Leaflet: information for the patient

Atovacuona/Hydrochloride of proguanil Viatris 250 mg/100 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What isAtovacuona/Hydrochloride of proguanil Viatrisand for what it is used

2. What you need to know before starting to takeAtovacuona/Hydrochloride of proguanil Viatris

3. How to takeAtovacuona/Hydrochloride of proguanil Viatris

4. Possible side effects

5. Storage ofAtovacuona/Hydrochloride of proguanil Viatris

6. Contents of the pack and additional information

Atovacuona/Hidrocloruro de proguanilViatrisbelongs to a group of medicines called antimalarials. It contains two active ingredients: atovacuona and hydrochloride of proguanil.

Atovacuona/Hidrocloruro de proguanilViatrisis used for the following:

• Preventing malaria
• Treating malaria

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

Protect yourself from contracting malaria

Anyone, regardless of age, can contract malaria or paludismo. It is a serious disease, but it is preventable.

Even when taking atovacuona/hydrochloride of proguanil, it is very important to take precautions to avoid mosquito bites.

• 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 more active.
• Sleep in a mosquito-protected room or under a mosquito net treated with insecticide.
• Close windows and doors in the evening, if they are not protected.
• Consider using an insecticide(pill, 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 possible to contract malaria. Some types of malaria infection can take a long time to cause symptoms; therefore, the disease may not begin 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.

Do not take Atovacuona/Hidrocloruro de proguanilViatris

• If you are allergic to atovacuona, hidrocloruro de proguanil, or any of the other components of this medication (listed in section 6).
• To prevent malaria, if you have a severe kidney disease.

Inform your doctor if any of these apply to you.

Warnings and precautions

Consult your doctor or pharmacistbefore using the Atovacuona/Hidrocloruro de proguanil Viatris treatment:

Children

Atovacuona/Hidrocloruro de proguanil Viatris 250 mg/100 mg is not recommended for children weighing less than 11 kg. There may be another atovacuona/proguanil tablet dose that is more suitable for children weighing less than 11 kg.

Other medications and Atovacuona/Hidrocloruro de proguanilViatris

Inform your doctor or pharmacist about any other medications you are taking, have recently taken, or may need to take.

Some medications may affect howatovacuona/hidrocloruro de proguanilfunctions or, atovacuona/hidrocloruro de proguanil may enhance or reduce the effectiveness of other medications taken at the same time.

The following medications are involved:

• Metoclopramida, for the treatment of nausea and vomiting.
• The following antibiotics: tetraciclina, rifampicina, and rifabutina.
• Efavirenz or certain very active protease inhibitorsfor HIV treatment.
• Warfarina and other anticoagulant medications.
• Etopósido, used in cancer treatment.

Consult your doctorif you are taking any of these medications. Your doctor may decide that atovacuona/hidrocloruro de proguanil is not suitable for you or that additional checks are needed while taking it.

Remember to consult your doctor if you start taking other medications during your atovacuona/hidrocloruro de proguanil treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not takeatovacuona/hidrocloruro de proguanil during pregnancy,unless your doctor recommends it.

You should not breastfeed while taking atovacuona/hidrocloruro de proguanil, as its components may pass into breast milk and harm your baby.

Driving and operating machinery

Do not drive if you feel dizzy.

Atovacuona/hidrocloruro de proguanil may cause dizziness in some people. If this happens, do not drive, operate machinery, or participate in activities that may put you or others at risk.

This medicationcontains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

For malaria prevention:

The recommended dose for adults and children weighing more than 40 kg is 1 tablet per day, taken as indicated below. Atovacuona/hidrocloruro de proguanil is not recommended for malaria prevention in children, nor in adults or adolescents weighing less than 40 kg. There may be various types of tablets marketed in your country to prevent malaria in children and adults weighing less than 40 kg.

• Start taking atovacuona/hidrocloruro de proguanil 1 or 2 days before traveling to a malaria-endemic area.
• Continue taking it every day during the trip.
• Continue taking it for another 7 days once you have returned to a non-malaria area.

For malaria treatment:

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

For childrenweighing 11 kg or more, the dose will depend 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

More than 40 kg – same dose as for adults

Not recommended for malaria treatment in children weighing less than 11 kg.

For children weighing less than 11 kg, consult your doctor. There may be other types of tablets available in your country, with a lower content of atovacuona and hidrocloruro de proguanil.

Administration method

For oral use.

Take this medication with food or a drink containing milk whenever possible.

Take this medication every day at the same time.

If you are sick (vomiting):

Malaria prevention

• If you vomit within the first hour after taking atovacuona/hidrocloruro de proguanil, take another dose quickly.
• It is essential to complete the atovacuona/hidrocloruro de proguanil treatment. If you need to take additional doses 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 atovacuona/hidrocloruro de proguanil absorbed has been reduced, it may not be as effective.

Malaria treatment:

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

If you take more Atovacuona/Hidrocloruro de proguanil Viatristhan you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Atovacuona/Hidrocloruro de proguanil Viatris

It is essential to complete the atovacuona/hidrocloruro de proguanil treatment.

If you forget to take a dose, do not worry. Simply take your next dose as soon as you remember. Then, continue your treatment normally. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Atovacuona/Hidrocloruro de proguanil Viatris

Do not stop taking atovacuona/hidrocloruro de proguanil without consulting your doctor.

Continue taking atovacuona/hidrocloruro de proguanil for the 7 days after returning to a non-malaria area. Take the complete treatment of Atovacuona/Hidrocloruro de proguanil Viatris to obtain maximum protection. If you interrupt the treatment prematurely, you will be at risk of contracting 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Be aware of the following severe reactions. They have been observed in a reduced number of people, although their exact frequency is unknown.

Severe allergic reactions– the signs are as follows:

• 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 experience any of these symptoms, contact a doctor immediately and stop taking Atovacuona/Hydrochloride Proguanil Viatris.

Severe skin reactions

• Severe skin rash that may present with blisters with a small, dark center surrounded by lighter areas with a dark ring around the edge (erythema multiforme).
• Severe widespread skin rash with blisters and skin peeling, especially around the mouth, nose, and genitals (Stevens-Johnson syndrome).

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

Most other reported side effects have been mild and did not last long.

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

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

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

• Dizziness.
• Difficulty sleeping (insomnia).
• Strange dreams.
• Depression.
• Loss of appetite.
• Fever.
• Rash that may itch.
• Cough.

Common side effects that may be discovered in blood tests:

• Decreased red blood cell count (anemia) that may cause fatigue, headache, and difficulty breathing.
• Decreased white blood cell count (neutropenia) that makes you more prone to infections.
• Low sodium concentration in the blood (hyponatremia).
• Increased liver enzymes.

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

• Anxiety.
• Unusual perception of an irregular heartbeat (palpitations).
• Inflammation and redness of the mouth.
• Hair loss.

Uncommon side effects that may be discovered in blood tests:

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

Rare side effects (may affect up to 1 in 1,000 people):

• To see or hear things that do not exist (hallucinations).

Unknown frequency (cannot be estimated from available data)

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

• Liver inflammation (hepatitis).
• Bile duct obstruction (cholestasis).
• Increased heart rate (tachycardia).
• Inflammation of blood vessels (vasculitis) that may be visible as red or purple spots with some elevation on the skin, although it may affect other parts of the body.
• Seizures.
• Panic attacks, crying.
• Nightmares.
• Severe mental disorder that leads to the person losing contact with reality and being unable to think or judge clearly.
• Mouth ulcers.
• Blisters.
• Skin peeling.
• Increased skin sensitivity to sunlight.

Other side effects that may appear in blood tests:

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Only for laminated PVC-aluminum blister pack: Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Atovacuona/Hydrochloride of Proguanil Viatris

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

The other components are:

Core tablet: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), iron oxide red (E172), iron oxide black (E172) and iron oxide yellow (E172).

Appearance of the product and contents of the package

Beige-colored, 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 containing 12, 24, 30, 36, 48 tablets or 12, 24, 30, 36, 48 single-dose perforated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

GermanyMalarex 250mg/100mgFilmtabletten

BelgiumAtovaquone/Proguanil Mylan 250 mg/100mg Filmomhulde tabletten

DenmarkProvaqomyl

SpainAtovacuona/Hidrocloruro de proguanil Viatris 250mg/100mg comprimidos recubiertos con película EFG

FranceAtovaquone/Proguanil MYLAN, 250 mg/100mg, comprimé pelliculé

IrelandAtovaquone/Proguanil hydrochloride 250 mg/100mgfilm-coated tablets

ItalyAtovaquone e Proguanile Mylan Generics

NorwayProvaqomyl

NetherlandsAtovaquon/Proguanil HCl Mylan 250/100 mg, filmomhulde tabletten

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

SwedenProvaqomyl

Last review date of this leaflet:August 2017

Further detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/