Aucilak

Package leaflet: Information for the patient

Aucilak, 875 mg + 125 mg, film-coated tablets
Amoxicillinum + Acidum clavulanicum
Please read the entire leaflet carefully before using this medicine, as 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. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents:

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 with bactericidal activity against bacteria causing infections.
It contains two different substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group
of medicines known as "penicillins", whose activity may sometimes be inhibited (inactivated).
The role of the second component (clavulanic acid) is to prevent this inactivation.
Aucilak is used in adults, adolescents, 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 Aucilak

When not to use Aucilak

• 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 a severe allergic reaction to any other antibiotic. Symptoms may include skin rash or swelling of the face or throat.
• if the patient has ever experienced liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

If any of the above conditions apply, the patient must not take Aucilak. In case of
doubt, consult a doctor or pharmacist before starting treatment with Aucilak.
Warnings and precautions
Before starting treatment with Aucilak, consult a doctor or pharmacist if the patient:

• has infectious mononucleosis
• is being treated for liver or kidney disease
• urinates irregularly.

If in doubt whether any of the above conditions apply, consult a doctor or pharmacist before starting
treatment with Aucilak.
In some cases, the doctor may test which type of bacteria caused the infection. Depending on the
results, the patient may be prescribed a different medicine.
Conditions to be aware of
Taking Aucilak may worsen certain medical conditions or cause serious adverse effects. These
include allergic reactions, seizures, and inflammation of the large intestine. Be vigilant for specific
symptoms during treatment with Aucilak to reduce the risk of complications. See “Conditions to be
aware of” in section 4.
Blood and urine tests
If the patient is scheduled for blood tests (such as tests for red blood cell count or liver function) or
urine tests (to measure glucose levels), inform the doctor or nurse that the patient is taking Aucilak.
Aucilak may affect the results of these tests.
Aucilak and other medicines
Tell the 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 for gout) at the same time as Aucilak, skin allergic reactions
are more likely to occur.
Concomitant use of probenecid (used for gout) and amoxicillin (the active substance in Aucilak) may
reduce the elimination of amoxicillin and is not recommended.
If the patient is taking anticoagulant medicines (such as warfarin) together with Aucilak, additional
blood tests may be required.
Aucilak may reduce the elimination of methotrexate (a medicine used to treat cancer or rheumatic
diseases), potentially increasing adverse effects.
Aucilak may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of
transplanted organs).
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she might be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Aucilak may cause adverse effects and symptoms that may impair the ability to drive. Do not drive
or operate machinery unless the patient feels well.
Aucilak contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is
considered "sodium-free".

3. How to use Aucilak

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Adults, adolescents and children with body weight of 40 kg or more

• Usual dose – 1 tablet twice daily.
• Higher dose – 1 tablet three times daily.

Children with body weight less than 40 kg
Children aged 6 years or younger should preferably be treated with medicines in another pharmaceutical form (e.g. oral suspension or sachets).
Medical advice from a doctor or pharmacist should be sought before using Aucilak tablets in children with body weight less than 40 kg. Tablets are not intended for use in children with body weight less than 25 kg.
Patients with kidney or liver disease

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

How to take Aucilak

• Swallow the tablets whole with a glass of water during a meal. Tablets may be divided along the break line to facilitate swallowing. Both parts of the tablet should be taken at the same time.
• Maintain regular intervals of at least 4 hours between doses taken during the day. Do not take 2 doses within 1 hour.
• Do not take Aucilak for longer than 2 weeks. If the patient still does not feel well, contact the doctor again.

Taking more Aucilak than recommended
If the patient takes more Aucilak than recommended, symptoms may include stomach irritation (nausea, vomiting or diarrhoea) or seizures. Contact a doctor as quickly as possible. Keep the medicine packaging available to show to the doctor.
Missed dose of Aucilak
If the patient forgets to take a dose, take it as soon as remembered. Do not take the next dose too early; wait approximately 4 hours before taking the next dose. Do not take a double dose to make up for a missed dose.
Stopping Aucilak treatment
Continue taking Aucilak 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 recurrence of 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.
The adverse reactions listed below may occur during treatment with this medicine.
Symptoms to be aware of
Allergic reactions:

• skin rash
• vasculitis (inflammation of blood vessels), which may appear as red or purple raised spots on the skin, but may affect other parts of the body
• fever, joint pain, swelling of lymph nodes in the neck, under the arms or in the groin
• swelling, sometimes involving the face or throat (angioedema), causing difficulty in breathing
• collapse
• chest pain related to an allergic reaction, which may be a sign of an allergy leading to heart attack (Kounis syndrome).

If any of these symptoms occur, seek immediate medical advice.
Discontinue use of Aucilak immediately.
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):
DIES has been reported mainly in children receiving amoxicillin with clavulanic acid. This is a type of allergic reaction, the main symptom of which is repeated vomiting (1–4 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 adverse reactions (may occur in more than 1 in 10 patients):

• diarrhoea (in adults).

Common adverse reactions (may occur in up to 1 in 10 patients):

• fungal infections (candidiasis – yeast infections of the vagina, mouth or skin folds)
• nausea, especially when high doses are used. If nausea occurs, take Aucilak before meals.
• vomiting
• diarrhoea (in children).

Uncommon adverse reactions (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 adverse reactions (may occur in up to 1 in 1,000 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 their doctor urgently.

Rare adverse reactions that may appear in blood test results:

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

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

• allergic reactions (see above)
• colitis (see above)
• blistering rash arranged in a ring-like pattern with crusts in the central area or resembling 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, 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 with small pustules filled with pus (pustular exanthema)
  • red, scaly rash with subcutaneous nodules and blisters (pustular eruption)
  • flu-like symptoms with 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 any of these symptoms occur, seek immediate medical advice.
• hepatitis (liver inflammation)
• jaundice, caused by increased blood levels of bilirubin (a substance produced in the liver), which may cause 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 Aucilak or with kidney disease)
• black hairy tongue.

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

• marked decrease in white blood cells
• 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 Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Aucilak medicine

Keep the medicine out of sight and reach of children.
Before first opening:
No special storage instructions for the medicine.
After first opening of the sachet:
Do not use after 45 days. Store 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 stated month.
Medicines must 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 packaging and other information

What Aucilak contains

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

What Aucilak looks like and contents of the pack
White or almost white, capsule-shaped tablets of approximately 21.50 mm x 10.00 mm ± 0.20 mm,
coated, biconvex on both sides, with embossed markings “C” and “49” on either side of the
breakline on one side and smooth on the other.
The breakline on the tablet is only intended to facilitate breaking the tablet for easier swallowing.
Film-coated tablets are available in PVDC/PVC/Aluminium blister packs with a protective aluminium pouch,
packaged in a cardboard box.
Pack sizes: 7, 14 or 21 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Aucilak
Poland: Aucilak
Slovakia: Aucilak
Romania: Amoxicilină/Acid Clavulanic Gemax Pharma 875 mg/125 mg comprimate filmate

Medical advice/education
Antibiotics are used to treat infections caused by bacteria. They are ineffective in treating
infections caused by viruses.
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 used.
This means that bacteria can survive and even multiply despite antibiotic treatment.
Bacteria may become resistant to antibiotics for various reasons. Prudent use of antibiotics
can help reduce the risk of bacterial resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current
condition. Paying attention to the following advice will help prevent the emergence of resistant
bacteria, which could compromise the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the prescribed number of days. Read the instructions in this leaflet carefully and, if any are unclear, ask your doctor or pharmacist for clarification.
2. Do not take an antibiotic unless it has been specifically prescribed for you, and use it only to treat the infection for which it was prescribed.
3. Do not take antibiotics that have been prescribed for another person, even if they had a similar infection.
4. Do not give your prescribed antibiotics to other people.
5. If you have any leftover antibiotic after completing the prescribed course of treatment, return it to the pharmacy for proper disposal.