50 mg/g and 10 mg/g cream
aciclovir and hydrocortisone
What Zoviduo is and what it is used for
Zoviduo contains two active substances: aciclovir and hydrocortisone. Aciclovir is an antiviral drug that helps fight the virus that causes cold sores. Hydrocortisone is a mild steroid that reduces inflammation that occurs when you have mouth ulcers.
Zoviduo cream is used to treat the early signs and symptoms (eg stinging, itching or redness ) of cold sores on the lips and the skin near the lips to reduce the risk of a cold sore developing into blisters in adults and adolescents (12 years and older).
Even if your mouth ulcer has developed into blisters, treatment with Zoviduo will shorten the healing process by about half to a day compared to treatment with cream without the active ingredients.
Cold sores are caused by a virus called herpes simplex. Virus et causes blisters and sores mainly on the lips but also other parts of the face. Mouth ulcers can break out when the body’s immune system is impaired, for example when you have a cold or other infection. Stress, strong sun, cold, or menstruation can also induce cold sores.
You must talk to your doctor if you do not feel better or if your symptoms persist 5 days after you have finished treatment.
What you need to know before using Zoviduo
Do not use Zoviduo
– if you are allergic to aciclovir, valaciclovir, hydrocortisone, or any other ingredient in this medicine (listed in section 6).
– in case of skin infections other than mouth ulcers
Warnings and precautions
Only use Zoviduo on cold sores on your lips and the skin near the lips.
Talk to your doctor if you suffer from severe recurrent mouth ulcers to make sure you are not suffering from any underlying disease.
Do not use Zoviduo:
– in the eye, inside the mouth or nose, or on the genitals.
– to treat genital herpes.
– if you have an immune system that does not work as it should (e.g. if you have had a bone marrow transplant or if you have HIV ) or if you have been diagnosed with a weakened immune system
– together with dressings such as plasters or special cold sore plasters
Wash your hands before and after using the cream to avoid worsening the mouth ulcer or spreading the infection to someone else.
Contact your doctor if you experience blurred vision or other visual disturbances.
Do not use it for longer than 5 days.
Children and young people
Do not give this medicine to children under 12 years of age, as it is not known if it works for them or if it is safe for them to use.
Other medicines and Zoviduo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
It has not been established whether the effect of Zoviduo can be affected by the simultaneous use of other medicines.
Zoviduo with food, drink, and alcohol
Do not apply the cream just before eating or drinking, as the cream can then be licked off.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
This medicine should not be used during pregnancy or breastfeeding unless your doctor believes that the benefits outweigh the unknown risks.
Driving ability and use of machinery
The use of Zoviduo does not affect your ability to drive or use machines.
Zoviduo contains propylene glycol and cetostearyl alcohol
This medicine contains 200 mg/g propylene glycol. Cetostearyl alcohol can cause local skin reactions (e.g. contact dermatitis).
Zoviduo contains sodium lauryl sulfate
This medicine contains 8mg/g of sodium lauryl sulfate.
Sodium lauryl sulfate may cause local skin reactions (stinging or burning) or increase skin reactions caused by other products used on the same skin surface.
How to use Zoviduo
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Intended for external use only.
Do not use more than the recommended dose.
Adults and children 12 years or older:
Apply the cream five times daily for 5 days (ie approximately every 3-4 hours during your waking hours). It is recommended that treatment be started as soon as possible, preferably at the first signs or symptoms (eg tingling, redness, itching ).
Do not use it for longer than 5 days. You must speak to a doctor if your symptoms persist for 5 days after the end of treatment.
Use
Wash your hands before and after using the cream to avoid worsening the mouth ulcer or infecting someone else.
To avoid the infection spreading to other parts of the body or your eyes, you should not touch any wounds that may have formed more than necessary.
If you use too much Zoviduo
If you accidentally use too much or accidentally swallow the cream, this is unlikely to cause any discomfort. If you have swallowed a large amount of cream, however, you should contact a doctor.
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 you have any further questions about this medicine, ask your doctor or pharmacist.
If you forget to use Zoviduo
If you forget to take a dose, apply the cream as soon as possible and continue the treatment as before.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using this medicine and contact your doctor immediately if you experience any of the following symptoms of an allergic reaction (very rare side effect: may affect up to 1 in 10,000 people):
– swelling of the face, tongue, or throat, which may result in difficulty swallowing or breathing
– hives
The side effects below are listed according to how often they occur:
Common: (may affect up to 1 in 10 users)
– Dry or flaky skin
Uncommon: (may affect up to 1 in 100 users)
– A temporary burning, stinging or stinging sensation can sometimes occur immediately after applying the cream
– Itching
Rare: (may affect up to 1 in 1,000 users)
– Flushing
– Pigment changes
– A limited rash or skin irritation with an itchy, burning sensation where the cream has been applied.
Frequency not known: (cannot be estimated from the available data)
– Blurred vision
How to store Zoviduo
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25°C. Store protected from cold. Do not freeze.
Use before the expiry date which is stated on the carton and tube after EXP. The expiration date is the last day of the specified month.
Shelf life after opening the tube: 3 months
Do not use this medicine if you notice that the cream has changed in appearance or consistency.
Medicines 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
– The active substances are aciclovir and hydrocortisone. One gram of cream contains 50 mg of aciclovir and 10 mg of hydrocortisone.
– Other ingredients are liquid paraffin, propylene glycol, isopropyl myristate, sodium lauryl sulfate, cetostearyl alcohol, white soft paraffin, poloxamer 188, citric acid monohydrate, sodium hydroxide, hydrochloric acid, purified water.
Appearance and package sizes of the medicine
Each tube contains 2 g of Zoviduo. The cream one is white to yellowish.
The tube is made of aluminum laminated polyethylene plastic or aluminum.
Marketing Authorisation Holder:
GlaxoSmithKline Consumer Healthcare ApS
PO Box 61
2610 Rødovre
Denmark
Manufacturer:
GlaxoSmithKline Consumer Healthcare ApS
Delta Park 37
2665 Vallensbæk Strand, Denmark