PACKAGE LEAFLET: INFORMATION FOR THE USER. NEFOXEF 120 MG FILM-COATED TABLETS NEFOXEF 180 MG FILM-COATED TABLETS Fexofenadine hydrochloride

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER NEFOXEF 120 MG FILM-COATED TABLETS NEFOXEF 180 MG FILM-COATED TABLETS Fexofenadine hydrochloride Read all of this leaflet carefully before you start using this medicine. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Nefoxef is and what it is used for 2. Before you take Nefoxef 3. How to take Nefoxef 4. Possible side effects 5. How to store Nefoxef 6. Further information 1. WHAT NEFOXEF IS AND WHAT IT IS USED FOR Fexofenadine hydrochloride, the active ingredient in your medicine, belongs to the group of medicines known as antihistamines. Nefoxef 120 mg Film-coated Tablets are approved for the relief of symptoms such as sneezing, running nose and nose itch, eye itch, tearing and flushing, which typically occur in connection with hay fever (allergic rhinitis). Nefoxef 180 mg Film-coated Tablets are approved for the relief of symptoms such as flushing, oedema and itching, which occur in connection with the allergic skin condition called chronic idiopathic urticaria (CIU). 2. BEFORE YOU TAKE NEFOXEF Do not take Nefoxef: - if you are allergic (hypersensitive) to fexofenadine hydrochloride or any of the other ingredients of Nefoxef. Take special care with Nefoxef: - if you are elderly. - if you have ever had heart problems. - if you have kidney or liver problems. Ask your doctor for advice before taking this medicine. 1

2 Taking other medicines If you are taking a remedy against an upset stomach containing aluminium or magnesium, it is recommended that you leave about 2 hours between the time that you take your remedy and Nefoxef. The remedy may lower the amount of drug absorbed and the action of Nefoxef may be effected. If you are taking Nefoxef together with erythromycin (an antibiotic) or ketoconazole (an antifungal medicine), the level of fexofenadine in your plasma may increase. Allergy tests: If you are taking an allergy test this medicine must be discontinued three days before the test. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Nefoxef with food and drink Nefoxef should be taken with water before a meal. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Pregnancy: You must only take Nefoxef according to your doctor s instructions. Breast-feeding: If you are breast-feeding, you must try to avoid taking Nefoxef. Please ask your doctor. Driving and using machines Trials have shown that Nefoxef does not cause drowsiness, and your ability to drive should therefore not be affected while you are on treatment with Nefoxef. However, there may be rare exceptions, so please ensure that you are alert before driving and performing tasks demanding your full attention. 3. HOW TO TAKE NEFOXEF Always take Nefoxef exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Nefoxef 120 mg Film-coated Tablets: For relief of symptoms of hay fever (allergic rhinitis): The usual dose is one tablet daily for adults and children 12 years or older. Nefoxef 180 mg Film-coated Tablets: For relief of symptoms of chronic idiopathic urticaria (allergic skin condition): The usual dose is one tablet daily for adults and children 12 years or older. Use in children Children under 12 years of age should not take Nefoxef 120 mg/180 mg film-coated tablets. For children 6 to 11 years of age: Other forms of this medicine may be more suitable; ask your doctor or pharmacist. Take the tablets orally with water before a meal. If you think the effects of Nefoxef are too strong or too weak, please consult your doctor or pharmacist. If you take more Nefoxef than you should 2

3 Contact your doctor, emergency room or pharmacist if you have taken more Nefoxef than stated in this leaflet or more than your doctor has prescribed. Symptoms of overdose include dizziness, feeling drowsy, feeling tired and a dry mouth. If you forget to take Nefoxef If you forget to take a dose, take it as soon as you remember it unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Nefoxef can cause side effects although not everybody gets them. The side effects described below have been experienced by people taking Nefoxef. Tell your doctor immediately and stop taking Nefoxef if you experience swelling of the face, lips tongue or throat and difficulty breathing, as these may be signs of a serious allergic reaction. Common (experienced by between 1 in 10 and 1 in 100 patients): headache, drowsiness, nausea and dizziness. Uncommon (experienced by between 1 in 100 and 1 in 1,000 patients): feeling tired or sleepy Additional side effects (frequency unknown) which may occur are: difficulty sleeping (insomnia), sleeping disorders, bad dreams, nervousness, fast or irregular heart beat, diarrhoea, skin rash and itching, hives, serious allergic reaction which can cause swelling of the face, lips, tongue or throat, flushing, chest tightness and difficulty breathing. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE NEFOXEF Keep out of reach and sight of children. Do not use Nefoxef after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. This medicinal product does not require special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Nefoxef contains The active substance is fexofenadine. Each Nefoxef 120 mg Film-coated Tablet contains 120 mg of fexofenadine hydrochloride, which is equivalent to 112 mg of fexofenadine. The other ingredients are microcrystalline cellulose, croscarmellose sodium, maize starch, povidone K30, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, macrogol 4000, iron oxide yellow (E172) and iron oxide red (E172). Each Nefoxef 180 mg Film-coated Tablet contains 180 mg of fexofenadine hydrochloride, which is equivalent to 168 mg of fexofenadine. The other ingredients are microcrystalline cellulose, 3

4 croscarmellose sodium, maize starch, povidone K30, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, macrogol 4000 and iron oxide yellow (E172). What Nefoxef looks like and contents of the pack Nefoxef 120 mg Film-coated tablets are peach coloured, oblong, biconvex and film-coated tablets; plain on both sides. Nefoxef 180 mg Film-coated tablets are yellow coloured, oblong, biconvex and film-coated tablets; plain on one side with a score line on the other. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Nefoxef come in packs of 7, 10, 15, 20, 30, 50, 100, 200 or 250 tablets; not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer To be completed nationally. Manufacturer(s): Chanelle Medical IDA Industrial Estate Loughrea, Co. Galway Ireland Generics (UK) Limited Station Close Potters Bar Hertfordshire, EN6 1 TL England McDermott Laboratories t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland NL only Mylan B.V. Dieselweg LB Bunschoten The Netherlands This medicinal product is authorised in the Member States of the EEA under the following names: Denmark Nefoxef Finland (120 mg only) Nefoxef 120 mg kalvopäällysteiset tabletit Hungary Fexgen 120 mg/180 mg filmtabletta Iceland Nefoxef 120 mg/180 mg filmuhúðaðar töflur Netherlands Fexofenadine HCl Mylan 120mg/180 mg, filmomhulde tabletten Norway Nefoxef 120 mg/180 mg filmdrasjerte tabletter Poland FexoGen Portugal Fexofenadina Mylan Slovakia Fexofenadin Generics 120mg/180mg 4

5 Sweden Nefoxef 120 mg/180 mg filmdragerade tabletter UK Fexofenadine Hydrochloride 120 mg/180 mg Film-coated Tablets This leaflet was last approved in {MM/YYYY} 5