Package leaflet: Information for the patient

AMOXICILLINA DOC Generici 1 g tablets

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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What AMOXICILLINA DOC Generici is and what it is used for

AMOXICILLINA DOC Generici is an antibiotic whose active ingredient, amoxicillin, belongs to a
group of medicines called penicillins.
AMOXICILLINA DOC Generici is used in adults to treat bacterial infections in various parts of the body:

acute and chronic respiratory tract infections
ear, nose, and throat infections
mouth infections
kidney, bladder, urethra, and genital organ infections
intestinal, liver, and biliary tract infections
skin and soft tissue infections (e.g.: muscles, tendons)
infections following surgical procedures
stomach infections caused by a bacterium called Helicobacter pylori, which causes gastric ulcer

2. What you need to know before taking AMOXICILLINA DOC Generici

Do not use AMOXICILLINA DOC Generici if

you are allergic to amoxicillin or to any of the other ingredients of this medicine (listed in section 6);
you are allergic to other antibiotics belonging to the penicillin or cephalosporin class;
you have an infection caused by bacteria that are not sensitive to this medicine;
you have a viral infection called "infectious mononucleosis", as there is an increased risk of skin reactions.

Warnings and precautions
Talk to your doctor or pharmacist before using AMOXICILLINA DOC Generici.
Inform your doctor if you think any of the following conditions apply to you:

you have previously experienced an allergic reaction to penicillin, cephalosporins, or other similar antibiotics, as you may be more likely to have a new, possibly severe, allergic reaction after taking AMOXICILLINA DOC Generici. If you experience an allergic reaction, stop treatment with AMOXICILLINA DOC Generici immediately and contact your doctor (see also section 4 “Possible side effects”);
you have mononucleosis or other viral infections caused by viruses such as herpes simplex, cytomegalovirus, or HIV (the AIDS virus), as you are very likely to develop a skin rash with small raised spots and reddish patches (maculopapular eruptions);
you develop severe and persistent diarrhoea during or after treatment. This may be a sign of a serious intestinal inflammation (pseudomembranous colitis). Diarrhoea can occur with the use of almost all antibiotics, including AMOXICILLINA DOC Generici, and is due to disruption of the normal intestinal bacterial flora, allowing excessive growth of a bacterium called Clostridium difficile. If you develop diarrhoea, your doctor will closely monitor your condition;
you develop mouth or vaginal infections caused by fungi (e.g.: oral or vaginal candidiasis), especially during prolonged treatment or at high doses.

During prolonged treatment with AMOXICILLINA DOC Generici, your doctor will carry out frequent blood tests or other examinations to monitor kidney and liver function.
Children
AMOXICILLINA DOC Generici must not be used in children.
Other medicines and AMOXICILLINA DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you are taking any of the following medicines:

penicillin G and cephalosporins, due to the possibility of cross-allergy to these antibiotics;
allopurinol (a medicine used for gout and uric acid accumulation). If you take this medicine together with AMOXICILLINA DOC Generici, skin rashes may occur more frequently;
oral contraceptives. Taking AMOXICILLINA DOC Generici may reduce the effectiveness of oral contraceptives, potentially leading to unintended pregnancies. In such cases, it is recommended to use alternative or additional contraceptive measures;
aminoglycosides (antibiotics). The effectiveness of AMOXICILLINA DOC Generici may be enhanced, and AMOXICILLINA DOC Generici may enhance the effectiveness of these antibiotics when administered together.

The following medicines may increase the efficacy and/or toxic effects of AMOXICILLINA DOC Generici:

methotrexate (used to treat cancer and severe psoriasis); penicillins may reduce methotrexate excretion, potentially increasing its side effects.
probenecid (used to treat gout); concomitant use with probenecid may reduce amoxicillin excretion and is not recommended;
acetylsalicylic acid, phenylbutazone (anti-inflammatory medicines) and other anti-inflammatory drugs.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, your doctor will assess the benefits of treatment with this medicine against any potential risks.
Driving and using machines
No negative effects of AMOXICILLINA DOC Generici on the ability to drive or operate machinery are known.

3. How to use AMOXICILLINA DOC Generici

Use this medicine exactly as prescribed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
AMOXICILLINA DOC Generici should be taken by mouth. Depending on the severity of the infection, your doctor may
increase the dosage of this medicine and determine the most appropriate treatment duration for you.
In adults, the recommended dose is:

1 tablet of 1 g twice daily (every 12 hours)

For the treatment of cystitis and acute gonococcal urethritis, the recommended dose is 3 g as a single dose or 1.5 g as a single dose followed by an additional 1.5 g as a single dose 4 hours later.
For the treatment of Helicobacter pylori infection, the recommended dose is 1 g every 12 hours for
7–10 days, in combination with other antibiotics and proton pump inhibitors, according to a regimen to be determined by the doctor.
Your doctor may decide to adjust the dose and duration of treatment depending on the type of
infection.
If you use more AMOXICILLINA DOC Generici than you should
In case of accidental ingestion or overdose of AMOXICILLINA DOC Generici,
contact your doctor immediately or go to the nearest hospital.
To date, no adverse effects have been reported due to overdosage of AMOXICILLINA DOC Generici.
If you forget to use AMOXICILLINA DOC Generici
If you miss a dose, take it as soon as you remember. Never take a double dose to make up for a missed dose.
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 gets them.
STOP using AMOXICILLIN DOC Generici immediately if you experience any of the following side
effects, as they are serious:

allergic reaction such as: sudden drop in blood pressure (hypotension), increased or decreased heart rate, unusual tiredness or weakness, anxiety, restlessness, dizziness, loss of consciousness, difficulty breathing or swallowing, generalized itching especially on the soles of the feet and palms of the hands, urticaria with or without angioedema (swollen, itchy areas of skin affecting more frequently the extremities, external genital organs, and face, especially around the eyes and lips), skin redness especially around the ears, bluish discoloration of the skin, mucous membranes, and nails (cyanosis), excessive sweating, nausea, vomiting, abdominal pain with cramps, diarrhoea
swelling and itching of the face, tongue, throat, hands and feet, genitals, leading to difficulty in swallowing and breathing (angioedema)
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
severe and widespread inflammation with skin peeling (exfoliative dermatitis)
severe skin reactions (toxic epidermal necrolysis or Lyell’s syndrome, Stevens-Johnson syndrome)
excessive destruction of red blood cells and reduction in haemoglobin levels (haemolytic anaemia and positive direct Coombs test)
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)
severe inflammation of the final part of the intestine called colon (colitis) caused by excessive growth of a bacterium called Clostridium difficile (pseudomembranous colitis) (see section 2 “Warnings and precautions”)
kidney problems (acute interstitial nephritis)
infections caused by bacteria resistant to amoxicillin (see section 2 “Warnings and precautions”)

Contact your doctor if you experience any of the following side effects:

increased number in the blood of a type of white blood cells called eosinophils (eosinophilia)
reduced number in the blood of red blood cells (anaemia)
reduced number in the blood of white blood cells (neutropenia, agranulocytosis, leucopenia)
reduced number in the blood of platelets (thrombocytopenia) and appearance of reddish spots on the skin (thrombocytopenic purpura)
altered platelet function
prolonged blood clotting time (prolonged bleeding time and prothrombin time)
serum sickness-like reactions (characterized by signs such as urticaria or allergic-type skin rashes accompanied by fever, muscle aches, joint pain and inflammation)
headache
dizziness
diarrhoea
vomiting
skin rash
crystals in the urine leading to acute kidney injury
skin rash with blisters arranged in a ring-shaped pattern 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)
urticaria
reduced or loss of appetite (anorexia)
pain in the upper part of the abdomen, at stomach level (epigastric pain)
inflammation of the stomach (gastritis)
inflammation of the tongue (glossitis)
inflammation of the mouth and oral cavity (stomatitis)
changes in liver function (cholestatic, hepatocellular, mixed cholestatic-hepatocellular)
increased levels in blood of certain liver enzymes (serum transferases)
skin rashes (urticarial or erythematous, maculopapular eruptions, morbilliform)
skin and/or mucosal lesions with redness, swelling and sometimes blisters (erythema multiforme)

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 website
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 DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25 °C.
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. Package contents and other information

What AMOXICILLINA DOC Generici contains

The active substance is amoxicillin. Each tablet contains 1.148 g of amoxicillin trihydrate equivalent to 1 g of amoxicillin.
The other components are: microcrystalline cellulose, magnesium stearate, sodium croscarmellose.

Description of the appearance of AMOXICILLINA DOC Generici and package contents
Blister pack containing 12 tablets of 1 g.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan - Italy.
Manufacturers
LA.FA.RE. S.r.l. – Via Sacerdote Benedetto Cozzolino 77 – 80056 Ercolano (NA) - Italy.