Amoxicillin/clavulanic acid Sala 1,000 mg/200 mg powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Amoxicillin/Clavulanic acid Sala 1,000 mg/200 mg powder for injectable solution and for infusion EFG

sodium amoxicillin, potassium clavulanate

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Amoxicillin/Clavulanic acid Sala is and what it is used for
2. What you need to know before receiving Amoxicillin/Clavulanic acid Sala
3. How to administer Amoxicillin/Clavulanic acid Sala
4. Possible adverse effects
   1. Storage of Amoxicillin/Clavulanic acid Sala
   2. Contents of the pack and other information

1. What Amoxicillin/Clavulanic Acid Sala is and what it is used for

Amoxicillin/Clavulanic Acid Sala is an antibiotic that kills bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/Clavulanic Acid 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 joint infections
• Intra-abdominal infections
• Genital infections in women

Amoxicillin/Clavulanic Acid Sala is used in adults and children to prevent infections associated with major surgical procedures.

2. What you need to know before starting Amoxicillin/Clavulanic Acid Sala

You should NOT receive Amoxicillin/Clavulanic Acid Sala:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or to any of the other components of this medicine (listed in section 6).
• if you have ever had a severe allergic reaction to any other antibiotic. This could include skin rash or swelling of the face or throat.
• if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

? Do not receive Amoxicillin/Clavulanic Acid Sala if any of the above apply to you. If you are unsure, consult your doctor, pharmacist, or nurse.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medicine 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 apply to 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 watch for

Amoxicillin/Clavulanic acid may worsen certain existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking Amoxicillin/Clavulanic acid to reduce the risk of complications. See “Symptoms to watch for” in section 4.

Blood and urine tests

If you are undergoing blood tests (such as studies of red blood cells or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are being administered Amoxicillin/Clavulanic acid. This is because Amoxicillin/Clavulanic acid may alter the results of these types of tests.

Use of Amoxicillin/Clavulanic acid with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are taking allopurinol (used for gout) with Amoxicillin/Clavulanic acid, you may be more likely to experience a skin allergic reaction.

If you are taking probenecid (used to treat gout), your doctor may adjust your dose of Amoxicillin/Clavulanic acid. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

If anticoagulants (such as warfarin) are taken with Amoxicillin/Clavulanic acid, more blood tests will be needed.

Amoxicillin/Clavulanic acid may affect how methotrexate (a medicine used to treat cancer, severe psoriasis, or rheumatic diseases) works. Penicillins may reduce methotrexate excretion and cause a potential increase in adverse effects.

Amoxicillin/Clavulanic acid may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Amoxicillin/Clavulanic acid may cause adverse effects, and the symptoms may impair your ability to drive. Do not drive or operate machinery unless you feel well.

Amoxicillin/clavulanic acid contains sodium and potassium

This medicine contains 62.9 mg (2.7 mmol) of sodium (the main component of table/cooking salt) in each vial. This corresponds to 3.14% of the maximum daily sodium intake recommended for an adult.

Patients with renal impairment or those on potassium-restricted diets should be aware that this medicine contains approximately 39.3 mg (1.0 mmol) of potassium per vial.

3. How to administer Amoxicillin/Clavulanic Acid Sala

You must never administer this medicine to yourself. A qualified person, such as a doctor or nurse, will administer it to you.

The recommended doses are:

Adults and children weighing 40 kg or more

Children weighing less than 40kg

• 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 adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor how your liver is functioning.

How Amoxicillin/Clavulanic Acid Sala will be administered

• Amoxicillin/Clavulanic Acid will be given to you as an injection into a vein or by intravenous infusion.
• Make sure you drink plenty of fluids while receiving Amoxicillin/Clavulanic Acid.
• Amoxicillin/Clavulanic Acid will not be administered for longer than 2 weeks without your doctor reviewing your treatment.

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

It is highly unlikely that you will be given too much Amoxicillin/Clavulanic Acid; however, if you think you have been given too much, tell your doctor, pharmacist, or nurse immediately. Symptoms may include gastrointestinal discomfort (nausea, vomiting, or diarrhoea) or seizures.

If you have further questions about the administration of this product, consult your doctor, pharmacist, or nurse.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, Amoxicillin/Clavulanic acid Sala may produce adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine.

Symptoms to watch for

Allergic reactions:

• skin rash

• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may 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), causing difficulty breathing

• collapse

• Contact your doctor immediately if you experience any of these symptoms**. Stop taking Amoxicillin/Clavulanic acid Sala.**

Inflammation of the large intestine

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

• Contact your doctor as soon as possible for advice if you have these symptoms.

Common adverse effects

May affect up to 1 in 10 people

• fungal infections (candida) of the vagina, mouth or mucous membranes
• diarrhoea

Uncommon adverse effects

May affect up to 1 in 100 people

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

? if this occurs, take Amoxicillin/Clavulanic acid Sala before meals

• vomiting
• indigestion
• dizziness
• headache

Uncommon adverse effects that may appear in your blood tests:

• increased levels of certain substances (enzymes) produced by the liver

Rare adverse effects

May affect up to 1 in 1,000 people

• skin rash, which may form blisters resembling small targets (a dark central spot surrounded by a paler 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 the vein, which is extremely tender to the touch

Rare adverse effects that may appear in your blood tests:

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

Frequency not known

• Frequency cannot be estimated from the available data.
  Allergic reactions (see above)
  Inflammation of the large intestine (see above)
  Inflammation of the protective membrane surrounding the brain (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 body surface – toxic epidermal necrolysis)

• Widespread rash with small pus-filled blisters (bullous exfoliative dermatitis)

• Red rash with lumps under the skin and blisters (exanthematous pustulosis)

• 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 may be a symptom of heart attack triggered by allergy (Kounis syndrome).
  Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. It is a specific 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 causing acute kidney injury
  Blistering rash arranged in a circular pattern with central crusting or resembling a "string of pearls" (linear IgA disease)
  Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
  Acute inflammation of the pancreas (acute pancreatitis).

If you have severe and persistent pain in the stomach 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 increased bilirubin in the blood (a substance produced by the liver), which may cause the skin and whites of the eyes to turn yellow
  Inflammation of the kidney ducts
  Prolonged blood clotting time
  Seizures (in patients taking high doses of Amoxicillin/Clavulanic acid or who have kidney problems)

Adverse effects that may appear in blood or urine tests:

• Marked decrease in the number of white blood cells
• Low red blood cell count (hemolytic anemia)
• Crystals in the urine

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if these are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es . By reporting adverse 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 physician, nurse, or pharmacist. Your medication will be reconstituted by the physician, pharmacist, or nurse and must be used within 20 minutes after reconstitution.

This medicine does not require any special storage temperature. Keep in the original packaging to protect from light.

Keep this medicine out of the sight and reach of children.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Amoxicilina/Ácido clavulánico Sala

The active substances are amoxicillin and clavulanic acid.

Each vial contains 1,000 mg of amoxicillin (as sodium amoxicillin) and 200 mg of clavulanic acid (as potassium clavulanate).

It contains no excipients. However, see section 2 for important information regarding the sodium and potassium content of Amoxicilina/Ácido clavulánico Sala.

The doctor, nurse, or pharmacist will prepare the injection before administration using an appropriate liquid (such as water for injections or a liquid for injections and infusion).

Presentation of the product and package contents

Vials containing a sterile white to off-white powder.

Pack sizes of 1 or 100 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

Date of most recent review of this leaflet: January 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Please refer to the Summary of Product Characteristics for additional information

Administration

Amoxicilina/Ácido clavulánico Sala can be administered by slow intravenous injection over a period of 3 to 4 minutes directly into a vein or by infusion over 30–40 minutes. Amoxicilina/Ácido clavulánico Sala is not suitable for intramuscular administration.

Reconstitution

Reconstitution of the solution for intravenous injection or reconstitution and dilution of the solution for infusion must be performed at the time of administration.

Preparation of solutions for intravenous injection

The usual solvent is water for injections. Amoxicilina/Ácido clavulánico Sala 1,000 mg/200 mg should be dissolved in 20 ml of solvent. This yields approximately 20.9 ml of solution for single-dose use. A pale pink coloration may be observed during reconstitution. Reconstituted solutions are normally colorless or pale yellow.

Amoxicilina/Ácido clavulánico Sala should be administered within 20 minutes after reconstitution.

Preparation of solutions for intravenous infusion

Amoxicilina/Ácido clavulánico Sala should be reconstituted as described above for injection. Immediately, the reconstituted solution should be added to 100 ml of infusion fluid using a minibag or in-line burette.

Injectable glucose (dextrose), sodium bicarbonate, or dextran solutions must not be used as solvents.

In general, it is recommended not to mix this product with any other medicine 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, and mannitol solutions.

AMOXICILINA/ÁCIDO CLAVULÁNICO SALA MUST NOT BE MIXED IN THE SAME SYRINGE WITH AMINOGLYCOSIDE ANTIBIOTICS, AS THIS MAY RESULT IN LOSS OF AMINOGLYCOSIDE ACTIVITY.

The vials of Amoxicilina/Ácido clavulánico Sala are not suitable for multiple-dose use.

Stability of prepared solutions

Reconstituted vials (for intravenous injection or prior to dilution for infusion)

The solution obtained after reconstitution of the vial with 20 ml of Water for Injections Ph. Eur. has been shown to be chemically and physically stable for 20 minutes at 25 °C ± 2°C / 60% ± 5% RH.

Reconstituted and diluted vials for infusion

Solutions for intravenous infusion of amoxicillin/clavulanic acid should be prepared immediately after reconstitution of the vial contents by dilution to 100 ml with one of the following fluids:

• Water for Injections
• Sodium chloride solution 9 mg/ml (0.9% w/v)
• Ringer's solution (simple)
• Ringer-Lactate solution (Hartmann's solution)
• Potassium chloride 0.3% w/v and sodium chloride 0.9% w/v solution (3 mg/ml and 9 mg/ml, respectively)

Chemical and physical stability of infusion solutions has been demonstrated under the following conditions:

For storage at 2-8°C (refrigerator), the reconstituted Amoxicillin/Clavulanic acid Sala solution may be added to pre-refrigerated infusion bags containing Water for Injections or Sodium Chloride (0.9% w/v), which can be stored (in the refrigerator) for up to 6 hours. After these 6 hours, the infusion must be administered immediately after reaching room temperature.