Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dimeticone 1000; Cetrimide
Derma UK Ltd
n/a
Dimeticone 1000; Cetrimide
100mg/1gram ; 3mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13020200; GTIN: 5060061550079
Siopel ® Cream Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Siopel cream is and what it is used for 4. Possible side effects 2. What you need to know before you use Siopel cream 5. How to store Siopel cream n o i t a m r o f n i r e h t o d n a k c a p e h t f o s t n e t n o C . 6 m a e r c l e p o i S e s u o t w o H . 3 1.WHAT SIOPEL CREAM IS AND WHAT IT IS USED FOR Siopel cream contains two active ingredients, cetrimide and dimeticone. Cetrimide is an antiseptic which destroys germs. Dimeticone protects the skin from water. Siopel cream is used as a water repellent barrier cream with antiseptic properties. It is useful when the skin needs to be protected from water or external irritants. 2.WHAT YOU NEED TO KNOW BEFORE YOU USE SIOPEL CREAM Do not use Siopel cream: • If you are allergic to cetrimide or dim eticone or any of the other ingredients of this medicine (listed in section 6). [Please note: Siopel cream contains Arachis oil (peanut oil) and should not be applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Siopel cream.] • In body cavities or as an enema • On skin that is acutely inflamed (i.e. red and angry) or weeping • Before the skin has been cleansed of any irritants Warnings and precautions Talk to your doctor, pharmacist or nurse before using Siopel cream. • Take care to avoid applica tion to the ears and eyes, and any deep cuts involving the head or spine. Wash out with water if Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Siopel Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cetrimide 0.3% w/w Dimeticone 1000 10% w/w 3 PHARMACEUTICAL FORM A smooth, white homogeneous cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS An effective water repellent barrier cream with antiseptic properties, useful whenever the skin needs to be protected from water-soluble irritants. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Wash and dry the skin. Apply the cream sparingly and massage well into the skin. Apply three to five times daily for three to four days then once or twice daily. 4.3 CONTRAINDICATIONS Siopel cream is contraindicated for patients who have previously shown a hypersensitivity reaction to cetrimide preparations. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For topical application only. Keep out of the eyes and avoid contact with the brain, meninges or middle ear. Do not use in body cavities or as an enema. Do not use on skin that is acutely inflamed or weeping, or before the skin has been cleansed of contaminating irritants. _Siopel cream contains Arachis oil (peanut oil) and should not be applied by _ _patients known to be allergic to peanut. As there is a possible relationship _ _between allergy to peanut and allergy to Soya, patients with Soya allergy _ _should also avoid Siopel cream. _ If Siopel cream is used as a barrier cream on nipples by nursing mothers consideration must be given to the possibility of allergic reaction in infants with known or suspected allergies to peanut or Soya. Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None have been reported or are known. 4.6 FERTILITY, PREGNANCY AND LACTATION There is no evidence of any ad Lugege kogu dokumenti