Label: Information for the user

Amoxicillin/ClavulanateSala1.000 mg/200 mg powder for injectable solution and for infusion EFG

amoxicillin sodium, potassium clavulanate

Read this label carefully before starting to usethis medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribedonlyto you, and you should not give it to other people even if they have the same symptomsas you,as it may harm them.
• If you experience any adverse effects,consult your doctor, pharmacist, or nurse,evenif they do not appear in this label. See section 4.

1.What is Amoxicillin/Clavulanate Sala and how is it used

2.What you need to knowbeforestarting to receiveAmoxicillin/Clavulanate Sala

3.How to administer Amoxicillin/Clavulanate Sala

4.Possible adverse effects

1. Storage of Amoxicillin/Clavulanate Sala
2. Contents of the package and additional information

Amoxicilina/Clavulanic Acid is an antibiotic that eliminates bacteria that cause infections. It contains two different medications called amoxicilina and clavulanic acid.amoxicilina and clavulanic acid. Amoxicilina belongs to a group of medications known as “penicillins” that sometimes may lose its effectiveness (become inactive). The other component (clavulanic acid) prevents this from happening.

Amoxicilina/Clavulanic Acid 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

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

You should not receive Amoxicillin/Clavulanic Acid Suspension:

•if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins or to any of the other components of this medication (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) when taking an antibiotic.

?Do not receive Amoxicillin/Clavulanic Acid Suspension if any of the above points 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 receive 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 receiving Amoxicillin/Clavulanic Acid.

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 Amoxicillin/Clavulanic Acid or another medication.

Be Aware of These Symptoms

Amoxicillin/Clavulanic Acid may worsen existing conditions or cause serious side effects. These include allergic reactions, convulsions and inflammation of the large intestine. Be aware of certain symptoms while using Amoxicillin/Clavulanic Acid to reduce the risk of problems. See “Be Aware of These Symptoms” 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 receiving Amoxicillin/Clavulanic Acid. This is because Amoxicillin/Clavulanic Acid may affect the results of these types of tests.

Using Amoxicillin/Clavulanic Acid Suspension with Other Medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

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 your Amoxicillin/Clavulanic Acid dose. Concomitant use of probenecid may reduce amoxicillin excretion and is not recommended.

If you are taking anticoagulants (such as warfarin) with Amoxicillin/Clavulanic Acid, you will need more blood tests.

Amoxicillin/Clavulanic Acid may affect the way methotrexate (a medication used to treat cancer and severe psoriasis or rheumatic diseases) works. Penicillins may reduce methotrexate excretion and cause a potential increase in side effects.

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

Pregnancy, Breastfeeding and Fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and Operating Machinery

Amoxicillin/Clavulanic Acid may cause side effects and symptoms that may make you unfit to drive. Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic Acid Suspension Contains Sodium and Potassium

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

Patients with kidney failure or low-potassium diets should note that this medication contains approximately 39.3 mg (1.0 mmol) of potassium per vial.

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

The recommended doses are:

Adults and children who weigh40kg or more

Children who weigh 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 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 injection or by 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 any further questions about how this product is administered, consult your doctor, pharmacist, or nurse.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Be aware of these symptoms

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 affectup to 1 in 10 people

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

Uncommon side effects

May affect up to1 in 100 people

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

?if this happens, administer Amoxicilina/Ácido clavulánico Sala 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 to1 in 1,000 people

• skin eruption, which may form blisters that resemble small darts (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

Unknown frequency

• the frequency cannot be estimated from available data.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 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)

• generalized rash with small blisters with pus (exfoliative bullous dermatitis)

• red rash, with bumps under the skin and blisters (exanthematic pustulosis)
• flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils (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 amoxicillin. 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 string of pearls (IgA linear disease)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• acute inflammation of the pancreas (acute pancreatitis).

If you have 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 increased bilirubin in the blood (a substance produced by the liver) that can turn the skin and white of the eyes yellow
• inflammation of the kidney tubes
• delayed blood clotting
• seizures (in patients taking high doses of Amoxicilina/Ácido clavulánico or those with kidney problems)

Side effects that may appear in blood or urine tests:

• significantly reduced count of white blood cells
• low count of red blood cells (hemolytic anemia)
• crystals in the urine.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://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 doctor, nurse or pharmacist. The doctor, pharmacist or nurse will reconstitute the medication, which must be used within 20 minutes of reconstitution.

This medication does not require any special temperature for conservation.Store in the original packaging to protect it from light

Keepthis medicationout of the sight and reach of children.

Do not use Amoxicillin/Clavulanate Vial 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 medications that you no longer need. This will help protect the environment.

Composition ofAmoxicillin/Clavulanic Acid Vial

The active principles are amoxicillin and clavulanic acid.

Each vial contains1,000 mg of amoxicillin (as amoxicillin sodium) and 200mg of clavulanic acid (as potassium clavulanate).

No excipients are present.However, see section 2 for important information on the sodium and potassium content ofAmoxicillin/Clavulanic Acid Vial.

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

Appearance of the product and contents of the package

Vials containing a sterile white to off-white powder.

1 or 100 vials of 20 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

Laboratorio Reig Jofré, S.A

Jarama, 111

45007-Toledo

Spain

Last review date of thisleaflet:January 2023

The detailed and updated information on 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 medical professionals or healthcare professionals:

Please see the Technical Dossier for additional information

Administration

Amoxicillin/Clavulanic Acid Vial can be administered by slow intravenous injection over a period of3 to4 minutes directly into a vein or by a drip over 30-40 minutes. Amoxicillin/Clavulanic Acid Vial is not suitable for intramuscular administration.

Reconstitution

The reconstitution of the intravenous injection solution or the reconstitution and dilution of the infusion solution should be performed at the time of administration.

Preparation of solutions for intravenous injection

The usual solvent is water for injection. Amoxicillin/Clavulanic Acid Vial 1,000 mg/200 mg should be dissolved in 20ml of solvent. This results in approximately 20.9 ml of solution for single-dose use. A pinkish color may be observed during reconstitution. The reconstituted solutions are normally colorless or pale yellowish.

Amoxicillin/Clavulanic Acid Vial should be administered within 20 minutes after reconstitution.

Preparation of solutions for intravenous infusion

Amoxicillin/Clavulanic Acid Vial 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.

No solutions for injection of glucose (dextrose), sodium bicarbonate, or dextran should be used as solvents.

It is generally 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 VIAL SHOULD NOT BE MIXED IN THE SAME SYRINGE WITH AMINOGLYCOSIDE ANTIBIOTICS, AS IT MAY RESULT IN A LOSS OF ACTIVITY OF THE AMINOGLYCOSIDE.

The vials of Amoxicillin/Clavulanic Acid Vial are not suitable for use in multiple doses.

Stability of prepared solutions

Vials reconstituted (for intravenous injection or before dilution for infusion)

The solution obtained after reconstitution of the vial with20ml ofwater for injection Ph. Eur.,has been shown to be stable from a chemical and physical point of view for20minutes at25 °C?2°C/ 60%?5% HR.

Vials reconstituted and diluted for infusion

The intravenous infusion solutions of amoxicillin/clavulanic acid should be prepared immediately after reconstitution of the vial content, by dilution to 100 ml with one of the following fluids:

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

The chemical and physical stability of the infusion solutions has been demonstrated in the following conditions:

For storage at 2-8°C (refrigerator), the reconstituted solution of Amoxicillin/Clavulanic Acid Vial can be added to pre-cooled infusion bags containing water for injection or sodium chloride solution (0.9% w/v), which can be stored (in refrigerator) for up to 6 hours. After those 6 hours, the infusion should be administered immediately after reaching room temperature.