Aucilak

Package Leaflet: Information for the Patient

Aucilak, 875 mg + 125 mg, Film-Coated Tablets

Amoxicillin + Clavulanic Acid

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What Aucilak is and what it is used for

Aucilak is an antibiotic that works by killing bacteria that cause infections.
It contains two different substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins”, which are sometimes inactivated (made ineffective) by bacteria. The other ingredient (clavulanic acid) stops this inactivation from happening.
Aucilak is used in adults, adolescents, 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 Aucilak

When not to take Aucilak

• if you are allergic to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had a severe allergic reaction to any other antibiotic.
• if you have ever had liver or kidney problems.

If any of these apply to you, do not take Aucilak.If you are not sure, consult your doctor or pharmacist before taking Aucilak.

Warnings and precautions

Before taking Aucilak, tell your doctor or pharmacist if:

• you have infectious mononucleosis
• you are being treated for liver or kidney disease
• you have irregular urine output.

If you are not sure if any of these apply to you, consult your doctor or pharmacist before taking Aucilak.
In some cases, your doctor may need to check the type of bacteria causing your infection.
Depending on the results, you may be given a different medicine.

Conditions to watch for

Taking Aucilak can make some conditions worse or cause severe side effects. These include allergic reactions, seizures, and colitis. You should be aware of certain symptoms to reduce the risk of any problems. See “Conditions to watch for”in section 4.

Blood and urine tests

If you are going to have blood tests (such as a red blood cell count or liver function tests) or urine tests (to check glucose levels), tell your doctor or nurse that you are taking Aucilak. Aucilak may affect the results of these tests.

Aucilak and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
If you are taking allopurinol (for gout), it may be more likely that you will experience skin allergic reactions.
Taking probenecid (for gout) and amoxicillin (the active substance in Aucilak) at the same time may reduce the excretion of amoxicillin and is not recommended.
If you are taking blood-thinning medicines (such as warfarin), you may need to have extra blood tests.
Aucilak may reduce the excretion of methotrexate (used to treat cancer or rheumatoid arthritis), potentially increasing side effects.
Aucilak may affect the action of mycophenolate mofetil (used to prevent organ rejection).

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Aucilak may cause side effects that could affect your ability to drive or use machines. Do not drive or use machines unless you feel well.

Aucilak contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Aucilak

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults, adolescents, and children over 40 kg

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

Children under 40 kg

Children under 6 years should be treated with other pharmaceutical forms of Aucilak (e.g., oral suspension or sachets).
Consult your doctor or pharmacist before giving Aucilak tablets to children under 40 kg. The tablets are not suitable for children under 25 kg.

Patients with kidney and liver disease

• If you have kidney disease, your doctor may need to adjust your dose.
• If you have liver disease, you may need to have more frequent blood tests to check how your liver is working.

How to take Aucilak

• Swallow the tablets whole with a glass of water during meals. The tablets can be broken in half to make them easier to swallow. Take both halves at the same time.
• Keep at least 4-hour intervals between doses during the day. Do not take 2 doses within 1 hour of each other.
• Do not take Aucilak for more than 2 weeks. If you still do not feel better, consult your doctor again.

Overdose of Aucilak

If you take more Aucilak than you should, you may experience stomach upset (nausea, vomiting, or diarrhea) or seizures. Contact your doctor as soon as possible. Bring the package leaflet with you to show the doctor.

Missing a dose of Aucilak

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 forgotten dose.

Stopping Aucilak

Keep taking Aucilak until you finish the treatment, even if you feel better. All doses are needed to kill the bacteria causing the infection. If some bacteria survive, they may cause the infection to come back.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aucilak can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with Aucilak.

Symptoms to watch for

Allergic reactions:

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

If you experience any of these symptoms, contact your doctor immediately.

Stop taking Aucilak.

Colitis:

Colitis, which can cause 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)

DIES has been reported mainly in children taking amoxicillin with clavulanic acid. It is a type of allergic reaction, with recurring vomiting (1-4 hours after taking the medicine) as the leading symptom. Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
If you experience any of these symptoms, contact your doctor as soon as possiblefor advice.
Very common side effects(may affect more than 1 in 10 people):

• diarrhea (in adults).

Common side effects(may affect up to 1 in 10 people):

• thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds)
• nausea, especially when taking high doses. If this happens, take Aucilak before meals.
• vomiting
• diarrhea (in children).

Uncommon side effects(may affect up to 1 in 100 people):

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

Uncommon side effects that may appear in blood test results:

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

Rare side effects(may affect up to 1 in 1,000 people):

• skin rash, which may blister and look like targets (dark spot in the center, surrounded by a lighter ring with a dark ring on the edge - erythema multiforme). If you notice any of these symptoms, contact your doctor immediately.

Rare side effects that may appear in blood test results:

• low platelet count
• low white blood cell count.

Frequency not known(frequency cannot be estimated from available data):

• allergic reactions (see above)
• colitis (see above)
• skin rash with blisters 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)
• severe skin reactions:
• widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing widespread skin peeling (more than 30% of body surface - toxic epidermal necrolysis)
• widespread, red, skin rash with small pus-filled blisters (pustular psoriasis)
• red, scaly rash with bumps under the skin and blisters (exfoliative dermatitis)
• 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)).

If you experience any of these symptoms, contact your doctor immediately.

• hepatitis
• jaundice, caused by increased bilirubin levels in the blood (a substance produced in the liver), which can cause yellowing of the skin and whites of the eyes
• inflammation of the renal tubules
• prolonged blood clotting
• restlessness
• seizures (in people taking high doses of Aucilak or with kidney disease)
• black hairy tongue, which looks like it is covered in hair.

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

• significantly reduced white blood cell count
• low red blood cell count (hemolytic anemia)
• crystals in the urine leading to acute kidney damage.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Aucilak

Keep the medicine out of the sight and reach of children.
Before first opening:
No special storage precautions are required.
After first opening the pouch:
Do not use after 45 days. Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aucilak contains

• The active substances are amoxicillin and clavulanic acid. Each film-coated tablet contains 875 mg amoxicillin as amoxicillin trihydrate and 125 mg clavulanic acid as potassium clavulanate.
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, and magnesium stearate. Tablet coating: hypromellose 2910, titanium dioxide (E 171), ethylcellulose, and triacetin.

What Aucilak looks like and contents of the pack

White or almost white, capsule-shaped, approximately 21.50 mm x 10.00 mm ± 0.20 mm, film-coated, biconvex tablets, with “C” and “49” embossed on one side and a score line on the other side.
The score line is only to facilitate breaking the tablet to make it easier to swallow.
The film-coated tablets are available in blisters of PVDC/PVC/Aluminum in an aluminum protective pouch, in a cardboard box.
Pack sizes: 7, 14, or 21 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer/Importer:

Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Aucilak
Poland:
Aucilak
Slovakia:
Aucilak
Romania:
Amoxicillin/Acid Clavulanic Gemax Pharma 875 mg/125 mg film-coated tablets

Date of last revision of the package leaflet: 05/2025

Medical advice/education

Antibiotics are used to treat infections caused by bacteria. 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 causing the infection are resistant to the antibiotic. This means that the bacteria can survive and even multiply despite the use of antibiotics.
Bacteria can become resistant to antibiotics for many reasons. The careful use of antibiotics can help reduce the risk of bacterial resistance.
The antibiotic prescribed by your doctor is intended only to treat 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 correct time, and for the correct number of days. Read the instructions in the package leaflet and ask your doctor or pharmacist to explain anything you do not understand.
• 2. Do not take an antibiotic unless it has been prescribed specifically for you, and only use it to treat the infection for which it was prescribed.

• 3. Do not take antibiotics that have been prescribed for someone else, even if they had a similar infection.
• 4. Do not give your prescribed antibiotics to anyone else.
• 5. If you have any leftover antibiotic after completing your treatment as directed by your doctor, return it to the pharmacy for proper disposal.