Amoxicillin + clavulanic acid aptapharma

Package leaflet: Information for the user

Amoxicillin + clavulanic acid AptaPharma, 1000 mg + 200 mg, powder for solution for injection/infusion
Amoxicillinum + Acidum clavulanicum
Please read 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 questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Amoxicillin + clavulanic acid AptaPharma is and what it is 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 pack and other information

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

Amoxicillin + clavulanic acid AptaPharma is an antibiotic with bactericidal activity against bacteria causing infections. It contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins," whose activity may 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 also used in adults and children for prophylaxis of 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 experienced severe allergic reactions to any other antibiotic. These may include skin rash or swelling of the face or throat.

• If the patient has ever had liver function disorders or jaundice (yellowing of the skin) while taking an antibiotic.

  • If any of the above apply, the patient should not take Amoxicillin + clavulanic acid AptaPharma. If in doubt, consult the doctor, pharmacist, or nurse before starting treatment with Amoxicillin + clavulanic acid AptaPharma.

Warnings and precautions

Before starting treatment with Amoxicillin + clavulanic acid AptaPharma, the patient should consult their doctor, pharmacist, or nurse if:

• They have infectious mononucleosis.
• They are being treated for liver or kidney disease.
• They are not passing urine regularly.

If in doubt whether any of the above apply, consult the doctor, pharmacist, or nurse before starting Amoxicillin + clavulanic acid AptaPharma.

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

Conditions to be aware of

Treatment with Amoxicillin + clavulanic acid AptaPharma may worsen certain conditions or cause serious side effects. These include allergic reactions, convulsions (seizures), and inflammation of the large intestine. Pay attention to whether the patient develops specific symptoms during treatment with Amoxicillin + clavulanic acid AptaPharma to reduce the risk of complications. See “Conditions to be aware of” in section 4.

Blood and urine tests

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

Amoxicillin + clavulanic acid AptaPharma and other medicines

Inform the doctor, pharmacist, or nurse about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

If the patient is taking allopurinol (used for gout), there may be an increased risk of skin allergic reactions when taken together with Amoxicillin + clavulanic acid AptaPharma.

If the patient is taking probenecid (used for gout), the doctor may decide to adjust the dose of Amoxicillin + clavulanic acid AptaPharma.

If the patient is taking anticoagulant medicines (such as warfarin) together with Amoxicillin + clavulanic acid AptaPharma, additional blood tests may be necessary.

Amoxicillin + clavulanic acid AptaPharma may affect the action of methotrexate (a medicine used in the treatment of 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, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor, pharmacist, or nurse before using this medicine.

Driving and operating machinery

Amoxicillin + clavulanic acid AptaPharma may cause side effects that impair the ability to drive. Do not drive or operate machinery unless the patient feels well.

Amoxicillin + clavulanic acid AptaPharma contains sodium and potassium

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

3. How to use Amoxicillin + clavulanic acid AptaPharmA

The patient will never take this medicine on their own. 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 body weight equal to or greater than 40 kg

Children with body weight below 40 kg

• All doses are determined according to 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 adjusted. The treating physician may choose a different strength or a different medicine.
• If the patient has liver disease, the treating physician will closely monitor their health condition, and liver function tests may be performed more frequently.

How Amoxicillin + clavulanic acid AptaPharma is administered

• Amoxicillin + clavulanic acid AptaPharma is administered by intravenous injection or intravenous infusion.
• During treatment with Amoxicillin + clavulanic acid AptaPharma, it is recommended to drink plenty of fluids.
• Usually, Amoxicillin + clavulanic acid AptaPharma is not administered for longer than 2 weeks without re-evaluation of the patient's health status by the physician.

Use of a higher than recommended dose of Amoxicillin + clavulanic acid AptaPharma
Administration of a dose higher than recommended is unlikely, but if the patient believes they have received a higher than recommended dose of Amoxicillin + clavulanic acid AptaPharma, they should immediately contact their physician, pharmacist, or nurse. Symptoms such as gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or convulsions may occur.
If in any doubt about the use of this medicine, consult a physician, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below may occur with this medicine.
Symptoms to be aware of
Allergic reactions:

• Skin rash
• Vasculitis, which may appear as red or purple raised spots on the skin, but may affect other organs
• Fever, joint pain, swelling of glands in the neck, armpits, or groin
• Swelling, sometimes involving the face or throat (angioedema), causing difficulty 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, seek immediate medical advice. You must stop taking Amoxicillin + clavulanic acid AptaPharma.

Inflammation of the large intestine
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, abdominal pain and/or fever.

Acute pancreatitis
If you have severe and persistent pain in the upper abdomen, this may be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis syndrome has occurred mainly in children receiving amoxicillin with clavulanic acid. It 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, contact your doctor as soon as possible for advice.

Common adverse reactions
May occur in up to 1 in 10 patients

• Oral, vaginal or skin fold fungal infections (candidiasis)
• Diarrhoea

Uncommon adverse reactions
May occur in up to 1 in 100 patients

• Skin rash, itching
• Raised, itchy rash (urticaria)
• Nausea, especially when taking high doses
• If this occurs, take Amoxicillin + clavulanic acid AptaPharma before meals
• Vomiting
• Indigestion
• Dizziness
• Headache

Uncommon adverse reactions that may be revealed in blood tests:

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

Rare adverse reactions
May occur in up to 1 in 1000 patients

• Skin rash, which may include blisters and resemble target-like lesions (dark spot in the centre surrounded by a lighter ring with a dark ring around the edge – erythema multiforme)
• If the patient notices any of these symptoms, they should contact a doctor urgently
• Swelling and redness along a vein, which is very painful to touch

Rare adverse reactions that may appear in blood test results:

• Low number of blood cells involved in blood clotting (thrombocytopenia)
• Low number of white blood cells (leukopenia)

Adverse reactions with unknown frequency
Frequency cannot be estimated from the available data.

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Severe skin reactions:
• Widespread skin rash, in which blisters and skin peeling may occur, especially around the mouth, nose, eyes, and genital organs (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (more than 30% of body surface area – toxic epidermal necrolysis [Lyell's syndrome])
• Widespread red rash with small pus-filled blisters (pustular exanthem)
• Red, scaly rash with subcutaneous nodules and blisters [acute generalised exanthematous pustulosis (AGEP)]
• Flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results [including increased white blood cell count (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS)
• Blistering rash arranged in a ring-like pattern or like a string of pearls (linear IgA dermatosis)
• If any of these symptoms occur in the patient, seek immediate medical advice.
• Inflammation of the liver (hepatitis)
• Jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• Inflammation of the kidney tubules
• Prolonged blood clotting time
• Seizures (in people receiving high doses of Amoxicillin + clavulanic acid AptaPharma or with kidney disease)

Adverse reactions that may appear in blood or urine tests:

• Marked decrease in white blood cell count
• Low number of red blood cells (haemolytic anaemia)
• Crystals in the urine leading to acute kidney injury

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 Amoxicillin + clavulanic acid AptaPharma

The information regarding expiry date and storage instructions printed on the packaging
is intended for the doctor, nurse, or pharmacist. The doctor, pharmacist, or nurse will prepare the medicine
for administration to the patient. The medicine should be used within 20 minutes after preparation. The medicine should be stored
in a place inaccessible and out of sight of children.
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 properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Amoxicillin + clavulanic acid AptaPharma contains

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

There are no other excipients. However, important information on the sodium and potassium content in 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 injections or infusion fluid).
What Amoxicillin + clavulanic acid AptaPharma looks like and contents of the pack
Amoxicillin + clavulanic acid AptaPharma is a sterile powder for solution for injection/infusion, supplied in vials made of colourless glass.
The pack contains 10 vials of 20 ml capacity made of colourless glass type II, with a stopper made of chlorobutyl rubber type I and an aluminium flip-off cap, packed in a cardboard box.
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:

Information intended exclusively for healthcare professionals.

For additional information, see the Summary of Product Characteristics.
Administration method
Amoxicillin + clavulanic acid AptaPharma may be administered as an intravenous injection over 3 to 4 minutes directly into a vein or into the infusion line, or as an intravenous infusion lasting 30 to 40 minutes. Amoxicillin + clavulanic acid AptaPharma is not intended for intramuscular administration.
Reconstitution
For single use only. Any unused solution must be discarded.
Reconstitution and dilution must be carried out under aseptic conditions. Before administration, the solution should be inspected visually for particulate matter or discoloration. The solution may only be used if it is clear and free from particulate matter. Vials of Amoxicillin + clavulanic acid AptaPharma are not intended for multiple use.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.
Preparation of solutions for intravenous injection
The standard solvent is water for injections (Ph. Eur.). Amoxicillin + clavulanic acid AptaPharma 1000 mg + 200 mg should be reconstituted with 20 ml of solvent to yield approximately 20.9 ml of solution for single use. A transient pinkish discoloration may be observed during dissolution of the powder. The prepared solutions are usually colorless to yellow.
Amoxicillin + clavulanic acid AptaPharma must be administered within 20 minutes after reconstitution.
Preparation of solutions for intravenous infusion
Amoxicillin + clavulanic acid AptaPharma 1000 mg + 200 mg should be reconstituted as described above to prepare a solution for injection. The reconstituted solution should be immediately added to 100 ml of infusion fluid using a mini-bag or an infusion set with a burette.
Only clear solutions free from particulate matter should be used.
Stability of prepared solutions
Vials with reconstituted solution (for intravenous injection or prior to dilution for infusion)
The reconstituted solution [contents of 1 vial reconstituted with 20 ml of water for injections (Ph. Eur.)] should be administered or diluted immediately, within 20 minutes of preparation.
Diluted solution for intravenous infusion
Chemical and physical stability of such a solution has been demonstrated to be 2–3 hours at 25°C or 6 hours at 5°C. From a microbiological standpoint, the solution resulting from reconstitution of the powder and subsequent dilution (contents of 1 vial after reconstitution diluted in a minimum volume of 100 ml of infusion fluid) should be used immediately.
Amoxicillin with clavulanic acid infusion solution can be prepared using various infusion fluids. The appropriate antibiotic concentration is maintained at 5°C and at room temperature (25°C) when the recommended volume of the following infusion fluids is used. If the diluted solution is stored at room temperature (25°C), the intravenous infusion should be completed no later than the time specified in the table below.

For storage at 5°C, the prepared solution of Amoxicillin + clavulanic acid AptaPharma may be added to a cooled infusion bag containing water for injections or 0.9% w/v sodium chloride solution, which can be stored for up to 6 hours. The infusion solution should then be administered immediately after reaching room temperature.
The stability of Amoxicillin + clavulanic acid AptaPharma solutions depends on the concentration. If a higher concentration solution is required, the stability period should be appropriately adjusted.
Amoxicillin + clavulanic acid AptaPharma is less stable in infusion solutions containing glucose, dextran, or bicarbonates. Prepared solutions of amoxicillin with clavulanic acid may be injected into an intravenous line over 3 to 4 minutes.
Any remaining antibiotic solution must be discarded.