Amoxicillin/clavulanic acid Sala 2.000 mg/200 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin/Clavulanic acid Sala 2.000 mg/200 mg

powder for solution for infusion EFG

Read the entire 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 experience any side effects that you consider to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor, pharmacist or nurse.

Leaflet contents:

1. What Amoxicillin/Clavulanic acid Sala is and what it is used for
2. Before you are given Amoxicillin/Clavulanic acid Sala
3. How Amoxicillin/Clavulanic acid Sala is administered
4. Possible side effects
5. How to store Amoxicillin/Clavulanic acid Sala
6. Further 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 skin infections
• Intra-abdominal infections
• Genital infections in women

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

2. Before receiving 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 may include skin rash or swelling of the face or neck.

• 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.

Take special care with Amoxicillin/Clavulanic acid Sala

Tell your doctor, pharmacist, or nurse before receiving 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 conditions 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 using amoxicillin/clavulanic acid to reduce the risk of problems. See “Symptoms to watch for” in section 4.

Blood and urine tests

If you are undergoing blood tests (such as studies of red blood cell status 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 other medicines

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

If you are taking allopurinol (used for gout) together 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/clavulanic acid.

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 potentially increase adverse effects.

Pregnancy and breastfeeding

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

Important information about some 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 to administer Amoxicillin/Clavulanic acid Sala

This medicine must never be self-administered. It will be administered by a qualified person, such as a doctor or nurse.

Standard 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 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 to you

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

If you are administered 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 diarrhea) or seizures.

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

4. Possible adverse effects

Like all medicines, Amoxicillin/Clavulanic Acid Sala may cause adverse effects, although not everyone will experience 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 patients

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

Uncommon adverse effects

May affect up to 1 in 100 patients

• skin rash, itching

• increased itchy rash (urticarial weals)

• nausea, especially when high doses are administered

• if this occurs, take amoxicillin/clavulanic acid before meals

• vomiting

• indigestion

• dizziness

• headache

Uncommon adverse effects that may appear in blood tests:

• increase in certain substances (enzymes) produced by the liver

Rare adverse effects

May affect up to 1 in 1,000 patients

• 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 a vein, which is extremely tender to touch

Rare adverse effects that may appear in blood tests:

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

Other adverse effects

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

• 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 pustules (exfoliative bullous dermatitis)

• red rash with bumps 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 a heart attack triggered by allergy (Kounis syndrome).

• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. It is a type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.

• Crystals in the urine causing acute kidney injury

• Rash with blistering arranged in circles with a central crust or resembling a string of pearls (linear IgA disease)

• Inflammation of the membranes covering 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 have 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 yellowish

• inflammation of the kidney tubules

• delayed blood clotting

• 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 reduction in the number of white blood cells
• low red blood cell count (haemolytic anaemia)
• crystals in the urine

If you experience adverse effects

• If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://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. The physician, pharmacist, or nurse will reconstitute your medication, which must be diluted immediately after reconstitution.

Do not store above 25°C. Keep 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 refers to 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 unused medicines and their packaging. 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 sodium amoxicillin) and 200 mg of clavulanic acid (as potassium clavulanate).

It contains no excipients.

Appearance of the product and pack contents

Vials containing a sterile white to off-white powder.

Pack sizes 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 last reviewed in January 2023.

Detailed and up-to-date information on this medicinal product 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 further information

Administration

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

Reconstitution

Reconstitution and dilution of the intravenous infusion solution must be carried out immediately before administration. Amoxicillin/Clavulanic Acid Sala 2,000 mg/200 mg is not suitable for rapid intravenous injection (bolus).

Amoxicillin/Clavulanic Acid Sala 2,000 mg/200 mg must be reconstituted with 20 ml of water for injectable preparations (this is the minimum volume). A pale pink coloration may be observed during reconstitution. Reconstituted solutions are usually colorless or pale yellow.

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

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

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

Amoxicillin/Clavulanic Acid Sala must not be mixed in the same syringe with aminoglycoside antibiotics, as inactivation of the aminoglycoside may occur under these conditions.

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 injectable preparations must be diluted immediately.

Reconstituted and diluted vials for infusion

The solution obtained by immediately diluting the reconstituted vial with 100 ml of water for injectable preparations or 0.9% sodium chloride or 1/6 M sodium lactate or Ringer's solution or Hartmann's solution has been shown to be chemically and physically stable for 60 minutes at 25°C ± 2°C / 60% ± 5% relative humidity.