Amoxicillin Zentiva Italia

Patient Information Leaflet

Amoxicillina Zentiva Italia 250 mg/5 ml powder for oral suspension

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

What this leaflet contains:

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

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

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

2. What you need to know before taking Amoxicillina Zentiva Italia

Do not take Amoxicillina Zentiva Italia:

• 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 skin rash or swelling of the face or throat.

Do not take Amoxicillina Zentiva Italia if any of the above situations apply to you. If you have
any doubts, consult your doctor or pharmacist before taking Amoxicillina Zentiva Italia.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillina Zentiva Italia 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 above points apply to you, consult your doctor or pharmacist before
taking Amoxicillina Zentiva Italia.
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 Zentiva Italia, as this medicine may alter the results of these tests.

Other medicines and Amoxicillina Zentiva Italia
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 Zentiva Italia, you may have a higher 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 Zentiva Italia.
• 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 Zentiva Italia may be reduced.
• If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), Amoxicillina Zentiva Italia may cause an increase in side effects.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Amoxicillina Zentiva Italia may cause side effects whose symptoms (such as allergic reactions, dizziness, and
seizures) could impair your ability to drive.
Do not drive or operate machinery if you do not feel well.
This medicine contains maltodextrin (glucose). If you have been diagnosed with an intolerance to certain
sugars, consult your doctor before taking this medicine.

3. How to take Amoxicillin Zentiva Italia

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

• Shake the bottle well before taking each dose.
• Take the doses at regular intervals throughout the day, at least 4 hours apart.

Instructions for reconstitution
Check that the cap seal is intact before use.
Invert and shake the bottle to loosen the powder.
Fill the bottle with water up to just below the mark on the label of the bottle.
Invert and shake thoroughly, wait for the foam to subside, then add more water up to the mark. Invert and shake vigorously again.
Shake well before taking each dose.
Further information for the preparation of the oral suspension in the pharmacy

The usual dose is:
Children weighing less than 40 kg
All doses are calculated according to the child's body weight expressed 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, to be administered in two or three divided 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
This suspension is generally not prescribed for adults and children weighing 40 kg or more. Please consult your doctor or pharmacist.
Kidney problems
If you have kidney problems, your dose may be lower than usual.
If you take more Amoxicillina Zentiva Italia than you should

If you take too much Amoxicillina Zentiva Italia, 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, taking the medicine with you so you can show it to him or her.

If you forget to take Amoxicillina Zentiva Italia

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

How long should you take Amoxicillina Zentiva Italia?

• Continue taking Amoxicillina Zentiva Italia for the length of time prescribed by your doctor, even if you start feeling better. It is important to take all the prescribed doses to fully treat the infection, as the infection may return if some bacteria survive.
• If, after completing the treatment, you still do not feel well, contact your doctor again.

Prolonged use of Amoxicillina Zentiva Italia may lead to the development of candidiasis (a yeast infection affecting moist areas of the body, causing irritation, itching and white discharge). If this occurs, consult your doctor.
If you take Amoxicillina Zentiva Italia for a prolonged period, your doctor may carry out additional tests to check 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 Zentiva Italia and consult a doctor immediately if you notice 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 signs such as 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
• delayed allergic reaction, usually occurring 7–12 days after taking Amoxicillina Zentiva Italia, 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 tiredness
• other serious skin reactions may include changes in skin colour, formation of lumps under the skin, appearance of blisters, pustules, peeling, redness, pain, itching and shedding of the skin, and may be associated with fever, headache and widespread pain
• flu-like symptoms with skin 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 disorder
• the Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease with Amoxil, causing fever, chills, headache, muscle pain and skin rash
• inflammation of the large intestine (colon) with diarrhoea (sometimes containing blood), abdominal pain and fever
• serious 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: 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, stop treatment with the medicine and contact your
doctor immediately.
Sometimes less serious skin reactions may occur, such as:

• a slightly itchy skin rash (roundish pink-reddish 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, contact your doctor, as treatment with Amoxicillina Zentiva Italia
will need to be stopped.
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 (yeast infection of the vagina, mouth or skin folds); your doctor or pharmacist will prescribe appropriate treatment
• kidney problems
• seizures, observed in patients treated with high doses or who have kidney problems
• dizziness
• hyperactivity
• presence of crystals in the urine, 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 reported 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: tiredness, 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.

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 the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amoxicillina Zentiva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Dry powder
Do not store this medicine above 25°C.
Liquid suspension
Store in the refrigerator (2°C – 8°C). Once prepared, the suspension must be used within 10 days.
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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Amoxicillina Zentiva Italia contains:
Each dose of suspension contains 250 mg/5 ml of amoxicillin as the active substance.
The other components are: crospovidone type A, silicon dioxide, xanthan gum, anhydrous colloidal silica,
acesulfame potassium, sodium saccharin, strawberry flavour (maltodextrin, triethyl citrate (E1505), flavouring components, propylene glycol and benzyl alcohol).

Description of the appearance of Amoxicillina Zentiva Italia and package contents
Amoxicillina Zentiva Italia 250 mg/5 ml oral suspension powder is a white to slightly yellowish powder for preparing a homogeneous suspension with water. It is supplied in brown glass bottles with a nominal volume of 100 ml (for 60 ml of oral suspension) or 150 ml (for 100 ml of oral suspension), closed with a white screw cap. These bottles are packaged in a cardboard box with a dosing device: a 6 ml PE syringe, a 10 ml PS spoon, a 5 ml PP or PS spoon, or a 5 ml PP cup.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale Luigi Bodio, 37/B
20158 – Milano (Italy)

Manufacturer
Pencef Pharma GmbH
Breitenbachstrasse 13
13509 Berlin - Germany
Or
Haupt Pharma Latina S.r.l.
SS.156 Monti Lepini Km. 47,600
04100 Borgo San Michele (Latina) - Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Netherlands: Amoxicilline Zentiva Italia 250 mg/5 ml powder for oral suspension
France: Amoxicilline Zentiva Italia 250 mg/5 ml poudre pour suspension buvable
Italy: Amoxicillina Zentiva Italia 250 mg/5 ml polvere per sospensione orale

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. This is most often due to the bacteria causing the infection being resistant to the prescribed 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 that bacteria will develop resistance.
An antibiotic prescription is intended solely to treat the current illness. By following the recommendations below, you can help prevent the development of resistant bacteria, which 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 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.
2. 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.
3. Do not take antibiotics prescribed for other people, even if the infection appears similar.
4. Do not give your prescribed antibiotics to other people.
5. If, after completing the treatment course as directed by your doctor, you have leftover antibiotics, return them to the pharmacy for proper disposal.