Amoxicillin and clavulanic acid Aurobindo Italia: detailed information

Package Leaflet: Information for the User

Amoxicillin and Clavulanic Acid Aurobindo Italia 875 mg + 125 mg film-coated tablets
Amoxicillin and Clavulanic Acid Aurobindo Italia 875 mg + 125 mg powder for oral suspension
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 (for 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 effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

Do not take Amoxicillin and Clavulanic Acid Aurobindo Italia:

if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or to any of the excipients in Amoxicillin and Clavulanic Acid Aurobindo Italia (listed in section 6);
if you have had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include a skin rash or swelling of the face or neck;
if you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take Amoxicillin and Clavulanic Acid Aurobindo Italia if any of the above apply to you. If you
have any doubts, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Aurobindo
Italia.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:

have infectious mononucleosis;
have previously been treated for liver or kidney problems;
do not urinate regularly.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before
taking Amoxicillin and Clavulanic Acid Aurobindo Italia.
In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection.
Based on the results, they may prescribe a different dose of Amoxicillin and Clavulanic Acid
Aurobindo Italia or a different medicine.
Conditions to which you should pay attention
Amoxicillin and Clavulanic Acid Aurobindo Italia may worsen certain pre-existing conditions or cause serious
adverse effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should
be alert to certain symptoms while taking Amoxicillin and Clavulanic Acid Aurobindo Italia in order to reduce
any risk. See “Conditions to which you should pay attention ” in section 4.
Blood and urine tests
If you are about to have blood tests (for example, checks on 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
Italia. This is because Amoxicillin and Clavulanic Acid Aurobindo Italia may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those purchased without a prescription and herbal products.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid Aurobindo Italia, you
are at high risk of developing a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of
Amoxicillin and Clavulanic Acid Aurobindo Italia.
If you are taking medicines such as warfarin (which help prevent blood clots) together with Amoxicillin and
Clavulanic Acid Aurobindo Italia, additional blood tests may be required.
Amoxicillin and Clavulanic Acid Aurobindo Italia may affect the action of methotrexate (a medicine used to
treat tumours or rheumatic diseases).
Amoxicillin and Clavulanic Acid Aurobindo Italia may affect the effectiveness of mycophenolate mofetil (a
medication 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,
please consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid Aurobindo Italia may cause adverse effects, and symptoms may make you
unsuitable for driving.
Do not drive or operate machinery unless you feel better.
Amoxicillin and Clavulanic Acid Aurobindo Italia 875 mg + 125 mg film-coated tablets
contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.
Amoxicillin and Clavulanic Acid Aurobindo Italia 875 mg + 125 mg powder for oral suspension
contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.

3. How to take Amoxicillin and Clavulanic Acid Aurobindo Italia

Take Amoxicillin and Clavulanic Acid Aurobindo Italia exactly as prescribed by your
doctor. If you have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
Amoxicillin and Clavulanic Acid Aurobindo Italia 875 mg + 125 mg film-coated tablets

Recommended dose – 1 tablet twice daily.
Higher dose – 1 tablet three times daily.

Amoxicillin and Clavulanic Acid Aurobindo Italia 875 mg + 125 mg powder for oral suspension

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

Children weighing less than 40 kg
Amoxicillin and Clavulanic Acid Aurobindo Italia 875 mg + 125 mg film-coated tablets
Children up to 6 years of age should preferably be treated with amoxicillin and clavulanic acid oral suspension or pediatric sachets.
Ask your doctor or pharmacist for advice on administering Amoxicillin and Clavulanic Acid Aurobindo Italia tablets to children weighing less than 40 kg.
Amoxicillin and Clavulanic Acid Aurobindo Italia 875 mg + 125 mg powder for oral suspension
Amoxicillin and Clavulanic Acid Aurobindo Italia 875 mg + 125 mg sachets are not recommended.
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 needed to monitor liver function.

How to take Amoxicillin and Clavulanic Acid Aurobindo Italia
Amoxicillin and Clavulanic Acid Aurobindo Italia 875 mg/125 mg film-coated tablets

Swallow the tablet whole with a glass of water at the beginning of a meal or just before.

Amoxicillin and Clavulanic Acid Aurobindo Italia 875 mg/125 mg powder for oral suspension

Just before taking Amoxicillin and Clavulanic Acid Aurobindo Italia, open the sachet and mix the contents with half a glass of water. Take at the beginning of a meal or just before.

Space your 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 Italia for longer than 2 weeks. If you continue to feel unwell, you should see your doctor again.
If you take more Amoxicillin and Clavulanic Acid Aurobindo Italia than you should
If you take too much Amoxicillin and Clavulanic Acid Aurobindo Italia, symptoms may include stomach disturbances (nausea, vomiting or diarrhoea) or seizures. Contact your doctor as soon as possible.
Take the medicine packaging along with you to show the doctor.
If you forget to take Amoxicillin and Clavulanic Acid Aurobindo Italia
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early; wait approximately 4 hours before taking the next dose. Do not take a double dose to make up for a forgotten dose.
If you stop treatment with Amoxicillin and Clavulanic Acid Aurobindo Italia
Continue taking Amoxicillin and Clavulanic Acid Aurobindo Italia until the treatment course is complete, even if you feel better. You need every dose to help fight the infection. If some bacteria survive, they may cause the infection to return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amoxicillin and Clavulanic Acid Aurobindo Italia can cause side effects,
although not everybody gets them. The side effects that may occur with this
medicine are listed below.
Conditions you should pay attention to
Allergic reactions:

skin rashes;
inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may also affect other parts of the body;
fever, joint pain, swelling of the glands in the neck, armpits or groin;
swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing;
collapse;
chest pain during allergic reactions, which may be a symptom of allergy-triggered heart attack (Kounis syndrome).

Contact your doctor immediately if any of these symptoms occur. Stop taking
Amoxicillin and Clavulanic Acid Aurobindo Italia.
Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually with blood and mucus, stomach pain
and/or fever.
Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent pain in the stomach area, this could 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).
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 side effects
May affect more than 1 in 10 people:

diarrhoea (in adults).

Common side effects
May affect up to 1 in 10 people:

oral, vaginal or skin fold fungal infection (candidiasis);
nausea, especially when taking high doses. If this affects you, take Amoxicillin and Clavulanic Acid Aurobindo Italia before meals;
vomiting;
diarrhoea (in children).

Uncommon side effects
May affect up to 1 in 100 people:

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

Uncommon side effects may be detected through 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 small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme); if any of these symptoms occur, contact your doctor urgently.

Rare side effects may be detected through blood tests:

low number of cells involved in blood clotting (thrombocytopenia);
low number of white blood cells (leukopenia).

Frequency not known
Other side effects occur in a very limited number of people, but their exact frequency
is not known.

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);
- a 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 number of 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 Flexural Erythema (SDRIFE)).

If you experience any of the following 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 Italia or who have kidney problems);
black hairy tongue, appearing covered with hair-like projections;
tooth staining (in children), usually removable by brushing.

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

severe reduction in the number of white blood cells (agranulocytosis);
low number of red blood cells (haemolytic anaemia);
crystals in the urine leading to acute kidney injury.

If you experience any side effects
If any of the side effects worsen or become troublesome, or if you notice any side effect not listed
in this leaflet, inform your doctor or pharmacist.
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 the website www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Amoxicillin and Clavulanic Acid Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect the medicine from light and moisture.
Do not use Amoxicillin and Clavulanic Acid Aurobindo Italia after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Amoxicillina e Acido Clavulanico Aurobindo Italia contains
Film-coated tablets
Each tablet contains:
The active substances are: amoxicillin trihydrate corresponding to 875 mg amoxicillin and potassium clavulanate corresponding to 125 mg clavulanic acid.
Other components: colloidal silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hydroxypropylmethylcellulose, titanium dioxide, polyethylene glycol 4000, polyethylene glycol 6000, dimethicone.
Oral suspension powder
Each sachet contains:
The active substances are: amoxicillin trihydrate corresponding to 875 mg amoxicillin and potassium clavulanate corresponding to 125 mg clavulanic acid.
Other components: colloidal silica, lemon flavour, strawberry flavour, xanthan gum, sucrose.

Description of the appearance of Amoxicillina e Acido Clavulanico Aurobindo Italia and contents of the pack
Film-coated tablets: cardboard box containing 12 tablets.
Oral suspension powder: cardboard box containing 12 sachets.

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

Manufacturer and Final Controller
Laboratorio Reig Jofré, S.A. - C/Jarama s/n, Poligono Industrial - 45007 Toledo - Spain

Behavioural hygiene
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 presence of the antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can help reduce the emergence of bacterial resistance.
When your doctor prescribes you an antibiotic treatment, it is intended solely for the illness you currently have. Please pay attention to the following advice to help prevent the emergence of bacterial resistance, which can lead to failure of antibiotic therapy.

It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the exact number of days indicated. Read the instructions in the package 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 that have been prescribed for other people, even if you believe you have a similar infection.
Do not give your prescribed antibiotics to other people.
If you have leftover antibiotic medication after completing your treatment, return it to your pharmacist for proper disposal.