BETACORTEN G OINTMENT

Israel - English - Ministry of Health

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Active ingredient:
BETAMETHASONE AS VALERATE; GENTAMICIN AS SULFATE
Available from:
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD
ATC code:
D07AC01
Pharmaceutical form:
OINTMENT
Composition:
BETAMETHASONE AS VALERATE 0.1 %W/W; GENTAMICIN AS SULFATE 0.1 %W/W
Administration route:
DERMAL
Prescription type:
Required
Manufactured by:
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
Therapeutic group:
BETAMETHASONE
Therapeutic area:
BETAMETHASONE
Therapeutic indications:
For local treatment of inflammatory dermatoses and allergic skin conditions complicated by infections.
Authorization number:
050 45 23262 00
Authorization date:
2015-02-28

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

22-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

PATIENT PACKAGE INSERT IN

ACCORDANCE WITH THE PHARMACISTS’

REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed with a doctor’s

prescription only

BETACORTEN G

Cream/Ointment

Active ingredients and their concentrations:

Betamethasone (as 17-valerate) 0.1%

Gentamicin (as sulphate) 0.1%

Inactive ingredients: see section 6 “Further

Information”.

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.

This medicine has been prescribed for you. Do

not pass it on to others. It may harm them, even

if it seems to you that their medical condition

is similar.

1. WHAT IS THE MEDICINE INTENDED

fOR?

Betacorten G is intended for the local treatment

of inflammatory and allergic skin conditions

accompanied by infection.

Therapeutic group:

Betamethasone - potent corticosteroid.

Gentamicin - antibiotic belonging to the

aminoglycoside group.

2. BEfORE USING THE MEDICINE

Do not use the medicine:

∙ if you are hypersensitive (allergic) to

betamethasone valerate, gentamicin or to

any of the other ingredients contained in

Betacorten G (listed in section 6).

∙ in children under 1 year of age.

∙ do not use the preparation on mucosal tissues

(anus, genitals, around the mouth/nose).

∙ to treat of any of the following skin problems,

since the medicine may cause them to

worsen:

- acne

- severe flushing of skin on and around the

nose (rosacea).

- spotty red rash around the mouth.

- skin infections originated from a virus (e.g.,

shingles/herpes, chickenpox), fungus or

tuberculosis of the skin.

Do not use if any of the above apply to you.

If you are not sure, talk to your doctor or

pharmacist before using Betacorten G.

Special warnings regarding use of the

medicine

Talk to your doctor or pharmacist before using

the medicine if:

- you have previously had an allergic reaction to

another steroid or to another antibiotic.

- you are suffering, or have suffered in the past,

from impaired function of the liver, kidney or

immune system.

- you are suffering, or have suffered in the past,

from diabetes, glaucoma or cataract.

- you are using the preparation for a prolonged

period or frequently.

- you have psoriasis - the doctor will want to see

you more often.

- if you have a chronic leg ulcer, as you may be

at increased risk of a local allergic reaction.

- you are applying to an extensive skin area.

- you are applying the ointment/cream on broken

skin, within the skin folds.

- you are applying to thin skin such as the face

or on children, as their skin is thinner than that

of adults and as a result, may absorb larger

amounts.

- you are applying near the eyes or on the

eyelids, as cataract or glaucoma may result

if the ointment/cream repeatedly enters the

eye.

- You are applying the ointment/cream under

a airtight dressing, including a child’s nappy.

These dressings make it easier for the active

ingredient to pass through the skin. You may

thereby accidentally end up using too much of

the medicine.

- Do not use dressings or bandages on children

or on the face where the ointment/cream is

applied.

- Use on children or on the face must be limited

to 5 days.

Special caution is required when using in

children and adolescents. Use at these ages

must be accompanied by medical monitoring

- If you are sensitive to any food or medicine,

especially antibiotics, inform the doctor before

using the medicine.

- Sometimes use of antibiotics for local treatment

promotes growth of other microorganisms,

including fungi. If you identified a fungal

infection or if an irritation develops due to

the use of the preparation which contains

gentamicin, you should stop treatment with

this medicine and replace it with another

appropriate treatment.

If you are not sure if any of the above apply to you,

talk to your doctor or pharmacist before using

this medicine.

If you are taking, or have recently taken,

other medicines, including non-prescription

medicines and nutritional supplements, tell

the doctor or pharmacist. In particular, if you are

taking ritonavir, itraconazole or if you are using

other preparation(s) for external use.

Pregnancy, breastfeeding and fertility

∙ Do not use the medicine without consulting

the doctor before starting the treatment if

you are pregnant or breastfeeding, think you

may be pregnant, or are planning to become

pregnant.

Important information about some of the

ingredients in the medicine

Betacorten G Cream contains chlorocresol, which

may cause allergic reactions, and cetostearyl

alcohol, which may cause local skin reactions

(e.g., contact dermatitis).

3. HOW SHOULD yOU USE THE MEDICINE?

Always use according to the doctor’s instructions.

Check with the doctor or pharmacist if you are

uncertain.

The dosage and treatment regimen will be

determined by the doctor only.

The usual dosage is:

∙ Apply Betacorten G once or twice a day. This

dosage may be reduced as the skin begins to

get better.

∙ This ointment/cream is for use on your skin

only.

∙ Do not use more than the amount prescribed

for you and do not exceed the recommended

frequency and duration of treatment.

∙ Do not apply on skin of the face for a period

exceeding 5 days, unless indicated otherwise

by the doctor.

∙ Do not use on extensive areas of the body for

a long time (e.g., every day for many weeks or

months), without instruction from the doctor.

∙ The bacteria that cause infections like warm

and moist conditions under bandages or

dressings; therefore, always clean the skin

before putting on a fresh dressing.

∙ If you are applying the ointment/cream on

someone else, make sure you wash your hands

after use or wear disposable plastic gloves.

∙ If the skin problem does not improve within one

week, consult the doctor.

The ointment is recommended for use on dry

skin where penetration is difficult.

The cream is recommended for use on wet

weepy areas and on areas where convenient

rinsing is desired.

Do not swallow.

For external use only.

Instructions for applying the ointment/cream

1. Wash your hands.

2. Apply a thin layer to the affected areas and

rub gently until it has been fully absorbed into

the skin.

3. Wash your hands again after using the

ointment/cream unless you are meant to apply

the ointment/cream to your hands as part of

the treatment.

for children

∙ Do not use in children under 1 year of age.

∙ The duration of treatment in children should not

exceed 5 days (particularly in areas covered

with nappies), unless the doctor has told you

to use the ointment/cream for longer.

∙ Parents must inform the attending doctor

about any side effect, as well as any additional

medicine being given to the child! See section

4 for a list of side effects.

If you have psoriasis

If you have thick lesions of psoriasis on the

elbows or knees, the doctor may suggest

applying the ointment/cream under an airtight

dressing. The dressing should only be put on at

night to help the ointment/cream start working.

After a short period of time, apply the ointment/

cream normally.

If you apply Betacorten G to the face

Apply the ointment/cream to the face only as per

the doctor’s instruction. Do not use for more than

5 days, since the skin of the face thins easily.

Do not allow the ointment/cream to enter the

eyes. In case of contact with the eyes, wash them

thoroughly with water.

Do not exceed the recommended dose. This is

especially important when treating children.

If you accidentally took a higher dosage

If you applied too much or accidentally swallowed

the ointment/cream, you may get sick. Refer

immediately to a doctor or proceed to a hospital

emergency room, and bring the package of the

medicine with you.

If you forgot to take this medicine

If you forgot to apply this medicine at the required

time, apply it as soon as you remember. If it is

close to the next time you meant to apply it, wait

until that time.

Adhere to the treatment as recommended by

the doctor.

If you stop taking the medicine

If you use Betacorten G regularly, speak with

your doctor before you stop the treatment with

the medicine. Your condition may worsen if the

treatment is stopped suddenly.

Do not take medicines in the dark! Check the

label and the dose each time you take medicine.

Wear glasses if you need them.

If you have further questions regarding use of the

medicine, consult a doctor or pharmacist.

4. SIDE EffECTS

As with any medicine, use of Betacorten G may

cause side effects in some users. Do not be

alarmed when reading the list of side effects.

You may not suffer from any of them.

Discontinue use and refer to a doctor

immediately if:

∙ you find that your skin condition is getting

worse, you develop a generalized rash or your

skin becomes swollen during treatment. You

may be allergic to Betacorten G or you need

other treatment.

∙ you have psoriasis and you develop bumps

with pus under the skin. This can happen very

rarely during or after treatment and is known

as pustular psoriasis.

Additional side effects:

Common side effects (may occur in up to 1 in

10 people)

∙ a feeling of heat, burning, pain, irritation

or itching where the ointment/cream was

applied.

These effects usually pass within a short time

after the adaptation period to the preparation.

However, if they do not pass or if there is some

other change for the worse in the skin, stop the

treatment and refer to the doctor.

Very rare side effects (may occur in up to 1 in

10,000 people) but are more common in children

and infants:

∙ an increased risk of infection

∙ an allergic skin reaction where the ointment/

cream is applied

∙ rash, irritated and bumpy skin or redness of the

skin

∙ dryness and thinning of your skin; it may also

damage or wrinkle more easily

∙ stretch marks may develop

∙ veins under the skin may become more

noticeable

∙ an increase or reduction in hair growth or hair

loss and changes in skin color

∙ weight gain, rounding of the face

∙ delayed weight gain or slowing of growth in

children

∙ bones may become thin, weak and break

easily

∙ cloudy lens in the eye (cataract) or increased

pressure in the eye (glaucoma)

∙ increased blood sugar levels or sugar in the

urine

∙ high blood pressure

If a side effect occurs, if one of the side effects

worsens or if you suffer from a side effect

not mentioned in the leaflet, consult with the

doctor.

Side effects can be reported to the Ministry

of Health via the online side effects reporting

form that can be found on the homepage of the

Ministry of Health www.health.gov.il or through

the following link:

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

sequence.aspx?formType=AdversEffectMedic@

moh.gov.il

5. HOW

SHOULD

THE

MEDICINE

BE

STORED?

∙ Avoid poisoning! This medicine and any other

medicine should be kept in a closed 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) appearing on the package.

The expiry date refers to the last day of that

month.

∙ Store in a cool place, at a temperature below

25°C.

6. fURTHER INfORMATION

∙ In addition to the active ingredients, the

medicine also contains:

Betacorten G Cream:

Liquid Paraffin, Cetostearyl Alcohol, Macrogol

Cetostearyl Ether, Chlorocresol, Sodium Acid

Phosphate, Phosphoric Acid, Purified Water.

Betacorten G Ointment:

Liquid Paraffin, White Soft Paraffin.

∙ What does the medicine look like and what

are the contents of the package? The package

contains a tube with 15 g white cream/

ointment.

Manufacturer and registration holder: Trima,

Israel Pharmaceutical Products Maabarot Ltd.,

Maabarot 4023000.

This leaflet was checked and approved by the

Ministry of Health in November 2015.

Registration number of the medicine in the

National Drug Registry of the Ministry of Health:

Betacorten G Cream:

050.42.23259.00

Betacorten G Ointment:

050.45.23262.00

0116D

0116D

106128110

106128110

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