Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Benzydamine hydrochloride
Viatris UK Healthcare Ltd
M02AA05
Benzydamine hydrochloride
30mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 10030200; GTIN: 5000485093554
Package leaflet: Information for the patient Difflam-P 3% Cream or Difflam 3% Cream Benzydamine hydrochloride Read all of this leaflet carefully before you start taking 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. • This medicine is available without prescription. However, you still need to use i t 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 Difflam 3 % 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 (inflam mation). 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: Прочитать полный документ
OBJECT 1 Difflam-P 3% Cream Summary of Product Characteristics Updated 04-Jul-2019 | Mylan • 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 Difflam 3% Cream or Difflam-P 3% 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 antiinflammatory 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. Прочитать полный документ