Amoxicillin ABC

Patient Information Leaflet

Amoxicillina ABC 1 g dispersible tablets

Amoxicillin
Generic Medicine
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Amoxicillina ABC is an antibiotic whose active ingredient, amoxicillin, belongs to a group of medicines called penicillins.
Amoxicillina ABC 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
• oral infections
• kidney, bladder, urethra and genital organ infections
• intestinal, liver and biliary tract infections
• skin and soft tissue infections (e.g.: muscles, tendons)
• post-surgical infections
• stomach infections caused by a bacterium called Helicobacter pylori, which causes gastric ulcers.

2. What you need to know before using Amoxicillina ABC

Do not use Amoxicillina ABC 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 classes;
• you have a bacterial 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;
• the patient is a child.

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

• you have previously had an allergic reaction to penicillin, cephalosporins, or other similar antibiotics, as you may be more likely to experience a new, possibly severe, allergic reaction after taking Amoxicillina ABC. If an allergic reaction occurs, stop treatment with Amoxicillina ABC immediately and contact your doctor (see also section 4 “Possible side effects”);
• you have mononucleosis or other viral infections caused by viruses known as herpes simplex, cytomegalovirus, or HIV (the AIDS virus), as you are more 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 ABC, and is due to disruption of the normal intestinal bacterial flora, allowing excessive growth of a bacterium called Clostridium difficile. If you experience diarrhoea, your doctor will closely monitor you;
• 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 ABC, your doctor will perform frequent blood tests or examinations to assess kidney and liver function.
Children
Amoxicillina ABC must not be used in children.
Blood and urine tests
If you are undergoing:

• urine tests (for glucose) or blood tests for liver function,
• estriol tests (used during pregnancy to monitor normal fetal development), inform your doctor or pharmacist that you are taking Amoxicillina ABC, as this medicine may alter the results of these tests.

Other medicines and Amoxicillina ABC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
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 ABC, you may have a higher chance of developing an allergic skin reaction;
• aminoglycosides (antibiotics). The effectiveness of Amoxicillina ABC may be enhanced, and Amoxicillina ABC may increase the effectiveness of these antibiotics when administered together;
• medicines used to reduce blood clot formation (e.g. warfarin); you may need additional blood tests;
• other antibiotics (e.g. tetracyclines); the effectiveness of Amoxicillina ABC may be reduced;
• methotrexate (used for cancer and severe psoriasis treatment); penicillins may reduce methotrexate excretion, potentially increasing side effects.

The following medicines may increase the effectiveness and/or toxic effects of Amoxicillina ABC:

• 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 may be pregnant, planning to become pregnant, 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 the possible
risks.
Driving and using machines
Amoxicillina ABC may cause side effects whose symptoms (such as allergic reactions, dizziness, and
seizures) may impair your ability to drive or operate machinery.
Do not drive or operate machinery if you do not feel well.
Amoxicillina ABC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to use Amoxicillina ABC

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Amoxicillina ABC is taken orally. 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.
Adults
The recommended dose is:

• 1 soluble tablet of 1 gram twice daily (every 12 hours).

Special dosage recommendations

• Acute bladder and urethra infections caused by a bacterium called Neisseria gonorrhoeae (gonococcal urethritis and cystitis). The recommended dose is:
  • 3 grams as a single dose, or
  • 1.5 grams as a single dose + 1.5 grams as a single dose 4 hours later
• Helicobacter pylori stomach infection. The recommended dose is 1 gram every 12 hours for 7–10 days, in combination with other medicines to eradicate the bacterium and treat stomach ulcer (macrolides or nitroimidazoles and proton pump inhibitors). Follow your doctor's instructions carefully.

If you have kidney problems
If you have severe kidney problems (severe renal impairment), your doctor will prescribe lower doses of Amoxicillina ABC and less frequent administration than normal. Follow your doctor's instructions exactly.
Method of administration and instructions for use

Amoxicillin ABC 1 g soluble tablets

The soluble tablets should be dissolved in half a glass of water or may be swallowed with water.
If you take more Amoxicillin ABC than you should
If you accidentally ingest/overdose on Amoxicillin ABC, contact your doctor immediately or go to the nearest hospital.
To date, no adverse effects due to overdosage of Amoxicillin ABC have been reported.
If you forget to take Amoxicillin ABC
If you forget a dose, take it as soon as you remember. Do not use a double dose to make up for the missed dose.
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 using Amoxicillin ABC immediately if you experience the following side effects, as they are serious:
The following side effects are very rare (may affect up to 1 in 10,000 people):

• allergic reaction such as: sudden drop in blood pressure (hypotension), rapid or slow heartbeat, 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, hives with or without angioedema (swollen, itchy areas of skin more frequently affecting 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, diarrhea
• swelling and itching of the face, tongue, throat, hands and feet, or genitals, leading to difficulty swallowing or breathing (angioedema)
• 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 caused by an allergic reaction. It may be accompanied by joint pain (arthritis) and kidney problems.
• serum sickness-like reactions (characterized by signs such as hives or allergic-type skin rashes accompanied by fever, muscle pain, joint pain and inflammation)
• severe and widespread skin inflammation with peeling (exfoliative dermatitis)
• severe skin reactions (toxic epidermal necrolysis or Lyell’s syndrome, Stevens-Johnson syndrome)
• other severe skin reactions may include skin color changes, formation of lumps under the skin, appearance of blisters, pustules, peeling, redness, pain, itching, and desquamation, and may be associated with fever, headache, and widespread pain.
• flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms)
• serious side effects affecting the liver may occur, observed mainly in patients treated for long periods. Inform your doctor urgently if you notice:
  • severe diarrhea 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 entry on anemia 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 an allergy-triggered heart attack (Kounis syndrome)
• signs of aseptic meningitis such as severe headache, high fever, chills, neck stiffness, or sensitivity to bright light
• excessive destruction of red blood cells and reduced hemoglobin levels (hemolytic anemia and positive direct Coombs test)
• severe inflammation of the last part of the intestine called the colon (colitis) caused by excessive growth of a bacterium called Clostridium difficile (pseudomembranous colitis) (see section 2 “Warnings and precautions”)
• 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, diarrhea, 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)
• kidney problems (acute interstitial nephritis)
• infections caused by bacteria resistant to amoxicillin (see section 2 “Warnings and precautions”)
• Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease, causing fever, chills, headache, muscle pain, and skin rash

Contact your doctor if you experience any of the following side effects:
Common (may affect up to 1 in 10 people):

• diarrhea
• nausea
• hives
• skin rash

Uncommon (may affect up to 1 in 100 people):

• vomiting
• itching

Very rare (may affect up to 1 in 10,000 people):

• prolonged blood clotting time (prolonged bleeding time and prothrombin time)
• seizures, observed in patients receiving high doses or with kidney problems
• increased blood levels of certain liver enzymes (transaminases)
• skin and/or mucous membrane lesions with redness, swelling, and sometimes blisters (erythema multiforme)
• dizziness
• hyperactivity
• candidiasis (vaginal, oral, or skin fold infection caused by yeast); your doctor or pharmacist will prescribe appropriate treatment
• the tongue may become yellowish, brownish, or blackish and appear hairy

Frequency not known (frequency cannot be estimated from available data):

• increased blood levels of a type of white blood cells called eosinophils (eosinophilia)
• reduced number of red blood cells in the blood (anemia)
• reduced number of white blood cells in the blood (neutropenia, agranulocytosis, leukopenia)
• reduced number of platelets in the blood (thrombocytopenia) and appearance of reddish spots on the skin (thrombocytopenic purpura)
• impaired platelet function
• headache
• vertigo
• reduced or absent appetite (anorexia)
• upper abdominal pain at the level of the stomach (epigastric pain)
• inflammation of the stomach (gastritis)
• inflammation of the tongue (glossitis)
• inflammation of the mouth and oral cavity (stomatitis)
• altered liver function (hepatocellular damage, mixed liver damage, altered liver function)
• prolonged bleeding time and activated partial thromboplastin time
• skin rashes (urticarial or erythematous, maculopapular eruptions, morbilliform)
• crystals in the urine leading to acute kidney injury, possibly causing cloudy urine, difficulty urinating, or discomfort during urination. Make sure to drink plenty of fluids to reduce the risk of developing these symptoms

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. You may 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 Amoxicillin ABC

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 pack after “Exp.”. The expiry date refers to the last day of that month.
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 ABC contains
The active substance is amoxicillin (as amoxicillin trihydrate).
Amoxicillina ABC 1 g effervescent tablets
Each 1 gram effervescent tablet of Amoxicillina ABC contains 1.148 grams of amoxicillin trihydrate
(equivalent to 1 gram of amoxicillin).
The other ingredients are: microcrystalline cellulose, crospovidone, sodium lauryl sulfate, magnesium
stearate, sodium saccharin, strawberry flavour. See section 2 “Amoxicillina ABC contains sodium”.
Description of the appearance of Amoxicillina ABC and the contents of the pack
The 1 g effervescent tablets of Amoxicillina ABC are available in blisters, pack size: 12 effervescent tablets.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturer
LA.FA.RE. S.r.l. – Via Sacerdote Benedetto Cozzolino, 77 – 80056 Ercolano (NA)