Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Amoxicillin Sugar Free 125 mg/ 5 ml Powder for Oral Suspension

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Amoxicillin trihydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Amoxicillin trihydrate

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

What Amoxicillin Sugar Free Suspension is Amoxicillin Sugar Free Suspension is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called 'penicillin'. What Amoxicillin Sugar Free Suspension is used for Amoxicillin Sugar Free Suspension is used to treat infections caused by bacteria in different parts of the body. Amoxicillin Sugar Free Suspension may also be used in combination with other medicines to treat stomach ulcers.

2.

What you need to know before you take it

e Amoxicillin Sugar Free Suspension

Do not take Amoxicillin Sugar Free Suspension:  

if you are allergic to amoxicillin, penicillin or any of the other ingredients of this medicine (listed in section 6) if you 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 Sugar Free Suspension if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking Amoxicillin Sugar Free Suspension. Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicillin Sugar Free Suspension if you:  have infectious mononucleosis (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 Sugar Free Suspension. Blood and urine tests If you are having :  urine tests (glucose), 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 Sugar Free Suspension. This is because Amoxicillin Sugar Free Suspension can affect the results of these tests. Other medicines and Amoxicillin Sugar Free Suspension 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 Sugar Free Suspension, it may be more likely that you will have an allergic skin reaction.  If you are taking probenecid, (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended. your doctor may decide to adjust your dose of Amoxicillin Sugar Free Suspension.  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 Sugar Free Suspension may be less effective.  If you are taking methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate causing a potential increase in side effects. 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 any medicine. Driving and using machines Amoxicillin Sugar Free Suspension 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. Important information about some of the ingredients of Amoxicillin Sugar Free Suspension 

This medicine contains sorbitol (E420). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Sodium benzoate (E211) is a mild irritant to the eyes, skin and mucous membrane and can cause an increased risk of jaundice in new born babies. 

This medicine contains less than 1 mmol sodium (23 mg) per ml that is to say essentially 'sodium-free'.

3.

How to take it

Amoxicillin Sugar Free Suspension

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 dose evenly during the day, at least 4 hours apart

The recommended dose is: Children weighing less than 40kg: 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 bodyweight a day given in two to 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. How long should you take Amoxicillin Sugar Free Suspension  

Keep taking Amoxicillin Sugar Free Suspension 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 Sugar Free Suspension is used for a long time. If this occurs tell your doctor. If you take Amoxicillin Sugar Free Suspension for a long time, your doctor may perform additional tests to check your kidneys, liver and blood are working normally. If you take more Amoxicillin Sugar Free Suspension than you should If you take too much Amoxicillin Sugar Free 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. Talk to your doctor as soon as possible. Take the medicine to show the doctor. If you forget to take Amoxicillin Sugar Free Suspension   

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 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 Sugar Free Suspension 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  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 Sugar Free Suspension, 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  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:  severe diarrhoea with bleeding  blisters, redness or bruising of the skin  darker urine or paler stools  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. The following side effects occur with undetermined frequency (frequency cannot be estimated from the available data):    

the Jarisch-Herxheimer reaction which occurs during treatment with Amoxicillin for Lyme disease and causes fever, chills, headache, muscle pain and skin rash. Chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome). A red rash, often occurring on both sides of the buttocks, inner thighs, armpits, and neck (symmetric drug-induced intertriginous and flexural exanthema (SDRIFE)). 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 administration). Further symptoms could comprise abdominal pain, lethargy, diarrhoea, and low blood pressure.

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 middle 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 Sugar Free Suspension 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 form 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 in 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. Not known (cannot be estimated from the available data)  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)  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 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 at 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 it

Amoxicillin Sugar Free Suspension

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date shown on the bottle and the carton after EXP. The expiry date refers to the last day of that month.

This medicine should be stored in a dry place in the container supplied. Do not transfer it to another container. Dry Powder: Store powder in a dry place below 25°C. Reconstituted Suspension: Store upto 14 days at 2°C – 8°C in a refrigerator. Keep the medicine in its original bottle. This medicine should not be used beyond 14 days from when it was dispensed. If dilution of the reconstituted product is required, water should be used. 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 to protect the environment.

6.

Contents of the pack and other information

What Amoxicillin Sugar Free Suspension contains: Amoxicillin Sugar Free suspension comes in two strengths containing either 125 mg or 250 mg of amoxicillin in each 5 ml. The active substance is amoxicillin This medicine is supplied to your pharmacist as a powder. The pharmacist will have made it into a suspension before it is given to you. The other ingredients are disodium edetate, sodium benzoate (E211), sodium saccharin, colloidal silicon dioxide, xanthan gum (E415), orange and raspberry flavours, golden caramel and sorbitol (E420). Each 5 ml dose of Amoxicillin Sugar Free 125 mg suspension contains 1.39 mg of sodium and 295 mg of sorbitol. Each 5 ml dose of Amoxicillin Sugar Free 250 mg suspension contains 2.78 mg of sodium and 590 mg of sorbitol What Amoxicillin Sugar Free Suspension looks like and contents of the pack Amoxicillin Sugar Free suspension comes in a carton with 150ml HDPE bottle containing white to pale yellow powder which produces a pale yellow to yellow coloured suspension upon reconstitution with or without a dosing syringe of 5ml. Marketing Authorisation Holder and Manufacturer Brown & Burk UK Ltd 5 Marryat Close Hounslow West Middlesex TW4 5DQ UK. This medicinal product is authorised in the Member States of the EEA under the following names: United Kingdom: Amoxicillin Sugar Free 125mg/ 5 ml & 250mg/5 ml Powder for Oral Suspension Germany: Amoxicillin-Micro Labs 125 mg/ 5 ml & 250mg/5 ml Pulver zur Herstellung einer Suspension zum Einnehmen

This leaflet was last approved on 10/2025

General advice regarding the use of antibiotics Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses. Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the commonest reasons for this to occur is because the bacteria causing the infection are resistant to the antibiotic that is being taken. This means that they can survive and even multiply despite the antibiotic. Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them. When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working. 1.

2. 3. 4. 5.

It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days. Read the instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain. You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the infection for which it was prescribed. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours. You should not give antibiotics that were prescribed for you to other people. If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.

————————————————————————————————————————–Instructions for reconstitution For the bottle without marking 125mg/5ml: Add 92ml of water to reconstitute the product. Close the cap securely. Shake the bottle vigorously to dissolve the content. The product appears pale yellow to yellow colored suspension with fruity aromatic odor after reconstitution. 250mg/5ml: Add 88ml of water to reconstitute the product. Close the cap securely. Shake the bottle vigorously to dissolve the content. The product appears pale yellow to yellow colored suspension with fruity aromatic odor after reconstitution. For the bottle with marking For 125 mg/5 ml: 1. Preparation of the ready-to-use suspension.Check before use that the cap is intact. Turn the bottle over and shake bottle to dissolve the powder. 2. Fill the bottle with water to just below the mark on the bottle. Turn the bottle over and shake vigorously. Then fill up with water to the mark. Turn the bottle over and shake it again. This gives 100 ml ready to use suspension.

3. Shake the bottle immediately before each withdrawal.

Close the bottle well after each use. An indication of the dose (40 mg to 90 mg per kg of body weight per day, administered in three divided doses) of the ready-to-use suspension in children is given in the following tableWeight of the child in kg

About age

5 6 – 7.5 8 – 10 11 – 15

Up to 3 months 3 – 6 months 6 – 12 months 1 – 3 years

Daily dose at 40- 90 mg per kg body weight 100 – 225 mg 120 – 337.5 mg 160 – 450 mg 220- 675 mg

16 – 20

3 – 6 years

320 – 900 mg

Volume (ml) per day 3 times daily, 1.5 ml – 3 ml 3 times daily, 2 ml – 4.5 ml 3 times daily, 2.5 ml – 6 ml 3 times daily, 3 ml – 9 ml 3 times daily, 4.5 ml – 12 ml

1 ml of the ready-to-use suspension corresponds to 25 mg amoxicillin. For 250 mg/5 ml: 1. Preparation of the ready-to-use suspension.Check before use that the cap is intact. Turn the bottle over and shake bottle to dissolve the powder. 2. Fill the bottle with water to just below the mark on the bottle. Turn the bottle over and shake vigorously. Then fill up with water to the mark. Turn the bottle over and shake it again. This gives 100 ml ready to use suspension. 3. Shake the bottle immediately before each withdrawal.

Close the bottle well after each use. An indication of the dose (40 mg to 90 mg per kg of body weight per day, administered in three divided doses) of the ready-to-use suspension in children is given in the following table-

Weight of the child in kg

About age

5 6 – 7.5 8 – 10 11 – 15

Up to 3 months 3 – 6 months 6 – 12 months 1 – 3 years

Daily dose at 40- 90 mg per kg body weight 200 – 400 mg 240 – 675 mg 320 – 900 mg 440 – 1350 mg

16 – 20

3 – 6 years

640 – 1800 mg

1 ml of the ready-to-use suspension corresponds to 50 mg amoxicillin.

Volume (ml) per day 3 times daily, 1.5 ml – 3 ml 3 times daily, 2 ml – 4.5 ml 3 times daily, 2.5 ml – 6 ml 3 times daily, 3 ml – 9 ml 3 times daily, 4.5 ml – 12 ml

Frequently asked questions about Amoxicillin Sugar Free 125 mg/ 5 ml Powder for Oral Suspension

How do I take Amoxicillin Sugar Free 125 mg/ 5 ml Powder for Oral Suspension?

Amoxicillin Sugar Free 125 mg/ 5 ml Powder for Oral Suspension comes as oral solution containing 125mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Amoxicillin Sugar Free 125 mg/ 5 ml Powder for Oral Suspension?

The active substance in Amoxicillin Sugar Free 125 mg/ 5 ml Powder for Oral Suspension is amoxicillin trihydrate.

Are there equivalent medicines to Amoxicillin Sugar Free 125 mg/ 5 ml Powder for Oral Suspension?

Medicines with the same active substance, strength and form include: Amoxicillin 125 mg/5 ml Powder for Oral Suspension Sugar Free. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Amoxicillin Sugar Free 125 mg/ 5 ml Powder for Oral Suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Amoxicillin Sugar Free 125 mg/ 5 ml Powder for Oral Suspension without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Amoxicillin trihydrate (24 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Amoxicillin Sugar Free Suspension is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1).

Acute bacterial sinusitis

Acute streptococcal tonsillitis and pharyngitis

Acute otitis media

Acute exacerbations of chronic bronchitis

Community acquired pneumonia

Acute Cystitis

Asymptomatic bacteriuria in pregnancy

Acute pyelonephritis

Typhoid and paratyphoid fever

Dental abscess with spreading cellulitis

Prosthetic joint infections

Helicobacter pylori eradication

Lyme disease

Amoxicillin is also indicated for the prophylaxis of endocarditis.

Consideration should be given to official guidelines on the appropriate use of antibacterial agents.

4.2. Posology and method of administration

Posology

The dose of Amoxicillin Sugar Free Suspension that is selected to treat an individual infection should take into account:

• The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)

• The severity and the site of the infection

• The age, weight and renal function of the patient; as shown below

The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible. Some infections require longer periods of treatment (see section 4.4 regarding prolonged therapy).

Adult and children ≥40 kg

Indication*

Dose*

Acute bacterial sinusitis

Asymptomatic bacteriuria in pregnancy

Acute pyelonephritis

Dental abscess with spreading cellulitis

Acute cystitis

250 mg to 500 mg every 8 hours or 750 mg to 1 g every 12 hours

For severe infections 750 mg to 1 g every 8 hours

Acute cystitis may be treated with 3 g twice daily for one day

Acute otitis media

500 mg every 8 hours, 750 mg to 1 g every 12 hours

For severe infections 750 mg to 1 g every 8 hours for 10 days

Acute streptococcal tonsillitis and pharyngitis

Acute exacerbations of chronic bronchitis

Community acquired pneumonia

500 mg to 1 g every 8 hours

Typhoid and paratyphoid fever

500 mg to 2 g every 8 hours

Prosthetic joint infections

500 mg to 1 g every 8 hours

Prophylaxis of endocarditis

2 g orally, single dose 30 to 60 minutes before procedure

Helicobacter pylori eradication

750 mg to 1 g twice daily in combination with a proton pump inhibitor (e.g. omeprazole, lansoprazole) and another antibiotic (e.g. clarithromycin, metronidazole) for 7 days

Lyme disease (see section 4.4)

Early stage: 500 mg to 1 g every 8 hours up to a maximum of 4 g/day in divided doses for 14 days (10 to 21 days)

Late stage (systemic involvement): 500 mg to 2 g every 8 hours up to a maximum of 6 g/day in divided doses for 10 to 30 days

*Consideration should be given to the official treatment guidelines for each indication

Children <40 kg

Children may be treated with Amoxicillin capsules, dispersible tablets, suspensions or sachets.

Amoxicillin Paediatric Suspension is recommended for children under six months of age.

Children weighing 40 kg or more should be prescribed the adult dosage.

Recommended doses:

Indication+

Dose+

Acute bacterial sinusitis

20 to 90 mg/kg/day in divided doses*

Acute otitis media

Community acquired pneumonia

Acute cystitis

Acute pyelonephritis

Dental abscess with spreading cellulitis

Acute streptococcal tonsillitis and pharyngitis

40 to 90 mg/kg/day in divided doses*

Typhoid and paratyphoid fever

100 mg/kg/day in three divided doses

Prophylaxis of endocarditis

50 mg/kg orally, single dose 30 to 60 minutes before procedure

Lyme disease (see section 4.4)

Early stage: 25 to 50 mg/kg/day in three divided doses for 10 to 21 days

Late stage (systemic involvement): 100 mg/kg/day in three divided doses for 10 to 30 days

+ Consideration should be given to the official treatment guidelines for each indication.

*Twice daily dosing regimens should only be considered when the dose is in the upper range.

Elderly

No dose adjustment is considered necessary

Renal impairment

GFR (ml/min)

Adults and children ≥ 40 kg

Children < 40 kg#

greater than 30

no adjustment necessary

no adjustment necessary

10 to 30

maximum 500 mg twice daily

15 mg/kg given twice daily

(maximum 500 mg twice daily)

less than 10

maximum 500 mg/day.

15 mg/kg given as a single daily dose (maximum 500 mg)

# In the majority of cases, parenteral therapy is preferred.

In patients receiving haemodialysis

Amoxicillin may be removed from the circulation by haemodialysis

Haemodialysis

Adults and children Over 40 kg

500 mg every 24 h

Prior to haemodialysis one additional dose of 500mg should be administered. In order to restore circulating drug levels, another dose of 500mg should be administered after haemodialysis.

Children under 40 kg

15 mg/kg/day given as a single daily dose (maximum 500 mg).

Prior to haemodialysis one additional dose of 15 mg/kg should be administered. In order to restore circulating drug levels, another dose of 15 mg/kg should be administered after haemodialysis.

In patients receiving peritoneal dialysis

Amoxicillin maximum 500 mg/day.

Hepatic impairment

Dose with caution and monitor hepatic function at regular intervals (see sections 4.4 and 4.8).

Method of administration

Amoxicillin is for oral use.

Absorption of Amoxicillin is unimpaired by food.

Therapy can be started parenterally according to the dosing recommendations of the intravenous formulation and continued with an oral preparation

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

4.3. Contraindications

Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients listed in section 6.1.

History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).

4.4. Special warnings and precautions for use

Hypersensitivity reactions

Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents (see sections 4.3 and 4.8).

Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction (see section 4.8). These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. If an allergic reaction occurs, amoxicillin therapy must be discontinued and appropriate alternative therapy instituted.

Drug-induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin (see section 4.8). DIES is an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after drug administration) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise abdominal pain, diarrhoea, hypotension or leucocytosis with neutrophilia. There have been severe cases including progression to shock.

Convulsions

Convulsions may occur in patients with impaired renal function or in those receiving high doses or in patients with predisposing factors (e.g. history of seizures, treated epilepsy or meningeal disorders (see section 4.8).

Non-susceptible microorganisms

Amoxicillin is not suitable for the treatment of some types of infection unless the pathogen is already documented and known to be susceptible or there is a very high likelihood that the pathogen would be suitable for treatment with amoxicillin (see section 5.1). This particularly applies when considering the treatment of patients with urinary tract infections and severe infections of the ear, nose and throat.

Crystalluria

In patients with reduced urine output, crystalluria (including acute renal injury) has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria. In patients with bladder catheters, a regular check of patency should be maintained (see sections 4.8 and 4.9).

Renal impairment

In patients with renal impairment, the dose should be adjusted according to the degree of impairment (see section 4.2).

Skin reactions

The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AGEP) (see section 4.8). This reaction requires amoxicillin discontinuation and contra-indicates any subsequent administration.

Amoxicillin should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.

Overgrowth of non-susceptible microorganisms

Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

Antibiotic-associated colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening (see section 4.8). Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibiotics. Should antibiotic-associated colitis occur, amoxicillin should immediately be discontinued, a physician consulted and an appropriate therapy initiated. Anti-peristaltic medicinal products are contra-indicated in this situation.

Prolonged therapy

Periodic assessment of organ system functions; including renal, hepatic and haematopoietic function is advisable during prolonged therapy. Elevated liver enzymes and changes in blood counts have been reported (see section 4.8).

Anticoagulants

Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see section 4.5 and 4.8).

Jarisch-Herxheimer reaction

The Jarisch-Herxheimer reaction has been seen following amoxicillin treatment of Lyme disease (see section 4.8). It results directly from the bactericidal activity of amoxicillin on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease.

Interference with diagnostic tests

Elevated serum and urinary levels of amoxicillin are likely to affect certain laboratory tests. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.

It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. The presence of amoxicillin may distort assay results for oestriol in pregnant women.

This medicine contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.

This medicinal product contains sodium benzoate (E211) which is a mild irritant to the eyes, skin and mucous membrane. May increase the risk of jaundice in new born babies.

Important information about excipients

• This medicine contains less than 1 mmol sodium (23 mg) per ml that is to say essentially 'sodium-free'.

4.5. Interaction with other medicinal products and other forms of interaction

Probenecid

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin.

Allopurinol

Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

Tetracyclines

Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.

Oral anticoagulants

Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction. However, in the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin. Moreover, adjustments in the dose of oral anticoagulants may be necessary (see sections 4.4 and 4.8).

Methotrexate

Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.

4.6. Fertility, pregnancy and lactation

Pregnancy:

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Limited data on the use of amoxicillin during pregnancy in humans do not indicate an increased risk of congenital malformations. Amoxicillin may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.

Breast-feeding:

Amoxicillin is excreted into breast milk in small quantities with the possible risk of sensitisation. Consequently, diarrhoea and fungus infection of the mucous membranes are possible in the breast-fed infant, so that breast-feeding might have to be discontinued. Amoxicillin should only be used during breast-feeding after benefit/risk assessment by the physician in charge.

Fertility:

There are no data on the effects of amoxicillin on fertility in humans

Reproductive studies in animals have shown no effects on fertility.

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines (see section 4.8).

4.8. Undesirable effects

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and skin rash.

The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin, presented by MedDRA System Organ Class are listed below.

The following terminologies have been used in order to classify the occurrence of undesirable effects

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1000 to <1/100)

Rare (≥1/10,000 to <1/1000),

Very rare (<1/10,000)

Not known (cannot be estimated from the available data).

Infections and infestations

Very Rare:

Mucocutaneous Candidiasis

Blood and lymphatic system disorders

Very rare:

Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia.

Prolongation of bleeding time and prothrombin time (see section 4.4)

Immune system disorders

Very rare:

Severe allergic reactions, including angioneurotic oedema, anaphylaxis (see section 4.4), serum sickness and hypersensitivity vasculitis.

Not known:

Jarisch-Herxheimer reaction (see section 4.4).

Nervous system disorders

Very rare:

Hyperkinesia, dizziness and convulsions (see section 4.4).

Not known;

Aseptic meningitis

Cardiac disorders

Not known:

Kounis syndrome (see section 4.4)

Gastrointestinal disorders

Clinical Trial Data

*Common:

Diarrhoea and nausea.

*Uncommon:

Vomiting.

Post-marketing Data

Very rare:

Antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis see section 4.4).

Black hairy tongue

Superficial tooth discolouration#

Not known:

Drug-induced enterocolitis syndrome (see section 4.4)

Hepato-biliary disorders

Very rare:

Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT.

Skin and subcutaneous tissue disorders

Clinical Trial Data

*Common:

Skin rash

*Uncommon:

Urticaria and pruritus

Post-marketing Data

Very rare:

Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS) (see section 4.4).

Not known:

Linear IgA disease, symmetrical drug-related intertriginous and flexural exanthema (SDRIFE) (baboon syndrome) (see section 4.4)

Renal and urinary tract disorders

Very rare:

Interstitial nephritis.

Not known:

Crystalluria (including acute renal injury) (see section 4.4 and 4.9)

*The incidence of these AE's was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.

# Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

Symptoms and signs of overdose

Gastrointestinal symptoms ( such as nausea, vomiting and diarrhoea) and disturbance of the fluid and electrolyte balances may be evident.. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (Convulsions may occur in patients with impaired renal function or in those receiving high doses (see sections 4.4 and 4.8).

Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see section 4.4)

Treatment of intoxication

Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.

Amoxicillin can be removed from the circulation by haemodialysis.

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