AMOXICILLINA 1000 mg Dispersible Tablet

Зміст інструкції

1. Amoxicillina HCS 1000 mg dispersible tablets
   1. What is Amoxicillina HCS and what is it used for
   2. What you need to know before taking Amoxicillina HCS
   3. How to take Amoxicillina HCS
   4. Possible side effects
   5. How to store Amoxicillina HCS
   6. Content of the pack and other information

Amoxicillina HCS 1000 mg dispersible tablets

amoxicillina

Generic medicine

Read this leaflet carefully before 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 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 HCS is and what it is used for
• 2. What you need to know before you take Amoxicillina HCS
• 3. How to take Amoxicillina HCS
• 4. Possible side effects
• 5. How to store Amoxicillina HCS
• 6. Contents of the pack and other information

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

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

What is Amoxicillina HCS used for
Amoxicillina HCS is used to treat some infections caused by bacteria in different parts of the body in
adults and children. Amoxicillina HCS can also be used in association with other medicines
for the treatment of gastric ulcers.

2. What you need to know before taking Amoxicillina HCS

Do not take Amoxicillina HCS

• if you are allergic to amoxicillin, to penicillin or to any of the other components of this medicine (listed in section 6).
• if you have previously had an allergic reaction to any antibiotic. This includes also a skin rash or the development of swelling of the face or throat.

Do not take Amoxicillina HCS if you recognise yourself in any of the situations above. If you have
any doubts, ask your doctor or pharmacist before taking Amoxicillina HCS.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillina HCS 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 points above apply to you, ask your doctor or pharmacist
before taking Amoxicillina HCS.

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

Other medicines and Amoxicillina HCS
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 Amoxicillina HCS, 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 Amoxicillina HCS.
• 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 (tetracyclines) the effectiveness of Amoxicillina HCS may be reduced.
• If you are taking methotrexate (a medicine used to treat cancer or rheumatic diseases) Amoxicillina HCS may increase the risk of side effects.

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

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

Amoxicillina HCS contains aspartame (E951) and sodium
This medicine contains 30 mg of aspartame per dispersible tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare
genetic disorder that causes a build-up of phenylalanine because the body cannot break it down
properly.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

3. How to take Amoxicillina HCS

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

• The tablets can be used in two ways. You can swallow the tablets with a glass of water or disperse them first in a glass of water before ingestion (place the tablet in water to drink, mix with a spoon and ingest after complete disintegration), then drink them. The tablets can be broken to facilitate swallowing.
• The Amoxicillina HCS tablets can be divided into equal doses.
• Take the doses at regular intervals throughout 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 Amoxicillina HCS 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 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 HCS 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 there are 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 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.

Renal impairment
If you have kidney problems, the dose may be lower than usual.

Hepatic impairment
If you have liver problems, your doctor will monitor liver function at regular intervals and will pay
particular attention when prescribing the dosage.

If you take more Amoxicillina HCS than you should
If you take an excessive amount of Amoxicillina HCS, signs 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 Amoxicillina HCS

• 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 Amoxicillina HCS?

• Continue to take Amoxicillina HCS 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 Amoxicillina HCS 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 Amoxicillina HCS for long periods, your doctor may subject you to 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, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking Amoxicillina HCS 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 itching, skin 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 caused by 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 Amoxicillina HCS, 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
• flu-like symptoms with skin rash, fever, swollen glands and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• fever, chills, sore throat or other signs of infection, or a tendency to bruise. These may be signs of a blood cell problem
• the Jarisch-Herxheimer reaction, which may occur during the treatment of Lyme disease with Amoxicillina HCS, causing fever, chills, headache, muscle pain and skin 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 or pale stools
o yellowing of the skin or the white of the eye (jaundice). See also the section
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 taking the medicine and seek immediate medical attention.
Sometimes less serious skin reactions may occur, such as:

• a slightly itchy rash (roundish, pink-reddish 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 treatment with Amoxicillina HCS may 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
• crystals may form in the urine, 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 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
• decreased number of white blood cells
• decreased number of cells involved in blood clotting
• increased time it takes for blood to clot compared to normal. This effect may be noticed in case of nosebleeds or if you get a cut.

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 HCS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the packaging after
EXP/Scad. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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. Content of the pack and other information

What Amoxicillina HCS contains

• The active ingredient is amoxicillin. Each dispersible tablet contains 1000 mg of amoxicillin (as amoxicillin trihydrate).
• The other ingredients (excipients) are aspartame (E951), crospovidone, magnesium stearate (E470b) and wild cherry flavour (maltodextrin, glycerol triacetate (E1518), sodium starch octenylsuccinate (E1450), flavouring components). See section 2 “Amoxicillina HCS contains aspartame (E951) and sodium”.

Description of the appearance of Amoxicillina HCS and content of the pack
Biconvex tablets of white to off-white colour, oval in shape, with a line of
incision on one side and with "A3" imprinted on the other side. Tablet dimensions: approximately
20 x10 mm. The tablet can be divided into equal doses.
Amoxicillina HCS is available in boxes containing 6, 8, 12, 14, 16, 20 and 24 dispersible tablets in
blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
HCS BV, H. Kennisstraat 53, B 2650 Edegem, Belgium

Local Representative for Italy
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturer
HCS BV, H. Kennisstraat 53, B 2650 Edegem, Belgium

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:

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 the treatment.
There are various reasons why bacteria can become resistant to antibiotics.
Correct use of antibiotics can help reduce the likelihood that bacteria develop resistance.
The prescription of a course of antibiotics is intended to treat only the current illness.
By following the advice below, you will help prevent 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 if they have not been specifically prescribed for you and should be used only to treat the infection for which they have been prescribed.
• 3. Do not take antibiotics prescribed to other people, even if the infection seems similar.
• 4. Do not give antibiotics prescribed to you to other people.
• 5. If, once the course of treatment has been completed according to the doctor's instructions, some antibiotic remains unused, this must be taken to the pharmacy so that it can be