Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Magnesium sulfate dried
Foran Healthcare Limited,
D11AX; D11AX05
Magnesium sulfate dried
38.5 percent weight/weight
Cutaneous paste
Product not subject to medical prescription
Other dermatologicals; magnesium sulfate
Marketed
1995-04-21
1 PACKAGE LEAFLET: INFORMATION FOR THE USER MAGNESIUM SULFATE 38.5% W/W CUTANEOUS PASTE (MAGNESIUM SULFATE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse. IN THIS LEAFLET 1. What Magnesium Sulfate Paste is and what it is used for 2. What you need to know before you use Magnesium Sulfate Paste 3. How to use Magnesium Sulfate Paste 4. Possible side effects 5. How to store Magnesium Sulfate Paste 6. Contents of the pack and other information 1. WHAT MAGNESIUM SULFATE PASTE IS AND WHAT IT IS USED FOR Magnesium Sulfate Paste is a white paste to be used on the skin for the treatment of boils and carbuncles. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MAGNESIUM SULFATE PASTE DO NOT USE MAGNESIUM SULFATE PASTE: • on broken skin • if you are allergic to magnesium sulfate or any of the other ingredients of this medicine (listed in Section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Magnesium Sulfate Paste. If the condition does not improve or if it is aggravated, consult your doctor or pharmacist. Prolonged use should be avoided. OTHER MEDICINES AND MAGNESIUM SULFATE PASTE Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. PREGNANCY, BREAST-FEEDING AND FERTILITY Pregnancy Magnesium Sulfate Paste can be used in pregnancy. Breast-feeding Do not apply on the breasts if breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before usin Przeczytaj cały dokument
Health Products Regulatory Authority 14 February 2022 CRN00CSK1 Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Magnesium Sulfate 38.5% w/w Cutaneous Paste 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dried magnesium sulfate 38.5% w/w. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous paste, white. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For local application to the unbroken skin over such infections as boils and carbuncles. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Apply liberally to the affected area with a disposable applicator. Cover with a non-occlusive dressing. Method of administration Cutaneous use. Stir before use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Do not apply to broken skin. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If there is no improvement, or if there is any aggravation of the condition, consult the doctor or pharmacist. Prolonged use should be avoided. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None known. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy Magnesium Sulfate 38.5% w/w Cutaneous Paste can be used during pregnancy. Breast-feeding Magnesium Sulfate 38.5% w/w Cutaneous Paste should not be applied on the breasts if breast-feeding. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Health Products Regulatory Authority 14 February 2022 CRN00CSK1 Page 2 of 3 Magnesium Sulfate 38.5% w/w Cutaneous Paste has no or negligible influence on the ability to drive and use machines. 4.8 UNDESIRABLE EFFECTS None known. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Przeczytaj cały dokument