Auglavin pph

Package leaflet: Information for the user

Auglavin PPH, (400 mg + 57 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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 action against bacteria causing infections.
Auglavin PPH 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 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 administering 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 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 the use of an antibiotic. → If any of the above applies to the child, do not give Auglavin PPH. If in doubt, consult a doctor or pharmacist before starting treatment with Auglavin PPH.

Warnings and precautions
Before starting to administer 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 urinates irregularly.

If in doubt whether any of the above conditions apply to the child, consult the treating doctor or pharmacist before starting Auglavin PPH.
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 at a different dose or another medicine.

Symptoms to watch for
Treatment with Auglavin PPH 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 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. Auglavin PPH may affect the results of such 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 medicines planned for future use. This includes medicines available without a prescription and herbal products.
If the patient is taking allopurinol (used in gout) at the same time as Auglavin PPH, skin allergic reactions are more likely to occur.
If the patient is taking probenecid (used in gout), the treating doctor may decide to adjust the dose of Auglavin PPH.
If the patient is taking anticoagulant medicines (such as warfarin) concurrently with Auglavin PPH, additional blood tests may be required.
Auglavin PPH may affect the action of methotrexate (a medicine used in cancer or rheumatic diseases).
Auglavin PPH 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, meaning the medicine is considered "sodium-free".

3. How to use Auglavin PPH

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 for your child.
• A plastic syringe, measuring spoon, or dosing cup has been included in the package. Use it to administer the correct dose to the child.
• 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 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

• 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 one hour.
• Do not administer Auglavin PPH to the child for longer than 2 weeks. If the patient still does not feel better, contact the doctor again.

Overdose of Auglavin PPH
If the child has taken more Auglavin PPH than recommended, symptoms may include irritation of the stomach and intestines (nausea, vomiting, or diarrhoea) or seizures. Contact the treating doctor as quickly as possible. Keep the medicine packaging available to show to the doctor.
Missed dose of Auglavin PPH
If a dose of Auglavin PPH was missed, administer it as soon as remembered. Do not administer the next dose too early; wait approximately 4 hours before giving the next dose.
Stopping Auglavin PPH treatment
Continue administering Auglavin PPH until the full course of treatment is completed, even if the child feels 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Below is a list of possible adverse effects associated with 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, under the arms, or in the groin
• Swelling, sometimes affecting the face or area around the mouth (angioedema), causing difficulty in breathing
• Fainting
• Chest pain related to an allergic reaction, possibly indicating an allergy leading to heart attack (Kounis syndrome). → If any of these symptoms occur, seek immediate medical advice. You must stop taking Auglavin PPH.

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 syndrome (DIES)
Drug-induced enterocolitis has mainly occurred in children receiving amoxicillin with clavulanic acid. This is a type of allergic reaction, the main symptom of which is recurrent 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, contact your doctor as soon as possible for advice.
Very common adverse effects
May affect more than 1 in 10 people

• Diarrhoea (in adults).

Common adverse effects
May affect up to 1 in 10 people

• Fungal infections (candidiasis – yeast infections of the vagina, mouth, or skin folds)
• Nausea, especially when high doses are used → if this occurs, take Auglavin PPH before meals
• Vomiting
• Diarrhoea (in children).

Uncommon adverse effects
May affect up to 1 in 100 people

• Skin rash, itching
• Raised, itchy rash (urticaria)
• Indigestion
• Dizziness
• Headache. Uncommon adverse effects that may be revealed in blood tests:
• Increased activity of certain substances (enzymes) produced in the liver.

Rare adverse effects
May affect up to 1 in 1,000 people

• Skin rash, possibly with blisters and resembling target 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, they should 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 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:
  • Widespread skin rash, with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genital organs (Stevens-Johnson syndrome), and a more severe form causing extensive peeling of the skin (over 30% of body surface area – 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 the patient experiences any of these symptoms, seek immediate medical advice.
• Hepatitis (inflammation of the liver)
• Jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• Inflammation of the kidney tubules
• Prolonged blood clotting
• Restlessness
• Seizures (in people receiving high doses of Auglavin PPH 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 of the adverse effects worsen or become bothersome, or if any adverse effects not listed in this leaflet occur.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
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

Keep this medicine out of 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 stated month.
The marking on the packaging: "EXP" refers to the expiry date, and "Lot" refers to the batch number.
Reconstituted suspension
Store in a refrigerator (2°C–8°C). Do not freeze.
The reconstituted 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 required. This 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 ml of reconstituted oral suspension contains amoxicillin trihydrate equivalent to 80 mg of amoxicillin and a mixture of potassium clavulanate and hydrated colloidal silicon dioxide or anhydrous colloidal silicon dioxide equivalent to 11.4 mg of clavulanic acid.
• Other components are: 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 substances and benzyl alcohol].

What Auglavin PPH looks like and contents of the pack
Auglavin PPH, (400 mg + 57 mg)/5 ml, powder for oral suspension, is a white or yellowish powder supplied in an amber glass bottle.
After reconstitution, the bottle contains a white or yellowish liquid mixture known as a suspension.
Bottles are packaged together 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 measure made of PP.

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

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 antibiotic administered.
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 development of bacterial resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your 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 correct number of days. Read the instructions provided in the package leaflet, and if any are unclear, ask your doctor or pharmacist for clarification.
2. The patient should not take an antibiotic unless it has been prescribed specifically for them. It should be taken only to treat the infection for which it was prescribed.
3. The patient should not take an antibiotic prescribed for another person, even if that person had a similar infection.
4. Do not give your prescribed antibiotics to other people.
5. If any antibiotic remains after completing the prescribed course of treatment, return it to a pharmacy for proper disposal.

Instructions for preparing the medicine for use
Before use, check whether the closure seal has been tampered with.
Shake the bottle to loosen the powder.
Fill the bottle with water up to below the line marked on the label. Invert the bottle and shake well. Wait for the foam to settle. Then fill with water exactly up to the line, invert the bottle again and shake thoroughly.
Shake the bottle well before each use.

Additional information on the preparation of the suspension
The final volume of the reconstituted oral suspension is indicated on the outer packaging and on the bottle label. The appropriate amount of water to be added is given in the table below.