Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE
Clonmel Healthcare Ltd
N02BE; N02BE01; R01BA; R01BA02
Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE
500/30 milligram(s)
Tablet
Anilides; paracetamol; Sympathomimetics; pseudoephedrine
Marketed
2017-01-27
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER PARALIEF SINUS TABLETS Paracetamol 500 mg / Pseudoephedrine Hydrochloride 30 mg READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have 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 or nurse. 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 after 3 days. THE NAME OF THIS MEDICINE IS Paralief Sinus Tablets. WHAT IS IN THIS LEAFLET 1. What Paralief Sinus Tablets are and what they are used for 2. What you need to know before you take Paralief Sinus Tablets 3. How to take Paralief Sinus Tablets 4. Possible side effects 5. How to store Paralief Sinus Tablets 6. Contents of the pack and other information 1. WHAT PARALIEF SINUS TABLETS ARE AND WHAT THEY ARE USED FOR Paralief Sinus Tablets relieves the symptoms of colds and flu including aches, pains, fever, nasal and sinus congestion. The tablets contain paracetamol, an analgesic and antipyretic to relieve pain and fever, and pseudoephedrine, a decongestant to clear nasal congestion and blocked sinuses. This medicine is for use in adults and adolescents aged 15 years and over 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARALIEF SINUS TABLETS DO NOT TAKE THIS MEDICINE: If you are allergic to paracetamol or pseudoephedrine or any of the other ingredients of this medicine (listed in section 6). If you have HIGH BLOOD PRESSURE or HEART DISEASE If you are taking any other PARACETAMOL containing products If you are taking, or have taken in the last two weeks, DRUGS FOR DEPRESSION known as Monoamine Oxidase Inhibitors (MAOIs) If you are taking tricyclic antidepressants. If you have H Прочитајте комплетан документ
Health Products Regulatory Authority 09 September 2022 CRN00C33V Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paralief Sinus Tablets Paracetamol 500 mg Pseudoephedrine hydrochloride 30 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of paracetamol and 30 mg of pseudoephedrine hydrochloride Excipient(s) with known effect Each tablet contains no more than 0,882 mg of sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Approximately 18 mm plain, white to off-white, capsule shaped tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paralief Sinus Tablets are indicated for the short term symptomatic treatment of nasal and sinus congestion associated with the symptoms of cold and flu, such as mild pain, headache and/or fever. Paralief Sinus Tablets are indicated in adults and adolescents aged 15 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND ADOLESCENTS AGED 15 YEARS AND OVER: Oral. One to two tablets, every four to six hours, two to three times a day. Maximum daily dose: 6 tablets (i.e. 180 mg pseudoephedrine hydrochloride, 3 g paracetamol). CHILDREN AND ADOLESCENTS AGED UNDER 15 YEARS: Paralief Sinus Tablets are not recommended in children and adolescents aged under 15 years. THE ELDERLY: Experience has indicated that normal adult dosage is appropriate. However in frail, immobile, elderly patients, a reduction in the amount or frequency of dosing may be appropriate. HEPATIC DYSFUNCTION In patients with impaired hepatic function or Gilbert’s Syndrome, the dose must be reduced or the dosing interval prolonged. RENAL DYSFUNCTION: Caution should be exercised when administering Paralief Sinus Tablets to patients with moderate to severe renal impairment, particularly if accompanied by cardiovascular disease. It is recommended, when giving paracetamol to patients with renal failure, to reduce the dose and to increase the minimum interval between each administration to at least 6 hours. Glomerular filt Прочитајте комплетан документ