Read the entire package insert carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administering the medicine in this leaflet or as instructed by your health care professional.
- Keep this leaflet, as you may have to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience adverse effects, please consult your doctor or pharmacist, even if they are not listed in this leaflet. See Section 4.
- You should see a doctor if it gets worse or does not get better after 10 days.
Contents of the leaflet:
1. What is Zoviduo and what is it used for
2. What you need to know before you start using Zoviduo
3. How to use Zoviduo
4. Possible adverse effects
5 Conservation of Zoviduo
6. Package contents and additional information
1.What is Zoviduo and what is it used for
Zoviduo contains two active ingredients: acyclovir and hydrocortisone. Acyclovir is an antiviral that helps fight the virus that causes hot flashes. Hydrocortisone is a mild steroid that reduces the inflammation associated with fever.
Zoviduo can be used by adults and adolescents 12 years and older.
Zoviduo cream is used to treat the early signs and symptoms (e.g., tingling, itching, or redness) of cold sores on the lips and skin near the lips to reduce the chance of progression of the cold sore to blisters.
Even if your fever develops into a blister, Zoviduo will shorten the healing process by approximately half a day to one day compared to the cream without the active ingredients.
A cold sore is caused by a virus called the herpes simplex virus. The virus causes blisters and sores mostly on the lips, but sometimes also on the skin near the lips.
Cold sores can develop when your immune system is weakened, such as when you have a cold or other infection. Stress, sunlight, cold temperatures, or menstruation can also trigger a cold sore.
You should see a doctor if it gets worse or does not get better after 10 days.
2. What you need to know before using Zoviduo
Do not use Zoviduo
- if you are allergic to acyclovir, valacyclovir, hydrocortisone, or any of the other ingredients in this medication. (included in section 6 ).
- for any skin infection other than cold sores
Warnings and Precautions
Use Zoviduo only on the cold sore on your lips and the area around your lips. See your doctor if you have a recurrent severe cold sore, to make sure you do not have another underlying health problem.
Do not use Zoviduo:
- In the eye, inside the mouth or nose, or on the genitals
- To treat genital herpes
-If your immune system is not working properly (for example, if you have had a bone marrow transplant or if you have HIV).
- With a bandage such as a dressing or a heat patch
Wash your hands before and after application to prevent the cold sore from getting worse or passing the infection to someone else.
Do not use for more than 5 days.
Children
- Do not apply this medicine to children under 12 years of age, because it is not known if it works on them or if it is safe for them to use.
Use of Zoviduo with other medications
Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medications, including those purchased without a prescription.
It is not known whether the effect of Zoviduo can be affected by the use of other medications at the same time as Zoviduo.
Use of Zoviduo with food and drink
Do not place the cream just before eating as the cream can then be licked off.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you might be pregnant, or plan to become pregnant, talk to your doctor or pharmacist before using this medication.
This medication should not be used during pregnancy or while nursing, unless your doctor feels that the potential benefits outweigh the possibility of unknown risks.
Driving and use of machines
The use of Zoviduo does not affect your ability to drive and use machines.
Zoviduo contains propylene glycol and keto-stearyl alcohol
Propylene glycol can cause skin irritation. Keto-stearyl alcohol can cause local skin reactions (such as contact dermatitis).
3. How to use Zoviduo
Follow exactly the instructions for administering this medicine contained in this leaflet or as instructed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
For external use only.
Adults and children 12 years and older
Apply the cream five times a day for 5 days (that is, approximately every 3-4 hours while you are awake). It is recommended to start treatment as soon as possible, preferably at the first signs or symptoms, (e.g. tingling, redness or itching).
Do not use for more than 5 days. If your symptoms persist for more than 10 days, you should consult your doctor.
Method of administration
Wash your hands before and after application to prevent the cold sore from getting worse or infecting someone else.
If you develop an ulcer, do not touch the ulcer more than necessary so as not to spread the infection to other areas of the body or to the eyes.
If you use more Zoviduo than you should
In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medication and the amount ingested
If you have any other questions about using this medicine, ask your doctor or pharmacist.
If you forgot to use Zoviduo
If you miss a dose, apply as soon as you remember and continue as before.
4. Possible adverse effects
Like all medications, this drug can produce adverse effects, although not everyone suffers from them.
Stop using this medication and contact your doctor immediately if you experience any of the following symptoms of an allergic reaction (very rare adverse reaction: can 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 adverse effects below are ordered according to how often they may occur:
Frequent (may affect up to 1 in 10 people):
- Dryness or peeling of the skin
Uncommon (may affect up to 1 in 100 people):
- Transient burning, tingling or itching may sometimes occur directly after application.
- Rare itching (can affect up to 1 in 1000 people)
- Reddening of the skin
- Changes in skin color
- An erythema or localized skin irritation with itching and burning sensation at the site of application of the cream.
Communication of adverse effects:
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also communicate them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects you can help provide more information about the safety of this medicine.
5. Conservation of Zoviduo
Keep out of sight and reach of children. Store at a temperature below 25 ° C. Do not refrigerate or freeze. Do not use this medicine after the expiration date shown on the box and tube after CAD. The expiration date is the last day of the month indicated.
Shelf life after first opening of the tube: 3 months. Do not use this medicine if you notice that the cream has changed in appearance and/or texture.
Medications should not be thrown down the drain or in the trash. Deposit the containers and medicines you do not need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines you do not need. In this way you will help to protect the environment.
6. Package contents and additional information
Composition of Zoviduo
- The active ingredients are acyclovir and hydrocortisone. One gram of cream contains 50 mg of acyclovir and 10 mg of hydrocortisone.
- The other components are liquid paraffin, propylene glycol, isopropyl myristate, sodium lauryl sulphate, keto-stearyl alcohol, soft white paraffin, poloxamer 188, citric acid monohydrate, sodium hydroxide, hydrochloric acid and purified water.
Product appearance and package contents
Each tube contains 2 grams of Zoviduo cream. Zoviduo is white in colour and the tube is made of polyethylene plastic laminated with aluminium or aluminium.
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