AGISTEN BABY

Israel - English - Ministry of Health

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Active ingredient:
CLOTRIMAZOLE
Available from:
PERRIGO ISRAEL PHARMACEUTICALS LTD
ATC code:
D01AC
Pharmaceutical form:
PASTE
Composition:
CLOTRIMAZOLE 1 %
Administration route:
DERMAL
Prescription type:
Not required
Manufactured by:
PERRIGO ISRAEL PHARMACEUTICALS LTD
Therapeutic group:
IMIDAZOLE AND TRIAZOLE DERIVATIVES
Therapeutic indications:
For treatment of fungal nappy rash in children, that lasts over 72 hours.
Authorization number:
125 94 26744 00
Authorization date:
2012-02-28

Documents in other languages

Patient Information leaflet Patient Information leaflet - Russian

26-01-2021

Patient Information leaflet Patient Information leaflet - Arabic

26-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

09-10-2016

PATIENT PACKAGE INSERT IN ACCORDANCE

WITH THE PHARMACISTS’ REGULATIONS

(PREPARATIONS) - 1986

The medicine is dispensed without

a doctor’s prescription

AGISTEN BABY

Paste

Clotrimazole 1%

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

doctor if:

∙ You are not sure if the patient suffers from a fungal

infection.

∙ 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

uncertain.

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

swallow.

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

treatment?

∙ 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

rubbing.

∙ 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

spread.

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

of them.

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

include:

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:

https://forms.gov.il/globaldata/getsequence/getsequ

ence.aspx?formType=AdversEffectMedic@moh.gov.

In addition, you can report to Perrigo via the following

address:

www.perrigo-pharma.co.il

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

also contains:

Wool fat, kaolin, paraffin white soft, isopropyl

myristate, zinc oxide, heavy liquid paraffin,

titanium dioxide, dimethicone, squalane, propyl

parahydroxybenzoate, butyl hydroxy toluene

)BHT(.

∙ What the medicine looks like and the contents of

the package:

An aluminum tube containing 30 grams of

white/cream-colored paste.

∙ 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:

12594.26744.

PRESCRIBING INFORMATION

1

NAME OF THE MEDICINAL PRODUCT

Agisten Baby

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Clotrimazole 1.0% w/w.

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

A white to cream colored paste for topical use.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

For treatment of fungal nappy rash in children, that lasts over 72 hours.

4.2

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.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in

section 6.1.

Do not use to treat nail or scalp infections.

4.4

Special warnings and precautions for use

Avoid contact with the eyes.

4.5

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.

4.6

Pregnancy and lactation

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 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.

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 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.

4.7

Effects on ability to drive and use machines

Not relevant.

4.8

Undesirable effects

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,

urticaria).

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,

nausea.

Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, erythema,

irritation, peeling/exfoliation, pruritus, rash, stinging/burning.

4.9

Overdose

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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Antifungals for topical use – imidazole and triazole

derivatives

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

membrane.

Pharmacodynamic Effects

Clotrimazole has a broad antimycotic spectrum of action

in vitro

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 0.062-8.0 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

substrate.

5.2

Pharmacokinetic properties

Pharmacokinetic

investigations

after

dermal

application

have

shown

that

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.

5.3

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.

6

PHARMACEUTICAL PARTICULARS

6.1

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.

6.2

Incompatibilities

Not applicable

6.3

Shelf life

36 months.

6.4

Special precautions for storage

Store below 25 °C.

6.5

Nature and contents of container

Agisten baby: Aluminium tube, 30 g.

6.6

Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Perrigo Israel Pharmaceuticals Ltd.

P.O.B 16, Yeruham.

8

MARKETING AUTHORISATION NUMBERS

Agisten baby: 125-94-26744

References:

םרק ןטסיגא לש אפורל ןולע

ראורבפ

2015

19.5.2015

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