Amoxiclav es

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Amoksiklav ES (Amoksiklav 600 mg/42.9 mg/5 ml)
(600 mg + 42.9 mg)/5 ml, powder for oral suspension
Amoxicillinum + Acidum clavulanicum
Amoksiklav ES and Amoksiklav 600 mg/42.9 mg/5 ml are different trade names of the same
medicinal product.
Please read the entire leaflet carefully before giving this medicine to your child, as it
contains important information for the patient.

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

Table of contents:

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

1. What Amoksiklav ES is and what it is used for

Amoksiklav ES 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 activity can sometimes be inhibited (inactivated). The second active substance (clavulanic acid) counteracts this inactivation. Amoksiklav ES is used in infants and children to treat the following infections:

• middle ear infections
• lung infections.

2. Important information before using Amoksiklav ES

When not to give Amoksiklav ES to a child

• if the child is allergic to amoxicillin, clavulanic acid, penicillin, or to any of the other ingredients 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, do not give the child Amoksiklav ES.
If in doubt, consult a doctor or pharmacist before administering Amoksiklav ES.

Warnings and precautions

Talk to a doctor or pharmacist before giving this medicine to a child if the child:

• has infectious mononucleosis;
• is being treated for liver or kidney problems;
• passes urine irregularly.

If in doubt whether any of these apply to the child, consult a doctor or pharmacist before administering Amoksiklav ES.

In some cases, the doctor may test which type of bacteria caused the infection. Depending on the results, the child may be given a different strength of Amoksiklav ES or another medicine.

Symptoms to watch for

Treatment with Amoksiklav ES may worsen certain pre-existing conditions or cause serious side effects, including allergic reactions, seizures, and inflammation of the large intestine (colitis). While taking Amoksiklav ES, monitor the child for specific symptoms to reduce the risk of complications. See "Symptoms 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 ES. Amoksiklav ES may affect the results of such tests.

Amoksiklav ES and other medicines

Tell the doctor or pharmacist about all medicines the child is currently taking, has recently taken, or is planned to take.

If the child is taking allopurinol (used to treat gout) at the same time as Amoksiklav ES, the risk of developing a skin allergic reaction increases.

If the child is taking probenecid (used to treat gout), concomitant use 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 ES, additional blood tests may be necessary.

Methotrexate (used in the treatment of cancer and severe psoriasis) – penicillins may reduce methotrexate elimination, increasing the risk of adverse effects.

Amoksiklav ES may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).

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 ES 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 ES 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 medical advice.

If the child has liver or kidney disease, or if the patient is pregnant or breastfeeding, consult a doctor before administration, as large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (so-called "metabolic acidosis").

Amoksiklav ES 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 ES 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 ES

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult
the 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 the 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.

• The doctor will advise what dose of Amoksiklav ES should be given to the infant or child.
• An oral syringe with measuring scale is supplied with the medicine. 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 ES 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 of the medicine or another medicine.
• Children with impaired liver function may require more frequent blood tests to monitor liver function.

How to take Amoksiklav ES

• Take with food.
• After taking the suspension, drink a glass of water.
• Always shake the bottle well before administering each dose.
• Doses should be evenly spaced throughout the day, with at least four hours between doses. Do not administer two doses within one hour.
• Do not give Amoksiklav ES to a child for longer than two weeks. If the child still feels unwell, contact the doctor again.

Taking more Amoksiklav ES than recommended
If too high a dose of Amoksiklav ES has been given to a child, symptoms such as stomach irritation (nausea, vomiting, or diarrhoea) or seizures may occur. Contact the doctor immediately. Take the medicine packaging along to show the doctor.
If a dose of Amoksiklav ES is missed
If a dose has been forgotten, give it as soon as remembered. 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 Amoksiklav ES treatment
Continue giving Amoksiklav ES to the child for the full duration of treatment, even if the child starts to feel better. All doses are needed to completely eliminate the infection. If some bacteria survive, they may cause the infection to return.
If there are any further questions about the use of this medicine, consult the 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, under the arm, or in the groin
• swelling, sometimes of the face or throat (angioedema), causing difficulty breathing
• fainting
• chest pain associated with 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 ES.
Inflammation of the large intestine (colitis)
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)

• fungal infections (candidiasis – yeast infection of the vagina, mouth or skin folds)
• nausea, especially when high doses of the medicine are taken

→ If nausea occurs, Amoksiklav ES 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 appear as target-like lesions (dark spot in the centre surrounded by a lighter ring with a dark border at the edge – erythema multiforme) → If the patient notices any of these symptoms, medical advice should be sought urgently.

Rare side effects that may appear in blood test results:

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

Side effects with unknown frequency (frequency cannot be estimated from available data)

• allergic reactions (see above)
• inflammation of the large intestine (colitis) (see above)
• crystals in the urine leading to acute kidney injury
• blistering rash 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 body surface – toxic epidermal necrolysis)
• widespread red skin rash with small pus-filled blisters (bullous exfoliative dermatitis)
• red, scaly rash with lumps under the skin and blisters (pustular eruption)
• flu-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results [including increased number of white blood cells (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS).

If your child experiences any of these symptoms, you must contact a doctor immediately.

• inflammation of the liver ( hepatitis )
• jaundice due to increased blood bilirubin levels (a substance produced in the liver), which may cause yellowing of the skin and the whites of the eyes in children
• inflammation of the kidney tubules
• prolonged blood clotting time
• motor hyperactivity
• seizures (in people receiving high doses of Amoksiklav ES or in people with impaired kidney function)
• black, hairy-looking 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 cells
• low number of red blood cells (haemolytic anaemia).

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Amoksiklav ES

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

6. Package contents and other information

What Amoksiklav ES contains

• The active substances are amoxicillin and clavulanic acid.
• Each ml of reconstituted suspension (corresponding to 0.3 g of powder) contains 120 mg amoxicillin (as amoxicillin trihydrate) and 8.58 mg clavulanic acid (as potassium clavulanate).
• Each 5 ml of reconstituted suspension contains 600 mg amoxicillin (as amoxicillin trihydrate) and 42.9 mg 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 components, corn maltodextrin, propylene glycol, glyceryl triacetate, benzyl alcohol, ethanol and sodium), orange flavour (containing natural and artificial flavouring components, corn maltodextrine, corn starch, sodium and sulphites), caramel flavour (containing flavouring and taste-improving components, 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 ES looks like and contents of the pack
Amoksiklav ES, (600 mg + 42.9 mg)/5 ml, powder for oral suspension is a white to slightly yellowish powder.
Pack contents: Brown glass bottle (hydrolytic class III) with a capacity of 180 ml, fitted with an HDPE screw cap and a PS/LDPE pipette graduated at 0.1 ml, marked from 0.4 ml to 5 ml, in a cardboard box.
Pack size: 1 bottle containing 33.1 g powder (for preparation of 100 ml oral suspension).
For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Romania, country of export:
Sandoz S.R.L.
Str. Livezeni Nr. 7A
Târgu Mureș
Romania

Manufacturer:
LEK PHARMACEUTICALS d.d.
Perzonali 47, SI-2391 Prevalje
Slovenia

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Romania, country of export: 13749/2021/02
Parallel Import Licence Number: 53/24
This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names:
Bulgaria Amoksiklav ES 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 ES
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

Medical education
Antibiotics are used to treat bacterial infections. They are ineffective in treating 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 antibiotic administered. 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 prescribed number of days. Please read the instructions in this leaflet carefully and, if any are unclear, ask your doctor or pharmacist for clarification.
2. The patient should not take an antibiotic unless it has been prescribed specifically for them. It should be taken only to treat the infection for which it was prescribed.
3. The patient should not take an antibiotic prescribed for another person, even if their symptoms were similar.
4. Do not give antibiotics prescribed for you to other people.
5. If any unused antibiotic remains after completing the prescribed course of treatment, return it to a pharmacy (which will accept it) for 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 securing the cap has not been broken.
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. Then add the remaining water and shake again vigorously.

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 and shake vigorously. Then add water exactly up to the marked line. Close the bottle again, invert and shake vigorously.

After reconstitution, the medicinal product forms a uniform suspension, almost white to slightly yellowish in colour.

Shake the bottle well before each use.