Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Soya oil
Almirall Ltd
Soya oil
847.5mg/1gram
Bath additive
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13020101; GTIN: 4042762060126 5000167019070 5000167019063
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 Lue koko asiakirja
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 Lue koko asiakirja