Find similiar products:
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL 25258/0064 .
Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets
Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets
atovaquone/proguanil hydrochloride
1. What Atovaquone/Proguanil Hydrochloride is and what it is used for
2. What you need to know before you take Atovaquone/Proguanil Hydrochloride
3. How to take Atovaquone/Proguanil Hydrochloride
4. Possible side effects
5 How to store Atovaquone/Proguanil Hydrochloride
6. Contents of the pack and other information
Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets belong to a group of medicines called antimalarials. It contains two active ingredients, atovaquone and proguanil hydrochloride.
Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets have two uses:
Malaria is spread by the bite of an infected mosquito, which passes the malaria parasite (Plasmodium falciparum) into the bloodstream. Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets prevent malaria by killing this parasite. For people who are already infected with malaria, Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets also kills these parasites.
People of any age can get malaria. It is a serious disease, but is preventable. As well as taking Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets, it is very important that you also take steps to avoid being bitten by mosquitoes.
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.
When preventing malaria:
When treating malaria:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can affect the way Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets works, or Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets themselves can strengthen or weaken the effectiveness of other medicines taken at the same time. These include:
Tell your doctor if you are taking any of these. Your doctor may decide that Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets aren’t suitable for you, or that you need extra check ups while you’re taking it.
REMEMBER to tell your doctor if you start taking any other medicines while you’re taking Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets.
Take Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets with food or a milky drink, where possible. This will increase the amount of Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets your body can absorb, and make your treatment more effective.
The tablets should preferably not be crushed.
If you are pregnant or if you have the intention to get pregnant, do not take Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets unless your doctor recommends it.
Ask your doctor or pharmacist for advice before taking Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets.
Do not breast feed while taking Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets, as the ingredients of Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets may pass into breast milk and may harm your baby.
If you feel dizzy, do not drive. Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets make 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.
Always take Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Take Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets with food or a milky drink, where possible.
It is best to take Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets at the same time each day.
The usual dose for adults and adolescents weighing more than 40 kg is 1 tablet once a day, taken as below.
For children, talk to your doctor.
Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets is not recommended for preventing malaria in children, or in adults or adolescents who weigh less than 40 kg.
There may be a different type of Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets available for children in your country.
To prevent malaria in adults:
The usual dose for adults is 4 tablets once a day for 3 days.
For children weighing 11 kg or more:
Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets is 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 Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablet available in your country
Contact a doctor or pharmacist for advice. If possible show them the Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets pack.
It is very important that you take the full course of Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets. 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 a double dose to make up for a missed dose.
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.
Please talk to your doctor or pharmacist if you need any advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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:
Severe skin reactions:
Most of the other side effects reported have been mild and have not lasted very long.
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100
Common side effects, which may show up in your blood tests are:
Uncommon: affects 1 to 10 users in 1,000
These may affect up to 1 in 100 people:
Uncommon side effects that may show up in your blood tests:
Rare: affects 1 to 10 users in 10,000
Other side effects: Other side effects have occurred in a small number of people but their exact frequency is unknown.
Other side effects that may show up in your blood tests:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
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 carton and the blister after EXP. The expiry date refers to the last day of that month.
This medicinal product 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. These measures will help protect the environment.
The active substances are atovaquone and proguanil hydrochloride.
Each tablet contains 250 mg atovaquone and 100 mg proguanil hydrochloride.
The other ingredients are:
Core
Poloxamer 188 , Microcrystalline Cellulose, Low-substituted Hydroxypropyl Cellulose, Povidone K30, Sodium Starch Glycolate Type A, Silica Colloidal anhydrous, Magnesium Stearate
Coating
Hypromellose, Titanium Dioxide (E171), Iron Oxide Red (E172), Macrogol 400, Macrogol 8000
Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets are Pinkish brown to brown coloured, circular, biconvex beveled edge Film-coated tablets with ‘404’ debossed on one side and ‘G’ debossed on the other side.
Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated are supplied in PVC/PVDC (clear) and hard tempered PVC/PVDC-Aluminium foil blister packs containing 12 tablets
Pack size: 12, 24, 36, 60
Not all pack sizes may be marketed.
This medicinal product is authorised in the Member States under the following names:
Denmark Atovaquon/Proguanilhydrochlorid Glenmark 250 mg /100 mg Filmovertrukne tabletter
Germany Atovaquon/Proguanilhydrochlorid Glenmark 250 mg /100 mg Filmtabletten
France Atovaquone/Proguanil Alfasigma 250 mg /100 mg comprimé pelliculé
United Kingdom Atovaquone/Proguanil Hydrochloride 250 mg /100 mg Film-coated tablets
The Netherlands Atovaquon/Proguanilhydrochloride Glenmark 250 mg /100 mg Filmomhulde Tabletten
Belgium Atovaquone/Proguanil Glenmark 250mg/100mg filmomhulde tabletten/comprimés pellicullés/Filmtabletten
Sweden Atovakvon / Proguanil Glenmark 250/100 mg filmdragerade tabletter
Spain Malaway 250 mg/100 mg Comprimidos recubiertos con película
Ireland Atovaquone/Proguanil Hydrochloride 250 mg /100 mg Film-coated tablets
Poland Falcimar
Iceland Atóvakón/Prógúanílhýdróklóríð Glenmark 250mg/100mg filmuhúðaðar töflur
Norway Atovakon/proguanil Glenmark
Austria Atovaquon/Proguanil-Hydrochlorid Glenmark 250 mg/100 mg Filmtabletten
Finland Atovaquone/Proguanil Glenmark 250 mg/100 mg kalvopäällysteinen tabletti
This leaflet was last revised in 02/2018.