Israel - English - Ministry of Health
PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s
Active ingredients and their concentrations:
Betamethasone (as 17-valerate) 0.1%
Gentamicin (as sulphate) 0.1%
Inactive ingredients: see section 6 “Further
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
1. WHAT IS THE MEDICINE INTENDED
Betacorten G is intended for the local treatment
of inflammatory and allergic skin conditions
accompanied by infection.
Betamethasone - potent corticosteroid.
Gentamicin - antibiotic belonging to the
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
- severe flushing of skin on and around the
- 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
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
- 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
- you are applying near the eyes or on the
eyelids, as cataract or glaucoma may result
if the ointment/cream repeatedly enters the
- 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
- Do not use dressings or bandages on children
or on the face where the ointment/cream is
- 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
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before using
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
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
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
∙ This ointment/cream is for use on your skin
∙ 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
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
∙ 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/
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
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
∙ 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
∙ 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
∙ a feeling of heat, burning, pain, irritation
or itching where the ointment/cream was
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
∙ an increased risk of infection
∙ an allergic skin reaction where the ointment/
cream is applied
∙ rash, irritated and bumpy skin or redness of the
∙ 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
∙ 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
∙ bones may become thin, weak and break
∙ cloudy lens in the eye (cataract) or increased
pressure in the eye (glaucoma)
∙ increased blood sugar levels or sugar in the
∙ 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
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:
∙ 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
∙ Store in a cool place, at a temperature below
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/
∙ Manufacturer and registration holder: Trima,
Israel Pharmaceutical Products Maabarot Ltd.,
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:
Betacorten G Ointment: