AMOXICILLIN/CLAVULANIC ACID SANDOZ 500 mg/50 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION
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Introduction
Package Leaflet: Information for the User
Amoxicillin/Clavulanic Acid Sandoz 500 mg/50 mg Powder for Solution for Injection and Infusion EFG
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 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 get 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
- What Amoxicillin/Clavulanic Acid Sandoz is and what it is used for.
- What you need to know before you use Amoxicillin/Clavulanic Acid Sandoz.
- How to use Amoxicillin/Clavulanic Acid Sandoz.
- Possible side effects.
- Storage of Amoxicillin/Clavulanic Acid Sandoz.
- Contents of the pack and other information.
1. What Amoxicillin/Clavulanic Acid Sandoz is and what it is used for
Amoxicillin/clavulanic acid is an antibiotic that eliminates the bacteria that cause infections. It contains two different medicines 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.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.
It is important that you follow the instructions regarding dosage, administration, and duration of treatment as indicated by your doctor.
Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.
Amoxicillin/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 skin infections,
- intra-abdominal infections,
- genital infections in women.
Amoxicillin/clavulanic acid is used in adults to prevent infections associated with major surgical procedures.
2. What you need to know before you use Amoxicillin/Clavulanic Acid Sandoz
Do not use Amoxicillin/Clavulanic Acid Sandoz:
- if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6)
- 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 Sandoz if any of the above applies to you.If you are not sure, consult your doctor, pharmacist, or nurse.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use amoxicillin/clavulanic acid if:
- you have infectious mononucleosis,
- you are receiving treatment 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 Sandoz.
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 being administered 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 red blood cell status or liver function studies) or urine tests (to check glucose levels), inform your doctor or nurse that you are being administered amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid can alter the results of these types of tests.
Use of Amoxicillin/Clavulanic Acid Sandoz with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or might use any 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.
Probenecid (used to treat gout), 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.
Methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.
Amoxicillin/clavulanic acid may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before using this medicine.
Amoxicillin/Clavulanic Acid Sandoz contains sodium and potassium
This medicine contains 29.6 mg of sodium per vial, equivalent to 1.48% of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.
This medicine contains less than 39 mg (1 mmol) of potassium per vial, and is therefore considered essentially "potassium-free".
3. How to use Amoxicillin/Clavulanic Acid Sandoz
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
Standard dose | 1,000 mg/100 mg every 8-12 hours. |
Higher dose | 1,000 mg/100 mg every 8 hours or 2,000 mg/200 mg every 12 hours. For very severe infections, the dose may be increased to 2,000 mg/200 mg every 8 hours. |
To prevent infections during and after surgery. | From 1,000 mg/100 mg to 2,000 mg/200 mg before surgery when you are given your anesthetic. The dose may vary depending on the type of operation you are having. Your doctor may repeat the dose if the surgery lasts more than one hour. |
Children weighing less than 40 kg
- All doses are calculated based on the child's body weight in kilograms.
Children 3 months or older: | 50 mg/5 mg per kilogram of body weight every 8 hours. |
Children under 3 months and weighing less than 4 kg | 50 mg/5 mg per kilogram of body weight every 12 hours. |
Patients with kidney and liver problems
How Amoxicillin/Clavulanic Acid Sandoz will be administered to you
- amoxicillin/clavulanic acid will be administered 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 to you for more than two weeks without your doctor reviewing your treatment.
If you use more Amoxicillin/Clavulanic Acid Sandoz than you should
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 on how this product is administered, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine 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) 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,
- 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 administering the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
Contact your doctor immediatelyif you experience any of these symptoms. Stop using Amoxicillin/Clavulanic Acid Sandoz.
Inflammation of the large intestine
Inflammation of the large intestine, which causes watery diarrhea normally 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 itchy rash (urticarial rash),
- nausea, especially when high doses are administered,
- 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),
- 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 unknown:
- allergic reactions (see above),
- 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 eruption),
- 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)),
- rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).
- inflammation of the liver (hepatitis),
- acute inflammation of the pancreas (acute pancreatitis); if you have severe and persistent stomach pain, this could be a sign of acute pancreatitis,
- jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver), which can cause the skin and the whites of the eyes to 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 that cause acute kidney injury.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Sandoz
The expiry date and storage instructions on the label are for the information of the doctor or nurse. The doctor, pharmacist, or nurse will reconstitute your medicine, which must be used within 15 minutes of reconstitution.
Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use Amoxicillin/Clavulanic Acid Sandoz after the expiry date stated on the pack. The expiry date refers to 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 of Amoxicillin/Clavulanic Acid Sandoz
Each vial contains as active ingredients 500 mg of amoxicillin (as amoxicillin sodium) and 50 mg of clavulanic acid (as potassium clavulanate).
It does not contain excipients.
Appearance of the Product and Container Content
Vials containing a sterile powder of white to off-white color.
Packaging of 1 vial, 10 vials, and 100 vials of 20 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz Pharmaceutical, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer
Sandoz GmbH
Biochemiestrasse, 10
A-6250 Kundl
Austria
Date of the Last Revision of this Prospectus:February 2023.
Detailed and updated information about 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 Sandoz 500 mg/50 mg powder for injectable solution and for perfusion, 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 Sandoz 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 Sandoz 500 mg/50 mg should be dissolved in 10 ml of solvent. This results in approximately 10.5 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 Sandoz should be administered within 15 minutes after reconstitution.
Preparation of solutions for intravenous perfusion
Amoxicillin/Clavulanic Acid Sandoz should be reconstituted as described above for injection. Immediately after reconstitution, the solution should be added to 25 ml of perfusion fluid using a minibag or in-line burette.
Solutions of glucose (dextrose), 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 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 Sandoz 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 Sandoz 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 reconstituting the vial with 10 ml of water for injection, has been shown to be stable from a chemical and physical point of view for 15 minutes at 25 °C ± 2°C / 60% ± 5% HR.
Reconstituted and diluted vials for perfusion
Reconstitution of the vial (see previous section)
The solution obtained by immediately diluting the reconstituted vial with 25 ml of water for injection Ph. Eur. or NaCl 0.9% or sodium lactate 1/6 M 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.
Any unused antibiotic solution should be discarded.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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