Hiconcil

Package leaflet: Information for the patient

Hiconcil, 250 mg/5 ml, powder for oral suspension
Amoxicillinum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents

1. What Hiconcil is and what it is used for
2. Important information before taking Hiconcil
3. How to take Hiconcil
4. Possible side effects
5. How to store Hiconcil
6. Contents of the pack and other information

1. What Hiconcil is and what it is used for

What Hiconcil is
Hiconcil is an antibiotic. The active substance is amoxicillin. Amoxicillin belongs to a group of medicines called "penicillins".
What Hiconcil is used for
Hiconcil is used to treat bacterial infections in various parts of the body. Hiconcil may also be used, together with other medicines, in the treatment of peptic ulcer disease.

2. Important information before using Hiconcil

When not to use Hiconcil

• if the patient is allergic to amoxicillin, penicillin, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever had an allergic reaction to any other antibiotic. Symptoms of allergy may include skin rash or swelling of the face or throat.

If any of the above apply to the patient, Hiconcil must not be taken. If in doubt, consult a doctor or pharmacist before starting treatment with Hiconcil.

Warnings and precautions

Before starting treatment with Hiconcil, discuss with a doctor or pharmacist if the patient:

• has infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue),
• has kidney disease,
• passes urine irregularly.

If in doubt whether any of the above apply, consult a doctor or pharmacist before taking Hiconcil.

Blood and urine tests

If the patient is due to have:

• urine tests (for glucose) or blood tests to assess liver function,
• estriol level tests (performed during pregnancy to monitor fetal development), inform the doctor or pharmacist that the patient is taking Hiconcil. Hiconcil may affect the results of these tests.

Hiconcil with other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• If allopurinol (used for gout) is taken at the same time as Hiconcil, skin allergic reactions may be more likely.
• If probenecid (used for gout) is taken, concomitant use may reduce amoxicillin excretion and is not recommended.
• If the patient takes anticoagulant medicines (such as warfarin), additional blood tests may be necessary.
• If the patient takes other antibiotics (such as tetracyclines), Hiconcil may be less effective.
• If the patient takes methotrexate (used in cancer treatment and severe psoriasis), penicillins may reduce methotrexate excretion, increasing the risk of adverse effects.

Hiconcil with food and drink

This medicine can be taken independently of meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

Hiconcil may cause adverse effects and symptoms (such as allergic reactions, dizziness, and seizures) that may impair the ability to drive.
Do not drive or operate machinery unless the patient feels well.

Hiconcil contains aspartame (E 951), sodium benzoate (E 211), sorbitol (E 420), and sodium

5 ml of prepared suspension (one measuring spoonful) contains 8.5 mg of aspartame, 7.1 mg of sodium benzoate, and approximately 0.15 mg of sorbitol.

Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the product is considered "sodium-free".

3. How to use Hiconcil

This medicine should be used exactly as prescribed by the doctor. If in doubt, consult your
doctor or pharmacist.

• Always shake the bottle well before administering each dose.
• Maintain equal intervals of at least 4 hours between doses given during the day.
• Hiconcil may be taken regardless of meals.

Usual dose
Children weighing less than 40 kg
All doses are determined according to the child's body weight in kilograms.

• The doctor will specify the dose of Hiconcil to be administered to the child.
• The usual dose is 20 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 suspension is generally not recommended for use in adults and children weighing more than
40 kg. Consult your doctor or pharmacist for advice.
Kidney disease
If the patient has kidney problems, the dose of medicine may be lower than the usual dose.
Instructions for preparing the suspension
To prepare 100 ml of suspension (250 mg/5 ml), always use boiled and cooled water.
First, turn the bottle upside down and gently shake it to loosen the powder. To prepare the suspension, fill the bottle with water up to about halfway below the mark indicated on the bottle. Close the bottle and shake immediately until the powder is completely dispersed. Wait a moment for the foam to settle, then slowly add water up to the mark indicated on the bottle and shake vigorously again. The bottle must be shaken vigorously before each use of the suspension.
If you take more Hiconcil than you should
If a patient takes more Hiconcil than recommended, symptoms such as irritation of the stomach and intestines (nausea, vomiting, or diarrhea) or crystals in the urine, which may appear as cloudy urine or difficulty passing urine, may occur. Seizures may occur in patients with impaired kidney function or those receiving high doses. Contact a doctor as quickly as possible. Take the medicine packaging along to show the doctor.
If you forget to take Hiconcil

• If a patient forgets to take a dose, it should be taken as soon as remembered.
• 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 missed dose.

How long to use Hiconcil

• Continue taking Hiconcil for as long as your doctor recommends, even if you start to feel better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to return.
• If the patient still does not feel better after completing treatment with Hiconcil, consult a doctor.

Prolonged use of Hiconcil may lead to fungal infections (candidiasis – yeast infections of mucous membranes causing local pain, itching, and white discharge). In such cases, consult a doctor.
If Hiconcil is taken for a prolonged period, the doctor may recommend additional tests to monitor kidney, liver, and blood function.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following serious adverse reactions, stop taking Hiconcil immediately and contact a doctor – immediate medical assistance may be required.
Very rare adverse reactions (may occur in less than 1 in 10,000 patients):

• allergic reactions, including: itching and skin rash, swelling of the face, lips, tongue, body, or difficulty breathing; these symptoms may be severe and rarely may lead to death;
• rash or small, flat, red, round spots under the skin or skin bruising, which may indicate vasculitis (inflammation of blood vessels) due to an allergic reaction; this may be associated with joint pain (arthritis) and kidney disease;
• delayed-type allergic reactions usually occurring 7 to 12 days after taking Hiconcil; observed symptoms may include: rash, fever, joint pain, and enlarged lymph nodes, especially under the arms;
• a skin reaction called erythema multiforme, characterized by itchy red-purple skin lesions, especially on the palms or soles of the feet, skin swelling (resembling hives), irritation around the mouth, eyes, or genital organs; fever and fatigue may also occur;
• other serious skin reactions such as changes in skin color, subcutaneous nodules, blisters, pustules, skin peeling, redness, pain, itching, and skin flaking; these may be accompanied by fever, headache, and body aches;
• flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results [including increased white blood cells (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS);
• fever, chills, sore throat and other signs of infection, or tendency to bruise easily. These may be symptoms of blood cell disorders;
• Jarisch-Herxheimer reaction; during treatment with Hiconcil for Lyme disease (borreliosis), fever, chills, muscle and headache, and skin rash may occur;
• inflammation of the large intestine causing diarrhoea (sometimes with blood), abdominal pain and fever;
• severe adverse effects affecting the liver may occur; these usually occur in patients treated for a prolonged period, in men, and in elderly patients. Inform the doctor immediately if the patient experiences:
• severe diarrhoea with bleeding,
• blisters, redness or bruising on the skin,
• dark urine or pale stools,
• yellowing of the skin and whites of the eyes (jaundice). Please also read the information below regarding anaemia that may cause jaundice.

Frequency unknown (cannot be estimated from available data):

• chest pain related to an allergic reaction, which may indicate an allergy leading to heart attack (Kounis syndrome)
• drug-induced enteritis (DIES), mainly reported in children receiving amoxicillin. This is a type of allergic reaction characterized by recurrent vomiting (1-4 hours after taking the drug). Further symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure

The above symptoms may occur during treatment or up to several weeks after stopping the medicine.
If the patient experiences any of the above symptoms, stop taking the medicine immediately and contact a doctor.
Less severe skin reactions may sometimes occur, such as:

• moderately itchy rash (round, red-pink lesions), hives-like swellings on the forearms, legs, hands, or feet. This occurs uncommonly (may occur in no more than 1 in 100 patients).

If the patient experiences any of these symptoms, contact a doctor and discontinue use of Hiconcil.
Other possible adverse reactions
Common adverse reactions (may occur in no more than 1 in 10 patients):

• skin rash
• nausea
• diarrhoea

Uncommon adverse reactions (may occur in no more than 1 in 100 patients):

• vomiting

Very rare adverse reactions (may occur in less than 1 in 10,000 patients):

• fungal infections (yeast infections of the vagina, mouth, or skin folds); a doctor or pharmacist can advise on treatment
• kidney problems
• seizures, especially in patients receiving high doses or with existing kidney problems
• dizziness
• excessive activity
• tooth discoloration (in children), which can usually be removed by brushing
• yellow, brown or black hairy tongue
• excessive breakdown of red blood cells, which may lead to anaemia; symptoms include: fatigue, headache, shortness of breath, dizziness, pallor, and yellowing of the skin and whites of the eyes
• decreased number of white blood cells
• decreased number of platelets (cells involved in blood clotting)
• blood may take longer than usual to clot; this may be noticeable during nosebleeds or cuts

Frequency unknown (cannot be estimated from available data):

• crystals in urine leading to acute kidney injury
• blistering rash arranged in ring-like patterns with central crusting or resembling a string of pearls (linear IgA dermatosis)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Hiconcil

Keep the medicine out of the sight and reach of children.
Oral suspension powder for oral suspension
Store below 25°C.
Ready-to-use suspension
Store the prepared suspension in the refrigerator (2°C–8°C) for up to 14 days.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Hiconcil contains

• The active substance is amoxicillin. 5 ml of the prepared suspension contains 287 mg of amoxicillin trihydrate, equivalent to 250 mg of amoxicillin.
• Other ingredients are: lemon flavour powder (sorbitol), apricot-peach flavour powder (sorbitol), citric acid, sodium benzoate, aspartame, talc, anhydrous sodium citrate, orange flavour powder, guar gum, colloidal anhydrous silica, silicon dioxide. See section 2: “Hiconcil contains aspartame (E 951), sodium benzoate (E 211), sorbitol (E 420) and sodium”.

What Hiconcil looks like and contents of the pack
White, slightly yellowish powder.
An amber glass bottle containing powder for preparing 100 ml of suspension, closed with a PP/PE screw cap with a child-resistant closure and tamper-evident seal, packed in a cardboard box.
A plastic dosing spoon is included in the pack.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

General advice on the use of antibiotics
Antibiotics are used to treat bacterial infections. They are ineffective in treating viral infections.
Sometimes bacterial infections do not respond to antibiotic treatment. One of the most common reasons for this is that bacteria are resistant to the antibiotic used. This means that bacteria can survive or multiply despite the use of the antibiotic.
Bacteria can become resistant to antibiotics for various reasons. Careful use of antibiotics may help reduce the development of bacterial resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Observing the following advice will help prevent the development of resistant bacteria that could hinder the effectiveness of antibiotics:

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the prescribed number of days. Please read the instructions in the leaflet carefully and, if any are unclear, ask your doctor or pharmacist for clarification.
2. Do not take an antibiotic unless it has been specifically prescribed for you. You should take it only to treat the infection for which it was prescribed.
3. Do not take an antibiotic prescribed for someone else, even if their symptoms were similar.
4. Do not give your prescribed antibiotics to other people.
5. If any antibiotic remains after completing the prescribed treatment, return it to your pharmacy for proper disposal.