Amosol: detailed information

Package leaflet: Information for the user

AMOSOL 1 g dispersible tablets

Amoxicillin
Generic medicine
Please read all of this leaflet carefully before you start 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 or pharmacist.
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.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Amosol is and what it is used for

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

2. What you need to know before taking Amosol

Do not take Amosol:

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 also includes a skin rash or the development of facial or throat swelling.

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

you have glandular fever (fever, sore throat, swollen glands, and extreme tiredness)
you have kidney problems
you do not urinate regularly

If you are unsure whether any of the above points apply to you, consult your doctor or pharmacist before taking Amosol.

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 Amosol, as this medicine may alter the results of these tests.

Other medicines and Amosol
Inform 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 Amosol, you may be more likely to develop an allergic skin reaction.
If you are taking probenecid (a medicine used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended. Your doctor may decide to adjust the dose of Amosol.
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 Amosol may be reduced.
If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), Amosol may reduce the excretion of methotrexate, potentially increasing its side effects.

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

3. How to take Amosol

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Add the tablet to a glass of water and stir until completely dissolved. Then,
drink immediately. Take doses at regular intervals throughout the day, spaced at least 4 hours
apart.
The recommended 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 Amosol to give your child.
The usual dose ranges from 40 mg to 90 mg per kilogram of body weight per day, given in two or three divided doses.
The maximum 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 Amosol 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: one 750 mg dose or one 1 g dose twice a day for 7 days, together with other antibiotics and medicines for treating gastric ulcers.
Prevention of heart infections during surgical procedures: the dose will vary depending on the type of surgery. Other medicines may also be administered simultaneously. Your doctor, pharmacist, or nurse will provide more detailed information.
The maximum recommended dose is 6 g per day.

Kidney problems
If you have kidney problems, your dose may be lower than usual.
If you take more Amosol than you should
If you take an excessive amount of Amosol, symptoms such as gastrointestinal disturbances
(nausea, vomiting, or diarrhea), presence of crystals in urine (possibly causing cloudy urine), or
difficulty urinating may occur. Contact your doctor as soon as possible, taking the medicine with you to show it.
If you forget to take Amosol
If you forget a dose, take it as soon as you remember. Do not take the next dose too soon—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 Amosol?
Continue taking Amosol for the duration prescribed by your doctor, even if you feel better. It is essential to take all prescribed doses to fully eliminate the infection. The infection may return if some bacteria survive. If you still do not feel well after completing the treatment, consult your doctor again.
Prolonged use of Amosol 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, consult your doctor.
If you take Amosol for a prolonged period, your doctor may perform additional tests to monitor your kidney, liver, and blood function.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking Amosol and contact a doctor immediately if you notice any of the following serious side
effects, as urgent medical treatment may be required:
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 reactions can be severe and, in some cases, have been fatal;
skin rash or appearance of small, round, flat, reddish spots beneath the skin surface, or skin bruising. This is due to inflammation of the blood vessel walls caused by an allergic reaction. It may be accompanied by joint pain (arthritis) and kidney problems;
a delayed allergic reaction, usually occurring 7–12 days after taking Amosol, accompanied by signs such as skin rash, fever, joint pain, and swollen lymph nodes, particularly those under the arm;
a skin reaction known 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. This may be accompanied by fever and a feeling of extreme fatigue;
other severe skin reactions may include changes in skin colour, formation of lumps under the skin, blistering, pustules, peeling, redness, pain, itching, and skin shedding. These may be associated with fever, headache, and widespread body aches;
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);
fever, chills, sore throat, or other signs of infection, or a tendency to bruise easily. These may be signs of a blood cell disorder;
the Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease with Amosol, causing fever, chills, headache, muscle pain, and skin rash;
inflammation of the large intestine (colon) with diarrhoea (sometimes containing blood), abdominal pain, and fever;
serious side effects affecting the liver may occur, observed mainly in patients treated for long periods, 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 whites of the eyes (jaundice). See also the entry on anaemia below as a possible cause of jaundice.

These effects may occur during treatment with the medicine or even several weeks later.
If any of the above effects occur, stop taking the medicine and contact your doctor immediately.
Sometimes less severe skin reactions may occur, such as:

a slightly itchy rash (roundish pinkish-red patches), localized swelling similar to hives on the 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, contact your doctor, as it will be necessary to stop treatment with Amosol.
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. Very rare (may affect up to 1 in 10,000 people)
candidiasis (yeast infection of the vagina, mouth, or skin folds); your doctor or pharmacist will prescribe appropriate treatment;
kidney problems;
seizures, observed in patients treated with high doses or in those with kidney problems;
dizziness;
hyperactivity;
presence of crystals in the urine leading to acute kidney injury, possibly causing cloudy urine, difficulty urinating, or discomfort during urination. Make sure you drink plenty of fluids to reduce the risk of developing these symptoms;
teeth may appear stained, but usually return to their normal appearance with brushing (this effect has been reported 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 whites of the eyes;
reduced number of white blood cells;
reduced number of cells involved in blood clotting;
prolonged blood clotting time compared to normal. This effect may become apparent in case of nosebleeds or cuts.

Not known (frequency cannot be estimated from available data)

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, speak to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 Amosol

Keep this medicine out of the sight and reach of children.
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.
This medicine requires no special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
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 Amosol contains

Each tablet contains 1 g of amoxicillin as the active substance.
The other components are: microcrystalline cellulose, crospovidone, sodium lauryl sulfate, magnesium stearate, sodium saccharin, strawberry flavouring.

Description of the appearance of Amosol and package contents
Amosol is presented as white, oval-shaped tablets.
The tablets are packaged in blisters enclosed in a box. Available in packs of 12 tablets.
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome) - Italy
Manufacturer
LA.FA.RE. S.r.l.
Via Sacerdote Benedetto Cozzolino, 77-80056 Ercolano (NA) - Italy
March 2023

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. The correct use of antibiotics can help reduce the likelihood of bacteria developing resistance.
An antibiotic prescription is intended solely to treat the current illness.
By following the recommendations below, you can help prevent the development of resistant bacteria, which could otherwise undermine the effectiveness of antibiotic therapy.

It is very important that antibiotics are taken 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 must 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 any unused antibiotics remaining, these should be returned to a pharmacy for proper disposal.