Hiconcil

Package Leaflet: Information for the Patient

Hiconcil, 250 mg/5 ml, Powder for Oral Suspension

Amoxicillin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 Package and Other Information

1. What is Hiconcil and What is it Used For

What is Hiconcil

Hiconcil is an antibiotic. The active substance 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 medications, to treat stomach ulcers.

2. Important Information Before Taking Hiconcil

When Not to Take Hiconcil

• if you are allergic to amoxicillin, penicillin, or any of the other ingredients of this medicine (listed in section 6),
• if you have 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 any of the above applies to you, do not take Hiconcil. If you are unsure, consult a doctor or pharmacist before taking Hiconcil.

Warnings and Precautions

Before taking Hiconcil, discuss with your doctor or pharmacist if you:

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

If you are unsure whether any of the above applies to you, consult a doctor or pharmacist before taking Hiconcil.

Blood and Urine Tests

If you are going to have:

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

Hiconcil and Other Medications

Tell your doctor or pharmacist about all the medications you are taking, have recently taken, or plan to take.

• If you are taking allopurinol (for gout), it is more likely that you will experience skin allergic reactions.
• If you are taking probenecid (for gout), taking probenecid at the same time may reduce the excretion of amoxicillin and is not recommended.
• If you are taking blood-thinning medications (such as warfarin), you may need to have additional blood tests.
• If you are taking other antibiotics (such as tetracycline), Hiconcil may be less effective.
• If you are taking methotrexate (for cancer or severe psoriasis), penicillins may reduce the excretion of methotrexate, leading to increased risk of side effects.

Hiconcil with Food and Drink

The medication can be taken with or without food.

Pregnancy and Breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medication.

Driving and Operating Machinery

Hiconcil may cause side effects that can affect your ability to drive or operate machinery. Do not drive or operate machinery unless you feel well.

Hiconcil Contains Aspartame (E 951), Sodium Benzoate (E 211), Sorbitol (E 420), and Sodium

5 ml of the prepared suspension (one measuring spoon) contains 8.5 mg of aspartame, 7.1 mg of sodium benzoate, and approximately 0.15 mg of sorbitol. 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. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of life). This product contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to Take Hiconcil

Take this medication exactly as your doctor has told you. If you are unsure, consult a doctor or pharmacist.

• Always shake the bottle well before each dose.
• Keep equal intervals of at least 4 hours between doses taken during the day.
• Hiconcil can be taken with or without food.

Usual Dose

Children Weighing Less Than 40 kg

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

• Your doctor will advise you on the dose of Hiconcil to give to your child.
• The usual dose is 20 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 Weighing 40 kg or More

The suspension is not usually recommended for adults and children weighing more than 40 kg. Consult a doctor or pharmacist for advice.

Kidney Disease

If you have kidney disease, your dose of Hiconcil may be lower than usual. Preparation of the Suspension To prepare 100 ml of the suspension (250 mg/5 ml), always use boiled and cooled water. Turn the bottle upside down and gently shake it to distribute the powder. To prepare the suspension, fill the bottle with water to about half the height marked on the bottle. Close the bottle and shake it immediately until the powder is fully mixed. Wait for a moment and, after the foam has settled, slowly fill the bottle with water to the marked line and shake it vigorously again. Shake the bottle vigorously before each use of the suspension.

Overdose of Hiconcil

If you have taken more Hiconcil than you should, you may experience symptoms such as stomach and intestinal upset (nausea, vomiting, or diarrhea) or crystals in the urine, which may be seen as cloudy urine or problems urinating. In patients with kidney problems or those taking large doses, seizures may occur. Contact a doctor as soon as possible. Take the package leaflet with you to show the doctor.

Missed Dose of Hiconcil

• If you forget to take a dose, take it as soon as you remember.
• Do not take the next dose too early; wait about 4 hours before taking the next dose.
• Do not take a double dose to make up for a missed dose.

How Long to Take Hiconcil

• Continue taking Hiconcil for as long as your doctor has told you, even if you feel better. All doses of the medication are needed to fight the infection. If some bacteria survive, they may cause a relapse of the infection.
• If, after completing the treatment with Hiconcil, you still do not feel better, consult a doctor.

In case of prolonged use of Hiconcil, thrush (candidiasis - fungal infections of the mucous membranes causing local pain, itching, and white discharge) may occur. In such a case, consult a doctor. If you are taking Hiconcil for a long time, your doctor may order additional tests of kidney, liver, and blood function. If you have any further doubts about the use of this medication, consult a doctor or pharmacist.

4. Possible Side Effects

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

If You Experience Any of the Following Serious Side Effects, Stop Taking Hiconcil and Contact a Doctor Immediately - You 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, or body, or difficulty breathing; these symptoms can be severe, and in rare cases, may be life-threatening;
• rash or pinpoint, flat, red, round spots under the skin or bruising of the skin, which may be a sign of an allergic reaction affecting the blood vessels; 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;
• a skin reaction called erythema multiforme characterized by itchy, red-purple patches on the skin, especially on the hands or soles of the feet, swelling of the skin (resembling hives), irritation around the mouth, eyes, or genitals; fever and a feeling of tiredness may also occur;
• other severe skin reactions include: changes in skin color, lumps under the skin, blisters, ulcers, peeling of the skin, redness, pain, itching, and flaking of the skin; these may be associated with fever, headache, and body aches;
• flu-like symptoms with a 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 a tendency to bruise. These may be signs of blood cell problems;
• Jarisch-Herxheimer reaction; when taking Hiconcil for the treatment of Lyme disease (borreliosis), fever, chills, muscle and headache, and skin rash may occur;
• inflammation of the colon, causing diarrhea (sometimes with blood), abdominal pain, and fever;
• severe liver side effects; these usually occur in patients treated for a long period, men, and the elderly. Inform your doctor immediately if you experience:
• severe diarrhea with blood,
• blisters, redness, or bruising of the skin,
• dark urine or pale stools,
• yellowing of the skin and whites of the eyes (jaundice). 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)
• drug-induced intestinal inflammation (DIES) occurred mainly in children receiving amoxicillin. It is a type of allergic reaction, the leading symptom of which is repeated vomiting (1-4 hours after taking the medication). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure

These symptoms may occur during or up to several weeks after stopping the medication.

If You Experience Any of the Above Symptoms, Stop Taking the Medication and Contact a 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 You Experience Any of These Symptoms, Contact a Doctor and Stop Taking Hiconcil.

Other Possible Side Effects

Common Side Effects(may occur in up to 1 in 10 patients):

• skin rash
• nausea
• diarrhea

Uncommon Side Effects(may occur in up to 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); your doctor or pharmacist will advise on the treatment
• kidney problems
• seizures, especially in patients taking large doses or having kidney problems
• dizziness
• hyperactivity
• tooth discoloration (in children), which can usually be removed by brushing
• yellow, brown, or black, hairy tongue
• excessive breakdown of red blood cells, which can lead to anemia (symptoms include fatigue, headache, 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
• rash with blisters arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

Reporting Side Effects If you experience any side effects, including those not listed in this package leaflet, inform your 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, you can help provide more information on the safety of this medication.

5. How to Store Hiconcil

Keep the medication out of sight and reach of children. Powder for Oral SuspensionStore in a temperature below 25°C. Prepared SuspensionStore in the refrigerator (2°C-8°C) for 14 days. Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Hiconcil Contains

• The active substance is amoxicillin. 5 ml of the prepared suspension contains 287 mg of amoxicillin trihydrate, equivalent to 250 mg of amoxicillin.
• The other ingredients are: lemon flavor powder (sorbitol), peach-apricot flavor powder (sorbitol), citric acid, sodium benzoate, aspartame, talc, anhydrous sodium citrate, orange flavor powder, guar gum, colloidal silica, and silicon dioxide. See section 2 "Hiconcil contains aspartame (E 951), sodium benzoate (E 211), sorbitol (E 420), and sodium".

What Hiconcil Looks Like and What the Package Contains

White to light yellow powder. Orange glass bottle containing powder for the preparation of 100 ml of suspension, closed with a PP/PE cap with a child-resistant closure and a tamper-evident seal, in a cardboard box. A plastic measuring spoon is included with the package.

Marketing Authorization Holder and Manufacturer

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

Date of Last Revision of the Package Leaflet:

General Advice on the Use of Antibiotics

Antibiotics are used to treat bacterial infections. They are ineffective against 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 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 render the antibiotic ineffective.

• 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 package leaflet and, if any of them are unclear, ask your doctor or pharmacist to explain.
• 2. You should not take an antibiotic if it was not prescribed specifically for you. You should only take it to treat the infection for which the antibiotic was prescribed.
• 3. You should not take an antibiotic prescribed for someone else, even if they had a similar infection.
• 4. Do not give your antibiotics to other people.
• 5. If, after completing the treatment as advised by your doctor, you have any leftover antibiotic, return it to the pharmacy for proper disposal.