- Therapeutic indications:
- Clovirax Cream is indicated for the treatment of Herpes Simplex virus infections of the skin
including initial and recurrent genital herpes and herpes labialis.
- Route of administration: topical.
- Do not use in eyes.

Adults and Children: Clovirax Cream should be applied five times daily at approximately four
hourly intervals, omitting the night time application.
Clovirax Cream should be applied to the lesions or impending lesions as soon as possible,
preferably during the early stages (prodrome or erythema). Treatment can also be started during
the later (papule or blister) stages.
Treatment should be continued for at least 4 days for herpes labialis and for 5 days for genital
herpes. If healing has not occurred then treatment may be continued for up to an additional 5
days.
Use in the elderly: No special comment

Clovirax Cream is not recommended for application to mucous membranes such as in the
mouth, eye or vagina, as it may be irritant.
Particular care should be taken to avoid accidental introduction into the eye.
In severely immunocompromised patients (eg AIDS patients or bone marrow transplant
recipients) oral Clovirax dosing should be considered. Such patients should be encouraged to
consult a physician concerning the treatment of any infection.
The excipient propylene glycol can cause skin irritations .
Clovirax Cream contains a specially formulated base and should not be diluted or used as a base
for the incorporation of other medicaments.

No clinically significant interactions have been identified.

Pregnancy Category B:
Pregnancy: A post-marketing Clovirax pregnancy registry has documented pregnancy
outcomes in women exposed to any formulation of Clovirax . The birth defects described
amongst Clovirax exposed subjects have not shown any uniqueness or consistent pattern to
suggest a common cause.
The use of Clovirax Cream should be considered only when the potential benefits outweigh the
possibility of unknown risks however the systemic exposure to aciclovir from topical
application of Clovirax Cream is very low.
Teratogenicity:Effects in non-clinical studies were observed only at exposures considered
sufficiently in excess of the maximum human exposure to indicate little relevance to clinical
use.
Lactation: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
Clovirax Cream would be insignificant.
Fertility:There is no information on the effect of Clovirax on human female fertility.
In a study of 20 male patients with normal sperm count, oral Clovirax administered at doses of
up to 1g per day for up to six months has been shown to have no clinically significant effect on
sperm count, motility or morphology.

None Known.

The following convention has been used for the classification of undesirable effects in
terms of frequency: very common ≥1/10, common ≥1/100 and <1/10, uncommon ≥1/1000
and <1/100, rare ≥1/10,000 and <1/1000, very rare <1/10,000.

Immune system disorders:
Very rare
• Immediate hypersensitivity reactions including angioedema and urticaria.
Skin and subcutaneous tissue disorders:
Redness of Skin.
Uncommon
• Transient burning or stinging following application of Clovirax Cream
• Mild drying or flaking of the skin
• Itching
Rare
• Erythema
• Contact dermatitis following application. Where sensitivity tests have been conducted, the
reactive substances have most often been shown to be components of the cream rather than
aciclovir.
-TO REPORT ANY SIDE EFFECT(S):
Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc
Other GCC States:
- Please contact the relevant competent authority

The accidental, repeated overdose of oral aciclovir, over several days has resulted in
gastrointestinal effects (nausea and vomiting) and neurological effects (headache and
confusion). Aciclovir is dialysable by haemodialysis.

Aciclovir is an antiviral agent which is highly active in vitro against herpes simplex virus
(HSV) types I and II and varicella zoster virus. Toxicity to mammalian host cells is low.

Aciclovir is phosphorylated after entry into herpes infected cells to the active compound
aciclovir triphosphate. The first step in this process is dependent on the presence of the HSVcoded
thymidine kinase. Aciclovir triphosphate acts as an inhibitor of and substrate for, the
herpes-specified DNA polymerase, preventing further viral DNA synthesis without affecting
normal cellular processes
In two large, double blind, randomised clinical studies involving 1,385 subjects treated over 4
days for recurrent herpes labialis, Clovirax Cream 5% was compared to vehicle cream. In these
studies, time from start of treatment to healing was 4.6 days using Clovirax Cream and 5.0 days
using vehicle cream (p<0.001). Duration of pain was 3.0 days after start of treatment in the
Clovirax Cream group and 3.4 days in the vehicle group (p=0.002). Overall, approximately
60% of patients started treatment at an early lesion stage (prodrome or erythema) and 40% at a
late stage (papule or blister). The results were similar in both groups of patients.

Pharmacology studies have shown only minimal systemic absorption of aciclovir following
repeated topical administration of Clovirax Cream.

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that aciclovir does
not pose a genetic risk to man.
Aciclovir was not found to be carcinogenic in long term studies in the rat and the mouse.
Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats
and dogs have been reported only at doses of aciclovir greatly in excess of those employed
therapeutically. Two generation studies in mice did not reveal any effect of orally administered
aciclovir on fertility.
Systemic administration of aciclovir in internationally accepted standard tests did not produce
embryotoxic or teratogenic effects in rats, rabbits or mice.
In a non-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.

Propylene glycol 
Cetostearyl Alcohol 
Sodium Lauryl Sulphate 
Poloxamer 
Petroleum Jelly 
Paraffin 
Purified water

None known.

Store below 30°C.

Collapsible aluminum tube & HDPE cap

No special instructions.