Auglavin Pph Extra

Leaflet attached to the packaging: information for the user

Auglavin PPH Extra, (600 mg + 42.9 mg)/5 ml, powder for oral suspension

Amoxicillin+Clavulanic acid

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not give it 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 your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

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

Auglavin PPH Extra is used in infants and children to treat the following infections:

• middle ear infections
• lung infections.

2. Important information before taking Auglavin PPH Extra

When not to give Auglavin PPH Extra 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 problems or jaundice (yellowing of the skin) associated with taking an antibiotic. → If any of the above applies to the child, do not give them Auglavin PPH Extra. In case of doubt, consult a doctor or pharmacist before starting treatment with Auglavin PPH Extra.

Warnings and precautions

Before giving Auglavin PPH Extra 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 doubt whether the above circumstances apply to the child, consult a doctor or pharmacist before starting treatment with Auglavin PPH Extra.

In some cases, the doctor may test the type of bacteria that caused the infection in the child.

Depending on the results, the patient may receive Auglavin PPH Extra in a different dose or a different medicine.

Symptoms to watch out for

Taking Auglavin PPH Extra 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 any of the following symptoms while taking Auglavin PPH Extra, in order 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, tell the doctor or nurse that the patient is taking Auglavin PPH Extra. Auglavin PPH Extra may affect the results of these tests.

Auglavin PPH Extra and other medicines

Tell your doctor or pharmacist about all medicines the child is taking, has recently taken, or might take, including those obtained without a prescription and herbal products.

If the patient is taking allopurinol (used for gout), it is more likely that they will experience skin allergic reactions.

If the patient is taking probenecid (used for gout), the doctor may decide to adjust the dose of Auglavin PPH Extra.

If the patient is taking medicines that reduce blood clotting (such as warfarin), additional blood tests may be necessary.

Auglavin PPH Extra may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).

Auglavin PPH Extra 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 the prepared suspension, i.e., the medicine is considered "sodium-free".

3. How to take Auglavin PPH Extra

This medicine should always be taken as directed by a doctor. In case of doubt, 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 Extra to give to the child.
• A plastic measuring spoon, plastic syringe, or measuring cup is attached to the packaging. Use these to give the child the correct dose of the medicine.
• The usual dose is 90 mg + 6.4 mg per kilogram of body weight per day, given in two divided doses. Auglavin PPH Extra is not recommended for use in children under 3 months of age.

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 Extra

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

Using a higher dose of Auglavin PPH Extra than recommended

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

Missing a dose of Auglavin PPH Extra

If a dose of Auglavin PPH Extra 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 treatment with Auglavin PPH Extra

Continue giving Auglavin PPH Extra 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 the infection to recur.

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Auglavin PPH Extra can cause side effects, although not everybody gets them.

Conditions to watch out for

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 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). → If any of these symptoms occur, consult a doctor immediately.

Stop taking Auglavin PPH Extra.

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 taking 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 a doctor as soon as possible for advice.

Very common side effects

May occur in more than 1 in 10 patients

• diarrhea (in adults).

Common side effects

May occur in less than 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 Extra before meals
• vomiting
• diarrhea (in children).

Uncommon side effects

May occur in less than 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 less than 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 immediately.

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 of the skin and blisters (acute generalized exanthematous pustulosis)
• flu-like symptoms with a rash, fever, swollen lymph nodes, 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 may 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 Extra or with kidney disease)
• black hairy tongue
• discoloration of teeth (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:

• 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.

If side effects occur

→ 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 a doctor or nurse. Side effects can be reported directly to the Department of Drug Safety, 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

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 Extra

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 your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Auglavin PPH Extra contains

• The active substances of the medicine are: amoxicillin and clavulanic acid. Each ml of the prepared oral suspension contains amoxicillin trihydrate equivalent to 120 mg of amoxicillin and a mixture of potassium clavulanate and colloidal silica hydrated or anhydrous equivalent to 8.58 mg of clavulanic acid.
• The other ingredients are: crospovidone type A, silicon dioxide, colloidal anhydrous silica, 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 Extra looks like and what the pack contains

Auglavin PPH Extra, (600 mg + 42.9 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.

Package size: 100 ml.

Marketing authorization 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

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:February 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 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, which 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 patient information leaflet and if any of them are unclear, ask your 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 give antibiotics prescribed for one patient to another person.

• 5. If there are any leftover antibiotics after completing the treatment as directed by the doctor, return them to the pharmacy for proper disposal.

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Instructions for preparing the medicine for use

Before use, check if the cap seal is intact.

Shake the medicine bottle to loosen the powder.

Fill the bottle with water below the level marked on the label. Turn the bottle upside down and shake well. Wait for the foam to settle. Then fill the 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 in a pharmacy