Amoxicillin sodium K24 Pharmaceuticals: detailed information

Package leaflet: Information for the user

AMOXICILLINA SODICA K24 PHARMACEUTICALS 500 mg

powder for solution for injection or infusion
AMOXICILLINA SODICA K24 PHARMACEUTICALS 1 g
powder for solution for injection or infusion
Amoxicillin
Please read all of this leaflet carefully before 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, pharmacist, or nurse.
If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What AMOXICILLINA SODICA K24 PHARMACEUTICALS is and what it is used for
What you need to know before taking AMOXICILLINA SODICA K24 PHARMACEUTICALS
How to take AMOXICILLINA SODICA K24 PHARMACEUTICALS
Possible side effects
How to store AMOXICILLINA SODICA K24 PHARMACEUTICALS
Contents of the pack and other information

1. What AMOXICILLINA SODICA K24 PHARMACEUTICALS is and what it is used for

What AMOXICILLINA SODICA K24 PHARMACEUTICALS is
AMOXICILLINA SODICA K24 PHARMACEUTICALS is an antibiotic. Its active substance,
amoxicillin, belongs to a group of medicines known as "penicillins".
What AMOXICILLINA SODICA K24 PHARMACEUTICALS is used for
AMOXICILLINA SODICA K24 PHARMACEUTICALS is used to treat bacterial infections in
various parts of the body.
AMOXICILLINA SODICA K24 PHARMACEUTICALS powder for injectable solution or
infusion is generally used for the urgent treatment of severe infections or when the patient
cannot take AMOXICILLINA SODICA K24 PHARMACEUTICALS orally.

2. What you need to know before taking AMOXICILLINA SODICA K24 PHARMACEUTICALS

PHARMACEUTICALS
Do not take AMOXICILLINA SODICA K24 PHARMACEUTICALS:

if you are allergic to amoxicillin, penicillin, 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 SODICA K24 PHARMACEUTICALS if any of the above situations apply to you. If you have any doubts, consult your doctor, pharmacist, or nurse before taking AMOXICILLINA SODICA K24 PHARMACEUTICALS.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking AMOXICILLINA SODICA K24 PHARMACEUTICALS 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, pharmacist, or nurse before taking AMOXICILLINA SODICA K24 PHARMACEUTICALS.
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, pharmacist, or nurse that you are taking AMOXICILLINA SODICA K24 PHARMACEUTICALS, as this medicine may alter the results of these tests.

Other medicines and AMOXICILLINA SODICA K24 PHARMACEUTICALS
Inform your doctor, pharmacist, or nurse 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 SODICA K24 PHARMACEUTICALS, you may have an increased risk of developing an allergic skin reaction.
If you are taking probenecid (a medicine used to treat gout), your doctor may decide to adjust the dose of AMOXICILLINA SODICA K24 PHARMACEUTICALS.
If you are taking medicines to reduce blood clot formation (e.g., warfarin), you may need additional blood tests.
If you are taking other antibiotics (e.g., tetracyclines), the effectiveness of AMOXICILLINA SODICA K24 PHARMACEUTICALS may be reduced.
If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), AMOXICILLINA SODICA K24 PHARMACEUTICALS may cause an increase in side effects.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Driving and using machines
AMOXICILLINA SODICA K24 PHARMACEUTICALS may cause side 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 SODICA K24 PHARMACEUTICALS 500 mg powder for solution for injection or infusion contains sodium

AMOXICILLINA SODICA K24 PHARMACEUTICALS contains 32 mg of sodium (a main component of table salt) per vial. This corresponds to 1.6% of the maximum daily recommended dietary intake for an adult.

AMOXICILLINA SODICA K24 PHARMACEUTICALS 1 g powder for solution for injection or infusion contains sodium

AMOXICILLINA SODICA K24 PHARMACEUTICALS contains 63 mg of sodium (a main component of table salt) per vial. This corresponds to 3.2% of the maximum daily recommended dietary intake for an adult.

3. How AMOXICILLINA SODICA K24 PHARMACEUTICALS is administered

This medicine must never be self-administered. Administration must be carried out by qualified personnel, such as a doctor or nurse.

AMOXICILLINA SODICA K24 PHARMACEUTICALS will be administered by intravenous injection or infusion (into a vein) or by intramuscular injection (into a muscle).
Your doctor will determine the daily dose of the medicine and how frequently the injections will be given.
Make sure you drink plenty of fluids during treatment with AMOXICILLINA SODICA K24 PHARMACEUTICALS.

For the treatment of infections
The following are usual doses.
Children up to 40 kg

Most infections: 20 mg to 200 mg per kilogram of body weight, given in divided doses throughout the day.
Lyme disease (infection caused by a parasite called a tick): isolated erythema migrans (early stage – circular reddish or rose-colored skin rash): 25 mg to 50 mg per kilogram of body weight in divided doses throughout the day; systemic manifestations (late stage – more severe symptoms or when the disease spreads to other parts of the body): 100 mg per kilogram of body weight in divided doses throughout the day.
Maximum single dose: 50 mg per kilogram of body weight.
Maximum daily intramuscular dose: 120 mg per kilogram of body weight, given in 2 to 6 equally divided doses.

Adults, elderly patients, and children weighing 40 kg or more

Usual daily dose: 750 mg to 6 g, administered in divided doses.
Maximum daily intravenous dose: 12 g per day.
Maximum single intravenous dose: 2 g by infusion or 1 g by bolus injection.
Maximum daily intramuscular dose: 4 g per day.
Maximum single intramuscular dose: 1 g.
Lyme disease (infection caused by a parasite called a tick): isolated erythema migrans (early stage – circular reddish or rose-colored skin rash): 4 g per day; systemic manifestations (late stage – more severe symptoms or when the disease spreads to other parts of the body): 6 g per day.

Renal impairment
If you have kidney problems, your dose may be lower than usual.
If you are given more AMOXICILLINA SODICA K24 PHARMACEUTICALS than you should
It is unlikely that you will be given an excessive amount of AMOXICILLINA SODICA K24 PHARMACEUTICALS, but if you think this has happened, contact your doctor, pharmacist, or nurse immediately. Symptoms may include gastrointestinal disturbances (nausea, vomiting, or diarrhea), presence of crystals in the urine (possibly causing cloudy urine), or difficulty urinating.
If you think you have missed an injection of AMOXICILLINA SODICA K24 PHARMACEUTICALS
Contact your doctor, pharmacist, or nurse.
How long should you take AMOXICILLINA SODICA K24 PHARMACEUTICALS?
Generally, AMOXICILLINA SODICA K24 PHARMACEUTICALS is not administered for longer than 2 weeks without a review of the treatment by your doctor.
Prolonged use of AMOXICILLINA SODICA K24 PHARMACEUTICALS 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, inform your doctor, pharmacist, or nurse.
If AMOXICILLINA SODICA K24 PHARMACEUTICALS is administered for prolonged periods, your doctor may perform additional tests to monitor kidney, liver, and blood function.
If you have any further questions about the use of this medicine, contact your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking AMOXICILLINA SODICA K24 PHARMACEUTICALS and consult a doctor immediately if you experience any of the following serious side effects, as urgent medical treatment may be required:
The following side effects are very rare (may affect up to 1 in 10,000 people):

allergic reactions, accompanied by symptoms such as skin itching or rash, swelling of the face, lips, tongue or body, or difficulty breathing. These reactions 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 associated with joint pain (arthritis) and kidney problems
delayed allergic reaction, usually occurring 7–12 days after taking AMOXICILLINA SODICA K24 PHARMACEUTICALS, accompanied by symptoms such as skin rash, fever, joint pain, and swollen lymph nodes, particularly those 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 fatigue
other severe skin reactions may include changes in skin colour, formation of lumps under the skin, blistering, pustules, skin peeling, redness, pain, itching, and flaking. These may be associated with fever, headache, and widespread body aches.
flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased number of white blood cells (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 SODICA K24 PHARMACEUTICALS, causing fever, chills, headache, muscle pain, and rash
inflammation of the large intestine (colon) with diarrhoea (sometimes containing blood), abdominal pain, and fever
severe side effects affecting the liver may occur, mainly observed in patients treated for long periods, in men, and in elderly people. Inform your doctor urgently if you notice any of the following: severe diarrhoea with bleeding or blisters, skin redness or bruising, dark urine, pale stools, or yellowing of the skin or the white part of the eye (jaundice). See also the section 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-mentioned effects occur, seek immediate medical advice from your doctor or nurse.
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 or nurse, as treatment with AMOXICILLINA SODICA K24 PHARMACEUTICALS will need to be discontinued.
Other possible side effects are:
Common (may affect up to 1 in 10 people)

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 (yeast infection of the vagina, mouth or skin folds); your doctor, pharmacist or nurse 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, 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
excessive destruction of red blood cells, leading to a type of anaemia. Symptoms include: fatigue, headache, shortness of breath, dizziness, paleness, and yellowing of the skin and the white part of the eye
reduction in the number of white blood cells
reduction in the number of cells involved in blood clotting
prolonged blood clotting time compared to normal. This effect may become apparent during nosebleeds or after cuts.

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

5. How to store AMOXICILLINA SODICA K24 PHARMACEUTICALS

AMOXICILLINA SODICA K24 PHARMACEUTICALS powder for injectable solution or infusion is intended for hospital use only. The expiry date and storage instructions indicated on the label are for the information of the physician, pharmacist, or nurse. The physician, pharmacist, or nurse will handle the preparation of the medicinal product. If administered directly into the muscle or into a vein, it must be used immediately after reconstitution (the reconstitution procedure usually takes about 5 minutes). (Administration of AMOXICILLINA SODICA K24 PHARMACEUTICALS by slow infusion takes approximately half an hour to one hour).

6. Package Contents and Other Information

What AMOXICILLINA SODICA K24 PHARMACEUTICALS Contains

Each vial contains as active substance 500 mg or 1 g of amoxicillin.
No other excipients are present. However, for information on the sodium content of AMOXICILLINA SODICA K24 PHARMACEUTICALS, please refer to section 2.
The doctor, nurse, or pharmacist will prepare the injection prior to administration using an appropriate liquid (e.g., water for injections or an injection/infusion fluid).

Description of the Appearance of AMOXICILLINA SODICA K24 PHARMACEUTICALS and Contents of the Package
AMOXICILLINA SODICA K24 PHARMACEUTICALS 500 mg powder for solution for injection or infusion appears as a sterile, white to off-white powder, packed in a colorless glass vial with a butyl rubber stopper and aluminum cap. Available in packs of 50 or 100 vials.
AMOXICILLINA SODICA K24 PHARMACEUTICALS 1 g powder for solution for injection or infusion appears as a sterile, white to off-white powder, packed in a colorless glass vial with a butyl-rubber stopper and aluminum cap. Available in packs of 50 or 100 vials.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
K24 Pharmaceuticals S.r.l. – Via Generale Orsini, 46 – 80132 - Naples
Manufacturer:
Biopharma S.r.l. – Via delle Gerbere 22/30 – 00134 Santa Palomba (Rome)

General Recommendation on the Use of Antibiotics
Antibiotics are used to treat bacterial infections and have no effect against infections caused by viruses.
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 enabling them to survive and multiply despite treatment.
There are several reasons why bacteria can become resistant to antibiotics. Correct use of antibiotics can help reduce the likelihood of bacteria developing resistance.
The prescription of an antibiotic course is intended solely for the treatment of the current illness. By following the recommendations below, you can help prevent the development of resistant bacteria, which could otherwise undermine the effectiveness of antibiotic therapy.

It is very important that antibiotics are taken at the correct dose, at the correct times, and for the prescribed number of days. It is important to read the instructions accompanying the medicine and, if they are 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 must be used only 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 your prescribed antibiotics to other people.
If, after completing the treatment course as directed by your doctor, you have any unused antibiotic remaining, it should be returned to a pharmacy for proper disposal.

Intravenous Administration
Vial Diluent (ml)
500 mg 10
1 g 20
The usual diluent is water for injections.
During reconstitution, the solution may occasionally develop a transient pinkish hue.
Typically, reconstituted solutions are colorless or pale yellow. All solutions must be shaken vigorously before injection.
Powder for solution for injection or infusion 500 mg
Preparation of intravenous infusions and stability: immediately add the reconstituted 500 mg solution (prepared according to the instructions above – the volumes indicated are the minimum) to 50 ml of infusion fluid.
Powder for solution for injection or infusion 1 g
Preparation of intravenous infusions and stability: immediately add the reconstituted 1 g solution (prepared according to the instructions above – the volumes indicated are the minimum) to 100 ml of infusion fluid (e.g., using a mini-bag or in-line burette).
Amoxicillin for intravenous use may be administered with a variety of intravenous fluids.
Intravenous Solution
Water for injections
NaCl
Ringer's NaCl
Sodium lactate
Ringer's sodium lactate
Dextrose
NaCl-dextrose
Amoxicillin is less stable in infusions containing carbohydrates. Reconstituted amoxicillin solutions may be administered by intravenous infusion over 0.5–1 hour.
Intramuscular Administration

Vial	Diluent
500 mg	2.5 ml of water for injectable preparations or 5.1 ml of benzyl alcohol solution
1 g	2.5 ml of lidocaine hydrochloride solution

All solutions must be shaken vigorously before injection and administered within 30 minutes after reconstitution.
Any remaining antibiotic solution must be discarded.
For single use only.