Hiconcil combi

Package leaflet: information for the patient

Hiconcil combi, 500 mg + 125 mg, film-coated tablets
Hiconcil combi, 875 mg + 125 mg, film-coated tablets
Amoxicillinum + Acidum clavulanicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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 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 action may 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. Information before using Hiconcil combi

When not to use 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 problems or jaundice (yellowing of the skin) associated with taking an antibiotic.

If any of the above situations apply to the patient, Hiconcil combi must not be used.
If in doubt, consult the patient's doctor or pharmacist before starting treatment with Hiconcil combi.
Warnings and precautions
Before starting treatment with Hiconcil combi, discuss with the 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 to the patient, consult a doctor or pharmacist before starting Hiconcil combi.
In some cases, the doctor may test which type of bacteria caused the patient's infection.
Depending on the results, the patient may receive Hiconcil combi at a different dose or another medicine.
Side effects to be aware of
Treatment with Hiconcil combi may worsen the course of certain diseases or cause serious adverse reactions, including allergic reactions, seizures, and colitis. It is important to monitor whether the patient develops specific symptoms during treatment with Hiconcil combi to reduce the risk of complications. See "Side effects 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 and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
If the patient takes allopurinol (used for gout) at the same time as Hiconcil combi, skin allergic reactions may be more likely.
If the patient is taking probenecid (used for gout), the 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 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. Swallow the tablets whole with a glass of water.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to use Hiconcil combi

This medicine should always be used exactly as directed by the doctor or pharmacist. In case of doubt,
consult the doctor or pharmacist.
Adults and children with body weight of 40 kg or more
500 mg + 125 mg, film-coated tablets
The usual dose is:

• 1 tablet three times a day.

875 mg + 125 mg, film-coated tablets

• Usual dose – 1 tablet twice a day.
• Higher dose – 1 tablet three times a day.

Use in children
Children with body weight less than 40 kg
Children aged 6 years or younger should preferably be treated with a medicine containing amoxicillin and clavulanic acid in the form of an oral suspension.
500 mg + 125 mg, film-coated tablets
Consult the attending physician or pharmacist before using Hiconcil combi tablets in children with 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 the attending physician or pharmacist before using Hiconcil combi tablets in children with body weight below 40 kg. The tablets are not intended for children weighing less than 25 kg.
Patients with kidney or liver disease

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

How to take Hiconcil combi

• Swallow the tablets whole with a glass of water, at the beginning of a meal or just before a meal.
• Maintain regular intervals of at least 4 hours between doses taken 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, contact the doctor again.

Taking more Hiconcil combi than recommended
If the patient takes more Hiconcil combi than recommended, symptoms such as stomach irritation (nausea, vomiting, or diarrhoea) or seizures may occur. Contact the attending physician as quickly as possible. Keep the cardboard packaging or the medicine bottle available to show to 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, take it as soon as remembered. Do not take the next dose too soon; wait approximately 4 hours before taking the next dose.
Stopping Hiconcil combi treatment
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 a recurrence of the infection.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Symptoms that require attention
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 glands in the neck, underarm, or groin
• Swelling, sometimes involving the face or area around the mouth (angioedema), causing difficulty 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 immediate medical advice.
You must 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 you have 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 occurred mainly 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 your doctor as soon as possible for advice.
Very common (may occur in more than 1 in 10 patients)

• Diarrhoea (in adults)

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

• Fungal infections (candidiasis – yeast infections of the vagina, mouth or skin folds)
• Nausea, particularly when high doses are used; if this occurs, take Hiconcil combi before meals
• 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 reactions that may be revealed in blood tests:

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

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

• Skin rash, which may include blisters and resemble target-like lesions (dark spot in the centre surrounded by a lighter ring and a dark ring at the edge – erythema multiforme). If a patient notices any of these symptoms, they should contact a doctor urgently.

Rare adverse reactions that may appear in blood test results:

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

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, in which blisters and skin peeling may occur, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome) and a more severe form causing extensive skin peeling (over 30% of body surface – toxic epidermal necrolysis)
• Widespread red rash, in which small pustule-filled blisters may appear (pustular exanthema)
• Red, scaly rash with subcutaneous nodules and blisters (acute generalised exanthematous pustulosis)
• Influenza-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results [including increased number of 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, underarms and neck (symmetrical, intertriginous and flexural exanthema – SDRIFE)

If any of these symptoms occur, seek immediate medical advice.

• Blistering rash arranged in ring-like patterns with crusts in the central area or resembling a string of pearls (linear IgA dermatosis)
• Hepatitis (liver inflammation)
• Jaundice, caused by increased bilirubin levels (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• Tubulointerstitial nephritis (inflammation of kidney tubules)
• Prolonged blood clotting time
• Hyperkinesia (increased motor activity)
• Seizures (in patients receiving high doses of Hiconcil combi or with kidney disease)
• Black hairy tongue, which appears furry

Adverse reactions that may appear in blood or urine tests:

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this 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 specified month.
Soft blister and blister
Do not store above 25°C.
Store in the original packaging to protect from moisture.
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 packaging and other information

What Hiconcil combi contains

• The active substances are amoxicillin and clavulanic acid.
  Hiconcil combi 500 mg + 125 mg, coated tablets
  Each coated tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).
  Hiconcil combi 875 mg + 125 mg, coated tablets
  Each coated tablet contains 875 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).
• Other ingredients are:
  Tablet core – microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.
  Coating – titanium dioxide (E 171), hypromellose (E 464), propylene glycol (E 1520), talc (E 553b), ethylcellulose (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, coated tablets
White or almost white, capsule-shaped tablets with an embossing "I 06" on one side and smooth on the other side, 19.40 ± 0.10 mm in length.
Hiconcil combi 875 mg + 125 mg, coated tablets
White or almost white, capsule-shaped tablets with an embossing "I 07" on one side and smooth on the other side, 21.70 ± 0.10 mm in length.
Cartons containing:

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

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 in the European Economic Area member states 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
tel. +48 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 development of bacterial resistance.
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 that 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. Please 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 any antibiotic remains after completing the treatment as directed by your doctor, return the unused medicine to a pharmacy (which will accept it) for proper disposal.