Auglavin pph extra

Package leaflet: Information for the user

Auglavin PPH Extra, (600 mg + 42.9 mg)/5 ml, powder for oral suspension
Amoxicillinum + Acidum clavulanicum
Please read this leaflet carefully before giving this medicine to your child, because
it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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.

Contents of the leaflet

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

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

Auglavin PPH Extra is an antibiotic with bactericidal activity against bacteria causing infections. Auglavin PPH Extra contains two different substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", whose action may sometimes be inhibited (inactivated). The second active component (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 administering Auglavin PPH Extra to a child

When not to give the child Auglavin PPH Extra

• If the patient has hypersensitivity (allergy) 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 skin rash or swelling of the face or neck.
• If the patient has ever experienced liver function disorders or jaundice (yellowing of the skin) associated with taking an antibiotic. → If any of the above applies to the child, do not administer Auglavin PPH Extra. If in doubt, consult a doctor or pharmacist before starting treatment with Auglavin PPH Extra.

Warnings and precautions
Before starting to administer Auglavin PPH Extra to the child, consult a doctor or pharmacist if:

• the child suffers from infectious mononucleosis,
• the child is being treated for liver or kidney disease,
• the child urinates irregularly.

If in doubt whether any of the above conditions apply to the child, consult the attending doctor or pharmacist before starting treatment with Auglavin PPH Extra.
In some cases, the doctor may investigate which type of bacteria caused the child's infection.
Depending on the results, the patient may receive Auglavin PPH Extra at a different dose or a different medicine.
Symptoms to watch for
Treatment with Auglavin PPH Extra may worsen certain diseases or cause serious adverse effects, including allergic reactions, seizures, and colitis. It is important to monitor whether the child develops specific symptoms during treatment with Auglavin PPH Extra to reduce the risk of complications. See 'Conditions to be aware of' in section 4.
Blood and urine tests
If the child is scheduled for blood tests (such as complete blood count or liver function tests) or urine tests, inform the doctor or nurse that the patient is taking Auglavin PPH Extra. Auglavin PPH Extra may affect the results of such tests.
Auglavin PPH Extra and other medicines
Inform the doctor or pharmacist about all medicines currently being given to the child, those recently administered, and any medicines planned for use. This includes over-the-counter medicines and herbal remedies.
If the patient is taking allopurinol (used for gout) at the same time as Auglavin PPH Extra, skin allergic reactions may be more likely.
If the patient is taking probenecid (used for gout), the treating doctor may decide to adjust the dose of Auglavin PPH Extra.
If the patient is taking anticoagulant medicines (such as warfarin) concurrently with Auglavin PPH Extra, additional blood tests may be required.
Auglavin PPH Extra may affect the action of methotrexate (a medicine used in the treatment of cancer or rheumatic diseases).
Auglavin PPH Extra may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Always consult a doctor or pharmacist before using any medicine.
The medicine contains maltodextrin (a source of glucose)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of reconstituted suspension; this means the medicine is considered "sodium-free".

3. How to use Auglavin PPH Extra

This medicine should always be used exactly as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
Adults and children with body weight equal to or greater than 40 kg

• This suspension is not usually recommended for adults and children with body weight equal to or greater than 40 kg. Consult your doctor or pharmacist for advice.

Children with body weight less than 40 kg
All doses are determined according to the child's body weight in kilograms.

• Your doctor will advise you on the appropriate dose of Auglavin PPH Extra for your child.
• A plastic dosing spoon, plastic syringe, or measuring cup is provided with the package. Use it to administer the correct dose to the child.
• Usual recommended dose – 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 or liver disease

• If the child has kidney problems, the dose of the medicine may need to be adjusted. The doctor may choose a different dose or an alternative medicine.
• If the child has liver problems, blood tests may be performed more frequently to monitor liver function.

How to administer Auglavin PPH Extra

• Always shake the bottle well before administering each dose.
• Administer at the beginning of a meal or just before a meal.
• Maintain regular intervals of at least 4 hours between doses given during the day. Do not administer two doses within 1 hour.
• Do not administer Auglavin PPH Extra to the child for longer than 2 weeks. If the patient still does not feel better, contact the doctor again.

Overdose of Auglavin PPH Extra
If the child has taken more Auglavin PPH Extra than recommended, symptoms may
include irritation of the stomach and intestines (nausea, vomiting, or diarrhea) or seizures. Contact
the treating doctor as quickly as possible. Keep the medicine packaging available to show the doctor.
Missed dose of Auglavin PPH Extra
If a dose of medicine was forgotten, give it as soon as you remember.
Do not administer the next dose too soon; wait approximately 4 hours before giving the
next dose.
Stopping Auglavin PPH Extra treatment
Continue administering Auglavin PPH Extra until the end of the prescribed treatment period, even if
the child feels better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause recurrence of the infection.
If you have any further doubts concerning the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Below are listed the possible adverse effects of this medicine.
Conditions requiring attention
Hypersensitivity 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, underarm, or groin
• Swelling, sometimes involving the face or oral cavity (angioedema), causing difficulty in breathing
• Fainting
• Chest pain related to an allergic reaction, which may indicate an allergy leading to myocardial infarction (Kounis syndrome). → If any of these symptoms occur, seek immediate medical advice. Discontinue use of Auglavin PPH Extra 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 upper abdomen, this may be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin with clavulanic acid. It is a type of allergic reaction, the main symptom of which is recurrent vomiting (1 to 4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
→ If any of these symptoms occur, contact your doctor as soon as possible for advice.
Very common adverse effects
May occur in more than 1 in 10 patients

• Diarrhoea (in adults).

Common adverse effects
May occur in up to 1 in 10 patients

• Oral, vaginal or skin fold candidiasis (yeast infections)
• Nausea, especially when taking high doses → if this occurs, take Auglavin PPH Extra before meals
• Vomiting
• Diarrhoea (in children).

Uncommon adverse effects
May occur in up to 1 in 100 patients

• Skin rash, itching
• Raised, itchy rash (urticaria)
• Indigestion
• Dizziness
• Headache.

Uncommon adverse effects that may be detected in blood tests:

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

Rare adverse effects
May occur in up to 1 in 1000 patients

• Skin rash, possibly with blisters and resembling target-like lesions (dark spot in the centre surrounded by a lighter ring and a dark ring at the edge – erythema multiforme) → if the patient notices any of these symptoms, contact a doctor urgently.

Rare adverse effects that may appear in blood test results:

• Low number of platelets (cells involved in blood clotting)
• Low number of white blood cells.

Other adverse effects
Other adverse effects have occurred in a very small number of people, but their exact frequency is unknown:

• Hypersensitivity reactions (see above)
• Colitis (see above)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Severe skin reactions:
  • Generalised skin rash, with possible blisters and skin peeling, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (over 30% of body surface area – toxic epidermal necrolysis)
  • Generalised red skin rash with small pustular blisters (pustular exanthema)
  • Red, scaly rash with subcutaneous nodules and blisters (acute generalised 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 the patient experiences any of these symptoms, seek immediate medical advice.
• Hepatitis (liver inflammation)
• Jaundice, caused by increased bilirubin (a substance produced in the liver) levels in the blood, leading to yellowing of the skin and whites of the eyes
• Inflammation of renal tubules
• Prolonged blood clotting
• Restlessness
• Seizures (in patients receiving high doses of Auglavin PPH Extra or with kidney disease)
• Black, hairy-looking tongue
• Tooth discoloration (in children), which can usually be removed by brushing
• Blistering rash arranged in a ring-like pattern or like a string of pearls (linear IgA dermatosis).

Adverse effects that may appear 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.

If the patient experiences adverse effects
→ seek immediate medical advice if any adverse effects worsen or become troublesome, or if any adverse effects not listed in this leaflet occur.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or nurse. Adverse effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide 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 specified month.
The marking on the packaging: "EXP" refers to the expiry date, and "Lot" refers to the batch number.
Prepared suspension
Store in the refrigerator (2°C–8°C). Do not freeze.
The prepared suspension must be used within 7 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Auglavin PPH Extra contains

• The active substances are: amoxicillin and clavulanic acid. Each ml of the reconstituted oral suspension contains anhydrous amoxicillin trihydrate equivalent to 120 mg of amoxicillin, and a mixture of potassium clavulanate and hydrated colloidal silicon dioxide or anhydrous colloidal silicon dioxide equivalent to 8.58 mg of clavulanic acid.
• Other ingredients include: crospovidone type A, silicon dioxide, anhydrous colloidal silicon dioxide, sodium carboxymethylcellulose, xanthan gum, potassium acesulfame (E 950), sodium saccharin (E 954), strawberry flavour [maltodextrin (from corn), triethyl citrate, propylene glycol, flavouring components, and benzyl alcohol].

What Auglavin PPH Extra looks like and contents of the pack
Auglavin PPH Extra (600 mg + 42.9 mg)/5 ml, powder for oral suspension, is a white or yellowish powder supplied in an amber-coloured glass bottle.
After reconstitution, the bottle contains a white or yellowish liquid mixture known as a suspension.
Bottles are packaged with a dosing device in the form of:

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

Pack size: 100 ml.
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
HAUPT Pharma Latina S.r.L.
SS. 156 Monti Lepini Km. 47,600
04100 Borgo San Michele (Latina)
Italy

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 bacteria are resistant to the prescribed antibiotic.
This means that bacteria can survive or multiply despite the use of the antibiotic.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics may help reduce the risk of bacterial resistance developing.
The antibiotic prescribed by your doctor is intended solely for the treatment of the current illness. Paying attention to the following advice will help prevent the development of resistant bacteria that could compromise the effectiveness of antibiotics.

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

Instructions for preparing the medicine for use
Before use, check that the cap seal has not been broken.
Shake the bottle to loosen the powder.
Fill the bottle with water up to the level just below the line marked on the label. Turn the bottle upside down and shake well. Wait for the foam to settle. Then fill with water exactly up to the marked line, turn the bottle upside down again, and shake thoroughly.
Shake the bottle well before each use.
Additional information on preparing the suspension in the pharmacy