Atovaquone and proguanil Mylan Generics

Package leaflet: Information for the user

Atovaquone and Proguanil Mylan Generics 250 mg/100 mg film-coated tablets

atovaquone/proguanil hydrochloride
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Atovaquone and Proguanil Mylan Generics is and what it is used for
2. What you need to know before taking Atovaquone and Proguanil Mylan Generics
3. How to take Atovaquone and Proguanil Mylan Generics
4. Possible side effects
5. How to store Atovaquone and Proguanil Mylan Generics
6. Contents of the pack and other information

1. What Atovaquone and Proguanil Mylan Generics is and what it is used for

Atovaquone and Proguanil Mylan Generics belongs to a group of medicines called antimalarials.
It contains two active substances: atovaquone and proguanil hydrochloride.
Atovaquone and Proguanil Mylan Generics is used to

• prevent malaria
• treat malaria.

Malaria is spread through the bite of an infected mosquito, which transmits the malaria parasite
( Plasmodium falciparum ) into the bloodstream. Atovaquone and Proguanil Mylan Generics prevents
malaria by killing this parasite. In people who have already contracted malaria, Atovaquone and
Proguanil Mylan Generics also kills these parasites.
Prevention of malaria
People of all ages can contract malaria. It is a serious illness, but it can be prevented.
In addition to taking Atovaquone and Proguanil Mylan Generics, it is very important to take measures to avoid being bitten by mosquitoes.

• Apply insect repellent products to exposed skin
• Wear light-coloured clothing covering most of the body, especially after sunset, as this is when mosquitoes are most active
• Sleep in screened rooms or under an insecticide-impregnated mosquito net
• Close doors and windows at dusk, if they are not screened
• Consider using an insecticide (mats, sprays, vaporisers) to kill insects in a room or to prevent mosquitoes from entering
• If you need further advice, consult your doctor or pharmacist.

You can still contract malaria even after taking the necessary precautions. Some types of
malaria infections cause symptoms after a long delay, so the illness may appear several
days, weeks, or even months after your return from abroad. Consult a doctor immediately if,
after returning, you develop symptoms such as fever, headache, chills, and fatigue.

2. What you need to know before taking Atovaquone and Proguanil Mylan Generics

Do not take Atovaquone and Proguanil Mylan Generics

• If you are allergic to atovaquone, proguanil hydrochloride, or any of the other ingredients of this medicine (listed in section 6).
• For the prevention of malaria, if you have severe kidney disease.
• Inform your doctor if any of these situations apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Atovaquone and Proguanil Mylan Generics.
Children
Atovaquone and Proguanil Mylan Generics 250 mg/100 mg film-coated tablets are not recommended for children weighing less than 11 kg. A different dosage strength of atovaquone and proguanil hydrochloride tablets may be available that is more suitable for children weighing less than 11 kg.
Other medicines and Atovaquone and Proguanil Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can affect how Atovaquone and Proguanil Mylan Generics works, or Atovaquone and Proguanil Mylan Generics may strengthen or weaken the effect of other medicines taken at the same time.
These include:

• metoclopramide, used to treat nausea and vomiting
• antibiotics, tetracyclines, rifampicin, and rifabutin
• efavirenz or certain highly active protease inhibitors used for the treatment of HIV
• warfarin and other medicines that inhibit blood clotting
• etoposide, used to treat cancer.

Inform your doctor if you are taking any of these medicines. Your doctor may decide that Atovaquone and Proguanil Mylan Generics is not suitable for you, or that you need additional monitoring while taking it.
Remember to inform your doctor if you start taking any other medicines while you are taking Atovaquone and Proguanil Mylan Generics.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Atovaquone and Proguanil Mylan Generics should not be used during pregnancy unless recommended by your doctor.
Do not breast-feed while taking Atovaquone and Proguanil Mylan Generics, as its components may pass into breast milk and harm the baby.
Driving and using machines
If you feel dizzy, do not drive.
Atovaquone and Proguanil Mylan Generics may cause dizziness in some people. If this happens to you, do not drive, operate machinery, or perform activities that could be dangerous to yourself or others.
Atovaquone and Proguanil Mylan Generics contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Atovaquone and Proguanil Mylan Generics

Take this medicine exactly as your doctor or pharmacist has told you. If you are
unsure, consult your doctor or pharmacist.
To prevent malaria:
The recommended dose for adults and children weighing at least 40 kg is 1 tablet once daily,
taken as described below. Atovaquone and Proguanil Mylan Generics is not recommended for
preventing malaria in children or adults or adolescents with a body weight below 40 kg.
A different type of tablet may be available in your country for preventing malaria in
children and adults weighing less than 40 kg.

• start taking Atovaquone and Proguanil Mylan Generics 1 to 2 days before travelling to an area where malaria is common,
• continue taking it every day during your stay,
• continue taking it for another 7 days after leaving the area.

To treat malaria:
The recommended dose for adults is 4 tablets once daily for 3 days.
For children weighing 11 kg or more, the dose depends on body weight:
11–20 kg body weight: 1 tablet daily for 3 days.
21–30 kg body weight: 2 tablets daily for 3 days.
31–40 kg body weight: 3 tablets daily for 3 days.
Over 40 kg body weight: the adult recommended dose.
Not recommended for the treatment of malaria in children weighing less than 11 kg.
For children weighing less than 11 kg, consult your doctor. A different type of tablet may be
available in your country for children, containing a lower amount of atovaquone and
proguanil hydrochloride.
Method of administration
For oral use.
Take Atovaquone and Proguanil Mylan Generics with food or a milk-based drink, if possible.
Take Atovaquone and Proguanil Mylan Generics at the same time each day.
If you feel unwell (vomiting):
To prevent malaria:

• If you feel unwell (vomit) within 1 hour after taking Atovaquone and Proguanil Mylan Generics film-coated tablets, take another dose immediately.
• It is important to take all tablets of Atovaquone and Proguanil Mylan Generics. If you need to take additional tablets due to vomiting, you will require another prescription.
• In case of vomiting, it is especially important to use additional protective measures, such as repellents and mosquito nets. Atovaquone and Proguanil Mylan Generics may be less effective, as the amount absorbed will be reduced.

For the treatment of malaria:
If you experience vomiting and diarrhoea, inform your doctor; you will need regular blood tests.
Atovaquone and Proguanil Mylan Generics may be less effective, as the amount absorbed will be reduced.
These tests will determine whether the malaria parasite has been eliminated from the blood.
If you take more Atovaquone and Proguanil Mylan Generics than you should
Ask for advice from a doctor or pharmacist. If possible, bring the pack of Atovaquone and
Proguanil Mylan Generics with you.
If you forget to take Atovaquone and Proguanil Mylan Generics
It is very important that you take all the tablets of Atovaquone and Proguanil Mylan Generics.
If you forget to take a dose, do not worry. Take the next dose as soon as you remember.
Then continue as usual with the rest of the tablets.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Atovaquone and Proguanil Mylan Generics
Do not stop taking Atovaquone and Proguanil Mylan Generics without warning.
Continue taking Atovaquone and Proguanil Mylan Generics for 7 days after leaving the area where malaria is common. Take all tablets of Atovaquone and Proguanil Mylan Generics for maximum protection. Stopping treatment early puts you at risk of contracting malaria, as 7 days are needed to kill parasites in the blood following a mosquito bite.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Pay attention to the following serious reactions. These have occurred in a small number of people, but their exact frequency is unknown.

Severe allergic reactions – signs include:

• skin rash and itching
• sudden wheezing, tightness in the chest or throat, difficulty breathing or low blood pressure
• swelling of the eyelids, face, lips, tongue or other parts of the body

If you experience any of the following symptoms, you must stop taking Atovaquone and Proguanil Mylan Generics and seek immediate medical advice:

Severe skin reactions

• Skin rash, which may appear as blisters and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• Severe widespread rash with blisters and peeling of the skin, particularly 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 reported side effects have been mild and short-lived.

Very common side effects (may affect more than 1 in 10 people):

• headache
• feeling unwell (nausea) or being unwell (vomiting)
• stomach ache
• diarrhoea

Common side effects (may affect up to 1 in 10 people):

• dizziness
• sleep disorders (insomnia)
• abnormal dreams
• depression
• loss of appetite
• fever
• rash, sometimes itchy
• cough

Common blood test abnormalities that may be detected:

• reduction in the number of red blood cells (anaemia), which may cause tiredness, headache and shortness of breath
• reduction in the number of white blood cells (neutropenia), which may make you more susceptible to infections
• low levels of sodium in the blood (hyponatraemia)
• increased liver enzymes

Uncommon side effects (may affect up to 1 in 100 people):

• anxiety
• palpitations (unusual awareness of an abnormal heartbeat)
• swelling and redness of the mouth
• hair loss

Uncommon blood test abnormalities that may be detected:

• increased 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 real (hallucinations)

Not known (frequency cannot be estimated from the available data)
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 (cholestasis)
• increased heart rate (tachycardia)
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may affect other parts of the body
• seizures
• panic attacks, crying
• nightmares
• severe mental condition in which the person loses contact with reality and is unable to think or understand clearly
• mouth ulcers
• blisters
• skin peeling
• increased sensitivity of the skin to sunlight

Other side effects that may be detected by blood tests:

• in people with severe kidney disease, reduction in the number of all blood cells (pancytopenia)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atovaquone and Proguanil Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The
expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
For PVC-aluminium blisters only: do not store above 25 °C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Atovaquone and Proguanil Mylan Generics contains

• The active substances are atovaquone and proguanil hydrochloride. Each film-coated tablet contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride.
• The other components are:
  Tablet core: Microcrystalline cellulose, Povidone (K-30), Crospovidone (Type A), Poloxamer 188, Magnesium stearate.
  Coating: Titanium dioxide (E171), Lactose monohydrate, Macrogol 4000, Hypromellose 15cP (E464), Hypromellose 50cP (E464), Hypromellose 3cP (E464), Iron oxide red (E172), Iron oxide black (E172), Iron oxide yellow (E172).

Description of the appearance of Atovaquone and Proguanil Mylan Generics and contents of the pack
These are film-coated tablets, yellow-brown in colour, round and biconvex, with "A-P" over "2" engraved on one side and "M" on the other side.
They are supplied in PVC-aluminum, OPA/Aluminum/PVC – Aluminum, PVC/PVdC – Aluminum blisters containing 12, 24, 30, 36, 48 tablets or 12x1, 24x1, 30x1, 36x1, 48x1 tablets in unit-dose divisible blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A
Via Vittor Pisani 20
20124 Milan, Italy

Batch release responsible person
Generics [UK] Ltd
Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft.
H-2900, Komárom
Mylan utca 1
Hungary

This medicinal product is authorized in the European Economic Area Member States under the following names:
Germany Malarex 250 mg/100 mg
Belgium Atovaquone/Proguanil Mylan 250 mg/100 mg Filmomhulde tabletten
Denmark Provaqomyl
France Atovaquone/Proguanil MYLAN, 250 mg/100 mg, comprimé pelliculé
Italy Atovaquone e Proguanile Mylan Generics
Ireland Atovaquone/Proguanil hydrochloride 250 mg/100 mg film-coated tablets
Norway Provaqomyl
Sweden Provaqomyl
Spain Atovaquona/Hidrocloruro de proguanil MYLAN 250 mg/100 mg comprimidos recubiertos con película EFG
Netherlands Atovaquon/Proguanil HCl Mylan 250/100 mg, filmomhulde tabletten
United Kingdom Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets