Auglavin pph

Package leaflet: Information for the patient

Auglavin PPH, (500 mg+125 mg), powder for oral suspension, in sachet
Amoxicillinum + Acidum clavulanicum
Please read carefully the entire leaflet before taking this 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for the adult patient (or child). Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the 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 (neutralized). The second active component (clavulanic acid) counteracts this inhibition.
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, penicillins, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever experienced severe allergic (hypersensitivity) reactions 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 apply, the patient should not take Auglavin PPH.
If in doubt, consult the doctor or pharmacist before starting treatment with
Auglavin PPH.
Warnings and precautions
Talk to your doctor or pharmacist before taking Auglavin PPH 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 apply, consult the doctor or pharmacist before starting
Auglavin PPH.
In some cases, the doctor may investigate which type of bacteria caused the patient’s infection.
Depending on the results, the patient may be given 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
conditions or cause serious side effects, including allergic reactions, seizures, and colitis.
Be alert for specific symptoms during treatment with Auglavin PPH 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 counts or liver function tests) or
urine tests (for glucose), inform the doctor or nurse that the patient is taking Auglavin PPH.
Medicines containing amoxicillin with clavulanic acid may affect the results of these tests.
Auglavin PPH and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently
taken, or plans to take. This includes medicines available without a prescription and herbal
medicines.
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 excretion
of amoxicillin and is not recommended.
If the patient is taking anticoagulant medicines (such as warfarin) at the same time as Auglavin
PPH, additional blood tests may be necessary.
If the patient is taking methotrexate (used to treat cancer and severe psoriasis) – penicillins may
reduce the excretion of methotrexate, increasing the risk of side effects.
Auglavin PPH may affect the action of mycophenolate mofetil (a medicine used to prevent organ
rejection).
Pregnancy, breastfeeding and fertility
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.
Always consult a doctor or pharmacist before taking any medicine.
Driving and using machines
Auglavin PPH may cause side effects that could affect the ability to drive.
Do not drive or operate machinery unless the patient feels well.
Auglavin PPH contains maltodextrin
This medicine contains maltodextrin, a source of glucose. If the patient has previously been
diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
Auglavin PPH contains aspartame (E 951)
This medicine contains 20 mg of aspartame per sachet. Aspartame is a source of phenylalanine.
It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which
phenylalanine accumulates in the body due to improper excretion.

3. How to use Auglavin PPH

This medicine should always be taken as directed by a 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 sachet three times a day.

Children with body weight less than 40 kg
The use of Auglavin PPH 500 mg + 125 mg is not recommended.
Patients with kidney or liver disease

• If the patient has kidney disease, the dose of the medicine may be adjusted. Your doctor may prescribe a different dose of Auglavin PPH or another medicine.
• If the patient has liver disease, blood tests may be performed more frequently to monitor liver function.

How to take Auglavin PPH

• Immediately before taking the medicine, open the sachet and dissolve it in half a glass of water. Mix the solution well and take immediately.
• The solution should be taken at the beginning of a meal or just before a meal.
• Maintain regular intervals of at least 4 hours between doses administered during the day. Do not take two doses within one 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.

Overdose of Auglavin PPH
If a patient takes more Auglavin PPH than recommended, symptoms such as stomach irritation (nausea, vomiting, or diarrhoea) or seizures may occur. Contact your doctor as soon as possible. Take the medicine packaging along to show to the doctor.
Missed dose of Auglavin PPH
If a 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.
Stopping Auglavin PPH treatment
Continue taking Auglavin PPH 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 the infection to 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 experiences them.
Below is a list of adverse reactions that may occur with this medicine.
Symptoms to be aware of
Allergic 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 glands in the neck, under the arm or in the groin
• swelling, sometimes affecting the face or areas around the mouth (angioedema), causing difficulty in breathing
• fainting
• 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 Auglavin PPH 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 occurred mainly in children receiving amoxicillin with clavulanic acid. This is a type of allergic reaction, the main symptom of which is repeated 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 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 this occurs, take Auglavin PPH 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 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 the patient notices any of these symptoms, contact a doctor urgently.

Rare adverse reactions that may appear in blood test results

• low number of blood platelets (thrombocytopenia)
• low number of white blood cells (leukopenia).

Other adverse reactions
Other adverse reactions occurred in a very small number of people, but their exact frequency is unknown

• allergic 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 detachment (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 ( acute generalized exanthematous pustulosis )
  • 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, contact a doctor immediately.
• hepatitis (liver inflammation)
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may result in yellowing of the skin and whites of the eyes
• interstitial nephritis (inflammation of the kidney tubules)
• prolonged blood clotting time
• hyperkinesis (increased motor activity)
• seizures (in patients receiving high doses of Auglavin PPH or with kidney disease)
• black hairy tongue
• tooth discoloration (in children), usually removable by brushing
• 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 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 at the 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 Auglavin PPH

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the carton and sachet following EXP. The expiry date refers to the last day of the specified month.
The marking on the packaging following EXP indicates the expiry date, and following 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. This will help protect the environment.

6. Contents of the pack and other information

What Auglavin PPH contains

• The active substances are amoxicillin trihydrate and clavulanic acid. Each sachet contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin (Amoxicillinum) and potassium clavulanate, granulate equivalent to 125 mg of clavulanic acid (Acidum clavulanicum).
• Other ingredients: crospovidone type A, colloidal anhydrous silica, aspartame (E 951), magnesium stearate, strawberry flavour (maltodextrin (corn), triethyl citrate (E 1505), flavouring components, propylene glycol (E 1520)).

What Auglavin PPH looks like and contents of the pack
Auglavin PPH, 500 mg + 125 mg powder for oral suspension in sachet is a white to yellowish powder in a sachet made of polyethylene terephthalate/aluminium/polyethylene (PET/Aluminium/PE).
Appearance of the suspension after reconstitution: white to creamy suspension with a strawberry odour.
Pack sizes: 12, 14, 20, 30 sachets in a cardboard box.
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 prescribed 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 may 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 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 correct 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. Patients 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. Patients 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.