Package Leaflet: Information for the User. Clonamox 125 mg/5 ml Powder for Oral Suspension Clonamox 250 mg/5 ml Powder for Oral Suspension

Transcription

1 Package Leaflet: Information for the User Clonamox 125 mg/5 ml Powder for Oral Suspension Clonamox 250 mg/5 ml Powder for Oral Suspension Amoxicillin Read all of this leaflet carefully before you start taking 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 get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. Clonamox Powder for Oral Suspension is prescribed mainly for children, but may also be prescribed for adults. This leaflet provides a summary of the information available on Clonamox Powder for Oral Suspension; it is written with young patients and their parents in mind; however, the information is just as important for an adult taking this medicine. In this leaflet: 1. What Clonamox powder for oral suspension is and what it is used for 2. Before you give Clonamox Oral Suspension 3. How to take Clonamox Oral Suspension 4. Possible side effects 5. How to store Clonamox oral suspension 6. Further information 1. What Clonamox powder for oral suspension is and what it is used for Clonamox contains the active ingredient amoxicillin. Amoxicillin is one of a group of antibiotic medicines called penicillins. Amoxicillin kills bacteria by interfering in the manufacture of the bacterial cell wall. Clonamox Powder for Oral Suspension is used in the treatment of a range of bacterial infections due to micro-organisms sensitive to amoxicillin, including prevention of endocarditis (preventing inflammation of the lining of the heart and its valves) and gonorrhoea. 2. Before you give Clonamox oral suspension If the answer to any of the following questions is YES, DO NOT GIVE this medicine to your child without consulting your doctor: Has your child previously suffered an allergic reaction to a medicine containing amoxicillin, other penicillin antibiotics or cephalosporins (e.g. cephalexin)?

2 Is your child allergic to any of the other ingredients in this medicine (see section 6. Further information)? Take special care with Clonamox oral suspension if you or your child: Have a kidney disorder Have glandular fever Is not passing water regularly Prolonged use of an antibiotic may result in infections due to bacteria resistant to the antibiotic. If your child is newborn or your child was born prematurely, your doctor will test their liver, kidney and blood functions while they are given Clonamox. Taking other medicines: Please tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially: Medicine to prevent blood clots (such as warfarin) Medicines used for the treatment of gout, which can be caused by uric acid build-up, such as allopurinol and probenecid. If you are an adult taking this medicine, you must also tell your doctor if You are taking a contraceptive pill (in which case you will need to take extra contraceptive precautions such as using a condom). Pregnancy and breast-feeding: You should consult with your doctor before taking this medicine if you are pregnant (or think you may be) or if you are breast feeding. Important information about some of the ingredients of Clonamox: Clonamox oral suspension contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Clonamox 125 mg/5 ml contains 2.59 g of sucrose in 5 ml of suspension. Clonamox 250 mg/5 ml contains 2.3 g of sucrose in 5 ml of suspension. Clonamox contains sodium: Clonamox 125 mg/5 ml contains 7.26 mg of sodium per 5 ml dose. Clonamox 250 mg/5 ml contains 7.65 mg of sodium per 5 ml dose. Tell your doctor if you are on a controlled sodium diet. 3. How to take Clonamox oral suspension You should give this medicine to your child as directed by your doctor. The pharmacist will reconstitute the dry powder with water:

3 To the pharmacist: Add 62 mls of water to reconstitute the 125mg/5ml oral suspension and 66 mls of water to reconstitute the 250mg/5ml oral suspension. To dispense: To dispense the oral suspensions, loosen powder, add approximately half the water, invert bottle and shake well. Add the remaining water. Shake to complete the suspension. The pharmacist's label should tell you how much to give and how often. If it does not or you are not sure ask your doctor or pharmacist. Children weighing less than 40 kg: Your doctor will advise you how much Clonamox you should give to your baby or child. All doses are worked out depending on your child s bodyweight in kilograms. The usual dose is 40 mg to 90 mg for each kilogram of bodyweight a day, given in two or three divided doses. Adults and children weighing over 40 kg: The usual adult dose is 250mg (one 5ml spoonful of Clonamox 250mg/5ml) three times daily. Your doctor may double the dose in cases of severe infections. You should NOT double the dose unless told to do so by your doctor. Prevention of heart infection (endocarditis) in patients undergoing dental treatment: Adults and children 40 kg or over: The usual dose is 3g one hour before treatment. Children weighing less than 40 kg: The usual dose is 50 mg/kg one hour before treatment. Gonorrhoea: Adults: Adult dose is 3g as a single dose. Kidney problems These doses may be reduced in patients with kidney problems. Use the 5ml spoon provided by your pharmacist to measure the amount of medicine to give to your child. Clonamox may be given before, with or after food, unless the pharmacist's label advises a specific time. The doses should be spaced as evenly as possible through the day. It is not normally necessary to give a dose to your child in the middle of the night, unless instructed to do so by your doctor. If your child still feels unwell at the end of the prescribed course of treatment, you should contact your doctor.

4 If you or your child take too much Clonamox oral suspension: If your child has taken too much Clonamox, contact your doctor or local hospital casualty department at once. Take the bottle with you to show what you have given your child. If a dose of Clonamox oral suspension has been missed: If you forget to give a dose of Clonamox oral suspension, give it to your child as soon as you remember. Do not give the next dose too soon, wait at least 4 hours before giving the next dose. If you stop treatment with Clonamox: Do not stop or change your child s treatment before talking to your doctor. You should keep giving this medicine until the prescribed course is finished; if you stop too soon, the infection may start up again. 4. Possible side effects Like all medicines, Clonamox oral suspension can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Serious side effects: Stop giving Clonamox oral suspension and see your doctor immediately if you or your child experience any of the following symptoms: - any unexplained bleeding, bruising or skin discolouration - reduction in blood cell counts which makes you more susceptible to infections, sore throats, fever - serious illness with blistering of the skin, mouth, eyes and genitals (toxic epidermal necrolysis, Stevens-Johnson Syndrome) - a skin condition with itching pink-red blotches (erythema multiforme) - hypersensitivity (e.g. skin rash and itching) or severe allergic reaction including swollen face or breathing problems - severe diarrhoea with bleeding - you notice your skin or whites of your eyes turning yellow - you notice your urine becoming darker or your faeces becoming paler - excessive body movements (hyperkinesias), becoming dizzy or convulsions. Patients who are on high doses or whose kidneys do not work properly may experience convulsions. Other possible side effects: Common: - Nausea (feeling of sickness) or diarrhoea Uncommon: - Vomiting Very rare: - Thrush (a yeast infection of the vagina, mouth or skin folds) after or during treatment. - Tooth discolouration. The colour usually returns to normal with brushing. - Inflammation of the kidney. Tell your doctor that you or your child are taking Clonamox if you are having urine tests because Clonamox may affect the results. - Inflammation of the colon (leading to abdominal pain, bloody diarrhoea and fever).

5 Tell your doctor that you are taking Clonamox if you are having blood tests as it may sometimes cause short-term changes in blood cell counts. Clonamox can cause an increase in the results of some liver blood tests such as alanine aminotransferase (ALT) and aspartate aminotransferase (AST). If you are having urine tests for glucose Clonamox may also interfere with the results. Clonamox can prolong the length of time you bleed and the time it takes for your blood to clot. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store Clonamox oral suspension Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the bottle label after EXP. The expiry date refers to the last day of that month. Do not use the reconstituted medicine after 14 days of being dispensed. Dry powder: Do not store above 25 C. Reconstituted suspension according to directions: Do not store above 25 C. 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 Clonamox oral suspension contains: The active substance is amoxicillin as amoxicillin trihydrate. Each 5ml spoonful contains 125 mg or 250 mg amoxicillin. The other ingredients are: Saccharin sodium, sodium benzoate (E211), sodium citrate anhydrous, silica colloidal anhydrous, microcrystalline cellulose (E460) and carboxymethylcellulose sodium (E466), lemon flavour, quinoline yellow (E104) and sucrose. What Clonamox oral suspension looks like and contents of the pack: Clonamox is an off-white powder for oral suspension which on reconstitution with water forms a pale yellow, lemon flavoured suspension. Pack sizes: 125 mg suspension 100 ml bottles 250 mg suspension 100 ml bottles Marketing authorisation holder/manufacturer: Clonmel Healthcare Ltd Waterford Road Clonmel

6 Co. Tipperary Ireland This leaflet was last updated in March 2012.