BALNEUM PLUS

Israel - English - Ministry of Health

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Active ingredient:
POLIDOCANOL; SOYA OIL
Available from:
NEOPHARM LTD
ATC code:
C05BB02
Pharmaceutical form:
SOLUTION
Composition:
SOYA OIL 82.95 G / 100 G; POLIDOCANOL 15 G / 100 G
Administration route:
TOPICAL
Prescription type:
Not required
Manufactured by:
ALMIRALL HERMAL GMBH, GERMANY
Therapeutic group:
POLIDOCANOL
Therapeutic area:
POLIDOCANOL
Therapeutic indications:
Refatting medical oil bath with antipruritic effect.
Authorization number:
135 49 25853 00
Authorization date:
2011-10-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

20-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

10-12-2017

Patient Package Insert according to Pharmacists’ Regulations (Preparations), 1986

This medicine can be sold without a doctor’s prescription

Balneum Plus

Medicinal bath oil, solution for external use

Composition of active ingredients in 100 gram bath oil:

Soya Oil 82.95 g

Polidocanol 15.00 g

Inactive ingredients and allergens: see section 6 “Additional Information”.

Read this entire leaflet carefully before you start using this medicine. This leaflet

contains concise information about the medicine. If you have any further questions, ask

your doctor or pharmacist.

1. What is the Medicine Intended for?

Medicinal bath oil that restores skin oiliness and helps reduce itching.

Therapeutic group:

emollients for the softening and refatting of the skin.

2. Before Using This Medicine

.X. Do not use this medicine:

if you are hypersensitive (allergic) to the active substances, to soya oil, soya,

peanuts or any of the other ingredients this medicine contains. See section 6.

if you suffer from pustular forms of psoriasis (psoriasis pustulosa, psoriasis with

blisters, which are sometimes accompanied with fever and damage to one’s

general physical state).

In cases of multiple skin injuries and acute skin diseases whose cause is unknown,

febrile illnesses and severe infectious diseases, heart muscle weakness (heart failure)

and high blood pressure, consult your doctor before taking any full baths—including

those to which Balneum Plus is added.

!. Special warnings regarding the use of this medicine

You must consult your doctor before using Balneum Plus.

This medicine is meant for external use only.

Avoid contact between the undiluted liquid and the eyes. If unintentional contact is made

with the eyes, rinse immediately with large amounts of cold water. If the irritation

continues, contact your doctor.

There is an increased risk of slipping due to the oily film on the skin and the oily film on

the surface of the bathtub or on the shower floor. Therefore, it is important to always

ensure that you are supporting yourself properly or are standing in a stable manner.

Clean the bathtub, shower, or children’s bathtub (if used) immediately after each wash

using regular household cleaning agents and after that wash them with hot water so that

residue from the bath oil will not adhere to them.

If you are taking, or have recently taken, other medicines including non-

prescription drugs and nutritional supplements,

tell your doctor or pharmacist.

Using additional soaps or artificial cleaning products (soapless products for the

cleansing of the skin) neutralizes the effect of Balneum Plus.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant or are planning to

become pregnant, consult your doctor or pharmacist before using this medicine.

There are no known limitations on use during pregnancy and breastfeeding.

Driving and Use of Machinery

There is no need for special caution.

Additional information about some of the medicine’s ingredients:

Balneum Plus contains propylene glycol and benzyl benzoate.

Propylene glycol may cause skin irritation.

Benzyl benzoate, found in the fragrance of the oil, can cause mild irritation of the skin,

eyes and mucous membranes.

3. How Should This Medicine Be Used?

Always use this medicine exactly as described in this leaflet, or according to your

doctor’s or pharmacist’s instructions. Ask your doctor or pharmacist if you are unsure.

For use in the bath, add Balneum Plus to the bath of water and mix it well until

fully distributed.

Manner of use:

For use in a bathtub or shower.

Instructions for use:

Shake the preparation before use!

In order to measure the desired amount, you can use the inner part of the cap as a

measuring cup.

Recommended dosage unless otherwise instructed by a doctor:

Bath:

First, fill bathtub with desired amount of water (according to the detailed instructions).

After that, add Balneum Plus to the bath of water according to the following amounts and

mix it well:

For a full bath (about 150 liters) – add 30-45 ml Balneum Plus (2-3 capfuls).

For a children’s bath (about 25 liters) – add 5 ml Balneum Plus (1/3 capful).

For a partial bath (about 5 liters) – add 1 ml Balneum Plus (1/4 teaspoon).

The temperature of the water must not exceed 36°C, since the effect that contributes to

the refatting of the skin gradually lessens at higher temperatures. A lower bath water

temperature (about 32°C) is preferable for the fattening of the skin and better suited for

treating itching.

The duration of the bath should be determined individually, but should not exceed 15-20

minutes.

Bath for infants and small children - a few minutes is sufficient.

It is recommended not to wash the body with clean water after the bath, in order

to preserve the oily layer.

Shower:

Balneum Plus can be used in the shower. For showering, distribute the appropriate

amount, undiluted, on wet skin and then wash.

After the bath or shower dry the body by dabbing lightly with a towel. Vigorous drying or

rubbing reduces the therapeutic effect.

The frequency of the use of Balneum Plus depends on the type and extent of the

symptoms and should be determined individually. In general, it should be used in baths

at intervals of 2-3 days; daily use is also possible if necessary.

Speak with your doctor or pharmacist if you think the effect of Balneum Plus is too strong

or too weak.

If you use more Balneum Plus than you should

There are no known adverse effects resulting from excessive concentrations of the oil in

the bath water.

If you forgot to use Balneum Plus,

do not use a double dose instead of the

forgotten dose. Continue to use the medicine as your doctor recommended or according

to the leaflet instructions.

If you stop using the medicine

You can stop use at any time. Usually stopping the use of Balneum Plus will cause no

harm.

If a child accidentally swallowed this medicine, proceed immediately to a hospital

emergency room and bring the package of the medicine with you.

Do not take medicines in the dark! Check the label and dose every time you use this

medicine.

Wear glasses if you need them.

If you have further questions about the use of this medicine, consult your doctor or

pharmacist.

4. Side Effects

As with any medicine, the use of Balneum Plus may cause side effects in some of its

users. Do not be alarmed while reading the list of side effects. You might not suffer from

any of them.

Side effects whose frequency is unknown (it is impossible to estimate their frequency

based on the existing data):

Redness, itching, burning, rash, rash accompanied with pus-filled blisters (pustular

rash).

Very rare side effects – side effects that appear in less than one user out of 10,000

Soya oil may cause allergic reactions.

If a side effect appears, stop the treatment and consult your doctor.

Reporting of Side Effects

Side effects can be reported to the Ministry of Health by clicking on the link “Report Side

Effects of Drug Treatment” that appears on the homepage of the Ministry of Health’s

website (www.health.gov.il) which links to an online form for reporting side effects, or by

following the link:

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffect

Medic@moh.gov.il

and by emailing the Registration Holder’s Patient Safety Unit at:

drugsafety@neopharmgroup.com

5. How Should You Store the Medicine?

Avoid poisoning! This medicine and any other medicine should be stored 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.

Storage: in a cool place, under 25°C. Do not use this medicine more than 6

months after opening the bottle.

Even when stored in the recommended packaging/storage conditions, medicines

can only be saved for a limited period of time.

Please note the expiration date of the preparation!

6. Additional Information

In addition to the active ingredients, this medicine also contains:

Propylene glycol, Ascorbyl palmitate, Perfume oil DV 5171, Glyceryl stearate citrate.

What the medicine looks like and the content of the package:

Balneum Plus is a light yellow, cloudy, oily liquid. The product is packed in plastic

pentagonal bottles.

Pack sizes: 100, 200, 500 ml.

Not all pack sizes may be marketed.

Manufacturer:

Almirall Hermal GmbH, Reinbek, Germany.

Registration Holder:

Neopharm Ltd., Hashiloach 8, P.O. Box 7063, Petach Tikva

49170001.

Drug registration number at the national medicines registry of the Ministry

of Health:

135-49-25853

This leaflet was checked and approved by the Ministry of Health in: 08/2017

Balneum Plus PIL PB1017-02

Page 1 of 4

The format of this leaflet was set by the Ministry of Health and its content checked and

approved

Summary of Product Characteristics

1.

Name of the medicinal product

Balneum Plus, topical solution liquid.

Contains soya oil, polidocanol

2.

Qualitative and quantitative composition

100 g of liquid bath additive contains:

soya oil (Ph.Eur.) 82.95 g

polidocanol (Ph. Eur.) 15.0 g

Excipients with known effect: propylene glycol, benzyl benzoate (aromatic ingredient).

For the full list of excipients, see section 6.1.

3.

Pharmaceutical form

Liquid bath additive

Balneum Plus is a light yellow, cloudy, oily liquid.

4.

Clinical particulars

4.1

Therapeutic indications

This medicinal product is a refatting medicinal oil bath with an itch-relieving (antipruritic)

effect for preparing full, partial and shower baths.

It is used for the supportive treatment of all skin diseases associated with drying out.

4.2

Posology and method of administration

The preparation should be shaken before use!

For bathing, Balneum Plus is added to the bath water and thoroughly mixed until evenly

distributed.

In order to correctly measure the required quantity, the inner section of the screw cap can be

used as a measuring beaker.

For a full bath (approx. 150 l) 2 – 3 measuring beakers (30 – 45 ml) are used,

for children's bath (approx. 25 l) 1/3 of a measuring beaker (5 ml) is used, and

for a partial bath (5 l) approx. ¼ of a teaspoon (1 ml) of Balneum Plus is used.

The bath water temperature should not exceed 36 °C as the refatting effect slowly diminishes

at higher temperatures. A lower bath water temperature (around 32 °C) is more favourable

for fattening of the skin and better suited for treating pruritus.

The duration of the bath should be determined individually, but should not exceed 15 – 20

minutes. In the case of infants and small children a bath of only a few minutes is mostly

sufficient.

Page 2 of 4

For showering Balneum Plus is distributed undiluted on the moistened body and then

showered off.

After bathing or showering the skin should only be lightly dabbed with a towel. Vigorous

drying or rubbing reduces the therapeutic effect.

The frequency of the application of Balneum Plus depends on the type and extent of the

symptoms and should be determined from individually. In general baths should be taken at

intervals of 2 - 3 days; daily application is also possible if this is necessary.

4.3

Contraindications

Balneum Plus must not be used in the case of

hypersensitivity to refined soya oil, soya, peanuts or any of the other ingredients of

Balneum Hermal Plus stated in section 6.1.

fresh pustular forms of psoriasis (Psoriasis pustulosa).

In the case of major skin injuries and acute skin diseases of unknown cause, severe febrile

and infectious diseases, cardiac insufficiency and hypertension, all full baths, including those

to which Balneum Plus has been added, should strictly only be taken after consultation with

the doctor.

4.4

Special warnings and precautions for use

Undiluted Balneum Plus must not be allowed to come into contact with the eyes.

In cases of accidental contact with the eyes rinse out immediately with copious amounts of

cold water. If irritation continues, an ophthalmological examination is recommended.

Propylene glycol may cause skin irritations.

Benzyl benzoate contained in the perfume oil may cause slight irritation to the skin, eyes and

mucous membranes.

There is an increased risk of slipping due to the oil film on the skin and the oil film in the bath

or shower.

The bathtub, shower or children's bathtub (if applicable) should be cleaned immediately after

every bath using conventional household detergent and then rinsed out with hot water.

4.5

Interaction with other medicinal products and other forms of interaction

The additional use of soaps or syndets neutralises the effect of Balneum Plus.

4.6

Fertility, pregnancy and lactation

There are no known restrictions with respect to use during pregnancy and lactation.

4.7

Effects on ability to drive and use machines

Balneum Plus has no influence on the ability to drive and use machines.

4.8

Undesirable effects

The frequencies of undesirable effects are indicated below:

Very common (≥ 1/10)

Common (≥ 1/100 to < 1/10)

Uncommon (≥ 1/1,000 to < 1/100)

Rare (≥ 1/10,000 to 1/1,000)

Page 3 of 4

Very rare (< 1/10,000)

Not known (cannot be estimated from the available data)

Skin and subcutaneous tissue disorders

Not known: flush, pruritus and burning, rash, pustular rash.

Very rarely, soya oil can cause allergic reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the

Ministry of Health according to the National Regulation by using an online form

(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic

@moh.health.gov.il) and emailed to the Registration Holder’s Patient Safety Unit at:

drugsafety@neopharmgroup.com

4.9

Overdose

There are no known adverse effects resulting from excessive oil concentrations in the bath

water.

5.

Pharmacological properties

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: dermatological balneotherapeutic preparations

ATC code: D11AB55

Balneum Plus results in a film of oil on the skin. This serves as a temporary protective layer

until the lipid coat of the skin has been restored.

Balneum Plus decreases the dissolving of physiological moisturising factors (natural

moisturizing factors: NMF) from the corneal layer and reduces the increased water

evaporation present in cases of eczema - the so-called transepidermal water loss (TEWL).

Due to the addition of polidocanol, Balneum Plus also considerably relieves itching even at

the low concentration in the bath water.

The use of Balneum Plus is medically indicated in the treatment of patients with skin which

is low in grease, dry and intensely pruritic.

5.2

Pharmacokinetic properties

Not applicable.

5.3

Preclinical safety data

There are no proven cases of toxic symptoms resulting from baths with Balneum Plus.

6.

Pharmaceutical particulars

6.1

List of excipients

Propylene glycol

Page 4 of 4

Ascorbic palmitate

Perfume Oil DV 5171

Glycerin stearate citrate

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

2 years

Shelf life after first opening: 6 months.

6.4

Special precautions for storage

Store in a cool place, below 25ºC.

6.5

Nature and contents of container

Pack sizes:

Bottles containing 100 ml

Bottles containing 200 ml

Bottles containing 500 ml

6.6

Special precautions for disposal

No special requirements.

7.

Manufacturer

Almirall Hermal GmbH, Scholtzstrasse, 3 D-21465 Reinbek, Hamburg, Germany

8.

Registration holder

Neopharm Ltd. 8 Hashiloach St, P.O. Box 7063, Petach Tiqva 49170001

Israel

The format of this leaflet has been defined by the Ministry of Health and its content has been

checked and approved in August 2017.

ךיראת

206//60/21

םש

רישכת

תילגנאב

רפסמ

םושיר

Balneum Plus 135 49 25853 00

םש

לעב

םושירה

אינ מ"עב םרפו

תורמחהה טורפל דעוימ הז ספוט

! דבלב

ןולעב קרפ

ירוקמ ןולע

שדח ןולע

4

8.

Undesirable

effects

During

Balneum

Plus

there

may be individual cases

of reddening, itching and

burning

Skin and subcutaneous tissue

disorders

Not known: flush, pruritus and

burning, rash, pustular rash.

ב"צמ נמוסמ ובש ,ןולעה תו

תורמחהה שקובמה תו בוהצב

ונמוס תורמחה רדגב םניאש םייוניש )ןולעב(

םוקימב םייוניש אלו יתוהמ ןכות קר ןמסל שי .הנוש עבצב .טסקטה

ךיראת

206//60/21

םש

רישכת

תילגנאב

רפסמ

םושיר

Balneum Plus 135 49 25853 00

םש

לעב

םושירה

מ"עב םרפואינ

! דבלב תורמחהה טורפל דעוימ הז ספוט

ןולעב קרפ

ןולע ירוקמ

שדח ןולע

שומישה ינפל הפורתב

תודחוימ תורהזא שומישל תועגונה הפורתב

: הפורתב שמתשהל ןיא

סיזאירוספ לש תויתלגומ תורוצ לש הרקמב

םע סיזאירוספ ,יתלגומ סיזאירוספ העיגפו םוח םהל םיוולנ םיתעלש ,תויחופלש .)יללכה ינפוגה בצמב

םיבר רוע יעצפ לש םירקמב רוע תולחמו עודי אל םרוגמ תועבונש תופירח

םוח תולחמ תורומח תוימוהיז תולחמו

רירש לש השלוח בלה

בל תקיפס יא

הובג םד ץחלו

ךירצ

ןורקיעב

םישועש ינפל אפורה םע ץעייתהל ןהשלכ תואלמ תויטבמא

םיפיסומש הלא ללוכ סולפ םואנלב ןהל

יאוול תועפות

ימוקמ יוריג חתפתה םא

תקלד לופיטה םוקמב החירפ וא

ךילע אפורב ץעוויהלו רשקתהל לפטמה

העודי הניא תוחיכשה

תורשפא ןיא םינותנה ךמס לע תוחיכשה תא ךירעהל םימייקה

תוימומדא

דוריג

הבירצ תשוחת

החירפ

הלגומ תואלמ תויחופלשב הוולמ החירפ

תיתלגומ החירפ

תועפות

יאוול

תורידנ

דואמ

(very rare)

תועפות

תועיפומש

תוחפב

שמתשממ

דחא

ךותמ

10,000

תויגרלא תובוגתל םורגל לוכי היוס ןמש

יאוול תעפות העיפוה םא

תא קיספהל שי אפורה םע ץעייתהל ךילעו לופיטה

ב"צמ נמוסמ ובש ,ןולעה תו

תורמחהה שקובמה תו בוהצב

ונמוס תורמחה רדגב םניאש םייוניש )ןולעב(

םוקימב םייוניש אלו יתוהמ ןכות קר ןמסל שי .הנוש עבצב .טסקטה

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