Amoxicillin and clavulanic acid Zentiva Italia

Patient Information Leaflet

Amoxicillin and Clavulanic Acid Zentiva Italia

875 mg/125 mg film-coated tablets
Generic Medicine
Please 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 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Amoxicillin and Clavulanic Acid Zentiva Italia is and what it is used for
2. What you need to know before taking Amoxicillin and Clavulanic Acid Zentiva Italia
3. How to take Amoxicillin and Clavulanic Acid Zentiva Italia
4. Possible side effects
5. How to store Amoxicillin and Clavulanic Acid Zentiva Italia
6. Contents of the pack and other information

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

Amoxicillina e Acido Clavulanico Zentiva 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 called 'penicillins', whose
activity can sometimes be blocked (rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Amoxicillina e Acido Clavulanico Zentiva 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 Zentiva Italia

Do not take Amoxicillin and Clavulanic Acid Zentiva Italia:

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

➔ Do not take Amoxicillin and Clavulanic Acid Zentiva 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 Zentiva Italia.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Zentiva Italia 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 Zentiva 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 Zentiva Italia or a different medicine.
Conditions requiring attention
Amoxicillin/clavulanic acid may worsen certain pre-existing conditions or cause serious adverse effects. These may include allergic reactions, seizures, and inflammation of the bowel. You should be aware of certain symptoms while taking amoxicillin/clavulanic acid in order to reduce any risk. See section 4 “Possible side effects”.
Blood and urine tests
If you are due to have blood tests (such as red blood cell counts or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking Amoxicillin and Clavulanic Acid Zentiva Italia. This is because amoxicillin/clavulanic acid may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid Zentiva Italia
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.

• allopurinol (a medicine used to treat gout): you are very likely to develop a skin allergic reaction.
• probenecid (another medicine used to treat gout): your doctor may decide to adjust the dose of Amoxicillin and Clavulanic Acid Zentiva Italia.
• medicines that help prevent blood clots (such as acenocoumarol or warfarin): additional blood tests may be required.
• methotrexate (a medicine used to treat tumours or rheumatic diseases).
• mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid Zentiva Italia may cause side effects that could affect your ability to drive. Do not drive or operate machinery unless you feel well.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Amoxicillin and Clavulanic Acid Zentiva Italia

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

• The recommended dose is 1 tablet twice a day.
• The highest recommended dose is 1 tablet three times a day.

Children weighing less than 40 kg

• Children aged 6 years or younger should preferably be treated with amoxicillin/clavulanic acid oral suspension or sachets.
• Ask your doctor or pharmacist for advice when administering Amoxicillin and Clavulanic Acid Zentiva Italia tablets to children weighing less than 40 kg. 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 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 Zentiva Italia

• Swallow the tablet whole with a glass of water at the beginning of a meal or just before. The tablets can be broken along the score line to make swallowing easier. You must take both parts of the tablet at the same time.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour of each other.
• Do not take Amoxicillin and Clavulanic Acid Zentiva Italia for longer than two weeks. If you still do not feel better, you should see your doctor again.

If you take more Amoxicillin and Clavulanic Acid Zentiva Italia than you should
If you take more Amoxicillin and Clavulanic Acid Zentiva Italia than you should, symptoms may
include stomach disturbances (nausea, vomiting, or diarrhoea) or seizures (fits). Speak to your
doctor as soon as possible. Take the medicine pack or bottle with you to show the doctor.
If you forget to take Amoxicillin and Clavulanic Acid Zentiva Italia
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early;
instead, 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 Italia
Continue taking Amoxicillin and Clavulanic Acid Zentiva Italia 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.
If you have any questions 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.

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 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 an allergy-triggered heart attack (Kounis syndrome)

➔ Contact your doctor immediately if you experience any of these symptoms.
Stop taking Amoxicillin and Clavulanic Acid Zentiva 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. 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.
➔ If you experience these symptoms, contact your doctor as soon as possible for advice.

Very common: may affect more than 1 in 10 people

• Diarrhoea

Common: 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 Zentiva Italia with food
• Vomiting
• Diarrhoea (in children)

Uncommon: may affect up to 1 in 100 people

• Skin rash, itching
• Raised itchy 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: 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 through 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)
• Intestinal inflammation (see above)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Severe skin reactions:
  • Widespread blistering rash with 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 eruption)
  • 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, upper inner thighs, armpits, and neck (symmetrical intertriginous flexural rash related to drug (SDRIFE))

➔ If you experience any of these symptoms, contact your doctor immediately.

• Rash with blistering arranged in a ring-shaped pattern 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 Zentiva Italia or who have kidney problems)
• Black hairy tongue

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

• Severe decrease in white blood cell count
• Low red blood cell count (haemolytic anaemia)
• Crystals in the urine leading to acute kidney damage

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. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Amoxicillin and Clavulanic Acid Zentiva Italia

Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Keep out of the sight and reach of children.
Do not use this medicine 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Amoxicillin and Clavulanic Acid Zentiva Italia contains

• The active substances are amoxicillin and clavulanic acid.
• Each 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: Microcrystalline cellulose, crospovidone, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate. Film coating: Basic butyl methacrylate copolymer, titanium dioxide (E171), talc, and macrogol 6000.

Description of the appearance of Amoxicillin and Clavulanic Acid Zentiva Italia and pack contents
Film-coated tablet, white to off-white, oblong in shape, with a score line.
Amoxicillin and Clavulanic Acid Zentiva Italia are available in blisters containing: 10, 12,
14, 20, 21 and 24 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7
20121 Milan
Italy

Manufacturer
PenCef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin, Germany
Prestige Promotion Verkaufsförderung & Werbeservice GmbH
Borsigstraße 2, 63755 Alzenau
Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Amoxicillin and Clavulanic Acid Zentiva Italia
Netherlands: Amoxicillin/Clavulanic Acid Zentiva
Bulgaria, Czech Republic, Poland, Slovakia: Penlac
Germany: Amoxicillin/Clavulansäure Zentiva

Behavioral 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 development of bacterial resistance.
When your doctor prescribes you an antibiotic, 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 the failure of antibiotic therapy.

1. 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.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
3. Do not use antibiotics that have been prescribed for other people, even if you think you have a similar infection.
4. Do not give your antibiotics to other people, even if they have a similar condition.
5. If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.