Coldrex for flu and cold x12 tablets

COLDREX / COLDREX Tablets description:· ascorbic acid· caffeine· paracetamol· phenylephrine hydrochloride· terpine hydrate5 active ingredients against 5 main symptoms of cold and flu. Provides short-term relief of cold and flu symptoms, including headache, high fever, sore throat, muscle and joint pain, stuffy nose, sinusitis and related pain.Special instructions:Read the instructions for use carefully before use.Do not use if you are hypersensitive to any of the ingredients.Store in a dry and cool place, away from children and direct sunlight.Store at a temperature below 25 degrees.Do not use after the expiration date.Do not use the product if the integrity of the packaging is broken. COLDREX / COLDREX Tablets use:Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. For oral use. Adults, including those over 65 years of age, and children 12 years of age and older: The recommended dose is 1 (one) - 2 (two) tablets every 4-6 hours as needed. Do not take at intervals shorter than 4 hours. Do not take more than 8 tablets in a 24-hour period. Do not take for longer than 7 (seven) days without consulting a doctor. Do not exceed the recommended dose. Use in children and adolescents Do not use in children under 12 years of age. If you take more Coldrex tablets than you should Taking too much can damage the liver. If you take more than the recommended dose, seek medical attention immediately, even if you feel well. Taking high doses of terpine hydrate and ascorbic acid can cause stomach problems, and caffeine and phenylephrine can make you irritable and tense. If you forget to take Coldrex tablets, do not take a double dose to make up for the missed dose. Take the dose when you remember. COLDREX / COLDREX Tablets composition: paracetamol: 500 mg; caffeine: 25 mg; phenylephrine hydrochloride: 5 mg; terpine hydrate: 20 mg; ascorbic acid: 30 mg. Other ingredients (excipients): corn starch, starch, talc, stearic acid, povidone, potassium sorbate, sodium lauryl sulfate, sunset yellow (E110). Leaflet: information COLDREX* 30mg/25mg/500mg/5mg/20mg Tablets COLDREX* 30mg/25mg/500mg/5mg/20mg Tablets Active ingredients: Ascorbic acid/Caffeine/Paracetamol/Phenylephrine hydrochloride/Terpine hydrate 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 has told you. Keep this leaflet. You may need to read it again. If you need further information or advice, ask your pharmacist. If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not listed in this leaflet. See section 4. If you do not feel better after 7 days or your condition worsens, you should seek medical advice. What this leaflet contains 1. What COLDREX Tablets are and what they are used for 2. What you need to know before you take COLDREX Tablets 3. How to take COLDREX Tablets 4. Possible side effects 5. How to store COLDREX Tablets 6. Contents of the pack and other information 1. What COLDREX Tablets are and what they are used for If you do not feel better after 7 days or your condition worsens, you should seek medical advice. COLDREX tablets are used to relieve the symptoms of colds and flu: fever, headache, sore throat, runny nose and stuffy nose, sinusitis pain and muscle aches. It contains paracetamol - an analgesic (pain reliever) and antipyretic (reduces fever), phenylephrine hydrochloride - a decongestant that causes swelling of the nasal and sinus mucosa, helping you breathe easier, caffeine, which acts as a mild stimulant, terpine hydrate - an expectorant (a nutrient) and ascorbic acid (vitamin C), which is usually used for flu and inflammatory diseases of the upper respiratory tract (colds and flu) due to the increased needs of the body, especially in the initial stage of the disease. 2. What you need to know before you take COLDREX Tablets Do not take COLDREX Tablets if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6). Do not take COLDREX tablets if you are allergic to paracetamol, caffeine, phenylephrine hydrochloride, terpine hydrate, ascorbic acid or any of the other ingredients. COLDREX tablets are not recommended during pregnancy. Consult your doctor or pharmacist before taking COLDREX tablets if: • you have kidney or liver disease; • you have hypertension, heart disease, peripheral blood vessel disease (Raynaud's disease); • you are taking digoxin or other medicines to treat heart disease; • you have diabetes or an overactive thyroid gland; • you suffer from glaucoma; • you have pheochromocytoma or prostate problems; • you are taking anticoagulants - medicines used to thin the blood; • you are taking medicines to treat Parkinson's disease; • you are taking beta-blockers or other medicines to control blood pressure; • you are taking appetite suppressants or stimulants; • you are breastfeeding. Remember: COLDREX tablets contain paracetamol. Do not take with other medicines containing paracetamol, medicines to treat colds and flu or to decongest your nose. Warnings and precautions Talk to your doctor or pharmacist before taking COLDREX Tablets. Children and adolescents Do not use in children under 12 years of age. Other medicines and COLDREX Tablets Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. Do not take COLDREX tablets if you are taking tricyclic antidepressants or other medicines to treat depression and are taking or have taken monoamine oxidase inhibitors in the last two weeks. COLDREX Tablets with food, drink and alcohol This medicine contains caffeine. Avoid drinking large amounts of tea, coffee or caffeinated drinks while taking COLDREX tablets. Increased caffeine intake may make you irritable and tense, have trouble sleeping or experience an unpleasant feeling of tightness and heaviness in the chest. Pregnancy, breast-feeding and fertility 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 using this medicine. The medicinal product is not recommended during pregnancy due to a possible increased risk of spontaneous abortion associated with caffeine use. Paracetamol is excreted in breast milk, but there is no evidence that it increases the risk to the breast-fed child. Due to the phenylephrine content, the medicinal product should be used during breast-feeding only on medical advice. Caffeine is excreted in breast milk and may have a stimulating effect on the breast-fed child, but toxic concentrations have not been observed. Driving and using machines Do not drive or use machines if you feel dizzy. 3. How to take COLDREX Tablets Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. For oral use. Adults, including those over 65 years of age, and children 12 years of age and older: The recommended dose is 1 (one) - 2 (two) tablets every 4-6 hours as needed. Do not take at intervals shorter than 4 hours. Do not take more than S tablets in a 24-hour period. Do not take for longer than 7 (seven) days without consulting a doctor. Do not exceed the recommended dose. Use in children and adolescents Do not use in children under 12 years of age. If you take more than the recommended dose of COLDREX Tablets Taking too much can damage the liver. If you take more than the recommended dose, seek medical attention immediately, even if you feel well. Taking high doses of terpine hydrate and ascorbic acid can cause stomach problems, and caffeine and phenylephrine can make you irritable and tense. If you forget to take use COLDREX Tablets Do not take a double dose to make up for a forgotten dose. Take the dose when you remember. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. With paracetamol, side effects are very rare (affecting less than 1 in 10,000 patients). Allergic reactions, e.g. skin rash, may occur. Stop taking the medicine and consult your doctor if: you experience an allergic reaction such as itching, rash, difficulty breathing, swelling of the lips, tongue, throat or face; mouth ulcers appear; you have had breathing problems when using acetylsalicylic acid or non-steroidal anti-inflammatory drugs; you have unexpected bleeding or a tendency to bruise; you experience loss or blurred vision, which may occur more often if you suffer from glaucoma; you feel an unusual increase in heart rate or heart palpitations; you experience fluid retention, which is more likely in men with an enlarged prostate. The colouring sunset yellow (E110) may cause an allergic reaction in some patients. Reporting of side effects If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system, Bulgarian Medicines Agency, 8 Damyan Gruev Str., 1303 Sofia, Tel.: +35 928903417, website: www.bda.bg. By reporting side effects, you can help to obtain more information on the safety of this medicine. 5. How to store COLDREX Tablets Keep out of the reach and sight of children. Store below 25°C. Do not use this medicine after the expiry date which is stated on the carton after „EXP“. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What COLDREX Tablets contain The active substances are: paracetamol 500mg caffeine 25mg phenylephrine hydrochloride 5mg terpin hydrate 20mg ascorbic acid 30mg The other ingredients (excipients) are: corn starch, starch, talc, stearic acid, povidone, potassium sorbate, sodium lauryl sulphate, sunset yellow (EEC) What COLDREX Tablets look like and contents of the pack COLDREX tablets are white-pink capsule-shaped tablets with rounded ends. The pack may contain 12 or 24 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: GlaxoSmithKline Consumer Healthcare GlaxoSmithKline Export Ltd. Brentford, TW8 9GS, United Kingdom Manufacturer: GlaxoSmithKline Dungarvan Ltd., Knockbrack, Dungarvan, Co. Waterford, Ireland and/or SC EUROPHARM SA 2 Panselelor St,, Brasov, Romania For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Bulgaria GlaxoSmithKline EOOD Mladost quarter, Tsarigradsko Shose 115G, 9th floor PK 1784, Sofia Tel: (02)953 1034 Fax: (02)950 5605 Shelf life - 4 years. Without a prescription. Date of last revision of the leaflet: 08/2013