Amoxicillin Ratiopharm: detailed information

Package leaflet: Information for the user

Amoxicillina ratiopharm 1 g tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

This medicine has been prescribed for you (or your child) only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What Amoxicillina ratiopharm is
Amoxicillina ratiopharm is an antibiotic. Its active ingredient, called amoxicillin, belongs to a
group of medicines known as "penicillins".
What Amoxicillina ratiopharm is used for
Amoxicillina ratiopharm is used to treat bacterial infections in various parts of the body.
Amoxicillina ratiopharm may also be used in combination with other medicines for the treatment
of gastric ulcers.

2. What you need to know before taking Amoxicillina ratiopharm

Do not take Amoxicillina ratiopharm:

if you are allergic to amoxicillin, penicillin, or any of the other ingredients of this medicine (listed in section 6);
if you have previously had an allergic reaction to any antibiotic. This includes also skin rash or development of swelling of the face or throat;
if you have infections caused by microorganisms producing penicillinase;
if you have or suspect you have infectious mononucleosis, because using amoxicillin may increase the risk of skin reactions.

Do not take Amoxicillina ratiopharm if any of the above situations apply to you. If you have any
doubts, consult your doctor or pharmacist before taking Amoxicillina ratiopharm.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillina ratiopharm if:

you have glandular fever (fever, sore throat, swollen glands, and extreme tiredness);
you have kidney problems;
you do not urinate regularly;
in the past, after taking other medicines, you developed a skin reaction known as DRESS, characterized by symptoms such as high levels of white blood cells in the blood (eosinophilia) and systemic symptoms, since cases of DRESS have also been reported after taking amoxicillin.

If you are unsure whether any of the above points apply to you, consult your doctor or pharmacist before
taking Amoxicillina ratiopharm.
Children
In premature infants and very young infants, this product should be used only if strictly
necessary and under direct medical supervision. If Amoxicillina ratiopharm has been prescribed for a newborn,
the doctor will regularly monitor the child's blood and liver and kidney function.
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 monitor normal fetal development); inform your doctor or pharmacist that you are taking Amoxicillina ratiopharm, as this medicine may alter the results of these tests.

Other medicines and Amoxicillina ratiopharm
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 Amoxicillina ratiopharm, you may have a higher chance of developing an allergic skin reaction;
if you are taking probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended;
if you are taking medicines to reduce blood clotting (e.g., warfarin), you may need additional blood tests;
if you are taking other antibiotics (e.g., tetracyclines), the effectiveness of Amoxicillina ratiopharm may be reduced;
if you are taking methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate, potentially increasing side effects;
if you are taking aspirin (acetylsalicylic acid), phenylbutazone, or other anti-inflammatory drugs at high doses, taking them together with amoxicillin may increase the concentration of amoxicillin in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Amoxicillina ratiopharm may cause side effects whose symptoms (such as allergic reactions, dizziness, and
seizures) may affect your ability to drive or operate machinery.
Do not drive or operate machinery if you do not feel well.

3. How to take Amoxicillina ratiopharm

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Swallow with water.
Take the doses at regular intervals throughout the day, at least 4 hours apart.

Amoxicillina ratiopharm 1 g tablets may be divided into two equal parts.
The usual dose is:
Children weighing less than 40 kg
All doses are calculated based on the child's body weight expressed in kilograms.

Your doctor will tell you how much Amoxicillina ratiopharm to give your child.
The usual dose ranges from 40 mg to 90 mg per kilogram of body weight per day, administered in two or three divided doses.
The maximum recommended dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children weighing 40 kg or more
The usual dose of Amoxicillina ratiopharm is 250–500 mg three times a day or 750 mg–1 g every
12 hours, depending on the severity and type of infection.

Severe infections: 750 mg to 1 g three times a day.
Urinary tract infections: 3 g twice a day for one day.
Lyme disease (infection caused by a parasite called tick): isolated erythema migrans (early stage – circular reddish or rosy skin rash): 4 g per day; systemic manifestations (late stage – more severe symptoms or when the disease spreads to other parts of the body): up to 6 g per day.
Gastric ulcers: a dose of 750 mg or 1 g twice a day for 7 days, together with other antibiotics and medications for treating gastric ulcers.
Prevention of heart infections during surgical procedures: the dose will vary depending on the type of surgery. Other medications may also be administered simultaneously. Your doctor, pharmacist, or nurse will provide more detailed information.
The maximum recommended dose is 6 g per day.

If the required dose cannot be achieved with Amoxicillina ratiopharm tablets, other formulations and dosage strengths are available commercially, allowing for different dosing regimens.
Kidney problems
If you have kidney problems, your dose may be lower than usual.
If you take more Amoxicillina ratiopharm than you should
If you take an excessive amount of Amoxicillina ratiopharm, symptoms such as gastrointestinal disturbances (nausea, vomiting, or diarrhea), presence of crystals in the urine (possibly causing cloudy urine), or difficulty urinating may occur. Contact your doctor as soon as possible, taking the medicine with you so you can show it to them.
If you forget to take Amoxicillina ratiopharm

If you forget a dose, take it as soon as you remember.
Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
Do not take a double dose to make up for a forgotten dose.

How long should you take Amoxicillina ratiopharm?

Continue taking Amoxicillina ratiopharm for the length of time prescribed by your doctor, even if you feel better. It is necessary to take all prescribed doses to fight the infection. The infection may return if some bacteria survive.
If you still do not feel well after completing the treatment, contact your doctor again.

Prolonged use of Amoxicillina ratiopharm may lead to the development of candidiasis (a yeast infection affecting moist areas of the body, causing irritation, itching, and white discharge). If this occurs, contact your doctor.
If you take Amoxicillina ratiopharm for a prolonged period, your doctor may perform additional tests
to monitor your kidney, liver, and blood function.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Amoxicillina ratiopharm and contact a doctor immediately if you experience any of the
following serious side effects, as urgent medical treatment may be required.

Chest pain occurring in the context of allergic reactions, which may be a symptom of allergic-triggered heart attack (Kounis syndrome);
Drug-Induced Enterocolitis Syndrome (DIES): DIES has mainly been reported in children treated with amoxicillin. It is a type of allergic reaction characterized primarily by repeated vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.

The following side effects are very rare (may affect up to 1 in 10,000 people):

Severe allergic reaction (anaphylactic shock) with characteristic symptoms (see section 2 “Warnings and precautions”) such as: severe and sudden drop in blood pressure (hypotension), rapid or slow heartbeat, unusual fatigue or weakness, anxiety, restlessness, dizziness, loss of consciousness, difficulty breathing or swallowing, widespread itching especially on soles of feet and palms of hands, hives with or without angioedema, 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;
Serum sickness-like reactions (hives or skin rash accompanied by arthritis, arthralgia, myalgia and fever);
Allergic reactions, accompanied by signs such as skin itching or rash, swelling of the face, lips, tongue or body, or breathing difficulties. These reactions may be severe and, in some cases, fatal;
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 (hypersensitivity vasculitis). It may be associated with joint pain (arthritis) and kidney problems;
Delayed allergic reaction, usually occurring 7–12 days after taking Amoxicillina ratiopharm, accompanied by signs such as skin rash, fever, joint pain and swollen lymph nodes, particularly those under the arm (serum sickness);
A skin reaction known as “erythema multiforme”, with itchy, reddish-purple patches on the skin, particularly on the palms of the hands or soles of the feet, areas of hive-like skin swelling, or painful areas on the surface of the mouth, eyes and genitals. This may be accompanied by fever and a feeling of extreme tiredness; other serious skin reactions may include changes in skin colour, formation of lumps under the skin, appearance of blisters, pustules, peeling, redness, pain, itching and flaking (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, acute generalized exanthematous pustulosis), and may be associated with fever, headache and widespread pain;
Flu-like symptoms with skin 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);
Fever, chills, sore throat or other signs of infection, or increased tendency to bruising. These may be signs of a blood cell disorder;
Inflammation of the large intestine (colon) with diarrhoea (sometimes containing blood), abdominal pain and fever (pseudomembranous colitis and haemorrhagic colitis);
Severe adverse effects affecting the liver (hepatitis), mainly observed in patients undergoing long-term treatment, in men and in elderly people. Inform your doctor urgently if you notice:
- severe diarrhoea 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 anaemia below as a possible cause of jaundice. These effects may occur during treatment or even several weeks later.

If any of the above-mentioned effects occur, stop taking the medicine and contact your doctor
immediately.
Sometimes less severe skin reactions may occur, such as:

Slightly itchy skin rash (roundish pink-red spots), localized swelling resembling hives on forearms, legs, palms of 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 Amoxicillina ratiopharm will need to be
stopped.
Other possible side effects are:
Common (may affect up to 1 in 10 people)

Skin rash;
Nausea;
Diarrhoea.

Uncommon (may affect up to 1 in 100 people)

Vomiting;
Hives and itching.

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

Vaginal, oral or skin fold infection caused by yeast (mucocutaneous candidiasis); your doctor or pharmacist will prescribe appropriate treatment;
Colitis associated with antibiotic use;
Kidney problems;
Seizures, observed in patients treated with high doses or with pre-existing kidney problems;
Dizziness;
Hyperactivity;
Inflammation of the kidneys (tubulointerstitial nephritis), presence of crystals in the urine leading to acute kidney injury, possibly with cloudy urine, difficulty urinating or discomfort during urination. Ensure you 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 blackish in colour and have a hairy appearance;
Excessive destruction of red blood cells, leading to a type of anaemia. Signs include: fatigue, headache, shortness of breath, dizziness, paleness, and yellowing of the skin and the white part of the eye;
Decrease in white blood cell count (reversible leucopenia, including severe neutropenia or agranulocytosis);
Decrease in the number of blood cells involved in blood clotting (reversible thrombocytopenia);
Prolonged blood clotting time compared to normal (prolonged bleeding time and prothrombin time). This effect may become apparent as nosebleeds or bleeding from minor cuts;
Moderate increase in certain liver enzymes (AST, ALT).

Not known (frequency cannot be estimated from the available data)

Superinfections by resistant organisms;
Decrease in red blood cell count (anaemia);
Decrease in the number of certain blood cells called platelets, accompanied by a purplish-red skin rash known as “purpura” (thrombocytopenic purpura);
Headache;
Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis);
Upper abdominal pain, inflammation of the tongue (glossitis), inflammation of the mouth (stomatitis), inflammation of the stomach (gastritis);
Reduced appetite;
Itching;
Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease;
Skin rash with blisters arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease);
Presence of antibodies on the surface of red blood cells capable of destroying them (positive direct Coombs test);
Defects in the blood clotting process (abnormal platelet aggregation, prolonged activated partial thromboplastin time).

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: 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 ratiopharm

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines 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 ratiopharm contains

The active substance is amoxicillin. Each tablet contains 1.15 g of amoxicillin trihydrate (equivalent to 1 g of amoxicillin).
The other components are: microcrystalline cellulose, talc, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Amoxicillina ratiopharm and contents of the package
Amoxicillina ratiopharm is supplied in a box containing 12 tablets of 1 g in blisters.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milan
Manufacturer
LA.FA.RE. S.r.l.
Via S. Benedetto Cozzolino, 77
80056 Ercolano (NA) - Italy

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 often, this is due to the fact that the bacteria causing the infection are resistant to the administered antibiotic and are therefore able to survive and multiply despite treatment.

There are several reasons why bacteria can become resistant to antibiotics. Correct use of antibiotics can help reduce the likelihood of bacteria developing resistance.
The prescription of an antibiotic course is intended solely to treat the current illness. By following the recommendations below, you can help prevent the development of resistant bacteria, which could undermine the effectiveness of antibiotic therapy.

It is very important to take antibiotics at the correct dose, at the right times, and for the prescribed number of days. It is important to read the instructions accompanying the medicine and, if they are difficult to understand, to ask your doctor or pharmacist for clarification.
Antibiotics must not be taken unless they have been specifically prescribed for you and should only be used to treat the infection for which they were prescribed.
Do not take antibiotics prescribed for other people, even if the infection appears similar.
Do not give your prescribed antibiotics to other people.
If, after completing the treatment course as directed by your doctor, you have unused antibiotic left, you should return it to a pharmacy for proper disposal.