PATIENT INFORMATION LEAFLET

Amoxicillin/Clavulanate Potassium 2,000 mg/200 mg

Powder for Solution for Infusion EFG

Read this leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you think you are having a serious side effect or if any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse.

Amoxicilina/Ácido clavulánico Sala is an antibiotic that eliminates bacteria that cause infections. It contains two different medications called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medications known as “penicilinas” which can sometimes lose its effectiveness (become inactive). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico Sala is used in adults and children to treat the following infections:

• Acute ear, nose, and throat infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections including dental infections
• Bone and skin infections
• Intra-abdominal infections
• Genital infections in women

Amoxicilina/ácido clavulánico Sala is used in adults to prevent infections associated with major surgical procedures.

You should not take Amoxicilina/Ácido clavulánico Sala:

• if you are allergic (hypersensitive) to amoxicilina, ácido clavulánico, or penicilinas.
• if you have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This could include skin rash or swelling of the face or neck.
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

• Do not take Amoxicilina/Ácido clavulánico Sala if any of the above applies to you.. If you are unsure, consult your doctor, pharmacist, or nurse.

Be especially careful with Amoxicilina/Ácido clavulánico Sala

Inform your doctor, pharmacist, or nurse before taking this medication if:

• you have infectious mononucleosis
• you are receiving treatment for liver or kidney problems
• you do not urinate regularly.

If you are unsure whether any of the above symptoms affect you, inform your doctor, pharmacist, or nurse before taking amoxicilina/ácido clavulánico.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different presentation of Amoxicilina/ácido clavulánico or another medication.

Symptoms to be aware of

Amoxicilina/ácido clavulánico may worsen existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine. Be aware of certain symptoms while using amoxicilina/ácido clavulánico to reduce the risk of problems. See “Symptoms to be aware of” in section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are being administered amoxicilina/ácido clavulánico. This is because Amoxicilina/ácido clavulánico may alter the results of these types of tests.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription and herbal medications.

If you are taking alopurinol (used for gout) with amoxicilina/ácido clavulánico, you may be more likely to have a skin allergic reaction.

If you are taking probenecid (used to treat gout), your doctor may adjust the dose of Amoxicilina/ácido clavulánico.The concomitant use of probenecid may reduce the excretion of Amoxicilina/Ácido clavulánico.

If you are taking anticoagulants (such as warfarin) with amoxicilina/ácido clavulánico, more blood tests will be required.

Amoxicilina/ácido clavulánico may affect the mode of action of methotrexate (a medication used to treat cancer and severe psoriasis or rheumatic diseases).Penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

Pregnancy and breastfeeding

Consult your doctor, pharmacist, or nurse if you are pregnant or breastfeeding.

Important information about some of the components of Amoxicilina/Ácido clavulánico Sala

• Amoxicilina/Ácido clavulánico Sala 2.000 mg/200 mg contains approximately 125.9 mg (5.5 mmol) of sodium. This should be taken into account in patients with low-sodium diets.
• Amoxicilina/Ácido clavulánico Sala 2.000 mg/200 mg contains approximately 39.3 mg (1.0 mmol) of potassium. This should be taken into account in patients with low-potassium diets or kidney problems.

This medication will not be self-administered. A qualified person, such as a doctor or nurse, will administer it to you.

The usual doses are:

Adults and children weighing 40 kg or more

Children weighing less than 40 kg

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

Patients with kidney and liver problems

• If you have kidney problems, your dose may be changed. Your doctor may choose a different presentation or another medication.
• If you have liver problems, you will have more frequent blood tests to check how your liver is functioning.

How Amoxicilina/Ácido clavulánico Sala will be administered to you

• Amoxicilina/ácido clavulánico will be administered to you as an intravenous infusion.
• Make sure to drink plenty of liquids while receiving amoxicilina/ácido clavulánico.
• Amoxicilina/ácido clavulánico will not be administered to you for more than 2 weeks without your doctor reviewing your treatment.

If you are given more Amoxicilina/ácido clavulánico Sala than recommended

It is very unlikely that you will be given too much amoxicilina/ácido clavulánico, but if you think you have been given too much, tell your doctor, pharmacist, or nurse immediately. The symptoms may be stomach upset (nausea, vomiting, or diarrhea) or seizures.

If you have more questions about how this product is administered, consult your doctor, pharmacist, or nurse.

Like all medicines, Amoxicilina/Ácido clavulánico Sala may cause side effects, although not everyone will experience them. The following side effects may occur with this medicine.

Symptoms to be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) that may appear as red or purple spots on the skin, but can affect other parts of the body
• fever, joint pain, swollen lymph nodes in the neck, armpits, or groin
• swelling of the face or mouth (angioedema), which can cause difficulty breathing
• collapse.

• Contact your doctor immediatelyif you experience any of these symptoms.Stop administering Amoxicilina/Ácido clavulánico Sala.

Colitis

Colitis, which causes watery diarrhea usually with blood and mucus, stomach pain, and/or fever.

• Contact your doctor as soon as possibleso they can advise you if you have these symptoms.

Common side effects

May affect up to 1 in 10 patients

• thrush (candida – fungal infection in the vagina, mouth, or mucous membranes)
• diarrhea

Uncommon side effects

May affect up to 1 in 100 patients

• skin rash, itching
• increased pruritic rash (urticarial hives)
• nausea, especially when high doses are administered

• if this occurs, administer amoxicilina/ácido clavulánico before meals

• vomiting
• indigestion
• dizziness
• headache.

Uncommon side effects that may appear in blood tests:

• increase in some substances (enzymes) produced by the liver.

Rare side effects

May affect up to 1 in 1,000 patients

• skin rash, which may form blisters that appear as small dianas (central dark spot surrounded by a lighter area, with a dark ring around the edge –erythema multiforme)

• if you experience any of these symptoms, contact a doctor urgently

• swelling and redness along a vein, which is extremely sensitive to the touch.

Uncommon side effects that may appear in blood tests:

• low count of cells involved in blood clotting
• low count of white blood cells

Other side effects

Other side effects that have occurred in a very small number of patients and whose exact frequency is unknown.

• Allergic reactions (see above)
• Colitis (see above)
• inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• severe skin reactions:

• generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (toxic epidermal necrolysis)
• generalized rash with small blisters containing pus (exfoliative bullous dermatitis)
• red rash, with lumps under the skin and blisters (pustular exanthema)
• flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as elevated white blood cell count (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

• Chest pain in the context of allergic reactions, which can be a symptom of allergic-induced heart attack (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES): DIES has mainly been reported in children taking amoxicilina. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
• Crystals in the urine that cause acute kidney injury
• Rash with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• acute pancreatitis.

If you experience intense and persistent pain in the abdominal area, this could be a sign of acute pancreatitis

• Contact a doctor immediately if you experience any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that can turn the skin and the white of the eyes yellow
• inflammation of the kidney ducts
• delayed blood clotting
• seizures (in patients taking high doses of Amoxicilina/ácido clavulánico or with kidney problems)

Side effects that may appear in blood or urine tests:

• significant reduction in the number of white blood cells
• low count of red blood cells (hemolytic anemia)
• crystals in the urine.

If you experience side effects

• If you consider that any of the side effects you experience areseriousor if you notice any side effect not mentioned in this leafletinform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

The expiration date and storage instructions on the label are for the information of the physician, nurse, or pharmacist. The physician, pharmacist, or nurse will reconstitute the medication, which must bediluted immediately afterreconstitution.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light

Keep out of the reach and sight of children.

Do not use Amoxicillin/Clavulanate Powder for Injection after the expiration date that appears on the container. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition of Amoxicillin/clavulanic acid Solution

Each vial contains as active ingredients 2,000 mg of amoxicillin (as amoxicillin sodium) and 200 mg of clavulanic acid (as potassium clavulanate).

No excipients are contained.

Appearance of the product and contents of the package

White to off-white sterile powder vials.

1 or 50 vials of 20 ml packaging.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Laboratorio Reig Jofré, S.A

Jarama, 111

45007-Toledo

Spain

This leaflet has been reviewed in January 2023.

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for doctors or healthcare professionals:

Please see the Technical Data Sheet for additional information

Administration

Amoxicillin/clavulanic acid Solution 2,000 mg/200 mg powder for solution for infusion, should be administered by infusion over 30 - 40 minutes. Amoxicillin/clavulanic acid Solution is not suitable for intramuscular administration.

Reconstitution

The reconstitution and dilution of the intravenous infusion solution should be performed at the time of administration. Amoxicillin/clavulanic acid Solution 2000 mg/200 mg is not suitable for rapid intravenous injection (bolus).

Amoxicillin/clavulanic acid Solution 2,000 mg/200 mg should be reconstituted with 20 ml of injectable water (this is the minimum volume). A pale pink coloration may be observed during reconstitution. The reconstituted solutions are normally colorless or pale yellowish.

Immediately, the reconstituted solution should be added to 100 ml of infusion fluid using a mini-bag or burette in-line.

Do not use injectable glucose (dextrose) solutions, sodium bicarbonate solutions, or dextran solutions as solvents.

Generally, it is recommended not to mix it with any other product in the same syringe or infusion bag. The combination of amoxicillin and clavulanic acid is incompatible with: blood and plasma, hydrocortisone succinate, amino acid solutions, protein hydrolysates, lipid emulsions, phenylephrine HCl, mannitol solutions.

Amoxicillin/clavulanic acid Solution should not be mixed in the same syringe with aminoglycoside antibiotics, as this may result in a loss of aminoglycoside activity.

The vials of Amoxicillin/clavulanic acid Solution are not suitable for use in multiple doses.

Stability of prepared solutions

Reconstituted vials (before dilution for infusion)

The obtained dissolutionafter reconstituting the vial with 20 ml of injectable water, should be diluted immediately.

Reconstituted and diluted vials for infusion

The obtained dissolution after dilutingimmediatelythe reconstituted vial, with 100 ml of injectable water or 0.9% NaCl or 1/6M sodium lactate or Ringer's solution or Hartmann's solution has been demonstrated to be chemically and physically stable for 60 minutes at 25°C ± 2°C/ 60% ±5% HR.