AMOXICILLINA 1000 mg Coated Tablet

Зміст інструкції

1. Amoxicillina Zentiva 1000 mg tablets
   1. What is Amoxicillina Zentiva and what is it used for
   2. What you need to know before taking Amoxicillina Zentiva
   3. How to take Amoxicillina Zentiva
   4. Possible side effects
   5. How to store Amoxicillina Zentiva
   6. Contents of the pack and other information

Amoxicillina Zentiva 1000 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine, as 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 for your child) only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Amoxicillina Zentiva is and what it is used for
• 2. What you need to know before you take Amoxicillina Zentiva
• 3. How to take Amoxicillina Zentiva
• 4. Possible side effects
• 5. How to store Amoxicillina Zentiva
• 6. Contents of the pack and other information

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

What is Amoxicillina Zentiva
Amoxicillina Zentiva is an antibiotic. The active ingredient is amoxicillin. It belongs to a group of medicines known as “penicillins”.

What is Amoxicillina Zentiva used for
Amoxicillina Zentiva is used to treat infections caused by bacteria in different parts of the body. Amoxicillina
Zentiva can also be used in combination with other medicines for the treatment of gastric ulcers.

2. What you need to know before taking Amoxicillina Zentiva

Do not take Amoxicillina Zentiva

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

Do not take Amoxicillina Zentiva if you recognize any of the situations above. If you have any
doubts, ask your doctor, pharmacist or nurse before taking Amoxicillina Zentiva

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Amoxicillina Zentiva if:

• you have glandular fever (fever, sore throat, swollen glands and extreme fatigue),
• you have kidney problems,
• you do not urinate regularly.

If you are unsure whether any of the points above apply to you, talk to your doctor or pharmacist before
taking Amoxicillina Zentiva.

Blood and urine tests
If you are undergoing:

• Urine tests (for glucose) or blood tests to check liver function.
• Tests for estriol (used during pregnancy to check the normal development of the fetus). Tell your doctor or pharmacist that you are taking Amoxicillina Zentiva. This is because Amoxicillina Zentiva can alter the results of these tests.

Other medicines and Amoxicillina Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.

• If you are taking allopurinol (a medicine used to treat gout) together with Amoxicillina Zentiva Italia, you may be more likely to develop an allergic skin reaction.
• If you are taking probenecid (used for the treatment of gout), the 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 to have additional blood tests.
• If you are taking other antibiotics (such as tetracyclines) the effectiveness of Amoxicillina Zentiva Italia may be reduced.
• If you are taking methotrexate (used for the treatment of cancer and severe psoriasis), penicillins can reduce the excretion of methotrexate causing a potential increase in side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Amoxicillina Zentiva can cause side effects whose symptoms (such as allergic reactions, dizziness and
convulsions) can interfere with the ability to drive vehicles.
Do not drive vehicles and do not use machines if you do not feel well.

Amoxicillina Zentiva contains aspartame and benzyl alcohol
This medicine contains 20 mg of aspartame in each 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 build up because the body cannot process it properly.
Amoxicillina Zentiva contains 0.003 mg of benzyl alcohol in each tablet. Benzyl alcohol can cause
allergic reactions.
Do not give to infants (up to 4 weeks).
Benzyl alcohol has been associated with the risk of serious side effects including breathing problems
(agonal respiratory syndrome) in young children. Do not use for more than one week in young children
(less than 3 years of age) unless otherwise recommended by your doctor or pharmacist.
Ask your doctor or pharmacist if you are pregnant or breastfeeding, or if you have a liver or
kidney condition. This is because large amounts of benzyl alcohol can accumulate in the body and cause adverse
effects (such as metabolic acidosis).

3. How to take Amoxicillina Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.

• Swallow the tablet with a sufficient amount of water. The tablets can be broken in half to facilitate swallowing or to divide them into equal doses.
• Space the doses evenly throughout the day, at least 4 hours apart.

The usual dose is:

Children weighing less than 40 kg
All doses are calculated based on the child's body weight expressed in kilograms.

• Your doctor will tell you how much Amoxicillina Zentiva Italia to give to your child.
• The usual dose ranges from 40 mg to 90 mg per kilogram of body weight per day, to be administered in 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 from 250 mg up to 500 mg three times a day or from 750 mg up to 1 g every
12 hours, depending on the severity and type of infection.

• Severe infections:from 750 mg to 1 g three times a day.
• Urinary tract infection:3 g twice a day for one day.
• Lyme disease (infection caused by a parasite called a tick):isolated erythema migrans (early stage - circular reddish or rosy rash): 4 g per day. Systemic manifestations (late stage - when there are 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 a dose of 1 g twice a day for 7 days together with other antibiotics and medicines for the treatment of gastric ulcers.
• Prevention of heart infections during surgery: 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 you with more detailed information.
• The maximum recommended dose is 6 g per day.

Kidney problems
If you have kidney problems, the dose may be lower than usual.
Some of the dosages cannot be treated with the dosage and pharmaceutical form of this
medicine. Other formulations/dosages should be used to meet these dosages.

If you take more Amoxicillina Zentiva than you should
If you take an excessive amount of Amoxicillina Zentiva, signs such as gastrointestinal disorders (nausea, vomiting or diarrhea) or the presence of crystals in the urine, with possible clouding of the
urine, or problems with urination may appear. Seek medical attention as soon as possible. Bring the medicine with you
to show it to them.

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 soon, wait about 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 Zentiva?

• Continue to take Amoxicillina Zentiva Italia for the time indicated by your doctor, even if you feel better. To fight the infection, it is necessary to take all the prescribed doses. The infection may return if some bacteria survive.
• If, once the treatment is finished, you still do not feel well, consult your doctor again.

The use of Amoxicillina Zentiva for long periods can lead to the development of candidiasis (an infection caused
by a yeast that affects the moist areas of the body, causing irritation, itching and whitish discharge). If
this happens, consult your doctor.
If you take Amoxicillina Zentiva for long periods, your doctor may subject you to additional tests to
verify that everything is normal at the level of kidneys, liver and blood.
If you have any doubts about the use of 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 your doctor immediately if you experience any of the
following serious side effects - urgent medical treatment may be needed:
The following side effects are very rare (may affect up to 1 in 10,000 people)

• allergic reactions, the signs can include: itchy skin or rash, swelling of the face, lips, tongue or body or difficulty breathing. These effects can be severe and, in some cases, have been fatal,
• rash or the appearance of small, reddish-purple, flat, round spots under the skin, or skin bruising. This is due to inflammation of the blood vessel walls caused by an allergic reaction. It may be accompanied by joint pain (arthritis) and kidney problems,
• a delayed allergic reaction may occur, typically 7-12 days after taking amoxicillin, accompanied by signs such as, for example, rash, fever, joint pain and swollen lymph nodes, especially those under the arms,
• a skin reaction defined as “erythema multiforme” where you may develop itchy, reddish-purple patches on the skin, especially on the palms of the hands or the soles of the feet, areas of skin swelling “like hives”, painful areas on the surface of the mouth, eyes and genitals. You may have a fever and a feeling of extreme fatigue,
• other serious skin reactions may include changes in skin color, the formation of bumps under the skin, the appearance of blisters, pustules, exfoliation, redness, pain, itching, scaling. They may be associated with fever, headache and widespread pain,
• 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 (DRESS)),
• fever, chills, sore throat or other signs of infection, or a tendency to bruise easily. These may be signs of a blood cell problem,
• the Jarisch-Herxheimer reaction, which may occur during the treatment of Lyme disease with amoxicillin, causing fever, chills, headache, muscle pain and rash,
• inflammation of the large intestine (colon) with diarrhea (sometimes containing blood), pain and fever
• serious liver effects may occur. These have been observed mainly in subjects treated for long periods, in men and in the elderly. Contact your doctor urgently if you notice the appearance of:
• severe diarrhea with bleeding
• blisters, redness or bruising of the skin
• dark urine or pale stools
• yellowing of the skin or the white of the eye (jaundice). See also the entry on anemia, below, as a possible cause of jaundice. The following is of unknown frequency
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (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
seek immediate medical attention.
Sometimes less serious skin reactions may occur, such as:

• a slightly itchy rash (pinkish-reddish round patches), localized swelling “like hives” on 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 certain type of allergic reaction with the main symptom of repetitive vomiting (1-4 hours after taking the drug). Further symptoms may include abdominal pain, lethargy, diarrhea and low blood pressure.

If any of these side effects occur, contact your doctor as it will be
necessary to stop treatment with Amoxicillina Zentiva Italia.
Other possible side effects are:

Common(may affect up to 1 in 10 people)

• rash
• feeling unwell (nausea),
• diarrhea.

Uncommon(may affect up to 1 in 100 people)

• feeling unwell (vomiting).

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

• candidiasis (infection of the vagina, mouth or skin folds caused by a yeast); your doctor or pharmacist will prescribe appropriate treatment,
• kidney problems,
• seizures, observed in patients treated with high doses or with kidney problems,
• dizziness,
• hyperactivity,
• presence of crystals in the urine (leading to acute kidney damage), with possible clouding of the 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 black and have a hairy appearance,
• excessive destruction of red blood cells, responsible for causing a type of anemia. The signs include: fatigue, headache, shortness of breath, dizziness, paleness and yellowing of the skin and the white of the eye,
• decreased number of white blood cells,
• decreased number of cells involved in blood clotting,
• increased time required for blood to clot compared to normal. This effect may be noticed in case of nosebleeds or if you get a cut.

Frequency not known

• rash with blisters arranged in a circle with a central crust or like 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 at a temperature below 25°C. Store in the original packaging to protect the medicine
from humidity.
If the 1000 mg Amoxicillina Zentiva tablet is halved, reposition the unused half of the
tablet in the open blister cell 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 which is stated on the pack after the letters EXP. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Amoxicillina Zentiva contains

• The active ingredient is amoxicillin. Each tablet contains amoxicillin trihydrate equivalent to 1000 mg of amoxicillin.
• The other ingredients are: microcrystalline cellulose, aspartame (E951), copovidone type A, magnesium stearate, strawberry flavour. Composition of the strawberry flavour: corn 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 from white to yellowish in colour, oblong in shape, with a breaking notch on both sides, with dimensions of 22.2 mm x 10 mm. The breaking notch on the tablet is designed to facilitate breaking it to make it easier to swallow or to divide it into equal doses.
The tablets are packaged in PVC/TE/PVDC/Alu blisters.
Pack size: 12 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7
20121 Milano

Manufacturer
Haupt Pharma Latina S.r.l.
SS.156 Monti Lepini Km. 47,600
04100 Borgo San Michele (Latina)

This medicinal product is authorised in the Member States of the European Economic Area 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 of the time this is due to the fact that the bacteria responsible for the infection are resistant to the antibiotic administered and are therefore able to survive and proliferate despite treatment.
There are various reasons why bacteria can become resistant to antibiotics. Correct use of antibiotics can help reduce the likelihood that bacteria will develop resistance.
The prescription of a course of antibiotics is intended to treat only your current illness. By following the advice below, you will help prevent the development of resistant bacteria that could render antibiotic therapy ineffective.

• 1. It is very important that antibiotics are taken at the correct dose, at the correct times and for the number of days prescribed. It is important to read the instructions accompanying the medicine and, if difficult to understand, ask your doctor or pharmacist for clarification.
• 2. Do not take antibiotics if they have not been specifically prescribed for you and use them only to treat the infection for which they have been prescribed.
• 3. Do not take antibiotics prescribed to other people, even if the infection appears similar.
• 4. Do not give antibiotics prescribed to you to other people.
• 5. If, once the course of treatment according to your doctor's instructions is completed, some antibiotic remains unused, you should take this to the pharmacy for correct disposal.