AMOXICILLIN/CLAVULANIC ACID VIAL 1000 mg/200 mg POWDER FOR INJECTION AND INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic AcidRoom1,000 mg/200 mg powder for solution for injection and infusion EFG

amoxicillin sodium, potassium clavulanate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Amoxicillin/Clavulanic Acid Room and what is it used for
2. What you need to know before you are given Amoxicillin/Clavulanic Acid Room
3. How to take Amoxicillin/Clavulanic Acid Room
4. Possible side effects
   1. Storage of Amoxicillin/Clavulanic Acid Room
   2. Contents of the pack and further information

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

Amoxicillin/Clavulanic Acid Room is an antibiotic that eliminates the bacteria that cause infections. It contains two different drugs called amoxicillin and clavulanic acid. Amoxicillin belongs to the 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 Room 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 Room is used in adults and children to prevent infections associated with major surgical procedures.

2. What you need to know before you are given Amoxicillin/Clavulanic Acid Room

You should not be given Amoxicillin/Clavulanic Acid Room:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, to penicillins or to any of the other ingredients of this medicine (listed in section 6).
• if you have ever had a severe allergic reaction to any other antibiotic. This could include a 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 take Amoxicillin/Clavulanic Acid Room if any of the above applies to you. If you are not sure, consult your doctor, pharmacist, or nurse.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking 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 applies to you, tell your doctor, pharmacist, or nurse before taking Amoxicillin/Clavulanic Acid.

In some cases, your doctor may investigate the type of bacteria that is 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 taking Amoxicillin/Clavulanic Acid to reduce the risk of problems. See “Symptoms to be aware of” in section4.

Blood and urine tests

If you are having blood tests (such as studies of the state of red blood cells or liver function studies) or urine tests (to check glucose levels), tell your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid. This is because Amoxicillin/Clavulanic Acid can alter the results of these types of tests.

Using Amoxicillin/Clavulanic Acid Room with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other 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 your dose of Amoxicillin/Clavulanic Acid. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

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.

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid may cause side effects that can affect your ability to drive or use machines. Do not drive or use machines unless you are feeling well.

Amoxicillin/Clavulanic Acid Room contains sodium and potassium

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

Patients with kidney problems or those on a low potassium diet should be aware that this medicine contains approximately 39.3 mg (1.0 mmol) of potassium per vial.

3. How to take Amoxicillin/Clavulanic Acid Room

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

The recommended doses are:

Adults and children who weigh 40 kg or more

Children who weigh 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, you may need to have your dose 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 Room will be given to you

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

If you are given too much Amoxicillin/Clavulanic Acid Room

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. The symptoms may be stomach upset (nausea, vomiting, or diarrhea) or convulsions.

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

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

4. Possible side effects

Like all medicines, Amoxicillin/Clavulanic Acid Room 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 the blood vessels (vasculitis) which 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 taking Amoxicillin/Clavulanic Acid Room.

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 people

• thrush (candida - fungal infection of the vagina, mouth, or mucous membranes)
• diarrhea

Uncommon side effects

May affect up to 1 in 100 people

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

? if this happens, take Amoxicillin/Clavulanic Acid Room before meals

• vomiting
• indigestion
• dizziness
• headache.

Uncommon side effects that may appear in your blood tests:

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

Rare side effects

May affect up to 1 in 1,000 people

• 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

Frequency not known

• The 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 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 myocardial infarction (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 surrounding 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 immediatelyif 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 whites of the eyes turn yellow
• inflammation of the kidney ducts
• 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 reduction in the number of white blood cells
• low count of red blood cells (hemolytic anemia)
• crystals in the urine.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://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 Room

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 used within 20 minutes of 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 Room after the expiry date stated on the pack. The expiry date is the last day of the month stated.

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. Container Content and Additional Information

Composition ofAmoxicillin/Clavulanic Acid Sala

The active ingredients are amoxicillin and clavulanic acid.

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

It does not contain excipients. However, see section 2 for important information about the sodium and potassium content of Amoxicillin/Clavulanic Acid Sala.

The doctor, nurse, or pharmacist will prepare the injection before administration, using a suitable liquid (such as water for injectables or a liquid for injectables and perfusion).

Appearance of the Product and Container Content

Vials containing a sterile white to off-white powder.

Packages 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 the Last Revision of thisProspectus: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 solely for doctors or healthcare professionals:

Please see the Technical Sheet for additional information

Administration

Amoxicillin/Clavulanic Acid Sala can be administered by slow intravenous injection over a period of 3 to 4 minutes directly into a vein or by a drip for perfusion over 30-40 minutes. Amoxicillin/Clavulanic Acid Sala is not suitable for intramuscular administration.

Reconstitution

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

Preparation of solutions for intravenous injection

The usual solvent is water for injectable preparations. Amoxicillin/Clavulanic Acid Sala 1,000 mg/200 mg should be dissolved in 20 ml of solvent. This results in approximately 20.9 ml of solution for single-dose use. A pale pink coloration may be observed during reconstitution. The reconstituted solutions are normally colorless or with a pale straw color.

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

Preparation of solutions for intravenous perfusion

Amoxicillin/Clavulanic Acid Sala should be reconstituted as described above for injection. Immediately, the reconstituted solution should be added to 100 ml of perfusion fluid using a minibag or in-line burette.

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

In general, it is recommended not to mix it with any other product in the same syringe or perfusion 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 ACTIVITY OF THE AMINOGLYCOSIDE.

The vials of Amoxicillin/Clavulanic Acid Sala are not suitable for multiple-dose use.

Stability of Prepared Solutions

Reconstituted vials (for intravenous injection or before dilution for perfusion)

The solution obtained after reconstitution of the vial with 20 ml of water for injectables Ph. Eur., has been shown to be stable from a chemical and physical point of view for 20 minutes at 25 °C ± 2°C / 60% ± 5% HR.

Reconstituted and diluted vials for perfusion

The intravenous perfusion solutions 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 injectable preparations
• Sodium chloride solution 9 mg/ml (0.9% p/v)
• Simple Ringer's solution
• Ringer-Lactate solution (Hartmann's solution)
• Potassium chloride solution 0.3% p/v and sodium chloride 0.9% p/v (3 mg/ml and 9 mg/ml, respectively)

The chemical and physical stability of the perfusion solutions has been demonstrated under the following conditions:

For storage at 2-8°C (refrigerator), the reconstituted solution of Amoxicillin/Clavulanic Acid Sala can be added to pre-refrigerated perfusion bags containing water for injectable preparations or sodium chloride (0.9% p/v), which can be stored (in the refrigerator) for up to 6 hours. After these 6 hours, the perfusion should be administered immediately after reaching room temperature.