Leaflet: information for the user
Amoxicilina Sandoz 1.000 mg film-coated tablets EFG
Amoxicilina
Read this leaflet carefully before you start taking this medicine, because
it contains important information for you.
1. What is Amoxicilina Sandoz and what it is used for
2. What you need to know before you start taking Amoxicilina Sandoz
3. How to take Amoxicilina Sandoz
4. Possible side effects
5. Storage of Amoxicilina Sandoz
6. Contents of the pack and additional information.
Amoxicilina Sandoz is an antibiotic. The active ingredient is amoxicilina. This belongs to a group of medicines called “penicillins”.
Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.
It is essential that you follow the instructions regarding the dose, administration interval, and duration of treatment indicated by your doctor.
Do not store or reuse this medication. If you have any leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.
What is Amoxicilina Sandoz used forSandoz
Amoxicilina Sandoz is used to treat bacterial infections in different parts of the body. Amoxicilina Sandoz may also be used in combination with other medications to treat stomach ulcers.
Do not take Amoxicilina Sandoz:
-if you are allergic to amoxicillin, penicillin, or any of the other components of this medication (listed in section 6),
-if you have ever had an allergic reaction to any other antibiotic. This could include a skin rash or swelling of the face or throat.
Do not take Amoxicilina Sandoz if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicilina Sandoz.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Amoxicilina Sandoz if:
If you are unsure whether any of the above situations apply to you, inform your doctor or pharmacist before taking Amoxicilina Sandoz.
Blood and urine tests
If you are having:
Inform your doctor or pharmacist that you are taking Amoxicilina Sandoz. This is because Amoxicilina Sandoz may affect the results of these types of tests.
Use of Amoxicilina Sandoz with other medications
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
Pregnancy and breastfeeding
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
Amoxicilina Sandoz may have adverse effects and symptoms (such as allergic reactions, dizziness, and seizures) that may make it unsafe to drive.
Do not drive or operate machinery unless you are feeling well.
Amoxicilina Sandoz contains sodium
This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.
Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
The usual dose is:
Children under 40 kg of weight
All doses are based on the child's body weight in kilograms.
Adults, elderly patients, and children 40 kg of weight or more
The usual dose of Amoxicilina Sandoz is 250 mg to 500 mg three times a day or 750 mg to 1 g every 12 hours, depending on the severity and type of infection.
Renal problems
If you have renal problems, the dose may be lower than the usual dose.
If you take more Amoxicilina Sandoz than you should
If you have taken more Amoxicilina Sandoz than you should, the signs may be stomach discomfort (nausea, vomiting, or diarrhea) or crystals in the urine, which may be observed as cloudy urine or difficulty urinating. Talk to your doctor as soon as possible. Bring the medication to show them. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
If you forgot to take Amoxicilina Sandoz
How long should you take Amoxicilina Sandoz
You may develop candidiasis (a fungal infection of the moist parts of the body that may cause pain, itching, and white discharge) if you take Amoxicilina Sandoz for a prolonged period. If this happens, consult your doctor.
If you take Amoxicilina Sandoz for a prolonged period, your doctor may perform additional tests to check that your kidneys, liver, and blood are functioning normally.
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking Amoxicilina Sandoz and see a doctor immediately if you experience any of the following severe side effects – you may need urgent medical treatment:
The following side effects are very rare (can affect up to 1 in 10,000 people)
These may occur during treatment or several weeks after.
If any of the above symptoms appear, stop taking the medicine and see your doctor immediately.
Occasionally, you may experience milder skin reactions such as:
If you experience any of them, talk to your doctor as you will need to interrupt your treatment with Amoxicilina Sandoz.
Other possible side effects are:
Frequent(can affect up to 1 in 10 people)
Rare(can affect up to 1 in 100 people)
Very rare(can affect up to 1 in 10,000 people)
Unknown frequency(cannot be estimated from available data)
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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance 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.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
Store below 25°C. Store in the original packaging.
Do not use this medication if you observe visible signs of deterioration.
Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at your local SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.
Composition of AmoxicillinSandoz
Appearance of the product and contents of the package
Amoxicillin Sandoz 1,000 mg tablets are film-coated white to cream-colored, oblong, biconvex, scored on both sides, approximately 11 x 22.5 mm.
The tablet can be divided into equal doses.
They are packaged in a blister pack in a box. It is available in packages of 20 and 30 tablets.
Only some package sizes may be marketed.
Holder of the marketing authorization and responsible for manufacturing
Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Responsible for manufacturing
Sandoz GmbH
Biochemiestraβe 10
A-6250 Kundl
Austria
Last review date of this leaflet:February 2023
The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
General advice on the use of antibiotics Antibiotics are used to treat bacterial infections.They are not effective against viral infections. Occasionally, an infection caused by bacteria does not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the antibiotic. Bacteria can become resistant to antibiotics for many reasons. Using antibiotics properly can reduce the likelihood of bacteria becoming resistant to them. When your doctor prescribes an antibiotic, it is only for your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that may make the antibiotic ineffective: 1.It is very important to take the antibiotic in the correct dose, at the indicated hours, and for the correct number of days. Read the prospectus instructions and, if you do not understand something, ask your doctor or pharmacist. 2.You should not take an antibiotic unless you have been prescribed it specifically for you and you should use it only for the infection for which it has been prescribed. 3.You should not take antibiotics that have been prescribed for other people, even if they had a similar infection to yours. 4.You should not give antibiotics that have been prescribed for you to other people. 5.If you still have antibiotics left over after completing treatment, hand over all unused medications to your pharmacy to ensure that the disposal requirements are met. |
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.