Leaflet: information for the user

Wellvone 750 mg/5 ml oral suspension

atovacuona

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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,evenifthey are not listed in this leaflet. See section 4.

1. What isWellvoneand what it is used for

2. What you need to knowbeforestarting totakeWellvone

3. How to takeWellvone

4. Possible side effects

5. Storage ofWellvone

6. Contents of the pack and additional information

Wellvone is used to treat a lung infection called Pneumocystis pneumonia (PCP) in people who cannot take cotrimoxazol (a combination of trimetroprim and sulfametoxazol).

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

The active ingredient of Wellvone is atovacuona. Wellvone belongs to a group of antiparasitic medications known as antiprotozoarios.

Do not take Wellvone

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

Consult your doctor or pharmacist beforestarting to take Wellvone.

Be especially careful with Wellvone

Your doctor needs to know before you start taking Wellvone:

• if you have anyrenal or hepatic disease
• if you havediarrheaespecially when starting treatment. Diarrhea reduces the body's absorption of Wellvone, so treatment may not be effective
• if you are over 65 years old.

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

Pregnancy, breastfeeding and fertility

• If you are pregnant, do not takeWellvoneunless your doctor recommends it.If you become pregnantwhile taking Wellvone, ask your doctorif you should continue with treatment.Consult your doctor or pharmacistbefore taking this medication during pregnancy.
• Do not breastfeed while taking Wellvone.It is not known if Wellvone passes into breast milk; if it does, it may harm the baby.

Other medications and Wellvone

Inform your doctor or pharmacist if you are taking, have taken recentlyor may need to takeany other medication,including any medicationbased on plantsor other medications acquired without a prescription.

Some medications mayreducethe effectiveness of Wellvone or Wellvone may modify the effect of other medications taken at the same time. These include:

• theantibiotics rifampicinandrifabutin
• theantibiotic tetracycline
• metoclopramideused to treatnauseaandvomiting
• indinavir, zidovudineordidanosine,used to treatHIV
• efavirenz or certain highly active protease inhibitorsused to treat HIV
• etoposideused to treat cancer.

Inform your doctorif you are taking any of these substances.Your doctor may considerthat Wellvone is not suitable for you, or that you need additional monitoring while taking it.

Remember to inform your doctorif you start taking other medications during treatment withWellvone.

Wellvone with food and drinks

Always take Wellvone with food -preferably withfoodsthat have a high fat content. This will increase the amount ofWellvonethat your body absorbs and make your treatment more effective.

Consult with your doctor which foods are suitable.

If you have difficulty taking Wellvonewith food, talk to your doctor to evaluate the possibility of administering another treatment.

Driving and using machines

Your abilityto drive or use machinery is not expected to be affected while taking Wellvone.

Wellvone contains benzyl alcohol

This medication contains 50.66 mg of benzyl alcohol in each 5 ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with 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 children under 3 years old unless your doctor or pharmacist advises 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 may accumulate in your body and cause adverse effects (metabolic acidosis).

Wellvone 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 dilute Wellvone.

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

How much to take

The recommended dose of Wellvone in adults is one 5 ml spoonful (containing 750 mg of atovacuona), taken twice a day for 21 days. Use the 5 ml spoon provided. Wash the spoon with clean water after taking each dose.

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

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 the missed doses.

If you interrupt treatment with Wellvone

Take Wellvone for the recommended time as advised 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 other questions about the use of this medication, ask your doctor or pharmacist.

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

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

• nausea
• skin rash
• itching.

Common side effects(may affectup 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 that may appear in blood tests are:

• low sodium levels 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).

Uncommon side effects(may affect up to1 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 the Pharmacovigilance of Medicines for Human Use: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 usethis medicationafter the expiration date that appears on the labelof the bottle. Once opened, the suspension may be stored for a maximum of 21 days.

Do not store at a temperature above 25°C.Do not freeze.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications.By doing so, you will help protect the environment.

Composition of Wellvone

Each 5 ml spoonful of Wellvone suspension contains 750 mg of active ingredient, atovacuone (1 ml of Wellvone contains 150 mg of atovacuone). The other components are benzyl alcohol (E1519), xanthan gum, poloxamer 188, sodium saccharin, purified water and tutti frutti aroma (sweet orange oil, concentrated orange oil, propylene glycol (E1520), benzyl alcohol (E1519), vanilla, 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 contents of the packaging

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

Holder of the marketing authorization:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible for manufacturing:

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublín 24

Irlanda

Date of the last review of this leaflet:July 2023

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