Auglavin Pph

Leaflet accompanying the packaging: information for the user

Auglavin PPH, (400 mg + 57 mg)/5 ml, powder for oral suspension

Amoxicillin+Clavulanic acid

Read carefully the contents of the leaflet before administering this medicine to a child, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. 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, tell the 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.
Auglavin PPH contains two different substances: amoxicillin and clavulanic acid. Amoxicillin
belongs to a group of medicines called "penicillins", which are sometimes inactivated (neutralized). The second active ingredient (clavulanic acid) counteracts this neutralization.
Auglavin PPH is used in infants 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 give Auglavin PPH to a child

• If the patient is allergic (hypersensitive) to amoxicillin, clavulanic acid, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. Symptoms may include a skin rash or swelling of the face or neck.
• If the patient has ever had liver function disorders or jaundice (yellowing of the skin) related to the use of an antibiotic. → If any of the above applies to the child, do not give them Auglavin PPH. In case of doubts, consult a doctor or pharmacist before starting Auglavin PPH.

Warnings and precautions

Before starting to give Auglavin PPH to a child, consult a doctor or pharmacist if:

• the child has infectious mononucleosis
• the child is being treated for liver or kidney disease
• the child has irregular urination.

In case of doubts whether the above circumstances apply to the child, consult the attending doctor or pharmacist before starting Auglavin PPH.
In some cases, the doctor may examine what type of bacteria caused the infection in the child.
Depending on the results, the patient may receive Auglavin PPH in a different dose or a different medicine.

Symptoms to watch out for

Taking Auglavin PPH may worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures, and colitis. Pay attention to whether the child has certain symptoms while taking Auglavin PPH to minimize the risk of any problems. See ' Conditions to watch out for'
in section 4.

Blood and urine tests

If the child is to have blood tests (such as blood count or liver function tests) or urine tests, inform the doctor or nurse that the patient is taking Auglavin PPH. Auglavin PPH may affect the results of these tests.

Auglavin PPH and other medicines

Tell the doctor or pharmacist about all medicines currently or recently given to the child, as well as any planned to be given. This includes medicines available without a prescription and herbal medicines.
If the patient is taking allopurinol (used in gout), it is more likely that the patient will experience skin allergic reactions.
If the patient is taking probenecid (used in gout), the doctor may decide to adjust the dose of Auglavin PPH.
If the patient is taking medicines that reduce blood clotting (such as warfarin), additional blood tests may be necessary.
Auglavin PPH may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).
Auglavin PPH may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of new organs after transplantation).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Before taking any medicine, consult a doctor or pharmacist.

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.
The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of prepared suspension, which means the medicine is considered "sodium-free".

3. How to take Auglavin PPH

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

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

• This suspension is not usually recommended for adults and children with a body weight of 40 kg or more. Consult a doctor or pharmacist for advice.

Children with a body weight of less than 40 kg

All doses are determined based on the child's body weight in kilograms.

• The doctor will advise what dose of Auglavin PPH to give to the child.
• A plastic syringe, measuring spoon, or measuring cup is attached to the packaging. Use them to give the child the correct dose of the medicine.
• Usual dose - from (25 mg + 3.6 mg) to (45 mg + 6.4 mg) per kilogram of body weight per day, given in two divided doses.
• Higher dose - up to (70 mg + 10 mg) per kilogram of body weight per day, given in two divided doses.

Patients with kidney and liver diseases

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

How to give Auglavin PPH

• Always shake the bottle well before giving each dose.
• Give at the beginning of a meal or just before a meal.
• Keep equal intervals of at least 4 hours between doses given during the day. Do not give 2 doses within 1 hour.
• Do not give Auglavin PPH to a child for more than 2 weeks. If the patient still does not feel well, consult the doctor again.

Taking a higher dose of Auglavin PPH than recommended

If the child has taken a higher dose of Auglavin PPH than recommended, symptoms may include stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures. Consult the doctor as soon as possible. Have the medicine packaging with you to show the doctor.

Missing a dose of Auglavin PPH

If a dose of Auglavin PPH is missed, give it as soon as remembered.
Do not give the next dose too early, wait about 4 hours before giving the next dose.

Stopping Auglavin PPH

Continue giving Auglavin PPH until the end of the treatment, even if the child feels better. All doses of the medicine are needed to fight the infection. If some bacteria survive, they may cause a relapse of the infection.
In case of any further doubts about taking this medicine, consult a 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 watch out for

Allergic reactions:

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

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 stomach 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.
→ If any of these symptoms occur, consult the doctor immediately.

Very common side effects

May occur in more than 1 in 10 patients

• diarrhea (in adults).

Common side effects

May occur in up to 1 in 10 patients

• thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds)
• nausea, especially when taking high doses → if they occur, take Auglavin PPH before eating
• vomiting
• diarrhea (in children).

Uncommon side effects

May occur in up to 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 in up to 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 contact a doctor urgently.

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:
• -generalized 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 peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
• -generalized, 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, lymph node enlargement, and abnormal blood test results [including an increased number of 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, they should contact a doctor immediately.
• inflammation of the liver
• jaundice, caused by an increased level of bilirubin (a substance produced in the liver) in the blood, which can cause yellowing of the skin and eyes
• inflammation of the renal tubules
• prolonged blood clotting
• restlessness
• seizures (in people taking high doses of Auglavin PPH or with kidney disease)
• black hairy tongue
• tooth discoloration (in children), which can usually be removed by brushing
• 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:

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

If the patient experiences side effects

→ consult a doctor immediatelyif any of the side effects worsen or become troublesome or if any side effects not listed in this leaflet occur.

Reporting side effects

If side effects occur, including any not listed in this leaflet, tell the doctor or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Auglavin PPH

Keep the medicine out of the sight and reach of children.

Dry powder

Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton and label on the bottle. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation "EXP" means the expiry date, and after the abbreviation "Lot" means the batch number.

Prepared suspension

Store in a refrigerator (2°C-8°C). Do not freeze.
Use the prepared suspension within 7 days.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. 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 and clavulanic acid. Each ml of prepared oral suspension contains amoxicillin trihydrate in an amount equivalent to 80 mg of amoxicillin and a mixture of potassium clavulanate and colloidal silicon dioxide hydrated or anhydrous in an amount equivalent to 11.4 mg of clavulanic acid.
• The other ingredients are: crospovidone type A, silicon dioxide, colloidal anhydrous silicon dioxide, sodium carmellose, xanthan gum, potassium acesulfame (E 950), sodium saccharin (E 954), strawberry flavor [maltodextrin (corn), triethyl citrate, propylene glycol, flavorings, and benzyl alcohol].

What Auglavin PPH looks like and what the packaging contains

Auglavin PPH, (400 mg + 57 mg)/5 ml, powder for oral suspension, is a white or yellowish powder supplied in an orange-colored glass bottle.
After preparation, the bottle contains a white or yellowish liquid mixture called a suspension.
The bottles are packaged with a dosing device in the form of:

• a 6 ml PE/PS syringe
• a 5 ml PS measuring spoon or a 10 ml PS measuring spoon
• a 5 ml PP measuring cup.

Pack sizes: 35 ml, 70 ml, 100 ml, 140 ml.
Not all pack sizes may be marketed.

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
HAUPT Pharma Latina S.r.L.
SS. 156 Monti Lepini Km. 47,600
04100 Borgo San Michele (Latina)
Italy
Date of last revision of the leaflet:November 2024

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 phenomenon is that bacteria are resistant to the administered antibiotic.
This means that bacteria can survive or multiply despite the use of an antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the possibility of bacteria developing resistance.
An antibiotic prescribed by a 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 reduce the effectiveness 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. Read the instructions in the medicine information and if any of them are unclear, ask the doctor or pharmacist to explain.

• 2. The patient should not take an antibiotic that was not prescribed specifically for them. They should only take it to treat 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. Do not pass on antibiotics prescribed for one patient to another person.
• 5. If any antibiotic remains after completing the treatment as directed by the doctor, return it to the pharmacy for proper disposal.

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Instructions for preparing the medicine for use

Before use, check if the bottle cap seal is intact.
Shake the medicine bottle to loosen the powder.
Fill the bottle with water up to the level marked on the label. Turn the bottle upside down and shake well. Wait for the foam to settle. Then fill the bottle with water exactly to the mark, turn the bottle upside down, and shake well again.
Shake the bottle well before each use.
Additional information on preparing the suspension
The final amount of prepared oral suspension is given on the outer packaging and the bottle label. The appropriate amount of water to be added is given in the following table.