Atovaquon/Proguanilhydrochloride Orifarm 250mg/100mg, filmomhulde tabletten

1. What is and what it is used for

<Product name> belongs to a group of medicines called antimalarials. It contains two active ingredients, atovaquone and proguanil hydrochloride

<product name> has two uses:

• to prevent malaria in adults and children who weigh at least 40 kg
• to treat malaria in adults and children who weigh at least 11 kg

Malaria is spread by the bite of an infected mosquito, which passes the malaria parasite (Plasmodium falciparum) into the bloodstream. <Product name> prevents malaria by killing this parasite. For people who are already infected with malaria, <product name> 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 <product name>, 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 Do not use atovaquone/proguanil:

• if you are allergic to atovaquone/proguanil or any of the other ingredients of this medicine (listed in section 6);
• for preventing malaria, if you have severe kidney problems;

If any of the above applies to you, talk to your doctor, before you start taking this medicine.

Warnings and precautions

Talk to your doctor before taking <product name>

If you are sick (vomit):

• For preventing malaria:

-If you are sick (vomit) within 1 hour of taking your tablet, take another dose straight away. -it is important to take the full course of [nationally completed name]. 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. [nationally completed name] may not be as effective, as the amount absorbed will be reduced.

• For treating malaria:

if you have vomiting and diarrhoea tell your doctor, you will need regular blood tests. [nationally completed name] 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

Other medicines and atovaquone/proguanil

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicine.

Some medicines can affect the way atovaquone/proguanil works, or atovaquone/proguanil itself can strengthen or weaken the effectiveness of other 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 <product name> isn’t suitable for you, or that you need extra check ups while you’re using it.

Remember to tell your doctor before you start taking any other medicines while you’re taking ,product name>.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using <product name>.

Pregnancy , breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

If you are pregnant, do not use this medicine unless your doctor recommends it. Ask your doctor or pharmacist for advice before using this medicine.

Breast-feeding

Do not breast feed while using <product name>, as the ingredients may pass into breast milk and may harm your baby.

Driving and using machines

If you feel dizzy, do not drive. This medicine 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.

3. How to use

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

To prevent malaria in adults and children weighing at least 40 kg.

The usual dose for adults is 1 tablet once a day, taken as below.

Not for children weighing less than 40 kg, talk to your doctor.

Not recommended for preventing malaria in children, or in adults who weigh less than 40 kgs. There may be a different type of Atovaquone/Proguanil tablet available for children weighing less than 40 kg.

To prevent malaria in adults:

• start taking <product name> 1 to 2 days before travelling to an area which has malaria
• continue taking it every day during your stay, which should not exceed 28 days

• continue taking it for another 7 days after your return to a malaria-free area.

To treat malaria in adults and children who weigh at least 11 kg

The usual dose for adults is 4 tablets once a day for 3 days.

For children the dose depends on their bodyweight:

• 11-20kg – 1 tablet once a day for 3 days
• 21-30kg – 2 tablets once a day for 3 days
• 31-40kg – 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 kgs.

For children who weigh less than 11 kgs talk to your doctor. There may be a different type of atovaquone/proguanil tablet.

Method of administration

Take with food or a milky drink, where possible. It is best to take <product name> at the same time each day. This will increase the amount of <product name> your body can absorb, and make your treatment more effective.

If you are sick (vomit) within 1 hour of taking your tablet, take another dose straight away. (see also section 2)

.

If you use more <product name> than you should

If you take more than you should, talk to a doctor or go to a pharmacist for advice. . Take the medicine pack with you.

If you forget to use <product name>.

It is very important that you take the full course . If you forget to take a dose, take it as soon as you remember – then continue as normal. Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you stop using <product name>

Use for preventing malaria: Keep taking <product name> for 7 days after you return to a malaria-free area. 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.

Do not take <product name> for longer than 37 days. If you are expecting to stay in an area with malaria for more than 28 days check with your doctor before travelling. <product name> may not be suitable for youUse for treatment: Take the full course of <product name> for maximum protection.. Do not stop taking <product name> just because you feel better.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:

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 using atovaquone/proguanil.

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.

Uncommon side effects that may show up in your blood tests:

• an increase in amylase (an enzyme produced in the pancreas).

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

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 the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store

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 label and carton after EXP (month,year). The expiry date refers to the last day of that month.

HDPE bottles only:

Use within 90 days of first opening

Do not use if you notice any visible signs of deterioration.

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.

What <product name> contains:

The active substance is atovaquone and proguanil hydrochloride. Each tablet contains 250mg of atovaquone and 100mg proguanil hydrochloride

The other ingredients are:

Poloxamer 188, microcrystalline cellulose (E460), povidone K30 (E2101), sodium starch glycolate (Type A), magnesium stearate (E572), hypromellose (E464), low-substituted hydroxypropyl cellulose (E463),, silica colloidal anhydrous (E551), titaniumdioxide (E171), red iron oxide (E172), macrogol 400 and macrogol 8000.

What <product name> looks like and contents of the pack

<Product name> film coated tablets are pink, round, biconvex film coated tablets debossed with 'H' on one side and '175' on the other side.

<Product name> is available in blister packs:

Pack sizes:

Alu-Alu Blister: 10, 12 film-coated tablets

Alu-PVC Blister: 10, 12 film-coated tablets

Not all pack sizes may be marketed

Marketing Authorisation Holder

Orifarm Generics A/S

Energivej 15, P.O. Box 69,

5260 Odense S

Denemarken

Manufacturer

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000

Malta

Ingeschreven in het register onder nummer:

RVG: 111748

This medicinal product is authorised in the Member States of the EEA under the following names:

<to be completed nationally>

Deze bijsluiter is voor het laatst goedgekeurd in september 2013