ATOVACUONE/PROGUANIL HYDROCHLORIDE VIATRIS 250 mg/100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Atovacuone/Hydrochloride Proguanil Viatris 250 mg/100 mg film-coated tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Atovacuone/Hydrochloride Proguanil Viatris is and what it is used for
2. What you need to know before you take Atovacuone/Hydrochloride Proguanil Viatris
3. How to take Atovacuone/Hydrochloride Proguanil Viatris
4. Possible side effects
5. Storage of Atovacuone/Hydrochloride Proguanil Viatris
6. Contents of the pack and other information

1. What Atovacuone/Hydrochloride Proguanil Viatris is and what it is used for

Atovacuone/Hydrochloride Proguanil Viatris belongs to a group of medicines called antimalarials. It contains two active substances: atovacuone and hydrochloride proguanil.

Atovacuone/Hydrochloride Proguanil Viatris is used for the following:

• Prevention of malaria
• Treatment of malaria

Malaria is transmitted through the bite of an infected mosquito that introduces the malaria parasite (Plasmodium falciparum) into the blood. Atovacuone/hydrochloride proguanil prevents malaria by killing this parasite. In people already infected with malaria, atovacuone/hydrochloride proguanil also kills these parasites.

Protect yourself from getting malaria

Anyone, of any age, can get malaria. It is a serious disease, but it is preventable.

Even when taking atovacuone/hydrochloride proguanil, it is very important that you take precautions to avoid being bitten by mosquitoes.

• Use mosquito repellent on all exposed areas of the body.
• Wear light-colored clothing that covers as much of the body as possible, especially in the evening when mosquitoes are most active.
• Sleep in a mosquito-proof roomor under a mosquito net impregnated with insecticide.
• Close windows and doors at sunset, if they are not screened.
• Consider using an insecticide(tablet, spray, electric) to clear the room of insects or prevent them from entering the room.

If you need clarification,talk to your doctor or pharmacist.

Even with all necessary precautions, it is still possible to get malaria. Some types of malaria infection can take a long time to cause symptoms; therefore, the disease may not start until several days, weeks, or even months after returning from travel. Consult a doctor immediately if you have symptomssuch as fever, headache, chills, or fatigue after returning from abroad.

2. What you need to know before you take Atovacuone/Hydrochloride Proguanil Viatris

Do not take Atovacuone/Hydrochloride Proguanil Viatris

• If you are allergic to atovacuone, hydrochloride proguanil, or any of the other ingredients of this medicine (listed in section 6).
• To prevent malaria, if you have severe kidney disease.

Tell your doctor if any of these apply to you.

Warnings and precautions

Consult your doctor or pharmacist before using Atovacuone/Hydrochloride Proguanil Viatris treatment:

Children

Atovacuone/Hydrochloride Proguanil Viatris 250 mg/100 mg is not recommended for children who weigh less than 11 kg. There may be another dose of atovacuone/proguanil tablets that is more suitable for children who weigh less than 11 kg.

Other medicines and Atovacuone/Hydrochloride Proguanil Viatris

Tell your doctor or pharmacist what you are taking, have recently taken, or might take, any other medicines.

Some medicines may affect how atovacuone/hydrochloride proguanil works or atovacuone/hydrochloride proguanil may increase or decrease the effectiveness of other medicines taken at the same time.

These medicines include:

• Metoclopramide, for the treatment of nausea and vomiting.
• The following antibiotics: tetracycline, rifampicin, and rifabutin.
• Efavirenz or certain protease inhibitors for the treatment of HIV.
• Warfarin and other anticoagulant medicines.
• Etoposide, used in the treatment of cancer.

Consult your doctorif you are taking any of these medicines. Your doctor may decide that atovacuone/hydrochloride proguanil is not suitable for you or that you need additional checks while taking it.

Remember to consultyour doctor if you start taking other medicines during your treatment with atovacuone/hydrochloride proguanil.

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 take atovacuone/hydrochloride proguanil during pregnancy, unless your doctor advises you to.

Do not breastfeed while taking atovacuone/hydrochloride proguanil, as its components may pass into breast milk and harm your baby.

Driving and using machines

If you feel dizzy, do not drive.

Atovacuone/hydrochloride proguanil can make some people feel dizzy. If this happens to you, do not drive, use machines, or take part in activities that may put you or others at risk.

This medicinecontains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Atovacuone/Hydrochloride Proguanil Viatris

Always take this medicine exactly as your doctor has told you.If you are not sure, check with your doctor or pharmacist.

To prevent malaria:

The recommended dose for adults and children weighing over 40 kg is 1 tablet per day, taken as follows. Atovacuone/hydrochloride proguanil is not recommended for preventing malaria in children or adults who weigh less than 40 kg. There may be different types of tablets available in your country to prevent malaria in children and adults who weigh less than 40 kg.

• Start taking atovacuone/hydrochloride proguanil 1 or 2 days before traveling to an area with malaria.
• Continue taking it every day during your trip.
• Keep taking it for another 7 days after you return to a malaria-free area.

To treat malaria:

The recommended dose for adultsis 4 tablets once a day for 3 days.

For childrenwho weigh 11 kg or more, 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 – same 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, consult your doctor. There may be a different type of tablet available in your country for children, with a lower content of atovacuone and hydrochloride proguanil.

Method of administration

For oral use.

Whenever possible, take this medicine with food or a drink that contains milk.

Take this medicine at the same time every day.

If you are sick (vomiting):

Malaria prevention

• If you vomit within the first hour of taking atovacuone/hydrochloride proguanil, take another dose as soon as possible
• It is important to take the full treatment of atovacuone/hydrochloride proguanil. If you need to take an extra dose due to vomiting, you may need another prescription.
• If you have been vomiting, it is especially important to use additional protection, with repellents and mosquito nets. As the amount of atovacuone/hydrochloride proguanil absorbed is reduced, it may not be as effective.

To treat malaria:

• If you have been vomiting and have diarrhea, consult your doctor. You will need regular blood tests. As the amount of atovacuone/hydrochloride proguanil absorbed is reduced, it may not be as effective. The tests will check if the malaria parasite has been eliminated from the blood.

If you take more Atovacuone/Hydrochloride Proguanil Viatris than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount taken.

If you forget to take Atovacuone/Hydrochloride Proguanil Viatris

It is important that you take the full treatment of atovacuone/hydrochloride proguanil.

If you forget to take a dose, do not worry. Just take your next dose as soon as you remember. Then, continue your treatment as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Atovacuone/Hydrochloride Proguanil Viatris

Do not stop taking atovacuone/hydrochloride proguanil without consulting your doctor.

Keep taking atovacuone/hydrochloride proguanil for the 7 days after returning to a malaria-free area. Take the full treatment of Atovacuone/Hydrochloride Proguanil Viatris to get maximum protection. If you stop treatment prematurely, you will be at risk of getting malaria, as 7 days are needed to ensure that all parasites that may be in your blood after a mosquito bite have been eliminated.

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

4. 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 been seen in a small number of people, but their exact frequency is unknown.

Severe allergic reactions– the signs are:

• Skin rash and itching.
• Sudden wheezing, chest or throat tightness, difficulty breathing, or low blood pressure.
• Swelling of the eyelids, face, lips, tongue, or other parts of the body.

If you get any of these symptoms, contact a doctor immediately and stop taking Atovacuone/Hydrochloride Proguanil Viatris

Severe skin reactions

• Skin rash that can have blisters with a target-like appearance (erythema multiforme).
• Severe widespread skin rash with blisters and skin peeling, especially around the mouth, nose, and genitals (Stevens-Johnson syndrome).

If you notice any of these symptoms, contact a doctor urgently.

Most other side effects reported have been mild and short-lived.

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

• Headache.
• Nausea or vomiting.
• Stomach pain.
• Diarrhea.

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

• Dizziness.
• Sleep problems (insomnia).
• Vivid dreams.
• Depression.
• Loss of appetite.
• Fever.
• Skin rash that can itch.
• Cough.

Common side effects that may be found in your blood tests:

• Decrease in the number of red blood cells (anemia) that can cause tiredness, headache, and difficulty breathing.
• Decrease in the number of white blood cells (neutropenia) that makes you more prone to infections.
• Low sodium levels in the blood (hyponatremia).
• Increase in liver enzymes.

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

• Anxiety.
• An unusual awareness of an abnormal heartbeat (palpitations).
• Inflammation and redness of the mouth.
• Hair loss.

Uncommon side effects that may be found 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).

Frequency not known (cannot be estimated from the available data)

Other side effects have been seen in a small number of people, but their exact frequency is unknown.

• Inflammation of the liver (hepatitis).
• Blockage of the bile ducts (cholestasis).
• Increase in heart rate (tachycardia).
• Inflammation of blood vessels (vasculitis) that can be seen as red or purple spots with some elevation on the skin, although it can affect other parts of the body.
• Epileptic seizures.
• Panic attacks, crying.
• Nightmares.
• Severe mental disorder that leads to a person losing contact with reality and being unable to think or judge clearly.
• Mouth ulcers.
• Blisters.
• Skin peeling.
• Increased sensitivity of the skin to sunlight.

Other side effects that may be found in your blood tests:

• In people with severe kidney failure, a decrease in all types of blood cells (pancytopenia).

Reporting of side effects

If you experience 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 Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atovacuone/Hydrochloride Proguanil Viatris

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, after EXP. The expiry date is the last day of the month stated.

Store in the original package to protect from moisture.

Only for PVC-aluminum blister: Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Atovacuone/Hydrochloride Proguanil Viatris

The active ingredients are atovacuone and hydrochloride proguanil. Each film-coated tablet contains 250 mg of atovacuone and 100 mg of proguanil.

The other components are:

Tablet core: Microcrystalline cellulose, povidone (K-30), crospovidone (type A), Poloxamer 188, magnesium stearate.

Film coating: Titanium dioxide (E171), lactose monohydrate, Macrogol 4000, hypromellose 15cP (E464), hypromellose 50cP (E464), hypromellose 3cP (E464), red iron oxide (E172), black iron oxide (E172), and yellow iron oxide (E172).

Product Appearance and Container Content

Beige, round, biconvex, film-coated tablets, marked with 'A-P' over '2' on one face and 'M' on the other.

They are supplied in PVC-Aluminum, OPA/Aluminum/PVC-Aluminum, PVC/PVdC-Aluminum blisters, which contain 12, 24, 30, 36, 48 tablets or 12, 24, 30, 36, 48 single-dose perforated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Hungary Kft

H-2900 Komarom,

Mylan utca 1,

Hungary

or

McDermott Laboratories Ltd t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate,

Grange Road,

Dublin 13

Ireland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Malarex 250 mg/100 mg Filmtabletten

Belgium Atovaquone/Proguanil Mylan 250 mg/100 mg Filmomhulde tabletten

Denmark Provaqomyl

Spain Atovacuona/Hidrocloruro de proguanil Viatris 250 mg/100 mg film-coated tablets EFG

France Atovaquone/Proguanil MYLAN, 250 mg/100 mg, comprimé pelliculé

Ireland Atovaquone/Proguanil hydrochloride 250 mg/100 mg film-coated tablets

Italy Atovaquone e Proguanile Mylan Generics

Norway Provaqomyl

Netherlands Atovaquon/Proguanil HCl Mylan 250/100 mg, filmomhulde tabletten

United Kingdom (Northern Ireland) Atovaquone/Proguanil hydrochloride 250 mg/100 mg film-coated tablets

Sweden Provaqomyl

Date of the last revision of this leaflet:August 2017

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/