国: マルタ
言語: 英語
ソース: Medicines Authority
AMANTADINE HYDROCHLORIDE
Fontus Health Ltd 70 Northumberland Road Ballsbridge Dublin 4 D04VH66, Ireland
N04BB01
AMANTADINE HYDROCHLORIDE 50 mg/5ml
ORAL SOLUTION
AMANTADINE HYDROCHLORIDE 50 mg/5ml
POM
ANTI-PARKINSON DRUGS
Withdrawn
2019-05-02
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRILASYM 50MG/ 5ML ORAL SOLUTION amantadine 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 possible side effects not listed in this leaflet. See section 4. The full name of this medicine is Trilasym 50mg/5ml Oral Solution but is referred to as Trilasym Solution within this leaflet. WHAT IS IN THIS LEAFLET 1. What Trilasym solution is and what it is used for 2. What you need to know before you take Trilasym solution 3. How to take Trilasym solution 4. Possible side effects 5. How to store Trilasym solution 6. Contents of the pack and other information 1. WHAT TRILASYM SOLUTION IS AND WHAT IT IS USED FOR Trilasym Solution contains the active substance amantadine. This is a dopaminergic drug, meaning that it can increase the levels of certain chemicals that transmit impulses in the nervous system, including the brain. It is also an antiviral medicine, which works against influenza A infections by stopping the virus from reproducing. Trilasym Solution can be used: - to treat Parkinson’s disease by improving muscle control and reducing stiffness, shakiness and shuffling - to prevent, or treat the signs and symptoms of, certain influenza (‘flu) infections (type A) - to reduce the pain caused by shingles (herpes zoster), a blistering skin rash caused by the same virus that causes chickenpox (the varicella zoster virus) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRILASYM SOLUTION DO NOT TAKE TRILASYM SOLUTION IF: - you are allergic to amantadine hydrochloride or any of the other ingredients of this medicine (listed in section 完全なドキュメントを読む
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trilasym 50 mg/5 ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of Oral Solution contains 50 mg of amantadine hydrochloride. Excipient(s) with known effect: Each 5 ml also contains: 3250 mg of sorbitol (E420) 10 mg of sodium benzoate (E211) 6.5 mg raspberry flavour containing ethanol, propylene glycol (E 1520) and benzyl alcohol For the full list of excipients, see section 6.1 . 3 PHARMACEUTICAL FORM Oral Solution Clear, colourless, raspberry-flavoured liquid 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _PROPHYLAXIS AND TREATMENT OF SIGNS AND SYMPTOMS OF INFECTION CAUSED BY INFLUENZA A VIRUS_ Trilasym is indicated in patients suffering from clinical influenza in which complications might be expected to occur. Additionally, amantadine is recommended prophylactically in cases particularly at risk, including: - those with chronic respiratory disease or debilitating conditions; - the elderly; - those living in crowded conditions; - individuals in families where influenza has already been diagnosed, for control of institutional outbreaks or for those in essential services who are unvaccinated or when vaccination is unavailable or contra-indicated. Trilasym does not completely prevent the host immune response to influenza A infection, so individuals who take this drug still develop immune responses to the natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Trilasym is also indicated in post-exposure prophylaxis in conjunction with inactivated vaccine during an outbreak until protective antibodies develop, or in patients who are not expected to have a substantial antibody response (immunosuppression). Page 2 of 10 _PARKINSON'S DISEASE _ _HERPES ZOSTER _ Trilasym is indicated in elderly or debilitated patients in whom the physician suspects that a severe and painful rash could occur. Trilasym can significantly reduce the proportion of patients experiencing pain 完全なドキュメントを読む