Hiconcil

Leaflet accompanying the packaging: patient information

Hiconcil, 250 mg hard capsules

Hiconcil, 500 mg hard capsules

Amoxicillin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Hiconcil and what is it 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 packaging and other information

1. What is Hiconcil and what is it used for

What is Hiconcil

Hiconcil is an antibiotic. The active substance of the medicine is amoxicillin. Amoxicillin belongs to a group of medicines called "penicillins".

What is Hiconcil used for

Hiconcil is used to treat bacterial infections of various parts of the body. Hiconcil can also be used, in combination with other medicines, to treat stomach ulcer disease.

2. Important information before taking Hiconcil

When not to take 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 an allergic reaction can include a skin rash or swelling of the face or throat.

If the above information applies to the patient, they should not take Hiconcil. In case of doubt, consult a doctor or pharmacist before taking Hiconcil.

Warnings and precautions

Before taking Hiconcil, the patient should discuss it with their doctor or pharmacist if they:

• have infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue),
• have kidney disease,
• have irregular urination.

In case of doubt whether the above information applies to the patient, they should consult a doctor or pharmacist before taking Hiconcil.

Blood and urine tests

If the patient is to undergo:

• urine tests (for glucose) or blood tests to check liver function,
• estriol tests (performed during pregnancy to check if the baby is developing properly), they should inform their doctor or pharmacist that they are taking Hiconcil. Hiconcil may affect the results of these tests.

Hiconcil and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

• If the patient takes allopurinol (used for gout) at the same time as Hiconcil, they may be more likely to experience skin allergic reactions.
• If the patient takes probenecid (used for gout), taking probenecid at the same time may reduce the excretion of amoxicillin and is not recommended. The doctor may decide to modify the dose of Hiconcil.
• If the patient takes blood-thinning medicines (such as warfarin), they may need to have additional blood tests.
• If the patient takes other antibiotics (such as tetracycline), Hiconcil may be less effective.
• If the patient takes methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate, leading to increased risk of side effects.

Hiconcil with food and drink

The medicine can be taken with or without food. The capsule should be swallowed with a glass of water.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Hiconcil may cause side effects that can affect the patient's ability to drive or use machines, such as allergic reactions, dizziness, and seizures. The patient should not drive or use machines unless they feel well.

Hiconcil contains azorubine

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

3. How to take Hiconcil

This medicine should be taken as directed by the doctor. In case of doubt, consult a doctor or pharmacist.

• The capsule should be swallowed with a glass of water.
• The patient should maintain equal intervals of at least 4 hours between doses taken during the day.
• Hiconcil can be taken with or without food.

Usual dose

Children with a body weight of less than 40 kg

All doses are determined based on the child's body weight in kilograms.

• The doctor will recommend the dose of Hiconcil to be given to the child.
• The usual dose 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, and children with a body weight of 40 kg or more

The usual dose of Hiconcil is 250 mg to 500 mg three times a day 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 a day.
• Urinary tract infections:3 g twice a day for one day.
• Lyme disease (borreliosis - infection transmitted by ticks):single migrating erythema (early stage - pinkish-red spot): 4 g per day. Systemic symptoms (late stage - more severe symptoms or when the disease affects multiple organs): up to 6 g per day.
• Stomach ulcer disease:750 mg or 1 g twice a day for 7 days in combination with other antibiotics and medicines used to treat stomach ulcers.
• Prevention of endocarditis during surgical procedures:the dose may vary depending on the type of surgical procedure. Other medicines may be given at the same time. 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 Hiconcil may be lower than usual.

Taking more Hiconcil than recommended

If the patient takes more Hiconcil than recommended, they may experience symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or crystals in the urine, which may be perceived as cloudy urine or problems urinating. The patient should contact their doctor as soon as possible. They should take the packaging of the medicine with them to show it to the doctor.

Missing a dose of Hiconcil

• If the patient forgets to take a dose, they should take it as soon as they remember.
• The patient should not take the next dose too early; they should wait about 4 hours before taking the next dose.
• The patient should not take a double dose to make up for a missed dose.

How long to take Hiconcil

• The patient should continue taking Hiconcil for as long as the doctor recommends, even if they feel better. All doses of the medicine are needed to fight the infection. If some bacteria survive, they may cause a recurrence of the infection.
• If the patient does not feel better after finishing the treatment with Hiconcil, they should consult their doctor.

If the patient takes Hiconcil for a long time, they may experience thrush (candidiasis - fungal infections of the mucous membranes causing local pain, itching, and white discharge). In this case, the patient should consult their doctor. If the patient takes Hiconcil for a long time, their doctor may order additional tests of kidney, liver, and blood function. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking Hiconcil and contact their doctor immediately - they may need urgent medical attention.

Very rare side effects (may occur less frequently 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, rarely leading to death;
• rash or pinpoint, flat, red, round spots under the skin or bruising of the skin, which may be a sign of vasculitis due to an allergic reaction; this may be associated with joint pain (arthritis) and kidney disease;
• late allergic reactions occurring usually 7 to 12 days after taking Hiconcil; some of the observed symptoms include: rash, fever, joint pain, and swollen lymph nodes, especially in the armpits;
• skin reaction called erythema multiforme, characterized by itchy, red-purple patches on the skin, especially on the hands or soles of the feet, skin swelling (resembling hives), irritation around the mouth, eyes, or genitals; fever and fatigue may occur;
• other severe skin reactions include: changes in skin color, lumps under the skin, blisters, ulcers, skin peeling, redness, pain, itching, and skin flaking; these may be associated with fever, headache, and body aches;
• flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results [including increased white blood cell count (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; these may be signs of blood cell problems;
• Jarisch-Herxheimer reaction; when taking Hiconcil to treat Lyme disease (borreliosis), the patient may experience fever, chills, muscle and headache, and skin rash;
• colitis, causing diarrhea (sometimes with blood), abdominal pain, and fever;
• severe liver reactions, which usually occur in patients treated for a longer period, men, and the elderly. The patient should immediately inform their doctor if they experience:
• severe diarrhea with bleeding,
• blisters, redness, or bruising of the skin,
• dark urine or pale stools,
• yellowing of the skin and whites of the eyes (jaundice). The patient should also read the information below about anemia that may cause jaundice.

Frequency not known (cannot be estimated from the available data):

• chest pain associated with an allergic reaction, which may be a sign of an allergy leading to a heart attack (Kounis syndrome);
• rash with blisters arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis);
• drug-induced enterocolitis syndrome (DIES) occurred mainly in children taking amoxicillin. It is a type of allergic reaction, the leading symptom of which is repeated vomiting (1-4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

The above symptoms may occur during or up to several weeks after stopping Hiconcil.

If the patient experiences any of the above symptoms, they should stop taking Hiconcil and contact their doctor immediately.

Sometimes, less severe skin reactions may occur, such as:

• mildly itchy rash (round, red-pink patches), resembling hives, swelling on the forearms, legs, hands, or feet. This occurs not very often (may occur in less than 1 in 100 patients).

If the patient experiences any of these symptoms, they should contact their doctor and stop taking Hiconcil.

Other possible side effects

Common side effects(may occur in less than 1 in 10 patients):

• skin rash
• nausea
• diarrhea

Uncommon side effects(may occur in less than 1 in 100 patients):

• vomiting

Very rare side effects(may occur less frequently than 1 in 10,000 patients):

• thrush (fungal infections of the vagina, mouth, or skin folds); the doctor or pharmacist will advise on treatment
• kidney problems
• seizures, especially in patients taking high doses or having kidney problems
• dizziness
• excessive activity
• yellow, brown, or black, hairy tongue
• excessive breakdown of red blood cells, which can lead to anemia (symptoms include fatigue, headaches, shortness of breath, dizziness, pallor, and yellowing of the skin and whites of the eyes)
• decreased white blood cell count
• decreased platelet count (cells involved in blood clotting)
• blood may take longer to clot than usual; this may be noticeable in case of nosebleeds or cuts

Frequency not known(cannot be estimated from the available data):

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

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Hiconcil

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated. The batch number is stated on the packaging after "Lot". Store below 25°C. Store in the original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Hiconcil contains

• The active substance of the medicine is amoxicillin. Hiconcil, 250 mg: each hard capsule contains 250 mg of amoxicillin in the form of amoxicillin trihydrate (286.95 mg). Hiconcil, 500 mg: each hard capsule contains 500 mg of amoxicillin in the form of amoxicillin trihydrate (573.90 mg).
• The other ingredients are: magnesium stearate, colloidal silica anhydrous. Capsule shell: titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), indigo carmine (E 132), azorubine (E 122), gelatin.

What Hiconcil looks like and contents of the packaging

250 mg: opaque, hard gelatin capsule with a reddish-brown (brown-red) cap and pink body, containing a white to slightly yellowish powder. 500 mg: opaque, hard gelatin capsule with a reddish-brown (brown-red) cap and pink body, containing a white to slightly yellowish powder. Packaging:16 hard capsules in blisters, in a cardboard box.

Marketing authorization holder and manufacturer:

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia. For more information about this medicine, the patient should contact the local representative of the marketing authorization holder: Krka - Polska Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, phone: +48 22 573 75 00.

Date of last revision of the leaflet:

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 the bacteria are resistant to the antibiotic. This means that the bacteria can survive or multiply despite the use of the antibiotic. Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the likelihood of bacteria developing resistance. The antibiotic prescribed by the doctor is intended solely for the treatment of the current illness. Paying attention to the following advice will help prevent the development of resistant bacteria that could interfere with the effectiveness of the antibiotic.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the right number of days. The patient should read the instructions in the leaflet and, if any of them are unclear, ask their doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic if it was not prescribed specifically for them. They should only take it to treat the infection for which the antibiotic was prescribed.
• 3. The patient should not take an antibiotic prescribed for another person, even if they had a similar infection.
• 4. The patient should not pass on antibiotics prescribed for them to other people.
• 5. If there are any leftover antibiotics after completing the treatment as recommended by the doctor, the patient should return them to the pharmacy, which will accept them for proper disposal.