Hiconcil combi

Leaflet attached to the packaging: patient information

Hiconcil combi, 500 mg + 125 mg, film-coated tablets

Hiconcil combi, 875 mg + 125 mg, film-coated tablets

Amoxicillin + Clavulanic acid

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this patient. 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 side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Hiconcil combi and what is it used for

Hiconcil combi is an antibiotic that works bactericidally on bacteria that cause infections.
Hiconcil combi contains two different ingredients: amoxicillin and clavulanic acid. Amoxicillin
belongs to a group of medicines called "penicillins", whose action can sometimes be inhibited
(inactivated). The second active substance (clavulanic acid) counteracts this inactivation.
Hiconcil combi is used in adults and children to treat the following infections:

• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections.

2. Important information before taking Hiconcil combi

When not to take Hiconcil combi

• if the patient is allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever had severe allergic reactions (hypersensitivity) to any other antibiotic. They may include skin rash or swelling of the face or neck.
• if the patient has ever had liver function disorders or jaundice (yellowing of the skin) associated with the use of an antibiotic.

If the above circumstances apply to the patient, they should not take Hiconcil combi.

In case of doubts, before starting to take Hiconcil combi, consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Hiconcil combi, discuss it with a doctor or pharmacist if the patient:

• has infectious mononucleosis
• is being treated for liver or kidney disease
• has irregular urination.

In case of doubts whether the above circumstances apply to the patient, consult a doctor or pharmacist before starting to take Hiconcil combi.
In some cases, the doctor may examine what type of bacteria caused the patient's infection.
Depending on the results, the patient may receive Hiconcil combi in a different dose or another medicine.

Conditions to be aware of

Taking Hiconcil combi may worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures, and colitis. Pay attention to whether the patient has certain symptoms during the treatment with Hiconcil combi in order to minimize the risk of any problems. See "Conditions to be aware of" in section 4.

Blood and urine tests

If the patient is to have blood tests (such as red blood cell tests or liver function tests) or urine tests (for glucose), they should inform their doctor or nurse that they are taking Hiconcil combi. Hiconcil combi may affect the results of these tests.

Hiconcil combi and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.
If the patient is taking allopurinol (used in gout), it is more likely that they will experience skin allergic reactions.
If the patient is taking probenecid (used in gout), the doctor may decide to change the dose of Hiconcil combi.
If the patient is taking medicines that reduce blood clotting (such as warfarin) at the same time as Hiconcil combi, additional blood tests may be necessary.
Hiconcil combi may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).
Hiconcil combi may affect the action of mycophenolate mofetil (a medicine used to prevent transplant rejection).

Taking Hiconcil combi with food and drink

Hiconcil combi should be taken at the beginning of a meal or just before a meal. The tablets should be swallowed whole, with a glass of water.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Hiconcil combi may cause side effects and symptoms that can impair the ability to drive vehicles.
Do not drive vehicles or operate machines unless the patient feels well.

Hiconcil combi contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Hiconcil combi

This medicine should always be taken exactly as prescribed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

Adults and children with a body weight of 40 kg or more

500 mg + 125 mg, film-coated tablets
Usually, the recommended dose is:

• 1 tablet three times a day.

875 mg + 125 mg, film-coated tablets

• Usually, the recommended dose is 1 tablet twice a day.
• A higher dose - 1 tablet three times a day.

Use in children

Children with a body weight of less than 40 kg

Children under 6 years of age should preferably be treated with a medicine containing amoxicillin with clavulanic acid in the form of an oral suspension.
500 mg + 125 mg, film-coated tablets
Consult a doctor or pharmacist before giving Hiconcil combi tablets to children with a body weight below 40 kg. The tablets are not intended for children weighing less than 25 kg.
875 mg + 125 mg, film-coated tablets
Consult a doctor or pharmacist before giving Hiconcil combi tablets to children with a body weight below 40 kg. The tablets are not intended for children weighing less than 25 kg.

Patients with kidney and liver diseases

• If the patient has kidney disease, the dose of the medicine may be changed. The doctor may choose a different dose of the medicine or another medicine.
• If the patient has liver disease, they may have blood tests more often to check how the liver is working.

How to take Hiconcil combi

• The tablets should be swallowed whole, with a glass of water, at the beginning of a meal or just before a meal.
• Keep equal intervals of at least 4 hours between doses taken during the day. Do not take 2 doses within 1 hour.
• Do not take Hiconcil combi for more than 2 weeks. If the patient still does not feel well, they should contact their doctor again.

Taking a higher dose of Hiconcil combi than recommended

If the patient has taken a higher dose of Hiconcil combi than recommended, they may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures. They should contact their doctor as soon as possible. They should have the carton or bottle of the medicine with them to show the doctor.

Missing a dose of Hiconcil combi

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

Stopping treatment with Hiconcil combi

Continue taking Hiconcil combi until the end of the treatment, even if the patient feels better. All doses of the medicine are necessary to combat the infection. If some bacteria survive, they may cause a relapse of the infection.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Conditions to be aware of

Allergic reactions:

• skin rash
• vasculitis (inflammation of blood vessels), which may appear as red or purple raised spots on the skin, but may also affect other organs
• fever, joint pain, swelling of the lymph nodes in the neck, armpit, or groin
• swelling, sometimes involving the face or mouth (angioedema), causing difficulty breathing
• fainting
• chest pain associated with an allergic reaction, which may be a sign of an allergy leading to a heart attack (Kounis syndrome).

If any of these symptoms occur, contact a doctor immediately.

Stop taking Hiconcil combi.

Colitis

Colitis, causing watery diarrhea usually with blood and mucus, abdominal pain, and (or) fever.

Acute pancreatitis

If you have severe and persistent stomach pain, it may be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)

Drug-induced enterocolitis syndrome occurred mainly in children receiving amoxicillin with clavulanic acid. It is a type of allergic reaction, the leading symptom of which is repeated vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
If any of these symptoms occur, contact a doctor immediately
for advice.
Very common (may occur more often than in 1 in 10 patients)

• diarrhea (in adults).

Common (may occur in less than 1 in 10 patients)

• thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds)
• nausea, especially when taking high doses; if they occur, take Hiconcil combi before meals
• vomiting
• diarrhea (in children).

Uncommon (may occur in less than 1 in 100 patients)

• skin rash, itching
• raised, itchy rash (hives)
• indigestion
• dizziness
• headache.

Uncommon side effects that may appear in blood test results:

• increased activity of certain substances (enzymes) produced in the liver.

Rare (may occur in less than 1 in 1000 patients)

• skin rash, which may be accompanied by blisters and look like small targets (dark spot in the center surrounded by a lighter border with a dark ring around the edge - erythema multiforme). If the patient notices any of these symptoms, they should contact a doctor urgently.

Rare side effects that may appear in blood test results:

• low number of blood cells involved in blood clotting
• low number of white blood cells.

Frequency not known: cannot be estimated from the available data

• allergic reactions (see above)
• colitis (see above)
• aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord)
• linear IgA dermatosis (skin rash with blisters arranged in a ring or like a string of pearls)
• severe skin reactions:
• widespread skin rash, which may be accompanied by blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form causing widespread peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
• widespread red skin rash, which may be accompanied by small pus-filled blisters (bullous exfoliative dermatitis)
• red scaly rash with thickening under the skin and blisters (acute generalized exanthematous pustulosis)
• flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results [including an increased number of white blood cells (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS).

If the patient experiences any of these symptoms, they should contact a doctor immediately.

• hepatitis
• jaundice, caused by an increase in bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and eyes
• interstitial nephritis
• prolonged blood clotting time
• restlessness
• seizures (in people taking high doses of Hiconcil combi or with kidney disease)
• black hairy tongue, which looks like a hairy tongue.

Side effects that may appear in blood or urine test results:

• significant decrease in the number of white blood cells
• low number of red blood cells (hemolytic anemia)
• crystals in the urine leading to acute kidney damage.

Reporting side effects

If side effects occur, including any not listed in this leaflet, they should be reported to a 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
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Hiconcil combi

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Soft blister and blister
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Hiconcil combi contains

• The active substances of the medicine are amoxicillin and clavulanic acid. Hiconcil combi, 500 mg + 125 mg, film-coated tablets Each film-coated tablet contains 500 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate). Hiconcil combi, 875 mg + 125 mg, film-coated tablets Each film-coated tablet contains 875 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).
• Other ingredients are: Tablet core - microcrystalline cellulose, sodium carboxymethyl cellulose type A, colloidal anhydrous silica, magnesium stearate. Coating - titanium dioxide (E 171), hypromellose (E 464), propylene glycol (E 1520), talc (E 553b), ethyl cellulose (E 462). See section 2 "Hiconcil combi contains sodium".

What Hiconcil combi looks like and contents of the pack

Hiconcil combi, 500 mg + 125 mg, film-coated tablets
White or almost white capsules-shaped tablets with "I 06" embossed on one side and smooth on the other, 19.40 ± 0.10 mm in length.
Hiconcil combi, 875 mg + 125 mg, film-coated tablets
White or almost white capsules-shaped tablets with "I 07" embossed on one side and smooth on the other, 21.70 ± 0.10 mm in length.
Cartons containing:

• 10, 12, 14, 16, 20, 21, 24, 30, 100, or 500 film-coated tablets in a soft blister,
• 10, 12, 14, 16, 20, 21, 24, 30, 100, or 500 film-coated tablets in a blister.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer/Importer

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
This medicine is authorized in the Member States of the European Economic Area under the following names:

For more information about this medicine, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: 22 57 37 500

Date of last revision of the leaflet: 24.03.2025

Medical education

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 phenomenon is that bacteria are resistant to the administered antibiotic.
This means that bacteria can survive or multiply despite the use of an antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the possibility 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 tips will help prevent the development of resistant bacteria that could hinder the action 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. Read the instructions in the patient information leaflet and if any of them are unclear, ask the doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic that 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. Do not pass on antibiotics prescribed for one patient to another person.
• 5. If there are any leftover antibiotics after completing the treatment as recommended by the doctor, return them to the pharmacy (which will accept them) for proper disposal.