AMOX 1 G Coated tablet

Зміст інструкції

1. AMOX 1 g compresse
   1. What AMOX is and what it is used for
   2. What you need to know before taking AMOX
   3. How to take AMOX
   4. Possible side effects
   5. How to store AMOX
   6. Package Contents and Other Information

AMOX 1 g compresse

Amoxicillin
Read this leaflet carefully before taking 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 their symptoms are the same as yours, as it could 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 AMOX is and what it is used for
• 2. What you need to know before you take AMOX
• 3. How to take AMOX
• 4. Possible side effects
• 5. How to store AMOX
• 6. Contents of the pack and other information

1. What AMOX is and what it is used for

What AMOX is
AMOX is an antibiotic. Its active ingredient, called amoxicillin, belongs to a group
of medicinal substances known as “penicillins”.

What AMOX is used for
AMOX is used to treat infections caused by bacteria in different parts of the body. Infections
caused by Gram-positive and Gram-negative germs, sensitive to the antibiotic (of the respiratory
tract and otitis media, enteric, hepato-biliary, salmonellosis, genito-urinary and venereal,
dermatological, surgical, endocarditis, sepsis).

2. What you need to know before taking AMOX

Do not take AMOX

• if you are allergic to amoxicillin, to penicillin or to 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 a skin rash or the development of swelling of the face or throat.
• if you suffer from or suspect you suffer from infectious mononucleosis

Do not take AMOX if you recognize yourself in any of the situations above. If you have any
doubts, ask your doctor or pharmacist before taking AMOX.
AMOX is not indicated for the treatment of infections caused by microorganisms producing
penicillinases.
Contraindicated in children.

Warnings and precautions
Talk to your doctor or pharmacist before taking AMOX 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, ask your doctor or pharmacist before taking AMOX.

Blood and urine tests
If you are undergoing:

• urine tests (for glucose) or blood tests for liver function
• tests for estriol (used in pregnancy to check the normal development of the fetus) tell your doctor or pharmacist that you are taking AMOX, as this medicine may alter the results of these tests.

Other medicines and AMOX
Tell 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 AMOX, you may be more likely to develop an allergic skin reaction.
• If you are taking probenecid (a medicine used to treat gout), your doctor may decide to adjust the dose of AMOX.
• If you are taking medicines to reduce blood clotting (e.g. warfarin) you may need to have additional blood tests.
• If you are taking other antibiotics (e.g. tetracyclines) the effectiveness of AMOX may be reduced.
• If you are taking aminoglycoside medicines.
• If you are taking acetylsalicylic acid, phenylbutazone or other anti-inflammatory drugs at high doses.
• Amoxicillin may decrease the effect of heparin.
• Methotrexate (used for the treatment of cancer and severe psoriasis), penicillins can reduce the excretion of methotrexate causing a potential increase in side effects. Probenecid (used for the treatment of gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Driving and using machines
AMOX may cause side effects whose symptoms (such as allergic reactions, dizziness and
convulsions) may interfere with the ability to drive vehicles.
Do not drive vehicles and do not use machines if you do not feel well.

AMOX contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially ‘sodium-free’.

3. How to take AMOX

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Take the doses at regular intervals throughout the day, at least 8/12 hours apart.

The usual dose of AMOX is 1 tablet every 8-12 hours. The dosage depends on the type and severity of the infection, body weight and the patient's condition, and the doctor's judgement.

If you take more AMOX than you should
If you take an excessive amount of AMOX, symptoms such as gastrointestinal disorders (nausea, vomiting or diarrhoea) or the presence of crystals in the urine, with possible clouding of the urine, or problems with urination may appear. Seek medical attention as soon as possible, bringing the medicine with you to show it.

If you forget to take AMOX

• If you forget a dose, take it as soon as you remember.
• Do not take the next dose too soon, wait about 4 hours before taking the next dose.
• Do not take a double dose to make up for a missed dose.

How long should you take AMOX for?

• Continue to take AMOX for the time indicated by your doctor, even if you feel better. To fight the infection, it is necessary to take all prescribed doses. The infection may return if some bacteria survive.
• If, once the treatment is finished, you continue to feel unwell, consult your doctor again.

The use of AMOX for long periods can lead to the development of candidiasis (an infection caused by a yeast that affects the moist areas of the body, causing irritation, itching and whitish discharge). If this happens, consult your doctor.
If you take AMOX for long periods, your doctor may subject you to additional tests to verify that everything is normal at the level of the kidneys, liver and blood.
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.
Stop taking AMOX and consult your doctor immediately if you experience any of the
following serious side effects, as urgent medical treatment may be needed:
The following side effects are very rare (may affect up to 1 in 10,000 people)

• allergic reactions, accompanied by signs such as skin itching or rash, swelling of the face, lips, tongue or body, or difficulty breathing. These effects can be severe and, in some cases, have been fatal
• skin rash or the appearance of small, pinpoint, round and flat, reddish 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

• a delayed allergic reaction may occur, typically 7-12 days after taking AMOX, accompanied by signs such as skin rash, fever, joint pain and swollen lymph nodes, especially those under the arm
• a skin reaction defined as “erythema multiforme”, with itchy, reddish-purple patches on the skin, especially 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. It may be accompanied by fever and a feeling of extreme fatigue
• other serious skin reactions may include changes in skin color, the formation of bumps under the skin, the appearance of blisters, pustules, exfoliation, redness, pain, itching and scaling, and may be associated with fever, headache and widespread pain
• fever, chills, sore throat or other signs of infection, or a tendency to bruise easily. These may be signs of a blood cell problem
• the Jarisch-Herxheimer reaction, which may occur during the treatment of Lyme disease with AMOX, causing fever, chills, headache, muscle pain and rash
• inflammation of the large intestine (colon) with diarrhea (sometimes containing blood), pain and fever
• serious liver effects may occur, observed mainly in subjects treated for long periods, in men and in the elderly. Inform your doctor urgently if you notice the appearance of: o severe diarrhea with bleeding o blisters, redness or bruising of the skin o dark urine o pale stools o yellowing of the skin or the white of the eye (jaundice). See also the entry on anemia, below, as a possible cause of jaundice.
• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome).
• 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 taking the drug). Further symptoms may include abdominal pain, lethargy, diarrhea and low blood pressure.
• Rash with blisters arranged in a circle 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)

These effects may occur during treatment with the medicine or even several
weeks later.

If any of the above effects occur, stop treatment with the
medicine and consult your doctor immediately.
Sometimes less serious skin reactions may occur, such as:

• a slightly itchy rash (pinkish-reddish round patches), localized swelling similar to hives on forearms, legs, palms of the hands, hands or feet. This is an uncommon effect (may affect up to 1 in 100 people).

If any of these side effects occur, consult your doctor as
treatment with AMOX will need to be stopped.
Other possible side effects are:

Common(may affect up to 1 in 10 people)

• skin rash
• nausea
• diarrhea.

Uncommon(may affect up to 1 in 100 people)

• vomiting.

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

• candidiasis (infection of the vagina, mouth or skin folds caused by a yeast); your doctor or pharmacist will prescribe appropriate treatment
• kidney problems
• seizures, observed in patients treated with high doses or with kidney problems
• dizziness
• hyperactivity
• the presence of 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
• teeth may appear stained, but usually regain their normal appearance with brushing (this effect has been documented in children)
• the tongue may become yellowish, brownish or black and have a hairy appearance
• excessive destruction of red blood cells, responsible for causing a type of anemia. Signs include: fatigue, headache, shortness of breath, dizziness, paleness and yellowing of the skin and the white of the eye
• reduction in the number of white blood cells
• reduction in the number of cells involved in blood clotting
• increased time required for blood to clot compared to normal. This effect may be noticed in case of nosebleeds or if you get a cut.

Other possible, although rare, side effects: glossitis, stomatitis, alteration of platelet aggregation, eosinophilia, vertigo, headache, anorexia, epigastric pain, gastritis, glossitis,
stomatitis, drug-induced enterocolitic syndrome, mixed liver damage, hepatocellular
damage, alteration of liver function, drug eruption with eosinophilia and systemic symptoms
(DRESS), angioedema, skin rashes (maculopapular rash, erythematous rash, morbilliform
rash), superinfections, positive direct Coombs test, prolonged bleeding time,
prolongation of activated partial thromboplastin time.
Changes in transaminase levels, anemia, hemolytic anemia, thrombocytopenia, thrombocytopenic
purpura, eosinophilia, leukopenia, neutropenia, agranulocytosis are usually reversible
with discontinuation of therapy.
With prolonged treatments, with high doses, periodic checks of blood count and liver and
kidney function are recommended.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store AMOX

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in the 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 AMOX contains
Each tablet contains 1 g of amoxicillin as the active ingredient.
The other ingredients are: Microcrystalline cellulose, Sodium carboxymethylamide, Peg 4000,
Cream caramel flavour, Magnesium stearate.

Description of the appearance of AMOX and package contents
AMOX tablets are presented in tablet form. The tablets are packaged in blisters
contained in a box available in a pack of 12 tablets.

Marketing Authorisation Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome

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

General recommendation on the use of antibiotics
Antibiotics are used to treat bacterial infections and have no effect against
infections caused by viruses.
It may happen that a bacterial infection does not respond to a course of antibiotic therapy. Most
of the time this is due to the fact that the bacteria responsible for the infection are
resistant to the antibiotic administered and are therefore able to survive and proliferate
despite treatment.
There are various reasons why bacteria can become resistant to antibiotics. Correct use of
antibiotics can help reduce the likelihood that bacteria will develop resistance.
The prescription of a course of antibiotics is intended to treat exclusively the current
illness. By following the advice below, you will contribute to preventing the development of
resistant bacteria that could nullify the effectiveness of antibiotic therapy.

• 1. It is very important that antibiotics are taken at the correct dose, at the correct times and for the number of days prescribed. It is important to read the instructions accompanying the medicine and, if difficult to understand, ask for explanations from your doctor or pharmacist.
• 2. Antibiotics should not be taken if they have not been specifically prescribed for you and should be used only to treat the infection for which they were prescribed.
• 3. You should not take antibiotics prescribed to other people, even if the infection seems similar.
• 4. You should not give antibiotics prescribed to you to other people.
• 5. If, once the treatment cycle is completed according to your doctor's instructions, any unused antibiotic remains, this must be taken to the pharmacy for correct disposal.