Amoxicillin Zentiva: detailed information

Package leaflet: Information for the user

Amoxicillina Zentiva 1000 mg tablets

Generic 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, pharmacist or nurse.
This medicine has been prescribed for you (or your child) only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Amoxicillina Zentiva is and what it is used for

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

2. What you need to know before taking Amoxicillin Zentiva

Do not take Amoxicillin Zentiva

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 includes a skin rash or the development of swelling of the face or throat.

Do not take Amoxicillin Zentiva if any of the above situations apply to you. If you have any
doubts, consult your doctor, pharmacist, or nurse before taking Amoxicillin Zentiva.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Amoxicillin Zentiva 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 Amoxicillin Zentiva.
Blood and urine tests
If you are undergoing:

urine tests (for glucose) or blood tests for liver function,
tests for oestriol (used during pregnancy to monitor normal fetal development),
inform your doctor or pharmacist that you are taking Amoxicillin Zentiva. This is because Amoxicillin Zentiva may alter the results of these tests.

Other medicines and Amoxicillin Zentiva
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 Amoxicillin Zentiva, you may have an increased risk of developing an allergic skin reaction.
If you are taking probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If you are taking medicines to reduce blood clotting (such as warfarin), you may need additional blood tests.
If you are taking other antibiotics (such as tetracyclines), the effectiveness of Amoxicillin Zentiva may be reduced.
If you are taking 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, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Amoxicillin Zentiva may cause adverse effects whose symptoms (such as allergic reactions, dizziness, and
seizures) may impair your ability to drive or operate machinery.
Do not drive or operate machinery if you do not feel well.
Amoxicillin Zentiva contains aspartame and benzyl alcohol
This medicine contains 20 mg of aspartame per tablet, equivalent to 20 mg/1000 mg.
Aspartame (E951) is a source of phenylalanine. It may be harmful to you if you have phenylketonuria, a rare
genetic disorder that causes phenylalanine to accumulate in the body because it cannot be properly metabolized.
Amoxicillin Zentiva contains 0.003 mg of benzyl alcohol per tablet. Benzyl alcohol may cause
allergic reactions.
Do not administer to newborns (up to 4 weeks of age).
Benzyl alcohol has been associated with a risk of serious adverse effects, including breathing problems
(agitated breathing syndrome), in young children. Do not use for more than one week in young children
(under 3 years of age) unless otherwise recommended by a doctor or pharmacist.
Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease.
This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take Amoxicillina Zentiva

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Swallow the tablet with a sufficient amount of water. The tablets may be divided in half to facilitate swallowing or to split the dose into equal parts.
Space the doses evenly throughout the day, at intervals of at least 4 hours.

Usual dose:
Children weighing less than 40 kg
All doses are calculated according to the child's body weight in kilograms.

Your doctor will tell you how much Amoxicillina Zentiva Italia to give your child.
The usual dose ranges from 40 mg to 90 mg per kilogram of body weight per day, divided into two or three separate doses.
The maximum recommended dose is 100 mg per kilogram of body weight per 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 infections: 3 g twice a day for one day.
Lyme disease (infection caused by a parasite called tick): isolated erythema migrans (early stage - circular reddish or pinkish rash): 4 g per day. Systemic manifestations (late stage - presence of 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 a day for 7 days, together with other antibiotics and medicines for treating 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 at the same time. 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.
Some dosage regimens cannot be achieved with the dosage strength and pharmaceutical form of this medicine. Other formulations/dosages should be used to meet such requirements.

If you take more Amoxicillina Zentiva than you should
If you take too much Amoxicillina Zentiva, symptoms such as gastrointestinal disturbances (nausea, vomiting or diarrhoea), presence of crystals in the urine (possibly causing cloudy urine), or difficulty urinating may occur. Contact your doctor as soon as possible. Take the medicine with you so you can show it to the doctor.

If you forget to take Amoxicillina Zentiva

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 the missed dose.

How long should you take Amoxicillina Zentiva?

Continue taking Amoxicillina Zentiva Italia for the length of time prescribed by your doctor, even if you start to feel better. It is important to take all prescribed doses to fully treat the infection, as the infection may return if some bacteria survive.
If you continue to feel unwell after completing the treatment, contact your doctor again.

Prolonged use of Amoxicillina Zentiva 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 Zentiva for a prolonged period, your doctor may carry out additional tests to monitor your kidney, liver and blood function.
If you have any doubts about how to use this medicine, consult 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 Zentiva and consult a doctor immediately if you experience any of the following
serious side effects – urgent medical treatment may be required:
The following side effects are very rare (may affect up to 1 in 10,000 people):

allergic reactions, signs of which may include: skin itching or 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,
a delayed allergic reaction, usually occurring 7–12 days after taking amoxicillin, accompanied by symptoms such as skin rash, fever, joint pain, and swollen lymph nodes, particularly under the arms,
a skin reaction known as "erythema multiforme", in which you may develop itchy, reddish-purple patches on the skin, particularly on the palms of the hands or soles of the feet, areas of skin swelling resembling hives, painful areas on the surface of the mouth, eyes, and genitals. You may also have fever and feel extremely tired,
other serious skin reactions may include changes in skin colour, formation of lumps under the skin, appearance of blisters, pustules, peeling, redness, pain, itching, or flaking. These may be associated with fever, headache, and widespread pain,
flu-like symptoms with 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 (DRESS)),
fever, chills, sore throat or other signs of infection, or a tendency to bruise easily. These may be signs of a blood cell disorder,
Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease with amoxicillin, 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. These have mainly been observed in patients treated for long periods, in men, and in elderly patients. Inform your doctor urgently if you notice:
- severe diarrhoea with bleeding,
- blisters, redness, or skin bruising,
- dark urine or pale stools,
- 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. The following occur with unknown frequency:
- chest pain occurring in the context of allergic reactions, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

These effects may occur during treatment with the medicine or even several weeks later.
If any of the above effects occur, stop taking the medicine and contact your doctor immediately.
Sometimes less serious skin reactions may occur, such as:

a slightly itchy rash (roundish pinkish-red patches), localized swelling resembling 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).
Drug-Induced Enterocolitis Syndrome (DIES): DIES has been reported mainly in children treated with amoxicillin. It is a type of allergic reaction with the main symptom being repeated vomiting (1–4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.

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

skin rash,
feeling unwell (nausea),
diarrhoea.

Uncommon (may affect up to 1 in 100 people)

feeling unwell (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 receiving high doses or with existing kidney problems,
dizziness,
hyperactivity,
presence of crystals in the urine (which may lead to acute kidney damage), possibly causing cloudy urine, difficulty urinating, or discomfort during urination. Make sure you 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 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,
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 as nosebleeds or prolonged bleeding from cuts.

Frequency not known

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

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

5. How to store Amoxicillina Zentiva

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect the medicine from moisture.
If a 1000 mg Amoxicillina Zentiva tablet is divided, reinsert the unused half of the tablet into the open blister cavity and store it in the original cardboard box until the next dose (for a maximum of 8 hours).
Do not use this medicine after the expiry date stated on the carton after the letters EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Amoxicillina Zentiva contains

The active substance is amoxicillin. Each tablet contains amoxicillin trihydrate equivalent to 1000 mg of amoxicillin.
The other components are: microcrystalline cellulose, aspartame (E951), crospovidone type A, magnesium stearate, strawberry flavour. Composition of the strawberry flavour: maize maltodextrin, triethyl citrate, flavouring components, propylene glycol (E 1520) and benzyl alcohol.

Description of the appearance of Amoxicillina Zentiva and contents of the pack
The tablets are white to yellowish, oval-shaped, with a score line on both sides, and measure 22.2 mm x 10 mm. The score line on the tablet is intended to facilitate breaking the tablet, making it easier to swallow or allowing it to be divided into equal doses.
The tablets are packaged in PVC/TE/PVDC/Alu blisters.
Pack: 12 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7
20121 Milano, Italy
Manufacturer
Haupt Pharma Latina S.r.l.
SS.156 Monti Lepini Km. 47,600
04100 Borgo San Michele (Latina), Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Malta Amoxicillin Zentiva
Italy Amoxicillina Zentiva

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 because the bacteria causing the infection are resistant to the prescribed antibiotic, thus enabling them to survive and multiply despite treatment.
There are several reasons why bacteria may become resistant to antibiotics. Correct use of antibiotics can help reduce the likelihood of bacteria developing resistance.
An antibiotic prescription is intended solely for the treatment of your current illness. By following the recommendations below, you will help prevent the development of resistant bacteria, which could render antibiotic therapy ineffective.

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 they are difficult to understand, to ask your doctor or pharmacist for clarification.
Do not take antibiotics unless they have been specifically prescribed for you, and use them 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 left, you must return it to a pharmacy for proper disposal.