Patient leaflet - Amoxicillin 250 mg / 5 ml oral suspension BP sugar free
1. What Amoxicillin Oral Suspension is and what it is used for
This oral suspension is available in two different strengths. Each 5ml of oral suspension contains 250mg of the active ingredient, amoxicillin (as trihydrate). Amoxicillin is one of a group of antibiotics called penicillins. lt is used to kill bacteria which cause infections in your body. Amoxicillin Oral Suspension is used to treat bacterial infections of the ear, respiratory tract (e.g. lungs and chest), urinary tract (e.g. kidneys and bladder), skin, and gastrointestinal tract (e.g. stomach and intestines) such as typhoid. It is also used to stop infections when you have a tooth removed or other surgery. It may also be used for other infections determined by your doctor.
2. What you need to know before you take
Amoxicillin Oral Suspension
Some people must not take this medicine.
Do not take Amoxicillin Oral Suspension:
- If you know you are allergic to amoxicillin, penicillin or to any of the other ingredients (these are listed in section 6)
- If you have ever had an allergic reaction (e.g. rash, itching, shortness of breath or swelling of face and neck) to another antibiotic in the past such as cephalosporins e.g. cefaclor.
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), lymphatic leukemia or HIV infection, since you may be more prone to developing a skin rash.
- If you are pregnant or trying to become pregnant
- If you are breastfeeding
- If you are not passing water regularly
- If you suffer from any kidney problems.
If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine. Having urine or blood tests
If you are having tests on your water (urine glucose tests), blood tests for liver function, or oestriol tests (used during pregnancy to check the
baby is developing normally), let the doctor or nurse know that you
are on Amoxicillin. This is because Amoxicillin can affect the results
of these tests.
Other medicines and Amoxicillin Oral Suspension
Amoxicillin Oral Suspension and other medicines you may be taking
may affect how each other work. Make sure your doctor knows if you
are taking any of the following:
If you are taking other antibiotics (such as Tetracycline) , Amoxicillin
suspension may be less effective.
Anticoagulants (to prevent blood clotting) e.g. warfarin or
phenindione, extra blood tests may be needed
Probenecid (used to treat gout), concomitant use of probenecid
may reduce the excretion of amoxicillin and is not recommended.
- Oral contraceptives (as it may not work properly and you will need to use other means of contraception e.g. a condom)
- Methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate causing a potential increase in side effects.
- Dietary fibre supplements.
If you are having tests on your water (urine glucose tests) or blood tests for liver function, let the doctor or nurse know you are taking amoxicillin because amoxicillin can affect the results of these tests. Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor.
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.
Other special warnings
Thrush (a yeast infection of moist areas of the body) may develop if amoxicillin is used for a long time. If this occurs tell your doctor. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains sorbitol (E420).
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.
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.
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. Shake the bottle well before use. Do not further dilute the prepared product.
For treating some infections the dose may be different to the usual dose given below. For example if your infection is more serious, the dose might be doubled.
The doctor will decide what dose you need to take. Always take the
medicine exactly as the doctor has told you. The dose will be on the pharmacist‘s label. If you are not sure, ask your doctor or pharmacist. Carry on taking the medicine for as long as you have been told unless you have any problems. In that case, check with your doctor. The recommended doses are as follows:
Adults: To treat an infection, you should usually take 250 mg of your medicine three times a day. This is one 5ml spoonful of Amoxicillin Oral Suspension 250 mg three times a day.
Use in children: The doctor will advise you of the 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, at least 4 hours apart. Never give 2 doses in 1 hour. Do not give doses of Amoxicillin at night. If child has kidney problems the dose might be
lower than the ususal dose. Keep taking this medicine until your doctor tells you to stop.
Do not stop taking it just because you feel better. If you stop taking the medicine, your condition may reoccur or get worse. If some bacteria survive they can cause the infection to come back. Treatment should be continued for 2 to 3 days after the symptoms have gone. Thrush (a yeast infection of moist areas of the bosy) may develop if Amoxicillin is used for a long time.
If you take more Amoxicillin Oral Suspension than you should: You should contact your doctor or go to your nearest hospital casualty department immediately. Take the bottle with you so that the doctor knows what you have taken. Signs might be an upset stomach (feeling sick or diarrhoea) or crystals in the urine, which may be seen as cloudy urine, or problems passing urine.
allergic reaction.
- 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 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 enlargement of the lymph nodes especially under the arms
Blistering of the skin, mouth, eyes and genitals, other serious skin reactions including itchy reddish purple patches on the skin, especially on the palms of hands and soles of the feet, which is a
skin reaction known as ‘erythema multiforme’ hives, pustules, swelling, peeling, redness, pain, itching and scaling. These may be associated with fever, tiredness, headache and aching body
- 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))
The Jarisch-Herxheimer reaction which occurs during treatment with Amoxicillin Suspension for Lyme disease and causes fever,
chills, headache, muscle pain and skin rash.
- 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, high temperature (fever), chills, a sore throat and make infections more likely
- Diarrhoea sometimes containing blood, pain and fever caused by inflammation of the large bowel (colon)
People having treatment over a long period, males and the elderly must tell your doctor urgently if you find: yellowing of the skin or whites of the eyes, (jaundice), severe diarrhoea with bleeding, blisters, redness or bruising of the skin, pale stools and dark urine, loss of appetite, stomach discomfort which may be caused due to
severe liver or blood problems.
- 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.
The following side effects have also been reported: Less than 1 in 10 people have experienced:
- Diarrhoea, indigestion, feeling sick
- Skin rash.
Less than 1 in 100 people have experienced:
A mildly itchy rash (round, pink-red patches), ‘hive-like’ swollen
areas on their forearms, legs, palms, hands or feet.
- Being sick.
Less than 1 in 10,000 people have experienced:
- 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)
- Increased or decreased urine output, fever, rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease), 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.
- Crystals in the urine leading to acute renal injury which may cause cloudy urine or difficulty or discomfort when passing urine. Make sure to drink plenty of fluids to reduce the chance of these symptoms.
- An increase in the length of time it takes to stop bleeding if you cut yourself or have a nosebleed
- 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
- Yellow, brown or black hairy tongue
- Tooth discolouration in children which usually returns to normal
Take it as soon as you remember. Then carry on as before, but do not take two doses within four hours of each other. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious. Stop taking the medicine and tell your doctor straightaway if you notice the following very rare effects (may occur in less than 1 in 10,000 people):
- Swelling of the face, lips, tongue, body or throat, difficulty in breathing or dizziness. These may be signs of a severe
Package leaflet: Information for the patient
Amoxicillin 250mg/5ml Oral Suspension
BP Sugar Free
This medicine will be called Amoxicillin Oral Suspension in this leaflet.
Keep this leaflet. you may need to read it again.
with brushing.
- 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 at: www.mhra.gov.uk/yellowcard. or search 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. Once made up, store up to 7 days at 2°C-8°C in a refrigerator. Do not freeze. Store in the original bottle and keep tightly closed to protect from light and moisture.
Do not transfer your medicine to another container.
Do not use your medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. If your doctor tells you to stop taking the medicine, please take any unused medicine back to your pharmacist to be destroyed. Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.
6. Contents of the pack and other information
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What Amoxicillin Oral Suspension contains
Each 5ml of medicine contains 250 mg of the active ingredient, amoxicillin (as trihydrate). The other ingredients are Sodium Benzoate (E211), Disodium Edetate, Sodium Citrate, Citric Acid, Colloidal Anhydrous Silica, Sorbitol (E420), Saccharin Sodium, Banana Flavour (containing Gum Arabic, Amyl Acetate, Amyl and Ethyl Butyrates, Euginol, Acetaldehyde, Citral, Ethyl and Allyl Heptanoates, Amyl Valerianate and Orange Oil), Quinoline Yellow E104 and Xanthan Gum.
What Amoxicillin Oral Suspension looks like and contents of the pack
The medicine is a yellow coloured suspension. This bottle contains 100ml of medicine.
Marketing Authorisation Holder
954.63x50mm
21/01/2023
135mmx50mm
The product licence holder is Cox Pharmaceutical Ltd. Elscot House, Arcadia Avenue, London, N3 2JU,
Manufactured by: RX Farma Ltd., Unit 3, Colonial Way, Watford, Hertfordshire, WD24 4YR.
Product Licence Numbers:
PL 42671/0011
Date of revision: January 2023
If you would like this leaflet in a different format, please contact the license holder at the above address.
Amoxicillin
#250 mg
#5 ml Oral
Suspension