ATOVACUONA GLENMARK 750 MG/5 ML ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Atovacuona Glenmark 750 mg/5 ml Oral Suspension EFG

Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Atovacuona Glenmark and what is it used for
2. What you need to know before taking Atovacuona Glenmark
3. How to take Atovacuona Glenmark
4. Possible side effects
5. Storage of Atovacuona Glenmark
6. Package Contents and Additional Information

1. What is Atovacuona Glenmark and what is it used for

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

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

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

2. What you need to know before taking Atovacuona Glenmark

Do nottake 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 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.

Tell your doctor if this affects you. Your doctor may considerthat Atovacuona Glenmark is not suitable for youor that you need additional monitoring while taking it.

Other medications and Atovacuona Glenmark

Tell your doctor or pharmacist if you are taking, have recently takenor may need to takeany other medication,including any herbal remedies or other medications purchased without a prescription.

Some medications may reduce the effectiveness of Atovacuona Glenmark, or Atovacuona Glenmark itself may alter 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.

Tell your doctorif 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 tell your doctorif you start taking other medications during treatment with Atovacuona Glenmark.

Taking Atovacuona Glenmark with food and drinks

Always take Atovacuona Glenmark with food- preferably with foods that have a high fat content. This will increase the amount of Atovacuona Glenmark absorbed by your body 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 takeAtovacuona Glenmarkunless your doctor recommends it. If you become pregnantwhile taking Atovacuona Glenmark, ask your doctor if you should continue treatment. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
• Do not breastfeed while taking Atovacuona Glenmark. It is unknown if Atovacuona Glenmark passes into breast milk; if it does, it may harm your baby.

Driving and using machines

It is not expected that your ability to drive or use machinery will 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 serious side effects, including respiratory problems ("gasping syndrome") in children. Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor has recommended it.

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

Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side 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).

3. How to take Atovacuona Glenmark

Follow the administration instructions ofthis medicationindicated by your doctor or pharmacist exactly.If in doubt, consult your doctor or pharmacist again.

Shake the bottle well before use.

Do not dilute Atovacuona Glenmark.

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

How much to take

The recommended doseof Atovacuona Glenmark in adultsis one 5 ml spoonful (containing 750 mg of atovacuona), twice a day for 21 days.

Take one dose in the morning and another in the evening/night.

If you take more Atovacuona Glenmark than you should

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology 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 forgotten doses.

If you stop taking Atovacuona Glenmark

Do not stop taking Atovacuona Glenmark without supervision.

Take Atovacuona Glenmark for the recommended time. 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 this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Very common side effects

May affect more than 1 in 10 people:

• nausea
• rash
• itching

Common side effects

May affect up to 1 in 10 people:

• diarrhea
• vomiting
• headache
• sleep problems (insomnia)
• high temperature (fever)
• allergic reactions, sometimes 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
  • nettle rash (hives)

Other common side effects that may appear in blood tests are:

• low sodium levels in the blood (hyponatremia)
• increased liver enzyme levels
• 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 certain types of white blood cells in the blood (neutropenia)

Uncommon side effects

May affect up to 1 in 100 people:

• increased amylase levels (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 a frequency not known:

• skin rash, which can form blisters that look like small targets (central dark spot surrounded by a paler 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: http://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Atovacuona Glenmark

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

Do not use this medication after the expiration date stated on the bottle label. Once opened, it must be used within 21 days.

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

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Atovacuona Glenmark

• Each 5 ml spoonful of Atovacuona Glenmark suspension contains 750 mg of the active ingredient, atovacuona (1 ml of Atovacuona Glenmark contains 150 mg of atovacuona).
• The other ingredients 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 package contents

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

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

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:

Glenmark 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 under the following names:

Date of the last revision of this package leaflet:February 2022.

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