Auglavin pph

Package leaflet: Information for the patient

Auglavin PPH, 500 mg + 125 mg, film-coated tablets
Amoxicillinum + Acidum clavulanicum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed only for you (or your child). Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Auglavin PPH is and what it is used for

Auglavin PPH is an antibiotic with bactericidal activity against bacteria causing infections.
It contains two different active substances: 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. Auglavin PPH 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 Auglavin PPH

When not to use Auglavin PPH

• 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 to any other antibiotic. These may include skin rash or swelling of the face or throat.
• 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 situations apply, the patient should not take Auglavin PPH.
If in doubt, consult the patient's doctor or pharmacist before starting treatment with Auglavin PPH.

Warnings and precautions
Before starting treatment with Auglavin PPH, discuss with the patient's 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 situations apply, consult the patient's doctor or pharmacist before starting Auglavin PPH.
In some cases, the doctor may test which type of bacteria caused the patient's infection. Depending on the results, the patient may receive Auglavin PPH at a different dose or a different medicine.

Conditions to be aware of
Treatment with a medicine containing amoxicillin and clavulanic acid may worsen certain diseases or cause serious adverse effects, including allergic reactions, seizures, and colitis. It is important to monitor whether the patient develops specific symptoms during treatment with a medicine containing amoxicillin and clavulanic acid 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 Auglavin PPH. Medicines containing amoxicillin and clavulanic acid may affect the results of these tests.

Auglavin PPH and other medicines
Tell the patient's doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

If the patient is taking allopurinol (used to treat gout), the risk of developing skin allergic reactions may be increased when taken together with Auglavin PPH.

If the patient is taking probenecid (used to treat gout), concomitant use may reduce the elimination of amoxicillin and is not recommended.

If the patient is taking anticoagulant medicines (such as warfarin) together with Auglavin PPH, additional blood tests may be necessary.

If the patient is taking methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce methotrexate elimination, increasing the risk of adverse effects.

Auglavin PPH may affect the action of mycophenolate mofetil (a medicine used to prevent transplant rejection).

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
Auglavin PPH may cause adverse effects and symptoms that may impair the ability to drive.
Do not drive or operate machinery unless the patient feels well.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Auglavin PPH

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

• The usual dose is: 1 tablet three times a day.

Children with body weight less than 40 kg
Children aged 6 years or younger should preferably be treated with a medicine containing amoxicillin with clavulanic acid in the form of an oral suspension.
Consult your doctor or pharmacist before using Auglavin PPH tablets in children with body weight below 40 kg. Auglavin PPH 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 problems, the dose of the medicine may need to be adjusted. Your doctor may prescribe a different dose of Auglavin PPH or another medicine.
• If the patient has liver problems, blood tests may be performed more frequently to monitor liver function.

How to take Auglavin PPH

• Swallow the tablets whole with a glass of water, at the beginning of a meal or just before a meal. The 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 Auglavin PPH for longer than 2 weeks. If the patient still does not feel better, they should contact their doctor again.

Taking more Auglavin PPH than recommended
If the patient takes more Auglavin PPH than recommended, symptoms such as stomach irritation (nausea, vomiting, or diarrhoea) or seizures may occur. Contact your doctor as quickly as possible. Take the medicine packaging with you to show the doctor.
If you forget to take Auglavin PPH
If the patient forgets to take a dose, they should take it as soon as they remember.
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 forgotten dose.
Stopping Auglavin PPH treatment
Continue taking Auglavin PPH for the full duration of the prescribed treatment, even if you start to feel better. All doses are necessary to eliminate the infection.
If some bacteria survive, the infection may return.
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 will experience them.

Symptoms to be aware of

Hypersensitivity reactions:

• Skin rash
• Vasculitis, 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 arm or in the groin
• Swelling, sometimes affecting the face or area around the mouth (angioedema), causing difficulty in breathing
• Collapse
• Chest pain related to an allergic reaction, which may indicate an allergy leading to myocardial infarction (Kounis syndrome).

If any of these symptoms occur, seek immediate medical advice. Auglavin PPH must be discontinued immediately.

Colitis

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

Acute pancreatitis

If the patient experiences 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. It 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, seek immediate advice from your doctor.

Very common adverse reactions
May affect more than 1 in 10 people

• Diarrhoea (in adults)

Common adverse reactions
May affect less than 1 in 10 people

• Fungal infections (candidiasis – yeast infections of the vagina, mouth or skin folds)
• Nausea, especially when high doses are used; if this occurs, Auglavin PPH should be taken with food
• Vomiting
• Diarrhoea (in children)

Uncommon adverse reactions
May affect no more than 1 in 100 people

• Skin rash, itching
• Raised, itchy rash (urticaria)
• Dyspepsia
• 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 affect no more than 1 in 1,000 people

• Skin rash, possibly with blisters and resembling target-like lesions (dark spot in the centre surrounded by a lighter ring and a dark ring at the edge – erythema multiforme). If the 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 blood cells involved in blood clotting (thrombocytopenia)
• Low number of white blood cells (leukopenia)

Adverse reactions with unknown frequency
Frequency cannot be estimated from the 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 (more than 30% of body surface – toxic epidermal necrolysis)
  • Widespread red skin rash with small pustular blisters (pustular exanthema)
  • Red, scaly rash with subcutaneous nodules and blisters (acute generalized exanthematous pustulosis)
  • Influenza-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)
    If the patient experiences any of these symptoms, seek immediate medical advice.
• Hepatitis (inflammation of the liver)
• Jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• Inflammation of the kidney tubules
• Prolonged blood clotting time
• Psychomotor hyperactivity
• Seizures (in patients receiving high doses of Auglavin PPH or with kidney disease)
• Black hairy tongue
• Blistering rash arranged in a ring-like pattern or like a string of pearls (linear IgA dermatosis)

Adverse reactions that may appear in blood or urine tests:

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

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions 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,
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 the medicine.

5. How to store Auglavin PPH

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Store in the original aluminium blister pack to protect from light and moisture.
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. The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
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 Auglavin PPH contains

• The active substances are amoxicillin and clavulanic acid. Each tablet contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin and potassium clavulanate granulate equivalent to 125 mg of clavulanic acid.
• Other components are: tablet core – microcrystalline cellulose (E 460), crospovidone type A (E 1202), sodium croscarmellose (E 468), colloidal anhydrous silica (E 551), magnesium stearate (E 470b); tablet coating – titanium dioxide (E 171), talc (E 553b), macrogol 6000 (E 1521), basic butyl methacrylate copolymer.

What Auglavin PPH looks like and contents of the pack
White or almost white, elongated coated tablet with a score line.
Auglavin PPH tablets are available in OPA/Aluminum/PVC/Aluminum blisters
containing 4, 5, 6, 10, 12, 14, 15, 16, 18, 20, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96,
100, 500 coated tablets, packed in cardboard cartons.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
PenCef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin
Germany

Medical education
Antibiotics are used to treat infections caused by bacteria. They are ineffective in treating
viral infections. Sometimes bacterial infections do not respond to antibiotic treatment.
One of the most common reasons for this is that bacteria are resistant to the administered
antibiotic.
This means that bacteria can survive or multiply despite the use of antibiotics.
Bacteria may become resistant to antibiotics for various reasons. Careful use of
antibiotics may help reduce the risk of 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 may 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 proper number of days. 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 that has not been prescribed specifically 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 recommended by your doctor, return it to a pharmacy for proper disposal.