Amoksiklav

1. What is Amoksiklav and what is it used for

Amoksiklav is an antibiotic that kills bacteria that cause infections. It contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called penicillins, whose action can sometimes be inhibited (inactivated). 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, abdominal cavity infections, and genital infections in women. Amoksiklav is used in adults and children to prevent infections associated with major surgical procedures.

2. Important information before taking Amoksiklav

When not to take 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 a skin rash, facial swelling, or throat swelling; if the patient 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 patient, they should not be given Amoksiklav

Amoksiklav.In case of doubts before taking Amoksiklav, consult a doctor, pharmacist, or nurse.

Warnings and precautions

Before starting treatment with the medicine, the patient should discuss it with their doctor, pharmacist, or nurse if they: have infectious mononucleosis, are being treated for liver or kidney function disorders, or do not urinate regularly. In case of doubts whether any of these statements apply to the patient, they should consult their doctor, pharmacist, or nurse before taking the medicine. In some cases, the doctor may examine what type of bacteria caused the infection. Depending on the results, the patient may receive Amoksiklav of a different strength or a different medicine.

Conditions to be aware of

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, one should be aware of certain symptoms to minimize the risk of any problems. See "Conditions to be aware of" in section 4.

Blood and urine tests

If the patient is to have a blood test (e.g., red blood cell test or liver function tests) or a urine test (for glucose), they should inform their doctor or nurse that they are taking Amoksiklav. The medicine may affect the results of these tests.

Amoksiklav and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. If the patient is taking allopurinol (used to treat gout) at the same time as Amoksiklav, the likelihood of a skin allergic reaction increases. If the patient is taking probenecid (used to treat gout), the doctor may decide to modify the dose of Amoksiklav. Concurrent use of probenecid may reduce the excretion of amoxicillin and is not recommended. If the patient is taking medicines that reduce blood clotting (such as warfarin) at the same time as Amoksiklav, additional blood tests may be necessary. Amoksiklav may affect the action of methotrexate (a medicine used to treat cancer and severe psoriasis). Penicillins may reduce the excretion of methotrexate, potentially leading to increased side effects. Amoksiklav may affect the action of mycophenolate mofetil, a medicine used to prevent transplant rejection. When taking Amoksiklav, the doctor will closely monitor the patient's health.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before taking this medicine.

Driving and operating machinery

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

Amoksiklav contains sodium and potassium

Amoksiklav (500 mg + 100 mg) The medicine contains 31.4 mg of sodium (the main component of common salt) per vial. This corresponds to 1.6% of the maximum recommended daily sodium intake in the diet for adults. This should be taken into account in patients controlling their sodium intake. The medicine contains less than 1 mmol (39 mg) of potassium per dose, which means the medicine is considered "potassium-free". Amoksiklav (1 g + 200 mg) The medicine contains 62.9 mg of sodium (the main component of common salt) per vial. This corresponds to 3.1% of the maximum recommended daily sodium intake in the diet for adults. This should be taken into account in patients controlling their sodium intake. The medicine contains 1 mmol (or 39.3 mg) of potassium per dose, which should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake. The medicine may be diluted - see "Information intended for healthcare professionals". The sodium and potassium content from the diluent should be taken into account when calculating the total sodium and potassium content in the prepared solution of the medicine. To obtain accurate information about the sodium and potassium content in the solution used to dilute the medicine, refer to the patient information leaflet of the diluent used.

3. How to take Amoksiklav

The patient will never administer this medicine themselves. The medicine will be administered to the patient by a qualified person - a doctor or nurse. The following doses are usually used.

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

Children with a body weight of less than 40 kg

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

Patients with kidney and liver function disorders

For patients with kidney function disorders, the dose of the medicine may be changed. The doctor may recommend administering the medicine at a different strength or a different medicine. Patients with liver function disorders may have their blood tested more frequently to monitor liver function.

How Amoksiklav is administered

Amoksiklav is administered by intravenous injection or intravenous infusion. When taking Amoksiklav, the patient should drink plenty of fluids. The administration of Amoksiklav usually does not last longer than 2 weeks without a repeat check-up by the doctor.

Using a higher dose of Amoksiklav than recommended

Administering too much Amoksiklav is unlikely, but if the patient feels they have been given too much medicine, they should immediately consult their doctor, pharmacist, or nurse. Symptoms of stomach upset (nausea, vomiting, diarrhea) or seizures may occur. In case of any further doubts about taking this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions to be aware of

Allergic reactions:

skin rash
vasculitis, 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 mouth (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 any of these symptoms occur, the patient should immediately contact their doctor.

The patient should stop taking Amoksiklav.

Colitis

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

Acute pancreatitis

If the patient experiences severe and persistent abdominal pain, it may be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)

Drug-induced enterocolitis syndrome occurred mainly in children taking amoxicillin with clavulanic acid. It is a type of allergic reaction, whose leading symptom is repeated vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
If any of these symptoms occur, the patient should immediately consult their doctor.
Common side effects (occurring in less than 1 in 10 people)
thrush (candidiasis - a fungal infection of the vagina, mouth, or skin folds)
diarrhea
Uncommon side effects (occurring in less than 1 in 100 people)
skin rash, itching
raised, itchy rash (hives)
nausea (especially when taking high doses of the medicine)
→ if they occur, the medicine should be administered before meals
vomiting
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 (occurring in less than 1 in 1000 people)
skin rash, which 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, they should immediately inform their doctor.
swelling and redness along the vein, which becomes very painful to the touch
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

Other side effects

Other side effects have occurred in a very small number of people, but their exact frequency is not known:
allergic reactions (see above)
colitis (see above)
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 (covering more than 30% of the body surface - toxic epidermal necrolysis [Lyell's syndrome])
• -extensive, red skin rash with small blisters filled with pus (bullous 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) crystals in the urine leading to acute kidney damage, rash with blisters arranged in a ring shape with crusts in the center or like 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, the patient should immediately contact their doctor.

and stop taking Amoksiklav.
hepatitis
jaundice due to increased bilirubin levels in the blood (a substance produced in the liver), which can cause yellowing of the skin and eyes
inflammation of the kidney tubules
prolonged blood clotting time
seizures (in people taking high doses of Amoksiklav or with kidney disease)
Side effects that may appear in blood or urine test results:
significant decrease in the number of white blood cells
low number of red blood cells (hemolytic anemia)
crystals in the urine

If the patient experiences side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Amoksiklav

The medicine should be stored out of sight and reach of children. Store in a temperature 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 month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 contains

The active substances are amoxicillin and clavulanic acid. Amoksiklav (500 mg + 100 mg) One vial contains 500 mg of amoxicillin in the form of sodium salt and 100 mg of clavulanic acid in the form of potassium clavulanate. Amoksiklav (1 g + 200 mg) One vial contains 1 g of amoxicillin in the form of sodium salt and 200 mg of clavulanic acid in the form of potassium clavulanate.

What Amoksiklav looks like and what the packaging contains

The powder for solution for injection and infusion Amoksiklav is white to yellowish in color. The medicine is available in vials made of colorless glass (type II) with a rubber stopper and a flip-off cap in a cardboard box. The packaging contains 1, 5, or 10 vials.

Marketing authorization holder and manufacturer

Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria. For more detailed information about this medicine, please contact the local representative of the marketing authorization holder: Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warsaw, tel. +48 22 209 70 00, Date of last revision of the leaflet:03/2024, (logo of the marketing authorization holder)

Information intended for healthcare professionals only:

Detailed information can be found in the Summary of Product Characteristics.

Method of administration

Amoksiklav can be administered by slow intravenous injection (lasting 3 to 4 minutes) directly into a vein or into a drip line, or by intravenous infusion lasting 30 to 40 minutes. Amoksiklav is not intended for intramuscular administration. Preparation of the solution for intravenous injection Amoksiklav (500 mg + 100 mg)The contents of the vial should be dissolved in 10 ml of water for injection. The solutions after preparation are usually pale yellow in color. The medicine should be administered within 20 minutes of dissolution. Amoksiklav (1 g + 200 mg)The contents of the vial should be dissolved in 20 ml of water for injection. The solutions after preparation are usually pale yellow in color. The medicine should be administered within 20 minutes of dissolution. Preparation of the solution for intravenous infusion Amoksiklav (500 mg + 100 mg)The contents of the vial should be dissolved in 10 ml of water for injection, and the resulting solution should be added to 50 ml of infusion fluid. The solutions after preparation are usually pale yellow in color. Amoksiklav (1 g + 200 mg)The contents of the vial should be dissolved in 20 ml of water for injection, and the resulting solution should be added to 100 ml of infusion fluid. The solutions after preparation are usually pale yellow in color. Stability and compatibilityAmoksiklav in the solution for infusion should be administered within 20 minutes of preparation. Only clear solutions should be administered. Amoksiklav in the solution for infusion can be administered with various infusion fluids. Satisfactory antibiotic concentrations are maintained in the recommended volumes of infusion fluids listed in the table: Prepared solutions for intravenous administration should not be frozen.

Storage at 5°C: prepared solutions should be placed in previously cooled infusion bags, where they can be stored for up to 8 hours. The solution should be administered immediately after reaching room temperature. The solution of Amoksiklav should not be mixed with other medicines. Any unused remainder of the product or its waste should be disposed of in accordance with local regulations.