• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
  This includes any possible side effects not listed in this leaflet. See section 4.

1. What Amoxicillin is and what it is used for
2. What you need to know before you are given Amoxicillin
3. How Amoxicillin is given
4. Possible side effects
5. How to store Amoxicillin
6. Contents of the pack and other information

Amoxicillin is used to treat infections caused by bacteria in different parts of the body.

Amoxicillin Powder for Solution for Injection is usually used for urgent treatment of severe infection or if patients cannot take Amoxicillin by mouth.

• if you are allergic to amoxicillin or penicillin. There are no other ingredients in this medicine (see section 6)
• if you have had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or throat
• if you have previously been told that your infection cannot be treated with amoxicillin or ampicillin
• Methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate causing a potential increase in side effects
• Probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

You should not be given Amoxicillin if any of the above applies to you.

If you are not sure speak to your doctor, nurse or pharmacist.

Talk to you doctor, pharmacist or nurse before you are given Amoxicillin if you:

• have glandular fever (fever, sore throat, swollen glands and extreme tiredness)
• have kidney problems
• are not urinating regularly
• have a problem with your heart
• have undiagnosed sore throat (pharyngitis) or a type of cancer known as lymphatic lymphoma, which affects white blood cells
• have HIV.

If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before taking Amoxicillin.

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, pharmacist or nurse that you are taking Amoxicillin. This is because Amoxicillin can affect the results of these tests.

Care should be taken in newborns and young infants as there is the chance of higher levels of amoxicillin in the blood.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

• 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
• If you are taking methotrexate (used for the treatment of cancer and severe psoriasis) Amoxicillin may cause an increase in side effects.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

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 250mg powder for solution for injection contains 14.9mg of sodium.

Amoxicillin 500mg powder for solution for injection contains 29.7mg of sodium.

Amoxicillin 1000mg powder for solution for injection contains 59.4mg of sodium.

This should be considered if you are on a controlled sodium diet.

• Most infections: 20mg to 200mg for every kilogram of body weight in divided doses throughout the day
• Lyme disease (an infection spread by parasites called ticks): isolated erythema migrans (early stage – red or pink circular rash) 25mg to 50mg for every kilogram of body weight in divided doses throughout the day; systemic manifestations (late stage – for more serious symptoms or when the disease spreads around your body) 100mg for every kilogram of body weight in divided doses throughout the day
• Intravenous maximum single dose: 50mg for every kilogram of body weight
• Intramuscular maximum daily dose: 120mg for every kilogram of body weight as 2 to 6 equally divided doses.

• Usual daily dosage: 750mg to 6g administered in divided doses
• Intravenous maximum daily dose: 12g per day
• Intravenous maximum single dose: 2g by infusion or 1g by bolus injection
• Intramuscular maximum daily dose: 4g per day
• Intramuscular maximum single dose: 1g
• Lyme disease (an infection spread by parasites called ticks): isolated erythema migrans (early stage – red or pink circular rash) 4g per day; systemic manifestations (late stage - for more serious symptoms or when the disease spreads around your body) 6g per day.

If you have kidney problems the dose might be lower than the usual dose.

Amoxicillin is removed by dialysis (artificial filtration and purification of the blood). Therefore, patients receiving dialysis may require another dose of Amoxicillin at the end of their dialysis session.

This medicine is given to you by a doctor or a nurse. It is unlikely that you will be given too much, but if you think you have been given too much Amoxicillin, tell your doctor or nurse immediately. 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.

The doctor will assess your condition and decide how to treat an overdose.

If you think that a dose of Amoxicillin has been missed, speak to your doctor or nurse.

You will not normally be given Amoxicillin for more than 2 weeks without the doctor reviewing your treatment.

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, pharmacist or nurse.

If you are given Amoxicillin for a long time, your doctor may perform additional tests to check your kidneys, liver and blood are working normally.

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, some signs include: rashes, high temperature (fever), joint pain, 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 which are often reversible. They are mainly associated with people having treatment over a long period, males and the elderly. You must tell your doctor or nurse 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.
• 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> <administration> <use>). Further symptoms could comprise abdominal pain, lethargy, diarrhoea, and low blood pressure
• Crystals in urine leading to acute renal injury
• 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).

These can happen when having the medicine or for up to several weeks after.

If any of the above occurs talk to your doctor or nurse straight away.

• 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).

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, pharmacist or nurse
• kidney problems
• fits (convulsions), seen in patients on high doses or with kidney problems
• dizziness
• hyperactivity
• crystals in the urine, 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
• 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 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
• inflammation of the protective membrane surrounding the brain (aseptic meningitis).

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

• Changes in your salt and electrolyte levels (shown in blood tests, e.g. low potassium)
• Hallucinations (hearing or seeing things that are not there)
• Signs of central nervous system toxicity (e.g. ringing in the ears or being sensitive to sound, difficulty in speaking, numbness of the tongue or around the mouth, fits, feeling sleepy, shakiness, blurred vision), generally associated with large intravenous doses of amoxicillin or kidney problems
• Encephalopathy (disease of the brain, e.g. confusion, fever, headache, hallucinations, paralysis, light sensitivity, disturbances in sight and movement, stiff neck), has been reported when administered into the arachnoid membrane of the brain or spinal cord and can be fatal
• Coma may develop with high doses of amoxicillin
• Difficulty breathing or shortness of breath; generally associated with large intravenous doses of amoxicillin or kidney problems
• Sore mouth and tongue.

If you get any side effects, talk to your doctor, pharmacist or nurse.

This also includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: http://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.

The active ingredient is amoxicillin sodium.

Each vial of amoxicillin 250mg powder for solution for injection contains 250mg amoxicillin as amoxicillin sodium.

Each vial of amoxicillin 500mg powder for solution for injection contains 500mg amoxicillin as amoxicillin sodium.

Each vial of amoxicillin 1000mg powder for solution for injection contains 1000mg amoxicillin as amoxicillin sodium.

There are no other ingredients. However, please see section 2 for further important information about sodium in Amoxicillin.

Amoxicillin is supplied as a vial of powder for making up as an injection.

Vials containing 250mg or 500mg of amoxicillin powder for solution for injection are available in packs of 10 vials.

Vials containing 1000mg of amoxicillin powder for solution for injection are available in single packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).

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Product name Reference numbers

Amoxicillin for injection 250mg 29831/0010

Amoxicillin for injection 500mg 29831/0012

Amoxicillin for injection 1000mg 29831/0011

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