Auroamoxi Duo

Leaflet attached to the packaging: patient information

Auroamoxi DUO, (400 mg + 57 mg)/5 ml, powder for oral suspension

Amoxicillin + Clavulanic acid

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific person. 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 any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Auroamoxi DUO and what is it 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 packaging and other information

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

Auroamoxi DUO is an antibiotic that works by killing bacteria that cause infections. Auroamoxi DUO contains two different substances: amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of medicines called "penicillins", which are sometimes inactivated (inhibited).
The second active ingredient (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 taking Auroamoxi DUO

When not to take 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 a 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 the use of an antibiotic.

If the above circumstances apply to the child, they should not take Auroamoxi DUO

In case of doubt, consult a doctor or pharmacist before taking Auroamoxi DUO.

Warnings and precautions

Before giving this medicine 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 has irregular urination.

In case of doubt whether the above circumstances apply to the child, consult a doctor or pharmacist before giving Auroamoxi DUO.
In some cases, the doctor may examine what type of bacteria caused the infection in the child.
Depending on the results, the patient may receive Auroamoxi DUO in a different dose or a different medicine.

Symptoms to watch out for

Taking Auroamoxi DUO may worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures, and colitis. You should pay attention to whether the child has certain symptoms while taking Auroamoxi DUO, in order to reduce the risk of any problems. See "Conditions to watch out for"in section 4.

Blood and urine tests

If the child is to have blood tests (such as 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 taking, has recently taken, or might take.

• If the patient is taking allopurinol (used for gout) at the same time as Auroamoxi DUO, it is more likely that the patient will experience skin allergic reactions.
• Probenecid (used for gout), concurrent use of probenecid may decrease the excretion of amoxicillin and is not recommended.
• If the patient is taking blood-thinning medicines (such as warfarin) at the same time as Auroamoxi DUO, additional blood tests may be necessary.
• Methotrexate (used for cancer and severe psoriasis), penicillins may decrease the excretion of methotrexate, potentially leading to increased side effects.
• Auroamoxi DUO may affect the action of mycophenolate mofetil (a medicine used to prevent organ rejection after transplantation).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

Auroamoxi DUO may cause side effects that can affect the ability to drive or use machines. Do not drive or use machines unless you feel well.

Auroamoxi DUO contains aspartame

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 to patients with a rare genetic disorder called phenylketonuria (PKU), in which phenylalanine accumulates because the body cannot remove it properly.

3. How to take Auroamoxi DUO

This medicine should always be taken exactly as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

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

• This suspension is not usually recommended for adults and children with a body weight of 40 kg or more. Consult a doctor or pharmacist for advice.

Children with a body weight of less than 40 kg

All doses are determined based on the child's body weight in kilograms.

• The doctor will advise on the dose of Auroamoxi DUO to be given to the child.
• A measuring spoon or syringe is provided with the packaging. Use these to give the child the correct dose of medicine.
• 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 and liver diseases

• If the child has kidney disease, the dose of the medicine may be changed. The doctor may choose a different dose of Auroamoxi DUO or a different medicine.
• If the child has liver disease, they may need to have blood tests more frequently to check how the liver is working.

How to give Auroamoxi DUO

• Instructions for preparing the suspension - see section 6 of the patient leaflet.
• Always shake the bottle well before giving each dose.
• Give at the start of a meal or just before a meal.
• Give the doses at least 4 hours apart. Do not give 2 doses within 1 hour of each other.
• Do not give Auroamoxi DUO to the child for more than 2 weeks. If the patient still does not feel well, consult a doctor again.

Overdose of Auroamoxi DUO

If the child takes more Auroamoxi DUO than they should, symptoms may include stomach and intestinal upset (nausea, vomiting, or diarrhea) or seizures. Consult a doctor as soon as possible. Take the packaging with you to show the doctor.

Missed dose of Auroamoxi DUO

If a dose of Auroamoxi DUO is missed, give it as soon as remembered. Do not give the next dose too soon, wait about 4 hours before giving the next dose. Do not take a double dose to make up for a missed dose.

Stopping Auroamoxi DUO

Continue giving Auroamoxi DUO until the end of the treatment, even if the child feels better. All doses of the medicine are needed to fight the infection. If some bacteria survive, they may cause the infection to come back.
In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Auroamoxi DUO can cause side effects, although not everybody gets them.
The following are side effects of Auroamoxi DUO that may occur.

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, swollen lymph nodes on the neck, under the arm, or in the groin, swelling, sometimes including the face or throat area (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, consult a doctor immediately.

Stop taking Auroamoxi DUO.

Colitis

Colitis, causing watery diarrhea usually with blood and mucus, abdominal pain, and (or) fever.

Acute pancreatitis

If the patient has severe and persistent stomach pain, it may be a sign of acute pancreatitis.
Drug-Induced Enterocolitis Syndrome (DIES)
DIES occurred mainly in children receiving amoxicillin with clavulanic acid. It is a type of allergic reaction, with recurring vomiting (1-4 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, consult a doctor immediately.

Common side effects

May occur in up to 1 in 10 patients

• thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds);
• nausea, especially when taking high doses - if they occur, take Auroamoxi DUO before meals;
• vomiting;
• diarrhea (in children).

Uncommon side effects

May occur in up to 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 in up to 1 in 1,000 patients

• skin rash, which may be blistering 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). If the patient notices any of these symptoms, they should contact a doctor urgently.

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.

Unknown frequency

Cannot be estimated from the available data.

• allergic reactions (see above);
• colitis (see above);
• crystals in the urine leading to acute kidney damage;
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis);
• severe skin reactions:
• generalized skin rash, which may include 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);
• generalized, red skin rash, which may include small pus-filled blisters (pustular exfoliative rash);
• 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);
• rash with blisters arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis).

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 the whites of the eyes;
• inflammation of the renal tubules;
• prolonged blood clotting;
• restlessness;
• seizures (in people taking high doses of Auroamoxi DUO or with kidney disease);
• black hairy tongue;
• tooth discoloration (in children), which can usually be removed by brushing.

Side effects that may appear in blood or urine test results:

• significant decrease in the number of white blood cells;
• low number of red blood cells (hemolytic anemia).

Reporting side effects

If side effects occur, including any not listed in this leaflet, tell a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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
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 Auroamoxi DUO

Keep the medicine out of the sight and reach of children.
Powder for oral suspension: do not store above 30°C.
Reconstituted suspension should be stored in the 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Auroamoxi DUO contains

• The active substances of Auroamoxi DUO are amoxicillin and clavulanic acid. Each ml of reconstituted oral suspension contains 80 mg of amoxicillin (as amoxicillin trihydrate) and 11.4 mg of clavulanic acid (as potassium clavulanate, microcrystalline).
• The other ingredients are: colloidal anhydrous silica, succinic acid (E 363) (to adjust pH), hypromellose, xanthan gum (E 415), aspartame (E 951), silicon dioxide (E 551), strawberry flavor (maltodextrin, propylene glycol, flavoring substance identical to natural, modified starch (E 1450), natural flavoring 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 a white, opaque PP cap, in a cardboard box.
For 70 ml, 100 ml, and 140 ml bottles, a PP measuring spoon with a scale allowing administration of 2.5 or 5 ml of reconstituted suspension is provided.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:
Auroamoxi DUO
Portugal:
Amoxicilina + Ácido Clavulânico Generis Phar

Date of last revision of the leaflet: 08/2024

General advice on the use of antibiotics

Antibiotics are used to treat infections caused by bacteria. They have no effect on viral infections.
Sometimes, a bacterial infection does not respond to treatment with the prescribed antibiotic. One of the most common reasons for this phenomenon is that the bacteria causing the infection are resistant to the antibiotic being taken. This means they can survive, and even multiply, despite the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the risk that bacteria will become resistant to them.
A doctor prescribes antibiotics to treat only the current illness. Paying attention to the following guidelines will help prevent the emergence of resistant bacteria that could stop antibiotics from working.

• 1. It is very important to take the antibiotic in the correct dose, at the correct time, and for the correct number of days. Read the instructions on the label, and if you do not understand them, ask a doctor or pharmacist for help.
• 2. Do not take antibiotics unless they have been prescribed specifically for you, and only use them to treat the infection for which they were prescribed.
• 3. Do not take antibiotics that have been prescribed for someone else, even if they had an infection similar to yours.
• 4. Do not give antibiotics prescribed for you to anyone else.
• 5. If you have any leftover antibiotic after completing the treatment as advised by your doctor, return it 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), turn upside down, and shake well.
Alternatively, shake the bottle to loosen the powder, then fill the bottle with water up to the mark, turn upside down, and shake well, then fill with water to the line, turn upside down, and shake well again.

Shake before use.
The reconstituted suspension has a white to pale yellow color, with a strawberry flavor.