Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Hydromorphone hydrochloride
Mundipharma Pharmaceuticals Limited
N02AA; N02AA03
Hydromorphone hydrochloride
16 milligram(s)
Prolonged-release capsule, hard
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids; hydromorphone
Marketed
1993-03-02
1 PACKAGE LEAFLET: INFORMATION FOR THE USER _PALLADONE_ _® _ _SR_ 2 MG, 4 MG, 8 MG, 16 MG AND 24 MG PROLONGED-RELEASE CAPSULES, HARD Hydromorphone hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What _PALLADONE SR _ is and what it is used for 2. What you need to know before you take _PALLADONE SR_ 3. How to take _PALLADONE SR_ 4. Possible side effects 5. How to store _PALLADONE SR _ 6. Contents of the pack and other information 1. WHAT _PALLADONE SR_ IS AND WHAT IT IS USED FOR These capsules have been prescribed for you to relieve severe pain over a period of 12 hours. They contain the active ingredient hydromorphone which is a strong analgesic (‘painkiller’) that belongs to a group of medicines called opioids. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE_ PALLADONE SR_ DO NOT TAKE _PALLADONE SR _IF YOU: • are allergic (hypersensitive) to hydromorphone or any of the other ingredients of the capsules (see section 6 ‘Further Information’); • have breathing problems, such as severe chronic obstructive airways disease, respiratory depression or severe asthma. Symptoms may include breathlessness, coughing or breathing more slowly and weakly than expected; • have a sudden severe pain in your abdomen (acute abdomen); • have a condition where the bowel does not work properly (paralytic ileus); • are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 04 September 2023 CRN00CST8 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Palladone SR 16 mg Prolonged-release Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release capsule, hard, contains hydromorphone hydrochloride 16 mg equivalent to 14.24 mg hydromorphone. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release Capsule, hard (Prolonged-release Capsule) Gelatin capsules with clear uncoloured bodies and opaque brown caps marked HCR16 containing white to off-white spherical pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and adolescents over 12 years: Palladone SR capsules should be administered at 12-hourly intervals. The dosage is dependent upon the severity of the pain and the patient's previous history of analgesic requirements. 4 mg of hydromorphone hydrochloride has an analgesic efficacy equivalent to 30 mg of morphine sulphate given orally. 2 mg, 4 mg, 8 mg, 16 mg and 24 mg capsules are available. Treatment should normally be started at a dosage of 4 mg prolonged release hydromorphone hydrochloride 12-hourly. Increasing severity of pain will require an increased dosage of hydromorphone hydrochloride prolonged release products alone or in combination with immediate release hydromorphone product to achieve the desired relief. Patients who are not currently receiving opioids should be titrated with immediate release hydromorphone hydrochloride initially, prior to changing to Palladone SR capsules. Transferring patients between oral and parental hydromorphone: Switching patients from parenteral hydromorphone to oral hydromorphone should be guided by the sensitivity of the individual patient. The oral starting dose should not be overestimated (for oral bioavailability see section 5.2). Paediatric population Not recommended for use in children under 12 years. Elderly As with adults, the el Lesen Sie das vollständige Dokument