Patient leaflet - Amoxicillin 125 mg / 5 ml oral suspension
1. WHAT AMOXICILLIN ORAL SOLUTION IS AND WHAT IT IS USED FOR
Amoxicillin oral suspension is an antibiotic. The active ingredient is amoxicillin trihydrate. This belongs to a group of medicines called ‘penicillins’. What amoxicillin oral solution is used for
Amoxicillin is used to treat infections caused by bacteria in different part of body. Amoxicillin 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 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 if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking amoxicillin oral suspension.
Warnings and Precautions
Talk to your doctor or pharmacist before taking amoxicillin oral suspension 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 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 oral suspension. This is because amoxicillin 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 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 to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
- If you are taking medicine to 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.
- 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, 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 and sodium benzoate
Each 5 ml dose of Amoxicillin 125 mg/5 ml Oral Suspension contains 2.86 g sucrose and each 5 ml dose of Amoxicillin 250 mg/5 ml Oral Suspension contains 2.74 g sucrose. Patients with rare hereditary problem of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This product also contains sodium benzoate, which is a mild irritant to the skin, eyes and mucous membrane. It may increase jaundice in newborn babies (up to 4 weeks old).
3. HOW TO TAKE AMOXICILLIN ORAL 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.
Amoxicillin Oral Suspension should be taken by mouth and only in the doses prescribed by your doctor. Do not take more of it, and do not take it more often or for a longer time than your doctor ordered.
Do not stop taking your medicine or change the dose unless your doctor tells you to. Dosages:
Your doctor will decide on the appropriate dose to suit the severity and type of infection you have. Shake the bottle well before use.
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 40-90 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 and Children weighing 40 kg or over:
The usual dose is 250 mg to 500 mg three time a day. This is equivalent to one or two spoonfuls (5-10 ml) of the 250 mg / 5 ml product or two to four spoonfuls (10-20 ml) of the 125 mg / 5 ml product. 750 mg to 1 g every 12 hours, depending on the severity and type of infection.
- Severe infections: 750 mg to 1 g three times a day.
- Urinary tract infection: 3 g twice daily for one day.
- Lyme disease (an infection spread by parasites called ticks): isolated erythema migrans (early stage – red or pink circular rash): 4 g a day, systemic manifestations (late stage – for more serious symptoms or when the disease spreads around your body): up to 6 g a day.
- Stomach ulcers: 750 mg or 1 g dose twice a day for 7 days with other antibiotics and medicines to treat stomach ulcers.
- To prevent heart infection during surgery: 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.
- The maximum recommended dose is 6 g per day.
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
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 urgently tell your doctor 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 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.
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 use). Further symptoms could comprise abdominal pain, lethargy, diarrhoea, and low blood pressure.
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 may 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 affects 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
- Inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis)
- rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease)
- hyperactivity
- crystals in urine leading to acute renal injury
- 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.
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: www.mhra.gov.uk/yellowcard or by searching for MHRA Yellow Card in the Google Play or Apple App Store.
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 oral 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 very rare (may affect up to 1 in 10,000 people)
- allergic reactions, the signs may include: skin itching or rash, swelling of face, lips, tongue, body or breathing difficulty. These can be serious and occasionally deaths have occurred.
- chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome)
- 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
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 carton. The expiry date refers to the last day of that month.
Store your medicine in the original container. Do not store above 25ºC prior to reconstitution by a pharmacist. After reconstitution, store suspension at 2ºC - 8ºC. Do not freeze.
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
Amoxicillin 125 mg/5 ml oral suspension oral Contains amoxicillin trihydrate equivalent to 125 mg amoxicillin per 5 ml.
Amoxicillin 250 mg/5 ml oral suspension oral Contains amoxicillin trihydrate equivalent to 250 mg amoxicillin per 5 ml
After the powder has been reconstituted, each 5 ml of mixture contains either 125 mg or 250 mg amoxicillin as amoxicillin trihydrate. It also contains sodium benzoate (E211), sodium citrate (E331), colloidal anhydrous silica, saccharin sodium, dispersible cellulose, quinoline yellow (E104), sucrose and lemon flavouring powder. It is available in powder in both 60 ml and 100 ml bottles for preparation by the pharmacist, and is available in two strengths.
Marketing Authorisation Holder and Manufacturer
The Product Licence holder is: Chelonia Healthcare Limited,
Boumpoulinas 11, 3rd floor, Nicosia, P.C. 1060, Cyprus.
The manufacturer is: DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London SW5 9JQ, England.
Amoxicillin 125 mg / 5 ml Oral Suspension PL33414/0007
Amoxicillin 250 mg / 5 ml Oral Suspension PL 33414/0008
This leaflet was revised in 02/2023.
CL0007/O/LL/CL2
70 mm urine, or problems urinating. Talk to your doctor as soon as possible. Take the medicine to show the doctor.
If you forgot to take Amoxicillin oral 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.
How long should you take Amoxicillin oral suspension 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 oral suspension for a long time, your doctor may perform additional tests to check your kidneys, liver and blood are working normally.