Amoxicillin + clavulanic acid Aptapharma

Leaflet accompanying the packaging: information for the user

Amoxicillin + clavulanic acid AptaPharma, 1000 mg + 200 mg, powder for solution for injection/infusion

for injection/infusion
Amoxicillin + Clavulanic acid

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Amoxicillin + clavulanic acid AptaPharma and what is it used for
• 2. Important information before using Amoxicillin + clavulanic acid AptaPharma
• 3. How to use Amoxicillin + clavulanic acid AptaPharma
• 4. Possible side effects
• 5. How to store Amoxicillin + clavulanic acid AptaPharma
• 6. Contents of the packaging and other information

1. What is Amoxicillin + clavulanic acid AptaPharma and what is it used for

Amoxicillin + clavulanic acid AptaPharma is an antibiotic that works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", which can sometimes be inhibited (inactivated). The second active ingredient (clavulanic acid) counteracts this inactivation. Amoxicillin + clavulanic acid AptaPharma 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.

Amoxicillin + clavulanic acid AptaPharma is used in adults and children to prevent infections associated with major surgical procedures.

2. Important information before using Amoxicillin + clavulanic acid AptaPharma

When not to use Amoxicillin + clavulanic acid AptaPharma

• If the patient is allergic to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever had a severe allergic reaction to any other antibiotic.
• If the patient has ever had liver function disorders or jaundice (yellowing of the skin) while taking an antibiotic.
• If any of the above conditions apply to the patient, they should not take Amoxicillin + clavulanic acid AptaPharma.In case of doubt, consult a doctor, pharmacist, or nurse before taking Amoxicillin + clavulanic acid AptaPharma.

pharmacist or nurse.

Warnings and precautions

Before taking Amoxicillin + clavulanic acid AptaPharma, the patient should consult a doctor, pharmacist, or nurse if:

• they have infectious mononucleosis
• they are being treated for liver or kidney disease
• they do not urinate regularly. In case of doubt, consult a doctor, pharmacist, or nurse before taking Amoxicillin + clavulanic acid AptaPharma.

In some cases, the doctor may test the type of bacteria that caused the patient's infection. Depending on the results, the patient may receive Amoxicillin + clavulanic acid AptaPharma in a different dose or a different medicine.

Conditions to watch out for

Taking Amoxicillin + clavulanic acid AptaPharma may worsen the course of certain diseases or cause severe side effects. These include allergic reactions, convulsions (seizures), and colitis. The patient should be aware of certain symptoms during treatment with Amoxicillin + clavulanic acid AptaPharma to minimize the risk of any problems. See " Conditions to watch out for" in section 4.

Blood and urine tests

If the patient is to have blood tests (such as red blood cell tests or liver function tests) or urine tests (for glucose), they should inform their doctor or nurse that they are taking Amoxicillin + clavulanic acid AptaPharma. Amoxicillin + clavulanic acid AptaPharma may affect the results of these tests.

Amoxicillin + clavulanic acid AptaPharma 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 for gout) at the same time as Amoxicillin + clavulanic acid AptaPharma, they are more likely to experience skin allergic reactions. If the patient is taking probenecid (used for gout), the doctor may decide to modify the dose of Amoxicillin + clavulanic acid AptaPharma. If the patient is taking blood-thinning medicines (such as warfarin) at the same time as Amoxicillin + clavulanic acid AptaPharma, additional blood tests may be necessary. Amoxicillin + clavulanic acid AptaPharma may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases). Amoxicillin + clavulanic acid AptaPharma may affect the action of mycophenolate mofetil (a medicine used to prevent transplant rejection).

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Amoxicillin + clavulanic acid AptaPharma may cause side effects and symptoms that can affect the ability to drive and use machines. The patient should not drive or operate machinery unless they feel well.

Amoxicillin + clavulanic acid AptaPharma contains sodium and potassium

• The medicine contains 62.9 mg of sodium (the main component of common salt) per vial, which is equivalent to 3.1% of the maximum recommended daily intake of sodium in the diet for adults.
• The medicine contains approximately 39.1 mg (1 mmol) of potassium. This should be taken into account in patients with kidney problems or those controlling their potassium intake.

3. How to use Amoxicillin + clavulanic acid AptaPharma

The patient will never take this medicine by themselves. The medicine will be administered to the patient by a qualified person, such as a doctor or nurse. The recommended doses are as follows:

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 diseases

• If the patient has kidney disease, the dose of the medicine may be changed. The doctor may choose a different strength or a different medicine.
• If the patient has liver disease, the doctor will closely monitor their condition and may perform more frequent liver function tests.

How Amoxicillin + clavulanic acid AptaPharma is administered

• Amoxicillin + clavulanic acid AptaPharma is administered by intravenous injection or infusion.
• During treatment with Amoxicillin + clavulanic acid AptaPharma, it is recommended to drink plenty of fluids.
• Amoxicillin + clavulanic acid AptaPharma is usually not administered for more than 2 weeks without re-examining the patient's condition by the doctor.

Using a higher than recommended dose of Amoxicillin + clavulanic acid AptaPharma

Administering a dose higher than recommended is unlikely, but if the patient thinks they have been given a higher dose of Amoxicillin + clavulanic acid AptaPharma than recommended, they should contact their doctor, pharmacist, or nurse immediately. Symptoms may include nausea (feeling sick), vomiting, or diarrhea. In case of any further doubts about using 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. The following are side effects of this medicine that may occur:

Conditions to watch out for

Allergic reactions:

• skin rash
• vasculitis, which can appear as red or purple, raised spots on the skin, but can also affect other organs
• fever, joint pain, swelling of the lymph nodes in the neck, armpit, or groin
• swelling, sometimes involving 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 any of these symptoms occur, contact a doctor immediately.

Stop using Amoxicillin + clavulanic acid AptaPharma.

Colitis

Colitis, causing watery diarrhea, usually with blood and mucus, abdominal 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 syndrome 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 abdominal pain, lethargy, diarrhea, and low blood pressure.

• If any of these symptoms occur, consult a doctor immediately for advice.

Common side effects

May occur in up to 1 in 10 patients

• thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds)
• diarrhea.

Uncommon side effects

May occur in up to 1 in 100 patients

• skin rash, itching
• raised, itchy rash (hives)
• nausea (feeling sick), especially when taking high doses
• if they occur, take Amoxicillin + clavulanic acid AptaPharma 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

May occur in up to 1 in 1000 patients

• skin rash, which can blister and look like small targets (dark spot in the center surrounded by a lighter ring with a dark ring around the edge - erythema multiforme)
• swelling and redness along a vein, which is 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.

Side effects with unknown frequency

Frequency cannot be estimated from the available data.

• allergic reactions (see above)
• colitis (see above)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• severe skin reactions:
• widespread skin rash, with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing widespread skin peeling (more than 30% of the body surface - toxic epidermal necrolysis [Lyell's syndrome])
• widespread red skin rash, with small pus-filled blisters (pustular psoriasis)
• red, scaly rash with thickening of the skin and blisters [acute generalized exanthematous pustulosis (AGEP)]
• flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results [drug reaction with eosinophilia and systemic symptoms (DRESS)].
• rash with blisters arranged in a ring or like a string of pearls (linear IgA dermatosis)
• If the patient experiences any of these symptoms, they should contact a doctor immediately.
• hepatitis
• jaundice, caused by an increase in the level of bilirubin (a substance produced in the liver) in the blood, 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 Amoxicillin + clavulanic acid AptaPharma 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 leading to acute kidney damage.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 collected on the safety of the medicine.

5. How to store Amoxicillin + clavulanic acid AptaPharma

Information about the expiration date and storage instructions on the packaging is intended for healthcare professionals. The doctor, pharmacist, or nurse will prepare the medicine for administration to the patient. The medicine should be used within 20 minutes of preparation. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. Ask a 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 Amoxicillin + clavulanic acid AptaPharma contains

• The active substances of the medicine are amoxicillin and clavulanic acid. Each vial contains amoxicillin sodium equivalent to 1000 mg of amoxicillin and potassium clavulanate equivalent to 200 mg of clavulanic acid.

There are no other ingredients. However, important information about the sodium and potassium content of Amoxicillin + clavulanic acid AptaPharma can be found in section 2. The doctor, nurse, or pharmacist will prepare the medicine for injection, using appropriate fluids (such as water for injection or infusion solution).

What Amoxicillin + clavulanic acid AptaPharma looks like and what the packaging contains

Amoxicillin + clavulanic acid AptaPharma is a sterile powder for solution for injection/infusion, supplied in vials made of colorless glass. The packaging contains 10 vials of 20 ml made of colorless glass type II with a chlorobutyl rubber stopper type I and an aluminum flip-off cap in a cardboard box.

Marketing authorization holder

Apta Medica Internacional d.o.o. Likozarjeva Ulica 6 1000 Ljubljana Slovenia

Manufacturer

LABORATORIO REIG JOFRE S.A. Jarama 111, Poligono Industrial 45007 Toledo Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: February 2023

Information intended for healthcare professionals only.

For further information, see the Summary of Product Characteristics.

Method of administration

Amoxicillin + clavulanic acid AptaPharma can be administered by intravenous injection over 3 to 4 minutes directly into a vein or into a drip set, or by intravenous infusion over 30 to 40 minutes. Amoxicillin + clavulanic acid AptaPharma is not intended for intramuscular administration.

Reconstitution

For single use only. Unused solution should be discarded. Reconstitution and dilution should be carried out under aseptic conditions. Before administration, the solution should be inspected for particulate matter and discoloration. The solution should only be used if it is clear and free from particles. Vials of Amoxicillin + clavulanic acid AptaPharma are not intended for multiple use. Any unused product or waste material should be disposed of in accordance with local requirements. Preparing solutions for intravenous injectionThe standard solvent is water for injection (Ph. Eur.). Amoxicillin + clavulanic acid AptaPharma, 1000 mg + 200 mg, should be reconstituted in 20 ml of solvent, resulting in approximately 20.9 ml of solution for single use. During reconstitution, the powder may exhibit a pink color for some time. The resulting solutions are usually colorless to yellow. Amoxicillin + clavulanic acid AptaPharma should be administered within 20 minutes of reconstitution. Preparing solutions for intravenous infusionAmoxicillin + clavulanic acid AptaPharma, 1000 mg + 200 mg, should be reconstituted as described above for the preparation of solutions for injection. The resulting solution should be added immediately to 100 ml of infusion fluid using a mini-bag or burette infusion set. Only use a clear solution free from particles.

Stability of reconstituted solutions

Vials of reconstituted solution (for intravenous injection or before dilution for infusion) The reconstituted solution [contents of 1 vial dissolved in 20 ml of water for injection (Ph. Eur.)] should be administered or diluted immediately, within 20 minutes of preparation. Diluted solution for intravenous infusion It has been demonstrated that the chemical and physical stability of such a solution is 2-3 hours at 25°C or 6 hours at 5°C. From a microbiological point of view, the solution produced by dissolving the powder and subsequent dilution (contents of 1 vial reconstituted in a minimum of 100 ml of infusion fluid) should be used immediately. Amoxicillin + clavulanic acid AptaPharma is less stable in infusion solutions containing glucose, dextran, or bicarbonates. Reconstituted solutions of amoxicillin with clavulanic acid can be injected into a drip set over 3 to 4 minutes. Any remaining solution of the antibiotic should be discarded.