AMOXICILLIN 500 MG CAPSULES - patient leaflet, side effects, dosage

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin Trihydrate

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

• 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 packs and other information

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

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

What Amoxicillin is used for

Amoxicillin is used to treat infections caused by bacteria in different parts of the 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 capsules do not take amoxicillin capsules:

• if you are hypersensitive (allergic) to amoxicillin, penicillin or other antibiotics such as cephalosporins or any of the ingredients (see section 6) in these capsules.
• 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 capsule.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Amoxicillin 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.

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 can affect the results of these tests.

Other medicines and Amoxicillin capsule

Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medications including medicines obtained without a prescription.

• If you are taking allopurinol for conditions such as gout, because the risk of allergic skin rashes is increased.
• If you are taking probenecid (used for gout) as this can cause the blood concentrations of amoxicillin to increase.
• If you are taking digoxin, used in heart conditions, as the levels of digoxin in the blood may increase.
• If you are taking warfarin, used to thin the blood and prevent clotting, as it may increase the time it takes for your blood to clot and you may need extra blood tests because of this.
• If you are taking antibiotics including macrolides, tetracycline, chloramphenicol or sulphonomides, as the effect of amoxicillin may be reduced.
• If you are taking methotrexate (used for the treatment of cancer and

severe psoriasis) Amoxicillin may cause an increase in side effects

Pregnancy and Breastfeeding:

Tell your doctor if you are pregnant, you think you might be pregnant or planning to become pregnant, also if you are breast-feeding or are planning to breast feed.

Driving and using machines

Amoxicillin capsule 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 capsules

Always take Amoxicillin Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

• Do not chew the capsules. Swallow the capsules with water without opening capsule.
• Space the doses evenly during the day, at least 4 hours apart. The usual oral dose is:

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 mg to 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, elderly patients and children weighing 40 kg or more The usual dose of Amoxicillin 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.

• 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: one 750 mg or one 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 capsule 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 capsule

• 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

If you stop taking Amoxicillin capsules

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

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

4. possible side effects:

Like all medicines, Amoxicillin Capsules can cause side effects, although not everyone gets them.

Stop taking Amoxicillin 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
• kidney problems (interstitial nephritis) with symptoms such as blood in urine, increases or decreases in the amount of urine, feeling and being sick.
• patients on larger doses of amoxicillin or who have impaired kidney function may experience fits.
• a delayed allergic reaction can occur after having 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 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: 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.

These can happen when having 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.

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 capsules will need to be stopped.

Other side effects that may occur are:

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

• skin rash
• nausea (feeling sick)
• diarrhoea

These symptoms are usually mild and disappear either during treatment or very soon after completion of treatment. These symptoms may be reduced by taking the capsules with food.

Uncommon (may affect up to 1 in 1000 people):

• vomiting (being sick)

Very rare (may affect up to 1 in 10,000 people)

• Yeast infection e.g. thrush.
• Black, hairy tongue
• Inflammation of the colon which causes bowel spasms and upper abdominal cramps sometimes with bloody diarrhoea
• Superficial tooth discolouration that can usually be removed by brushing
• changes in the composition of the blood including decrease in some white blood cells, red blood cells, platelets and crystals of urine in the blood
• prolonged bleeding time and an increase in blood clotting times. The blood changes returned to normal after stopping treatment
• Liver problems (liver enzymes) and jaundice with symptoms of skin or whites of the eyes turning yellowish, urine becoming darker or faeces become very pale
• Muscle spasms
• Dizziness

Reporting of side effects

If you get any side effects, talk to your doctor, 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: or by searching 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 out of the sight and reach of children.
• Store in the original packaging.
• Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month.
• Keep container tightly closed
• Do not store above 25 °C.

6. contents of the packs and other informationwhat amoxicillin capsules contain:the active substance in this medicine is called amoxicillin and is present as amoxicillin trihydrate.

Amoxicillin 250mg capsules contain 250mg amoxicillin trihydrate and Amoxicillin 500mg capsules contain 500mg amoxicillin trihydrate. The other ingredients are colloidal anhydrous silica and magnesium stearate.

The capsule shells contain; gelatin, titanium dioxide (E171), erythrosine (E127), iron oxide black (E172), iron oxide red (E172) and iron oxide yellow (E172).

What Amoxicillin Capsules look like and contents of the pack:

Amoxicillin 250 mg and 500 mg Capsules are maroon and yellow capsules which are supplied in blister packs of 3, 6, 12, 15, 21, 50 capsules and pots of 500 capsules (250 mg), 100 capsules (500 mg)

This leaflet was last updated: May 2018.

0001 & 0002/O/PIL/001/I

Marketing Authorisation Holder and Manufacturer

M medreich plc

Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK

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Amoxicillin 500mg Capsules PL 21880/0002

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