Maa: Ruotsi
Kieli: ruotsi
Lähde: Läkemedelsverket (Medical Products Agency)
ivermektin
Paranova Läkemedel AB
D11AX22
ivermectin
10 mg/g
Kräm
metylparahydroxibensoat Hjälpämne; propylparahydroxibensoat Hjälpämne; glycerol Hjälpämne; stearylalkohol Hjälpämne; cetylalkohol Hjälpämne; ivermektin 10 mg Aktiv substans; propylenglykol Hjälpämne
Receptbelagt
Avregistrerad
2017-06-21
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SOOLANTRA 10 MG/G CREAM ivermectin 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 Soolantra is and what it is used for 2. What you need to know before you use Soolantra 3. How to use Soolantra 4. Possible side effects 5. How to store Soolantra 6. Contents of the pack and other information 1. WHAT SOOLANTRA IS AND WHAT IT IS USED FOR Soolantra contains the active substance ivermectin that belongs to a group of medicines called avermectins. The cream is used on the skin to treat pimples and spots found with rosacea. Soolantra should be used in adults only (18 years of age or older). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOOLANTRA DO NOT USE SOOLANTRA: - if you are allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Soolantra. At the start of the treatment, some patients may experience worsening of the symptoms of rosacea, however this is uncommon and usually resolves within 1 week of the treatment. Talk to your doctor if this happens. OTHER MEDICINES AND SOOLANTRA Other medicines may have an effect on Soolantra, you should therefore tell your doctor if you are using, have recently used or might use any other medicines. PREGNANCY AND BREAST-FEEDING Soolantra is not recommended during pregnancy. If you are breast-feeding, you should not use this medicine, alternatively, you should stop breast- feeding before start treatment with Soolantra Lue koko asiakirja
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Soolantra 10 mg/g cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cream contains 10 mg of ivermectin. Excipient(s) with known effect: One gram of cream contains 35 mg of cetyl alcohol, 25 mg of stearyl alcohol, 2 mg of methyl parahydroxybenzoate (E218), 1 mg of propyl parahydroxybenzoate (E216) and 20 mg of propylene glycol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream. White to pale yellow hydrophilic cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Soolantra is indicated for the topical treatment of inflammatory lesions of rosacea (papulopustular) in adult patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One application a day for up to 4 months. Soolantra should be applied daily over the treatment course. The treatment course may be repeated. It can be applied as monotherapy or as part of combination treatment (see section 5.1). In case of no improvement after 3 months, the treatment should be discontinued. _Special population_ _Renal impairment_ No dosage adjustment is necessary. _Hepatic impairment_ Caution should be exercised in patients with severe hepatic impairment. _Elderly patients_ No dosage adjustment is necessary in the geriatric population (see also section 4.8). _Paediatric population_ 2 The safety and efficacy of Soolantra in children and adolescents aged less than 18 years have not been established. No data are available. Method of administration Cutaneous use only. Cutaneous application of a pea-size amount of medicinal product to each of the five areas of the face: forehead, chin, nose, and each cheek. The medicinal product should be spread as a thin layer across the entire face, avoiding the eyes, lips and mucosa. Soolantra should be applied only to the face. Hands should be washed after applying the medicinal product. Cosmetics may be applied after the medicinal product has dried. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of Lue koko asiakirja