WELLVONE 750mg/5ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Wellvone 750 mg/5 ml Oral Suspension

Atovaquone

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Wellvone and what is it used for
2. What you need to know before you take Wellvone
3. How to take Wellvone
4. Possible side effects
5. Storage of Wellvone
6. Contents of the pack and other information

1. What is Wellvone and what is it used for

Wellvone is used to treat a lung infection called Pneumocystis jiroveci pneumonia (PCP) in people who cannot take cotrimoxazole (a combination of trimethoprim and sulfamethoxazole).

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

The active substance in Wellvone is atovaquone. Wellvone belongs to a group of medicines called antiprotozoals.

2. What you need to know before you take Wellvone

Do not take Wellvone

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

Consult your doctor or pharmacist before taking Wellvone.

Be careful with Wellvone

Before you start taking Wellvone, your doctor needs to know:

• if you have any kidney or liver disease
• if you have diarrhea, especially when starting treatment. Diarrhea reduces the absorption of Wellvone, 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 Wellvone is not suitable for you, or that you need extra checks while you are taking it.

Pregnancy, breast-feeding and fertility

• If you are pregnant, do not take Wellvoneunless your doctor advises you to. If you become pregnant while taking Wellvone, ask your doctor for advice on whether to continue treatment.Consult your doctor or pharmacist before taking this medicine during pregnancy.
• Do not breast-feed while taking Wellvone.It is not known whether Wellvone passes into breast milk; if it does, it may harm the baby.

Other medicines and Wellvone

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

Some medicines may reducethe effectiveness of Wellvone or Wellvone itself may alter the effect of other medicines taken at the same time. These include:

• the antibiotics rifampicinand rifabutin
• the antibiotic tetracycline
• metoclopramideused to treat nausea and vomiting
• indinavir, zidovudineor didanosine, used to treat HIV
• efavirenz or certain highly active protease inhibitorsused to treat HIV
• etoposideused to treat cancer.

Tell your doctor if you are taking any of these substances. Your doctor may decide that Wellvone is not suitable for you, or that you need extra checks while you are taking it.

Remember to tell your doctor if you start taking other medicines during treatment with Wellvone.

Taking Wellvone with food and drinks

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

Consult your doctor about which foods are suitable.

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

Driving and using machines

It is not expected that your ability to drive or use machines will be affected while taking Wellvone.

Wellvone contains benzyl alcohol

This medicine contains 50.66 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 give this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

This medicine should not be used for more than one week in children under 3 years of age unless indicated 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 can accumulate in your body and cause side effects (metabolic acidosis).

Wellvone contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml; i.e., it is essentially "sodium-free".

3. How to take Wellvone

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

Shake the bottle well before use.

Do not dilute Wellvone.

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

How much to take

The recommended doseof Wellvone in adultsis one 5 ml spoonful (containing 750 mg of atovaquone), twice a day for 21 days. Use the 5 ml spoon included. Wash the spoon with clean water after taking each dose.

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

If you take more Wellvone than you should

Contact your doctor or pharmacist for advice or call the Toxicology Information Service, phone 91 562 04 20. If possible, show them the Wellvone packaging.

If you forget to take Wellvone

If you forget to take a dose of Wellvone, 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 Wellvone

Take Wellvone 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 treatment duration, the infection may recur.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• nausea
• rash
• itching.

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

• 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
• hives (urticaria).

Other common side effects that may appear in blood testsare:

• 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 tiredness, headaches, and difficulty breathing
• decrease in the number of some types of white blood cells in the blood (neutropenia).

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

• 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 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Wellvone

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, the suspension can be stored for a maximum of 21 days.

Do not store above 25°C. Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Wellvone

Each 5 ml spoonful of Wellvone suspension contains 750 mg of active substance, atovaquone (1 ml of Wellvone contains 150 mg of atovaquone). The other ingredients are benzyl alcohol (E1519), xanthan gum, poloxamer 188, sodium saccharin, purified water, and tutti-frutti flavor (sweet orange oil, concentrated orange oil, propylene glycol (E1520), benzyl alcohol (E1519), vanillin, acetic aldehyde, amyl acetate, and ethyl butyrate). For more information on benzyl alcohol and sodium in Wellvone, see section 2.

If you think you may be allergic to any of these ingredients:

Tell your doctor and do not take Wellvone

Appearance of the product and pack contents

Wellvone is a yellow oral suspension. The medicine is supplied in a 240 ml plastic bottle with a child-resistant cap and contains 226 ml of oral suspension. Each pack includes a 5 ml dosing spoon.

Marketing authorization holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Date of last revision of this leaflet:July 2023

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