Amoksiklav Es

Leaflet accompanying the packaging: patient information

Warning! Keep the 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
Amoxicillin + Clavulanic acid
Amoksiklav ES and Amoksiklav 600 mg/42.9 mg/5 ml are different trade names for the same medicine.

You should carefully read the contents of the leaflet before giving this medicine to a child, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a 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 the child experiences any side effects, including any side effects not listed in the leaflet, you should tell the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Amoksiklav ES is an antibiotic that works by killing bacteria that cause infections. It contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", which can sometimes be 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 taking Amoksiklav ES

When not to give Amoksiklav ES to a child

If any of the above situations apply to the child, do not give them Amoksiklav ES

Amoksiklav ES.If you are unsure before giving Amoksiklav ES to a child, consult a doctor or pharmacist.

Warnings and precautions

Before starting to give this medicine to a child, you should discuss it with a doctor or pharmacist if the child:

• has infectious mononucleosis
• is being treated for liver or kidney problems
• has irregular urination.

If you are unsure whether any of these statements apply to the child, consult a doctor or pharmacist before giving Amoksiklav ES.
In some cases, the doctor may test what type of bacteria caused the infection. Depending on the results, the child may receive Amoksiklav ES with a different strength or a different medicine.

Conditions to watch out for

Taking Amoksiklav ES may worsen the course of some existing diseases or cause severe side effects. These include allergic reactions, seizures, and colitis. When taking Amoksiklav ES, you should pay attention to whether the child is experiencing certain symptoms to minimize the risk of any problems. See "Conditions to watch out for" in section 4.

Blood and urine tests

If the child is to have a blood test (e.g., a red blood cell test or liver function tests) or a urine test (for glucose), you should inform the doctor or nurse that the child is taking Amoksiklav ES. Amoksiklav ES may affect the results of these tests.

Amoksiklav ES and other medicines

You should tell the doctor or pharmacist about all medicines the child is currently taking or has recently taken, as well as any medicines planned to be given to the child.
If the child is taking allopurinol(used to treat gout) at the same time as Amoksiklav ES, the likelihood of a skin allergic reaction increases.
If the child is taking probenecid(used to treat gout) - concurrent use of probenecid may decrease the excretion of amoxicillin and is not recommended.
If the child is taking medicines that reduce blood clotting (such as warfarin), additional blood tests may be necessary.
Methotrexate(used to treat cancer and severe psoriasis) - penicillins may decrease the excretion of methotrexate, potentially leading to increased side effects.
Amoksiklav ES 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, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Amoksiklav ES contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e., 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 (which corresponds to 1.5 g of powder). Benzyl alcohol may cause allergic reactions. Do not give to small children (under 3 years) for more than a week without consulting a doctor or pharmacist.
If the child has liver or kidney disease or is pregnant or breastfeeding, you should consult a doctor before giving the medicine, as a large amount of benzyl alcohol may accumulate in the body and cause side effects (so-called "metabolic acidosis").

Amoksiklav ES contains ethanol

This medicine contains less than 0.004 mg of ethanol in 5 ml of suspension (which corresponds to 1.5 g of powder). The amount of ethanol 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 ethanol in this medicine will not cause noticeable effects.

Amoksiklav ES contains sulfites

This medicine contains less than 0.000017 mg of sulfites in 5 ml of suspension (which corresponds to 1.5 g of powder). The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Amoksiklav ES

This medicine should always be taken as directed by a doctor. If you are unsure, consult a doctor or pharmacist.

Adults and children with a body weight of 40 kg or more

• This suspension is not usually recommended for adults and children with a body weight of 40 kg or more. Consult a doctor or pharmacist for advice.

Children with a body weight of less than 40 kg

All doses are determined based on the child's body weight in kilograms.

• The doctor will advise what dose of Amoksiklav ES to give to the infant or child.
• A measuring syringe is attached to the medicine packaging. You should use it to give the infant or child the correct dose.
• 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 children under 3 months of age.

Patients with kidney and liver diseases

• For children with kidney problems, the dose may be changed. The doctor may recommend taking a medicine with a different strength or a different medicine.
• Children with liver problems may need to have blood tests more frequently to monitor liver function.

How to take Amoksiklav ES

• Take with food.
• After taking the suspension, drink a glass of water.
• Before giving each dose, always shake the bottle well
• Doses should be spaced evenly throughout the day, with at least 4-hour intervals. Do not give 2 doses within 1 hour.
• Do not give Amoksiklav ES to a child for more than 2 weeks. If the child still feels unwell, consult a doctor again.

Taking more than the recommended dose of Amoksiklav ES

If too much Amoksiklav ES is given to a child, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Consult a doctor as soon as possible. Take the medicine packaging with you to show the doctor.

Missing a dose of Amoksiklav ES

If a dose of Amoksiklav ES is missed, give it as soon as you remember. Do not give the next dose too soon, but wait about 4 hours before giving it. Do not give a double dose to make up for a missed dose.

Stopping Amoksiklav ES

Give Amoksiklav ES to the child until the end of the treatment, even if they feel better. All doses are needed to fight the infection. If some bacteria survive, they may cause the infection to come back.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur when taking Amoksiklav ES.

Conditions to watch out for

Allergic reactions:

• skin rash
• vasculitis (inflammation of blood vessels), which can appear as red or purple raised spots on the skin, but can also affect other parts of the body
• fever, joint pain, swelling of lymph nodes in the neck, armpit, or groin
• swelling, sometimes of the face or throat (angioedema), causing difficulty breathing
• fainting
• chest pain associated with an allergic reaction, which can be a sign of an allergy leading to a heart attack (Kounis syndrome).

If the child experiences any of these symptoms, you should immediately consult a doctor
and stop taking Amoksiklav ES.

Colitis

Colitis, causing watery diarrhea, usually with blood and mucus, stomach pain, and (or) fever.

Acute pancreatitis

If you have severe and persistent stomach pain, it may be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis occurred mainly in children taking amoxicillin with clavulanic acid. It is a type of allergic reaction, with recurring vomiting (1 to 4 hours after taking the medicine) as the leading symptom. Further symptoms may include stomach pain, lethargy, diarrhea, and low blood pressure.
If the child experiences any of these symptoms, you should immediately consult a doctor
for advice.
Very common side effects(may occur more often than in 1 in 10 people)

• diarrhea (in adults).

Common side effects(may occur in 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 you experience nausea, take Amoksiklav ES with food.

• vomiting
• diarrhea (in children).

Uncommon side effects(may occur in up to 1 in 100 people)

• skin rash, itching
• raised, itchy rash (hives)
• 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 occur in up to 1 in 1,000 people)

• skin rash, which can change into blisters and looks like small targets (a dark spot in the center surrounded by a lighter border with a dark edge - erythema multiforme) → If you notice any of these symptoms, you should immediately consult a doctor.

Rare side effects that may appear in blood test results:

• low number of blood 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)
• colitis (see above)
• crystals in the urine leading to acute kidney damage
• skin rash with blisters arranged in a ring 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, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form, causing widespread peeling of the skin (covering more than 30% of the body surface - toxic epidermal necrolysis)
• widespread, red skin rash with small blisters filled with pus (pustular exfoliative dermatitis)
• red, scaly rash with thickening under the skin and blisters (pustular psoriasis)
• flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results [including an increased number of white blood cells (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS).

If the child experiences any of these symptoms, you should immediately consult a doctor.

• hepatitis (inflammation of the liver)
• jaundice due to increased bilirubin levels in the blood (a substance produced in the liver), which can cause yellowing of the child's skin and eyes
• inflammation of the renal tubules
• prolonged blood clotting time
• restlessness
• seizures (in people taking high doses of Amoksiklav ES or people with kidney problems)
• black hairy tongue
• tooth discoloration (in children), which can usually be removed by brushing.

Side effects that may appear in blood test results:

• significant decrease in the number of white blood cells
• low number of red blood cells (hemolytic anemia).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 can help gather more information on the safety of the medicine.

5. How to store Amoksiklav ES

Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
After preparing the ready-to-use suspension:
Store in the 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 specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Amoksiklav ES contains

• The active substances are amoxicillin and clavulanic acid.
• Each ml of the prepared suspension (which corresponds to 0.3 g of powder) contains 120 mg of amoxicillin (in the form of amoxicillin trihydrate) and 8.58 mg of clavulanic acid (in the form of potassium clavulanate).
• Each 5 ml of the prepared suspension contains 600 mg of amoxicillin (in the form of amoxicillin trihydrate) and 42.9 mg of clavulanic acid (in the form of potassium clavulanate).
• The other ingredients are: citric acid, sodium citrate, microcrystalline cellulose, sodium carmellose, xanthan gum, anhydrous colloidal silica, silicon dioxide, raspberry flavor (containing flavor and aroma enhancers, corn maltodextrin, propylene glycol, glycerol triacetate, benzyl alcohol, ethanol, and sodium), orange flavor (containing natural and artificial flavor and aroma enhancers, corn maltodextrin, cornstarch, sodium, and sulfites), caramel flavor (containing flavor and aroma enhancers, corn maltodextrin, triethyl citrate, ethanol, and sodium), sodium saccharin (E 954).
• For more information on benzyl alcohol, ethanol, and sulfites, see section 2.

What Amoksiklav ES looks like and what the packaging contains

Amoksiklav ES, (600 mg + 42.9 mg)/5 ml, powder for oral suspension is a white to light yellow powder.
Packaging contents: A brown glass bottle (III hydrolytic class) with a capacity of 180 ml with an HDPE cap and a PS/LDPE pipette with a scale from 0.1 ml, marked from 0.4 ml to 5 ml, in a cardboard box.
Packaging size: 1 bottle containing 33.1 g of powder (to prepare 100 ml of oral suspension).
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:13749/2021/02

Parallel import authorization number: 53/24

This medicinal product is authorized 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 powder for oral suspension
Italy
BAMKLA
Poland
Amoksiklav ES
Portugal
Amoxicilina + Ácido Clavulânico Sandoz
Romania
Amoksiklav 600 mg/ 42.9 mg/5 ml, powder for oral suspension
Slovenia
Amoksiklav 600 mg/42.9 mg in 5 ml powder for oral suspension
Slovakia
Amoksiklav 600 mg/42.9 mg/5 ml
Date of leaflet approval: 06.02.2024
[Information about the trademark]

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 phenomenon is that the bacteria are resistant to the administered antibiotic. This means that the bacteria can survive or multiply despite the use of the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the possibility of bacteria developing resistance.
The antibiotic prescribed by the doctor is intended solely for the treatment of the current illness. Paying attention to the following tips will help prevent the development of resistant bacteria, which could hinder the effectiveness of the antibiotic.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the correct number of days. You should read the instructions in the patient information leaflet and if any of them are unclear, you should ask the doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic that was not prescribed specifically for them. They should only take it to treat the infection for which the antibiotic was prescribed.
• 3. The patient should not take an antibiotic prescribed for someone else, even if they had a similar infection.
• 4. Do not give antibiotics prescribed for one patient to other people.
• 5. If there are any leftover antibiotics after completing the treatment as recommended by the doctor, they should be returned to the pharmacy (which will accept them) for proper disposal.

Instructions for preparing the medicine

Before giving the medicine from the dry powder, you should prepare an oral suspension, as described in detail below:
Before use, check that the bottle seal has not been broken.
Tap the bottle until the powder is loose. Add about 2/3 of the total volume of water to prepare the suspension (see the table below) and shake vigorously to suspend the powder.
Add the remaining volume of water and shake vigorously again.
Alternative method of preparing the suspension: Tap the bottle until the powder is loose. Fill the bottle with water to the level just below the mark on the label. Close the cap, turn the bottle upside down, and shake vigorously. Then fill the bottle with water exactly to the mark. Close the cap again, turn the bottle upside down, and shake vigorously.
After preparation, the medicinal product is a homogeneous suspension with a nearly white to light yellow color.

Shake the bottle well before each use.