Amoxicillin Alter: detailed information

PATIENT INFORMATION LEAFLET

AMOXICILLINA ALTER 1 g tablets

Amoxicillin
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, your child's doctor, or pharmacist.
This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms appear to be the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, your child's doctor, or pharmacist. See section 4.

Contents of this leaflet:

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

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

Amoxicillina Alter is an antibiotic whose active substance, amoxicillin, belongs to a group
of medicines called penicillins.
Amoxicillina Alter is used in adults and children to treat bacterial infections in different parts of the body:

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

2. What you need to know before taking Amoxicillina Alter

Do not take Amoxicillina Alter if you or your child:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillina Alter.
Inform your doctor if you think that any of the following conditions apply to you or your child:

you have previously had an allergic reaction to penicillin, cephalosporins, or other similar antibiotics, as you may be more likely to experience a new allergic reaction, even a severe one, after taking Amoxicillina Alter. If an allergic reaction occurs, stop treatment with Amoxicillina Alter 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 may develop a skin rash with small raised spots and reddish patches (maculopapular eruptions);
you develop severe and persistent diarrhoea during or after treatment, which could be a sign of a serious intestinal inflammation (pseudomembranous colitis). Diarrhoea may occur with the use of almost all antibiotics, including Amoxicillina Alter, due to disruption of the normal intestinal bacterial flora, allowing excessive growth of a bacterium called Clostridium difficile. If diarrhoea occurs, your doctor will carefully monitor you or your child;
you develop fungal infections of the mouth or vagina (e.g., oral or vaginal candidiasis), especially during prolonged treatment or at high doses.

During prolonged treatment with Amoxicillina Alter, your doctor will perform frequent blood tests or other examinations to monitor kidney and liver function.
Children
Caution is recommended when administering Amoxicillina Alter to newborns and premature infants.
In very early infancy, the medicine should be administered only when clearly necessary and under the direct supervision of a doctor, who will monitor the child frequently to assess liver, kidney, and bone marrow function during treatment with Amoxicillina Alter.
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 Alter, as this medicine may alter the results of these tests.

Other medicines and Amoxicillina Alter
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you or your child 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 high uric acid levels). If you take this medicine together with Amoxicillina Alter, you may have a higher chance of developing an allergic skin reaction;
aminoglycosides (antibiotics). The effectiveness of Amoxicillina Alter may be enhanced, and Amoxicillina Alter may increase the effectiveness of these antibiotics when administered together;
medicines used to reduce blood clotting (e.g., warfarin); you may need additional blood tests;
other antibiotics (e.g., tetracyclines); the effectiveness of Amoxicillina Alter may be reduced;
methotrexate (used to treat cancer and severe psoriasis); penicillins may reduce methotrexate excretion, potentially increasing its side effects.

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

probenecid (used to treat gout); concomitant use of 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, are 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 any potential risks.
Driving and using machines
Amoxicillina Alter may cause side effects such as allergic reactions, dizziness, and seizures, which may impair your ability to drive or operate machinery.
Do not drive or operate machinery if you do not feel well.
Amoxicillina Alter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take Amoxicillin Alter

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

Adults and children weighing over 40 kg
The recommended dose is:

500 mg every 6–8 hours, or 1 tablet of 1 gram every 8–12 hours.

Children weighing less than 40 kg
The recommended dose is 40–90 mg per kg of body weight, divided into 2–3 daily doses (do not exceed 3 grams per day).

Special dosage recommendations

Acute bladder and urethral 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;
Tonsillitis. The recommended daily dose is:
- 50 mg per kg of body weight, divided into 2 doses (administered every 12 hours);
Acute otitis media. The dose will be determined by the doctor.
Lyme disease, also known as "isolated erythema migrans" or "borreliosis" (an infection particularly affecting children). The recommended daily dose is:
- 50 mg per kg of body weight, divided into 3 doses (administered every 8 hours) for a duration of not less than 14–21 days.
Prevention of heart lining infection (endocarditis). The recommended dose is:
- 50 mg per kg of body weight, administered as a single dose one hour before surgery.
Stomach infection caused by Helicobacter pylori. 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/your child have kidney problems
If you or your child have severe kidney problems (severe renal impairment), your doctor will prescribe lower doses of Amoxicillin Alter and less frequent administration than usual. Follow your doctor’s instructions carefully.

If you take more Amoxicillin Alter than you should
In case of accidental ingestion or overdose of Amoxicillin Alter, contact your doctor immediately or go to the nearest hospital.
To date, no adverse effects due to overdosage of Amoxicillin Alter have been reported.

If you forget to take Amoxicillin Alter
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor, the doctor treating your child, or your pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP IMMEDIATELY using Amoxicillin Alter if you or your child 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 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.
serum sickness-like reactions (involving 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 syndrome, Stevens-Johnson syndrome)
other severe skin reactions may include changes in skin color, 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 number of white blood cells (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms)
severe side effects affecting the liver may occur, mainly observed 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 whites of the eyes (jaundice). See also the section 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 allergic-triggered heart attack (Kounis syndrome)
signs of aseptic meningitis such as severe headache, high temperature, chills, neck stiffness, or sensitivity to bright light
excessive destruction of red blood cells and reduction in hemoglobin levels (hemolytic anemia and positive direct Coombs test)
severe inflammation of the final 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 mainly reported 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-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)
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 or your child 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 levels in blood of certain liver enzymes (transaminases)
skin and/or mucosal lesions with redness, swelling, and sometimes blisters (erythema multiforme)
dizziness
hyperactivity
candidiasis (vaginal, oral, or skin fold infection caused by a yeast); your doctor or pharmacist will prescribe appropriate treatment
the tongue may become yellowish, brownish, or blackish in color and have a hairy appearance

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

increased number in blood of a type of white blood cells called eosinophils (eosinophilia)
reduced number of red blood cells in blood (anemia)
reduced number of white blood cells in blood (neutropenia, agranulocytosis, leukopenia)
reduced number of platelets in blood (thrombocytopenia) and appearance of reddish spots on the skin (thrombocytopenic purpura)
impaired platelet function
headache
vertigo
reduced or loss of appetite (anorexia)
pain in the upper abdomen 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)
changes in liver function (hepatocellular damage, mixed liver damage, altered liver function)
prolonged bleeding time and prolonged activated partial thromboplastin time
skin rashes (urticarial or erythematous, maculopapular eruptions, morbilliform)
crystals in urine leading to acute kidney injury with possible clouding of 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 or your child experience any side effect, including those not listed in this leaflet, talk to your doctor, the doctor treating your child, 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 Alter

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 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 Alter contains

The active substance is amoxicillin (as amoxicillin trihydrate).

Each tablet contains 1.148 grams of amoxicillin trihydrate (equivalent to 1 gram of
amoxicillin).

The other components are: microcrystalline cellulose, magnesium stearate, sodium carboxymethylcellulose.

Description of the appearance of Amoxicillina Alter and package contents
Blister pack containing 12 tablets of 1 g.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratori Alter S.r.l., Via Egadi 7, 20144 - Milan.
Manufacturer
LA.FA.RE. S.r.l.
Via Sacerdote Benedetto Cozzolino, 77 – 80056 Ercolano (NA)
Italy