Auglavin Pph

Leaflet attached to the packaging: patient information

Auglavin PPH, (500 mg+125 mg), powder for oral suspension, in a sachet

Amoxicillin + Clavulanic acid

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you as an adult (or child). Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Auglavin PPH and what is it 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 packaging and other information

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

Auglavin PPH is an antibiotic that works by killing bacteria that cause infections.
It contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", which are sometimes inactivated (deactivated). The second active ingredient (clavulanic acid) counteracts this deactivation.
Auglavin PPH is used in adults 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 Auglavin PPH

When not to take 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 had severe allergic reactions (hypersensitivity) 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.

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If the above circumstances apply to the patient, they should not take Auglavin PPH

Auglavin PPH.In case of doubt, before starting treatment with Auglavin PPH, consult your doctor or pharmacist.

Warnings and precautions

Before starting treatment with Auglavin PPH, the patient should discuss it with their doctor or pharmacist if they:

• have infectious mononucleosis
• are being treated for liver or kidney disease
• have irregular urination.

In case of doubt whether the above circumstances apply to the patient, they should consult their doctor or pharmacist before starting treatment with Auglavin PPH.
In some cases, the doctor may test what type of bacteria caused the patient's infection. Depending on the results, the patient may receive Auglavin PPH in a different dose or another medicine.

Conditions to be aware of

Taking a medicine containing amoxicillin with clavulanic acid may worsen the course of certain diseases or cause severe side effects, including allergic reactions, seizures, and colitis. The patient should be aware of whether they experience certain symptoms while taking Auglavin PPH to minimize the risk of any problems. See " Conditions to be aware of" in section 4.

Blood and urine tests

If the patient is to have blood tests (such as red blood cell tests or liver function tests) or urine tests (for glucose), they should inform their doctor or nurse that they are taking Auglavin PPH. The medicine containing amoxicillin with clavulanic acid may affect the results of these tests.

Auglavin PPH and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines available without a prescription and herbal medicines.
If the patient is taking allopurinol (used to treat gout) at the same time as Auglavin PPH, they may be more likely to experience skin allergic reactions.
If the patient is taking probenecid (used to treat gout) - concurrent use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If the patient is taking medicines that reduce blood clotting (such as warfarin) at the same time as Auglavin PPH, they may need to have additional blood tests.
If the patient is taking methotrexate (used to treat cancer and severe psoriasis) - penicillins may reduce the excretion of methotrexate, potentially leading to increased side 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Auglavin PPH may cause side effects and symptoms that can impair the ability to drive vehicles.
The patient should not drive vehicles or operate machines unless they feel well.

Auglavin PPH contains maltodextrin

The medicine contains maltodextrin, a source of glucose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Auglavin PPH contains aspartame (E 951)

The medicine contains 20 mg of aspartame in each 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 its improper excretion.

3. How to take Auglavin PPH

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Adults and children with a body weight of 40 kg or more

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

Children with a body weight of less than 40 kg

Taking Auglavin PPH at a strength of 500 mg + 125 mg is not recommended.

Patients with kidney and liver diseases

• If the patient has kidney disease, the dose of the medicine may be changed. The doctor may choose a different dose of Auglavin PPH or another medicine.
• If the patient has liver disease, they may need to have blood tests more frequently to check how their liver is working.

How to take Auglavin PPH

• Immediately before taking the medicine, the sachet should be opened and the contents dissolved in half a glass of water. The mixture should be stirred well and taken immediately.
• The mixture should be taken at the beginning of a meal or just before a meal.
• The patient should maintain equal, at least 4-hour, intervals between doses taken during the day. They should not take 2 doses within 1 hour.
• The patient should not take Auglavin PPH for more than 2 weeks. If they still do not feel well, they should consult their doctor again.

Taking a higher dose of Auglavin PPH than recommended

If the patient has taken a higher dose of Auglavin PPH than recommended, they may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures. They should contact their doctor as soon as possible. They should take the packaging of the medicine with them to show it to the doctor.

Missing a dose of Auglavin PPH

If the patient forgets to take a dose, they should take it as soon as they remember.
They should not take the next dose too early, but wait about 4 hours before taking the next dose.

Stopping treatment with Auglavin PPH

The patient should continue taking Auglavin PPH until the end of the treatment, even if they feel better. All doses of the medicine are necessary to combat the infection.
If some bacteria survive, they may cause a recurrence of the infection.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following are side effects of this medicine that may occur.

Conditions to be aware of

Allergic reactions:

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

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If any of these symptoms occur, the patient should immediately contact
their doctor. They should stop taking Auglavin PPH.

Colitis

Colitis, causing watery diarrhea, usually with blood and mucus, abdominal pain, and (or) fever.

Acute pancreatitis

If the patient experiences severe and persistent abdominal pain, it may be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis syndrome occurred mainly in children receiving amoxicillin with clavulanic acid. It is a type of allergic reaction, the leading symptom of which is repeated vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
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If any of these symptoms occur, the patient should contact their doctor as soon as possible
for advice.

Very common side effects

May occur more frequently than in 1 in 10 patients

• diarrhea (in adults).

Common side effects

May occur less frequently than in 1 in 10 patients

• thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds)
• nausea, especially when taking large doses ➔ if they occur, the patient should take Auglavin PPH before a meal
• vomiting
• diarrhea (in children).

Uncommon side effects

May occur less frequently than in 1 in 100 patients

• skin rash, itching
• raised, itchy rash (hives)
• 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 occur less frequently than in 1 in 1000 patients

• skin rash, which may be accompanied by blisters and look like small targets (a dark spot in the center surrounded by a lighter border with a dark ring around the edge - erythema multiforme) ➔ if the patient notices any of these symptoms, they should urgently contact their doctor.

Rare side effects that may appear in blood test results

• low number of blood cells involved in blood clotting
• low number of white blood cells.

Other side effects

Other side effects have occurred in a very small number of people, but their exact frequency is not known

• 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, which may include blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome), and a more severe form causing widespread skin peeling (over 30% of the body surface - toxic epidermal necrolysis)
• -widespread red skin rash, which may include small pus-filled blisters ( bullous exfoliative dermatitis)
• -red, scaly rash with thickening under the skin and blisters ( acute generalized exanthematous pustulosis)
• -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 ( Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS). ➔

If the patient experiences any of these symptoms, they should immediately contact their doctor.

• hepatitis
• jaundice, caused by an increase in bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and eyes
• inflammation of the renal tubules
• prolonged blood clotting time
• restlessness
• seizures (in people taking high doses of Auglavin PPH or with kidney disease)
• black hairy tongue
• tooth discoloration (in children), usually removed by brushing
• skin rash with blisters arranged in a ring or like a string of pearls ( linear IgA dermatosis).

Side effects that may appear in blood or urine test results

• significant decrease in the number of white blood cells
• low number of red blood cells (hemolytic anemia)
• crystals in the urine leading to acute kidney damage.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Auglavin PPH

The medicine should be stored out of 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 after EXP. The expiry date refers to the last day of the month stated.
The entry on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Auglavin PPH contains

• The active substances of the medicine are amoxicillin trihydrate and clavulanic acid. Each sachet contains amoxicillin trihydrate in an amount equivalent to 500 mg of amoxicillin ( Amoxicillinum) and potassium clavulanate, powder in an amount equivalent to 125 mg of clavulanic acid ( Acidum clavulanicum).
• The other ingredients are: crospovidone type A, colloidal silica anhydrous, aspartame (E 951), magnesium stearate, strawberry flavor (maize maltodextrin, triethyl citrate (E 1505), flavorings, propylene glycol (E 1520)).

What Auglavin PPH looks like and what the packaging contains

Auglavin PPH, 500 mg + 125 mg powder for oral suspension in a sachet is a white to yellowish powder, in a sachet made of polyethylene terephthalate/aluminum/polyethylene (PET/Aluminum/PE).
Appearance of the suspension after preparation: suspension white to creamy, with a strawberry smell.
Pack size: 12, 14, 20, 30 sachets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: + 48 22 364 61 01

Manufacturer

PenCef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin
Germany
Date of last revision of the leaflet:April 2023

Medical education

Antibiotics are used to treat bacterial infections. 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 administered antibiotic.
This means that the bacteria can survive or multiply despite the use of the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the possibility of bacteria developing resistance.
The antibiotic prescribed by the doctor is intended solely for the treatment of the current disease. Paying attention to the following tips will help prevent the development of resistant bacteria that could inhibit the action of the antibiotic.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the right number of days. The patient should read the instructions in the patient information leaflet and if any of them are unclear, they should ask their doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic if it was not prescribed specifically for them. They should only take it for the treatment of the infection for which the antibiotic was prescribed.
• 3. The patient should not take an antibiotic prescribed for another person, even if they had a similar infection.
• 4. The patient should not pass on antibiotics prescribed for them to other people.
• 5. If there are any leftover antibiotics after completing the treatment as directed by the doctor, the patient should return them to the pharmacy for proper disposal.