Patient Information Leaflet

Amoksiklav, (400 mg + 57 mg)/5 ml, powder for oral suspension
Amoxicillinum + Acidum clavulanicum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

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 has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Amoksiklav is and what it is used for
Important information before taking Amoksiklav
How to take Amoksiklav
Possible side effects
How to store Amoksiklav
Contents of the pack and other information

1. What Amoksiklav is and what it is used for

Amoksiklav is an antibiotic that kills 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 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.

2. Important information before using Amoksiklav

When not to give Amoksiklav to a child:
if the child is allergic (hypersensitive) 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 (hypersensitivity) to any other antibiotic;
such a reaction may include skin rash, swelling of the face or neck;
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 Amoksiklav. If in doubt, consult a doctor or pharmacist before administering Amoksiklav.

Warnings and precautions
Talk to a doctor or pharmacist before using this medicine if the child:
has infectious mononucleosis,
is being treated for liver or kidney function disorders,
does not urinate regularly.
If in doubt whether any of these statements apply to the patient, consult a doctor or pharmacist before using the medicine.
In some cases, the doctor may test which type of bacteria caused the infection. Depending on the test results, the patient may be prescribed a different strength of Amoksiklav or another medicine.

Side effects to watch for
Taking Amoksiklav may worsen certain pre-existing conditions or cause serious adverse effects (such as allergic reactions, seizures, and colitis). To reduce the risk of any problems, watch carefully for certain symptoms during treatment with Amoksiklav (see "Side effects 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 patient is taking Amoksiklav. This medicine may affect the results of such tests.

Amoksiklav and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, herbal medicines, and medicines the patient plans to use.
If the patient takes allopurinol (used to treat gout) at the same time as Amoksiklav, the risk of developing a skin allergic reaction increases.
If the patient takes probenecid (used to treat gout), the doctor may decide to adjust the dose of Amoksiklav. Concurrent use of probenecid may reduce the elimination of amoxicillin and is not recommended.
If the patient takes medicines that reduce blood clotting (such as warfarin) together with Amoksiklav, additional blood tests may be necessary.
Amoksiklav may affect the action of methotrexate (a medicine used to treat cancer, rheumatic diseases, and severe psoriasis). Penicillins may reduce the elimination of methotrexate, increasing the risk of adverse effects.
If the patient is receiving mycophenolate mofetil (a medicine used to prevent rejection of a transplanted organ), the doctor will closely monitor the patient's health during treatment with Amoksiklav.

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

Driving and operating machinery
Amoksiklav may cause adverse effects and symptoms that impair the ability to drive. The patient should not drive or operate machinery unless they feel well.

Excipients
Amoksiklav contains aspartame (E 951), potassium, and sodium.
The medicine contains 16.64 mg of aspartame in each 5 ml of suspension. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
The medicine contains less than 1 mmol (39 mg) of potassium in 5 ml of suspension. The medicine contains 11.7 mg of potassium in each 5 ml of suspension. The medicine contains 1.2 mmol (48.6 mg) of potassium per maximum daily dose (20 ml), which should be considered in patients with impaired kidney function and in patients monitoring dietary potassium intake.
This medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of suspension, meaning the medicine is considered "sodium-free".

3. How to use Amoksiklav

This medicine should always be used exactly as directed by the doctor. If in doubt, consult the doctor or pharmacist.
Adults and children with body weight of 40 kg and above
The suspension is generally not recommended for use in adults and children with body weight of 40 kg and above.
Please consult a doctor or pharmacist in this matter.
Children with body weight below 40 kg
All doses are calculated according to the child's body weight expressed in kilograms.
The doctor will advise how much medicine should be given to the child.
Usual dose: from (25 mg + 3.6 mg) to (45 mg + 6.4 mg) per kilogram of body weight per day, administered in two divided doses.
Higher dose: up to (70 mg + 10 mg) per kilogram of body weight per day, administered in two divided doses.
An oral dosing syringe or measuring spoon is provided with the medicine for measuring and administering the suspension. Use it to give the child the correct dose of the medicine.
Patients with kidney or liver function disorders
For children with impaired kidney function, the dose may be adjusted. The doctor may recommend taking a medicine of different strength or a different medicine.
Children with impaired liver function may require more frequent blood tests to monitor liver function.
How to prepare the oral suspension
Instructions for preparing the medicine for use are provided at the end of this leaflet.
How to administer Amoksiklav
Shake the bottle well before administering each dose.
The medicine should be given at the beginning of a meal or just before a meal.
Maintain regular intervals of at least 4 hours between doses administered during the day. Do not take two doses within one hour.
Do not give the child Amoksiklav for longer than 2 weeks. If the child still feels unwell, contact the doctor again.
To ensure that the prescribed dose of medicine has been administered to the patient, use the chart printed on the cardboard outer packaging. This chart indicates consecutive doses administered over 7 days. After each dose is given, push out the cardboard disc with a perforated edge marked with the number corresponding to the next dose.
If the doctor has recommended using the medicine for longer than 7 days, open a new package, prepare the suspension, and continue treatment, marking the administration of subsequent doses as described above.
Taking more than the recommended dose of Amoksiklav
If the patient takes more than the recommended dose of Amoksiklav, symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures may occur. Contact a doctor as soon as possible. Take the cardboard packaging or empty medicine bottle with you to show the doctor.
Missed dose of Amoksiklav
If a dose of Amoksiklav was missed, give it as soon as you remember.
Do not give the next dose too early; instead, wait approximately 4 hours before administering the next dose.
Stopping treatment with Amoksiklav
Continue giving Amoksiklav for the full duration of treatment, even if the child feels better. All doses are needed to completely eliminate the infection. If some bacteria survive, they may cause the infection to return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions listed below may occur with this medicine.
Symptoms to be aware of
Allergic reactions:
skin rash
inflammation of blood vessels, 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 mouth (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 any of these symptoms occur in a child, contact a doctor immediately.
Stop giving 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 the patient experiences severe and persistent pain in the abdominal area, this may be a sign of acute
pancreatitis.
Drug-induced enterocolitis (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 (1-4 hours after taking the medicine). Further symptoms may include abdominal
pain, lethargy, diarrhoea, and low blood pressure.
➔ If any of these symptoms occur in a child, seek medical advice as quickly as possible.
Adverse reactions that occur frequently (less than 1 in 10 people)
candidiasis – fungal infection of the vagina, mouth (oral thrush), or skin folds
nausea, especially when taking high doses of the medicine
→ If nausea occurs, Amoksiklav should be administered before meals.
vomiting
diarrhoea
Adverse reactions that occur less frequently (less than 1 in 100 people)
skin rash, itching
raised, itchy rash (urticaria)
dyspepsia
dizziness
headache
Less frequent adverse reactions that may appear in blood test results:
increased activity of certain substances (enzymes) produced in the liver
Adverse reactions that occur rarely (less than 1 in 1000 people)
skin rash, which may develop into blisters and resemble target-like lesions
(dark spot in the center surrounded by a lighter ring with a dark border at the edge –
erythema multiforme)
➔ If any of these symptoms occur in a child, contact a doctor urgently.
Rare adverse reactions that may appear in blood test results:
low number of platelets (cells involved in blood clotting)
low number of white blood cells
Other adverse reactions
Other adverse reactions have occurred in a very small number of people, but their exact frequency is
unknown.
allergic reactions (see above),
inflammation of the large intestine (see above),
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 area – toxic epidermal necrolysis)
widespread red skin rash with small pustules filled with pus (bullous exfoliative dermatitis)
red, scaly rash with subcutaneous nodules 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)
red rash often visible on both buttocks, inner upper thighs, underarms, and neck (symmetrical drug-related intertriginous and flexural exanthema, SDRIFE), crystals in urine leading to acute kidney injury, blistering rash arranged in ring-like patterns with crusts in the center or resembling a string of pearls (linear IgA dermatosis), inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

➔ If any of the above symptoms occur in a child, contact a doctor immediately.
inflammation of the liver
jaundice due to increased blood levels of bilirubin (a substance produced in the liver),
which may cause yellowing of the skin and whites of the eyes
interstitial nephritis
prolonged blood clotting time
hyperactivity
seizures (in people receiving high doses of Amoksiklav or with kidney disease)
black hairy tongue
tooth discoloration (in children), usually removable during tooth brushing
development of infection caused by overgrowth of resistant bacteria
Adverse reactions that may appear in blood or urine test results:
marked decrease in white blood cells
low number of red blood cells (hemolytic anaemia)
crystals in urine
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Amoksiklav

Keep the medicine out of sight and reach of children.
Dry powder: store below 30°C.
Reconstituted suspension: store in a refrigerator at a temperature between 2°C and 8°C
and use within 7 days.
Before each use, shake the bottle vigorously.
After each use, close the bottle tightly.
Do not use this medicine after the expiry date stated on the packaging after EXP.
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. This will help protect
the environment.

6. Package contents and other information

What Amoksiklav contains
The active substances are amoxicillin and clavulanic acid.
Each 5 ml of suspension (1 measuring spoon) contains 400 mg amoxicillin in the form of amoxicillin trihydrate and 57 mg clavulanic acid in the form of potassium clavulanate.
The other ingredients are: anhydrous colloidal silica, xanthan gum, strawberry flavour, crospovidone, aspartame (E 951), sodium carmellose, silicon dioxide.

What Amoksiklav looks like and contents of the pack
The powder for oral suspension is a white or light yellow powder. The medicine is available in amber glass bottles with a plastic screw cap with a tamper-evident seal or a child-resistant plastic cap with a tamper-evident seal, containing powder for the preparation of 35 ml, 70 ml or 140 ml of oral suspension. The bottle is placed in a cardboard box together with a plastic oral dosing syringe or a measuring spoon.

Marketing Authorisation Holder and Manufacturer
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
For detailed information about this medicine, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. +48 22 209 70 00
(logo of the marketing authorisation holder)

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 antibiotic resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of the current infection.
Paying attention to the following advice will help prevent the development of resistant bacteria that could interfere with the effectiveness of antibiotics.

It is very important to take the antibiotic at the correct dose, at the right time, and for the prescribed number of days. Read the instructions in the package leaflet carefully and, if any are unclear, ask your doctor or pharmacist for clarification.
The patient should not take an antibiotic unless it has been specifically prescribed for them. It should be taken only to treat the infection for which it was prescribed.
The patient should not take an antibiotic prescribed for another person, even if that person had a similar infection.
Do not give antibiotics prescribed for you to other people.
If any antibiotic remains after completing the treatment as prescribed by your doctor, return it to a pharmacy for proper disposal.

Instructions for preparing the medicine for use
How to prepare the oral suspension
Before opening, check whether the bottle seal has been broken or is not tightly attached to the neck of the bottle. Do not use the medicine if the seal is damaged.
Do not use this medicinal product if lumps of powder are visible in the bottle before preparing the suspension.
Shake the bottle to loosen the powder.

Pack size: 1 bottle containing powder for preparation of 35 ml of suspension
Shake the contents of the bottle (powder for oral suspension), add 34 ml of water and shake vigorously.

Pack size: 1 bottle containing powder for preparation of 70 ml of suspension
Shake the contents of the bottle (powder for oral suspension), add 66 ml of water and shake vigorously.

Pack size: 1 bottle containing powder for preparation of 140 ml of suspension
Shake the contents of the bottle (powder for oral suspension), add 132 ml of water and shake vigorously.

The resulting suspension will be white or light yellow and ready for use.
Do not use this product if, after preparation, the suspension is a different colour than white or light yellow.
Shake the bottle vigorously before each use.
After each use, close the bottle tightly.