Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diclofenac sodium
DE Pharmaceuticals
M02AA15
Diclofenac sodium
30mg/1gram
Cutaneous gel
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13080100
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SOLARAZE 3%, GEL Diclofenac Sodium 3% w/w 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 your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor of pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Solaraze is and what it is used for 2. What you need to know before you use Solaraze 3. How to use Solaraze 4. Possible side effects 5. How to store Solaraze 6. Contents of the pack and other information 1. WHAT SOLARAZE IS AND WHAT IT IS USED FOR Solaraze is a non-steroidal anti-inflammatory dermatological gel. When applied to the skin, Solaraze gel is used to treat a skin problem known as actinic or solar keratosis that is caused by long-term sun exposure. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOLARAZE DO NOT USE SOLARAZE • If you are allergic to diclofenac or any of the ingredients of this medicine (listed in section 6). • If you have had an allergic reaction such as skin rash (nettle rash), breathing difficulties (wheezing) or runny nose (allergic rhinitis) after taking aspirin or any other non-steroidal anti- inflammatory agents. • If you are in the final 3 months of your pregnancy. WARNINGS AND PRECAUTIONS • The possibility of systemic side effects from application of Solaraze cannot be excluded if the product is used on large areas of skin and over a prolonged period. Consult your doctor if: • you have, or have had in the past, a stomach ulcer or bleeding from the stomach. • you have heart, liver or kidney problems. • you have any type of bleeding disorder or bruise very easily. • Avoid sun exposure, including tanning salons, w Baca dokumen lengkapnya
OBJECT 1 SOLARAZE 3% GEL Summary of Product Characteristics Updated 08-Jan-2019 | 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 Solaraze 3%, gel 2. Qualitative and quantitative composition Each gram contains 30 mg diclofenac sodium (3% w/w). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gel A clear, transparent, colourless or pale yellow gel. 4. Clinical particulars 4.1 Therapeutic indications For the treatment of actinic keratosis (AK). 4.2 Posology and method of administration _USE IN ADULTS: _Solaraze is applied locally to the affected area twice daily, with the gel smoothed into the skin gently. The amount needed depends on the size of the affected area. Normally 0.5 grams (the size of a pea) of the gel is used on a 5 cm x 5 cm lesion site. The maximum daily amount of 8 grams of product allows simultaneous treatment of up to 200 cm 2 skin surface area. The usual duration of therapy is from 60 to 90 days. Maximum efficac Baca dokumen lengkapnya