AMOXICILLINA 875 mg/125 mg Film-Coated Tablets

Зміст інструкції

1. Amoxicillina e Acido Clavulanico Zentiva Srl 875 mg /125 mg film-coated tablets
   1. What is Amoxicillina e Acido Clavulanico Zentiva Srl and what is it used for
   2. What you need to know before taking Amoxicillina e Acido Clavulanico Zentiva Srl
   3. How to take Amoxicillina e Acido Clavulanico Zentiva Srl
   4. Possible side effects
   5. How to store Amoxicillina e Acido Clavulanico Zentiva Srl
   6. Package contents and other information

Amoxicillina e Acido Clavulanico Zentiva Srl 875 mg /125 mg film-coated tablets

Amoxicillin/clavulanic acid
Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Amoxicillina e Acido Clavulanico Zentiva Srl is and what it is used for
• 2. What you need to know before you take Amoxicillina e Acido Clavulanico Zentiva Srl
• 3. How to take Amoxicillina e Acido Clavulanico Zentiva Srl
• 4. Possible side effects
• 5. How to store Amoxicillina e Acido Clavulanico Zentiva Srl
• 6. Contents of the pack and other information

1. What is Amoxicillina e Acido Clavulanico Zentiva Srl and what is it 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 called “penicillins”, whose activity can sometimes be blocked (the
medicines are thus rendered inactive). The other active ingredient (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 Amoxicillina e Acido Clavulanico Zentiva Srl

DO NOT take Amoxicillina e Acido Clavulanico Zentiva Srl:

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

► If any of these applies to you, DO NOT take Amoxicillina e Acido Clavulanico Zentiva
Srl.If you have doubts, consult your doctor or pharmacist before taking Amoxicillina e Acido Clavulanico
Zentiva Srl.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillina e Acido Clavulanico Zentiva Srl if:

• you have contracted infectious mononucleosis
• you have been treated for liver or kidney problems
• you do not urinate regularly.

If you are not sure whether any of the above conditions apply to you, consult your doctor or
pharmacist before taking Amoxicillina e Acido Clavulanico Zentiva Srl.
In some cases, the doctor may perform an investigation to identify the type of bacteria that caused the infection. Depending on the results, they may prescribe you a different dosage of Amoxicillina e Acido Clavulanico Zentiva Srl,
or another medicine.

Conditions to pay attention to
Amoxicillina e Acido Clavulanico Zentiva Srl can worsen some existing conditions, or
cause serious side effects. These may include allergic reactions, convulsions and inflammation
of the large intestine. While taking Amoxicillina e Acido Clavulanico Zentiva Srl, you should pay
attention to certain specific symptoms, in order to reduce the risk of any problem. See Conditions to

pay attention toin 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), tell your doctor or nurse that you are taking Amoxicillina e Acido
Clavulanico Zentiva Srl. This is because Amoxicillina e Acido Clavulanico Zentiva Srl can affect the
results of these types of tests.

Other medicines and Amoxicillina e Acido Clavulanico Zentiva Srl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
If you are taking allopurinol (used for gout) together with Amoxicillina e Acido Clavulanico Zentiva Srl, you are
very likely to develop an allergic skin reaction.
Probenecid (used for the treatment of gout), concomitant use of probenecid may reduce the excretion of
amoxicillin and is not recommended.
If you are taking medicines that help to
prevent blood clots (such as warfarin) together with Amoxicillina e Acido Clavulanico Zentiva Srl, additional blood
tests may be necessary.
Methotrexate (used for the treatment of cancer and severe psoriasis), penicillins can reduce
the excretion of methotrexate causing a potential increase in side effects.
Amoxicillina e Acido Clavulanico Zentiva Srl can affect the way that mycophenolate mofetil (a
medicine used to prevent rejection of transplanted organs) works.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Amoxicillina e Acido Clavulanico Zentiva Srl can cause side effects, the symptoms of which may
make you unfit to drive.
Do not drive vehicles or use machines unless you feel well.
Amoxicillina e Acido Clavulanico 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 Amoxicillina e Acido Clavulanico Zentiva Srl

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.

Adults and children weighing 40 kg or more

• Normal dose - one tablet twice a day
• High dose - one tablet three times a day

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

Patients with kidney and liver problems

• If you have kidney problems, the dose may be adjusted. Your doctor may prescribe a different dosage, or a different medicine.
• If you have liver problems, you may need to have blood tests more frequently to check liver function.

How to take Amoxicillina e Acido Clavulanico Zentiva Srl

• Take the tablets with a glass of water, with a meal.
• Space the intakes evenly throughout the day, at least 4 hours apart. Do not take 2 doses within one hour.
• Do not take Amoxicillina e Acido Clavulanico Zentiva Srl for more than 2 weeks. If you continue to feel unwell, you will need to consult your doctor again.
• The tablet can be divided into equal doses.

If you take more Amoxicillina e Acido Clavulanico Zentiva Srl than you should
If you take too much Amoxicillina e Acido Clavulanico Zentiva Srl, symptoms may include stomach upset (nausea, vomiting or diarrhoea) or convulsions. Consult your doctor as soon as possible. Bring the package of the medicine with you to show it to the doctor.

If you forget to take Amoxicillina e Acido Clavulanico Zentiva Srl
If you forget to take a dose, take it as soon as you remember. However, you should not take the next dose too soon: you should wait about 4 hours before taking the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amoxicillina e Acido Clavulanico Zentiva Srl
Continue to take Amoxicillina e Acido Clavulanico Zentiva Srl until the end of the treatment cycle, even if you feel better. You need all the doses to fight the infection. If some bacteria survive, they can cause the infection to return.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Conditions to watch out for
Allergic reactions:

• skin rash
• inflammation of the blood vessels ( vasculitis), which may appear as red or purple raised spots on the skin, but may 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), which causes difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome)

► If you experience any of these symptoms, contact a doctor immediately. Stop taking Amoxicillina e Acido Clavulanico Zentiva Srl.

Inflammation of the large intestine
Inflammation of the large intestine, causing watery diarrhea, 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 enterocolitic syndrome (DIES):
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a certain type of
allergic reaction with the main symptom of repetitive vomiting (1-4 hours after taking the medicine).
Further symptoms may include abdominal pain, lethargy, diarrhea 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)

• diarrhea (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 Amoxicillina e Acido Clavulanico Zentiva Srl with food
• vomiting
• diarrhea (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 can be highlighted by blood tests:

• increase in certain substances (enzymes) produced by the liver.

Rare side effects(may affect up to 1 in 1000 people)

• skin rash, with possible blistering, which appears as small “targets” (dark central spots surrounded by lighter areas, with a dark circle around the edge - erythemamultiforme) ► if you notice any of these symptoms, contact a doctor urgently.

Rare side effects that can be highlighted by blood tests:

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

Frequency not known(frequency cannot be estimated on the basis of the available data)

• allergic reactions (see above)
• inflammation of the large intestine (see above)
• severe skin reactions:
• widespread rash, with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome) and a more severe form, which determines extensive detachment of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
• widespread red rash, with small blisters containing pus ( exfoliative bullous dermatitis)
• red and scaly rash with raised areas under the skin and blisters ( pustulous exanthematous rash)
• 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))
• crystals in the urine leading to acute kidney damage
• rash with blisters arranged in a circle with a central crust or like 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 a doctor immediately.

• inflammation of the liver ( hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver), which can give the skin and whites of the eyes a yellowish tinge
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in patients taking high doses of Amoxicillina e Acido Clavulanico Zentiva Srl or who have kidney problems)
• black tongue that appears covered in hair

Side effects that can be highlighted by blood or urine tests:

• severe reduction in the number of white blood cells
• low number of red blood cells ( hemolytic anemia)
• presence of crystals in the urine.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 Amoxicillina e Acido Clavulanico Zentiva Srl

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister and the package after “Scad.”.
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 in 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 Zentiva Srl contains
The active ingredients 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 ingredients 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 Amoxicillina e Acido Clavulanico Zentiva Srl and package contents
The film-coated tablets are oval, from white to cream colored, with a fracture line on both sides
(10.5 mm x 22.5 mm)
Aluminum blisters (Alu/alu blister) consisting of an aluminum foil with a PVC coating on the inside
and an aluminum closure foil, possibly printed (aluminum foil 25 μm with a
plastic coating based on PVC on the inside)
Package: 12 film-coated tablets

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l. – Via P. Paleocapa 7 – 20121 Milano

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

This medicinal product is authorized in the Member States of the EEA under the following denominations
Austria Amoxicillin/Clavulansäure Sandoz GmbH 875 mg/125 mg - Filmtabletten
Italy Amoxicillina e Acido Clavulanico Zentiva Srl

Recommendations/medical information
Antibiotics are used to treat infections caused by bacteria. They are not effective
against infections caused by viruses.
Sometimes an infection caused by bacteria does not respond to a course of treatment with an
antibiotic: one of the most common reasons is that the bacteria causing the infection are
resistant to the antibiotic being administered. 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, the risk that bacteria become resistant to them can be reduced.
When the doctor prescribes antibiotic therapy, this is indicated only for the current illness.
Pay attention to the following recommendations, so as to prevent the emergence of resistant bacteria,
which cause the blocking of the antibiotic's activity.

• 1. It is very important to take the antibiotic at the right dose, at the right time and for the right number of days. Read the instructions on the label and, if something is not clear, ask your doctor or pharmacist.
• 2. 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.
• 3. Do not use antibiotics that have been prescribed to other people, even if their infection is similar to yours.
• 4. Do not give antibiotics prescribed expressly for you to others.
• 5. If, once the treatment cycle prescribed by the doctor is finished and you have some antibiotics left over, return them to the pharmacy so that they can be disposed of properly.