150 mg/ml oral suspension
atovaquone
What Wellvone is and what it is used for
Wellvone is used to treat a type of lung inflammation called Pneumocystis pneumonia (PCP) in people who cannot take the medicine co-trimoxazole.
This disease is caused by an organism called Pneumocystis jiroveci (which used to be called Pneumocystis carinii ).
The active substance in Wellvone is atovaquone. Wellvone belongs to a group of medicines used against a type of parasite called protozoa.
The atovaquone contained in Wellvone may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Wellvone
Do not take Wellvone
- if you are allergic to atovaquone or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor or pharmacist before taking Wellvone.
Be especially careful with Wellvone
Before you take Wellvone, your doctor needs to know
- if you have kidney or liver disease
- if you have diarrhea, especially when you start treatment. Diarrhea reduces the amount of Wellvone absorbed by the body, which can make the treatment less effective.
- if you are over 65 years of age.
Tell your doctor if any of these apply to you. The doctor can decide if Wellvone is not suitable for you or if you need extra checks while you are taking it.
Pregnancy, breastfeeding, and fertility
- Do not take Wellvone if you are pregnant unless your doctor recommends it. If you become pregnant while taking Wellvone, consult your doctor about continuing treatment. Consult a doctor or pharmacist before taking this medicine during pregnancy.
- Do not breastfeed during treatment with Wellvone. It is not known whether Wellvone passes into breast milk. If this were to happen, it could harm your child.
Other medicines and Wellvone
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines, herbal medicines, herbal medicines, or other natural products.
Some medicines can reduce the effect of Wellvone, and Wellvone can change the effect of other medicines taken at the same time. These include:
- rifampicin and rifabutin ( antibiotics )
- tetracycline ( antibiotic )
- metoclopramide used to treat nausea and vomiting
- indinavir, zidovudine, or didanosine used to treat HIV
- efavirenz or certain highly active protease inhibitors used in the treatment of HIV
- etoposide is used in the treatment of cancer.
Tell your doctor if you are taking any of these medicines. The doctor can decide if Wellvone is unsuitable for you or if you need extra checks while you are taking it.
Remember to tell your doctor if you start taking any other medicine while using Wellvone.
Wellvone with food and drink
Always take Wellvone with food – preferably food with high-fat content. This will increase the absorption of Wellvone in the body and make your treatment more effective. Consult a doctor about suitable food.
If you have difficulty taking Wellvone with food, talk to your doctor about alternative treatments.
Driving ability and use of machinery
Your ability to drive or use machines is not expected to be affected while you are taking Wellvone.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Wellvone contains benzyl alcohol and sodium
Wellvone contains benzyl alcohol
This medicine contains 50.66 mg of benzyl alcohol per 5 ml.
Benzyl alcohol can cause allergic reactions.
Benzyl alcohol is associated with the risk of serious side effects such as breathing difficulties in young children. Do not give the medicine to newborns (up to 4 weeks of age) unless a doctor has prescribed it.
Do not use the medicine for more than 1 week in newborns (younger than 3 years) unless a doctor or pharmacist has recommended it.
If you are pregnant or breastfeeding, consult a doctor or pharmacist before using this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).
If you have impaired liver function or impaired kidney function, consult a doctor or pharmacist before using this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).
Wellvone contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, i.e. it is almost ‘sodium-free’.
How to take Wellvone
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Shake the bottle well before use.
Do not dilute Wellvone.
Always take Wellvone with food – preferably food with high-fat content. This significantly improves the absorption of Wellvone and makes your treatment more effective.
Dosage
The recommended dose of Wellvone for adults is one 5 ml scoop (containing 750 mg of atovaquone) 2 times daily for 21 days. Use the larger end (5 mL end) of the measuring spoon to measure out the indicated dose.
Take one dose in the morning and one dose in the evening.
If you have taken too much Wellvone
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. If possible, show the Wellvone packaging.
If you forget to take Wellvone
If you forget to take a dose of Wellvone, take the next dose as soon as you remember (again with food) and then continue your treatment as before.
Do not take a double dose to make up for a missed dose.
Do not stop taking Wellvone without consulting your doctor.
Take Wellvone for as long as the doctor has prescribed. Do not stop without a doctor’s prescription even if you feel better. If you do not complete the entire course of treatment, the infection may return.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects are
These may affect more than 1 in 10 users:
- nausea
- rash
- itching.
Common side effects are
These may affect up to 1 in 10 users:
- diarrhea
- vomiting
- headache
- difficulty sleeping (insomnia)
- fever
- allergic reactions, sometimes severe. Symptoms of allergic reactions include:
- sudden wheezing or wheezing, chest and throat tightness, or difficulty breathing ( bronchospasm )
- swelling of the eyelids, face, lips, tongue, or other parts of the body.
- hives ( urticaria ).
Other common side effects that can be detected in blood tests are:
- low sodium levels in the blood ( hyponatremia )
- elevations of liver enzymes
- reduced number of red blood cells (anemia), which can cause fatigue, headache, and shortness of breath
- reduced number of certain types of white blood cells ( neutropenia ).
Less common side effects are
These may affect up to 1 in 100 users:
- increase in amylase, which can be detected by a blood test (amylase is an enzyme produced in the pancreas).
Other side effects ar
Other side effects have occurred in a very small number of users but the exact frequency of side effects is unknown:
- skin rash (erythema multiforme) which may blister and look like small targets (dark spot in the center surrounded by a lighter field and a dark ring along the edge)
- widespread skin rash with blisters and peeling skin occurs especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ).
- If you notice any of these symptoms, contact your doctor immediately.
How to store Wellvone
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the bottle label after EXP. Opened packaging is stable for a maximum of 21 days.
Store at a maximum of 25 ºC. Do not freeze.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
Each dosing spoon with 5 ml of Wellvone suspension contains 750 mg of the active substance atovaquone (1 ml of Wellvone contains 150 mg of atovaquone). Other ingredients are benzyl alcohol, xanthan gum, poloxamer 188, saccharin sodium, purified water, tutti frutti flavor (orange oil, concentrated orange oil, propylene glycol, benzyl alcohol, vanillin, acetyl aldehyde, amyl acetate, and ethyl butyrate). See section 2 for additional information about benzyl alcohol and sodium in Wellvone.
If you think you may be allergic to any of these ingredients:
- Tell your doctor and do not take Wellvone.
Appearance and package sizes of the medicine
Wellvone oral suspension is a yellow liquid. The medicine is supplied in a 240 ml plastic bottle with a child-resistant cap, containing 226 ml of oral suspension. A double-sided measuring spoon (the larger end, the 5 ml end, must be used) is included in each package.
GlaxoSmithKline AB, Box 516, 169 29 Solna
Phone: 08-638 93 00
Email: info.produkt@gsk.com
Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk,
Citywest Business Campus
Dublin 24,
Ireland