Amoxicillin and clavulanic acid Aurobindo Pharma Italia: detailed information

Patient Information Leaflet: Information for the User

Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia

875 mg/125 mg powder for oral suspension in sachets
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you (or your child) only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia is and what it is used for
What you need to know before taking Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia
How to take Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia
Possible side effects
How to store Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia
Contents of the pack and other information

1. What Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia is and what it is used for

Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia is an antibiotic that works by killing the bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (i.e. rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia is used in adults 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. What you need to know before taking Amoxicillin and Clavulanic Acid Aurobindo Pharma

Italy
Do not take Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy if:

you are allergic to amoxicillin, clavulanic acid, penicillins, or to any of the other ingredients of this medicine (listed in section 6);
you have had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include skin rash or swelling of the face or throat;
you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. ➔ Do not take Amoxicillin if any of these cases apply to you. If you are in doubt, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:

have glandular fever;
have been treated for liver or kidney problems;
do not urinate regularly.

If you are unsure whether any of the above conditions apply to you, discuss them with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy.
In some cases, your doctor may perform tests to identify the type of bacteria causing your infection. Based on the results, they may prescribe a different dosage of Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy or a different medicine.
Conditions you should be aware of
Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the bowel. You should pay attention to certain symptoms while taking Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy in order to reduce any risk. See “Conditions you should be aware of” in section 4.
Blood and urine tests
If you are scheduled to have blood tests (such as checks for red blood cells or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy. This is because Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy, you are more likely to develop a skin allergic reaction.
Probenecid (used to treat gout): concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If you are taking medicines such as warfarin (which help prevent blood clots) together with Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy, additional blood tests may be required.
Methotrexate (used to treat cancer and severe psoriasis): penicillins may reduce the excretion of methotrexate, potentially increasing its side effects.
Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy may cause side effects, and symptoms may make you unfit to drive or operate machinery. Do not drive or use machines until you feel better.
Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy contains aspartame and maltodextrins
Each sachet of Amoxicillin and Clavulanic Acid Aurobindo Pharma Italy 875 mg/125 mg powder for oral suspension contains 22.5 mg of aspartame (E951).
This medicine contains aspartame (E951). Aspartame is a source of phenylalanine, which may be harmful to you if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot eliminate it properly.
This medicine contains maltodextrins (glucose). If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more

Recommended dose: 1 sachet twice daily.
Higher dose: 1 sachet three times daily.

Children weighing less than 40 kg
Ask your doctor or pharmacist for advice when administering Amoxicillin and Clavulanic Acid
Aurobindo Pharma Italia 875 mg/125 mg oral suspension powder in sachets to children weighing
less than 40 kg.
Patients with kidney or liver problems

If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
If you have liver problems, more frequent blood tests may be required to monitor liver function.

How to take Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia

Just before taking Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia, open the sachet and mix the contents in half a glass of water.
Take the mixture immediately at the beginning of a meal or shortly before.
Space the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
Do not take Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia for more than 2 weeks. If you still do not feel better, you must return to your doctor.

If you take more Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia than you should
If you take too much Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia, symptoms may
include gastrointestinal disturbances (nausea, vomiting or diarrhoea) or seizures. Speak to your doctor
as soon as possible. Bring the medicine packaging with you to show the doctor.
If you forget to take Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early, but wait approximately 4 hours. Do not take a double dose to make up for a
missed dose.
If you stop treatment with Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia
Continue taking Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia until the treatment course
is complete, even if you feel better. You need every dose to fight the infection. If some
bacteria survive, they may cause the infection to return.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions you should pay attention to
Allergic reactions:

skin rash;
inflammation of blood vessels ( vasculitis ), which may appear as raised red or purple spots on the skin, but can also affect other parts of the body;
fever, joint pain, swelling of the lymph nodes in the neck, armpits, or groin;
swelling, sometimes of the face or throat ( angioedema ), causing difficulty in breathing;
collapse;
chest pain during allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome). ➔ Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia.

Inflammation of the large intestine
Inflammation of the large intestine, causing watery diarrhoea usually accompanied by blood and mucus, stomach pain and/or fever.

Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent stomach pain, this may be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
➔ Consult your doctor as soon as possible if you experience these symptoms.

Very common side effects
May affect more than 1 in 10 people

diarrhoea (in adults).

Common side effects
May affect up to 1 in 10 people

candidiasis (a fungal infection of the vagina, mouth, or skin folds);
nausea, especially when high doses are taken; ➔ if you experience this, take Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia with meals;
vomiting;
diarrhoea (in children).

Uncommon side effects
May affect up to 1 in 100 people

skin rash, itching;
raised itchy rash (urticaria);
indigestion;
dizziness;
headache.

Uncommon side effects may be detected in blood tests:

increased levels of certain proteins (enzymes) produced by the liver.

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

skin rashes, which may appear as blisters and resemble "target" lesions (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme ); ➔ if you notice any of these symptoms, contact your doctor urgently.

Rare side effects may be detected in blood tests:

low number of cells involved in blood clotting;
low white blood cell count.

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

allergic reactions (see above);
intestinal inflammation (see above);
inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis);
severe skin reactions:
- widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ) and a more severe form causing extensive skin detachment (more than 30% of body surface – toxic epidermal necrolysis );
- widespread red rash with small pus-filled blisters ( exfoliative bullous dermatitis );
- red rash with crusts, swellings under the skin, and blisters ( pustular exanthema );
- flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms, DRESS);
- a red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, and neck ( Symmetrical Drug-Related Intertriginous and Flexural Erythema (SDRIFE) ). ➔ If you experience any of these symptoms, contact your doctor immediately.
skin rash with ring-shaped blisters with a central crust or resembling a string of pearls ( linear IgA disease );
inflammation of the liver ( 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;
blood takes longer to clot;
hyperactivity;
seizures (in people taking high doses of Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia or who have kidney problems);
black hairy tongue;
tooth staining (in children), usually removable by brushing.

Side effects that may be detected in blood or urine tests:

severe reduction in white blood cell count;
low red blood cell count ( haemolytic anaemia );
crystals in the urine leading to acute kidney injury.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amoxicillin and Clavulanic Acid Aurobindo Pharma Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet or carton after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Keep in the original container to protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amoxicillina e Acido Clavulanico Aurobindo Pharma Italia contains

The active substances are amoxicillin and clavulanic acid. Each sachet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
The other components are: Crospovidone (type A), magnesium stearate, silicon dioxide, aspartame (E951).

Strawberry-guarana flavour composition: Maize maltodextrins, propylene glycol (E1520), flavouring agents, triethyl citrate (E1505), flavour preparations.
Lemon flavour composition: Natural flavouring substances, flavour preparations, flavouring substances, maize maltodextrins, alpha-tocopherol (E307).
Peach flavour composition: Maize maltodextrins, glyceryl triacetate (E1518), flavouring agents, flavour preparations, natural flavouring substances.

For further information on the excipients aspartame and maltodextrins, see section 2.

Description of the appearance of Amoxicillina e Acido Clavulanico Aurobindo Pharma Italia and
pack contents
Powder for oral suspension in sachets.
White to pale yellow powder.
Amoxicillina e Acido Clavulanico Aurobindo Pharma Italia 875 mg/125 mg powder for oral suspension is available in sachets in Paper/PE/Al/PE packaging.
Pack sizes: 8, 12, 20 and 30 sachets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate
Qasam Industrijali Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica SA
Rua Joao de Deus, 19
Venda Nova,
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier,
Lyon, 69007
France

This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
France: Amoxicilline/Acide Clavulanique Arrow Lab 1 g/125 mg, poudre pour suspension buvable en sachet-dose (ratio amoxicilline/acide clavulanique: 8/1)
Italy: Amoxicillina e Acido clavulanico Aurobindo Pharma Italia
Malta: Amoxicillin/clavulanic acid Aurobindo 875 mg/125 mg /1000 mg/125 mg powder for oral suspension in sachet
Spain: Amoxicilina/Ácido clavulánico Aurovitas 875 mg/125 mg polvo para suspensión oral EFG

Medical advice/education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes a bacterial infection does not respond to antibiotic treatment. The most common reason for this is that the bacteria causing the infection are resistant to the antibiotic being used. This means that bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the development of bacterial resistance.
When your doctor prescribes you an antibiotic, it is intended only for the illness you currently have. Please follow the advice below to help prevent the development of bacterial resistance, which could make antibiotics ineffective.

It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the instructions in this leaflet carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
Do not use antibiotics prescribed for other people, even if you think your infection is similar.
Do not give your antibiotics to other people.
If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.

Reconstitution instructions
Pour the contents of the sachet into half a glass of water, stir until a suspension is obtained, and drink immediately.