Auglavin pph

Package leaflet: Information for the patient

Auglavin PPH, (875 mg + 125 mg), powder for oral suspension, in sachet
Amoxicillinum + Acidum clavulanicum
Please read carefully the entire leaflet before using 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions 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 infections and sinusitis
• 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 reactions to any other antibiotic. These may include skin rash or swelling of the face or neck.
• 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 to the patient, the patient should not take Auglavin PPH.
In case of doubt, consult the treating physician or pharmacist before starting treatment with
Auglavin PPH.
Warnings and precautions
Before starting treatment with Auglavin PPH, discuss with the treating physician or
pharmacist if the patient:

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

If in doubt whether the above conditions apply to the patient, consult the treating physician or pharmacist before starting treatment with
Auglavin PPH.
In some cases, the doctor may investigate which type of bacteria caused the infection in the patient. Depending on the results, the patient may receive Auglavin PPH at a different dose or another medicine.
Conditions to be aware of
Treatment with a medicine containing amoxicillin and clavulanic acid may worsen the course of 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 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 scheduled for 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 such tests.
Auglavin PPH and other medicines
Tell the treating physician or pharmacist about all medicines currently taken or recently taken by the patient, as well as any medicines the patient plans to take. This includes over-the-counter medicines and herbal remedies.
If the patient is taking allopurinol (used to treat gout), the risk of skin allergic reactions may be increased when taken together with Auglavin PPH.
If the patient is taking probenecid (used to treat gout), concomitant use of probenecid 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 required.
If the patient is taking methotrexate (used in the treatment of 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, 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.
Consult a doctor or pharmacist before taking any 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.
Auglavin PPH contains maltodextrin
The medicine contains maltodextrin, a source of glucose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Auglavin PPH contains aspartame (E 951)
The medicine contains 20 mg of aspartame per sachet. 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 improper excretion.

3. How to take 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

• Recommended dose: 1 sachet twice daily.
• Higher dose: 1 sachet three times daily.

Children with body weight less than 40 kg
The use of Auglavin PPH 875 mg + 125 mg is not recommended.
Patients with kidney or liver disease

• If the patient has kidney problems, the dose of this 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

• Immediately before taking the medicine, open the sachet and dissolve the contents in half a glass of water. Mix well and take immediately.
• The mixture should be taken at the beginning of a meal or just before a meal.
• Maintain regular intervals between doses, with at least 4 hours between each dose 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.

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 soon as possible. Bring the medicine packaging with you to show the doctor.
If a dose of Auglavin PPH is missed
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.
Stopping Auglavin PPH treatment
Continue taking Auglavin PPH for the full duration of treatment, even if the patient starts 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.
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, armpits or groin
• Swelling, sometimes involving 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 a heart attack ( Kounis syndrome ).

➔ If any of these symptoms occur, seek immediate medical advice. Discontinue use of Auglavin PPH immediately.
Inflammation of the large intestine
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). Other 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 no more than 1 in 10 patients

• Thrush (candidiasis – fungal infections of the vagina, mouth or skin folds)
• Nausea, especially when high doses are used ➔ if nausea occurs, take Auglavin PPH before meals
• Vomiting
• Diarrhoea (in children)

Uncommon adverse reactions
May occur in no more than 1 in 100 patients

• Skin rash, itching
• Raised, itchy rash (urticaria)
• Indigestion
• Dizziness
• Headache

Uncommon adverse reactions that may be revealed in blood test results

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

Rare adverse reactions
May occur in no more than 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, contact a doctor urgently.

Rare adverse reactions that may appear in blood test results

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

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

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the membranes surrounding the brain and spinal cord ( aseptic meningitis )
• Severe skin reactions:
  • Widespread skin rash, within 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 (over 30% of body surface – toxic epidermal necrolysis )
  • Widespread red skin rash, within which small pus-filled blisters may appear ( bullous pemphigoid )
  • 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 number of white blood cells (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 (inflammation of the liver)
• Jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may lead to 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 Auglavin PPH or with kidney disease)
• Black hairy tongue, appearing furry
• Discoloration of teeth (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 test results

• Marked decrease in the number of 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 Reactions of Medicinal Products 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 this 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 stated 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 875 mg of amoxicillin (Amoxicillinum) and potassium clavulanate, powder equivalent to 125 mg of clavulanic acid (Acidum clavulanicum).
• Other components: crospovidone type A, colloidal anhydrous silica, aspartame (E 951), magnesium stearate, strawberry flavour (maltodextrin (from corn), triethyl citrate (E 1505), flavouring components, propylene glycol (E 1520)).

What Auglavin PPH looks like and contents of the pack
Auglavin PPH 875 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
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 the bacteria are resistant to the antibiotic administered. This means that bacteria can survive or multiply despite antibiotic therapy.
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. Observing 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 prescribed duration. Please read the instructions provided in the package leaflet and, if any are unclear, ask your doctor or pharmacist for clarification.
2. The patient 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. The patient should not take an antibiotic prescribed for another person, even if that person had a similar infection.
4. Do not give your prescribed antibiotics to other people.
5. If any antibiotic remains after completing the treatment as directed by your doctor, return it to a pharmacy for proper disposal.