Amoxicillin EG: detailed information

Package leaflet: Information for the patient

AMOXICILLINA EG 1 g tablets

Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you (or your child) only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What AMOXICILLINA EG is and what it is used for
What you need to know before taking AMOXICILLINA EG
How to take AMOXICILLINA EG
Possible side effects
How to store AMOXICILLINA EG
Contents of the pack and other information

1. What AMOXICILLINA EG is and what it is used for

What AMOXICILLINA EG is
AMOXICILLINA EG is an antibiotic. Its active substance, amoxicillin, belongs to a group of medicines known as "penicillins".
What AMOXICILLINA EG is used for
AMOXICILLINA EG is used to treat bacterial infections in various parts of the body.
AMOXICILLINA EG may also be used in combination with other medicines for the treatment of gastric ulcers.

2. What you need to know before taking AMOXICILLINA EG

Do not take AMOXICILLINA EG

if you are allergic to amoxicillin, penicillins, or any of the other ingredients of this medicine (listed in section 6);
if you have previously had an allergic reaction to any antibiotic. This also includes skin rash or development of swelling of the face or throat.

Do not take AMOXICILLINA EG if any of the situations listed above apply to you. If you have any
doubts, consult your doctor or pharmacist before taking AMOXICILLINA EG.
Warnings and precautions
Consult your doctor or pharmacist before taking AMOXICILLINA EG if:

you have glandular fever (fever, sore throat, swollen glands, and extreme tiredness);
you have kidney problems;
you do not urinate regularly. If you are unsure whether any of the points listed above apply to you, consult your doctor or pharmacist before taking AMOXICILLINA EG.

Blood and urine tests
If you are undergoing:

urine tests (for glucose) or blood tests for liver function;
tests for estriol (used during pregnancy to monitor normal fetal development);

inform your doctor or pharmacist that you are taking AMOXICILLINA EG, as this medicine
may alter the results of these tests.
Other medicines and AMOXICILLINA EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.

If you are taking allopurinol (a medicine used to treat gout) together with AMOXICILLINA EG, you may have an increased risk of developing an allergic skin reaction.
Probenecid (used to treat gout): concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended. If you are taking probenecid, your doctor may decide to adjust the dose of AMOXICILLINA EG.
If you are taking medicines to reduce blood clotting (e.g. warfarin), you may need additional blood tests.
If you are taking other antibiotics (e.g. tetracyclines), the effectiveness of AMOXICILLINA EG may be reduced.
Methotrexate (used to treat cancer and severe psoriasis): penicillins may reduce the excretion of methotrexate, potentially increasing its adverse effects.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Driving and using machines
AMOXICILLINA EG may cause adverse effects whose symptoms (such as allergic reactions, dizziness, and
seizures) may impair your ability to drive vehicles.
Do not drive or operate machinery if you do not feel well.
AMOXICILLINA EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take AMOXICILLINA EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take the doses at regular intervals throughout the day, at least 4 hours apart.
The usual dose is:
Adults, elderly patients, and children weighing 40 kg or more
The usual dose of AMOXICILLINA EG is 250–500 mg three times daily or 750 mg–1 g every 12
hours, depending on the severity and type of infection.

Severe infections: 750 mg to 1 g three times daily.
Urinary tract infections: 3 g twice daily for one day.
Lyme disease (infection caused by a parasite called tick): isolated erythema migrans (early stage – circular reddish or pink rash): 4 g per day; systemic manifestations (late stage – more severe symptoms or when the disease spreads to other parts of the body): up to 6 g per day.
Gastric ulcers: a dose of 750 mg or 1 g twice daily for 7 days, together with other antibiotics and medicines for the treatment of gastric ulcers.
Prevention of heart infections during surgical procedures: the dose will vary depending on the type of surgery. Other medicines may also be administered simultaneously. Your doctor, pharmacist, or nurse will provide more detailed information.
The maximum recommended dose is 6 g per day.

Kidney problems
If you have kidney problems, your dose may be lower than usual.
If you take more AMOXICILLINA EG than you should
If you take an excessive amount of AMOXICILLINA EG, symptoms such as gastrointestinal
disturbances (nausea, vomiting, or diarrhoea) or presence of crystals in the urine, possibly causing
cloudy urine or difficulty urinating, may occur. Contact your doctor as soon as possible, bringing
the medicine with you to show it.
If you forget to take AMOXICILLINA EG

If you forget a dose, take it as soon as you remember.
Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
Do not take a double dose to make up for a missed dose.

How long should you take AMOXICILLINA EG?

Continue taking AMOXICILLINA EG for the duration prescribed by your doctor, even if you feel better. To fight the infection, it is necessary to take all prescribed doses. The infection may return if some bacteria survive.
If, after completing the treatment, you still do not feel well, consult your doctor again. Long-term use of AMOXICILLINA EG may lead to the development of candidiasis (a yeast infection affecting moist areas of the body, causing irritation, itching, and whitish discharge). If this occurs, consult your doctor. If you take AMOXICILLINA EG for prolonged periods, your doctor may carry out additional tests to ensure that your kidneys, liver, and blood are functioning normally.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking AMOXICILLINA EG and consult a doctor immediately if you notice any of the following
serious side effects, as urgent medical treatment may be required:
Chest pain occurring in the context of allergic reactions, which may be a symptom of myocardial infarction triggered by allergy (Kounis syndrome).
Drug-induced enterocolitis syndrome (DIES):
DIES has been reported mainly in children treated with amoxicillin. It is a specific type of allergic reaction with the main symptom being recurrent vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
The following side effects are very rare (may affect up to 1 in 10,000 people):

allergic reactions, accompanied by symptoms such as itching or skin rash, swelling of the face, lips, tongue or body, or breathing difficulties. These effects can be severe and, in some cases, have been fatal;
skin rash or appearance of small, round, flat, reddish spots under the skin surface, or skin bruising. This is due to inflammation of the walls of blood vessels caused by an allergic reaction. It may be accompanied by joint pain (arthritis) and kidney problems;
delayed allergic reaction, usually occurring 7-12 days after taking AMOXICILLINA EG, accompanied by symptoms such as skin rash, fever, joint pain, and swollen lymph nodes, particularly under the arm;
a skin reaction known as “erythema multiforme”, with itchy, reddish-purple patches on the skin, particularly on the palms of the hands or soles of the feet, areas of skin swelling similar to hives, or painful areas on the surface of the mouth, eyes, and genitals. This may be accompanied by fever and a feeling of extreme tiredness;
other serious skin reactions may include changes in skin colour, formation of lumps under the skin, blistering, pustules, peeling, redness, pain, itching, and skin shedding. These may be associated with fever, headache, and widespread body aches;
flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms);
fever, chills, sore throat or other signs of infection, or a tendency to bruise easily. These may be signs of a blood cell disorder;
the Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease with AMOXICILLINA EG, causing fever, chills, headache, muscle pain, and skin rash;
inflammation of the large intestine (colon) with diarrhoea (sometimes containing blood), pain, and fever;
serious side effects affecting the liver may occur, observed mainly in patients treated for long periods, in men, and in elderly people. Inform your doctor urgently if you notice: o severe diarrhoea with bleeding, o blistering, redness or bruising of the skin, o dark urine or pale stools, o yellowing of the skin or the white part of the eye (jaundice). See also the entry on anaemia below as a possible cause of jaundice. These effects may occur during treatment with the medicine or even several weeks later.

If any of the above-listed effects occur, stop treatment with the medicine and seek immediate
medical advice.
Sometimes less severe skin reactions may occur, such as:

a slightly itchy rash (roundish pinkish-red patches), localized swelling similar to hives on the forearms, legs, palms of the hands, hands or feet. This is an uncommon effect (may affect up to 1 in 100 people).

If any of these side effects occur, consult your doctor, as treatment with AMOXICILLINA EG will need to be discontinued.
Other possible side effects are:
Common (may affect up to 1 in 10 people)

skin rash;
nausea;
diarrhoea.

Uncommon (may affect up to 1 in 100 people)

vomiting.

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

candidiasis (vaginal, oral or skin fold infection caused by a yeast); your doctor or pharmacist will prescribe appropriate treatment;
kidney problems;
seizures, observed in patients treated with high doses or with pre-existing kidney problems;
dizziness;
hyperactivity;
presence of crystals in the urine leading to acute kidney injury, possibly causing cloudy urine, difficulty urinating or discomfort during urination. Make sure to drink plenty of fluids to reduce the risk of developing these symptoms;
teeth may appear stained, but usually return to their normal appearance with brushing (this effect has been documented in children);
the tongue may become yellowish, brownish or blackish in colour and have a hairy appearance;
excessive destruction of red blood cells, leading to a type of anaemia. Signs include: fatigue, headache, shortness of breath, dizziness, paleness, and yellowing of the skin and the white part of the eye;
reduced number of white blood cells;
reduced number of cells involved in blood clotting;
prolonged blood clotting time compared to normal. This effect may be noticed in case of nosebleeds or if you get a cut.

Frequency not known (frequency cannot be estimated from the available data)

inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
Skin rash with blisters arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects helps provide more information on the safety of this medicine.

5. How to store AMOXICILLINA EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What AMOXICILLINA EG contains

The active substance is amoxicillin. Each tablet contains amoxicillin trihydrate equivalent to 1 g of amoxicillin.
The other components are: talc, precipitated silica, microcrystalline cellulose, magnesium stearate, sodium carboxymethylstarch.

Description of the appearance of AMOXICILLINA EG and package contents
Blister pack containing 12 tablets of 1 g.
Marketing Authorization Holder
EG S.p.A., Via Pavia 6 - 20136 Milan
Manufacturers
Biopharma S.r.l. - Via delle Gerbere, 22/30 (loc. S. Palomba), 00134 - Rome

General recommendation on the use of antibiotics
Antibiotics are used to treat bacterial infections and have no effect against viral infections.
It may happen that a bacterial infection does not respond to a course of antibiotic therapy. Most often this is due to the bacteria causing the infection being resistant to the administered antibiotic, thus surviving and multiplying despite treatment.
There are several reasons why bacteria can become resistant to antibiotics. Correct use of antibiotics can help reduce the likelihood that bacteria develop resistance.
Prescription of an antibiotic course is intended solely to treat the current illness. By following the advice below, you contribute to preventing the development of resistant bacteria, which could undermine the effectiveness of antibiotic therapy.

It is very important that antibiotics are taken at the correct dose, at the right times, and for the prescribed number of days. It is important to read the instructions accompanying the medicine and, if difficult to understand, to ask your doctor or pharmacist for clarification.
Antibiotics should not be taken unless they have been specifically prescribed for you and should only be used to treat the infection for which they were prescribed.
Do not take antibiotics prescribed for other people, even if the infection appears similar.
Do not give antibiotics prescribed for you to other people.
If, after completing the treatment course as directed by your doctor, you have any unused antibiotic remaining, you should return it to a pharmacy for proper disposal.