Patient leaflet - Amoxicillin 250 mg / 5 ml oral suspension
1. What Amoxicillin Oral Suspension is and what it is used for
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 infections caused by bacteria in different parts of the body. It may also be used in combination with other medicines to treat stomach ulcers.
2. What you need to know before you take Amoxicillin Oral Suspension
Do not take Amoxicillin Oral Suspension if:
- you are allergic to amoxicillin, penicillin or any of the other ingredients of this medicine (listed in section 6). (An allergic reaction may be recognised as shortness of breath, blocked nose, rash, itching, swollen throat, face or lips).
- you have ever had an allergic reaction to another penicillin antibiotic or any other antibiotic in the past.
Do not take Amoxicillin Oral Suspension if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking Amoxicillin.
Warnings and precautions
Talk to your doctor before taking Amoxicillin Oral Suspension if:
- you have glandular fever (a viral infection which causes fever, sore throat, swollen glands and extreme high temperature, tiredness, muscle pains and headache)
- you are not passing water (urine) regularly
- you suffer from any kidney problems.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amoxicillin Oral Suspension. Conditions you need to look out for
Amoxicillin Oral Suspension can make some existing conditions worse, or cause serious side effects, such as severe allergic reactions, chest pain, serious skin reactions, repetitive vomiting within 1 to 4 hours of Amoxicillin administration or severe diarrhoea (pseudomembranous colitis). You must look out for certain symptoms while you are receiving Amoxicillin to help reduce the risk of any problems (see section 4).
Amoxicillin Oral Suspension can cause a serious immune system condition, in which the part of the body that fights disease is overactive, and this condition can be life-threatening. If you have any of the symptoms listed under ‘Conditions you need to look out for’ while taking Amoxicillin Oral Suspension, contact your doctor straight away.
Urine, blood or other tests
If you are having tests on your water (urine glucose tests), blood tests for liver function or Oestriol test (used during pregnancy to check the baby is developing normally). Tell your the doctor or nurse that you are taking this medicine as it can affect the results of these tests.
Other medicines and Amoxicillin Oral Suspension
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:
- probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
- allopurinol (used to treat gout), as it may be more likely that you will have an allergic skin reaction if taken with amoxicillin
- medicines to help stop blood clots (such as warfarin) as extra blood tests may be needed when taken with amoxicillin
- other antibiotics (such as tetracycline), as amoxicillin may be less effective
methotrexate (used for the treatment of cancer and severe
psoriasis), penicillins may reduce the excretion of methotrexate causing a potential increase in side effects. 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 taking this medicine. Driving and using machines
Amoxicillin can have side effects and the symptoms (such as allergic reactions, dizziness and convulsions) may make you unfit to drive. Do not drive or operate machinery unless you are feeling well.
Amoxicillin Oral Suspension contains sucrose & E219
Each 5ml dose of the medicine contains 3.13g 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 sodium methyl parahydroxybenzoate (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 take this medicine exactly as your doctor has told you. The pharmacist's label will tell you how much medicine to take and how often to take it. Check with your doctor or pharmacist if you are not sure.
Dosage:
Children weighing less than 40 kg
All doses are worked out depending on the child’s body weight in kilograms.
- Your doctor will advise you how much Amoxicillin you should give to your baby or child.
- The usual dose is 40 mg to 90 mg for each kilogram of body weight a day given in two or three divided doses.
- The maximum recommended dose is 100 mg for each kilogram of body weight a day.
Adults, elderly patients and children weighing 40 kg or more
This suspension is not usually prescribed for adults and children weighing more than 40kg. Ask your doctor or pharmacist for advice.
Kidney problems
If you have kidney problems the dose might be lower than the usual 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.
If you take more Amoxicillin Oral Suspension than you should
If you have taken too much Amoxicillin oral suspension, signs might be an upset stomach (feeling sick, being sick or diarrhoea) or crystals in the urine, which may be seen as cloudy urine, or problems urinating.
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 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, wait about 4 hours before taking the next dose.
Do not take a double dose to make up for a forgotten dose. If you stop taking Amoxicillin Oral Suspension
- Keep taking this medicine for as long as your doctor has told you to, even if you feel better. You need every dose to help fight the infection. If some bacteria survive they can cause the infection to come back.
- Once you finish treatment, if you still feel unwell you should go back to see the doctor. Sometimes an infection caused by bacteria does not respond to acourse of amoxicillin. Thrush (a yeast infection of moist areas of the body which can cause
Product: Amoxicillin 250mg/5ml Oral Solution
soreness, itching and white discharge) may develop if Amoxicillin oral suspension is used for a long time. If this occurs tell your doctor.
If you take this medicine for a long time, your doctor may perform additional tests to check your kidneys, liver and blood are working normally.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and tell your doctor straight away if you notice any of the following serious side effects
- you may need urgent medical treatment:
The following are very rare (may affect up to 1 in 10,000 people):
- allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue, body or difficulty in breathing. These may be signs of a severe allergic reaction these can be serious and occasionally death have occurred.
- chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome
- 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. It can be associated with joint pain (arthritis) and kidney problems
- 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 especially under the arms. These symptoms may also be due to a severe allergic reaction called DRESS syndrome with additional changes in the blood and liver or kidney function
- a skin reaction known as ‘erythema multiforme’ where you may develop: itchy reddish purple patches on the skin especially on the palms of the hands or soles of the feet, ‘hive-like’ raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and genitals. You may have a fever and be very tired
- blistering of the skin, mouth, eyes and genitals, other serious skin reactions including itchy reddish purple patches on the skin colour, bumps under the skin, blistering, hives, pustules, swelling, peeling, redness, pain, itching and scaling. These may be associated with fever, tiredness, headache and aching body
- flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
- a red rash commonly seen on both sides of buttocks, upper inner thighs, armpits, neck [Symmetrical Drug-Related Intertriginous and Flexural Exanthema (SDRIFE)]
- fever, chills, a sore throat or other signs of an infection, or if you bruise easily. These may be signs of a problem with your blood cells
- repetitive vomiting (1 to 4 hours after Amoxicillin administration), stomach pain, abnormal drowsiness, diarrhoea and low blood pressure which can be a sign of a serious allergic reaction called drug induced enterocolitis syndrome
- 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)
- the Jarisch-Herxheimer reaction which occurs during treatment with Amoxicillin for Lyme disease and causes fever, chills, headache, muscle pain and skin rash
- serious immune system condition (haemophagocytic lymphohistiocytosis/macrophage activation syndrome). Signs include: fever, skin rashes, problems related to nerves, such as shaking or tremor, confusional state, upper abdominal pain, yellowing of the skin and/or eyes, swollen glands in the neck, armpit and/or groin, bleeding and/or bruising more easily; looking pale, feeling tired.
- Serious liver side effects may occur. They are mainly associated with people having treatment over a long period, males and the elderly. You must urgently tell your doctor if you get: yellowing of the skin or whites of the eyes (jaundice), See also anaemia below which might result in jaundice, pale stools and dark urine, loss of appetite, severe diarrhoea with bleeding, blisters, redness or bruising of the skin, stomach discomfort caused by liver or blood problems. These can happen when taking the medicine or for up to several weeks after. If any of the above happens stop taking the medicine and see your doctor straight away.
Sometimes you may get less severe skin reactions such as:
- a mildly itchy rash (round, pink-red patches), ‘hive-like’ swollen areas on forearms, legs, palms, hands or feet. This is uncommon (may affect up to 1 in 100 people).
Tell your doctor or pharmacist if you notice any of the side effects listed in the following sections:
Common: may affect up to 1 in 10 people
- diarrhoea, feeling sick (nausea)
- skin rash.
Uncommon: may affect up to 1 in 100 people
- being sick (vomiting).
Very rare: may affect up to 1 in 10,000 people
- an excessive breakdown of red blood cells causing a type of anaemia. Signs include: 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), you can get treatment for thrush from your doctor or pharmacist
- 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
- Chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome)
- Drug-induced enterocolitis syndrome (DIES):
- DIES has been reported mainly in children receiving amoxicillin. It is a certain kind of allergic reaction with the leading symptom of repetitive vomiting (1-4 hours after drug intake). Further symptoms could comprise abdominal pain, lethargy, diarrhoea, and low blood pressure.
- crystals in the urine leading to acute renal injury which may cause cloudy urine or difficulty or discomfort when passing urine (make sure you drink plenty of fluids to reduce the chance of these symptoms)
- Rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease)
- serious immune system condition (haemophagocytic lymphohistiocytosis/macrophage activation syndrome)
- Inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis)
- the tongue may change to yellow, brown or black and it may have a hairy appearance
- low number of white blood cells
- an increase in the length of time it takes to stop bleeding if you cut yourself or have a nosebleed
- low number of cells involved with blood clotting
- high blood level of protein that stores iron in the body
- high blood levels of triglycerides
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: www.mhra.qov.uk/yellowcard or by searching for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Amoxicillin Oral Suspension
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Dry powder: Store in a cool, dry place.
Oral suspension: Store in a cool, dry place. Once made up the suspension should be used within 7 days.
Do not transfer your medicine to another container. Do not use this medicine if there are visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Amoxicillin Oral Suspension contains
Each 5 ml of oral suspension contains 250 mg of the active ingredient, amoxicillin (as trihydrate). The other ingredients are sucrose, carmellose sodium, sodium citrate, colloidal anhydrous silica, quinoline yellow lake (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 Amoxicillin Oral Suspension looks like and contents of the pack
After preparation the medicine is a pale yellow coloured suspension. The bottle contains 100 ml of medicine. Marketing Authorisation Holder
Crescent Pharma Ltd, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hampshire RG25 3ED, UK. Manufacturer
Crescent Manufacturing Ltd, 2 Cunard Road, Park Royal, London, NW10 6PN, UK.