Patient leaflet - ATOVAQUONE/PROGUANIL HYDROCHLORIDE 250 MG / 100 MG FILM-COATED TABLETS
1. what atovaquone/proguanil hydrochloride is and what it is used for
Atovaquone/Proguanil Hydrochloride belongs to a group of medicines called antimalarials. It contains two active ingredients, atovaquone and proguanil hydrochloride
Atovaquone/Proguanil Hydrochloride has two uses:
- to prevent malaria
- to treat malaria
Dosage instructions for each use are in Section 3, How to take Atovaquone/Proguanil Hydrochloride.
Malaria is spread by the bite of an infected mosquito, which passes the malaria parasite (Plasmodium falciparum ) into the bloodstream. Atovaquone/Proguanil Hydrochloride prevents malaria by killing this parasite. For people who are already infected with malaria, Atovaquone/Proguanil Hydrochloride also kills these parasites.
Protect yourself from catching malaria
People of any age can get malaria. It is a serious disease, but is preventable.
As well as taking Atovaquone/Proguanil Hydrochloride, it is very important that you also take steps to avoid being bitten by mosquitoes.
- Use insect repellent on exposed areas of the 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 screened room or under a mosquito net impregnated with insecticide
- Close windows and doors at sunset, if they are not screened
- Consider using an insecticide (mats, spray, plug-ins) to clear a room of insects or to deter mosquitoes from entering the room.
If you need further advice, talk to your doctor or pharmacist.
It is still possible to get malaria after taking the necessary precautions. Some types of malaria infection take a long time to cause symptoms, so the illness may not start until several days, weeks or even months after returning from abroad.
See a doctor immediately if you get symptoms such as high temperature, headache, shivering and tiredness after returning home.
2. what you need to know before you use atovaquone/ proguanil hydrochloride
Do not take Atovaquone/Proguanil Hydrochloride:
- if you are allergic to atovaquone, proguanil hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- for preventing malaria, if you have severe kidney disease.
Take special care with Atovaquone/Proguanil Hydrochloride
Talk to your doctor or pharmacist before taking Atovaquone/Proguanil Hydrochloride if:
- you have severe kidney disease
- your child is being treated for malaria and weighs less than 11 kg. There is another tablet strength to treat children who weigh less than 11 kg (see section 3).
Tell your doctor or pharmacist if any of these applies to you.
Other medicines and Atovaquone/Proguanil Hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines taken at the same time. These include:
- metoclopramide, used to treat nausea and vomiting
- the antibiotics, tetracycline, rifampicin and rifabutin
- efavirenz or certain highly active protease-inhibitors used to treat HIV
- warfarin and other medicines that stop blood clotting
- etoposide used to treat cancer.
Tell your doctor if you are taking any of these. Your doctor may decide that Atovaquone/Proguanil Hydrochloride isn't suitable for you, or that you need extra check-ups while you're taking it.
Remember to tell your doctor before you start taking any other medicines while you're taking Atovaquone/Proguanil Hydrochloride.
Atovaquone/Proguanil Hydrochloride with food and drink
Take Atovaquone/Proguanil Hydrochloride with food or a milky drink, where possible. This will increase the amount of Atovaquone/Proguanil Hydrochloride your body can absorb, and make your treatment more effective.
Pregnancy and breast feeding
If you are pregnant, do not take Atovaquone/Proguanil Hydrochloride unless your doctor recommends it.
Ask your doctor or pharmacist for advice before taking Atovaquone/Proguanil Hydrochloride.
Do not breast feed while taking Atovaquone/Proguanil Hydrochloride, as the ingredients of Atovaquone/Proguanil Hydrochloride may pass into breast milk and may harm your baby.
Driving and using machines
If you feel dizzy, do not drive. Atovaquone/Proguanil Hydrochloride makes some people feel dizzy. If this happens to you, do not drive, use machines or take part in activities where you may put yourself or others at risk.
Atovaquone/Proguanil Hydrochloride contains sodium
This medicine contains less than 1 mmol sodium (23mg) per film-coated tablet, that is so to say essentially ‚sodium-free‘.
3. how to take atovaquone/proguanil hydrochloride
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Take Atovaquone/Proguanil Hydrochloride with food or a milky drink, where possible.
It is best to take Atovaquone/Proguanil Hydrochloride at the same time each day.
To prevent malaria
The recommended usual dose for adults is 1 tablet once a day, taken as below.
Not recommended for preventing malaria in children, or in adults who weigh less than 40 kg. Atovaquone/Proguanil Hydrochloride paediatric tablets are recommended for preventing malaria in adults and children who weigh less than 40 kg.
To prevent malaria in adults:
- start taking Atovaquone/Proguanil Hydrochloride 1 to 2 days before travelling to an area which has malaria
- continue taking it every day during your stay
- continue taking it for another 7 days after your return to a malaria-free area.
To treat malaria
The recommended dose for adults is 4 tablets once a day for 3 consecutive days.
For children the dose depends on their 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 – dose as for adults.
Not recommended for treating malaria in children who weigh less than 11 kg.
For children who weigh less than 11 kg talk to your doctor. There may be a different type of tablets available in your country.
If you are sick (vomit)
For preventing malaria:
- if you are sick (vomit) within 1 hour of taking your Atovaquone/Proguanil Hydrochloride tablet, take another dose straight away
- it is important to take the full course of Atovaquone/Proguanil Hydrochloride. If you have to take extra tablets due to sickness, you may need another prescription.
- if you have been vomiting, it is especially important to use extra protection, such as repellents and bednets. Atovaquone/Proguanil Hydrochloride may not be as effective, as the amount absorbed will be reduced.
For treating malaria:
- if you have vomiting or diarrhoea tell your doctor, you Will need regular blood tests. Atovaquone/Proguanil Hydrochloride will not be as effective, as the amount absorbed will be reduced. The tests will check whether the malaria parasite is being cleared from your blood.
If you take more Atovaquone/Proguanil Hydrochloride than you should
Contact a doctor or pharmacist for advice. If possible show them the Atovaquone/Proguanil Hydrochloride pack.
If you forget to take Atovaquone/Proguanil Hydrochloride
It is very important that you take the full course of Atovaquone/Proguanil Hydrochloride.
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If you forget to take a dose, don't worry. Just take your next dose as soon as you remember. Then continue your treatment as before.
Don't take extra tablets to make up for a missed dose. Just take your next dose at the usual time.
If you stop taking Atovaquone/Proguanil Hydrochloride
Do not stop taking Atovaquone/Proguanil Hydrochloride without advice.
Keep taking Atovaquone/Proguanil Hydrochloride for 7 days after you return to a malaria-free area. Take the full course of Atovaquone/Proguanil Hydrochloride for maximum protection. Stopping early puts you at risk of getting malaria, as it takes 7 days to ensure that any parasites that may be in your blood following a bite from an infected mosquito are killed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Look out for the following severe reactions. They have occurred in a small number of people, but their exact frequency is unknown.
Severe allergic reactions – signs include:
- rash and itching
- sudden wheezing, tightness of the chest or throat, or difficulty breathing
- swollen eyelids, face, lips, tongue or other part of the body.
Contact a doctor immediately if you get any of these symptoms. Stop taking Atovaquone/Proguanil
Hydrochloride.
Severe skin reactions
- skin rash, which may blister and looks like small targets (central dark spots, surrounded by paler area with a dark ring around the edge) (erythema multiforme)
- severe widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
If you notice any of these symptoms contact a doctor urgently.
Most of the other side effects reported have been mild and have not lasted very long.
Very common side effects (may affect more than 1 in 10 people)
- headache
- feeling sick and being sick (nausea and vomiting)
- stomach pain
- diarrhoea.
Common side effects (may affect up to 1 in 10 people):
- dizziness
- sleeping problems (insomnia)
- strange dreams
- depression
- loss of appetite
- fever
- rash which may be itchy
- cough.
Common side effects, which may show up in your blood tests are:
- reduced numbers of red blood cells (anaemia) which can cause tiredness, headaches and shortness of breath
- reduced numbers of white blood cells (neutropenia) which may make you more likely to catch infections
- low levels of sodium in the blood (hyponatraemia)
- an increase in liver enzymes.
Uncommon side effects (may affect up to 1 in 100 people)
- anxiety
- an unusual awareness of abnormal beating of the heart (palpitations)
- swelling and redness of the mouth
- hair loss
- itchy, bumpy rash (hives)
Uncommon side effects that may show up in your blood tests:
- an increase in amylase (an enzyme produced in the pancreas).
Rare side effects (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 occurred in a small number of people but their exact frequency is unknown.
- Inflammation of the liver (hepatitis)
- blockage of the bile ducts (cholestatis)
- increase in heart rate (tachycardia)
- inflammation of the blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin but can affect other parts of the body
- fits (seizures)
- panic attacks, crying
- nightmares
- severe mental health problems in which the person loses contact with reality and is unable to think and judge clearly
- indigestion
- mouth ulcers
- blisters
- peeling skin
- increased sensitivity of the skin to sunlight.
Other side effects that may show up in your blood tests:
- A decrease in all types of blood cells (pancytopenia).
5. how to store atovaquone/proguanil hydrochloridekeep this medicine out of the sight and reach of children.do not use this medicine after the expiry date which is stated on the carton after exp. the expiry date refers to the last day of that month.
Atovaquone/Proguanil Hydrochloride does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will will help protect the environment.
6. contents of the pack and other informationwhat atovaquone/proguanil hydrochloride contains:the active ingredients are atovaquone and proguanil hydrochloride. each tablet contains 250 mg of atovaquone and 100 mg proguanil hydrochloride
The other ingredients are:
Tablet core: Poloxamer 188, microcrystalline cellulose (E460), low-substituted hydroxypropyl cellulose (E463), sodium starch glycolate (Type A), silica colloidal anhydrous (E551), povidone (E2101), magnesium stearate (E572)
Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), iron oxide red (E172).
Tell your doctor, without taking Atovaquone/Proguanil Hydrochloride if you might be allergic to any of these ingredients.
What Atovaquone/Proguanil Hydrochloride looks like and contents of the pack
Atovaquone/Proguanil Hydrochloride film coated tablets are round, pink, biconvex film coated tablets debossed with ‚H‘ on one side and ‚175‘ on the other side.
Atovaquone/Proguanil Hydrochloride is available in blister packs and HDPE containers.
Pack sizes
Alu-Alu Blister: 1, 12, 21, 24, 28, 36 film-coated tablets
Alu-PVC Blister: 1, 12, 21, 24, 28, 36 film-coated tablets
HDPE containers: 30, 100 film-coated tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder
Amarox Limited
Congress House, 14 Lyon Road
Harrow, Middlesex HA1 2EN
United Kingdom
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
This leaflet was last revised in 11/2020.
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