Israel - English - Ministry of Health
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed without
a doctor’s prescription
Inactive and allergenic ingredients in the preparation
- see section 6.
Read this leaflet carefully in its entirety before
using the medicine. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
Use the medicine in the correct manner.
Consult the pharmacist if you need further information.
Refer to the doctor if symptoms of the illness worsen
or if they do not improve after 7 days.
1. WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of fungal diaper rash in children,
that lasts for more than 72 hours.
Therapeutic group: An antifungal preparation from
the imidazole group.
2. BEFORE USING THE MEDICINE
Do not use the medicine:
∙ if you or your child are sensitive )allergic( to
the active ingredient or any of the additional
ingredients contained in the medicine.
∙ for treatment of infections of the scalp or nails.
Special warnings regarding use of this medicine
Before first use of this preparation, it is advisable
to consult a doctor in order to avoid unnecessary
use. This preparation should only be used in cases of
irritation that have not passed after 72 hours.
Do not use this medicine frequently or for a prolonged
period without consulting a doctor.
Do not use on open wounds.
Avoid contact between the preparation and the eyes
and mouth. In case of contact with the eyes or mouth,
wash thoroughly with water and refer to a doctor.
Before treatment with Agisten Baby, tell the
∙ You are not sure if the patient suffers from a fungal
∙ The patient is sensitive to any food or medicine.
If you or your child are taking, or have recently
taken, other medicines, including non-prescription
medicines and nutritional supplements, tell the
doctor or pharmacist.
3. HOW SHOULD YOU USE THE MEDICINE?
Check with the doctor or pharmacist if you are
If the medicine was prescribed for you by a doctor,
follow his/her instructions.
If you purchased the medicine without a prescription,
carefully follow the following instructions:
The recommended dosage and instructions for use,
unless instructed otherwise by a doctor: apply to the
affected area twice a day, for 7-10 days.
Instructions for use:
Apply a thin and even layer of paste on clean, dry and
aired skin and gently massage into the skin.
A quantity of a length of ½ cm of paste is enough to
cover an area about the size of a palm.
It is recommended to change diapers frequently. It
is preferable to leave the baby without a diaper as
much as possible.
The symptoms of skin infection, such as itching or
pain, should improve within a few days of treatment.
However, signs such as redness and skin peeling
may disappear after a longer period of time. If the
symptoms persist, consult a doctor.
Do not exceed the recommended dose.
For external use only.
Do not put the medicine into the mouth or
If a child or someone else has accidentally swallowed
the medicine, immediately refer to a doctor or proceed
to a hospital emergency room, and bring the package
of the medicine with you.
If you forget to take the medicine at the required
time, use the medicine as soon as possible and
continue treatment as usual.
How can you contribute to the success of the
∙ Although the affected area will itch, avoid scratching
it. Scratching will damage the surface of the skin
and cause the infection to spread further.
∙ Keep the affected area clean.
∙ Moisture encourages fungal growth. Therefore,
keep the affected area dry, but avoid excessive
∙ Wash and dry the affected area before each
application of the medicine.
∙ Wash your hands after treating the infection to avoid
it from spreading.
∙ Do not share towels, bathmats and the like with
the baby, since this can cause the infection to
Do not take medicines in the dark! Check the label
and the dose each time you take the medicine. Wear
glasses if you need them.
If you have further questions regarding use of the
medicine, consult the doctor or pharmacist.
4. SIDE EFFECTS
As with any medicine, use of Agisten Baby may cause
side effects in some users. Do not be alarmed by
the list of side effects. You may not suffer from any
As with any medicine, some people may be allergic
to the medicine. If you or your child are allergic, the
reaction will develop immediately after commencing
use. If you or your child are experiencing an allergic
reaction, discontinue use and seek medical attention
immediately. The signs of an allergic reaction can
rash, swallowing or breathing problems, swelling of
the lips, face, throat or tongue, weakness, nausea,
dizziness or fainting.
In addition, stop treatment and refer to a doctor if
the following occur after use: redness, skin irritation
or rash )rare(, itching, blisters, burning, discomfort,
swelling, skin peeling.
If you or your child experience one of the side effects
mentioned above, if one of the side effects worsens
or if you or your child suffer from a side effect not
mentioned in this leaflet, consult with the doctor.
Reporting side effects:
Side effects can be reported to the Ministry of Health
by clicking on the link “Report Side Effects of Drug
Treatment” found on the Ministry of Health homepage
)www.health.gov.il( that directs you to the online form
for reporting side effects, or by entering the link:
In addition, you can report to Perrigo via the following
5. HOW SHOULD THE MEDICINE BE STORED?
∙ Avoid poisoning! This medicine, and any other
medicine, should be kept in a safe place out of the
sight and reach of children and/or infants in order
to avoid poisoning. Do not induce vomiting unless
explicitly instructed to do so by the doctor.
∙ Do not use the medicine after the expiry date
)exp. date( that appears on the package. The expiry
date refers to the last day of that month.
∙ After first opening, can be used for 3 months.
∙ Store below 25°C.
6. FURTHER INFORMATION
∙ In addition to the active ingredient, the medicine
Wool fat, kaolin, paraffin white soft, isopropyl
myristate, zinc oxide, heavy liquid paraffin,
titanium dioxide, dimethicone, squalane, propyl
parahydroxybenzoate, butyl hydroxy toluene
∙ What the medicine looks like and the contents of
An aluminum tube containing 30 grams of
∙ Manufacturer and registration holder: Perrigo Israel
Pharmaceuticals Ltd., P.O.B. 16, Yerucham.
∙ This leaflet was checked and approved by the
Ministry of Health in May 2015.
∙ Registration number of the medicine in the
National Drug Registry of the Ministry of Health:
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1.0% w/w.
For the full list of excipients, see section 6.1.
A white to cream colored paste for topical use.
For treatment of fungal nappy rash in children, that lasts over 72 hours.
Posology and method of administration
A thin layer should be applied to the affected sites and gently rubbed in 2 times daily. A
strip of paste ½ cm long is sufficient to treat an area about the size of a hand.
Hypersensitivity to the active substance or to any of the excipients listed in
Do not use to treat nail or scalp infections.
Special warnings and precautions for use
Avoid contact with the eyes.
Interaction with other medicinal products and other forms of interaction
Laboratory tests have suggested that, when Clotrimazole paste is used together, this
product may cause damage to latex contraceptives. 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.
Pregnancy and lactation
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.
There is a 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
topical 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.
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 breast-feeding or to discontinue/abstain from clotrimazole therapy
taking into account the benefit of breast-feeding for the child and the benefit of
therapy for the woman.
Effects on ability to drive and use machines
As the listed undesirable effects are based on spontaneous reports, assigning an
accurate frequency of occurrence for each is not possible.
Immune system disorders: allergic reaction (syncope, hypotension, dyspnea,
Signs of an allergic reaction may include: rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue, weakness, feeling dizzy or faint,
Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, erythema,
irritation, peeling/exfoliation, pruritus, rash, stinging/burning.
No risk of acute intoxication is seen as it is unlikely to occur following a single
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: Antifungals for topical use – imidazole and triazole
ATC Code: D01A C01
Mechanism of Action
Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of
ergosterol synthesis leads to structural and functional impairment of the cytoplasmic
Clotrimazole has a broad antimycotic spectrum of action
includes dermatophytes, yeasts, moulds, etc.
Under appropriate test conditions, the MIC values for these types of fungi are in the
region of less than 0.062-8.0 μg/ml substrate. The mode of action of clotrimazole is
primarily fungistatic or fungicidal depending on the concentration of clotrimazole at
the site of infection. In vitro activity is limited to proliferating fungal elements;
fungal spores are only slightly sensitive.
In addition to its antimycotic action, clotrimazole also acts on gram-positive
microorganisms (Streptococci / Staphylococci / Gardnerella vaginalis), and gram-
negative microorganisms (Bacteroides).
In vitro clotrimazole inhibits the multiplication of Corynebacteria and gram-positive
cocci - with the exception of Enterococci – in concentrations of 0.5-10 μg/ml
clotrimazole is minimally absorbed from the intact or inflamed skin into the human
blood circulation. The resulting peak serum concentrations of clotrimazole were
below the detection limit of 0.001 mcg/ml, suggesting that clotrimazole applied
topically is unlikely to lead to measurable systemic effects or side effects.
Preclinical safety data
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.
List of excipients
Wool fat, kaolin ,paraffin white soft, isopropyl myristate, zinc oxide, titanium
dioxide, heavy liquid paraffin, dimethicone, sequalane, propyl parahydroxybenzoate,
butyl hydroxy toluene.
Special precautions for storage
Store below 25 °C.
Nature and contents of container
Agisten baby: Aluminium tube, 30 g.
Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Perrigo Israel Pharmaceuticals Ltd.
P.O.B 16, Yeruham.
MARKETING AUTHORISATION NUMBERS
Agisten baby: 125-94-26744
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