Amoxicillin and clavulanic acid Zentiva Generics

Patient Information Leaflet

Amoxicillin and Clavulanic Acid Zentiva Generics

400 mg/57 mg/5 ml powder for oral suspension
Generic medicine
Please read this leaflet carefully before giving this medicine to your child, as it contains important information for your child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your child's doctor or pharmacist.
• This medicine is usually prescribed for infants or children. Do not give it to other people, even if their symptoms are the same as your child's, as it could be harmful.
• If your child experiences any side effects, including those not listed in this leaflet, contact your child's doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Amoxicillin and Clavulanic Acid Zentiva Generics is and what it is used for
2. What you need to know before giving Amoxicillin and Clavulanic Acid Zentiva Generics
3. How to give Amoxicillin and Clavulanic Acid Zentiva Generics
4. Possible side effects
5. How to store Amoxicillin and Clavulanic Acid Zentiva Generics
6. Package contents and other information

1. What Amoxicillin and Clavulanic Acid Zentiva Generics is and what it is used for

Amoxicillin and Clavulanic Acid Zentiva Generics is an antibiotic that works by killing bacteria causing 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 (i.e. rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid Zentiva Generics is used in infants 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.

What you should know before giving Amoxicillin and Clavulanic Acid Zentiva Generics
Do not give Amoxicillin and Clavulanic Acid Zentiva Generics to your child:

• if he/she is allergic to amoxicillin, clavulanic acid, penicillin, or to any of the excipients of this medicine (listed in section 6)
• if he/she has had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include rash or swelling of the face or throat
• if he/she has had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. → Do not give Amoxicillin and Clavulanic Acid Zentiva Generics to your child if any of these cases apply to him/her. If you have any doubts, speak with your child’s doctor or pharmacist before giving Amoxicillin and Clavulanic Acid Zentiva Generics.

Warnings and precautions
Talk to your doctor or pharmacist before giving your child Amoxicillin and Clavulanic Acid Zentiva Generics if:

• he/she has infectious mononucleosis (glandular fever)
• he/she has been treated for liver or kidney problems
• he/she does not urinate regularly.

If you are unsure whether any of the above conditions apply to your child, speak with your child’s doctor or pharmacist before giving Amoxicillin and Clavulanic Acid Zentiva Generics.
In some cases, your child’s doctor may perform tests to identify the type of bacteria causing your child’s infection. Based on the results, he/she may prescribe a different dose of Amoxicillin and Clavulanic Acid Zentiva Generics or a different medicine.
Conditions you should monitor
Amoxicillin and Clavulanic Acid Zentiva Generics may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures (fits), and inflammation of the bowel. You should watch for certain symptoms while giving Amoxicillin and Clavulanic Acid Zentiva Generics to your child, in order to reduce any risk. See “Conditions you should monitor” in Section 4.
Blood and urine tests
If your child is due to have blood tests (for example, checks on red blood cells or liver function tests) or urine tests (for glucose), inform the doctor or nurse that your child is taking Amoxicillin and Clavulanic Acid Zentiva Generics. This is because Amoxicillin and Clavulanic Acid Zentiva Generics may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid Zentiva Generics
Tell the doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
If your child is taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid Zentiva Generics, it is very likely that your child may develop a skin allergic reaction.
If your child is taking probenecid (used for gout), the doctor may decide to adjust the dose of Amoxicillin and Clavulanic Acid Zentiva Generics.
If your child is taking medicines (such as warfarin) that help prevent blood clots, additional blood tests may be needed.
Amoxicillin and Clavulanic Acid Zentiva Generics may affect how methotrexate (a medicine used to treat tumours or rheumatic diseases) works.
Amoxicillin and Clavulanic Acid Zentiva Generics may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If your daughter taking this medicine is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Side effects (e.g. allergic reactions, dizziness, seizures) may occur during treatment with Amoxicillin and Clavulanic Acid Zentiva Generics, which could affect the ability to drive or operate machinery.
Amoxicillin and Clavulanic Acid Zentiva Generics contains maltodextrin, sodium, and benzyl alcohol
Amoxicillin and Clavulanic Acid Zentiva Generics contains maltodextrin, a source of glucose. If your child’s doctor has diagnosed your child with intolerance to certain sugars, consult your doctor before administering this medicine.
Amoxicillin and Clavulanic Acid Zentiva Generics contains less than 1 mmol of sodium (23 mg) per maximum single dose, i.e. essentially "sodium-free".
Amoxicillin and Clavulanic Acid Zentiva Generics contains 0.23 mcg of benzyl alcohol in each ml of reconstituted oral suspension. Benzyl alcohol may cause allergic reactions.
Do not use for more than one week in young children (under 3 years), unless advised by a doctor or pharmacist.
Seek advice from your doctor or pharmacist if your daughter is pregnant or breastfeeding, or has liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in their body and may cause side effects (called "metabolic acidosis").

3. How to administer Amoxicillin and Clavulanic Acid Zentiva Generics

Always give this medicine exactly as directed by your child's doctor or pharmacist.
If you have any doubts, consult your child's doctor or pharmacist.

Adults and children weighing 40 kg or more

• This suspension is generally not recommended for adults and children weighing 40 kg or more. If you have any doubts, consult your child's doctor or pharmacist.

Children weighing less than 40 kg
All doses are calculated based on the child's body weight expressed in kilograms.

• Your child's doctor will advise you on the correct dose of Amoxicillin and Clavulanic Acid Zentiva Generics to give your infant or child.
• A plastic syringe or measuring spoon may be provided. You should use it to ensure the correct dose is given to your infant or child.
• Recommended dose – from 25 mg/3.6 mg up to 45 mg/6.4 mg per kg of body weight per day, administered in two divided doses.
• Higher dose – up to 70 mg/10 mg per kg of body weight per day, administered in two divided doses.

Patients with kidney or liver problems

• If your child has kidney problems, the dose may be reduced. The doctor may choose a different dosage or a different medicine.
• If your child has liver problems, more frequent blood tests may be needed to monitor liver function.

How to administer Amoxicillin and Clavulanic Acid Zentiva Generics

• Always shake the bottle well before each dose.
• Administer the dose at the beginning of a meal or immediately before a meal.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not give two doses within one hour.
• Do not give your child Amoxicillin and Clavulanic Acid Zentiva Generics for longer than 2 weeks. If your child does not feel better, you must return to the doctor.

If you give more Amoxicillin and Clavulanic Acid Zentiva Generics than you should
If you give your child too much Amoxicillin and Clavulanic Acid Zentiva Generics, symptoms may include stomach upset (feeling sick, nausea, or diarrhoea) or seizures. Contact your child's doctor as soon as possible. Take the medicine bottle with you to show the doctor.

If you forget to give Amoxicillin and Clavulanic Acid Zentiva Generics
If you forget to give your child a dose, give it as soon as you remember. Do not give the next dose too early, but wait approximately 4 hours before administering the next dose. Do not give a double dose to make up for a missed dose.

If your child stops treatment with Amoxicillin and Clavulanic Acid Zentiva Generics
Continue giving Amoxicillin and Clavulanic Acid Zentiva Generics to your child until the treatment is complete, even if they feel better. Your child needs every dose to 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 child's doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 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 an allergy-triggered heart attack (Kounis syndrome).

→ Contact your doctor immediately if your child experiences any of these symptoms. Stop taking
Amoxicillin and Clavulanic Acid Zentiva Generics.
Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.
→ If your child experiences these symptoms, contact your child's doctor as soon as possible for advice.
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 mainly reported 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). Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
Common: may affect up to 1 in 10 people

• thrush (candida – a fungal infection of the vagina, mouth or skin folds)
• feeling unwell (nausea), especially when taking high doses → if affected, take Amoxicillin and Clavulanic Acid Zentiva Generics before meals
• vomiting
• diarrhoea

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:

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

Rare: may affect up to 1 in 1,000 people

• skin rash, 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 may be detected through blood tests:
• low number of cells involved in blood clotting
• low number of white blood cells

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 rash with blisters and skin peeling, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing extensive skin shedding (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis)
  • 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 (drug-related symmetric intertriginous and flexural exanthema (SDRIFE))

→ If your child experiences 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 bilirubin levels in the blood (a substance produced in the liver), which may make your child’s skin and the whites of the eyes appear yellow
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Amoxicillin and Clavulanic Acid Zentiva Generics or who have kidney problems)
• black hairy tongue, appearing covered in 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 white blood cell count
• low number of red blood cells (haemolytic anaemia)
• crystals in urine leading to acute kidney injury

Reporting of side effects
If your child experiences 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 Generics

Keep this medicine out of the sight and reach of children.
Dry powder
Store below 25 °C.
Keep in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the carton or on the label of the bottle after
Exp. The expiry date refers to the last day of that month.
Liquid suspension
Store in the refrigerator (2 °C - 8 °C) and in the original packaging. Do not freeze.
Once prepared, the suspension must be used within 7 days.
Do not dispose of any medicine 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 Amoxicillina e Acido Clavulanico Zentiva Generics contains

• The active substances are amoxicillin and clavulanic acid. Each ml of suspension contains amoxicillin trihydrate equivalent to 80 mg of amoxicillin and potassium clavulanate equivalent to 11.4 mg of clavulanic acid.
• The other components are crospovidone type A (E1202), hydrated colloidal silica (E551), xanthan gum (E415), sodium carmellose (E466), anhydrous colloidal silica (E551), potassium acesulfame (E950), sodium saccharin (E954), strawberry flavour (maltodextrin, triethyl citrate (E1505), flavouring components, propylene glycol, benzyl alcohol).

Description of the appearance of Amoxicillina e Acido Clavulanico Zentiva Generics and contents of the
pack
Amoxicillina e Acido Clavulanico Zentiva Generics is a white to yellowish powder supplied in an amber glass bottle. Once reconstituted, the bottle contains a white to yellowish liquid mixture called a suspension.
The bottles are packaged together with a dosing device:

• 6 ml PE/PS syringe
• 5 ml PP dosing cup

Pack sizes: 35 ml, 70 ml, 140 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7
20121 Milano
Italy

Manufacturers
PenCef Pharma GmbH
Breitenbachstrasse 13-14, 13509 Berlin, Germany
Haupt Pharma Latina S.r.l.
Strada Statale 156, Km 47,600, Monti Lepini, 04100 Borgo San Michele, Latina, Italy

This medicinal product is authorised in the European Economic Area countries under the following
names:
Portugal Amoxicilina + Ácido Clavulânico Zentiva
Italy Amoxicillina e Acido Clavulanico Zentiva Generics

Advice/health education

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 antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the development of bacterial resistance.
When your doctor prescribes an antibiotic treatment for your child, it is intended solely for the illness your child currently has. Please follow the advice below to help prevent the emergence of bacterial resistance, which can lead to antibiotics becoming ineffective.

1. It is very important that you give the antibiotic in the correct dose, at the prescribed times, and for the exact number of days. Read the instructions on the label carefully and, if anything is unclear, ask your child’s doctor or pharmacist for clarification.
2. Do not give antibiotics unless they have been specifically prescribed for your child, and use them only for the infection they were prescribed for.
3. Do not give antibiotics prescribed for other people, even if their infection seems similar to your child’s.
4. Do not give to others antibiotics that have been specifically prescribed for your child.
5. If, after completing the treatment as directed by your child’s doctor, you have leftover antibiotic, return it to the pharmacist for proper disposal.

Instructions for reconstitution

Check that the seal on the cap is intact before use. Shake the bottle to loosen the powder.
Add water to just below the mark on the bottle label.
Invert and shake well, then allow the foam to settle.
Then top up with water exactly to the mark, invert again and shake thoroughly.
Shake the bottle well before each dose.
Further information on the preparation of the oral suspension is available at pharmacies.