Amoxicillin and clavulanic acid Zentiva Srl: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Amoxicillin and Clavulanic Acid Zentiva Srl 875 mg/125 mg film-coated tablets

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 for your child) only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Amoxicillina e Acido Clavulanico Zentiva Srl is and what it is used for

Amoxicillina e Acido Clavulanico Zentiva Srl is an antibiotic that works by killing the bacteria that cause 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 (i.e. the medicines are rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Amoxicillina e Acido Clavulanico Zentiva Srl 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 Zentiva Srl

DO NOT take Amoxicillin and Clavulanic Acid Zentiva Srl:

if you are allergic to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6)
if you have previously had a severe allergic reaction (hypersensitivity) to any other antibiotic. These reactions may include rash or swelling of the face or throat
if you have previously had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

► If any of these apply to you, DO NOT take Amoxicillin and Clavulanic Acid Zentiva Srl.
If you are in doubt, consult your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid
Zentiva Srl.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Zentiva Srl if:

you have infectious mononucleosis
you have been treated for liver or kidney problems
you 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 Zentiva Srl.
In some cases, your doctor may carry out tests to identify the type of bacteria causing the infection.
Depending on the results, your doctor may prescribe a different dose of Amoxicillin and Clavulanic Acid
Zentiva Srl, or another medicine.
Conditions to be aware of
Amoxicillin and Clavulanic Acid Zentiva Srl may worsen certain pre-existing conditions or cause serious
adverse effects. These may include allergic reactions, seizures, and inflammation of the large intestine.
While taking Amoxicillin and Clavulanic Acid Zentiva Srl, be alert for specific symptoms in order to
minimize the risk of any problems. See Conditions to be aware of in section 4.
Blood and urine tests
If you need to have blood tests (such as red blood cell counts or liver function tests) or urine tests (for blood
sugar), inform your doctor or nurse that you are taking Amoxicillin and Clavulanic Acid Zentiva Srl.
This is because Amoxicillin and Clavulanic Acid Zentiva Srl may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid Zentiva Srl
Inform 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 Zentiva Srl, you
are very 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 that help prevent blood clots (such as warfarin) together with Amoxicillin and
Clavulanic Acid Zentiva Srl, additional blood tests may be required.
Methotrexate (used to treat cancer, rheumatic diseases, and severe psoriasis): penicillins may reduce the
excretion of methotrexate, potentially increasing its side effects.
Amoxicillin and Clavulanic Acid Zentiva Srl may affect how mycophenolate mofetil (a medicine used to
prevent rejection of transplanted organs) works.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid Zentiva Srl may cause adverse effects that could impair your ability to
drive.
Do not drive or operate machinery unless you feel well.
Amoxicillin and Clavulanic Acid Zentiva Srl contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Amoxicillin and Clavulanic Acid Zentiva Srl

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

Adults and children weighing 40 kg or more

Normal dose – one tablet twice daily
High dose – one tablet three times daily

Children weighing less than 40 kg
Children aged 6 years and younger should preferably be treated with amoxicillin/clavulanic acid oral suspension or sachets.
For administration of this medicine to children weighing less than 40 kg, please consult your doctor or pharmacist. The tablets are not suitable for children weighing less than 25 kg.

Patients with kidney or liver problems

If you have kidney problems, your dose may need to be adjusted. Your doctor may prescribe a different dosage or an alternative medicine.
If you have liver problems, you may need to have blood tests more frequently to monitor liver function.

How to take Amoxicillin and Clavulanic Acid Zentiva Srl

Take the tablets with a glass of water, with a meal.
Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within one hour.
Do not take Amoxicillin and Clavulanic Acid Zentiva Srl for longer than 2 weeks. If you still do not feel better, you should consult your doctor again.
The tablet may be divided into equal doses.

If you take more Amoxicillin and Clavulanic Acid Zentiva Srl than you should
If you take too much Amoxicillin and Clavulanic Acid Zentiva Srl, symptoms may include stomach disturbances (nausea, vomiting or diarrhoea) or seizures. Contact your doctor as soon as possible. Take the medicine pack with you to show the doctor.

If you forget to take Amoxicillin and Clavulanic Acid Zentiva Srl
If you forget to take a dose, take it as soon as you remember. However, do not take the next dose too soon: 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 taking Amoxicillin and Clavulanic Acid Zentiva Srl
Continue taking Amoxicillin and Clavulanic Acid Zentiva Srl for the full duration of the prescribed course, even if you feel better. To fight the infection, you need to take all the doses. 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 will experience them.

Conditions to watch for

Allergic reactions:

skin rash
inflammation of blood vessels ( vasculitis ), which may appear as raised 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 throat ( angioedema ), causing difficulty in breathing
collapse
chest pain during allergic reactions, which may be a symptom of allergy-triggered heart attack (Kounis syndrome).

► If you experience any of these symptoms, contact a doctor immediately. Stop taking Amoxicillin and Clavulanic Acid Zentiva Srl.

Inflammation of the large intestine
Inflammation of the large intestine, causing watery diarrhoea, usually containing 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, consult your doctor as soon as possible.

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)

thrush ( candida – a fungal infection of the vagina, mouth or skin folds)
nausea, especially when taking high doses → in this case, take Amoxicillin and Clavulanic Acid Zentiva Srl with food
vomiting
diarrhoea (in children)

Uncommon side effects (may affect up to 1 in 100 people)

skin rash, itching
itchy skin rash ( urticaria )
indigestion
dizziness
headache

Uncommon side effects that may be revealed by blood tests:

increased levels of certain substances (enzymes) produced by the liver

Rare side effects (may affect up to 1 in 1,000 people)

skin rash, possibly with blistering, appearing as small "target" lesions (dark central spots surrounded by lighter areas, with a dark ring around the edge – erythema multiforme )
► if you notice any of these symptoms, contact a doctor urgently.

Rare side effects that may be revealed by blood tests:

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

Frequency not known (frequency cannot be estimated from the available data)

allergic reactions (see above)
inflammation of the large intestine (see above)
severe skin reactions:
- widespread rash with blistering 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 pustule-filled blisters ( 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 white blood cell count (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
- a red rash commonly seen on both sides of the buttocks, inner upper thighs, armpits, and neck (Symmetric Drug-Related Intertriginous and Flexural Erythema (SDRIFE))
crystals in the urine leading to acute kidney injury
rash with ring-shaped blisters with a central crust or resembling a string of pearls (IgA linear disease)
inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

► If you experience any of these symptoms, contact a doctor immediately.

inflammation of the liver ( hepatitis )
jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), 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 patients taking high doses of Amoxicillin and Clavulanic Acid Zentiva Srl or who have kidney problems)
black hairy tongue

Side effects that may be revealed by blood or urine tests:

severe decrease in white blood cell count
low red blood cell count ( haemolytic anaemia )
presence of crystals in the urine

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 https://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 Zentiva Srl

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Amoxicillin and Clavulanic Acid Zentiva Srl contains
The active substances are amoxicillin trihydrate and potassium clavulanate.
Each film-coated tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
The other components are:
Tablet core:
Anhydrous colloidal silica, magnesium stearate, talc (E 553), povidone K25, microcrystalline cellulose, crospovidone (E 1202).
Coating:
Triethyl citrate (E 1505), hypromellose (E 464), talc (E 553), titanium dioxide (E 171), ethylcellulose, cetyl alcohol, sodium lauryl sulfate.

Description of the appearance of Amoxicillin and Clavulanic Acid Zentiva Srl and contents of the pack
The film-coated tablets are oval, white to cream-colored, with a breakline on both sides (10.5 mm x 22.5 mm).
Aluminium blisters (Alu/alu blister) consisting of an aluminium foil with a PVC coating on the inner side and a sealing aluminium foil, optionally printed (aluminium foil 25 μm with a plastic coating based on PVC on the inner side).
Pack: 12 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l. – Via P. Paleocapa 7 – 20121 Milan, Italy

Manufacturer
Sandoz GmbH
Biochemiestrasse, 10
6250 Kundl
Austria
Lek Pharmaceuticals d.d.
Verovskova ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in EEA Member States under the following names
Austria: Amoxicillin/Clavulansäure Sandoz GmbH 875 mg/125 mg - Filmtabletten
Italy: Amoxicillin and Clavulanic Acid Zentiva Srl

Recommendations/Medical education
Antibiotics are used to treat infections caused by bacteria. They are not effective against infections caused by viruses.
Sometimes, a bacterial infection does not respond to a course of antibiotic treatment: one of the most common reasons is that the bacteria causing the infection are resistant to the administered antibiotic. This means that bacteria can survive and even multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. By using antibiotics carefully and appropriately, you can reduce the risk of bacteria becoming resistant to them.
When your doctor prescribes an antibiotic treatment, it is intended solely for your current illness. Please pay attention to the following recommendations to help prevent the emergence of resistant bacteria, which can lead to failure of antibiotic therapy.

It is very important to take the antibiotic at the correct dose, at the right time, and for the correct number of days. Read the instructions on the label carefully, and if anything is unclear, consult your doctor or pharmacist.
Do not take an antibiotic unless it has been specifically prescribed for you; use the antibiotic only to treat the infection for which it was prescribed.
Do not use antibiotics that have been prescribed for other people, even if their infection seems similar to yours.
Do not give your prescribed antibiotics to other people.
If, after completing the treatment course prescribed by your doctor, you have leftover antibiotics, return them to a pharmacy for proper disposal.