Patient leaflet - Amoxicillin 250 mg/5 ml oral suspension BP
1. What this medicine is and what it is used for
Amoxicillin is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called 'penicillin'.
Amoxicillin is used to treat infections caused by bacteria in different parts of the body. Amoxicillin may also be used in combination with other medicines to treat stomach ulcers.
2. What you need to know before you take this medicine
Do not take this medicine if you:
- are allergic to amoxicillin, PENICILLINS, cephalosporins or to any of the other ingredients of this medicine (listed in section 6).
have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the
face or throat.
Do not take Amoxicillin 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 or pharmacist before taking Amoxicillin if you:
- have glandular fever (fever, sore throat, swollen glands and extreme tiredness)
- have kidney problems
- are not urinating regularly.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amoxicillin. Conditions you need to look out for
Amoxicillin 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).
Blood and urine tests
If you are having:
- Urine tests (glucose) or blood tests for liver function
- Oestriol tests (used during pregnancy to check the baby is developing normally) Tell your doctor or pharmacist that you are taking Amoxicillin. This is because Amoxicillin can affect the results of these tests
Other medicines and Amoxicillin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- If you are taking allopurinol (used for gout) with Amoxicillin, it may be more likely that you will have an allergic skin reaction.
- If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Amoxicillin.
If you are taking medicines to help stop blood clots (such as warfarin), you may need extra blood tests.
- If you are taking other antibiotics (such as tetracycline) Amoxicillin may be less effective.
- Methotrexate (used to treat 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 sunset yellow, sucrose, sodium benzoate and sodium
- Sucrose: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
- This medicine also contains sunset yellow (E110) which may cause allergic reactions.
- Sodium benzoate: This medicine contains 4.82 mg sodium benzoate in each 5 ml which is equivalent to 0.964 mg per ml.
- Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially 'sodium-free'.
3. How to take this medicine
- Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
- Shake bottle well before each dose.
Space the doses evenly during the day, at least 4 hours apart
The usual dose is:
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 40 kg. Ask your doctor or pharmacist for advice.
Kidney problems
If you have kidney problems the dose might be lower than the usual dose.
If you take more Amoxicillin than you should
If you have taken too much Amoxicillin, 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. Talk to your doctor as soon as possible. Take the medicine to show the doctor.
If you forget to take Amoxicillin
- If you forget to take a dose, take it as soon as you remember.
- Do not take the next dose too soon, wait about 4 hours before taking the next dose.
- Do not take a double dose to make up for a forgotten dose.
How long should you take Amoxicillin for?
- Keep taking Amoxicillin 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. Thrush (a yeast infection of moist areas of the body which can cause soreness, itching and white discharge) may develop if Amoxicillin is used for a long time. If this occurs tell your doctor.
If you take Amoxicillin 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 or pharmacist.
4. Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Amoxicillin and see a 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 breathing difficulties. These can be serious and occasionally deaths have occurred
- chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome
- 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
- a red rash commonly seen on both sides of buttocks, upper inner thighs, armpits, neck [Symmetrical Drug-Related Intertriginous and Flexural Exanthema (SDRIFE)]
- rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems
- a delayed allergic reaction can occur usually 7 to 12 days after having Amoxicillin, some signs include: rashes, fever, joint pains and enlargement of the lymph nodes especially under the arms
- 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
- other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches and body aches
- 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)).
- 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
- the Jarisch-Herxheimer reaction which occurs during treatment with Amoxicillin for Lyme disease and causes fever, chills, headache, muscle pain and skin rash.
- inflammation of the large bowel (colon) with diarrhoea (sometimes containing blood), pain and fever
serious liver side effects may occur. They are mainly associated with people having treatment over a long period, males and the elderly. You must tell your doctor urgently if you get:
o severe diarrhoea with bleeding
o blisters, redness or bruising of the skin
o darker urine or paler stools
o yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might result in jaundice.
These can happen when having 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). If you have any of these talk to your doctor as Amoxicillin will need to be stopped. The other possible side effects are:
Common (may affect up to 1 in 10 people)
- skin rash
- feeling sick (nausea)
- diarrhoea.
Uncommon (may affect up to 1 in 100 people)
- being sick (vomiting).
Very rare (may affect up to 1 in 10,000 people)
- thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your doctor or pharmacist
- kidney problems
- fits (convulsions), seen in patients on high doses or with kidney problems
- dizziness
- hyperactivity
- teeth may appear stained, usually returning to normal with brushing (this has been reported in children)
- the tongue may change to yellow, brown or black and it may have a hairy appearance
- an excessive breakdown of red blood cells causing a type of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes
- low number of white blood cells
- low number of cells involved with blood clotting
- the blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or cut yourself.
- Crystals in urine leading to acute renal injury, 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
- Rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease)
Inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis)
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 Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store this medicine
- Keep this medicine out of the sight and reach of children.
- Store in a cool dry place, below 25°C.
- Do not use this medicine after the expiry date shown on the label 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 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
- There are two strengths available, each 5ml of the suspension either contains 125mg or 250mg of the active ingredient Amoxicillin (as amoxicillin trihydrate).
- The other ingredients are: sodium benzoate (E211), disodium edetate, sodium citrate, flavour orange/bramble, sunset yellow (E110) and sucrose.
Amoxicillin Oral Suspension is a citrus flavoured suspension.
Amoxicillin Oral Suspension is presented as a powder in bottles for preparing 100ml of suspension. Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, United Kingdom, HP4 1EG
Telephone: 0044 (0)1442 200922
Fax: 0044(0)1442 873717
Email: info@bristol-labs.co.uk
Amoxicillin 250mg/5ml Oral Suspension BP; PL 17907/0009
This leaflet was last revised in December 2024
To request a copy of this leaflet in Braille, large print or audio format, please contact the marketing authorisation holder at the address (or telephone, fax, email) above.
MA Holder :
BN:
EXP:
TO THE PHARMACIST: To
prepare, add 58ml of potable
water and shake until all the
powder is dispersed.
Each 5ml contains 250mg
Amoxicillin (as trihydrate) as
the active ingredient.
Also contains Sucrose, Sodium
benzoate and Sunset yellow
(E110). See leaflet for further
information.
TO THE PATIENT: For oral
use. Use as instructed by a
physician. Read the package
leaflet before use. Keep the
container tightly closed. Shake
well before each use. Use
within 7 days of preparation.
Complete the prescribed
course of treatment.
Keep this medicine out of the
sight and reach of children.
Store in a cool dry place, below
25°C.
TO THE PHARMACIST: To prepare,
add 58ml of potable water and shake
until all the powder is dispersed.
Each 5ml contains 250mg Amoxicillin
(as trihydrate) as the active
ingredient.
Also contains Sucrose, Sodium
benzoate and Sunset yellow (E110).
See leaflet for further information.
TO THE PATIENT: For oral use. Use
as instructed by a physician. Read
the package leaflet before use. Keep
the container tightly closed. Shake
well before each use. Use within 7
days of preparation. Complete the
prescribed course of treatment.
Keep this medicine out of the sight
and reach of children.
Store in a cool dry place, below 25°C.
5 060013 940194
PL 17907/0009
ATD - Pilfer proof cap.
Amoxicillin #bej mg _/ #e ml Oral Suspension
Amoxicillin #bej mg _/ #e ml Oral Suspension
Amoxicillin
#250 mg /
#5 ml Oral
Suspension