Package leaflet: Information for the user

AMOXICILLIN TecniGen 1g tablets

Amoxicillin trihydrate
Generic 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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What Amoxicillina Tecnigen is
Amoxicillina Tecnigen is an antibiotic. Its active substance, called amoxicillin, belongs to a group of medicines known as "penicillins".
What Amoxicillina Tecnigen is used for
Amoxicillina Tecnigen is used to treat bacterial infections in various parts of the body:
infections of the throat, ears, nose, or lungs (including infectious complications of influenza)
urinary and genital tract infections
gastrointestinal tract infections
liver and biliary tract infections
infections of the heart valves or the inner lining of the heart (endocarditis)
blood infections (septicaemia)
infections of the membranes surrounding the brain and spinal cord (meningitis)
skin and soft tissue infections
surgical infections
infections caused by the bacterium Haemophilus influenzae, etc.

2. What you need to know before taking Amoxicillina Tecnigen

Do not take Amoxicillina Tecnigen:

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

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillina Tecnigen 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.

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 Tecnigen, as this medicine may alter the results of these tests.

Other medicines and Amoxicillina Tecnigen
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, 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 prevent blood clots (e.g., warfarin), you may need additional blood tests.
If you are taking other antibiotics (e.g., tetracyclines), the effectiveness of Amoxicillina Tecnigen may be reduced.
If you are taking methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce methotrexate excretion, potentially increasing side effects.
If you are taking high doses of acetylsalicylic acid, phenylbutazone, or other anti-inflammatory medicines: levels and duration of Amoxicillina TecniGen in the blood may increase;
If you are taking aminoglycoside antibiotics.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

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

3. How to take Amoxicillina Tecnigen

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is: 2–3 tablets daily, according to your doctor's judgment.
For cystitis and acute gonococcal urethritis (acute urinary tract infections): 3 g (3 tablets) as a single dose, or 1.5 g as a single dose repeated after 4 hours.
The dose and duration of treatment will be determined by your doctor according to the progression of your infection. As with any antibiotic treatment, do not stop taking the medicine before 48 hours after the fever has subsided and you have recovered.
If you take more Amoxicillina TecniGen than you should
If you accidentally ingest/overdose on Amoxicillina TecniGen, contact your doctor immediately or go to the nearest hospital.
If you take an excessive amount of Amoxicillina Tecnigen, symptoms such as gastrointestinal disturbances (nausea, vomiting, or diarrhea), presence of crystals in the urine (possibly causing cloudy urine), or difficulty urinating may occur. Seek medical advice as soon as possible, and bring the medicine with you to show to the doctor.
If you stop treatment with Amoxicillina TecniGen
Do not stop treatment before consulting your doctor. Stopping treatment too early may cause the infection to recur; furthermore, bacteria may develop resistance to the medicine.
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 everybody gets them.
Stop taking Amoxicillina Tecnigen 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 symptoms 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 red 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 Tecnigen, 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 general 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 aches
fever, chills, sore throat or other signs of infection, or a tendency to bruise easily. These may be signs of a blood cell disorder
serious side effects affecting the liver may occur, observed mainly 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.

The frequency of the following side effects cannot be determined from available data:

Chest pain occurring in the context of allergic reactions, which may be a symptom of heart attack triggered by allergy (Kounis syndrome)
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.
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)
Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease with Amoxicillina Tecnigen, causing fever, chills, headache, muscle pain, and skin rash

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

a slightly itchy rash (roundish pink-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 you experience any of these side effects, contact your doctor, as treatment with Amoxicillina
Tecnigen will need to be discontinued.
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 (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 with existing 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 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 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of that month.
Do not store this medicine above 25°C.
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 you no longer use. This will help protect the environment.

6. Pack contents and other information

What Amoxicillina Tecnigen contains

Each tablet contains as active substance Amoxicillina triidrata g 1.148 (equivalent to anhydrous Amoxicillina g 1).
The other components are: starch, magnesium stearate.

Description of the appearance of Amoxicillina Tecnigen and pack contents
The tablets are packaged in blisters enclosed in a box. Available in a pack containing
12 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Tecnigen S.r.l.
Via Galileo Galilei 40
20092 Cinisello Balsamo (MI).
Manufacturer
Laboratorios Atral SA
Rua da Estação, nº42 Vala do Carregado, 2600 - 726, Castanheira do Ribatejo, Portugal