Package leaflet: Information for the patient

Transcription

1 Package leaflet: Information for the patient Triflu Paracetamol, Ascorbic Acid, Pheniramine Maleate 500 mg/200 mg/ 25 mg granules for oral solution in sachet 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. 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 5 days. What is in this leaflet 1. What is Triflu and when is it used? 2. What you need to know before you take Triflu? 3. How to take Triflu 4. Possible side effects 5. How to store Triflu 6. Contents of the pack and other information 1. What Triflu is and what it is used for? Triflu is indicated for treatment of symptoms associated with the common cold, influenza and upper respiratory tract infections such as runny nose, watery eyes, sneezing, headache and/or fever. This medicine should only be used if you have all of the following symptoms - pain and/or fever, and at the same time runny nose, watery eyes or sneezing. Do not use it if you have only one of the symptoms. Triflu is indicated for adults and adolescent older than 15 years. You must talk to a doctor if you do not feel better or if you feel worse after 5 days. 2. What you need to know before you take Triflu? Do not take Triflu: - if you are allergic to paracetamol, ascorbic acid, pheniramine maleate or any of the other ingredients of this medicine (listed in section 6) - if you have liver disease - if you have narrow-angle glaucoma - if you are taking or have taken within the last two weeks monoamine oxidase inhibitors (for depression) - if you are a man with prostate problems - do not give Triflu to children under 15 years Page 1 of 5

2 Warnings and precautions Talk to your doctor or pharmacist before taking Triflu: - if you have kidney problems - if you have a deficiency of a certain enzyme called glucose-6-phosphata dehydrogenase - if you have haemolytic anaemia (abnormal breakdown of red blood cells - if you have predisposition to constipation, vertigo and urinary problems - if you have asthma, chronic obstructive pulmonary disease, cardiovascular disease, hypertension, hyperthyroidism and pyloroduodenal obstruction Do not use any other products containing paracetamol if you are taking this product as you could exceed the recommended daily dose (see the section "How to take Triflu"). Do not drink alcohol or use medicinal products containing alcohol while you are taking this product. This product may cause drowsiness increased by alcohol. Each sachet contains 11.5 g of sucrose. This should be taken into account in patients with diabetes mellitus. In cases of high fever, signs of a secondary infection, or persistence of your symptoms for more than 5 days, consult your doctor or pharmacist. Other medicines and Triflu Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not use Triflu in combination with other paracetamol- or antihistamine-containing medicines. Please talk to your doctor before you take Triflu in case you use one of the following medicines: - metoclopramide or domperidone (medicines used to treat nausea and vomiting) - cholestyramine (used to lower your cholesterol); - warfarin and other coumarin derivatives (medicines to thin the blood) - probenecide (a medicine used to treat gout) - isoniazid or rifampicin (a medicine used to treat tuberculosis) - phenytoin (a medicine used to treat epilepsy) - sedatives, especially barbiturates (medicines that cause relaxation and sleepiness) - sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine) - hypnotics - zidovudine (a medicine used for the treatment of HIV/AIDS infection) Triflu with food, drink and alcohol Do not drink alcohol or use medicinal products containing alcohol while you are taking this product. This product may cause drowsiness increased by alcohol. Pregnancy and 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 taking this medicine. Triflu is not recommended during pregnancy or breast-feeding. Page 2 of 5

3 Driving and using machines Triflu could cause drowsiness and/or dizziness. If you experience drowsiness and/or dizziness you should not drive or use machine. Triflu contains sucrose and ethanol (alcohol). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Each sachet contains 11.5 g of sucrose. This should be taken into account in patients with diabetes mellitus. This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per maximal daily dose. 3. How to take Triflu Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacistif you are not sure. Triflu is indicated for adults and children older than 15 years. The recommended dose is one sachet 2 or 3 times per day. The interval has to be at least 4 hours between 2 doses. Do not take more than 3 sachets per day. Dissolve content of the sachet must be dissolved in cold or warm water. In case of flu it is best to take Triflu dissolved in warm water in the evening. If you have kidney problems the interval between 2 doses will be determined by your doctor. The maximum period of treatment is 5 days without seeking the medical advice. If you take more Triflu than you should If you have taken more Triflu or it was accidently taken by a child, seek medical advice immediately because of the risk of delayed, serious liver damage. Symptoms of paracetamol overdose are nausea, vomiting and reduced appetite. If you forget to take Triflu Do not take a double dose to make up for a forgotten dose. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Triggering an acute attack of glaucoma in susceptible individuals Urinary disorders (significant decrease of urine, difficult urination) Dry mouth, blurred vision, constipation Difficulties with memory or concentration, confusion, vertigo (more common in the elderly) Impaired motor coordination, tremors Drowsiness, reduced alertness, stronger at the beginning of treatment Page 3 of 5

4 Dizziness after quick change of position (standing or sitting) due to drop of blood pressure Skin rash, redness or an allergic reaction resulting in sudden face and neck swelling or general discomfort (malaise) with a significant drop in blood pressure may occur in rare cases. In such case, immediately stop taking this product, tell your doctor and never take medication containing paracetamol or pheniramine again. Exceptionally blood disorders (reduction in platelets, white blood cells) have been observed which can result in bleeding from the nose or gums. In such case contact your doctor. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via ADR Reporting Website: By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Triflu Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Store below 25 C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Triflu contains: - The active substances are 500 mg paracetamol, 200 mg ascorbic acid, 25 mg pheniramine maleate. - The excipients are sucrose, carribbean flavour, anhydrous citric acid, acacia spray dried, saccharin sodium. What Triflu looks like and contents of the pack Triflu is packed in paper/al/pe sachets. Each sachet contains white to slightly yellow powder with a characteristic odour of citrus fruit and rum. Pack sizes: 2, 4, 5, 6, 8, 10, 12, 14, 15, 16, 18, 20 sachets Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Dr. Max Pharma Limited First Floor Roxburghe House, Page 4 of 5

5 Regent Street, W1B 2HA London United Kingdom Manufacturer Farmea, 10, Rue Bouché Thomas ZAC d Orgemont, Angers France This medicinal product is authorised in the Member States of the EEA under the following names: Czech Republic Poland Slovakia Nogrip 500 mg/200 mg/25 mg Fluxin Nogrip 500 mg/200 mg/25 mg This leaflet was last revised in August 2015 Page 5 of 5