Hiconcil

Package leaflet: Information for the patient

Hiconcil, 250 mg hard capsules
Hiconcil, 500 mg hard capsules
Amoxicillinum
Please read the entire leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with 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, inform the 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 known as "penicillins".
What Hiconcil is used for
Hiconcil is used to treat bacterial infections in various parts of the body. Hiconcil may also be used, in combination 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. In case of doubt, consult a doctor or pharmacist before starting treatment with Hiconcil.

Warnings and precautions

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

• has infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue),
• has kidney disease,
• urinates 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 proper 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

Inform the doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines planned for future use.

• If allopurinol (used in gout) is taken at the same time as Hiconcil, skin allergic reactions are more likely to occur.
• If probenecid (used in gout) is taken with Hiconcil, it may reduce the excretion of amoxicillin and is not recommended. The doctor may decide to adjust the dose of Hiconcil.
• If the patient is taking anticoagulant medicines (such as warfarin), additional blood tests may be required.
• If the patient is taking other antibiotics (such as tetracyclines), Hiconcil may be less effective.
• If the patient is taking methotrexate (used in the treatment of cancer and severe psoriasis), penicillins may reduce methotrexate excretion, increasing the risk of adverse effects.

Hiconcil with food and drink

The medicine can be taken independently of meals. Swallow the capsule with a glass of water.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 or operate machinery.

Do not drive or operate machinery unless the patient feels well.

Hiconcil contains azorubine

Azorubine (E 122) is an azo dye which may cause allergic reactions (hypersensitivity).

3. How to use Hiconcil

This medicine should be taken as directed by the doctor. If in doubt, consult a
doctor or pharmacist.

• Swallow the capsule with a glass of water.
• Maintain regular intervals of at least 4 hours between doses administered during the day.
• Hiconcil can be taken regardless of meals.

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

• The doctor will advise the dose of Hiconcil to be given to the child.
• The usual dosage is 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 dosage of Hiconcil is 250 mg to 500 mg three times daily or 750 mg to 1 g
every 12 hours, depending on the severity and type of infection.

• Severe infections: 750 mg to 1 g three times daily.
• Urinary tract infections: 3 g twice daily for one day.
• Lyme disease (borreliosis - tick-borne infection): erythema migrans (early stage - pink-red rash): 4 g per day. Systemic symptoms (late stage - more severe symptoms or when multiple organs are involved): up to 6 g per day.
• Peptic ulcer disease: 750 mg or 1 g twice daily for 7 days in combination with other antibiotics and ulcer medications.
• Prevention of endocarditis during surgical procedures: the dose may vary depending on the type of surgical procedure. Other medicines may also be administered. For more detailed information, consult a doctor, pharmacist, or nurse.
• The maximum recommended dose is 6 g per day.

Kidney disease
If the patient has kidney disease, the dose of medicine may be lower than usual.
Taking more Hiconcil than recommended
If a patient takes more Hiconcil than recommended, symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or crystals in the urine, which may appear as cloudy urine or difficulty passing urine, may occur. Contact a doctor as soon as possible. Take the medicine packaging along to show the doctor.
Missed dose of Hiconcil

• If a patient forgets to take a dose, take it 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 take Hiconcil

• Continue taking Hiconcil for as long as directed by the doctor, even if the patient feels 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.

If Hiconcil is used for a prolonged period, fungal infections (candidiasis - yeast infections of mucous membranes causing local pain, itching, and white discharge) may occur. In such cases, consult a doctor.
If a patient takes Hiconcil for a prolonged period, the doctor may order additional tests to monitor kidney, liver function, and blood.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences any of the following serious adverse effects, stop taking Hiconcil immediately
and contact a doctor – immediate medical assistance may be required.

Very rare adverse effects (may occur in fewer 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 can 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, particularly on the palms or soles of the feet, skin swelling (resembling urticaria), irritation around the mouth, eyes or genital organs; fever and fatigue may also occur;
• other serious skin reactions include: changes in skin color, subcutaneous nodules, blisters, pustules, skin peeling, redness, pain, itching and skin desquamation; these may be associated with fever, headache and body aches;
• influenza-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results [including increased white blood cell count (eosinophilia) and elevated 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). Also read the information below regarding anaemia which may cause jaundice.

Frequency unknown (cannot be estimated from available data):

• chest pain associated with an allergic reaction, which may indicate an allergy leading to myocardial infarction (Kounis syndrome);
• blistering rash arranged in ring-like patterns with central crusts or resembling a string of pearls (linear IgA dermatosis);
• drug-induced enterocolitis syndrome (DIES), which has occurred mainly in children receiving amoxicillin. This is a type of allergic reaction characterized primarily by recurrent vomiting (1-4 hours after taking the medicine). 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), urticarial swelling on 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 effects

Common adverse effects (may occur in no more than 1 in 10 patients):

• skin rash
• nausea
• diarrhoea

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

• vomiting

Very rare adverse effects (may occur in fewer than 1 in 10,000 patients):

• fungal infections (vaginal, oral or skin fold candidiasis); a doctor or pharmacist can advise on treatment
• kidney problems
• seizures, especially in patients receiving high doses or with kidney problems
• dizziness
• excessive activity
• 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 minor cuts

Frequency unknown (cannot be estimated from available data):

• crystals in urine leading to acute kidney injury
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects 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.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
Store below 25°C.
Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the package and other information

What Hiconcil contains

• The active substance is amoxicillin. Hiconcil 250 mg: each hard capsule contains 250 mg of amoxicillin as amoxicillin trihydrate (286.95 mg). Hiconcil 500 mg: each hard capsule contains 500 mg of amoxicillin as amoxicillin trihydrate (573.90 mg).
• Other ingredients: magnesium stearate, colloidal anhydrous silica. Capsule shell composition: titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), indigotine (E 132), azorubine (E 122), gelatin.

What Hiconcil looks like and contents of the pack
250 mg: opaque gelatin hard capsule with burgundy (brown-red) cap and pink body, containing white to slightly yellowish powder.
500 mg: opaque gelatin hard capsule with burgundy (brown-red) cap and pink body, containing white to slightly yellowish powder.
Packaging: 16 hard capsules in blisters, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer:
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Krka - Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa, Poland
Telephone: +48 22 573 75 00

General advice on the use of antibiotics
Antibiotics are used to treat bacterial infections. They are ineffective against 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 administered. This means that bacteria can survive or multiply despite antibiotic treatment.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics can help reduce the risk of development of bacterial resistance.
The antibiotic prescribed by your doctor is intended solely for treatment of your current illness. Observing the following advice will help prevent the development of resistant bacteria that could compromise the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the exact number of days prescribed. Read the instructions in this leaflet carefully and, if any are unclear, ask your doctor or pharmacist for clarification.
2. Do not take an antibiotic unless it has been prescribed specifically for you. Take it only to treat the infection for which it was prescribed.
3. Do not take an antibiotic prescribed for another person, 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 course of treatment, return it to a pharmacy for proper disposal.