Amoxicillin Aurobindo Italia: detailed information

Patient Information Leaflet: Information for the patient

Amoxicillina Aurobindo Italia 500 mg dispersible tablets, 1000 mg dispersible tablets

Equivalent medicine
Please read 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What Amoxicillina Aurobindo Italia is
Amoxicillina Aurobindo Italia is an antibiotic. Its active ingredient, called amoxicillin,
belongs to a group of medicines known as "penicillins".
What Amoxicillina Aurobindo Italia is used for
Amoxicillina Aurobindo Italia is used to treat bacterial infections in various parts of the
body. Amoxicillina Aurobindo 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 Aurobindo Italia

Do not take Amoxicillina Aurobindo 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 development of swelling of the face or throat.
Do not take Amoxicillina Aurobindo Italia if any of the above situations apply to you. If you have any doubts, consult your doctor or pharmacist before taking Amoxicillina Aurobindo Italia.

Warnings and precautions
Consult your doctor or pharmacist before taking Amoxicillina Aurobindo 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 Aurobindo 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 Aurobindo Italia, as this medicine may alter the results of these tests.

Other medicines and Amoxicillina Aurobindo Italia
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
If you are taking allopurinol (a medicine used to treat gout) together with Amoxicillina Aurobindo Italia, 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 Aurobindo Italia.
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 Aurobindo Italia may be reduced.
If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), Amoxicillina Aurobindo Italia may cause an increase in adverse effects.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Amoxicillina Aurobindo Italia may cause adverse effects whose symptoms (such as allergic reactions, dizziness, and convulsions) may interfere with your ability to drive vehicles.
Do not drive or operate machinery if you do not feel well.

Amoxicillina Aurobindo Italia dispersible tablets contain aspartame and maltodextrin (glucose).
Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria.
Maltodextrin is absorbed as glucose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Amoxicillina Aurobindo Italia

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

Add the tablet to a glass of water and stir until completely dissolved. Then drink immediately.
Take the doses at regular intervals throughout the day, at least 4 hours apart.

Recommended 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 Aurobindo Italia to give your child.
The usual dose ranges from 40 mg to 90 mg per kilogram of body weight per day, given 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
The usual dose of Amoxicillina Aurobindo Italia is 250–500 mg three times a day 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 a day.
Urinary tract infections: 3 g twice a day for one day.
Lyme disease (infection caused by a parasite called a tick): isolated erythema migrans (early stage – single 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 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 surgical procedure. 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.

Renal impairment
If you have kidney problems, your dose may be lower than usual.
The tablet may be divided into equal doses.
If you take more Amoxicillina Aurobindo Italia than you should
If you take an excessive amount of Amoxicillina Aurobindo Italia, symptoms such as
gastrointestinal disturbances (feeling unwell, malaise, or diarrhoea) or the 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 them.
If you forget to take Amoxicillina Aurobindo Italia

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 forgotten dose.

How long should you take Amoxicillina Aurobindo Italia?

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

Long-term use of Amoxicillina Aurobindo Italia 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 Aurobindo Italia for a prolonged period, your doctor may perform additional tests
to monitor your kidney, liver, and blood function.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Amoxicillina Aurobindo Italia 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 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.
a delayed allergic reaction, usually occurring 7–12 days after taking Amoxicillina Aurobindo Italia, accompanied by signs 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, especially 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 serious skin reactions may include changes in skin colour, formation of lumps under the skin, appearance of blisters, pustules, peeling, redness, pain, itching and flaking, and may be associated with fever, headache and widespread body pain.
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 Aurobindo Italia, 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, 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 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 effects occur, stop taking the medicine and contact your doctor immediately.
Less severe skin reactions may sometimes occur, such as:

a slightly itchy 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 it will be necessary to stop treatment with
Amoxicillina Aurobindo Italia.
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 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 causing 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 with nosebleeds or if you get a cut.

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 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 Aurobindo Italia

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging. 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 you no longer use. This will help protect the environment.

6. Package Contents and Other Information

The active substance is amoxicillin. Each dispersible tablet contains amoxicillin trihydrate equivalent to 500 mg or 1000 mg of amoxicillin.
The other components are Tablet core: Microcrystalline cellulose (Grade-101), Anhydrous colloidal silica, Aspartame, Sodium croscarmellose, Mannitol, Talc, Magnesium stearate, Peach flavour, Orange flavour. Tablet coating: Aspartame (E951), Mannitol, Maltodextrin, Maize starch, Titanium dioxide (E171), Talc.

Description of the appearance of Amoxicillina Aurobindo Italia and package contents
Dispersible tablets.
Amoxicillin 500 mg dispersible tablets: [Size: 17.8 mm x 8.8 mm]
Oblong, biconvex, film-coated tablets, white to off-white in colour, marked with ‘C 500’ on one side and a score line on the other.
Amoxicillin 1000 mg dispersible tablets: [Size: 22.3 mm x 10.3 mm]
Oblong, biconvex, film-coated tablets, white to off-white in colour, marked with ‘C 1000’ on one side and a score line on the other.
Amoxicillina Aurobindo Italia tablets are available in blister packs.
Pack sizes:
Blister packs: 6, 12, 14, 16, 20, 24 and 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l., via San Giuseppe 102, 21047 Saronno (VA)
Manufacturer
APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Generis Farmacêutica, S.A., Rua João de Deus, 19, 2700-487 Amadora, Portugal
Arrow Génériques, 26 avenue Tony Garnier, 69007 Lyon, France
This medicinal product is authorized in EEA Member States under the following names
Belgium: Amoxicillin AB 500 mg/750 mg/1000 mg, dispergeerbare tabletten
France: Amoxicilline Arrow Lab 1000 mg, comprimé dispersible
Italy: Amoxicillina Aurobindo Italia
Poland: Amoxicillin Aurovitas
Portugal: Amoxicilina Aurobindo
Netherlands: Amoxicilline Aurobindo Disper 375 mg/500 mg/750 mg, dispergeerbare tabletten
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 surviving and multiplying 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.
A prescription for an antibiotic course 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 treatments ineffective.

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 difficult to understand, to ask your doctor or pharmacist for clarification.
Antibiotics should not be taken if they have not 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 your prescribed antibiotics to other people.
If, after completing the prescribed treatment course, you have unused antibiotics remaining, these should be returned to a pharmacy for proper disposal.