Zovirax Cold Sore Cream
- Revised
- November 2023
- Source updated
- 07 Dec 2023
- MA number
- PL 44673/0039
- ATC
- D06BB03
- Legal status
- General Sales List
Indications
Concepts (25)
+Allergy to the medicineContraindicated
Zovirax Cold Sore Cream is contraindicated in patients known to be hypersensitive to aciclovir, valaciclovir,propylene glycol or any of the excipients of Zovirax Cold Sore Cream
Source SmPC ↗+Propylene glycolContraindicated
Zovirax Cold Sore Cream is contraindicated in patients known to be hypersensitive to aciclovir, valaciclovir,propylene glycol or any of the excipients of Zovirax Cold Sore Cream
Source SmPC ↗+AlcoholWarning
equivalent to 7.5 mg/g. Sodium laurilsulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area. The excipient cetyl alcohol can cause local skin reactions (e.g. contact dermatitis). Ocular herpes Zovirax Cold Sore Cream must not be used for treatment of ocular herpes infections. Genital herpes Zovirax Cold Sore Cream must not be used for treatment of genital herpes.
Source SmPC ↗+InfectionWarning
ly severe recurrent herpes labialis should be encouraged to seek medical advice. Cold sore sufferers should be advised to avoid transmitting the virus, particularly when active lesions are present. Zovirax cold sore cream is not recommended for use by people who know that they are immunocompromised. Such individuals should be encouraged to consult a physician concerning the treatment of any infection. Zovirax Cold Sore Cream contains 200 mg propylene glycol in each daily dose which is equivalent to 400 mg/g. Propylene glycol can cause skin irritations. Zovirax Cold Sore Cream contains 3.75 mg
Source SmPC ↗+Eye conditionsWarning
nging or burning sensation) or increase skin reactions caused by other products when applied on the same area. The excipient cetyl alcohol can cause local skin reactions (e.g. contact dermatitis). Ocular herpes Zovirax Cold Sore Cream must not be used for treatment of ocular herpes infections. Genital herpes Zovirax Cold Sore Cream must not be used for treatment of genital herpes.
Source SmPC ↗+UnclassifiedWarning
Zovirax Cold Sore cream should only be used on cold sores on the mouth and face. It is not recommended for application to mucous membranes, such as in the mouth or eye and must not be used to treat genital herpes. Particular care should be taken to avoid contact with eye. People with particularly severe recurrent herpes labialis should be encouraged to seek medical advice. Cold sore sufferers should be advi
Source SmPC ↗+FertilityPregnancy
es pass into breast milk following systemic administration. However, the dosage received by a nursing infant following maternal use of Zovirax Cold Sore Cream would be expected to be insignificant. Fertility There is no information on the effect of aciclovir on human female fertility. See Clinical Studies in section 5.2.
Source SmPC ↗+ChildrenPregnancy
am should be considered only when the potential benefits outweigh the possibility of unknown risks however the systemic exposure to aciclovir from topical application of aciclovir cream is very low. Limited human data show that the drug does pass into breast milk following systemic administration. However, the dosage received by a nursing infant following maternal use of Zovirax Cold Sore Cream would be expected to be insignificant. Fertility There is no information on the effect of aciclovir on human female fertility. See Clinical Studies in section 5.2.
Source SmPC ↗+PregnancyPregnancy
standard test in rats, foetal abnormalities were observed, but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain. A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Zovirax. The birth defects described amongst Zovirax exposed subjects have not shown any uniqueness or consistent pattern to suggest a common cause. The use of Zovirax Cold Sore Cream should be considered only when the potential benefits outweigh the possibility of unknown risks however the systemic exposure to aciclovir from topical applicatio
Source SmPC ↗+Benzyl alcoholNot in scanned sections
+BreastfeedingNot in scanned sections
+Taken with other medicinesNot in scanned sections
+DehydrationNot in scanned sections
+Older peopleNot in scanned sections
+Enzyme deficiencyNot in scanned sections
+Intolerance to an ingredientNot in scanned sections
+Blood disordersNot in scanned sections
+Liver conditionsNot in scanned sections
+LactoseNot in scanned sections
+CancerNot in scanned sections
+Sodium and potassium contentNot in scanned sections
+Sugar alcoholsNot in scanned sections
+Kidney conditionsNot in scanned sections
+Breathing conditionsNot in scanned sections
+Gap needed after another medicineNot in scanned sections
Storage and shelf life
§6.3 — Shelf life
36 months in aluminium tubes.
24 months in pump container.
§6.4 — Special precautions for storage
Store below 25°C, do not refrigerate.