Patient Medication Information: uses, side effects, how to take - Xerese
ABOUT THIS MEDICATION
What the medication is used for:
XERESE (acyclovir and hydrocortisone) is a prescription medicine used in people ages 12 and older to lessen the chance of a cold sore becoming worse (ulcerating). XERESE is not a cure for cold sores.
It is not known if XERESE is safe or works in children younger than 12 years old.
What it does:
Acyclovir helps stop the virus from replicating, which stops the infection and hydrocortisone reduces the inflammation, which helps the healing.
When it should not be used:
Do not take XERESE if you have a known allergy to acyclovir, hydrocortisone or to any of the other ingredients XERESE contains (see what the nonmedicinal ingredients are). Do not use XERESE if you have untreated bacterial, viral, tuberculous or fungal infections.
What the medicinal ingredients are:
Acyclovir and hydrocortisone
What the nonmedicinal ingredients are:
Cetostearyl Alcohol, Citric Acid, Isopropyl Myristate, Mineral Oil, Poloxamer 188, Propylene Glycol, Sodium Hydroxide, Sodium Lauryl Sulfate, Water, and White Petrolatum.
What dosage forms it comes in:
XERESE (acyclovir 5% and hydrocortisone 1%) Cream is supplied in plastic-laminated aluminum tubes containing 5 g of XERESE.
Each tube comes in a carton.
WARNINGS AND PRECAUTIONS
XERESE is for cold sores on lips and around the mouth only. XERESE should not be used in eyes, mouth, nose, genitals, around the anus or on any mucous membrane.
This product should not be used if you are severely immunocompromised (e.g. have HIV, cancer or are a transplant patient).
Do not use XERESE for longer than your doctor tells you. Using XERESE for extended periods of time may cause thinning of the skin, particularly on the face.
BEFORE you use XERESE talk to your doctor or pharmacist if you:
- Have a weak immune system (become sick very easily). It is not known if XERESE will harm you.
- Have any other medical conditions.
Are pregnant or plan to become pregnant. It is not known if XERESE will harm your unborn baby.
- Are breast-feeding or plan to breast-feed. Because hydrocortisone is passed into breast milk, breast feeding is not recommended.
INTERACTIONS WITH THIS MEDICATION
Inform your doctor or pharmacist about all of your medicines, including over-the-counter drugs that may interact with XERESE.
Athletes should be aware that this product contains hydrocortisone, which is on the list of doping substances.
No drug interaction studies were done for XERESE.
PROPER USE OF THIS MEDICATION
Use XERESE exactly as directed by your doctor.
Use XERESE early, at the first sign of a cold sore (e.g. itching, burning, tingling or redness)
In case of accidental contact with the eyes or the inside of the nose or mouth, rinse thoroughly with water.
To avoid spreading the infection, do not share this medicine.
Wash your hands before and after using XERESE.
Clean and dry the skin before applying XERESE. Spread a thin layer of XERESE on the affected area.
Do not rub the cold sore because it may spread to other areas around your mouth or make your cold sore worse.
Do not cover the cold sore or area around the cold sore with a bandage (or napkin).
Do not use other skin products (such as make-up, sunscreen or lip balm) or other skin medicine on the cold sore or area around the cold sore.
Do not bathe, shower or swim until 30 minutes after applying XERESE.
Talk to your doctor if your cold sore is not better in 2 weeks.
Usual adult dose:
Apply XERESE topically 5 times per day for 5 days. You should topically apply a quantity of XERESE sufficient to cover the affected area, including the outer margin. Avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. Wash your hands before and after the use of the cream to avoid spreading the infection.
For adolescents 12 years of age and older, the dosage is the same as in adults.
Overdose:
| In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
If you miss a dose of XERESE, apply it as soon as possible. However, if it is almost time for your next dose, go back to your regular dosing schedule. Do not use extra medicine to make up the missed dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, XERESE can cause side effects, although not everybody gets them.
The most common side effects of XERESE are:
drying or flaking of the skin, tingling or burning, redness of the skin, changes in your skin color where the cream is applied (pigmentation changes), swelling, bitter taste after you apply XERESE . If these effects become bothersome, contact your doctor.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XERESE. For more information, ask your doctor or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
|---|---|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking the drug and seek immediate emergency medical attention | ||||
| Only if severe | In all cases | |||||
Hypersensitivity (allergic) reaction Hypercortisolism (excess absorption of hydrocortisone) Skin infection | swelling of tissues (mouth, throat, lips, hands), red, inflamed, irritated skin (contact dermatitis). moon face (round, red, full), buffalo hump (fat deposit between the shoulders), weight gain, weakness, backache, acne, thirst. | √ | √ √ | |||
| Changes in sight | √ | |||||
This is not a complete list of side effects. For any unexpected effects while taking XERESE, contact your doctor or pharmacist.
HOW TO STORE IT
- Keep XERESE out of the reach and sight of children.
- Store at room temperature between 20-25°C; excursions permitted to 15-30°C
- Do not freeze.
- Keep the XERESE tube tightly closed.
Does not use after the expiry date.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at http://webprod.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp or by contacting the sponsor:
Bausch Health, Canada Inc.
2150 St-Elzear Blvd, West
Laval (Québec) H7L 4A8
www.bauschhealth.ca