adults and adolescents under 40 kg. In some countries, Falcimar for children may also be available in other pharmaceutical forms. Malaria prevention in adults: start taking Falcimar 1 or 2 days before traveling to an area where malaria is present, take the medicine every day during your stay and for 7 days after returning to an area where malaria is not present. To ensure maximum protection, complete the full treatment cycle with Falcimar. Since it takes 7 days to ensure that all parasites introduced by the mosquito are killed, stopping 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 over 11 kg: 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 - the same dose as for adults. Falcimar is not recommended for treating malaria in children under 11 kg. For children under 11 kg, consult your doctor. In some countries, Falcimar may also be available in other pharmaceutical forms.

Taking more Falcimar than recommended

Consult your doctor or pharmacist for advice. If possible, show them the Falcimar packaging.

Missing a dose of Falcimar

It is crucial to complete the full treatment cycle with Falcimar. If you miss a dose, do not worry. Take the next dose as soon as possible. Then, continue treatment as before. Do not take a double dose to make up for the missed dose.

Stopping Falcimar treatment

Take Falcimar for 7 days after returning to an area

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

4. Possible side effects

Like all medicines, Falcimar can cause side effects, although not everybody gets them. Pay attention to the following serious reactions, which may be caused by the medicine. They have occurred in a small number of people, but their exact frequency is not known. Serious allergic reactions - symptoms include: 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.

If you experience any of these symptoms, contact your doctor immediately and stop taking the medicine.

Severe skin reactions: skin rash that can cause blisters and looks like small targets (dark 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 you notice any of these symptoms, contact your doctor immediately.

Most other side effects are mild and do not last long. Very common: affects more than 1 in 10 patientsheadache, nausea and vomiting, abdominal pain, diarrhea, Common: affects 1 to 10 in 100 patientsdizziness, sleep problems (insomnia), unusual dreams, depression, loss of appetite, fever, rash, cough, allergic reactions, itching (pruritus). Common side effects that may appear in blood tests: decreased red blood cell count (anemia), which can cause fatigue, headaches, and shortness of breath, decreased 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 patientsMay affect up to 1 in 100 people: anxiety, awareness of an abnormal heartbeat (palpitations), swelling and redness of the lips, 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 patientsseeing or hearing things that do not exist (hallucinations). Other side effects:These have occurred in a small number of people, but their exact frequency is not known. Liver inflammation (hepatitis), blockage of the bile ducts (cholestasis), rapid heartbeat (tachycardia), inflammation of blood vessels (vasculitis), which can cause 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, which can cause people to lose touch with reality and be unable to think clearly and make judgments, mouth ulcers, blisters, peeling skin, increased sensitivity of the skin to sunlight, effect on 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 you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Falcimar

Keep the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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.
• Other ingredients of the medicine are:

Tablet core:microcrystalline cellulose PH101, hydroxypropylcellulose low-substituted, sodium carboxymethylcellulose (type A), poloxamer 188, povidone K30, microcrystalline cellulose PH102, colloidal silica anhydrous, magnesium stearate. Tablet coating:hypromellose 6cP, titanium dioxide (E171), macrogol 400, iron oxide red (E172), macrogol 8000.

What Falcimar looks like and contents of the pack

The tablets are pink-brown to brown, round, biconvex, and film-coated, with the imprint "404" on one side and the imprint "G" on the other. Falcimar tablets are supplied in PVC/PVDC/Aluminum blisters, in a cardboard box. Pack sizes: 12, 24, 36, 60 tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

Glenmark Pharmaceuticals s.r.o.

Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer / importer:

Glenmark Pharmaceuticals s.r.o.

Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Glenmark Pharmaceuticals s.r.o.

Fibichova 143
566 17 Vysoké Mýto
Czech Republic

To obtain more detailed information, please contact the representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: [email protected]

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

Date of last revision of the leaflet:May 2024