Amoxicillin Tecnigen Italia: detailed information

Package leaflet: Information for the user

Amoxicillina TecniGen Italia

1 g dispersible tablets
Amoxicillin
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 (or for your child) 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 side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

2. What you should know before taking Amoxicillina TecniGen Italia

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillina TecniGen Italia 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 above points apply to you, consult your doctor or pharmacist before taking Amoxicillina TecniGen Italia.

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 check normal fetal development)

Inform your doctor or pharmacist that you are taking Amoxicillina TecniGen Italia, as this medicine may affect the results of these tests.

Other medicines and Amoxicillina TecniGen 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 TecniGen Italia, you may be more likely to develop 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 TecniGen 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 TecniGen Italia may be reduced.
If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), Amoxicillina TecniGen Italia may cause an increase in side effects.

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

Driving and using machines
Amoxicillina TecniGen Italia may cause side effects such as allergic reactions, dizziness, or seizures, which may impair your ability to drive.
Do not drive or operate machinery if you do not feel well.

Amoxicillina TecniGen Italia contains aspartame.
This medicine contains 20 mg of aspartame per dispersible tablet, equivalent to 20 mg/1000 mg.
Aspartame (E951) is a source of phenylalanine, a substance that may be harmful to patients with a condition called phenylketonuria.

Amoxicillina TecniGen Italia contains maltodextrin.
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.

Amoxicillina TecniGen Italia contains benzyl alcohol.
This medicine contains 0.003 mg of benzyl alcohol per dispersible tablet, equivalent to 0.003 mg/1000 mg.
Benzyl alcohol may cause allergic reactions.

3. How to take Amoxicillina Tecnigen Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The tablets can be taken in the following ways:

Swallow the tablets whole with a glass of water. To facilitate swallowing, the tablet may be divided along the score line.
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.
The usual dose is:
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 TecniGen Italia to give your child.

The usual dose ranges from 40 mg to 90 mg per kilogram of body weight per day, administered in two or three divided doses.
The maximum 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 TecniGen 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 tick): isolated erythema migrans (early stage - circular reddish or rosy skin 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 the treatment of 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 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.
If you take more Amoxicillina TecniGen Italia than you should
If you take too much Amoxicillina TecniGen Italia, symptoms such as gastrointestinal disturbances (nausea, vomiting or diarrhoea) or 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 to show it.
If you forget to take Amoxicillina TecniGen 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 TecniGen Italia?

Continue taking Amoxicillina TecniGen Italia for the duration prescribed by your doctor, even if you start feeling better. It is necessary to take all prescribed doses to fight the infection. The infection may return if some bacteria survive.
If, after completing the treatment, you still do not feel well, consult your doctor again. Prolonged use of Amoxicillina TecniGen 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 TecniGen Italia for a long time, your doctor may carry out additional tests to ensure that your kidneys, liver and blood are functioning normally.
If you have any doubts 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 everybody gets them.
Stop taking Amoxicillina TecniGen 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, with signs such as skin itching 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.
Skin rash or appearance of small, round, flat, reddish spots beneath the skin surface, or skin bruising. This is due to inflammation of blood vessel walls, related to 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 TecniGen 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 color, 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.
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 TecniGen Italia, causing fever, chills, headache, muscle pain, and skin 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:
severe diarrhoea with bleeding
blisters, redness, or bruising of the skin
dark urine or pale stools
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 effects occur, stop taking the medicine immediately and contact your doctor.
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, contact your doctor, as treatment with Amoxicillina TecniGen 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 receiving high doses or with 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 in color 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 be noticed with nosebleeds or when sustaining 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: 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 TecniGen Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “EXP”. The expiry date refers to the last day of that month.
Do not store this medicine above 25°C. Store in the original container to protect from moisture.
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 required. This will help protect the environment.

6. Package contents and other information

What Amoxicillina Tecnigen Italia contains
The active substance is amoxicillin.

Each tablet contains amoxicillin trihydrate equivalent to 1 g of amoxicillin.
The other components are magnesium stearate, microcrystalline cellulose, crospovidone, strawberry flavour, aspartame.
Components of the strawberry flavour: maize maltodextrin, triethyl citrate (E1505), flavourings, propylene glycol and benzyl alcohol.

Description of the appearance of Amoxicillina TecniGen Italia and contents of the pack
Amoxicillina TecniGen Italia 1 g dispersible tablets
The tablets are white or almost white, oval-shaped, measuring 22 mm x 10 mm, with a score line on both sides.
The tablets are packaged in PVC/PVDC/Aluminium or PVC/TE/PVDC/Aluminium blisters.
Amoxicillina TecniGen Italia 1 g dispersible tablets are available in packs of 12 tablets.

Marketing Authorisation Holder
Tecnigen S.r.l.
Via Galileo Galilei n. 40
20092 Cinisello Balsamo
Italy

Manufacturer
Pencef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin
Germany
HAUPT Pharma Latina Srl
SS.156 Monti Lepini Km.47,600
04100 Borgo S. Michele (Latina)
Italy

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 fact that the bacteria causing the infection are resistant to the administered antibiotic and are therefore able 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.
The prescription of an antibiotic course is intended solely to treat the current illness.
By following the advice 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 must 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.
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 should return it to a pharmacy for proper disposal.