Amoxiclav

Patient Information Leaflet

Amoksiklav, (500 mg + 100 mg), powder for solution for injection and infusion
Amoksiklav, (1 g + 200 mg), powder for solution for injection and infusion
Amoxicillinum + Acidum clavulanicum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell 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 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, which may sometimes be inactivated by bacteria. The second active substance (clavulanic acid) counteracts this inactivation.
Amoksiklav is used in adults and children to treat the following infections:
severe ear, nose and throat infections,
respiratory tract infections,
urinary tract infections,
skin and soft tissue infections, including dental infections,
bone and joint infections,
intra-abdominal infections,
genital infections in women.
Amoksiklav is also used in adults and children to prevent infections associated with major surgical procedures.

2. Important information before using Amoksiklav

When not to use Amoksiklav
if the patient is allergic to amoxicillin, clavulanic acid, or penicillin;
if the patient 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 patient has ever experienced liver function disorders or jaundice (yellowing of the skin) caused by taking an antibiotic.
➔ If any of the above situations apply, do not give Amoksiklav to the patient. If in doubt, consult a doctor, pharmacist, or nurse before using Amoksiklav.

Warnings and precautions
Before starting treatment, discuss with a doctor, pharmacist, or nurse if the patient:
has infectious mononucleosis;
is being treated for liver or kidney function disorders;
does not urinate regularly.
If in doubt whether any of these conditions apply, consult a doctor, pharmacist, or nurse before using the medicine.
In some cases, the doctor may test which type of bacteria caused the infection. Depending on the results, the patient may receive Amoksiklav of a different strength or another medicine.

Conditions to be aware of
Treatment with Amoksiklav may worsen the course of certain pre-existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. While taking Amoksiklav, be alert for specific symptoms to reduce the risk of complications. See "Conditions to be aware of" in section 4.

Blood and urine tests
If the patient is scheduled for 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. The medicine may affect the results of such tests.

Amoksiklav and other medicines
Tell the doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If allopurinol (used to treat gout) is taken together with Amoksiklav, the risk of developing a skin allergic reaction increases.
If probenecid (used to treat gout) is taken, the doctor may adjust the dose of Amoksiklav. Concurrent use of probenecid may reduce the elimination of amoxicillin and is not recommended.
If Amoksiklav is taken together with medicines that reduce blood clotting (such as warfarin), 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.
Amoksiklav may affect the action of mycophenolate mofetil, a medicine used to prevent transplant rejection. While taking Amoksiklav, the doctor will closely monitor the patient's health.

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, pharmacist, or nurse before using this medicine.

Driving and operating machinery
No studies have been conducted on the effect of the medicine on the ability to drive or operate machinery. However, adverse effects (e.g. allergic reactions, dizziness, seizures) may occur that could affect the ability to drive or operate machinery (see section 4).

Amoksiklav contains sodium and potassium

Amoksiklav (500 mg + 100 mg)
This medicine contains 31.4 mg of sodium (main component of table salt) per vial. This corresponds to 1.6% of the maximum recommended daily sodium intake in the adult diet. This should be taken into account in patients controlling dietary sodium intake.
The medicine contains less than 1 mmol (39 mg) of potassium per dose, meaning the medicine is considered "potassium-free".

Amoksiklav (1 g + 200 mg)
This medicine contains 62.9 mg of sodium (main component of table salt) per vial. This corresponds to 3.1% of the maximum recommended daily sodium intake in the adult diet. This should be taken into account in patients controlling dietary sodium intake.
The medicine contains 1 mmol (or 39.3 mg) of potassium per dose, which should be taken into account in patients with impaired kidney function and in patients controlling dietary potassium intake.
The medicine may be diluted – see "Information for healthcare professionals". The sodium and potassium content from the diluent should be considered when calculating the total sodium and potassium content in the prepared diluted solution. For accurate information on sodium and potassium content in the diluent used, refer to the patient leaflet of the diluent used.

3. How to use Amoksiklav

The patient must never administer this medicine to themselves. The medicine will be given to the patient by a qualified person – a doctor or nurse.
The following doses are usually used.
Adults and children with body weight of 40 kg or more

Children weighing less than 40 kg
All doses are determined according to the child's body weight in kilograms.

Patients with renal and hepatic impairment
For patients with impaired renal function, the dose of the medicine may be adjusted. The doctor may
recommend administration of a medicine with different strength or another medicine.
Patients with impaired liver function may have blood tests performed more frequently to monitor
liver function.
How Amoksiklav is administered
Amoksiklav is administered by intravenous injection or intravenous infusion.
During treatment with Amoksiklav, patients should drink plenty of fluids.
Treatment with Amoksiklav usually does not last longer than 2 weeks without a follow-up medical
evaluation of the patient's health status.
Administration of a higher than recommended dose of Amoksiklav
Administration of an excessive amount of Amoksiklav is unlikely, but if the patient feels that too
much medicine has been given, they should immediately contact a doctor, pharmacist, or nurse.
Symptoms such as gastrointestinal disturbances (nausea, vomiting, diarrhoea) or seizures may occur.
If there are any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Symptoms that require attention
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, swelling of lymph nodes in the neck, armpits 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, contact a doctor immediately.
Discontinue use of Amoksiklav.
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 the patient experiences severe and persistent pain in the abdominal area, it 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 recurrent vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
➔ If any of these symptoms occur, seek medical advice as quickly as possible.
Adverse reactions occurring frequently (less than 1 in 10 people)
thrush (candidiasis – fungal infection of the vagina, mouth or skin folds)
diarrhoea
Adverse reactions occurring not very frequently (less than 1 in 100 people)
skin rash, itching
raised, itchy rash (urticaria)
nausea (especially when receiving high doses of the medicine)
→ if this occurs, the medicine should be taken with food
vomiting
dyspepsia
dizziness
headache
Not very common adverse reactions that may appear in blood test results:

• increased activity of certain substances (enzymes) produced in the liver

Adverse reactions occurring rarely (less than 1 in 1000 people)
skin rash which may develop into blisters and resemble target 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, they should urgently inform their doctor.
swelling and redness along a vein, which becomes very painful to touch
Rare adverse reactions that may appear in blood test results:
low number of cells involved in blood clotting (thrombocytes)
low number of white blood cells
Other adverse reactions
Other adverse reactions 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 – toxic epidermal necrolysis [Lyell's syndrome])
• widespread red 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 sides of the buttocks, inner upper thighs, armpits, 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 centre or resembling a string of pearls (linear IgA dermatosis)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

➔ If any of these symptoms occur, contact a doctor immediately.
inflammation of the liver (hepatitis)
jaundice due to increased concentration of bilirubin in the blood (a substance produced in the liver), which may cause yellowing of the skin and whites of the eyes
inflammation of the kidney tubules
prolonged blood clotting time
seizures (in patients receiving high doses of Amoksiklav or with kidney disease)
Adverse reactions that may appear in blood or urine test results:
marked decrease in the number of white blood cells
low number of red blood cells (haemolytic anaemia)
crystals in urine
If the patient experiences any adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Amoksiklav

Keep the medicine out of the sight and reach of children.
Store below 25 °C.
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. 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.
Amoksiklav (500 mg + 100 mg)
One vial contains 500 mg amoxicillin as the sodium salt and 100 mg clavulanic acid as potassium clavulanate.
Amoksiklav (1 g + 200 mg)
One vial contains 1 g amoxicillin as the sodium salt and 200 mg clavulanic acid as potassium clavulanate.

What Amoksiklav looks like and contents of the pack
Amoksiklav powder for solution for injection and infusion is white to off-white in colour.
The medicine is available in colourless glass vials (type II) with a rubber stopper and flip-off cap, packed in cardboard cartons.
The pack contains 1, 5 or 10 vials.

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

For detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
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)

Information intended exclusively for medical professionals:

Detailed information is provided in the Summary of Product Characteristics.
Administration method
Amoksiklav may be administered as a slow intravenous injection (lasting 3 to 4 minutes) directly
into a vein or into the infusion device port, or as a 30 to 40-minute intravenous infusion.
Amoksiklav is not intended for intramuscular administration.

Preparation of solution for intravenous injection
Amoksiklav (500 mg + 100 mg)
The contents of the vial should be dissolved in 10 ml of water for injections.
The resulting solutions are usually pale pink in colour.
The medicinal product should be administered within 20 minutes after reconstitution.

Amoksiklav (1 g + 200 mg)
The contents of the vial should be dissolved in 20 ml of water for injections.
The resulting solutions are usually pale pink in colour.
The medicinal product should be administered within 20 minutes after reconstitution.

Preparation of solution for intravenous infusion
Amoksiklav (500 mg + 100 mg)
The contents of the vial should be dissolved in 10 ml of water for injections, and the resulting solution added to 50 ml of infusion fluid.
The resulting solutions are usually pale pink in colour.

Amoksiklav (1 g + 200 mg)
The contents of the vial should be dissolved in 20 ml of water for injections, and the resulting solution added to 100 ml of infusion fluid.
The resulting solutions are usually pale pink in colour.

Stability and compatibility
The Amoksiklav infusion solution should be administered within 20 minutes after preparation. Only clear solutions should be used.
Amoksiklav infusion solution may be administered with various infusion fluids.
Satisfactory antibiotic concentrations are maintained in the recommended infusion fluid volumes listed in the table:

Do not freeze prepared solutions for intravenous administration.
Storage at 5 °C: prepared solutions should be placed in previously cooled infusion bags and may be stored for up to 8 hours. The solution should be administered immediately after reaching room temperature.
Do not mix the Amoksiklav solution with other medicinal products.
Any unused residues of the product or waste materials should be disposed of in accordance with local regulations.