Atovaquone/proguanil hydrochloride Viatris 250 mg/100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atovaquone/Proguanil hydrochloride Viatris 250 mg/100 mg film-coated tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Atovastone/Hydrochloride Proguanil Viatris is used for the following:

• To prevent malaria
• To treat malaria

Malaria is transmitted through the bite of an infected mosquito, which introduces the malaria parasite (Plasmodium falciparum) into the bloodstream. Atovaquone/proguanil hydrochloride prevents malaria by killing this parasite. In people who are already infected and have malaria, atovaquone/proguanil hydrochloride also kills these parasites.

Protect yourself from getting malaria

Anyone, of any age, can contract malaria. It is a serious illness, but it is preventable.

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

• Use mosquito repellent on all exposed areas of skin.
• 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 room protected against mosquitoes or under an insecticide-impregnated mosquito net.
• Close windows and doors in the evening if they are not protected.
• Consider using an insecticide (tablet, spray, electric device) to clear the room of insects or prevent them from entering.

If you need any clarification, speak with your doctor or pharmacist.

Even when taking all necessary precautions, it is still possible to contract malaria. Some types of malaria infection may take a long time to produce symptoms; therefore, the illness may not start until several days, weeks, or even months after returning from travel. Seek medical advice immediately if you experience symptoms such as fever, headache, chills, or fatigue after returning from abroad.

2. What you need to know before taking Atovaquone/Proguanil Hydrochloride Viatris

Do not take Atovaquone/Proguanil Hydrochloride Viatris

• If you are allergic to atovaquone, proguanil hydrochloride, or to 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 apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before using Atovaquone/Proguanil Hydrochloride Viatris:

Children

The use of Atovaquone/Proguanil Hydrochloride Viatris 250 mg/100 mg is not recommended in children weighing less than 11 kg. There may be another dosage strength of atovaquone/proguanil tablets more suitable for children weighing less than 11 kg.

Other medicines and Atovaquone/Proguanil Hydrochloride Viatris

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

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

These medicines include:

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

Talk to your doctor if you are taking any of these medicines. Your doctor may decide that atovaquone/proguanil hydrochloride is not suitable for you or that you need additional monitoring while taking it.

Remember to consult your doctor if you start taking any other medicines during your treatment with atovaquone/proguanil hydrochloride.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take atovaquone/proguanil hydrochloride during pregnancy unless your doctor specifically recommends it.

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

Driving and using machines

If you feel dizzy, do not drive.

Atovaquone/proguanil hydrochloride may cause dizziness in some people. If this occurs, do not drive, operate machinery, or engage in activities that could put you or others at risk.

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, talk to him or her before taking this medicine.

3. How to take Atovaquone/Proguanil Hydrochloride Viatris

Follow exactly the instructions for taking this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

For preventing malaria:

The recommended dose for adults and children weighing more than 40 kg is 1 tablet daily, taken as described below. Atovaquone/proguanil hydrochloride is not recommended for preventing malaria in children, or in adults or adolescents weighing less than 40 kg. There may be different types of tablets available in your country for preventing malaria in children and adults weighing less than 40 kg.

• Start taking atovaquone/proguanil hydrochloride 1 or 2 days before travelling to a malaria-risk area.
• Continue taking it every day during your trip.
• Keep taking it for another 7 days after returning to a malaria-free area.

For treating 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 – 1 tablet once daily for 3 days
21–30 kg – 2 tablets once daily for 3 days
31–40 kg – 3 tablets once daily for 3 days
Over 40 kg – same dose as adults

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

For children weighing less than 11 kg, consult your doctor. There may be different types of paediatric tablets available in your country with lower amounts of atovaquone and proguanil hydrochloride.

Method of administration

For oral use.

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

Take this medicine at the same time each day.

If you are sick (vomiting):

Malaria prevention

• If you vomit within 1 hour after taking atovaquone/proguanil hydrochloride, take another dose immediately.
• It is important to complete the full course of atovaquone/proguanil hydrochloride. If you need to take additional doses due to vomiting, you may require another prescription.
• If you have been vomiting, it is especially important to use additional protective measures such as insect repellent and mosquito nets. Since the amount of atovaquone/proguanil hydrochloride absorbed may be reduced, the medicine may be less effective.

For treatment of malaria:

• If you have been vomiting and have diarrhoea, consult your doctor. You will need regular blood tests. Since the amount of atovaquone/proguanil hydrochloride absorbed may be reduced, the treatment may be less effective. Blood tests will check whether the malaria parasite has been eliminated from your blood.

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Atovaquone/Proguanil Hydrochloride Viatris

It is important that you complete the full course of atovaquone/proguanil hydrochloride.

If you miss a dose, do not worry. Simply 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 a missed dose.

If you stop taking Atovaquone/Proguanil Hydrochloride Viatris

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

Continue taking atovaquone/proguanil hydrochloride for 7 days after returning to a malaria-free area. Completing the full course of Atovaquone/Proguanil Hydrochloride Viatris is essential for maximum protection. If you stop treatment prematurely, you risk developing malaria, as 7 days of treatment are needed to ensure that all parasites that may be present in your blood following a mosquito bite are eliminated.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Be alert for the following serious reactions. These have been observed in a small number of people, although 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 these symptoms, contact a doctor immediately and stop taking Atovaquone/Proguanil Hydrochloride Viatris.

Severe skin reactions

• Skin rash which may present with blisters and resemble small targets (dark centers surrounded by paler areas with a dark ring around the edge) (erythema multiforme).
• Severe widespread rash with blistering and peeling of the skin, particularly around the mouth, nose, and genitals (Stevens-Johnson syndrome).

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

Most of the other reported adverse effects have been mild and short-lived.

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

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

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

• Dizziness.
• Sleep problems (insomnia).
• Strange dreams.
• Depression.
• Loss of appetite.
• Fever.
• Skin rash which may be itchy.
• Cough.

Common adverse effects that may be detected in your blood tests:

• Decrease in the number of red blood cells (anemia), which may cause tiredness, headache, and difficulty breathing.
• Decrease in the number of white blood cells (neutropenia), making you more susceptible to infections.
• Low sodium concentration in the blood (hyponatremia).
• Increase in liver enzymes.

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

• Anxiety.
• Unusual awareness of a fast or irregular heartbeat (palpitations).
• Inflammation and redness of the mouth.
• Hair loss.

Uncommon adverse effects that may be detected in your blood tests:

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

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

• Seeing or hearing things that are not real (hallucinations).

Frequency not known (cannot be estimated from available data)

Other adverse effects have been observed in a small number of people, but their 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 raised red or purple spots on the skin, although it may affect other parts of the body.
• Seizures.
• Panic attacks, crying spells.
• Nightmares.
• Severe mental disorder causing the person to lose touch with reality and become unable to think or judge clearly.
• Mouth ulcers.
• Blisters.
• Skin peeling.
• Increased sensitivity of the skin to sunlight.

Other adverse effects that may appear in blood tests:

• In people with severe renal impairment, reduction in all types of blood cells (pancytopenia).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atovaquone/Proguanil Hydrochloride Viatris

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from moisture.

For PVC-aluminum laminated blisters only: Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atovaquone/Proguanil hydrochloride Viatris

The active substances are atovaquone and proguanil hydrochloride. Each film-coated tablet contains 250 mg of atovaquone 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).

Appearance of the product and contents of the pack

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

The tablets are supplied in PVC-Aluminium, OPA/Aluminium/PVC-Aluminium, PVC/PVdC-Aluminium blisters containing 12, 24, 30, 36, 48 tablets or 12, 24, 30, 36, 48 unit-dose perforated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorised in the European Economic Area member states 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 comprimidos recubiertos con película 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 most recent review of this leaflet: August 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/