AMOXICILLIN CLAVULANATE POWDER FOR SOLUTION FOR INFUSION 2000 mg/200 mg

2. Before you receive Amoxicillin/Clavulanic Acid Sala

You should not receive Amoxicillin/Clavulanic Acid Sala:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, or penicillins.
• 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 receive Amoxicillin/Clavulanic Acid Sala if any of the above applies to you. If you are not sure, consult your doctor, pharmacist, or nurse.

Be careful with Amoxicillin/Clavulanic Acid Sala

Tell your doctor, pharmacist, or nurse before you receive this medicine if:

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

If you are not sure if any of the above symptoms affect you, inform your doctor, pharmacist, or nurse before receiving amoxicillin/clavulanic acid.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, you may be prescribed a different formulation of Amoxicillin/Clavulanic Acid or another medicine.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid can worsen certain existing conditions or cause serious side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. You should be aware of certain symptoms while using amoxicillin/clavulanic acid 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 status or liver function studies) or urine tests (to check glucose levels), inform your doctor or nurse that you are being given amoxicillin/clavulanic acid. This is because Amoxicillin/Clavulanic Acid can alter the results of these types of tests.

Use of other medicines

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

If you are taking allopurinol (used for gout) with amoxicillin/clavulanic acid, 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 Amoxicillin/Clavulanic Acid. Concomitant use of probenecid may reduce the excretion of Amoxicillin/Clavulanic Acid.

If you are taking anticoagulants (such as warfarin) with amoxicillin/clavulanic acid, more blood tests will be needed.

Amoxicillin/Clavulanic Acid may affect the way metotrexate (a medicine used to treat cancer and severe psoriasis or rheumatic diseases) works. Penicillins may reduce the excretion of metotrexate 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 Amoxicillin/Clavulanic Acid Sala

• Amoxicillin/Clavulanic Acid Sala 2,000 mg/200 mg contains approximately 125.9 mg (5.5 mmol) of sodium. This should be taken into account in patients on low-sodium diets.
• Amoxicillin/Clavulanic Acid Sala 2,000 mg/200 mg contains approximately 39.3 mg (1.0 mmol) of potassium. This should be taken into account in patients on low-potassium diets or with kidney problems.

3. How Amoxicillin/Clavulanic Acid Sala is administered

You will never administer this medicine to yourself. 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 formulation or another medicine.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How Amoxicillin/Clavulanic Acid Sala will be administered to you

• Amoxicillin/Clavulanic Acid will be administered to you as an intravenous infusion.
• Make sure to drink plenty of fluids while receiving amoxicillin/clavulanic acid.
• Amoxicillin/Clavulanic Acid will not be administered to you for more than 2 weeks without your doctor reviewing your treatment.

If you are given more Amoxicillin/Clavulanic Acid Sala than recommended

It is very unlikely that you will be given too much amoxicillin/clavulanic acid, but if you think you have been given too much, tell your doctor, pharmacist, or nurse immediately. Symptoms may include stomach upset (nausea, vomiting, or diarrhea) or convulsions.

If you have any further questions about how this product is administered, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Amoxicillin/Clavulanic Acid Sala can cause side effects, although not everybody gets 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 can appear as red or purple spots on the skin, but can affect other parts of the body
• fever, joint pain, swollen glands in the neck, armpits, or groin
• swelling sometimes of the face or mouth (angioedema), which can cause difficulty breathing
• collapse.

• Contact your doctor immediatelyif you experience any of these symptoms. Stop using Amoxicillin/Clavulanic Acid Sala.

Inflammation of the large intestine

Inflammation of the large intestine, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

• Contact your doctor as soon as possiblefor advice 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 itchy rash (urticarial rash)
• nausea, especially when high doses are given

• vomiting
• indigestion
• dizziness
• headache.

Uncommon side effects that may appear in your blood tests:

• Increased levels of some substances (enzymes) produced by the liver.

Rare side effects

May affect up to 1 in 1,000 patients

• Skin rash, which can form blisters that look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme)

• If you have any of these symptoms, contact a doctor urgently

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

Rare side effects that may appear in your 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 not known.

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the membrane that surrounds the brain and spinal cord (aseptic meningitis)
• Severe skin reactions:

• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
• widespread rash with small blisters containing pus (bullous exfoliative dermatitis)
• red rash with bumps under the skin and blisters (pustular exanthematous rash)
• flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as increased white blood cells (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 allergy-induced heart attack (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medicine). 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 like a string of pearls (linear IgA disease)
• Inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis)
• Acute inflammation of the pancreas (acute pancreatitis).

If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis

• Contact a doctor immediately if you have 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 make the skin and the whites of the eyes turn yellow
• delayed blood clotting
• convulsions (in patients taking high doses of Amoxicillin/Clavulanic Acid or with kidney problems)

Side effects that may appear in your blood or urine tests:

• significant decrease 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 think any of the side effects you are experiencing are seriousor if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, 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 Pharmacovigilance System for Human Use Medicines: http://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid Sala

The expiry date and storage instructions on the label are for the information of the doctor, nurse, or pharmacist. The doctor, pharmacist, or nurse will reconstitute your medicine, which must be diluted immediately after reconstitution.

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

Keep out of the reach and sight of children.

Do not use Amoxicillin/Clavulanic Acid Sala after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Additional Information

Composition of Amoxicillin/Clavulanic Acid Sala

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

It does not contain excipients.

Appearance of the Product and Packaging Content

Vials containing a sterile white to off-white powder.

Packaging of 1 or 50 vials of 20 ml.

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 was revised in January 2023.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for doctors or healthcare professionals:

Please see the Technical Sheet for additional information

Administration

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

Reconstitution

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

Amoxicillin/Clavulanic Acid Sala 2,000 mg/200 mg should be reconstituted in 20 ml of water for injectable preparations (this is a minimum volume). A pale pink coloration may be observed during reconstitution. The reconstituted solutions are normally colorless or with a pale straw color.

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

Glucose (dextrose) injectable solutions, sodium bicarbonate, or dextran should not be used as solvents.

In general, it is recommended not to mix it with any other product in the same syringe or infusion bottle. 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 Sala 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 Sala are not suitable for multiple-dose use.

Stability of Prepared Solutions

Reconstituted vials (before dilution for infusion)

The solution obtained after reconstituting the vial with 20 ml of water for injectables should be diluted immediately.

Reconstituted and diluted vials for infusion

The solution obtained by immediately diluting the reconstituted vial with 100 ml of water for injectables or NaCl 0.9% or 1/6M sodium lactate or Ringer's solution or Hartmann's solution has been shown to be stable from a chemical and physical point of view for 60 minutes at 25°C ± 2°C/ 60% ± 5% HR.