Hiconcil combi

Leaflet attached to the packaging: patient information

Hiconcil combi (400 mg + 57 mg)/5 ml, powder for oral suspension

Amoxicillin + Clavulanic acid

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.
• If you have any doubts, consult your 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.
• If the patient experiences any side effects, including any side effects 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/administer 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 may sometimes be inhibited
(inactivated). The second active ingredient (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/administer Hiconcil combi to a child

• 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, do not take/administer Hiconcil combi

Hiconcil combi.In case of doubt, before starting treatment with Hiconcil combi, consult your doctor or
pharmacist.

Warnings and precautions

Before starting treatment with Hiconcil combi, discuss it with your doctor or pharmacist if the patient:

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

In case of doubt whether the above circumstances apply to the patient, consult a doctor or pharmacist before starting treatment with 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 a different medicine.

Conditions to watch out for

Taking Hiconcil combi may worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures, and colitis. You should pay attention to whether the patient has certain symptoms during treatment with Hiconcil combi to minimize the risk of any problems. See "Conditions to watch out for" 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), inform the doctor or nurse that the patient is taking Hiconcil combi. Hiconcil combi may affect the results of these tests.

Hiconcil combi and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.
If the patient is taking allopurinol (used in gout) at the same time as Hiconcil combi, it is more likely that the patient will experience skin allergic reactions.
If the patient is taking probenecid (used in gout), the doctor may decide to modify the dose of Hiconcil combi.
If the patient is taking blood-thinning medicines (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.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 aspartame (E 951) and potassium

The medicine contains 2.5 mg of aspartame in each ml of suspension. 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 its improper excretion.
15.8 ml of suspension contains 1 mmol (39 mg) of potassium, which should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake.

3. How to take/administer Hiconcil combi

This medicine should always be taken/administered according to the doctor's or pharmacist's instructions. In case of doubt, consult a doctor or pharmacist.

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

This suspension is not usually recommended for adults and children with a body weight of 40 kg or more. Consult a doctor or pharmacist for advice.

Children with a body weight of less than 40 kg

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

• The doctor will recommend the dose of Hiconcil combi to be given to the child.
• The usual recommended dose is from 25 mg + 3.6 mg to 45 mg + 6.4 mg per kilogram of body weight per day, given in two divided doses.
• A higher dose - up to 70 mg + 10 mg per kilogram of body weight per day, given in two divided doses.

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 or a different medicine.
• If the patient has liver disease, they may need to have blood tests more often to check how their liver is functioning.

How to take/administer Hiconcil combi

• Before administering each dose, always shake the bottle well.
• The medicine should be given at the beginning of a meal.
• Equal intervals of at least 4 hours should be maintained between doses given 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.

Instructions for preparing Hiconcil combi (400 mg + 57 mg)/5 ml for use

• Before use, check if the cap seal has been broken. Shake the bottle with the medicine to loosen the powder.
• Fill the bottle with water (as described below). Close the bottle and shake it well.

• Another way to prepare the suspension: shake the bottle with the medicine to loosen the powder, then fill the bottle with water below the line marked on the bottle.
• Close the bottle and shake it.
• Add water exactly to the level of the line.
• Shake well again.

Before each use, shake the bottle with the medicine energetically.

Overdose of Hiconcil combi

If the patient has taken a larger dose of Hiconcil combi than recommended, they may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures. Contact a doctor as soon as possible. Have the carton or bottle of medicine with you 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. Do not take the next dose too early, 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 needed to fight the infection. If some bacteria survive, they may cause the infection to recur.
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 watch out for

Hypersensitivity 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 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 the patient has 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, whose leading symptom 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 as soon as possible for advice.
Very common (may occur more often than in 1 in 10 patients)

• diarrhea (in adults).

Common (may occur no more often than in 1 in 10 patients)

• thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds)
• nausea, especially when taking high doses.

Hiconcil combi should be taken before meals if the patient experiences:

• vomiting
• diarrhea (in children).

Uncommon (may occur no more often than in 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 no more often than in 1 in 1000 patients)

• skin rash, which may be accompanied by blisters and look like small targets (a 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

• hypersensitivity reactions (see above)
• colitis (see above)
• aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord)
• skin rash with blisters arranged in a ring or like a string of pearls (linear IgA dermatosis)
• severe skin reactions:
• widespread skin rash with blisters and peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form causing widespread skin peeling (more than 30% of the body surface - toxic epidermal necrolysis)
• widespread red skin rash with small pus-filled blisters (pustular exfoliative dermatitis)
• red scaly rash with thickening under the skin and blisters (acute generalized exanthematous pustulosis)
• flu-like symptoms with rash, fever, lymph node enlargement, 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).

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 can 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
• tooth discoloration (in children), which can usually be removed by brushing.

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 side effects not listed in this leaflet, the patient should tell 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
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 gather more information on the safety of this medicine.

5. How to store Hiconcil combi

Keep the medicine 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.
Powder for oral suspension:
Store in a temperature below 25°C.
Store in the original packaging to protect from moisture.
Reconstituted suspension:
Store in the refrigerator (2°C - 8°C).
Shelf life of the reconstituted suspension (medicine after adding water): 7 days.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 (in the form of amoxicillin trihydrate) and clavulanic acid (in the form of potassium clavulanate). 5 ml of the reconstituted suspension contains 400 mg of amoxicillin (in the form of amoxicillin trihydrate) and 57 mg of clavulanic acid (in the form of potassium clavulanate). 1 ml of the reconstituted oral suspension contains 80 mg of amoxicillin (in the form of amoxicillin trihydrate) and 11.4 mg of clavulanic acid (in the form of potassium clavulanate).
• The other ingredients are: silicon dioxide, colloidal anhydrous silica, aspartame (E 951), succinic acid, xanthan gum, hypromellose 5 mPaS, raspberry flavor (Rasberry DC 107), orange flavor (Orange DC 100 BB), and caramel flavor (Golden Carmel 501118 AP0551). See section 2 "Hiconcil combi contains aspartame (E 951) and potassium".

What Hiconcil combi looks like and what the pack contains

White to almost white powder, which after dissolution in water gives a white to almost white suspension with a fragrant, fruity smell.
HDPE bottle with a level indicator for reconstitution, a PP child-resistant cap ("CRC cap"), and a dosing syringe made of polystyrene with a scale from 0.5 ml to 5 ml, every 0.5 ml, in a carton containing: 6 g, 12 g, 14 g, or 20 g of powder for preparation, respectively, 30 ml, 60 ml, 70 ml, or 100 ml of oral suspension.
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: 21.06.2024

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 effectiveness of the antibiotic.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the correct 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 any antibiotic remains after completing the treatment as recommended by the doctor, return it to the pharmacy (which will accept it) for proper disposal.