Hiconcil combi

Package leaflet: Information for the patient

Hiconcil combi (400 mg + 57 mg)/5 ml, powder for oral suspension
Amoxicillinum + Acidum clavulanicum
Please read this leaflet carefully before taking this medicine, because 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 pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Hiconcil combi is and what it is 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 pack and other information

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

Hiconcil combi is an antibiotic with bactericidal activity against bacteria causing infections.
Hiconcil combi contains two different components: amoxicillin and clavulanic acid. Amoxicillin
belongs to a group of medicines called "penicillins," whose activity may sometimes be inhibited
(inactivated). The second active component (clavulanic acid) counteracts this inactivation.
Hiconcil combi is used in adults and children for the treatment of 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 using Hiconcil combi

When not to take/give the child 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 experienced severe allergic reactions (hypersensitivity) to any other antibiotic. These 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 any of the above conditions apply to the patient, do not take/give the child Hiconcil combi.
In case of doubt, consult your doctor or pharmacist before starting treatment with Hiconcil combi.
Warnings and precautions
Before starting treatment with Hiconcil combi, discuss with your doctor or pharmacist if the patient:

• has infectious mononucleosis,
• is being treated for liver or kidney disease,
• passes urine irregularly.

If in doubt whether any of the above conditions apply, consult your doctor or pharmacist before starting Hiconcil combi.
In some cases, the doctor may investigate which type of bacteria caused the infection. Depending on the results, the patient may receive Hiconcil combi at a different dose or another medicine.

Conditions to be aware of
Treatment with Hiconcil combi may worsen the course of certain diseases or cause serious adverse effects, including allergic reactions, seizures, and colitis. Be vigilant for specific symptoms during treatment with Hiconcil combi to reduce the risk of complications. See "Conditions to be aware of" in section 4.

Blood and urine tests
If the patient is due to have blood tests (such as red blood cell count 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 with other medicines
Tell your 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 the patient is taking allopurinol (used in gout) at the same time as Hiconcil combi, skin allergic reactions may be more likely.
If the patient is taking probenecid (used in gout), the prescribing doctor may decide to adjust the dose of Hiconcil combi.
If the patient is taking anticoagulant 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 in the treatment of 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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Hiconcil combi may cause adverse effects and symptoms that may impair the ability to drive.
Do not drive or operate machinery unless the patient feels well.

Hiconcil combi contains aspartame (E 951) and potassium
The medicine contains 2.5 mg of aspartame per 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 improper excretion.
15.8 ml of suspension contains 1 mmol (39 mg) of potassium, which should be taken into account in patients with impaired kidney function and in patients controlling potassium intake in their diet.

3. How to take/administer Hiconcil combi

This medicine should always be taken/administered according to the instructions given by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults and children weighing 40 kg or more
This suspension is not usually recommended for use in adults and children weighing 40 kg or more. Please consult your doctor or pharmacist for advice.

Children weighing less than 40 kg
All doses are determined based on the child's body weight.

• Your doctor will prescribe the dose of Hiconcil combi to be given to the child.
• The usual recommended dose – from 25 mg + 3.6 mg to 45 mg + 6.4 mg per kilogram of body weight per day, administered in two divided doses.
• Higher dose – up to 70 mg + 10 mg per kilogram of body weight per day, administered in two divided doses.

Patients with kidney or liver disease

• If the patient has kidney disease, the dose of the medicine may be adjusted. The doctor may prescribe a different dose or an alternative medicine.
• If the patient has liver disease, blood tests may be performed more frequently to monitor liver function.

How to take/administer Hiconcil combi

• Always shake the bottle well before administering each dose.
• The medicine should be taken at the beginning of a meal.
• Maintain regular intervals of at least 4 hours between doses administered during the day. Do not take two doses within one hour.
• Do not take Hiconcil combi for longer than 2 weeks. If the patient still does not feel better, they should contact their doctor again.

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

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

• Another method of preparing the suspension: shake the bottle with the medicine to loosen the powder, then fill the bottle with water below the mark indicated on the bottle.
• Close the bottle and shake.
• Add water exactly up to the level of the mark.
• Shake thoroughly again.

Before each use, shake the bottle vigorously.
Use of a higher than recommended dose of Hiconcil combi
If a patient has taken a higher dose of Hiconcil combi than recommended, symptoms such as stomach irritation (nausea, vomiting, or diarrhoea) or seizures may occur. Contact the treating physician as quickly as possible. Keep the cardboard packaging or the medicine bottle available to show to the doctor.
Missed dose of Hiconcil combi
Do not take a double dose to make up for a missed dose. If a patient forgets to take a dose, take it as soon as remembered. Do not take the next dose too soon; wait approximately 4 hours before taking the next dose.
Discontinuation of Hiconcil combi
Continue taking Hiconcil combi for the full duration of treatment, even if the patient feels better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to recur.
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Symptoms to be aware of

Hypersensitivity reactions:

• Skin rash
• Vasculitis (inflammation of blood vessels), which may appear as red or purple raised spots on the skin, but may affect other organs
• Fever, joint pain, swelling of glands in the neck, under the arm or in the groin
• Swelling, sometimes affecting the face or area around the mouth (angioedema), causing difficulty in breathing
• Fainting
• Chest pain related to an allergic reaction, which may indicate an allergy leading to heart attack (Kounis syndrome)

If any of these symptoms occur, seek medical advice immediately.
Stop taking Hiconcil combi.

Colitis (inflammation of the large intestine)
Colitis causing watery diarrhoea, usually with blood and mucus, abdominal pain and/or fever.

Acute pancreatitis
If the patient has severe and persistent pain in the stomach area, this may be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis has mainly occurred in children receiving amoxicillin with clavulanic acid. This is a type of allergic reaction, the main symptom of which is recurrent vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.

If any of these symptoms occur, contact the doctor immediately for advice.

Frequent (may occur in up to 1 in 10 patients)

• Oral, vaginal or skin fungal infections (candidiasis)
• Nausea, particularly when high doses are used

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

• Vomiting
• Diarrhoea (in children)

Uncommon (may occur in up to 1 in 100 patients)

• Skin rash, itching
• Raised, itchy rash (urticaria)
• Indigestion
• Dizziness
• Headache

Uncommon adverse effects that may be revealed in blood test results:

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

Rare (may occur in up to 1 in 1000 patients)

• Skin rash, possibly with blisters and appearing as target-like lesions (dark spot in the centre surrounded by a lighter ring and a dark ring around the edge – erythema multiforme). If the patient notices any of these symptoms, they should contact a doctor urgently.

Rare adverse effects that may appear in blood test results:

• Low number of cells involved in blood clotting (thrombocytopenia)
• Low number of white blood cells (leukopenia)

Frequency not known: cannot be estimated from available data

• Hypersensitivity reactions (see above)
• Colitis (see above)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Severe skin reactions:
  • Widespread skin rash, with blisters and skin peeling, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome) and a more severe form causing extensive skin detachment (over 30% of body surface – toxic epidermal necrolysis)
  • Widespread red rash with small pus-filled blisters (pustular exanthema)
  • Red, scaly rash with subcutaneous nodules and blisters (acute generalised exanthematous pustulosis)
  • 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)
  • Red rash usually observed on both buttocks, inner upper thighs, under the arms and on the neck (symmetrical, intertriginous and flexural exanthema caused by a medicine (SDRIFE))

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

• Blistering rash arranged in a ring-like pattern with crusts in the central area or resembling a string of pearls (linear IgA dermatosis)
• Hepatitis (inflammation of the liver)
• Jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may result in yellowing of the skin and whites of the eyes
• Inflammation of the kidney tubules
• Prolonged blood clotting time
• Restlessness
• Seizures (in patients receiving high doses of Hiconcil combi or with kidney disease)
• Black, hairy-looking tongue
• Discolouration of teeth (in children), which can usually be removed by brushing

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

• Marked decrease in the number of white blood cells
• Low number of red blood cells (haemolytic anaemia)
• Crystals in the urine leading to acute kidney injury

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Hiconcil combi

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after EXP. The expiry date refers to the last day of the stated month.
Powder for oral suspension:
Store below 25 °C.
Keep in the original packaging to protect from moisture.
Reconstituted suspension:
Store in a refrigerator (2 °C - 8 °C).
The shelf life of the prepared suspension (medicine after adding water) is 7 days.
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 pack and other information

What Hiconcil combi contains

• The active substances are amoxicillin (in the form of amoxicillin trihydrate) and clavulanic acid (in the form of potassium clavulanate). 5 ml of reconstituted suspension contains 400 mg of amoxicillin (as amoxicillin trihydrate) and 57 mg of clavulanic acid (as potassium clavulanate). 1 ml of reconstituted oral suspension contains 80 mg of amoxicillin (as amoxicillin trihydrate) and 11.4 mg of clavulanic acid (as potassium clavulanate).
• Other ingredients are: silicon dioxide, anhydrous colloidal silicon dioxide, aspartame (E 951), succinic acid, xanthan gum, hypromellose 5 mPaS, raspberry flavour (Rasberry DC 107), orange flavour (Orange DC 100 BB), and caramel flavour (Golden Carmel 501118 AP0551). See section 2 "Hiconcil combi contains aspartame (E 951) and potassium".

What Hiconcil combi looks like and contents of the pack
A white to almost white powder, which when reconstituted with water forms a white to almost white suspension with an aromatic, fruity odour.
HDPE bottle with a reconstitution level mark, PP child-resistant closure („CRC cap”), and a polystyrene dosing syringe graduated from 0.5 ml to 5 ml in 0.5 ml increments, in a cardboard box containing: 6 g, 12 g, 14 g or 20 g of powder for oral suspension, yielding 30 ml, 60 ml, 70 ml or 100 ml of oral suspension, respectively.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised for sale in the European Economic Area
under the following names:

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

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 the antibiotic.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics
can help reduce the likelihood of bacterial resistance developing.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness.
Paying attention to the following advice will help prevent the development of resistant bacteria,
which 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 full prescribed duration. Read the instructions provided in the package leaflet, and if any of them are unclear, ask your doctor or pharmacist for clarification.
2. The patient should not take an antibiotic unless it has been specifically prescribed for them. It should be taken only to treat the infection for which it was prescribed.
3. The patient should not take an antibiotic prescribed for another person, even if that person had a similar infection.
4. Do not give antibiotics prescribed for you to other people.
5. If there are any leftover antibiotic tablets remaining after completing the prescribed treatment, return them to a pharmacy (which will accept them) for proper disposal.