Amoxicillin 250mg Capsules BP (PL06453/0017)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

What Amoxicillin Capsules are

Amoxicillin Capsules are antibiotics. The active ingredient is amoxicillin. This belongs to a group of medicines called ‘penicillin’.

What Amoxicillin Capsules are used for

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.

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).
• 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 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.

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. This is because Amoxicillin Capsules can affect the results of these tests.

Other medicines and Amoxicillin Capsules

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.
• If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Amoxicillin Capsules.
• 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 Capsules may be less effective.
• If you are taking methotrexate (used for the treatment of cancer and severe psoriasis) Amoxicillin Capsules may cause an increase in side effects.
• If you are taking oral typhoid vaccine (may not work if taken with amoxicillin)

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.

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.

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

Kidney problems

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

If you take more Amoxicillin Capsules than you should

If you have taken too much 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 urinating. Talk to your doctor as soon as possible. Take the medicine to show the doctor.

If you forget to take Amoxicillin Capsules

• 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 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.
• Once you finish treatment, if you still feel unwell you should go back to 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 Capsules for a long time, your doctor may perform additional tests to check your kidneys, liver and blood are working normally.

Stop taking Amoxicillin Capsules 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 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 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 Capsules 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 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.

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

Sometimes you may get less severe skin reaction 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 Capsules will need to be stopped.

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
• 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
• 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. By reporting side effects you can help provide more information on the safety of this medicine.

What Amoxicillin Capsules contain

• The active substance in each capsule is 250 mg or 500 mg amoxicillin.
• The other ingredients are Magnesium stearate, Maize starch, Gelatin, Erythrosin (E127), Quinoline yellow (E104), Titanium dioxide (E171) and Red iron oxide (E172).

What Amoxicillin Capsules look like and contents of the pack

• Amoxicillin Capsules are scarlet and ivory opaque hard gelatin capsules, each capsule is marked with the characters “AMOX 250” or “AMOX 500”.
• Securitainers are available in pack sizes of 15, 18, 20, 21, 28, 30, 50, 100, 500 & 1000 capsules, the pack size of 1000 is available for the 250 mg strength only.
• Blister packs are available in pack sizes of 15, 16, 18, 20, 21, 28, 30, 50, 100, 500 & 1000 capsules, the pack size of 1000 is available for the 250 mg strength only and the pack size of 16 is available for the 500 mg strength only.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

PL 06453/0017

PL 06453/0018