Auroamoxi duo

Package leaflet: Information for the patient

Auroamoxi DUO, (400 mg + 57 mg)/5 ml, powder for oral suspension
Amoxicillinum + Acidum clavulanicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• 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 you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

1. What Auroamoxi DUO is and what it is used for

Auroamoxi DUO is an antibiotic with bactericidal activity against bacteria causing infections. Auroamoxi DUO contains two different substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", the action of which may sometimes be inhibited (inactivated). The second active component (clavulanic acid) counteracts this inactivation. Auroamoxi DUO is used in 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 using Auroamoxi DUO

When not to use Auroamoxi DUO

• 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 a severe allergic reaction to any other antibiotic. Symptoms may include skin rash or swelling of the face or throat.
• 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 situations apply to the child, Auroamoxi DUO should not be given.
If in doubt, consult a doctor or pharmacist before starting treatment with Auroamoxi DUO.
Warnings and precautions
Before starting treatment with this medicine, 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 doctor in charge or a pharmacist before starting treatment with Auroamoxi DUO.
In some cases, the doctor may investigate which type of bacteria caused the child's infection.
Depending on the results, the patient may receive Auroamoxi DUO at a different dose or another medicine.
Symptoms to watch for
Treatment with Auroamoxi DUO may worsen the course of certain diseases or cause serious adverse effects, including allergic reactions, seizures, and inflammation of the large intestine.
It is important to monitor whether the child develops specific symptoms during treatment with Auroamoxi DUO to reduce the risk of complications. See “Conditions to watch for” in section 4.
Blood and urine tests
If the child is due to have blood tests (such as complete blood count or liver function tests) or urine tests (for glucose), inform the doctor or nurse that the patient is taking Auroamoxi DUO.
Auroamoxi DUO may affect the results of these tests.
Auroamoxi DUO 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 in gout) is taken at the same time as Auroamoxi DUO, skin allergic reactions are more likely to occur.
• Probenecid (used in the treatment of gout): concurrent use of probenecid may reduce the elimination of amoxicillin and is not recommended.
• If the patient is taking anticoagulant medicines (such as warfarin) at the same time as Auroamoxi DUO, additional blood tests may be necessary.
• Methotrexate (used in the treatment of cancer and severe psoriasis): penicillins may reduce methotrexate elimination, increasing the risk of adverse effects.
• Auroamoxi DUO may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).

Pregnancy, breastfeeding, and fertility
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
Auroamoxi DUO may cause adverse effects and symptoms that impair the ability to drive. Do not drive or operate machinery unless the patient feels well.
Auroamoxi DUO contains aspartame and maltodextrin (glucose)
Each ml of oral suspension contains 2.26 mg of aspartame (E 951)

• This medicine contains aspartame (E 951). Aspartame is a source of phenylalanine. It may be harmful for patients with a disease called "phenylketonuria" (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot remove it properly.
• Maltodextrin is absorbed as glucose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to use Auroamoxi DUO

This medicine should always be used exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Adults and children weighing 40 kg or more

• This suspension is not usually recommended for adults and children weighing 40 kg or more. Please consult your doctor or pharmacist for advice.

Children weighing less than 40 kg
All doses are based on the child's body weight in kilograms.

• Your doctor will advise you on the appropriate dose of Auroamoxi DUO for your child.
• An oral syringe or dosing spoon is provided with the package. Use it to give your child the correct dose.
• Recommended 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 your child has kidney problems, the dose may need to be adjusted. Your doctor may choose a different dose of Auroamoxi DUO or another medicine.
• If your child has liver problems, blood tests may be performed more frequently to monitor liver function.

How to administer Auroamoxi DUO

• Instructions for preparing the suspension – see section 6 of the patient leaflet.
• Always shake the bottle well before each dose.
• Administer at the beginning of a meal or just before a meal.
• Maintain equal intervals between doses, with at least 4 hours between doses during the day. Do not administer two doses within one hour.
• Do not give Auroamoxi DUO to your child for longer than 2 weeks. If the patient still does not feel better, contact your doctor again.

Overdose of Auroamoxi DUO
If your child has taken more Auroamoxi DUO than recommended, symptoms may include irritation of the stomach and intestines (nausea, vomiting, or diarrhoea) or seizures. Contact your doctor immediately. Bring the medicine packaging with you to show the doctor.

Missed dose of Auroamoxi DUO
If you forget to give a dose, give it as soon as you remember. Do not give the next dose too soon; wait approximately 4 hours before giving the next dose. Do not give a double dose to make up for a missed dose.

Stopping Auroamoxi DUO treatment
Continue giving Auroamoxi DUO for the full duration of treatment, even if your child starts to feel better. All doses are necessary to completely eliminate the infection. If some bacteria survive, the infection may return.

If you have any further questions about the use of this medicine, please 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 adverse effects of this medicine that may occur.

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, armpits or groin, swelling sometimes involving the face or throat area (angioedema), causing difficulty breathing;
• collapse;
• chest pain related to an allergic reaction, which may be a sign of an allergy leading to heart attack (Kounis syndrome).

If any of these symptoms occur, seek immediate medical advice.
You must stop taking Auroamoxi DUO.

Colitis
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, abdominal pain and (or) fever.

Acute pancreatitis
If the patient has 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 occurred mainly in children receiving amoxicillin with clavulanic acid. It is a type of allergic reaction, the main symptom of which is recurrent vomiting (1-4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
If any of these symptoms occur, contact the treating physician as soon as possible for advice.

Common adverse effects
May affect up to 1 in 10 patients

• oral or vaginal thrush (candidiasis – fungal infections of the mouth, vagina or skin folds);
• nausea, particularly when high doses are used – if this occurs, take Auroamoxi DUO before meals;
• vomiting;
• diarrhoea (in children).

Uncommon adverse effects
May affect up to 1 in 100 patients

• 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 patients

• skin rash, which may include blisters and resemble target lesions (dark spot in the center surrounded by a lighter ring with a dark ring around 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 cells involved in blood clotting;
• low number of white blood cells.

Frequency not known
Frequency cannot be estimated from available data.

• hypersensitivity reactions (see above);
• colitis (see above);
• crystals in urine leading to acute kidney injury;
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis);
• severe skin reactions:
  • widespread skin rash, within which blisters and skin peeling may occur, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome), and the more severe form causing extensive skin peeling (over 30% of body surface – toxic epidermal necrolysis);
  • widespread red rash, within which small pus-filled blisters may appear (bullous exfoliative dermatitis);
  • 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);
  • red rash usually observed on both buttocks, inner upper thighs, underarms and neck (symmetrical, intertriginous and flexural drug eruption (SDRIFE));
  • blistering rash arranged in a ring-like pattern with crusts in the center or resembling a string of pearls (linear IgA dermatosis).

If the patient experiences any of these symptoms, seek immediate medical advice.

• hepatitis;
• 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;
• hyperkinesia;
• seizures (in patients receiving high doses of Auroamoxi DUO or with kidney disease);
• black hairy tongue;
• tooth discoloration (in children), which can usually be removed by brushing.

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).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist 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, tel.: +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 the medicine.

5. How to store Auroamoxi DUO

Keep the medicine out of the sight and reach of children.
Powder for the preparation of suspension: do not store above 30°C.
The prepared suspension should be stored in a refrigerator (2–8°C) and used within 7 days.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Auroamoxi DUO contains

• The active substances are amoxicillin and clavulanic acid. Each ml of reconstituted oral suspension contains 80 mg amoxicillin (as amoxicillin trihydrate) and 11.4 mg clavulanic acid (as potassium clavulanate, granulate).
• Other ingredients are: colloidal anhydrous silica, succinic acid (E 363) (for pH adjustment), hypromellose, xanthan gum (E 415), aspartame (E 951), silicon dioxide (E 415), strawberry flavour (maltodextrin, propylene glycol, flavouring substance identical to natural, modified starch (E 1450), natural flavouring substance).
• See also section 2.

What Auroamoxi DUO looks like and contents of the pack
Powder for oral suspension.
White to off-white granular powder.
HDPE bottle with white, opaque PP cap, in a cardboard box.
For 70 ml, 100 ml and 140 ml bottles, a PP measuring spoon is included, marked to allow administration of 2.5 ml or 5 ml of reconstituted suspension.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area member states under the following names:
Poland: Auroamoxi DUO
Portugal: Amoxicilina + Ácido Clavulânico Generis Phar

General advice on antibiotic use

Antibiotics are used to treat infections caused by bacteria. They have no effect on infections caused by viruses.

Sometimes, a bacterial infection does not respond to treatment with the prescribed antibiotic. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being used. This means they can survive, and even multiply, despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully may help reduce the risk of bacteria becoming resistant.

Your doctor prescribes antibiotics only to treat your current illness. Observing the following advice will help prevent the development of resistant bacteria, which could stop antibiotics from working.

1. It is very important to take the antibiotic at the correct dose, at the correct time, and for the correct number of days. Read the instructions on the label carefully and, if you do not understand, ask your doctor or pharmacist for help.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only to treat the infection for which they were prescribed.
3. Do not take antibiotics prescribed for someone else, even if their infection seemed similar to yours.
4. Do not give your prescribed antibiotics to anyone else.
5. If any antibiotic remains after completing the prescribed course, return the unused portion to a pharmacy for proper disposal.

Instructions for reconstitution of the oral suspension

Before use, check that the cap seal is intact. Shake the bottle to loosen the powder. Add the appropriate volume of water (as indicated below), invert and shake well. Alternatively, shake the bottle to loosen the powder, then fill the bottle with water just below the mark on the bottle, invert and shake well, then add water exactly up to the mark, invert and shake again thoroughly.

Shake before use.
The reconstituted suspension is white to pale yellow in colour, with a strawberry flavour.