Atovacuone Glenmark 750 mg/5 ml oral suspension EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atovacuone Glenmark 750 mg/5 ml oral suspension EFG

Read the entire package leaflet carefully before you start taking this medicine, as 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 only for you; do not give it to others, even if they have the same symptoms as you, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What Atovacuone Glenmark is and what it is used for
2. What you need to know before taking Atovacuone Glenmark
3. How to take Atovacuone Glenmark
4. Possible adverse effects
5. How to store Atovacuone Glenmark
6. Contents of the pack and other information

1. What Atovacuona Glenmark is and what it is 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 (which used to be known as Pneumocystis carinii).

The active substance is atovaquone. Atovacuona Glenmark belongs to a group of antiparasitic medicines known as antiprotozoals.

2. What you need to know before taking Atovacuone Glenmark

Do not take Atovacuone Glenmark

• if you are allergic to atovaquone or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Atovacuone Glenmark.

Take special care with Atovacuone Glenmark

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

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

Tell your doctor if any of these apply to you. Your doctor may decide that Atovacuone Glenmark is not suitable for you or that you need additional monitoring while taking it.

Other medicines and Atovacuone Glenmark

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal remedies or other medicines obtained without a prescription.

Some medicines may reduce the effectiveness of Atovacuone Glenmark, or Atovacuone Glenmark itself may alter the effect of other medicines 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 doctor if you are taking any of these medicines. Your doctor may decide that atovaquone is not suitable for you, or that you need additional monitoring while taking it.

Remember to tell your doctor if you start taking any other medicines during treatment with Atovacuone Glenmark.

Taking Atovacuone Glenmark with food and drink

Always take Atovacuone Glenmark with food – preferably with fatty meals. This increases the amount of Atovacuone Glenmark absorbed by your body and makes your treatment more effective.

Ask your doctor which foods are suitable.

If you have difficulty taking Atovacuone Glenmark with food, speak to your doctor to consider whether alternative treatment may be appropriate.

Pregnancy, breast-feeding and fertility

• If you are pregnant, do not take Atovacuone Glenmark unless your doctor recommends it. If you become pregnant while taking Atovacuone Glenmark, consult your doctor on whether you should continue treatment. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
• Do not breast-feed while taking Atovacuone Glenmark. It is not known whether Atovacuone Glenmark passes into breast milk; if it does, it may harm your baby.

Driving and using machines

Your ability to drive or operate machinery is not expected to be affected while taking Atovacuone Glenmark.

Atovacuone Glenmark contains benzyl alcohol

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

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems (“gasping syndrome”), in children. Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor has specifically recommended it.

This medicine should not be used for longer than one week in young children (under 3 years of age) unless directed by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breast-feeding, or if you 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”).

Atovacuone Glenmark contains sodium

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

3. How to take Atovaquone Glenmark

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

Shake the bottle well before use.

Do not dilute Atovaquone Glenmark.

Always take Atovaquone Glenmark with food – preferably with fatty foods. This will increase the amount of Atovaquone Glenmark absorbed and make your treatment more effective.

How much to take

The recommended dose of Atovaquone Glenmark in adults is one 5 ml spoonful (containing 750 mg of atovaquone), twice daily for 21 days.

Take one dose in the morning and another in the afternoon or evening.

If you take more Atovaquone Glenmark than you should

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Atovaquone Glenmark

If you forget to take a dose of Atovaquone Glenmark, take it as soon as you remember (with food), and then continue your treatment as before. Do not take a double dose to make up for a missed dose.

If you stop taking Atovaquone Glenmark

Do not stop treatment with Atovaquone Glenmark without medical supervision.

Take Atovaquone Glenmark for the length of time recommended 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 course of treatment, the infection may return.

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 experiences them.

Very common adverse effects

May affect more than 1 in 10 people:

• nausea
• rash
• itching

Common adverse 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, tightness in the chest or throat, difficulty breathing
  • swelling of the eyelids, face, lips, tongue, or other parts of the body
  • hives (urticaria)

Other common adverse effects that may be detected in blood tests include:

• low levels of sodium in the blood (hyponatremia)
• increased levels of liver enzymes
• reduced number of red blood cells in the blood (anemia), which may cause fatigue, headaches, and difficulty breathing
• decreased number of certain types of white blood cells in the blood (neutropenia)

Uncommon adverse effects

May affect up to 1 in 100 people:

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

Other adverse effects

Other adverse effects have been reported in a very small number of people, with frequency not known:

• skin rash, which may blister and appear as target-like spots (a dark center surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• widespread rash with blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens–Johnson syndrome)

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

Reporting of adverse effects

If you experience any type of 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: http://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atovaquone Glenmark

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

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

This medicine does not require special storage temperature conditions. Do not refrigerate or freeze.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the Sigre Point located at the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atovaquone Glenmark

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

Appearance of the product and contents of the pack

Atovaquone Glenmark oral suspension is a yellow liquid. The medicine is supplied in a plastic bottle with a child-resistant cap, containing 226 ml of oral suspension. Each pack includes a 5 ml dosing 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

Further information on this medicine can be requested from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicine is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: February 2022.

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