Patient leaflet - Amoxicillin oral suspension BP 125 mg / 5 ml
1. WHAT AMOXICILLIN IS AND WHAT IT IS USED FOR
PATIENT INFORMATION LEAFLET AMOXICILLIN ORAL SUSPENSION
125 mg/5 ml AND 250 mg/5 ml
Read this leaflet carefully BEFORE you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Amoxicillin is
Amoxicillin is one of a group of antibiotic medicines called penicillins.
What Amoxicillin is used for
Amoxicillin kills bacteria by interfering in the manufacture of the bacterial cell wall.
Amoxicillin can treat a wide range of bacterial infections including the following:
- chest (bronchitis or pneumonia)
- tonsils (tonsillitis)
- sinuses (sinusitis)
- heart (endocarditis)
- blood (septicaemia)
- kidneys
- ears (otitis media)
- the bladder or the urethra (the tube which carries urine from the bladder),
- infections associated with pregnancy and childbirth (puerperal sepsis and septic abortion)
- abdomen (intra-abdominal sepsis and peritonitis)
- skin, bone, teeth and gums (abscesses).
Amoxicillin can also be used to treat:
- gonorrhoea (a sexually transmitted infection)
- typhoid and paratyphoid (fevers caused by a group of bacteria called Salmonella).
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AMOXICILLIN
Amoxicillin may also be used in combination with other medicines to treat stomach ulcers.
Do not take Amoxicillin if:
- You are allergic to Amoxicillin, penicillin or any of the other ingredients of this medicine (listed in section 6)
- You have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or throat
- You are pregnant, planning to become pregnant or breast feeding.
- You have an intolerance to some sugars (hereditary fructose intolerance)
Prolonged use of an antibiotic may result in infections due to bacteria resistant to the antibiotic.
This medicinal product contains sucrose and sodium benzoate. Sucrose is broken down in the digestive system, by substances called enzymes, into glucose and fructose and thus is unsuitable for patients who suffer from fructose intolerance, glucose-galactose malabsorption syndrome(faulty absorption from the digestive tract) or a deficiency in the enzyme which breaks down sucrose.
Sodium benzoate may increase the risk of jaundice (yellowing of the skin or the whites of the eyes) in newborn babies.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin if:
- You suffer from kidney disease or kidney problems, as you may require a lower dose than normal
- You are not passing urine regularly
- You have glandular fever (fever, sore throat, swollen glands and extreme tiredness)
If you are not sure if any of the any of the above apply to you, talk to your doctor or pharmacist before taking Amoxil.
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, 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).
Having urine or blood tests:
- If you are having urine tests for diabetes (sugar in the urine) or blood tests for liver function
- Oestriol tests (used during pregnancy to check the baby is developing normally)
Tell your doctor you are taking amoxicillin. This is because amoxicillin can affect the results of these tests.
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, even those not prescribed by a doctor. In particular tell your doctor if you are taking any of the following:
- Anticoagulants e.g. warfarin, phenindione, you may need extra blood tests.
3. HOW TO TAKE AMOXICILLIN
- Chemotherapy drugs e.g. methotrexate Amoxicillin may cause an increase in side effects.
- Drugs used to treat gout (which can be caused by the build-up of uric acid) e.g. probenecid (used to treat gout), allopurinol, sulfinpyrazone. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
- Methotrexate (used for the treatment of cancer and severe psoriasis) penicillins may reduce the excretion of methotrexate causing a potential increase in side effects.
- Some other antibiotics (e.g. neomycin and tetracyclines can reduce the effect of amoxicillin)
- Oral typhoid vaccine (may not work if taken with amoxicillin)
- Some penicillins may increase the effects of muscle relaxing drugs given as part of an anaesthetic for surgery. Tell the doctor you are taking amoxicillin if you need to have an anaesthetic.
Pregnancy and breast-feeding
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 and sodium
125mg suspension: Each 5 ml of suspension contains 2.59 g sucrose and a total of 6.1 mg sodium.
250 mg suspension: Each 5 ml of suspension contains 2.3 g sucrose and a total of 6.5 mg sodium.
Always take your medicine exactly as your doctor or pharmacist has told you. The pharmacist's label should tell you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist.
The maximum daily dose is 6 g given in divided doses.
Dosage:
Note: One teaspoon is equivalent to 5ml Adults (including the elderly):
- The usual dose for most infections is 5ml of 250mg/5ml to be taken 3 times a day.
- For more serious infections the dose may be doubled to 10ml of 250mg/5ml 3 times a day.
High doses may be given in the following conditions:
- For severe or recurrent chest infections a dose of 3 g twice daily given orally is usually recommended
- For simple urinary tract infections the adult dose is two 3g doses given orally with 10 to 12 hours between doses (short course)
- For the treatment of dental abscesses two 3 g doses given orally with 8 hours between doses is recommended
- For gonorrhoea a single 3g dose given orally is recommended
4. POSSIBLE SIDE EFFECTS
The following are the usual adult dosages for preventing infection during dental or other surgery:
- If a general anaesthetic is not used, 3g given orally one hour before surgery and another dose six hours later if necessary
- If a general anaesthetic is used, 3g given orally four hours before anaesthesia and 3g six hours after the initial dose
Children:
- Children weighing more than 40kg should be given the usual adult dosage
- Children under 40kg:
- The usual dose for most infections is 5ml of 125mg/5ml to be given 3 times a day (or 2.5ml of 250mg/5ml 3 times a day).
- For more serious infections the dose may be doubled to 10ml of 125mg/5ml 3 times a day (or 5ml of 250mg/5ml 3 times a day).
- In severe or frequent ear infections, a dose of 750mg (15 ml of the 250mg/5ml) may be given twice a day for two days in children aged 3 to 10 years
- The dose for preventing infection during dental procedures or other surgery is 1.5g given orally one hour before surgery
Kidney problems
If you have kidney problems the dose might be lower than the usual dose.
If you take more Amoxicillin that you should
If you have taken too much Amoxil, 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.
If you stop taking Amoxicillin
Keep taking this medicine until it is finished or your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, some bacteria may survive and cause the infection to come back, or your condition may re-occur or get worse. You should make sure you have several drinks of water each day unless told otherwise by your doctor.
If you are still unwell after taking all the medicine, go and see your doctor. Never take more than the recommended dose each day.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious events STOP taking your medicine, tell your doctor or go to your nearest hospital immediately:
The following reactions have been reported but the frequency is unknown (the frequency cannot be estimated from the available data):
- 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.
- Rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease)
- Crystals in urine leading to acute renal injury
- Inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis)
The following are very rare (may affect up to 1 in 10,000 people).
- Hypersensitivity or severe allergic reaction including skin itching or rash, swollen face, lips tongue, body or breathing problems. These can be serious and occasionally deaths have occurred.
- Repetitive vomiting (1-4 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
- rash or pinpoint flat red spots under the skin surface or bruising of the skin. This is due to inflammation of the 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
- Inflammation of the large bowel (colon) with severe diarrhoea with bleeding, pain and fever
- Allergic skin reactions with itching e.g. changes in skin colour, bumps under the skin, pustules, hives, nettle rash, blistering, scaling or peeling of the skin. These may be associated with fever, headaches and body aches. If you start to itch or get a rash, STOP taking amoxicillin and tell your doctor immediately.
- Flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eoshophilia) and liver enzymes) [Drug reactions 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 a sign 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.
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:
- Notice your urine becoming darker or your faeces becoming paler
- Severe diarrhoea with bleeding
- Notice your skin or the white of your eyes turning yellow (jaundice). See also anaemia below which might result in jaundice.
- Convulsions may occur in patients on high doses or with kidney problems
5. HOW TO STORE AMOXICILLIN
6. CONTENTS OF THE PACK AND OTHER INFORMATION
- Difficulty or discomfort in passing urine or having cloudy urine
The following symptoms are less serious but you may wish to discuss them with your doctor or pharmacist if they become troublesome or last a long time.
Common side effects of amoxicillin (i.e. more than 1 in 100 people):
- Nausea (feeling sick) or diarrhoea
- Skin rash
Uncommon side effects (i.e. between 1 in 100 and 1 in 1,000 people):
- Vomiting
- a mildly itchy rash (round, pink-red patches), ‘hive-like’ swollen areas on forearms, legs, palms, hands or feet.
Very rare side effects (i.e. less that 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
- Hyperactivity
- Tooth discolouration. The colour usually returns to normal with brushing
- the tongue may change to yellow, brown or black and it may have a hairy appearance
- Inflammation of the kidney
- Excessive body movements (hyperkinesia) or dizziness
- Reduction (reversible) in blood cell counts including anaemia (a reduction in the body’s red blood cells or haemoglobin which may be characterised by feeling weak or light- headed) or a longer time taken for blood to clot.
- low number of white blood cells
Not known (frequency cannot be estimated from available data)
- Meningitis (signs may include stiff neck, fever and vomiting)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 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.
KEEP ALL MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use this medicine after the expiry date which is printed on the pack. This medicine should be used within 14 days of the date dispensed.
Store below 25°C in a dry place, away from direct light.
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.
The pharmacist will prepare the suspension for you by adding water to the dry powder.
What Amoxicillin looks like and contents of the pack
Amoxicillin oral suspension 125 mg/5ml: Yellow, lemon flavoured suspension. Each 5 ml contains amoxicillin trihydrate equivalent to 125 mg amoxicillin, the active ingredient.
Amoxicillin oral suspension 250 mg/5ml: Yellow, lemon flavoured suspension. Each 5 ml contains amoxicillin trihydrate equivalent to 250 mg amoxicillin, the active ingredient.
The suspension also contains the inactive ingredients saccharin sodium, sodium citrate, colloidal anhydrous silica, microcrystalline cellulose and carboxymethylcellulose sodium, preservative (sodium benzoate, E211), lemon flavour, sucrose, water and colour (quinoline yellow, E104).
Pack sizes: 60ml and 100ml bottles.
MA Holder/Manufacturer: Kent Pharmaceuticals Limited, Connect 38, 1, Dover Place, Ashford, Kent, United Kingdom, TN23 1FB.
Distributed by: Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL
Marketing authorisation numbers:
Amoxicillin Oral Suspension 125 mg/5 ml: PL 08215/0167 Amoxicillin Oral Suspension 250 mg/5 ml: PL 08215/0168
This leaflet was last revised in: September 2025