Auglavin Pph

Leaflet attached to the packaging: patient information

Auglavin PPH, 500 mg + 125 mg, film-coated tablets

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 only for you (or your 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 those not listed in this leaflet, they should inform 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, penicillin, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever had severe allergic reactions to any other antibiotic. These can include skin rash or swelling of the face or throat.
• If the patient has ever had liver function disorders or jaundice (yellowing of the skin) associated with taking an antibiotic.

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, discuss it with your doctor or pharmacist if the patient:

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

In case of doubt whether the above circumstances apply to the patient, consult your 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 watch out for

Taking a medicine containing amoxicillin with clavulanic acid can worsen the course of certain diseases or cause severe side effects, including allergic reactions, seizures, and colitis. You should pay attention to whether the patient experiences certain symptoms during treatment with a medicine containing amoxicillin with clavulanic acid, in order to reduce the risk of any problems. See "Conditions to watch out for" 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

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.
If the patient is taking allopurinol (used to treat gout), they may be more likely to experience skin allergic reactions.
If the patient is taking probenecid (used to treat gout), taking probenecid at the same time may reduce the excretion of amoxicillin and is not recommended.
If the patient is taking medicines that reduce blood clotting (such as warfarin), 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, potentially leading to increased side effects.
Auglavin PPH may affect the action of mycophenolate mofetil (a medicine used to prevent transplant rejection).

Pregnancy and breastfeeding

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.

Driving and using machines

Auglavin PPH may cause side effects and symptoms that can impair the ability to drive or operate machinery.
Do not drive or operate machinery unless the patient feels well.

The medicine contains sodium

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

3. How to take Auglavin PPH

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

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

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

Children with a body weight of less than 40 kg

Children under 6 years of age should preferably be treated with a medicine containing amoxicillin with clavulanic acid in the form of an oral suspension.
Consult your doctor or pharmacist before taking Auglavin PPH tablets in children with a body weight below 40 kg. Auglavin PPH tablets are not intended for use in children with a body weight of less than 25 kg.

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 often to check how the liver is working.

How to take Auglavin PPH

• Swallow the tablets whole with a glass of water, at the beginning of a meal or just before a meal. The tablets can be broken in half along the break line to make them easier to swallow. Both halves of the tablet should be taken at the same time.
• Keep equal intervals of at least 4 hours between doses taken during the day. Do not take 2 doses within 1 hour.
• Do not take Auglavin PPH for longer than 2 weeks. If the patient still does 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. They should not take a double dose to make up for a missed 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 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 your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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 involving the face or mouth (angioedema), causing difficulty breathing
• anaphylaxis
• 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, contact 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 abdominal pain, it may be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis occurred mainly in children receiving amoxicillin with clavulanic acid. It is a type of allergic reaction, with recurring vomiting (1 to 4 hours after taking the medicine) as the leading symptom. Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
If any of these symptoms occur, contact a 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, take Auglavin PPH with food
• vomiting
• diarrhea (in children).

Uncommon side effects

May occur no more 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 no more frequently than in 1 in 1000 patients

• skin rash, which can occur with 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)

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.

Side effects with unknown frequency

Frequency cannot be estimated from the available data.

• 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 can occur with 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)
• -widespread red skin rash, which can occur with 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 increased white blood cell count (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.

• hepatitis
• jaundice, caused by an increase in 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 time
• restlessness
• seizures (in people taking high doses of Auglavin PPH or with kidney disease)
• black hairy tongue
• blistering rash 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.

Reporting side effects

If side effects occur, including those not listed in this leaflet, they should be reported to a doctor or pharmacist. 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.
Do not store above 25°C. Store in the original aluminum blister pack to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month. The entry on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should 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 packaging and other information

What Auglavin PPH contains

• The active substances of the medicine are amoxicillin and clavulanic acid. Each tablet contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin and potassium clavulanate, powder equivalent to 125 mg of clavulanic acid.
• The other ingredients are: tablet core- microcrystalline cellulose (E 460), crospovidone type A (E 1202), sodium carmellose (E 468), colloidal anhydrous silica (E 551), magnesium stearate (E 470b); tablet coating- titanium dioxide (E 171), talc (E 553b), macrogol 6000 (E 1521), basic butyl methacrylate copolymer.

What Auglavin PPH looks like and what the pack contains

White or off-white, elongated, film-coated tablet with a break line.
Auglavin PPH film-coated tablets are available in OPA/Aluminum/PVC/Aluminum blisters containing 4, 5, 6, 10, 12, 14, 15, 16, 18, 20, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 100, 500 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
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:May 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.
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 correct 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 if it 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 other people.
• 5. If there are any remaining antibiotics after completing the treatment as directed by the doctor, they should be returned to the pharmacy for proper disposal.