Amoxiclav es

Patient Information Leaflet

Amoksiklav ES, (600 mg + 42.9 mg)/5 ml, powder for oral suspension
Amoxicillinum + Acidum clavulanicum
Please read this leaflet carefully before giving this medicine to your child, because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine is usually prescribed for infants or children. Do not give it to anyone else. This medicine may harm another person, even if their symptoms are the same.
• If your child experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Amoksiklav is and what it is used for
2. Important information before using Amoksiklav
3. How to use Amoksiklav
4. Possible side effects
5. How to store Amoksiklav
6. Contents of the package and other information

1. What Amoksiklav is and what it is used for

Amoksiklav is an antibiotic that works by killing bacteria causing infections.
It contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", whose action can sometimes be blocked (inactivated).
The second active substance (clavulanic acid) prevents this inactivation.
Amoksiklav is used in infants and children to treat the following infections:
middle ear infections
lung infections

2. Important information before using Amoksiklav

When not to give Amoksiklav to a child
if the child is allergic to amoxicillin, clavulanic acid, penicillin, or to any of the other
components of this medicine (listed in section 6).
if the child has ever had a severe allergic reaction to any other antibiotic.
This may include skin rash, swelling of the face or throat.
if the child has ever had liver problems or jaundice (yellowing of the
skin) caused by taking an antibiotic.
If any of the above situations apply to the child, do not give Amoksiklav
. If in doubt, consult a doctor or pharmacist before administering Amoksiklav.

Warnings and precautions
Before starting this medicine for the child, discuss with a doctor or pharmacist if the child:
has infectious mononucleosis
is being treated for liver or kidney function disorders
passes urine irregularly.
If in doubt whether any of these conditions apply to the child, consult a doctor or pharmacist before administering Amoksiklav.
In some cases, the doctor may test which type of bacteria caused the infection. Depending on the results, the child may receive Amoksiklav of a different strength or another medicine.

Conditions to watch for
Taking Amoksiklav may worsen the course of certain existing diseases or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. While taking Amoksiklav, it is important to monitor whether the child develops specific symptoms to reduce the risk of any problems. See "Conditions to watch for" in section 4.

Blood and urine tests
If the child is due to have blood tests (e.g. red blood cell count or liver function tests) or urine tests (for glucose), inform the doctor or nurse that the child is taking Amoksiklav. Amoksiklav may affect the results of these tests.

Amoksiklav and other medicines
Tell the doctor or pharmacist about all medicines the child is currently taking or has recently taken, as well as any medicines planned for administration.
If the child is taking allopurinol (used to treat gout) at the same time as Amoksiklav, the likelihood of a skin allergic reaction increases.
If the child is taking probenecid (used to treat gout) – concurrent use of probenecid may reduce the elimination of amoxicillin and is not recommended.
If the child is taking medicines that reduce blood clotting (such as warfarin) together with Amoksiklav, additional blood tests may be necessary.
Methotrexate (used to treat cancers, rheumatic diseases, and severe psoriasis) – penicillins may reduce methotrexate elimination, increasing the risk of adverse effects.
Amoksiklav may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of a transplanted organ).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Amoksiklav contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, meaning the medicine is considered "sodium-free".

Amoksiklav contains benzyl alcohol
This medicine contains 0.017 mg of benzyl alcohol in 5 ml of suspension (corresponding to 1.5 g of powder).
Benzyl alcohol may cause allergic reactions. Do not administer to young children (under 3 years of age) for longer than one week without a doctor's or pharmacist's recommendation.
If the child has liver or kidney disease, or is pregnant or breastfeeding, contact a doctor before administration, as a large amount of benzyl alcohol may accumulate in the body and cause adverse effects (so-called "metabolic acidosis").

Amoksiklav contains ethanol
This medicine contains less than 0.004 mg of alcohol (ethanol) in 5 ml of suspension (corresponding to 1.5 g of powder). The amount of alcohol in 5 ml of this medicinal product is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

Amoksiklav contains sulphites
This medicine contains less than 0.000017 mg of sulphites in 5 ml of suspension (corresponding to 1.5 g of powder). This medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Amoksiklav

This medicine should always be taken as directed by the doctor. If in doubt, consult your
doctor or pharmacist.
Adults and children with body weight of 40 kg or more
This suspension is not usually recommended for use in adults and children with body weight equal to or
greater than 40 kg. Consult your doctor or pharmacist for advice.
Children with body weight less than 40 kg
All doses are determined according to the child's body weight in kilograms.
Your doctor will advise you on the appropriate dose of Amoksiklav to give to the infant or
child.
An oral syringe is provided with the medicine package. Use it to administer the correct dose to the infant or
child.
The usual dose is (90 mg + 6.4 mg) per kilogram of body weight per day, given in two divided doses.
Amoksiklav is not recommended for use in children under 3 months of age.
Patients with kidney or liver disease
For children with impaired kidney function, the dose may be adjusted. The doctor may recommend
using a different strength or another medicine.
Children with impaired liver function may require more frequent blood tests to monitor liver function.
How to take Amoksiklav
Take with food.
After taking the suspension, drink a glass of water.
Before administering each dose, always shake the bottle well.
Doses should be evenly spaced throughout the day, with at least four-hour intervals. Do not
administer two doses within one hour.
Do not give Amoksiklav to a child for longer than 2 weeks. If the child still feels unwell, contact the doctor again.
Taking more Amoksiklav than recommended
If too high a dose of Amoksiklav has been given to the child, symptoms such as stomach irritation (nausea, vomiting, or diarrhoea) or seizures may occur. Contact a doctor as quickly as possible. Take the medicine packaging with you to show the doctor.
Missed dose of Amoksiklav
If a dose of Amoksiklav has been missed, give it as soon as you remember. Do not give the next dose too soon, but wait approximately 4 hours before administering it. Do not give a double dose to make up for a missed dose.
Stopping treatment with Amoksiklav
Continue giving Amoksiklav to the child until the end of the prescribed treatment period, even if the child feels better. All doses are needed to eliminate the infection. If some bacteria survive, they may cause a recurrence of the infection.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects listed below may occur during treatment with this medicine.
Symptoms to be aware of
Allergic reactions:
skin rash
inflammation of 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 lymph nodes in the neck, underarm, or groin
swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing
fainting
chest pain related to an allergic reaction, which may be a sign of an allergy leading to heart attack (Kounis syndrome).
If your child experiences any of these symptoms, you must contact a doctor immediately. You must stop taking Amoksiklav.
Inflammation of the large intestine
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, stomach pain and (or) fever.
Acute pancreatitis
If you have severe and persistent pain in the stomach area, this may be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin with clavulanic acid. This is a type of allergic reaction, the main symptom of which is repeated vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
If your child experiences any of these symptoms, you should seek medical advice 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 (candidiasis – a fungal infection of the vagina, mouth or skin folds)
nausea, especially when taking high doses of the medicine
→ If nausea occurs, Amoksiklav should be taken with 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 that may appear in blood test results:
increased activity of certain substances (enzymes) produced in the liver.
Rare side effects (may affect up to 1 in 1,000 people)
skin rash which may develop into blisters and looks like target lesions (dark spot in the centre surrounded by a paler ring with a dark edge – erythema multiforme)
→ If the patient notices any of these symptoms, contact a doctor urgently.
Rare side effects that may appear in blood test results:
low number of platelets (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)
inflammation of the large intestine (see above)
crystals in the urine leading to acute kidney injury
blisters arranged in a ring-like pattern or like a string of pearls (linear IgA dermatosis)
inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
severe skin reactions:

• widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome) and a more severe form causing extensive peeling of the skin (affecting more than 30% of the body surface – toxic epidermal necrolysis)
• widespread, red skin rash with small pustules filled with pus (pustular exanthema)
• red, scaly rash with subcutaneous nodules and blisters (bullous pemphigoid)
• flu-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results [including increased white blood cell count (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS)
• red rash often seen on both sides of the buttocks, inner upper thighs, underarms, neck (symmetrical drug-related intertriginous and flexural exanthema, SDRIFE)

If your child experiences any of these symptoms, you must contact a doctor immediately.
inflammation of the liver (hepatitis)
jaundice due to increased bilirubin levels in the blood (a substance produced in the liver), which may cause yellowing of the skin and whites of the eyes in the child
inflammation of the kidney tubules
prolonged blood clotting time
hyperkinesia
seizures (in people receiving high doses of Amoksiklav or in people with impaired kidney function)
black hairy tongue
tooth discoloration (in children), which can usually be removed by brushing.
Side effects that may appear in blood test results:
marked decrease in white blood cell count
low number of red blood cells (haemolytic anaemia)
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Amoksiklav

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging to protect from moisture.
After reconstitution of the ready-to-use suspension:
Store in a refrigerator (at 2°C to 8°C) and use within 10 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Amoksiklav contains

• The active substances are amoxicillin and clavulanic acid.
• Each ml of reconstituted suspension (corresponding to 0.3 g of powder) contains 120 mg of amoxicillin (as amoxicillin trihydrate) and 8.58 mg of clavulanic acid (as potassium clavulanate).
• Each 5 ml of reconstituted suspension contains 600 mg of amoxicillin (as amoxicillin trihydrate) and 42.9 mg of clavulanic acid (as potassium clavulanate).
• Other ingredients are: citric acid, sodium citrate, microcrystalline cellulose, sodium carboxymethylcellulose, xanthan gum, colloidal anhydrous silica, silicon dioxide, raspberry flavour (containing flavouring and taste-improving substances, corn maltodextrin, propylene glycol, glyceryl triacetate, benzyl alcohol, ethanol and sodium), orange flavour (containing natural and artificial flavouring substances, corn maltodextrin, corn starch, sodium and sulphites), caramel flavour (containing flavouring and taste-improving substances, corn maltodextrin, triethyl citrate, ethanol and sodium), sodium saccharin (E 954).
• For further information on benzyl alcohol, ethanol and sulphites, see section 2.

What Amoksiklav looks like and contents of the pack
Amoksiklav ES (600 mg + 42.9 mg)/5 ml powder for oral suspension is a powder for preparing an oral suspension, white to slightly yellow in colour.
Pack contents: Amber glass bottles (type III) with a capacity of 100 ml or 180 ml, closed with a polypropylene cap with a sealing membrane or a child-resistant polypropylene-polyethylene cap with a sealing membrane, packaged together with a measuring syringe with a propylene body and a polyethylene plunger and stopper. The total capacity of the measuring syringe ranges from 0.5 to 5 ml. Each black marking indicates 0.1 ml.
Pack sizes:
1 bottle containing 17.7 g of powder (to prepare 50 ml of oral suspension)
1 bottle containing 33.8 g of powder (to prepare 100 ml of oral suspension)
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Bulgaria Amoksiklav 600 mg/42.9 mg/5 ml powder for oral suspension
Spain Amoxicilina/Ácido clavulánico Sandoz 600 mg/42.9 mg/5 ml polvo para suspensión oral
Italy BAMKLA
Poland Amoksiklav
Portugal Amoxicilina + Ácido Clavulânico Sandoz
Romania Amoksiklav 600 mg/42.9 mg/5 ml, Pulbere pentru suspensie orală
Slovenia Amoksiklav 600 mg/42.9 mg v 5 ml prašek za peroralno suspenzijo
Slovakia Amoksiklav 600 mg/42.9 mg/5 ml
(logo of the Marketing Authorisation Holder)

Medical education
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
Sometimes bacterial infections do not respond to antibiotic treatment. One of the most common reasons for this is that bacteria are resistant to the prescribed antibiotic. This means that bacteria can survive or multiply despite the use of the antibiotic.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics may help reduce the risk of development of bacterial resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Observing the following advice will help prevent the development of resistant bacteria that could impair the effectiveness of antibiotics.

1. 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 in this leaflet carefully. If any of them are unclear, ask your doctor or pharmacist for clarification.

2. Do not take an antibiotic unless it has been prescribed specifically for you. Take it only to treat the infection for which it was prescribed.

3. Do not take an antibiotic prescribed for another person, even if they had a similar infection.

4. Do not give your prescribed antibiotics to other people.

5. If any antibiotic remains after completing the treatment as directed by your doctor, return it to a pharmacy (which will accept it) to ensure its proper disposal.

Instructions for preparing the medicine
Before administration, the oral suspension must be prepared from the dry powder as described in detail below:
Before use, check that the seal protecting the closure has not been tampered with.
Tap the bottle until the powder becomes free-flowing. Add approximately 2/3 of the total volume of water required for reconstitution (see table below) and shake vigorously to suspend the powder.
Add the remaining water and shake vigorously again.
Alternative method for preparing the suspension: Tap the bottle until the powder becomes free-flowing. Fill the bottle with water up to just below the line marked on the label. Close the bottle with the cap, invert it, and shake vigorously. Then add water to exactly the level of the marked line. Close the bottle again, invert it, and shake vigorously.
After reconstitution, the medicinal product is a homogeneous suspension, almost white to slightly yellow in colour.

Shake the bottle well before each use.