AMOKSIKLAV 600 mg + 42.9 Mg/5 Ml Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Amoksiklav ES, (600 mg + 42.9 mg)/5 ml, powder for oral suspension
   1. Read the leaflet carefully before giving this medicine to a child, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Amoksiklav and what is it used for
4. Important information before taking Amoksiklav
   1. When not to give Amoksiklav to a child
   2. If any of the above situations apply to the child, do not give them Amoksiklav
   3. Warnings and precautions
   4. Conditions to watch out for
   5. Blood and urine tests
   6. Amoksiklav and other medicines
   7. Pregnancy and breastfeeding
   8. Amoksiklav contains sodium
   9. Amoksiklav contains benzyl alcohol
   10. Amoksiklav contains ethanol
   11. Amoksiklav contains sulfites
5. How to take Amoksiklav
   1. Adults and children with a body weight of 40 kg or more
   2. Children with a body weight of less than 40 kg
   3. Patients with kidney and liver diseases
   4. How to take Amoksiklav
   5. Taking more than the recommended dose of Amoksiklav
   6. Missing a dose of Amoksiklav
   7. Stopping Amoksiklav treatment
6. Possible side effects
   1. Conditions to watch out for
   2. Allergic reactions:
   3. Colitis
   4. Acute pancreatitis
   5. If the child experiences any of these symptoms, consult a doctor immediately.
7. How to store Amoksiklav
8. Contents of the packaging and other information
   1. What Amoksiklav contains
   2. What Amoksiklav looks like and contents of the packaging
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   5. Medical education
   6. Instructions for preparing the medicine

Leaflet accompanying the packaging: patient information

Amoksiklav ES, (600 mg + 42.9 mg)/5 ml, powder for oral suspension

Amoxicillin + Clavulanic acid

Read the leaflet carefully before giving this medicine to a child, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine is usually prescribed for infants or children. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the child experiences any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Amoksiklav and what is it used for

Amoksiklav 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 (inhibited).
The second active substance (clavulanic acid) counteracts this inactivation.
Amoksiklav is used in infants and children to treat the following infections:
middle ear infections
lung infections

2. Important information before taking Amoksiklav

When not to give Amoksiklav to a child

if the child is allergic to amoxicillin, clavulanic acid, penicillin, or 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 a skin rash, swelling of the face or throat.
if the child has ever had liver function disorders or jaundice (yellowing of the skin), caused by taking an antibiotic.

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

.If in doubt before giving Amoksiklav, consult a doctor or pharmacist.

Warnings and precautions

Before starting to give this medicine to a child, discuss it with a doctor or pharmacist if the child:
has infectious mononucleosis
is being treated for liver or kidney function disorders
has irregular urination.
If in doubt whether any of these statements apply to the child, consult a doctor or pharmacist before giving Amoksiklav.
In some cases, the doctor may examine what type of bacteria caused the infection. Depending on the results, the child may receive Amoksiklav with a different strength or a different medicine.

Conditions to watch out for

Taking Amoksiklav may worsen the course of some existing diseases or cause severe side effects. These include allergic reactions, seizures, and colitis. When taking Amoksiklav, pay attention to whether the child has certain symptoms to reduce 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., red blood cell test or liver function tests) or a urine test (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 your doctor or pharmacist about all medicines the child is taking now 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, 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) at the same time as Amoksiklav, 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 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 contains sodium

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

Amoksiklav 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 old) for more than a week without consulting a doctor or pharmacist.
If the child has liver or kidney disease or is pregnant or breastfeeding, 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 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 have noticeable effects.

Amoksiklav 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 can rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Amoksiklav

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your 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 to give to the infant or child.
A measuring syringe is included with the medicine packaging. Use it to give 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 children under 3 months old.

Patients with kidney and liver diseases

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

How to take Amoksiklav

Take with food.
After taking the suspension, drink a glass of water.
Always shake the bottle well before each dose.
Space out the doses evenly throughout the day, leaving at least 4-hour intervals. Do not give 2 doses within 1 hour.
Do not give Amoksiklav 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

If too much Amoksiklav 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

If a dose of Amoksiklav is missed, give it as soon as remembered. 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 treatment

Give Amoksiklav 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 can cause the infection to come back.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Conditions to watch out for

Allergic reactions:

skin rash
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, swollen 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 may be a sign of an allergy leading to a heart attack (Kounis syndrome).
If the child experiences any of these symptoms, consult a doctor immediately. Stop taking Amoksiklav.

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 receiving 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, consult a doctor immediately.
Very common side effects(may affect more than 1 in 10 people)
diarrhea (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, take Amoksiklav with food.
vomiting
diarrhea (in children).
Uncommon side effects(may affect up to 1 in 100 people)
skin rash, itching
hives (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 that can change into blisters and looks like small targets (dark spot in the center surrounded by a lighter border with a dark edge - erythema multiforme)
→ If the patient notices any of these symptoms, consult a doctor immediately.
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:

• extensive skin rash with blisters and peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form, causing extensive skin peeling (toxic epidermal necrolysis)
• extensive, 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, consult a doctor immediately.

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 kidney tubules
prolonged blood clotting time
restlessness
seizures (in people taking high doses of Amoksiklav or those with kidney function disorders)
black hairy tongue, which looks like it is hairy
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 any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Amoksiklav

Keep the medicine out of the 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 month.
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 (at a temperature between 2°C and 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. This will help protect the environment.

6. Contents of the packaging and other information

What Amoksiklav 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).
• Other ingredients are: citric acid, sodium citrate, microcrystalline cellulose, sodium carmellose, xanthan gum, colloidal anhydrous 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, corn starch, sodium, and sulfites), caramel flavor (containing flavor and aroma enhancers, corn maltodextrin, triethyl citrate, ethanol, and sodium), sodium saccharin (E 954).
• Further information on benzyl alcohol, ethanol, and sulfites can be found in section 2.

What Amoksiklav looks like and contents of the packaging

Amoksiklav ES, (600 mg + 42.9 mg)/5 ml, powder for oral suspension is a white to light yellow powder.
Packaging contents: Orange glass bottles (type III) with a capacity of 100 or 180 ml, closed with a polypropylene cap with a sealing membrane or a polypropylene-polyethylene cap with a child-resistant closure and a sealing membrane, and packaged with a measuring syringe with a propylene body and a polyethylene piston and plug. The total range of the measuring syringe is from 0.5 to 5 ml. Each black mark indicates 0.1 ml.
Packaging 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 packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria