Falcimar

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Falcimar (Malaway)
250 mg + 100 mg, film-coated tablets
Atovaquonum + Proguanili hydrochloridum
Falcimar and Malaway are different trade names for the same medicinal product.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Falcimar is and what it is 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 Falcimar is and what it is used for

Falcimar belongs to a group of medicines known as antimalarials. This medicine contains two active substances: atovaquone and proguanil hydrochloride.
Falcimar is indicated:

• for malaria prophylaxis in adults and children weighing over 40 kg
• for the treatment of malaria in adults and children weighing more than 11 kg.

Malaria is transmitted through the bite of an infected mosquito, which introduces the malaria parasite (Plasmodium falciparum) into the bloodstream. Falcimar prevents malaria by killing this parasite. It also kills the parasites in individuals already infected with malaria.
Protection against malaria infection is essential.
Malaria can affect people of any age. It is a serious illness, but it can be prevented. In addition to taking Falcimar, it is important to take measures to avoid mosquito bites.

• Use insect repellent on exposed areas of skin.
• Wear light-coloured clothing covering most of the body, especially after sunset, when mosquitoes are most active.
• Sleep in a closed room or under an insecticide-impregnated mosquito net.
• Close windows and doors at sunset, if they are not protected by mesh screens.
• Consider using insecticides (mats, sprays, mosquito plug-ins) to clear the room of insects or to prevent mosquitoes from entering.

If you have any further doubts, consult your doctor or pharmacist.
Malaria may occur even when all necessary precautions have been taken.
Some symptoms of malaria infection may appear only after a delay; therefore, the disease may manifest several days, weeks, or even months after returning from a malaria-endemic area.
If you develop symptoms such as high fever, headache, chills, and fatigue after returning home, seek medical advice immediately.

2. Important information before using Falcimar

When not to use 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).
• For malaria prevention, if the patient has chronic kidney disease.

Warnings and precautions
Malaria prevention:

• If the patient becomes ill (vomits) within 1 hour after taking a Falcimar tablet, another dose should be taken immediately.
• It is important to complete the entire prescribed course of Falcimar treatment. If additional tablets need to be taken due to vomiting, the patient will likely require another prescription.
• If the patient vomits, it is especially important to use additional protective measures, such as repellents or bed nets. Falcimar may be less effective because less of the medicine will be absorbed by the body.

Malaria treatment:

• If the patient vomits and develops diarrhoea, inform the doctor, as regular blood tests will be necessary. Falcimar may be less effective because less of the medicine will be absorbed by the body. These tests will determine whether the malaria parasite has been eliminated 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 an alternative medicine.
• If malaria is being treated but has recurred multiple times, or if malaria is caused by a specific type of parasite, the doctor may recommend additional treatment alongside Falcimar.

Falcimar and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Some medicines may affect the action of Falcimar, or Falcimar 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 in the treatment of HIV,
• indinavir used in the treatment of HIV,
• warfarin and other medicines that inhibit blood clotting,
• etoposide used in the treatment of cancer.

Inform the doctor if the patient is taking any of these medicines. The doctor may decide that Falcimar is not suitable for the patient or that additional monitoring tests are required during treatment.
REMEMBER to inform the doctor about taking any other medicines while using Falcimar.
Taking Falcimar with food and drink
Falcimar should be taken with food or milk, if possible. This enables the patient's body to absorb more of the medicine, making treatment more effective.
Crushing the tablets is not recommended.
Pregnancy and breastfeeding
If the patient is pregnant or planning to become pregnant, do not take Falcimar unless advised by a doctor.
Consult a doctor or pharmacist before taking Falcimar.
Breastfeeding should not be undertaken while taking Falcimar, as the active ingredients may pass into breast milk and may harm the infant.
Driving and operating machinery
Do not drive if the patient experiences dizziness. Falcimar may cause dizziness in some people. In such cases, the patient should not drive, operate machinery, or perform any activities where they could endanger themselves or others.

3. How to use Falcimar

This medicine should always be taken exactly as described in the patient information leaflet, or as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Falcimar should preferably be taken with food or milk-based drinks.
It is best to take Falcimar at the same time each day.

Malaria prevention
The usual dose for adults and adolescents weighing more than 40 kg is one tablet once daily, taken as described below.
For use in children, consult your doctor.
Falcimar is not recommended for malaria prevention in children, or in adults and adolescents weighing less than 40 kg.
In certain 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 a malaria-endemic area.
• Take the medicine daily during your stay and for an additional 7 days after returning to a malaria-free area.
• To ensure maximum protection, the full course of Falcimar treatment must be completed. Since it takes 7 days to ensure all parasites introduced by mosquitoes are eliminated, stopping treatment early increases the risk of infection.

Treatment of malaria
In adults, the usual dose is 4 tablets once daily for 3 days.
In children weighing 11 kg or more:

• 11 to 20 kg – 1 tablet once daily for 3 days
• 21 to 30 kg – 2 tablets once daily for 3 days
• 31 to 40 kg – 3 tablets once daily for 3 days
• above 40 kg – same dose as adults

Falcimar is not recommended for the treatment of malaria in children weighing less than 11 kg.
For children weighing less than 11 kg, consult your doctor. In certain countries, Falcimar may also be available in other pharmaceutical forms.

Taking more Falcimar than recommended
Contact your doctor or pharmacist for advice. If possible, show the medicine’s packaging.

Missed dose of Falcimar
It is very important to complete the full course of Falcimar treatment. If you miss a dose, do not be alarmed. Take the next dose as soon as possible. Then continue treatment as previously scheduled. Do not take a double dose to make up for a missed dose.

Stopping Falcimar treatment
Falcimar must be taken for 7 days after the patient returns to a malaria-free area. To ensure maximum protection, the full prescribed course of treatment must be completed. Since it takes 7 days to ensure all parasites transmitted by mosquitoes are eliminated, stopping treatment prematurely exposes the patient to the risk of ongoing infection.

If you have any questions, consult your doctor or pharmacist.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
Please pay attention to the serious reactions listed below, which may be caused by this medicine.
These reactions have occurred in a small number of people, but the exact frequency of their occurrence is unknown.

Severe 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 any of these symptoms occur, contact your doctor immediately
and stop taking the medicine.

Severe skin reactions:

• skin rash which may cause blistering and resemble target-like spots (dark spots in the center surrounded by paler, dark rings – erythema multiforme),
• severe and widespread rash with blisters and peeling skin – particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome).

If any of the above symptoms appear, contact your doctor immediately.

Most other adverse effects are mild and do not last long.

Very common: affects more than 1 in 10 patients

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

Common: affects 1 to 10 in 100 patients

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

Common adverse reactions which may appear in blood tests:

• decreased number of red blood cells (anaemia), which may cause fatigue, headaches and shortness of breath
• decreased number of white blood cells (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 1,000 patients
May occur in 1 in 100 people:

• anxiety
• awareness of an abnormally fast heartbeat (palpitations)
• swelling and redness of the lips
• red blisters on the skin (urticaria)
• hair loss.

Uncommon adverse reactions which may appear in blood tests:

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

Rare: affects 1 to 10 in 10,000 patients

• seeing or hearing things that are not real (hallucinations).

Other adverse reactions: These have occurred in a small number of people, but their exact frequency is unknown.

• hepatitis (hepatitis)
• blockage of bile ducts (cholestasis)
• increased heart rate (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 (fits)
• panic attacks, crying
• nightmares
• severe mental problems, causing people to lose touch with reality and be unable to think clearly or make sound judgments
• mouth ulcers
• blisters
• peeling skin
• increased sensitivity of the skin to sunlight
• effects on stomach function (food intolerance).

Other adverse reactions which may appear in blood tests:

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

If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Falcimar

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

6. Contents of the pack and other information

What Falcimar contains

• The active substances in this medicine are atovaquone and proguanil hydrochloride. Each tablet contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride.
• Other components of the medicine are:
  Tablet core: microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch (type A), poloxamer 188, povidone K 30, colloidal anhydrous silica, magnesium stearate.
  Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), macrogol 8000.

What Falcimar looks like and contents of the pack
The tablets are pinkish-brown to brown, round, biconvex, and film-coated, with the imprint "404" on one side and the imprint "G" on the other.
The tablets are supplied in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Pack sizes: 12, 24, 36, 60 tablets.
For more detailed information about the medicine, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Spain, 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
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Spain, country of export: 712700.0
Parallel Import Licence Number: 371/24
This medicinal product is authorised for sale in the Member States under the following names: