250 mg / 100 mg film-coated tablets
atovaquone / proguanil hydrochloride
What Profaqomyl is and what it is used for
Tryqomyl belongs to a group of medicines called malaria medicines. Each tablet contains two active substances, atovaquone, and proguanil hydrochloride.
Probacomyl is used to:
- prevent malaria ( prophylaxis )
- treat malaria.
Malaria is spread through the bite of infected mosquitoes, which carry the malaria parasite ( Plasmodium falciparum ) further into the bloodstream. Probacomyl kills the parasite and can prevent malaria from developing ( prophylaxis ). Tryqomyl also kills Plasmodium falciparum parasites in individuals who have already developed malaria.
Advice on how to protect yourself against malaria
People of all ages can get malaria. It is a serious disease, but it can be prevented.
In addition to taking Probqomyl, it is very important that you also make sure to avoid mosquito bites, e.g. by:
- use insect repellent on exposed skin surfaces
- wear light clothing that covers most of the body, especially after sunset because that is when the mosquitoes are most active
- sleep in a room with mosquito nets or under a mosquito net impregnated with insect repellent
- close windows and doors at sunset if mosquito nets are missing
- Consider using insect repellent (substrate, spray, electric mosquito coil) to get rid of mosquitoes before nightfall or to prevent mosquitoes from entering.
If you need further advice, talk to your doctor or pharmacist.
However, you can get malaria even though all precautions have been taken. In some types of malaria infection, it takes a long time for symptoms to appear, and the disease only breaks out after several days, weeks, or even months after you have returned home from your stay abroad.
Seek medical attention immediately if you experience symptoms such as fever, headache, chills, and fatigue after returning home.
Atovaquone and proguanil hydrochloride contained in Probqomyl may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Probqomyl
Do not take Probqomyl:
- if you are allergic to atovaquone, proguanil hydrochloride, or any of the other ingredients of this medicine (listed in section 6).
- as prophylaxis (prevention) against malaria if you have serious kidney disease.
Tell your doctor if any of these apply to you.
Warnings and cautions
Talk to your doctor or pharmacist before taking Tryqomyl.
Children
Tryqomyl 250 mg / 100 mg film-coated tablets are not recommended for children weighing less than 11 kg. Another strength of atovaquone/proguanil tablets, which are more suitable for children weighing less than 11 kg, may be available.
Other medicines and Profaqomyl
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the effect of Tryqomyl and Tryqomyl may also increase or decrease the effect of other medicines taken at the same time, eg:
- metoclopramide (antiemetic and antiemetic)
- tetracyclines, rifampicin, and rifabutin ( antibiotics )
- efavirenz or some very active protease inhibitors (used to treat HIV )
- warfarin and other blood thinners
- etoposide (used to treat cancer).
Tell your doctor if you are taking any of these medicines. Your doctor may decide that Tryqomyl is not suitable for you or that more frequent checks are needed while you are taking Tryqomyl.
Remember to tell your doctor if you start taking any other medicine while you are taking Tryqomyl.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Probqomyl if you are pregnant, unless your doctor recommends it.
Do not breastfeed while taking Tryqomyl as the ingredients may pass into breast milk and thus harm your baby.
Driving and using machines
If you get dizzy, do not drive.
Some people get dizzy when they take Probqomyl. If you feel affected, do not drive, use machines or engage in risky activities, where you may put yourself or others at risk.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Probacomyl contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Probqomyl
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
To prevent malaria ( prophylaxis ):
The recommended dose for adults and children weighing at least 40 kg is 1 tablet daily as shown below. Tryqomyl 250 mg / 100 mg tablets are not recommended as prophylaxis against malaria infection in children, adults, or adolescents weighing less than 40 kg. Another type of tablet, for the prophylaxis of malaria infection in children, adults, or adolescents weighing less than 40 kg, may be available.
- start Tryqomyl treatment 1 to 2 days before arrival in a malaria-infected area
- continue to take Probqomyl every day throughout your stay
- continue to take Probqomyl for another 7 days after returning to the malaria-free area.
To treat malaria:
The recommended dose for adults is 4 tablets once daily for 3 days.
Dosage in the treatment of children weighing 11 kg or more is based on body weight:
- 11-20 kg – 1 tablet daily for 3 days
- 21-30 kg – 2 tablets once daily for 3 days
- 31-40 kg – 3 tablets once daily for 3 days
- more than 40 kg – adult dosage
Tryqomyl is not recommended for the treatment of malaria infection in children weighing less than 11 kg.
Talk to your doctor if your child weighs less than 11 kg, as there may be another tablet available for children, which contains less atovaquone and proguanil hydrochloride.
Method of administration
To be swallowed. Whenever possible, take Provqomyl with food or milk. Take Probqomyl at the same time each day.
In case of illness (vomiting):
Prophylaxis (prevention) against malaria:
- If you vomit within one hour of taking the Proqomomil tablet, take a new dose immediately.
- You must complete the prescription of Proqqomyl. If you have to take additional tablets due to vomiting, you may need to get more Probqomyl prescribed.
- If you have vomiting, it is especially important to use other protective measures such as. insecticides and mosquito nets. The effect of Probqomyl may be reduced as the number of drugs taken up by the body then becomes smaller.
Treatment of malaria:
- If you experience vomiting and diarrhea, consult your doctor as regular blood tests should be taken. The effect of Probqomyl decreases because the amount of drugs taken up in the body then becomes smaller. Blood samples are taken to show if the malaria parasite has disappeared from the blood.
If you take more Profaqomyl than you should
If you have ingested too much medicine or if e.g. a child ingested the drug
accidentally contact a doctor or hospital immediately for
risk assessment and advice. Bring the Probqomyl package if you can.
If you forget to take Probqomyl
You must complete the prescription of Proqqomyl.
Do not worry if you forget to take a dose. Take the next dose as soon as possible. Then continue treatment according to the prescribed dosing schedule.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Tryqomyl
Do not discontinue your treatment with Probqomyl without advice.
Continue to take Probqomyl for 7 days after returning to the malaria-free area. For maximum protection, a prescription must be completed. If treatment is stopped earlier, you risk getting malaria because it must be 7 days since the mosquito bite to be sure that all the parasites in the blood have died.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Be aware of the following serious reactions. They have occurred in a few individuals, but the exact occurrence is unknown.
Severe allergic reactions – symptoms include:
- skin rash and itching
- wheezing, swelling of the airways or throat, difficulty breathing, or low blood pressure that occurs suddenly
- swelling of the eyelids, face, lips, tongue, or other parts of the body.
Contact a doctor immediately if you experience any of these symptoms and stop taking Tryqomyl.
Severe skin reactions
- rash, possibly with blisters that look like small bumps (annular, dark spots, surrounded by a lighter area with a dark ring around the edge) ( erythema multiforme )
- severe, scattered rash with blisters and scaling, especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ).
If you notice any of these symptoms, consult a doctor immediately.
Most other side effects reported have been mild and transient.
Very common side effects (may affect more than 1 in 10 people):
- headache
- nausea and vomiting
- abdominal pain
- diarrhea.
Common side effects (may affect up to 1 in 10 people):
- dizziness
- insomnia
- strange dreams
- Depression
- loss of appetite
- fever
- skin rash, possibly itchy
- cough.
Common side effects that can be detected with blood tests:
- decreased number of red blood cells ( anemia ), which can cause fatigue, headaches, and shortness of breath
- decreased white blood cell count ( neutropenia ), which may make it easier for you to get infected
- low levels of sodium in the blood ( hyponatremia )
- elevated liver enzyme values.
Uncommon side effects (may affect up to 1 in 100 people):
- anxiety
- palpitations that are experienced as unpleasant ( palpitation )
- swelling and redness in the oral cavity
- hair loss
Uncommon side effects that can be detected by blood tests:
- elevated amylase values (an enzyme produced in the pancreas).
Rare side effects (may affect up to 1 in 1,000 people):
- to see and hear things that do not exist (hallucinations).
Has been reported (occurs in an unknown number of users)
Other side effects have occurred in a few individuals, but the exact occurrence is unknown.
- inflammation of the liver ( hepatitis )
- clogging of the bile ducts (bile stasis)
- increased heart rate ( tachycardia )
- inflammation of the blood vessels ( vasculitis ). This can appear as red or dark violet raised spots on the skin, but can also affect other parts of the body.
- cramps
- panic attacks, crying
- nightmares
- severe mental states where the person loses contact with reality and is unable to think and act clearly
- sores in the oral cavity
- blisters
- scaly skin
- increased sun sensitivity of the skin.
Other side effects that can be detected with blood tests:
- decreased number of all blood cells (pancytopenia) in people with severe kidney disease.
How to store Profaqomyl
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
Only for blisters of PVC-aluminum foil: Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substances are atovaquone and proguanil hydrochloride. Each film-coated tablet contains 250 mg atovaquone and 100 mg proguanil hydrochloride.
Other ingredients are:
- Tablet core: microcrystalline cellulose, povidone K30, crospovidone (type A), poloxamer 188, magnesium stearate.
- Film coatings: titanium dioxide (E171), lactose monohydrate, macrogol 4000, hypromellose 15cP (E464), hypromellose 50cP (E464), hypromellose 3cP (E464), red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
Light yellow-brown, round, biconvex, film-coated tablets marked with “AP” above “2” on one side and “M” on the other side. They are available in PVC aluminum, OPA / aluminum / PVC aluminum, PVC / PVdC aluminum blisters containing 12, 24, 30, 36, 48 tablets or 12 x 1, 24 x 1, 30 x 1, 36 x 1, 48 x 1 tablet in perforated unit dose blisters.
Not all pack sizes may be marketed
Marketing Authorisation Holder:
Manufacturer:
Mylan Hungary Kft
H-2900 Komárom
Hungary