Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Benzydamine hydrochloride
Mawdsley-Brooks & Company Ltd
M02AA05
Benzydamine hydrochloride
30mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 10030200
PACKAGE LEAFLET: INFORMATION FOR THE USER DIFFLAM-P 3% CREAM OR DIFFLAM 3% CREAM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. • This medicine is available without prescription. However, you still need to use it carefully to get the best results. • Keep this leaflet. You may need to read it again. • Ask your doctor or pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve. • 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 Difflam-P 3 % Cream or Difflam 3 % Cream is and what it is used for 2. What you need to know before you use Difflam-P 3 % Cream or Difflam 3 % Cream 3. How to use Difflam-P 3 % Cream or Difflam3 % Cream 4. Possible side effects 5. How to store Difflam-P 3 % Cream or Difflam 3 % Cream 6. Contents of the pack and other information. 1. WHAT DIFFLAM-P 3 % CREAM OR DIFFLAM 3 % CREAM IS AND WHAT IT IS USED FOR Difflam-P 3 % Cream or Difflam 3 % Cream contains the active substance benzydamine hydrochloride and belongs to a group of medicines called nonsteroidal anti-inflammatory drugs or NSAIDS. Difflam-P 3 % Cream or Difflam 3 % Cream works by stopping pain and swelling (inflammation). When rubbed into the skin of the affected area it is used to treat aches and pains including: • Sprains • Strains • Bruises • Sore muscles • Stiff joints. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DIFFLAM-P 3 % CREAM OR DIFFLAM 3 % CREAM Do not use Difflam-P 3 % Cream or Difflam 3 % Cream if • you are allergic to benzydamine hydrochloride. • you are allergic to any of the other ingredients of Difflam-P 3 % Cream or Difflam 3 % Cream (see section 6). WARNINGS AND PRECAUTIONS: Talk to your doctor, pharmacist or nurse before using Difflam-P 3% Cream or Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Difflam Cream or Difflam 3% P Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tube of Difflam 3% Cream/ Difflam-P 3% Cream contains Benzydamine Hydrochloride 3% w/w. Contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol and propylene glycol For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream for topical application to skin. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Difflam 3% Cream/ Difflam-P 3% Cream is a topical analgesic and non-steroidal anti-inflammatory agent. It is recommended as a short-term treatment for the relief of symptoms associated with painful inflammatory conditions of the musculo-skeletal system, including: Acute inflammatory disorders such as myalgia and bursitis. Traumatic conditions such as sprains, strains, contusions and the after-effects of fractures. Difflam 3% Cream/ Difflam-P 3% Cream is well absorbed through the skin and has been shown to have anti-inflammatory and local anaesthetic actions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Difflam Cream/ Difflam 3% P Cream should be massaged lightly into the affected area. Depending on the size of the site to be treated, 35 - 85 mm (1 - 2 g) should be applied three times daily and at the discretion of the doctor, up to six times daily in more severe conditions. It is recommended that treatment be limited to not more than ten days. ELDERLY: No special dosage recommendations are made for elderly patients. 4.3 CONTRAINDICATIONS Difflam 3% Cream/ Difflam-P 3% Cream is contraindicated in patients with known hypersensitivity to the active substance benzydamine hydrochloride or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE To avoid possible irritation, Difflam 3% Cream/ Difflam-P 3% Cream should be kept away from eyes and mucosal surfaces. Cetyl alcohol may cause local skin reactions (e.g. dermatitis). Propylene glycol may cause skin irritation. Benzydamine use is not advisable in p Διαβάστε το πλήρες έγγραφο