AMOXICILLINA 1 G Soluble tablet

Зміст інструкції

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

Amoxicillina ABC 1 g soluble tablets

Amoxicillina

Equivalent Medicinal Product

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use Amoxicillina ABC
• 3. How to use Amoxicillina ABC
• 4. Possible side effects
• 5. How to store Amoxicillina ABC
• 6. Contents of the pack and other information

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

Amoxicillina ABC is an antibiotic whose active ingredient, amoxicillin, belongs to a group of medicines
called penicillins.
Amoxicillina ABC is used in adultsfor the treatment of infections caused by bacteria in different parts of the
body:

• acute and chronic infections of the respiratory tract
• ear, nose and throat infections
• mouth infections
• infections of the kidney, bladder, urethra and genital organs
• infections of the intestine, liver and biliary tract
• skin and soft tissue infections (e.g. muscles, tendons)
• infections after surgery
• 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 any of the other ingredients of this medicine (listed in section 6);
• you are allergic to other antibiotics that belong to the class of penicillins or cephalosporins;
• you have an infection caused by bacteria that are not sensitive to this medicine;
• you have a viral infection called “infectious mononucleosis” because there may be an increased risk of skin reactions;
• the patient is a child.

Warnings and precautions
Consult your doctor or pharmacist beforeusing Amoxicillina ABC.
Tell your doctor if you think that any of the following conditions apply to you:

• you have had an allergic reaction to penicillin, cephalosporins or other similar antibiotics as you are more likely to have a new allergic reaction, even a serious one, after taking Amoxicillina ABC. If you experience an allergic reaction, stop taking Amoxicillina ABC immediatelyand consult your doctor (see also section 4 “Possible side effects”);
• you suffer from mononucleosis or have other viral infections caused by viruses called herpes simplex,cytomegalovirusor HIV (the AIDS virus) as you are very likely to develop a rash with small bumps and reddish spots (maculopapular rashes);
• you experience severe and persistent diarrhea during or after treatment; this may be a sign of a serious intestinal inflammation (pseudomembranous colitis). Diarrhea can occur with the use of almost all antibiotics, including Amoxicillina ABC, and is due to the alteration of the normal bacterial flora of the intestine which allows the excessive growth of a bacterium called Clostridiumdifficile. If you experience diarrhea, your doctor will subject you to careful monitoring;
• you experience mouth or vaginal infections caused by fungi (e.g. oral or vaginal candidiasis) especially in cases of prolonged or high-dose treatment.

During prolonged treatment with Amoxicillina ABC, your doctor will subject you to frequent blood tests or examinations to evaluate the functioning of the kidneys and liver.

Children
Amoxicillina ABC should not be used in children.

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 check the normal development of the fetus) tell your doctor or pharmacist that you are taking Amoxicillina ABC, this medicine may alter the results of the tests in question.

Other medicines and Amoxicillina ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• penicillin Gand cephalosporins, due to the possibility of allergy even to these antibiotics;
• allopurinol(medicine for gout and uric acid accumulation). If you take this medicine together with Amoxicillina ABC, you may be more likely to develop an allergic skin reaction;
• aminoglycosides(antibiotics). The effectiveness of Amoxicillina ABC may be increased and Amoxicillina ABC may increase the effectiveness of these antibiotics, if administered simultaneously;
• medicines to reduce blood clotting (e.g. warfarin) you may need to undergo additional blood tests;
• other antibiotics (e.g. tetracyclines), the effectiveness of Amoxicillina ABC may be lower;
• methotrexate(used for the treatment of cancer and severe psoriasis), penicillins can reduce the excretion of methotrexate causing a potential increase in side effects.

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

• probenecid(used for the treatment of gout), the concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
• acetylsalicylic acid, phenylbutazone(anti-inflammatory drugs) and other medicines against inflammation.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice 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 can cause side effects whose symptoms (such as allergic reactions, dizziness and convulsions) can interfere with the ability to drive vehicles.
Do not drive vehicles and do not use machines 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 following the instructions of your doctor or pharmacist exactly. If you have any doubts, ask your
doctor or pharmacist.
Amoxicillina ABC should be taken orally. Depending on the severity of the infection, your doctor may increase the dosages
of this medicine and will determine the most suitable treatment duration for you.

Adults
The recommended dose is:

• 1 soluble tabletof 1 gram2 times a day (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 in a single administration or
• 1.5 grams in a single administration + 1.5 grams in a single administration after 4 hours
• Stomach infection by Helicobacter pylori.The recommended dose is 1 gram every 12 hours for 7-10 days in association with other medicines to eliminate the bacterium and for the treatment of stomach ulcers (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 insufficiency), your doctor will prescribe lower doses of
Amoxicillina ABC and less frequent administrations than usual. Follow your doctor's instructions carefully.

Method of administration and instructions for use

Amoxicillina ABC 1 g soluble tablets
The soluble tablets should be dissolved in half a glass of water or they can be swallowed with water.

If you use more Amoxicillina ABC than you should
In case of accidental ingestion/intake of an excessive dose of Amoxicillina ABC, inform your
doctor immediately or go to the nearest hospital.
To date, no adverse effects caused by excessive doses of Amoxicillina ABC are known.

If you forget to use Amoxicillina ABC
If you forget a dose, take it as soon as you remember. Do not take a double dose to make up for the
forgotten dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

STOPusing Amoxicillina ABC immediately if you experience the following side effects
because 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), acceleration or slowing of the 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 (areas of swollen, itchy skin that most often involve the extremities, external genitalia and face, especially around the eyes and lips), redness of the skin especially around the ears, bluish discoloration of the skin, mucous membranes and nails (cyanosis), profuse sweating, nausea, vomiting, abdominal pain with cramps, diarrhea
• swelling and itching of the face, tongue, throat, hands and feet, genitals resulting in an inability to swallow and breathe (angioedema)
• skin rash or appearance of small, reddish, round and flat spots under the skin surface, or skin bruising. This is due to inflammation of the blood vessel walls due to an allergic reaction. It may be accompanied by joint pain (arthritis) and kidney problems.
• reactions similar to serum sickness (which involve signs such as hives or allergic-type skin rashes accompanied by fever, muscle pain, pain and inflammation of the joints)
• severe and widespread inflammation with skin peeling (exfoliative dermatitis)
• severe skin reactions (toxic epidermal necrolysis or Lyell's syndrome, Stevens-Johnson syndrome)
• other severe skin reactions may include changes in skin color, formation of bumps under the skin, appearance of blisters, pustules, exfoliation, redness, pain, itching and scaling, 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)
• serious liver effects may occur, observed mainly in subjects treated for long periods. Contact your doctor urgently if you notice the appearance of:
• 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 defined on the basis of available data:

• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome)
• signs of aseptic meningitis such as severe headache, high temperature, chills, stiff neck or intolerance to bright light
• excessive destruction of red blood cells and reduction of hemoglobin levels (hemolytic anemia and positive direct Coombs test)
• severe inflammation of the last part of the intestine called the colon (colitis) caused by the overgrowth of a bacterium called Clostridium difficile(pseudomembranous colitis) (see section 2 “Warnings and precautions”)
• drug-induced enterocolitic syndrome (DIES): DIES has been reported mainly in children treated with amoxicillin. It is a certain type of allergic reaction with the main symptom of repetitive vomiting (1-4 hours after use of the drug). Further symptoms may include abdominal pain, lethargy, diarrhea and low blood pressure.
• rash with blisters arranged in circles with a central crust or like 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”)
• the Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease, causing fever, chills, headache, muscle pain and rash

See 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):

• increased time required for blood to clot (prolongation of bleeding and prothrombin time)
• seizures, observed in patients treated with high doses or with kidney problems
• increase in the blood of certain liver enzymes (transaminases)
• skin and/or mucous membrane lesions with redness, swelling and sometimes the presence of blisters (erythema multiforme)
• dizziness
• hyperactivity
• candidiasis (infection of the vagina, mouth or skin folds caused by a yeast); your doctor or pharmacist will prescribe appropriate treatment
• the tongue may take on a yellowish, brownish or blackish color and a villous appearance

Frequency not known(the frequency cannot be estimated on the basis of the available data):

• increase in the blood of the number of a type of white blood cells called eosinophils (eosinophilia)
• reduction in the blood of the number of red blood cells (anemia)
• reduction in the blood of the number of white blood cells (neutropenia, agranulocytosis, leucopenia)
• reduction in the blood of the number of platelets (thrombocytopenia) and appearance of reddish spots on the skin (thrombocytopenic purpura)
• altered platelet function
• headache
• vertigo
• loss or lack of appetite (anorexia)
• pain in the upper part of the 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)
• 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 rashes, morbilliform)
• crystals in the urine leading to acute kidney damage, with possible clouding of the 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 ABC

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Amoxicillina ABC contains
The active ingredient is amoxicillin (as amoxicillin trihydrate).
Amoxicillina ABC 1 g soluble tablets
Each 1 gram soluble tablet of Amoxicillina ABC contains 1.148 grams of amoxicillin trihydrate
(corresponding to 1 gram of amoxicillin).

The other components 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 contents of the pack
Amoxicillina ABC 1 g soluble tablets are available in blisters in packs of 12 soluble
tablets.

Marketing Authorisation Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Torino

Manufacturer
LA.FA.RE. S.r.l. – Via Sacerdote Benedetto Cozzolino, 77 – 80056 Ercolano (NA)