AMOSOL 1 G Tabletka orodispersyjna

Treść ulotki

1. AMOSOL 1 g dispersible tablets
   1. What Amosol is and what it is used for
   2. What you need to know before you take Amosol
   3. How to take Amosol
   4. Possible side effects
   5. How to store Amosol
   6. Contents of the pack and other information

AMOSOL 1 g dispersible tablets

Amoxicillin
Generic medicine
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 only for you (or for your child). Do not give it to other people, even if they have the same symptoms as you, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1.What Amosol is and what it is used for
• 2.What you need to know before you take Amosol
• 3.How to take Amosol
• 4.Possible side effects
• 5.How to store Amosol
• 6.Contents of the pack and other information

1. What Amosol is and what it is used for

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

Amosolis used to treat infections caused by bacteria in different parts of the body. Amosolcan also
be used in combination with other medicines for the treatment of gastric ulcers.

2. What you need to know before you take Amosol

Do not take Amosol:

• 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 had an allergic reaction to any antibiotic in the past. This includes also a skin rash or the development of swelling of the face or throat.

Do not take Amosolif you recognize yourself in any of the situations above. If you have any doubts, ask
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 points above apply to you, talk to 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 oestriol (used in pregnancy to check the normal development of the foetus) tell your doctor or pharmacist that you are taking Amosol, as this medicine may alter the results of these tests.

Other medicines and Amosol
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any
other medicine.

• 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 to have additional blood tests.
• If you are taking other antibiotics (e.g. tetracyclines) the effectiveness of Amosolmay be reduced.
• If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), Amosolmay reduce the excretion of methotrexate, potentially increasing the side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Amosol can 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.

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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Add the tablet to a glass of water and stir until completely dissolved. Afterwards,
drink immediately. Take the doses at regular intervals during the day, 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 to your child.
• The usual dose ranges from 40 mg to 90 mg per kilogram of body weight per day, to

be administered in two or three separate 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:from 750 mg to 1 g three times a day.
• Urinary tract infection:3 g twice a day for one day.
• Lyme disease (infection caused by a parasite called a tick):isolated erythema migrans (early stage - circular reddish or rosy rash): 4 g per day, systemic manifestations (late stage - when more serious symptoms are present 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 a dose of 1 g twice a day for 7 days together with other antibiotics and medicines for the treatment of gastric ulcers.
• Prevention of heart infections during surgery:the dose will vary depending on the type of surgery. Other medicines may also be administered at the same time. Your doctor, pharmacist or nurse will provide you with more detailed information.
• The maximum recommended dose is 6 g per day.

Kidney problems
If you have kidney problems, the 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 disorders
(nausea, vomiting or diarrhea) 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 to them.

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 about 4 hours before taking the next dose. Do not take a double dose to
make up for the missed dose.

How long should you take Amosol?
Continue taking Amosolfor the time indicated by your doctor, even if you feel better. To fight
the infection, it is necessary to take all the prescribed doses. The infection may return if some
bacteria survive. If, once the treatment is finished, you continue to feel unwell, see
your doctor again.
The use of Amosolfor 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, see your doctor.
If you take Amosolfor long periods, your doctor may perform additional tests to verify that
everything is normal at the level of 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 everyone will experience them.

Stop taking Amosol and consult your doctor immediately if you observe any of the following serious side effects, as urgent medical treatment may be necessary:
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 serious 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 Amosol, accompanied by signs such as 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 formation of blisters, pustules, exfoliation, redness, pain, itching and scaling. These may be associated with fever, headache and widespread pain throughout the body;
• 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);
• fever, chills, sore throat or other signs of infection, or a predisposition to bruising. These may be signs of a blood cell problem;
• the Jarisch-Herxheimer reaction, which may occur during the treatment of Lyme disease with Amosol, 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 elderly people. 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 of the eye (jaundice). See also the entry on anemia 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 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, contact your doctor as it will be necessary to stop treatment with Amosol.
The 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;
• presence of crystals in the urine leading to acute kidney damage with possible clouding of the urine, difficulty urinating or discomfort during urination. Be sure to drink plenty of fluids to reduce the risk of developing these symptoms;
• teeth may appear stained, but generally return to 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.

Not known(frequency cannot be estimated 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);
• Drug-induced enterocolitis 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 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).

Reporting of side effects
If you experience any side effects, including 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 Amosol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after “Exp.” The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in waste water 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 Amosol contains

• Each tablet contains 1 g of amoxicillin as the active ingredient.
• The other ingredients are: Microcrystalline cellulose, crospovidone, sodium lauryl sulfate, magnesium stearate, sodium saccharin, strawberry flavour.

Description of the appearance of Amosol and contents of the pack
Amosol is presented in the form of oblong, white tablets.
The tablets are packaged in blisters contained in a carton. Available in packs of 12
tablets.

Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Roma) - 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 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. Proper use of
antibiotics can help reduce the chances that bacteria 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 invalidate 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 unless they have been specifically prescribed for you and should be used only to treat the infection for which they have been 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 course has been completed according to the doctor's instructions, some antibiotic remains unused, this must be taken to the pharmacy for correct disposal.