Balneum 84.75% bath oil

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Soya oil

Disponibil de la:

Almirall Ltd

INN (nume internaţional):

Soya oil

Dozare:

847.5mg/1gram

Forma farmaceutică:

Bath additive

Calea de administrare:

Cutaneous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 13020101; GTIN: 4042762060126 5000167019070 5000167019063

Prospect

1/4
PACKAGE LEAFLET: INFORMATION FOR THE USER
BALNEUM
ACTIVE SUBSTANCE:
soya oil 84.75 %
Bath additive
WHAT IS IN THIS LEAFLET
:
1.
What Balneum
is and what it is used for
2.
What you need to know before you use Balneum
3.
How to use Balneum
4.
Possible side effects
5.
How to store Balneum
6.
Content of the pack and other information
1.
WHAT BALNEUM IS AND WHAT IT IS USED FOR
Balneum is a bath additive that contains soya oil and is used for the
treatment of dry skin disorders
such as eczema and dermatitis.
Balneum relieves symptoms associated with dry skin whilst also
cleansing, and helping to protect
against further drying.
Soya oil is an emollient (moisturiser) which soothes and softens dry
skin by helping to replace lost
oils. The oil forms tiny droplets in the water which leave a thin film
on your skin. This film helps to
stop your skin from drying out and so makes it feel soft.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BALNEUM
DO NOT USE BALNEUM
•
If you are allergic (hypersensitive) to soya, peanut or any of the
other ingredients of this
medicine (listed in section 6)
•
If you suffer from fresh pustular forms of Psoriasis (Psoriasis
pustulosa).
All full baths – including those to which Balneum has been added –
should only be taken after
consultation with your doctor in the following cases: major skin
injuries, acute skin diseases of
unknown cause, feverish and infectious diseases, heart failure and
high blood pressure.
If the above applies to you,
DO NOT
use this medicine and talk to your doctor.
WARNINGS AND PRECAUTIONS
•
Avoid getting Balneum in your eyes, however, if this should occur,
rinse immediately
with clean water. If eye irritation remains please see your doctor.
•
Undiluted Balneum SHOULD NOT
be swallowed. If this happens talk to your doctor or
pharmacist immediately.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask yo

Caracteristicilor produsului

OBJECT 1
BALNEUM BATH OIL
Summary of Product Characteristics Updated 23-Jun-2015 | Almirall
Limited
1. Name of the medicinal product
Balneum
Soya oil 84,75 % w/w bath additive
2. Qualitative and quantitative composition
Soya oil, 84.75% w/w
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oily liquid for external use.
4. Clinical particulars
4.1 Therapeutic indications
Dry skin conditions including those associated with dermatitis and
eczema.
4.2 Posology and method of administration
Bath additive
The liquid should be added to bath water and thoroughly mixed until
evenly distributed
For full bath (approx. 100 litres)
20ml (1 measure)
For child's bath (approx. 25 litres)
5ml (1/4 measure)
For partial bath (approx. 5 litres)
2.5ml (1/8 measure)
In particularly dry skin, 2-3 times the above quantities can be used.
Generally, 2-3 baths should be taken
weekly. For babies and infants a daily bath is recommended.
The temperature of the bath water should not exceed 36 °C as the
re-greasing effect is diminished at
higher temperatures.
For the treatment of pruritus the temperature should be 32 °C or as
low as can be tolerated.
The bath should not be longer than 20 minutes. In the case of infants
and small children a bath of only a
few minutes is mostly sufficient.
The duration of the therapy depends on the course of the disease. The
instructions in the section 4.4
“Special warnings and precautions for use“ should be taken into
account.
4.3 Contraindications
• hypersensitivity to the active ingredient or to any of the
excipients listed in section 6.1.
• hypersensitivity to peanut or soya
• fresh pustular forms of psoriasis (Psoriasis pustulosa).
In cases of
• major injuries to the skin and acute skin diseases of unknown
cause,
• severe febrile and infectious diseases,
• cardiac muscle weakness (cardiac insufficiency),
• high blood pressure (hypertension)
full baths should only be taken - irrespective of the ingredients -
after consultation with a doctor.
4.4 Special warnings and pre