Amoxicillin 500 mg – patient leaflet, side effects, dosage

1. What Amoxicillin Capsules are and what they are used for

Amoxicillin Capsules are an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called ‘penicillins’.

Amoxicillin Capsules are used to treat infections caused by bacteria in different parts of the body. Amoxicillin Capsules may also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before you take Amoxicillin Capsules

Do not take Amoxicillin Capsules 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.

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

Warnings and Precautions

Talk to your doctor or pharmacist before taking Amoxicillin Capsules 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 Capsules.

Conditions you need to look out for

Amoxicillin Capsules can make some existing conditions worse, or cause serious side effects, such as severe allergic reactions, chest pain, serious skin reactions, 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 Capsules to help reduce the risk of any problems (see section 4).

• Severe infections: 750 mg to 1 g three times

• Chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome) Blood and urine tests

  a day.

If you are having:

• Urinary tract infection: 3 g twice daily for one day.
• Urine tests (glucose) or blood tests for liver function
• Oestriol tests (used during pregnancy to check the baby is developing normally).

• Lyme disease (an infection spread by

  parasites called ticks): Isolated erythema

Tell your doctor or pharmacist that you are taking Amoxicillin Capsules. This is because amoxicillin can affect the results of these tests.

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.

Other medicines and Amoxicillin Capsules

• Stomach ulcers: one 750 mg or one 1 g dose twice a day for 7 days with other antibiotics and medicines to treat stomach ulcers.

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 Capsules, it may be more likely that you will have an allergic skin reaction.

  • 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.

• If you are taking probenecid (used for gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

  • The maximum recommended dose is 6 g per day.

• If you are taking medicines to help stop blood clots (such as warfarin), you may need extra blood tests.

  Kidney problems

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

• If you are taking other antibiotics (such as tetracycline), Amoxicillin Capsules may be less effective.

• If you are taking methotrexate (used for the treatment of cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate causing a potential increase in side effects.

  If you take more Amoxicillin Capsules than you should

  If you have taken too many Amoxicillin Capsules, 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 passing urine. Talk to your doctor as soon as possible. Take the medicine to show the doctor.

Taking Amoxicillin Capsules with food and drink

Amoxicillin Capsules do not have known interactions with food or drink.

If you forget to take Amoxicillin Capsules

• If you forget to take a dose do not worry, take it as soon as you remember.

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.

• 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.

Driving and using machines

Amoxicillin Capsules can have side effects and the symptoms (such as allergic reactions, dizziness and convulsions) may make you unfit to drive.

How long should you take Amoxicillin Capsules for?

• Keep taking Amoxicillin Capsules 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.

Do not drive or operate machinery unless you are feeling well.

• Once you finish treatment, if you still feel unwell you should go back to see the doctor.

Amoxicillin Capsules contain Carmoisine (E122)

This medicine contains Carmoisine (E122), which may cause allergic reactions.

Thrush (a yeast infection of moist areas of the body which can cause soreness, itching and white discharge) may develop if Amoxicillin Capsules are used for a long time. If this occurs, tell your doctor.

3. How to take Amoxicillin Capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

• Swallow with water without opening the capsule.

• Space the doses evenly during the day, at least 4 hours apart.

  If you have any further questions on the use of this product, ask your doctor or pharmacist.

The recommended dose is:

4. Possible side effects

Children weighing less than 40 kg

All doses are worked out depending on the child’s body weight in kilograms.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Your doctor will advise you how much Amoxicillin Capsules you should give to your baby or child.

• The usual dose is 40 mg to 90 mg for each kilogram of body weight a day, given in two or three divided doses.

  Stop taking Amoxicillin Capsules and see a doctor straight away, if you notice any of the following serious side effects

• The maximum recommended dose is 100 mg for each kilogram of body weight a day.

  • you may need urgent medical treatment:

The following side effects are very rare (may affect up to 1 in 10,000 people):

Adults, elderly patients and children weighing 40 kg or more

• 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

The usual dose of Amoxicillin Capsules is 250 mg to 500 mg three times a day or 750 mg to 1 g every 12 hours, depending on the severity and type of infection.

• 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 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 Capsules, 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 private parts. 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))
• A red rash commonly seen on both sides of buttocks, upper inner thighs, armpits, neck (Symmetrical Drug-Related Intertriginous and Flexural Exanthema (SDRIFE))
• High temperature (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 which are often reversible. Hepatitis and cholestatic jaundice, 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:

  o severe diarrhoea with bleeding

  o blisters, redness or bruising of the skin

  o darker urine or paler stools

  o yellowing of the skin or the whites of the eyes (jaundice).

  See also anaemia below which might result in jaundice. The following side effect frequency is not known (frequency cannot be estimated from the available data):

• The Jarisch-Herxheimer reaction which occurs during treatment with Amoxicillin Capsules for Lyme disease and causes fever, chills, headache, muscle pain and skin rash.

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

If any of the above happen stop taking the medicine and see your doctor straight away.

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 (affects less than 1 in 100 people).

If you have any of these talk to your doctor as treatment with Amoxicillin Capsules will need to be stopped.

The following side effects have been reported at the approximate frequencies shown:

Common (may affect up to 1 in 10 people):

• Diarrhoea
• Skin rash
• Feeling sick (nausea).

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
• 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
• The blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or cut yourself.
• Low number of white blood cells
• Low number of cells involved with blood clotting
• Crystals in the 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
• 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).

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 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 Capsules

Keep this medicine out of the sight and reach of children.

The capsules must be kept in their original package and stored in a dry place below 25°C.

Do not take this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not take this medicine if you notice visible signs of deterioration.

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

What Amoxicillin Capsules contain

• The active substance is amoxicillin (as amoxicillin trihydrate).

• The other ingredients are Magnesium Stearate (E572) and Colloidal Anhydrous Silica. The capsule shell contains Gelatin, Carmoisine (E122), Quinoline Yellow (E104), Titanium Dioxide (E171), and Iron Oxide Yellow (E172). The printing ink contains Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Black Iron Oxide (E172) and Purified water.

  What Amoxicillin Capsules look like and contents of the pack

  • Amoxicillin 500 mg Capsules are hard, Scarlet (body) and Ivory (cap) capsules, printed with AMOXI on cap and 500 on body.
  • Amoxicillin 500 mg Capsules come in blister packs of 10, 15, 21, 28 and 105 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited,

Sage House, 319, Pinner Road,

North Harrow, Middlesex, HA1 4HF, United Kingdom

This leaflet was last revised in 06/2024.