Amoxicillin HCS

Package leaflet: Information for the patient

Amoxicillina HCS 1000 mg dispersible tablets

amoxicillin
Generic medicine
Please read all of this leaflet carefully before you take 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• 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:

1. What Amoxicillina HCS is and what it is 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. Contents of the pack and other information

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

What Amoxicillina HCS is
Amoxicillina HCS is an antibiotic. Its active substance, called amoxicillin, belongs to a group of medicinal substances known as "penicillins".
What Amoxicillina HCS is used for
Amoxicillina HCS is used to treat certain bacterial infections in various parts of the body in adults and children. Amoxicillina HCS may also be used in combination 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, 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 skin rash or the development of swelling of the face or throat.

Do not take Amoxicillina HCS if any of the above situations apply to you. If you
have any doubts, consult 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 tiredness)
• you have kidney problems
• you do not urinate regularly.

If you are unsure whether any of the points listed above apply to you, consult 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 estriol (used during pregnancy to monitor normal fetal development), inform 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
Inform 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 have an increased risk of developing 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 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, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Amoxicillina HCS may cause side effects whose symptoms (such as allergic reactions, dizziness, and
seizures) may impair your ability to drive vehicles.
Do not drive or operate machinery 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 causing phenylalanine to accumulate in the body because it cannot be properly metabolized.
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 exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.

• The tablets can be taken in two ways. You may swallow the tablets with a glass of water, or you may first disperse them in a glass of water before ingestion (place the tablet in drinking water, mix with a spoon and take after complete disintegration), then drink the solution. The tablets may be broken to facilitate swallowing.
• Amoxicillina HCS tablets may be divided into equal doses.
• Take the doses at regular intervals throughout the day, at least 4 hours apart.

Recommended dose:
Children weighing less than 40 kg
All doses are calculated according to the child's body weight expressed in kilograms.

• Your doctor will tell you how much Amoxicillina HCS 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 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: 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 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 at the same time. Your doctor, pharmacist or nurse will provide more detailed information.
• The maximum recommended dose is 6 g per day.

Renal impairment
If you have kidney problems, your 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 too much Amoxicillina HCS, symptoms such as gastrointestinal disturbances (nausea, vomiting or diarrhoea), 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 to show it.

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 early; wait approximately 4 hours before taking the next dose.
• Do not take a double dose to make up for the forgotten dose.

How long should you take Amoxicillina HCS?

• Continue taking Amoxicillina HCS 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, after completing the treatment, you still do not feel well, consult your doctor again.

Prolonged use of Amoxicillina HCS may lead to the development of candidiasis (a yeast infection affecting moist areas of the body, causing irritation, itching and whitish discharge). If this occurs, consult your doctor.
If you take Amoxicillina HCS for prolonged periods, your doctor may carry out additional tests to ensure that your kidneys, liver and blood are functioning normally.
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 a doctor immediately if you experience 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, with 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 appearance of small, round, flat, reddish spots under the skin surface, or skin bruising. This is due to inflammation of blood vessel walls caused by an allergic reaction. It may be accompanied by joint pain (arthritis) and kidney problems

• delayed allergic reaction, usually occurring 7–12 days after taking Amoxicillina HCS, accompanied by signs such as skin rash, fever, joint pain, and swollen lymph nodes, particularly under the arm

• 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 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 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, 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 easily. These may be signs of a blood cell disorder

• Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease with Amoxicillina HCS, causing fever, chills, headache, muscle pain, and skin rash

• inflammation of the large intestine (colon) with diarrhoea (sometimes containing blood), pain, and fever

• severe liver-related side effects may occur, mainly observed in patients undergoing long-term treatment, in men, and in elderly people. Contact your doctor urgently if you notice:
  o severe diarrhoea with bleeding or blisters, skin redness or bruising
  o dark urine or pale stools
  o yellowing of the skin or the white part of the eye (jaundice). See also the section on anaemia below as a possible cause of jaundice.
  These effects may occur during treatment with the medicine or 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 treatment with Amoxicillina HCS may need to be stopped.
Other possible side effects include:
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 who have kidney problems
• dizziness
• hyperactivity
• presence of crystals in the urine, 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 and appear hairy
• 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
• 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 with nosebleeds or when a cut occurs.

Reporting of side effects
If you experience any side effects, 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 Amoxicillin HCS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP/Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Pack contents and other information

What Amoxicillina HCS contains

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

Description of the appearance of Amoxicillina HCS and pack contents
Biconvex oval tablets, white to off-white in colour, with a score line on one side and engraved with "A3" on the other side. Tablet dimensions: approximately 20 x 10 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 Authorization 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 authorized in the European Economic Area Member States under the following names:

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 antibiotic
administered, thus being 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 that bacteria develop resistance.
An antibiotic prescription is intended solely to treat the current illness.
By following the advice below, you will help prevent the development of resistant bacteria, which
could otherwise undermine the effectiveness of antibiotic therapy.

1. 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.
2. Antibiotics should 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.
3. Do not take antibiotics prescribed for other people, even if the infection seems similar.
4. Do not give your prescribed antibiotics to other people.
5. If, after completing the treatment course as directed by your doctor, you have leftover unused antibiotic, it should be taken to a pharmacy for proper disposal.