Amoxicillin 250mg Capsules
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Amoxicillin 250mg Capsules / Amoxicillin 500mg Capsules
Amoxicillin Trihydrate
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 effects not listed in the leaflet, please tell your doctor or pharmacist.
This medicine is known as Amoxicillin 250mg Capsules or Amoxicillin 500mg Capsules, but will be referred to as Amoxicillin or Amoxicillin Capsules throughout this leaflet.
In this leaflet:
1. What Amoxicillin Capsules are and what they are used for
2. Before you take Amoxicillin Capsules
3. How to take Amoxicillin Capsules
4. Possible side effects
5. How to store Amoxicillin Capsules
6. Further Information
1. What Amoxicillin Capsules are and what they are used for
Amoxicillin is a broad spectrum antibiotic for treating infections. It belongs to a group of antibiotics called 'penicillins'. Amoxicillin works by killing the bacteria that cause some types of infection.
Amoxicillin can treat a wide range of infections including those of the:
• Chest (bronchitis or pneumonia)
• Ear
• Throat
• Gut and areas around the gut
• Tonsils
• Sinuses
• Kidneys and bladder
• Skin infections
Amoxicillin may also be used to prevent infections of the heart valves that may follow some surgical and dental operations in patients who have a particular risk of developing such infections.
2. Before you take Amoxicillin Capsules Do not take Amoxicillin Capsules:
• If you are hypersensitive (allergic) to amoxicillin, penicillin or other antibiotics such as cephalosporins or any of the ingredients in these capsules.
• If you have a viral infection, including a viral infection called infectious mononucleosis (also known as glandular fever).
• If you have a blood disease called acute lymphatic leukemia.
Take special care with Amoxicillin Capsules:
• If you are suffering from diarrhoea and vomiting as this may reduce the effect of your medicine.
• If you have asthma.
• If you suffer from allergies.
• If you have kidney problems or have a catheter to pass urine.
• If you are having blood or urine tests for sugar or a substance found in bile called urobilinogen because false positive results may occur.
• If you are diabetic it is important that you know that Amoxicillin Capsules can affect the results of certain glucose tests.
• If you are pregnant the levels of a hormone called oestriol in your urine may fall. It is important that your doctor and midwife know that you are taking Amoxicillin so that they can interpret the results correctly.
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Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medications including medicines obtained without a prescription.
Please tell your doctor if you are taking any of the following medicines:
• Allopurinol for conditions such as gout, because the risk of allergic skin rashes is increased.
• Probenecid as this can cause the blood concentrations of amoxicillin to increase.
• Digoxin, used in heart conditions, as the levels of digoxin in the blood may increase.
• Warfarin or acenocoumaral, used to thin the blood and prevent clotting, as it may increase the time it takes for your blood to clot and you may need extra blood tests because of this.
• Antibiotics including macrolides, tetracycline, chloramphenicol or sulphonomides, as the effect of amoxicillin may be reduced.
• Contraceptive Pill as amoxicillin may reduce the effect of the Pill. You should therefore take additional contraceptive precautions such as using a condom, or diaphragm with a spermicide.
Taking Amoxicillin Capsules with food and drink:
Always take your capsules exactly how you doctor has told you. Swallow the capsules with a drink of water. Do not chew the capsules. The capsules can be taken before, with or after food.
Pregnancy and Breastfeeding:
Tell your doctor if you are pregnant, you think you might be pregnant or planning to become pregnant, also if you are breast-feeding or are planning to breast feed.
When breast feeding a small amount of amoxicillin may enter the breast milk and may cause hypersensitivity in infants.
Important information about some of the ingredients of Amoxicillin Capsules:
Amoxicillin Capsules contain colouring agents which may cause allergic reactions such as skin rash, swelling of the face or neck or breathlessness. These colouring agents tartrazine (E102), sunset yellow (E110), carmosine (E122) or brilliant blue (E133) are present in the capsule shells.
3. How to take Amoxicillin Capsules
Always take Amoxicillin Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The capsules can be taken before or with or after food. Do not chew the capsules. Swallow the capsules with a glass of water and space the doses evenly throughout the day.
The usual oral dose:
Adults dose including elderly patients:
One 250mg capsule three times a day increasing to 500mg three times daily for more severe infections.
High dose therapy:
The maximum oral dose is 6g daily in divided doses.
Short course therapy:
Urinary tract (treatment: two 3g doses (6 x 500 mg capsules) with 10-12 hours between the doses.
Dental abscess: two 3g doses with 8 hours between the doses. Gonorrhoea: a single 3g dose.
Use during surgical or dental procedures:
The dose will vary according to the type of surgery. Other medicines may also be given at the same time. Your doctor, pharmacist or nurse can give you more details.
Children weighing less than 40kg
The dose should be 40 to 90mg/kg/day in two to three divided doses, this should be advised by your doctor.
For tonsillitis a dose of 50mg/kg/day in two divided doses should
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Children Weighing more than 40kg
Should be given the adult dosage of one 250mg capsule three times a day increasing to 500mg three times daily for more severe infections
Patients with kidney problems may have a lower dose recommended by their doctor.
If you take more Amoxicillin Capsules than you should:
If you take too many of these capsules or someone else accidentally swallows these capsules, contact your doctor, pharmacist or nearest hospital immediately, remember to show them this packet. Never take more than the recommended dose each day.
If you forget to take Amoxicillin Capsules:
If you forget to take a dose, take it as soon as you remember. Then carry on as before. Do not take a double dose to make up for forgotten individual doses.
If you stop taking Amoxicillin Capsules:
Do not stop taking Amoxicillin Capsules without first discussing it with your doctor. Keep taking the capsules even if you feel better. You need every capsule to help fight off the infection. If you stop taking your medicine before the end of the course, some bacteria may survive and cause the infection to come back. If you still feel unwell after the course of treatment go and see your doctor.
If you have any further questions on the use of Amoxicillin Capsules ask your doctor or pharmacist.
4. Possible Side Effects:
Like all medicines, Amoxicillin Capsules can cause side effects, although not everyone gets them.
Allergic (hypersensitive) reactions may occur commonly during treatment with amoxicillin but severe allergic reactions are rare.
If any of the following happen, stop taking Amoxicillin Capsules and tell your doctor immediately. You may need urgent medical attention or hospitalisation.
• Skin rash, redness or itching. Some sort of skin rash may occur commonly.
• Swelling of the face or neck. Mild forms occur commonly but severe forms are rare.
• Blistering or peeling of the skin with or without ulceration in the mouth, and sore eyes or genitals can occur rarely.
• Joint pain and fever, breathing problems, sweating, rapid heartbeat or loss of consciousness can occur rarely.
• Increases in numbers of white blood cells called eosinophils, drops in numbers of red blood cells causing anaemia, inflammation and damage to blood vessels causing purple spots or blotches in and under the skin and inflammation of the kidney can occur rarely.
Other side effects that may occur are:
Common (between 1 in 10 and 1 in 100 patients):
• Skin rash.
• Nausea (feeling sick) and diarrhoea
These symptoms are usually mild and disappear either during treatment or very soon after completion of treatment. These symptoms may be reduced by taking the capsules with food.
Uncommon (between 1 in 100 and 1 in 1000patients):
• Severe skin rash.
• Hives.
• Vomiting (being sick)
Very Rare (between 1 in 1000 patients and 1 in 10,000 patients)
• Kidney problems with symptoms such as blood in urine, increases or decreases in the amount of urine, feeling and being sick.
• Yeast infection e.g. thrush.
• Black, hairy tongue
• Inflammation of the colon which causes bowel spasms and upper abdominal cramps sometimes with bloody diarrhoea
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• Superficial tooth discolouration that can usually be removed by brushing.
• There have been isolated reports of changes in the composition of the blood including decreased in some white blood cells, red blood cells and platelets. There have also been isolated reports of prolonged bleeding time and an increase in blood clotting times. The blood changes returned to normal after stopping treatment.
• Patients on larger doses of amoxicillin or who have impaired kidney function may experience fits.
• Crystals in the urine, which may be seen as cloudy urine, or difficulty or discomfort in passing urine. Make sure you drink plenty of fluids to reduce the chance of these symptoms
• Liver problems and jaundice with symptoms of skin or whites of the eyes turning yellowish, urine becoming darker or faeces become very pale.
• A rise in liver enzymes found during blood tests, although the significance of this is unclear
• Muscle spasms
• Dizziness
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard. By reporting side affects you can help provide more information on the safety of this medicine.
5. How to store Amoxicillin Capsules:
Keep out of the reach and sight of children.
Store in the original packaging.
Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month.
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 protect the environment.
6. Further information
What Amoxicillin Capsules contain:
The active substance in this medicine is called amoxicillin and is present as amoxicillin trihydrate.
Amoxicillin 250mg capsules contain 250mg amoxicillin trihydrate and Amoxicillin 500mg capsules contain 500mg amoxicillin trihydrate.
The other ingredients are colloidal anhydrous silica and magnesium stearate.
The capsule shells contain; gelatin, sunset yellow (E110), carmosine (E122), brilliant blue (E133), tartrazine (E102) and titanium dioxide (E171).
What Amoxicillin Capsules look like and contents of the pack:
Amoxicillin 250 mg and 500 mg Capsules are maroon and yellow capsules which are supplied in blister packs of 3, 6, 12, 15, 21, 50 capsules and pots of 500 capsules (250 mg), 100 capsules (500 mg)
Marketing Authorisation Holder and Manufacturer MEDREICH PLC,
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK E-mail : info@medreich.co.uk
PL 21880/0001 PL 21880/0002
POM
This leaflet was last updated: June 2013.
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