Auglavin pph

Package leaflet: Information for the patient

Auglavin PPH, 875 mg + 125 mg, film-coated tablets
Amoxicillinum + Acidum clavulanicum
Please read carefully all the information in this leaflet before taking the 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 doubts, please 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 someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any 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", the action of which may sometimes be inhibited (inactivated). The second active ingredient (clavulanic acid) counteracts this inactivation. Auglavin PPH is used in adults and children for the treatment of 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 using Auglavin PPH

When not to use 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 experienced severe allergic reactions to any other antibiotic. These may include skin rash or swelling of the face or throat.
• If the patient has ever had liver problems or jaundice (yellowing of the skin) related to taking an antibiotic.

If any of the above situations apply, the patient should not take Auglavin PPH.
In case of doubt, consult the doctor or pharmacist before starting treatment with Auglavin PPH.
Warnings and precautions
Before starting treatment with Auglavin PHP, discuss with the doctor or pharmacist if the patient:

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

If in doubt whether any of the above conditions apply, consult the doctor or pharmacist before starting Auglavin PPH.
In some cases, the doctor may test which type of bacteria caused the infection. 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 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 due to have 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 with clavulanic acid may affect the results of such tests.
Auglavin PPH and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If allopurinol (used to treat gout) is taken at the same time as Auglavin PPH, the risk of skin allergic reactions may increase.
If probenecid (used to treat gout) is taken, concurrent use may reduce the elimination of amoxicillin and is not recommended.
If anticoagulant medicines (such as warfarin) are taken at the same time as Auglavin PPH, additional blood tests may be required.
If methotrexate (used in the treatment of cancer and severe psoriasis) is taken, 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 and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this 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.
This medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Auglavin PPH

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
Adults and children with body weight of 40 kg or more

• Usual dose – 1 tablet twice daily.
• Higher dose – 1 tablet three times daily.

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

• If the patient has kidney problems, the dose of the medicine may need to be adjusted. Your doctor may prescribe a different dose of Auglavin PPH or an alternative medicine.
• If the patient has liver problems, blood tests may be performed more frequently to monitor liver function.

How to take Auglavin PPH

• Take this medicine with food.
• Swallow the tablets whole with a glass of water.
• Tablets may be broken along the score line to facilitate swallowing. Both parts of the tablet should be taken at the same time.
• Maintain regular intervals between doses, with at least 4 hours between each dose. 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, contact the doctor again.

Taking more Auglavin PPH than recommended
If the patient takes more Auglavin PPH than prescribed, symptoms such as stomach irritation (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible. Bring the medicine packaging with you to show the doctor.
If you forget to take Auglavin PPH
If the patient forgets to take a dose, take it as soon as remembered.
Do not take the next dose too soon; wait approximately 4 hours before taking the next dose. Do not take a double dose to make up for a missed 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, they may cause the infection to 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.

Symptoms that require attention

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, underarms or groin
• Swelling, sometimes affecting the face or throat (angioedema), causing difficulty in breathing
• Collapse
• Chest pain related to an allergic reaction, possibly indicating an allergy leading to myocardial infarction (Kounis syndrome).

If any of these symptoms occur, seek immediate medical advice. Discontinue use of Auglavin PPH immediately.

Colitis

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 (DIES)

Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin with clavulanic acid. This is a type of allergic reaction characterised primarily by repeated vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.

If any of these symptoms occur, seek immediate advice from your doctor.

Very common adverse reactions
May occur in more than 1 in 10 patients

• Diarrhoea (in adults)

Common adverse reactions
May occur in less than 1 in 10 patients

• Oral, vaginal or skin fold fungal infections (candidiasis)
• Nausea, especially when high doses are used; if nausea occurs, take Auglavin PPH with food
• 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 detected in blood tests:

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

Rare adverse reactions
May occur in no more than 1 in 1000 patients

• Skin rash, possibly with blisters and resembling target-like lesions (dark center surrounded by a lighter ring and a dark outer ring – erythema multiforme). If the patient notices any of these symptoms, medical advice should be sought 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

Adverse reactions 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 with blisters and skin peeling, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome), and a more severe form causing extensive skin detachment (over 30% of body surface – toxic epidermal necrolysis)
  • Widespread red rash with small pus-filled blisters (bullous exfoliative dermatitis)
  • 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 white blood cell count (eosinophilia) and increased liver enzyme activity); drug reaction with eosinophilia and systemic symptoms (DRESS)
    If any of these symptoms occur, seek immediate medical advice.
• Hepatitis (liver inflammation)
• Jaundice caused by increased bilirubin levels (a substance produced in the liver) in the blood, leading 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-looking tongue
• Blistering rash arranged in a ring-like pattern or resembling a string of pearls (linear IgA dermatosis)

Adverse reactions that may be detected in blood or urine tests:

• Marked decrease in white blood cell count
• 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 Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Auglavin PPH

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Store in the original aluminum blister
to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton and blister after
EXP. The expiry date refers to the last day of the stated month. The marking on the packaging after the abbreviation
EXP indicates the expiry date, and after the abbreviation 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 in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Auglavin PPH contains

• The active substances are amoxicillin and clavulanic acid. Each tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
• Other ingredients are: tablet core – microcrystalline cellulose (E 460), crospovidone type A (E 1202), sodium croscarmellose (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 contents of the pack
White or almost white, elongated coated tablet with a division line.
Auglavin PPH is available in OPA/Aluminium/PVC/Aluminium 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
coated tablets, packed in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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 bacteria are resistant to the antibiotic used.
This means that bacteria can survive or multiply despite the use of an antibiotic.
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
infection. Paying attention to the following advice may help prevent the development of resistant bacteria that could hinder the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the appropriate number of days. Please read the instructions provided in the package leaflet, and if any of them are unclear, ask your doctor or pharmacist for clarification.
2. Patients should not take an antibiotic unless it has been prescribed specifically for them. It should be taken only to treat the infection for which the antibiotic was prescribed.
3. Patients should not take an antibiotic prescribed for another person, even if that person had a similar infection.
4. Do not give antibiotics prescribed for you to other people.
5. If any antibiotic remains after completing the treatment as recommended by your doctor, return it to a pharmacy for proper disposal.