Balneum Plus bath oil

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Soya oil; Lauromacrogols

Available from:

Almirall Ltd

INN (International Name):

Soya oil; Lauromacrogols

Dosage:

829.5mg/1gram ; 150mg/1gram

Pharmaceutical form:

Bath additive

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13020101; GTIN: 5000167019094

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
BALNEUM PLUS 82.95 % W/W AND 15 % W/W BATH ADDITIVE
Soya oil and lauromacrogols
WHAT IS IN THIS LEAFLET
1.
What Balneum Plus is and what it is used for
2.
What you need to know before you use Balneum Plus
3.
How to use Balneum Plus
4.
Possible side effects
5.
How to store Balneum Plus
6.
Contents of the pack and other information
1. WHAT BALNEUM PLUS IS AND WHAT IT IS USED FOR
Balneum Plus is a bath additive that contains lauromacrogols and soya
oil and is used for the treatment
of dry skin disorders such as eczema and dermatitis where itching is a
problem.
Balneum Plus rapidly relieves symptoms associated with dry, itchy skin
whilst also cleansing and
helping to protect the skin against further drying.
Soya oil is an emollient which soothes and softens dry skin by helping
to replace lost oils. The oil
forms tiny droplets in the water which leaves a thin film on your
skin. This film helps to stop your skin
drying out and so makes it feel soft.
The lauromacrogols are local anaesthetics for the relief of itching
associated with eczema, dermatitis
and problem dry skin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BALNEUM PLUS
DO NOT USE BALNEUM PLUS
•
If you are allergic 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 Plus 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 Plus in your eyes, however, if this should
occur, rinse immediately
with clean water. If eye irritation remains please see your doctor.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMP

Summary of Product characteristics

OBJECT 1
BALNEUM PLUS BATH OIL
Summary of Product Characteristics Updated 16-Jun-2022 | Almirall
Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Balneum Plus 82.95 % w/w and 15.00 % w/w bath additive
2. Qualitative and quantitative composition
1 g of bath additive contains 829.5 mg of soya oil and 150 mg of
lauromacrogols.
Excipients with known effect:
1g of bath additive contains 8,5 mg of propylene glycol (E 1520) and
fragrance containing allergens.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Clear bath oil.
4. Clinical particulars
4.1 Therapeutic indications
Balneum Plus is a bath oil the active ingredients of which have
emollient and local anaesthetic properties and
provide relief of pruritus. It is recommended for the treatment of dry
skin conditions including those
associated with dermatitis and eczema where severe pruritus is also
experienced.
4.2 Posology and method of administration
Posology
Frequency and duration of the appl