Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tacalcitol monohydrate
Almirall Ltd
D05AX04
Tacalcitol monohydrate
4microgram/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13050200; GTIN: 5000167019148 5000167019155 5000167030037
PACKAGE LEAFLET: INFORMATION FOR THE USER CURATODERM® 4 MICROGRAMS/G OINTMENT Tacalcitol 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Curatoderm Ointment is and what it is used for 2. What you need to know before you use Curatoderm Ointment 3. How to use Curatoderm Ointment 4. Possible side effects 5. How to store Curatoderm Ointment 6. Contents of the pack and other information 1. WHAT CURATODERM OINTMENT IS AND WHAT IT IS USED FOR Curatoderm Ointment contains tacalcitol which is a drug that belongs to a group of medicines called antipsoriatics and is a vitamin D derivative. Curatoderm Ointment is used to treat a condition known as psoriasis vulgaris. Psoriasis is a skin disorder in which itchy, red, flaky patches appear on the skin or scalp. Within affected areas of skin, new cells are being produced faster than normal, but old dead cells are only being shed at the normal rate. As live skin cells accumulate, the skin becomes thickened and inflamed. Curatoderm Ointment works by slowing down cell production and bringing it back to normal and helps reduce inflammation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CURATODERM OINTMENT DO NOT USE CURATODERM OINTMENT if you are allergic to tacalcitol or any of the other ingredients of this medicine (listed in section 6). if you have ever had problems with too much calcium in your blood (hypercalcaemia or other disorders of calcium metabolism). If this applies to you do not use this medicine and speak to your doctor. TAKE SPECIAL CARE W Прочитайте повний документ
OBJECT 1 CURATODERM OINTMENT Summary of Product Characteristics Updated 27-Feb-2018 | Almirall Limited 1. Name of the medicinal product Curatoderm 4μg/g Ointment 2. Qualitative and quantitative composition One gram of ointment contains 4μg/g of tacalcitol (4.17μg/g of tacalcitol monohydrate). Excipients with known effect Butylhydroxytoluene (E 321) contained in the excipient Paraffin, white soft For the full list of excipients, see section 6.1. 3. Pharmaceutical form Ointment 4. Clinical particulars 4.1 Therapeutic indications Curatoderm ointment is indicated for the treatment of psoriasis vulgaris in adults. 4.2 Posology and method of administration Posology _Adults and the Elderly: _ Apply sparingly, once daily to the affected areas, preferably at bedtime. The amount applied should not exceed l0g of ointment/day. Ointment). Normally duration of treatment depends on the severity of the lesions and should be decided by the physician. There is clinical trial experience with continuous and intermittent treatment in adults up to twelve months. Curatoderm Ointment can be used on all areas of the body (including face, hairline, scalp, axilla and other flexures). When used on the scalp the ointment can be shampooed out the next morning. _Paediatric population:_ The safety and efficacy of Curatoderm Ointment in children and adolescents under 18 years have not been established. 4.3 Contraindications • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Patients with hypercalcaemia or other known disorders of calcium metabolism. 4.4 Special warnings and precautions for use At the doctor's discretion, in patients at risk of hypercalcaemia, or patients taking high Vitamin D preparations (in excess of 500 IU vitamin D) albumin corrected serum calcium levels should be closely monitored. Treatment should be stopped if hypercalcaemia occurs. Serum calcium levels should also be monitored in patients with renal impairment. Care should be exercised in patients with generalised pustu Прочитайте повний документ