Treatment of susceptible fungal infections including:
• Vulvo-vaginal moniliasis or candidiasis.
• Symptomatic treatment of Trichomonas vaginalis when other drugs are contraindicated.

For intravaginal administration using the applicator provided. This is best achieved when lying back
with legs bent up.
Adults:
One vaginal tablet should be inserted daily for six days, preferably at night. Alternatively, two vaginal
tablets should be inserted daily (preferably at night) for three consecutive days. A second treatment may
be carried out if necessary.
There is no separate dosage schedule for the elderly.
Clotrizole Vaginal Tablets need moisture in the vagina in order to dissolve completely, otherwise
undissolved pieces of the vaginal tablet might crumble out of the vagina. Pieces of undissolved vaginal
tablet may be noticed by women who experience vaginal dryness. To help prevent this it is important
that the vaginal tablet is inserted as high as possible into the vagina at bedtime.

Generally:
treatment during the menstrual period should not be performed due to the risk of the vaginal tablet
being washed out by the menstrual flow. The treatment should be finished before the onset of
menstruation.
Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this
product.
Vaginal intercourse should be avoided in case of vaginal infection and while using this product because
the partner could become infected.
Children:
Not for use in children under 16.
 

Hypersensitivity to clotrimazole or any other ingredient in the medicinal product. 4.4 Special warnings and precautions for use Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis. Before using Clotrizole Vaginal Tablets, medical advice must be sought if any of the following are applicable:  Previous history of a sexually transmitted disease or exposure to partner with sexually transmitted disease.  Pregnancy or suspected pregnancy.  Aged under 16 or over 60 years.  Known hypersensitivity to imidazoles or other vaginal antifungal products. Clotrizole Vagial Tablets should not be used if the patient has any of the following symptoms where upon medical advice should be sought:  Irregular vaginal bleeding.  Abnormal vaginal bleeding or a bloodstained discharge.  Vulval or vaginal ulcers, blisters or sores.  Lower abdominal pain or dysuria.  Any adverse events such as redness, irritation or swelling associated with the treatment.  Fever or chills.  Nausea or vomiting.  diarrhoea.  Foul smelling vaginal discharge.

Medical advice should be sought if this is the first time the patient has experienced symptoms of
candidal vaginitis.
Before using Clotrizole Vaginal Tablets, medical advice must be sought if any of the following are
applicable:
 Previous history of a sexually transmitted disease or exposure to partner with sexually transmitted
disease.
 Pregnancy or suspected pregnancy.
 Aged under 16 or over 60 years.
 Known hypersensitivity to imidazoles or other vaginal antifungal products.
Clotrizole Vagial Tablets should not be used if the patient has any of the following symptoms where
upon medical advice should be sought:
 Irregular vaginal bleeding.
 Abnormal vaginal bleeding or a bloodstained discharge.
 Vulval or vaginal ulcers, blisters or sores.
 Lower abdominal pain or dysuria.
 Any adverse events such as redness, irritation or swelling associated with the treatment.
 Fever or chills.
 Nausea or vomiting.
 diarrhoea.
 Foul smelling vaginal discharge.

Patients should be advised to consult their physician if the symptoms have not been relieved within one
week of using Clotrizole Vaginal Tablets. The vaginal tablets can be used again if the candidal infection
returns after 7 days. However, if the candidal infection recurs more than twice within six months,
patients should be advised to consult their physician.

Laboratory tests have suggested that, when used together, this product may cause damage to latex
contraceptives (e.g. condoms). Consequently the effectiveness of such contraceptives may be reduced.
Patients should be advised to use alternative precautions for at least five days after using this product.
Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK506; immunosuppressant)
might lead to increased tacrolimus plasma levels and similarly with sirolimus. Patients should thus be
closely monitored for signs and symptoms of tacrolimus or sirolimus overdosage, if necessary by
determination of the respective plasma levels.

Fertility:
No human studies of the effects of clotrimazole on fertility have been performed, however, animal
studies have not demonstrated any effects of the drug on fertility.
Pregnancy:
There are limited amount of data from the use of clotrimazole in pregnant women. Animal studies with
clotrimazole have shown reproductive toxicity at high oral doses (see section 5.3). At the low systemic
exposures of clotrimazole following vaginal treatment, harmful effects with respect to reproductive
toxicity are not predicted.
Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.
During pregnancy the vaginal tablet should be inserted without using an applicator.
Lactation:
Available pharmacodynamic/toxicological data in animals have shown excretion of
clotrimazole/metabolites in milk after intravenous administration (see section 5.3). A risk to the
suckling child cannot be excluded. A decision must be made whether to discontinue breastfeeding
or to discontinue/abstain from clotrimazole therapy taking into account the benefit of breastfeeding
for the child and the benefit of therapy for the woman.

The medication has no or negligible influence on the ability to drive or use machinery.

As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of
occurrence for each is not possible.
Immune system disorders:
allergic reaction (syncope, hypotension, dyspnea, urticaria, pruritus).
Reproductive system and breast disorders:
genital peeling, pruritus, rash, oedema, erythema, discomfort, burning, irritation, pelvic pain, vaginal
haemorrhage.
Gastrointestinal disorders:
abdominal pain.
- To report any side effect(s) in Saudi Arabia;
- National Pharmacovigilance Center (NPC)
 Fax: +966-11-205-7662
 Call NPC at +966-11-2038222 Exts: 2317- 2356- 2353- 2354- 2334- 2340.
 Toll- free number: 8002490000
 E-mail: npc.drug@sfda.gov.sa
 Website: www.sfda.gov.sa/npc

No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal or dermal
application of an overdose (application over a large area under conditions favourable to absorption)
or inadvertent oral ingestion. There is no specific antidote.
However, in the event of accidental oral ingestion, routine measures such as gastric lavage should be
performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or
vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.

Pharmacotherapeutic group: Gynaecological antiinfectives and antiseptics – imidazole derivatives.
ATC code: G01AF02
Mechanism of Action
Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis
leads to structural and functional impairment of the fungal cytoplasmic membrane.

Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes
dermatophytes, yeasts, moulds, etc.
Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than
0.0628.0 μg/ml substrate. The mode of action of clotrimazole is fungistatic or fungicidal depending on
the concentration of clotrimazole at the site of infection. Invitro activity is limited to proliferating
fungal elements; fungal spores are only slightly sensitive.
Primarily resistant variants of sensitive fungal species are very rare; the development of secondary
resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic
conditions.

Pharmacokinetic investigations after vaginal application have shown that only a small amount of
clotrimazole (3 – 10% of the dose) is absorbed. Due to the rapid hepatic metabolism of absorbed
clotrimazole into pharmacologically inactive metabolites the resulting peak plasma concentrations of
clotrimazole after vaginal application of a 500mg dose were less than 10 ng/ml, reflecting that
clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects.

Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity,
genotoxicity and carcinogenicity.
Clotrimazole was not teratogenic in reproductive toxicity studies in mice, rats and rabbits. In rats high
oral doses were associated with maternal toxicity, embryotoxicity, reduced fetal weights and decreased
pup survival.
In rats clotrimazole and/or its metabolites were secreted into milk at levels higher than in plasma by a
factor of 10 to 20 at 4 hrs after administration, followed by a decline to a factor of 0.4 by 24 hrs.

Lactose monohydrate
Maize starch
Magnesium stearate
Hydroxypropyl methylcellulose
Microcrystallinecellulose PH102
Colloidal silicone dioxide

Not applicable.

36 months.

Store at temperature not exceeding 30°C.
Keep out of reach and sight of children.

CLOTRIZOLE® is presented as a carton box containing one blister (Aluminum foil/PVC) which
contains six vaginal tablets, along with a patient information leaflet & an applicator.

No special requirements.