Aciclovir Agepha 30 mg/g eye ointment
- Revised
- 02/04/2021
- Source updated
- 23 Oct 2021
- MA number
- PL 49118/0002
- ATC
- S01AD03
- Legal status
- Prescription only medicine
Indications
Concepts (25)
+Allergy to the medicineContraindicated
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Hypersensitivity to Valaciclovir.
Source SmPC ↗+InfectionWarning
ntake. There is insufficient clinical data on the use of Aciclovir Agepha eye ointment for deep corneal defects and the combined use of Aciclovir Agepha eye ointment with topical corticosteroids. In case of a bacterial coinfection, an additional antibiotic therapy must be carried out. Patients should be informed that transient mild stinging immediately following application may occur. Patients should avoid wearing contact lenses when using Aciclovir Agepha eye ointment.
Source SmPC ↗+Eye conditionsWarning
For ocular use only. Not for injection or oral intake. There is insufficient clinical data on the use of Aciclovir Agepha eye ointment for deep corneal defects and the combined use of Aciclovir Agepha eye ointment with topical corticosteroids. In cas
Source SmPC ↗+UnclassifiedWarning
For ocular use only. Not for injection or oral intake. There is insufficient clinical data on the use of Aciclovir Agepha eye ointment for deep corneal defects and the combined use of Aciclovir Agepha eye ointment with topical corticosteroids. In case of a bacterial coinfection, an additional antibiotic therapy must be carried out. Patients should be informed that transient mild stinging immediately following application may occur. P
Source SmPC ↗+FertilityPregnancy
Fertility No studies have been performed to investigate the effect of topically ophthalmic use of aciclovir on fertility. There is no information on the effect of aciclovir on human female fertility. In
Source SmPC ↗+ChildrenPregnancy
igible. When necessary, Aciclovir Agepha eye ointment can be used during pregnancy. Breast Feeding Limited data show that the drug does pass into breast milk following systemic administration. However, the dosage received by the nursing infant following maternal use of Aciclovir Agepha eye ointment would be insignificant. The use of Aciclovir Agepha eye ointment can be considered during breast feeding.
Source SmPC ↗+PregnancyPregnancy
ignificant effect on sperm count, motility or morphology. With the recommended use of Aciclovir Agepha , the systemic exposure of aciclovir is expected to be negligible and no risk is anticipated. Pregnancy A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to aciclovir. The registry findings have not shown an increase in the number of birth defects descri
Source SmPC ↗+AlcoholNot in scanned sections
+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
+Propylene glycolNot 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
5 years.
Chemical and physical in-use stability has been demonstrated for 30 days at 25 °C.
From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 25°C. Other in-use storage times and conditions are the responsibility of the user.
§6.4 — Special precautions for storage
Store below 25°C.