P0206T PATIENT INFORMATION LEAFLET AMOXICILLIN 125mg/5ml Oral Suspension Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet, you may need to read it again. If you have any questions or are not sure about anything, 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 Amoxicillin Oral Suspension is and what it is used for 2. Before you take Amoxicillin Oral Suspension 3. How to take Amoxicillin Oral Suspension 4. Possible side effects 5. How to store Amoxicillin Oral Suspension 6. Further information • oral contraceptives (as they may not work properly and you will need to use other means of contraception e.g. a condom) • medicines to help stop blood clots e.g. warfarin as extra blood tests may be needed when taken with amoxicillin • cephalosporin antibiotics (also used to treat infections e.g. cefaclor, cefalexin). 1. W hat Amoxicillin Oral Suspension is and what it is used for Other special warnings: Thrush (a yeast infection of moist areas of the body) may develop if amoxicillin is used for a long time. If this occurs tell your doctor. This medicine contains the active ingredient, amoxicillin (as trihydrate). Amoxicillin is one of a group of antibiotics called penicillins. It is used to kill bacteria which cause infections in your body. Amoxicillin Oral Suspension is used to treat bacterial infections of the ear, respiratory tract (e.g. lungs and chest), urinary tract (e.g. kidneys and bladder), skin, and gastrointestinal tract such as typhoid. It may also be used for other infections determined by your doctor. 2. B efore you take Amoxicillin Oral Suspension Do not take this medicine if: • you know you are allergic to amoxicillin or to any of the other ingredients which are listed in section 6. (An allergic reaction may be recognised as shortness of breath, blocked nose, rash, itching, swollen face or lips) • you have ever had an allergic reaction to another penicillin antibiotic or any other antibiotic in the past. Check with your doctor before taking this medicine if: • you are pregnant or trying to become pregnant • you are breastfeeding • you have a history of allergies • you have glandular fever (a viral infection which causes sore throat, high temperature, tiredness, muscle pains and headache) • you are not passing water regularly • you suffer from any kidney problems. Having urine or blood tests If you are having tests on your water (urine glucose tests) or blood tests for liver function, let the doctor or nurse know you are taking this medicine as it can affect the results of these tests. Taking other medicines Amoxicillin Oral Suspension and other medicines you may be taking may affect how each other work. Make sure your doctor or pharmacist knows if you are taking any other medicines, especially: • probenecid (used to treat gout) • allopurinol (used to treat gout) as it may be more likely that you will have an allergic skin reaction if taken with amoxicillin Driving and using machinery: This medicine should not affect the ability to drive or to operate machinery. However, if you think you are affected do not drive or operate machinery. Important information about some of the ingredients: Each 5 ml dose of the medicine contains 3.05 g of sucrose. This should be taken into account in patients with diabetes mellitus. Also, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Also contains E219 which may cause allergic reactions (possibly delayed). 3. How to take Amoxicillin Oral Suspension Shake the bottle well before use. Do not further dilute the prepared product. The dose will be different for different medical conditions and patients. Your doctor has decided the dose which is best for you. Always follow your doctor’s instructions. The pharmacist’s label will tell you how much medicine to take and how often to take it. If you do not understand anything, ask your doctor or pharmacist. Dosage: Adults: • Infections: The usual dose to treat an infection is 250 mg (two 5 ml spoonfuls) three times a day. In more severe infections this dose may be increased to 500 mg (four 5 ml spoonfuls) three times a day. The following doses may be given for the following conditions: • Urinary tract infection: Two 3 g doses with 10 to 12 hours between each dose. • Severe or recurrent chest infections: Maximum 6 g daily in divided doses. • Gonorrhoea: A single 3 g dose. • Prevention of infection during dental procedures: If a local or no anaesthetic is used, 3 g one hour before surgery. If a general anaesthetic is used, 3 g four hours before surgery and 3 g after surgery. Measure bar should be 150mm at 100% scale Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client’s brief, the final responsibility must be taken by our client. If you sign this proof you are signifying full approval of design and text. Customer Crescent Pharma Colours Used Description Amoxicillin 125mg/5ml Black Item Code P0206T Profile - Size 210 x 297mm Min. Point Size 9.75pt Market UK Language English Proof By Gill Kennedy Proof No. Three Date 15/10/2012 Artwork No. 429039 Keyline(Does Not Print) Pharma Code N/A - Children: • Children weighing more than 40 kg should be given the usual adult dose. • Children under 40 kg will be given a dose dependent on their weight and the type of infection being treated. The doctor will advise on the correct dose. It is important that you take your medicine at the right times of day. Space the doses out as evenly as possible throughout the day. Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, your condition may reoccur or get worse. If you take more medicine than you should If you think you have taken too much medicine, contact your doctor straightaway or go to the nearest hospital casualty department. Take the bottle with you so that the medicine can be identified. If you forget to take a dose of Amoxicillin Oral Suspension If you forget to take a dose of this medicine, take it as soon as you remember. However if it is almost time for the next dose, skip the missed dose and take the next dose at the usual time. DO NOT TAKE TWO DOSES AT THE SAME TIME. 4. Possible side effects Some people may have side effects when taking this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or healthcare professional. Also you can help to make sure medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday-Friday) or fill in a paper form available from your local pharmacy. Stop taking the medicine and tell your doctor straightaway if you notice any of the following very rare serious side effects (may occur in less than 1 in 10,000 people): • swelling of the face, lips or throat, difficulty in breathing or dizziness. These may be signs of a severe allergic reaction • rash or pinpoint flat red round spots under the skin surface or bruising of the skin due to inflammation of blood vessel walls caused by an allergic reaction • a delayed allergic reaction may occur 7 to 12 days after taking the medicine. Symptoms may include rash, fever, joint pains and swollen lymph nodes. These symptoms may also be due to a severe allergic reaction called DRESS syndrome with additionally changes in the blood and liver or kidney function. • blistering of the skin, mouth, eyes and genitals, other serious skin reactions including itchy reddish purple patches on the skin, hives, pustules, swelling, peeling, redness, pain, itching and scaling. These may be associated with fever, tiredness, headache and aching body • blood disorders including severe reduction in the number of white or red blood cells which may cause pale yellow skin, weakness, breathlessness, increased risk of bruising or bleeding, and make infections more likely • diarrhoea sometimes containing blood, pain and fever caused by inflammation of the large bowel (colon) • yellowing of the skin or whites of the eyes, pale stools and dark urine, loss of appetite, stomach discomfort caused by liver or blood problems. Tell your doctor or pharmacist if you notice any of the side effects listed in the sections below: Less than 1 in 10 people have experienced: • diarrhoea, indigestion, feeling sick • skin rash. Less than 1 in 100 people have experienced: • itching, hives • being sick. Less than 1 in 10,000 people have experienced: • tiredness, headache, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes. These may be symptoms of a type of anaemia • thrush (a yeast infection of the vagina, mouth or skin folds) • increased or decreased urine output, fever, rash, swelling of any area of the body or weight gain caused by kidney problems • fits (convulsions) which may be seen in patients taking high doses or with kidney problems, hyperactivity, dizziness • crystals in the urine which may cause cloudy urine or difficulty or discomfort when passing urine • an increase in the length of time it takes to stop bleeding if you cut yourself or have a nosebleed • black hairy tongue • tooth discolouration in children which usually returns to normal with brushing. Other effects: • indigestion. 5. How to store Amoxicillin Oral Suspension Store in a cool, dry place. Use within 7 days of preparation. Do not transfer your medicine to another container. KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN. Do not take the medicine if the expiry date on the label has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal. 6. Further information Ingredients: Each 5 ml of oral suspension contains 125 mg of the active ingredient, amoxicillin (as trihydrate). The other ingredients are sucrose, carmellose sodium, sodium citrate, colloidal anhydrous silica, quinoline yellow (E104), sodium methyl parahydroxybenzoate (E219), lemon and apricot flavourings (containing maltodextrin, citric acid, gum arabic, natural lemon oil flavour and nature identical flavouring ingredients). What the medicine looks like: After preparation the medicine is a lime coloured suspension. The bottle contains 100 ml of medicine. Who makes this medicine and holds the Product Licence: Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED. Date leaflet prepared: September 2012. If you would like this leaflet in a different format, please contact the licence holder at the above address. Measure bar should be 150mm at 100% scale Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client’s brief, the final responsibility must be taken by our client. If you sign this proof you are signifying full approval of design and text. Customer Crescent Pharma Colours Used Description Amoxicillin 125mg/5ml Black Item Code P0206T Profile - Size 210 x 297mm Min. Point Size 9.75pt Market UK Language English Proof By Gill Kennedy Proof No. Three Date 15/10/2012 Artwork No. 429039 Keyline(Does Not Print) Pharma Code N/A -