Package Insert: Information for the User

Atovacuona Glenmark 750 mg/5 ml Oral Suspension EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you should 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,consultyour doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Atovacuona Glenmark is used to treat a lung infection called Pneumocystis pneumonia (PCP) in people who cannot take cotrimoxazol.

This disease is caused by an organism called Pneumocystis jiroveci (which was previously known as Pneumocystis carinii).

The active ingredient is atovacuona.Atovacuona Glenmark belongs to a group of antiparasitic medications known as antiprotozoal agents.

Do not take Atovacuona Glenmark

• if you are allergic to atovacuona or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atovacuona Glenmark.

Be especially careful with Atovacuona Glenmark

Before you start taking Atovacuona Glenmark, your doctor needs to know:

• if you have any kidney or liver disease
• if you have diarrhea, especially when starting treatment. Diarrhea reduces the body's absorption of Atovacuona Glenmark, so the treatment may not be effective
• if you are over 65 years old.

Inform your doctor if this affects you. Your doctor may consider that Atovacuona Glenmark is not suitable for you or that you need additional monitoring while taking it.

Other medications and Atovacuona Glenmark

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, including any herbal medication or other medications obtained without a prescription.

Some medications may reduce the effectiveness of Atovacuona Glenmark, or Atovacuona Glenmark itself may modify the effect of other medications taken at the same time. These include:

•the antibiotics rifampicin and rifabutin

•the antibiotic tetracycline

•metoclopramide used to treat nausea and vomiting

•indinavir, zidovudine or didanosine, used to treat HIV

•efavirenz or certain highly active protease inhibitors used to treat HIV

•etoposide used to treat cancer.

Inform your doctor if you are taking any of these medications.Your doctor may consider that atovacuona is not suitable for you, or that you need additional monitoring while taking it.

Remember to inform your doctor if you start taking other medications during treatment with Atovacuona Glenmark.

Taking Atovacuona Glenmark with food and drinks

Take Atovacuona Glenmark always with food - preferably with foods that have a high fat content. This will increase the amount of Atovacuona Glenmark that your body absorbs and make your treatment more effective.

Consult your doctor about which foods are suitable.

If you have difficulty taking Atovacuona Glenmark with food, talk to your doctor to assess the possibility of administering another treatment.

Pregnancy, breastfeeding and fertility

• If you are pregnant, do not take Atovacuona Glenmark unless your doctor recommends it.If you become pregnant while taking Atovacuona Glenmark, ask your doctor for advice on whether to continue treatment.If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.
• Do not breastfeed while taking Atovacuona Glenmark.It is unknown whether Atovacuona Glenmark passes into breast milk; if it does, it may harm your baby.

Driving and using machines

Your ability to drive or use machinery is not expected to be affected while taking Atovacuona Glenmark.

Atovacuona Glenmark contains benzyl alcohol

This medication contains 50.00 mg of benzyl alcohol in each 5 ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked to the risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children. Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor recommends it.

This medication should not be used for more than a week in young children (under 3 years old) unless your doctor or pharmacist advises it.

Consult your doctor or pharmacist if you are pregnant or breastfeeding or have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (called "metabolic acidosis").

Atovacuona Glenmark contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 5 ml; this is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.Consult your doctor or pharmacist again if you are unsure.

Shake the bottle well before use.

Do not diluteAtovacuona Glenmark.

Take Atovacuona Glenmark always with food - preferably with foods that have a high amount of fat.This will increase the amount ofAtovacuona Glenmark absorbed,and make your treatment more effective.

How much to take

The recommended doseof Atovacuona Glenmark inadultsis a 5 ml spoonful (which contains 750 mg of atovacuona), taken twice a day for 21 days.

Take one dose in the morning and another at night.

If you take more Atovacuona Glenmark than you should

Contact your doctor or pharmacist for advice. If possible, show them the Atovacuona Glenmark packaging.

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 Glenmark

If you forget to take a dose of Atovacuona Glenmark, take the next one as soon as you remember (with food) and continue treatment as before. Do not take a double dose to make up for the missed ones.

If you interrupt the treatment with Atovacuona Glenmark

Do not stop taking Atovacuona Glenmark without supervision.

Take Atovacuona Glenmark for the recommended time by your doctor.Do not stop taking it unless your doctor tells you to - even if you feel better. If you do not complete the full treatment, the infection may recur.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

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

Very common side effects

May affect more than 1 in 10people:

• nausea
• skin rash
• itching

Common side effects

May affect up to 1 in 10people:

• diarrhea
• vomiting
• headache
• sleep problems (insomnia)
• high temperature (fever)
• allergic reactions, which can be severe. These include the following symptoms:
• • sudden wheezing, chest or throat tightness, difficulty breathing
  • swelling of eyelids, face, lips, tongue, or other parts of the body
  • hives (urticaria)

Other common side effects, which may appear in blood tests are:

• low levels of sodium in the blood (hyponatremia)
• increased levels of liver enzymes
• reduction in the number of red blood cells in the blood (anemia), which can cause fatigue, headaches, and difficulty breathing
• decrease in the number of some types of white blood cells in the blood (neutropenia)

Rare side effects

May affect up to 1 in 100people:

• increased levels of amylase (digestive enzyme produced by the pancreas) in blood tests.

Other side effects

Other side effects have been reported in a very small number of people, with unknown frequency:

• skin rash, which can form blisters that look like small targets (central dark spot surrounded by a lighter area, with a dark ring around the edge), (erythema multiforme)
• widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).

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

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 Pharmacovigilance of Medicines for Human Use: http://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 label of the bottle. Once opened, it must be used within 21 days.

This medication does not require any special storage temperature. Do not refrigerate or freeze.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the Pharmacy Take-Back Point. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

Composition of Atovacuona Glenmark

• Each 5 ml of Atovacuona Glenmark suspension contains 750 mg of active ingredient, atovaquone (1 ml of Atovacuona Glenmark contains 150 mg of atovaquone).
• The other components are benzyl alcohol, xanthan gum, poloxamer 188, sodium saccharin, hypromellose, purified water, tutti frutti flavor (containing flavoring substances, corn maltodextrin, propylene glycol, and alpha-tocopherol), citric acid monohydrate, sodium citrate trihydrate.

Appearance of the product and contents of the package

Atovacuona Glenmark oral suspension is a yellow liquid. The medication is supplied in a plastic bottle with a child-resistant safety cap, containing 226 ml of oral suspension. Each package includes a 5 ml dosing spoon.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the Marketing Authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31, Gröbenzell

Germany

Responsible for manufacturing:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoke Myto

Czech Republic

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

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7th Floor

28045 Madrid

Spain

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

Last review date of this leaflet:February 2022.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).