Amoxicillin and clavulanic acid Aristo: detailed information

Patient Information Leaflet

AMOXICILLIN AND CLAVULANIC ACID ARISTO

875 mg + 125 mg film-coated tablets
875 mg + 125 mg powder for oral suspension
Amoxicillin and clavulanic acid
Generic medicine
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 only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

What AMOXICILLIN AND CLAVULANIC ACID ARISTO is and what it is used for
What you need to know before taking AMOXICILLIN AND CLAVULANIC ACID ARISTO
How to take AMOXICILLIN AND CLAVULANIC ACID ARISTO
Possible side effects
How to store AMOXICILLIN AND CLAVULANIC ACID ARISTO
Contents of the pack and other information

1. What AMOXICILLINA E ACIDO CLAVULANICO ARISTO is and what it is used for

AMOXICILLINA E ACIDO CLAVULANICO ARISTO is an antibiotic that works by killing the bacteria causing infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (rendered inactive). The other active component (clavulanic acid) prevents this from happening. AMOXICILLINA E ACIDO CLAVULANICO ARISTO is used in adults and children to treat the following infections:

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 ARISTO

Do not take AMOXICILLIN AND CLAVULANIC ACID ARISTO:

if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic (hypersensitive) to penicillin;
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 ARISTO if any of the above applies to you.
If you have any doubts, speak with your doctor or pharmacist before taking AMOXICILLIN AND CLAVULANIC ACID ARISTO.

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 above conditions apply to you, discuss this with your doctor or pharmacist before taking AMOXICILLIN AND CLAVULANIC ACID ARISTO.
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 dosage or a different medicine.

Conditions you should be aware of
AMOXICILLIN AND CLAVULANIC ACID ARISTO may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should pay attention to certain symptoms while taking AMOXICILLIN AND CLAVULANIC ACID ARISTO in order to reduce any risk.
See Section 4 “Conditions you should be aware of ”.

Blood and urine tests
If you are due to have blood tests (such as tests for red blood cells or liver function) or urine tests (for glucose), inform your doctor or nurse that you are taking AMOXICILLIN AND CLAVULANIC ACID ARISTO. This is because AMOXICILLIN AND CLAVULANIC ACID ARISTO may affect the results of these types of tests.

Other medicines and AMOXICILLIN AND CLAVULANIC ACID ARISTO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal products.
If you are taking allopurinol (used for gout) together with AMOXICILLIN AND CLAVULANIC ACID ARISTO, you are more likely to develop 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 ARISTO.
If you are taking medicines that help prevent blood clots (such as warfarin) together with AMOXICILLIN AND CLAVULANIC ACID ARISTO, additional blood tests may be required.
AMOXICILLIN AND CLAVULANIC ACID ARISTO may affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.

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 taking this medicine.

Driving and using machines
AMOXICILLIN AND CLAVULANIC ACID ARISTO may cause side effects, and symptoms may make you unfit to drive or operate machinery.
Do not drive or operate machinery unless you feel well.

AMOXICILLIN AND CLAVULANIC ACID ARISTO contains aspartame
This medicine contains 12.5 mg of aspartame per sachet, equivalent to 12.5 mg/g. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot eliminate it properly.

3. How to take AMOXICILLINA E ACIDO CLAVULANICO ARISTO

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Use in adults and children weighing 40 kg or more
875 mg/125 mg film-coated tablets

Usual dose – 1 tablet twice daily
Higher dose – 1 tablet three times daily

875 mg/125 mg powder for oral suspension

Usual dose – 1 sachet twice daily
Higher dose – 1 sachet three times daily

Use in children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with amoxicillin and clavulanic acid oral suspension or paediatric sachets.
875 mg/125 mg film-coated tablets
Ask your doctor or pharmacist for advice on administering AMOXICILLINA E ACIDO CLAVULANICO ARISTO tablets to children weighing less than 40 kg.
875 mg/125 mg powder for oral suspension
AMOXICILLINA E ACIDO CLAVULANICO ARISTO 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, you may require more frequent blood tests to monitor liver function.

How to take AMOXICILLINA E ACIDO CLAVULANICO ARISTO 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.
Space doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
Do not take AMOXICILLINA E ACIDO CLAVULANICO ARISTO for longer than 2 weeks. If you continue to feel unwell, you must see your doctor.

How to take AMOXICILLINA E ACIDO CLAVULANICO ARISTO 875 mg/125 mg powder for oral suspension

Immediately before taking AMOXICILLINA E ACIDO CLAVULANICO ARISTO, open the sachet and mix the contents with half a glass of water.
Take at the beginning of a meal or just before.
Space doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
Do not take AMOXICILLINA E ACIDO CLAVULANICO ARISTO for longer than 2 weeks. If you continue to feel unwell, you must see your doctor.

If you take more AMOXICILLINA E ACIDO CLAVULANICO ARISTO than you should
If you take too much AMOXICILLINA E ACIDO CLAVULANICO ARISTO, symptoms may include gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or seizures. Contact your doctor as soon as possible. Bring the medicine packaging or container to show the doctor.

If you forget to take AMOXICILLINA E ACIDO CLAVULANICO ARISTO
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 before taking the next dose.

If you stop taking AMOXICILLINA E ACIDO CLAVULANICO ARISTO
If you have any doubts about using this medicine, consult your doctor or pharmacist.
Continue taking AMOXICILLINA E ACIDO CLAVULANICO ARISTO for the full duration of treatment, 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.

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 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 in breathing
collapse
chest pain in the context of 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 AMOXICILLINA E ACIDO CLAVULANICO ARISTO.

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 you experience these symptoms, 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 (candida)
nausea, especially when taking high doses ➔ if affected, take AMOXICILLINA E ACIDO CLAVULANICO ARISTO before food
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 detectable 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 small targets (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 detectable in blood tests:

low number of cells involved in blood clotting
low number of white blood cells

Side effects with unknown frequency (frequency cannot be estimated from the available data):

Allergic reactions (see above)
Intestinal inflammation (see above)
Severe skin reactions:
- widespread rash with blisters and peeling, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (more than 30% of body surface, toxic epidermal necrolysis)
- widespread red rash with small blisters containing pus (exfoliative bullous dermatitis)
- red, scaly rash with raised areas under the skin and blisters (exanthematous pustulosis)
- 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)
- rash with blistering arranged in a ring-like pattern with a central crust or resembling a string of pearls (linear IgA disease)
- inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
  ➔ If you experience any of these symptoms, contact your doctor immediately.
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 AMOXICILLINA E ACIDO CLAVULANICO ARISTO or who have kidney problems)
black hairy tongue
tooth staining (in children), usually removable by brushing

Side effects detectable in blood or urine tests:

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

If you experience side effects
➔ If any of the side effects worsen or become bothersome, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you get any side effects, 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 following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AMOXICILLINA E ACIDO CLAVULANICO ARISTO

Keep in the original packaging to protect the medicine from light and moisture, at a temperature not exceeding 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the word “Scad.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What AMOXICILLINA E ACIDO CLAVULANICO ARISTO contains
AMOXICILLINA E ACIDO CLAVULANICO ARISTO 875 mg + 125 mg film-coated tablets
Each tablet contains:
Active substances: amoxicillin trihydrate corresponding to 875 mg amoxicillin, potassium clavulanate
corresponding to 125 mg clavulanic acid.
Other excipients:
Anhydrous colloidal silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hypromellose,
talc, titanium dioxide, diethyl phthalate, dimethicone.

What AMOXICILLINA E ACIDO CLAVULANICO ARISTO contains
AMOXICILLINA E ACIDO CLAVULANICO ARISTO 875 mg + 125 mg Powder for oral suspension
Each sachet contains:
Active substances:
amoxicillin trihydrate corresponding to 875 mg amoxicillin, potassium clavulanate
corresponding to 125 mg clavulanic acid.
Other excipients:
Anhydrous colloidal silica, orange flavour, aspartame.

Description of the appearance of AMOXICILLINA E ACIDO CLAVULANICO ARISTO and pack contents
AMOXICILLINA E ACIDO CLAVULANICO ARISTO 875 mg + 125 mg film-coated tablets
Film-coated tablets: Carton containing 12 tablets

AMOXICILLINA E ACIDO CLAVULANICO ARISTO 875 mg + 125 mg Powder for oral suspension
Powder for oral suspension: Carton containing 12 sachets.

Marketing Authorization Holder
Aristo Pharma GmbH
Wallenroder Straße 8 - 10
13435 Berlin, Germany

Selling Authorization Holder
Aristo Pharma Italy S.r.l.
Strada Milanofiori Str. 6 Palazzo n. 3,
20089 Rozzano (MI)

Manufacturers
Film-coated tablets:
Elpen SA - 95 Marathonos Avenue
19009 Pikermi Attica, Greece
Powder for oral suspension:
Elpen SA - 95 Marathonos Avenue
19009 – Pikermi Attica, Greece

Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, bacterial infections do 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 emergence of bacterial resistance.
When your doctor prescribes an antibiotic, it is intended solely for the illness you currently have.
Please follow the advice below to help prevent the development 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 prescribed for other people, even if you have an infection similar to theirs.
Do not give antibiotics prescribed for you to other people.
If you have leftover antibiotic after completing your treatment, return it to your pharmacist for proper disposal.