国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Soya oil; Lauromacrogols
Almirall Ltd
Soya oil; Lauromacrogols
829.5mg/1gram ; 150mg/1gram
Bath additive
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13020101; GTIN: 5000167019094
1/4 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 阅读完整的文件
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 阅读完整的文件