Medvirox 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: Medvirox
Cream should be applied five times daily at approximately four hourly intervals, omitting
the night time application.
Medvirox 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

Medvirox 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 Medvirox
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 and the excipient cetyl alcohol can
cause local skin reactions (e.g. contact dermatitis).
Medvirox 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.

4.6 Fertility, pregnancy and lactation
Pregnancy:
A post-marketing Acyclovir pregnancy registry has documented pregnancy outcomes in
women exposed to any formulation of Medvirox. The registry findings have not shown an
increase in the number of birth defects amongst Acyclovir exposed subjects compared with
the general population, and any birth defects showed no uniqueness or consistent pattern to
suggest a common cause. Systemic administration of acyclovir in internationally accepted
standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats 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.

The use of Medvirox Cream should be considered only when the potential benefits
outweigh the possibility of unknown risks however the systemic exposure to Acyclovir
from topical application of Medvirox 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 (see section
5.3)
Breast-feeding:
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
Medvirox Cream would be insignificant.
Fertility:
There is no information on the effect of Acyclovir on human female fertility.
In a study of 20 male patients with normal sperm count, oral Acyclovir 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.
See Clinical Studies in section 5.2

Not applicable.

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:
Uncommon
• Transient burning or stinging following application of Medvirox 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
Acyclovir.
Reporting of suspected adverse reactions
To Report any side effect (s):
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.

No untoward effects would be expected if the entire contents of a 15-gram tube of Medvirox
Cream containing 750 mg of Acyclovir were ingested orally. However, the accidental,
repeated overdose of oral Acyclovir, over several days has resulted in gastrointestinal effects
(nausea and vomiting) and neurological effects (headache and confusion). Acyclovir is
dialysable by haemodialysis.

Pharmacotherapeutic group: Antiviral agent
ATC Code: D06BB03
Acyclovir 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.
Acyclovir is phosphorylated after entry into herpes infected cells to the active compound
acyclovir triphosphate. The first step in this process is dependent on the presence of the HSVcoded
thymidine kinase. Acyclovir 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, Acyclovir Cream 5% was compared to vehicle cream. In
these studies, time from start of treatment to healing was 4.6 days using Acyclovir Cream
and 5.0 days using vehicle cream (p<0.001). Duration of pain was 3.0 days after start of
treatment in the Acyclovir 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 acyclovir following
repeated topical administration of Acyclovir Cream.

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that acyclovir
does not pose a genetic risk to man.
Acyclovir 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 acyclovir greatly in excess of those employed therapeutically. Two generation studies in mice did not reveal any effect of orally
administered acyclovir on fertility.
Systemic administration of acyclovir 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.

 Potassium Sorbate
 Propylene Glycol
 Cetostearyl Alcohol
 Cetomacrogol 1000
 Liquid Paraffin
 White Soft Paraffin
 Purified Water

None Known.

Store below 30° C.
Do not refrigerate.
Keep out of the reach of children.
Do not use after the expiry date stated on the label.
Do not use if there is any physical change on the product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.

White to off white smooth homogenous cream. 15gm filled in collapsible aluminum tube
covered with plastic screw cap, packed in secondary carton box along with a leaflet.

No special insMedpharma Pharmaceutical & Chemical Industries L.L.C
Industrial Area No. 13
Sharjah,
United Arab Emirates.tructions