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.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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”.

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:

• you have infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue),
• you have kidney problems,
• you do not urinate regularly.

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:

• urine tests (glucose in urine) or blood tests for liver function,
• estriol tests (used during pregnancy to check if the baby is developing normally).

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.

• If you are taking allopurinol (used for gout) with Amoxicilina Sandoz, it may be more likely that you will have a skin rash.
• If you are taking probenecid (used to treat gout), the concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Sandoz, more blood tests may be necessary.
• If you are taking other antibiotics (such as tetracycline), Amoxicilina Sandoz may be less effective.
• If you are taking methotrexate (a medication used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in adverse effects.

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.

• Swallow the tablets.
• Space the doses uniformly throughout the day, at least separated by 4 hours.

The usual dose is:

Children under 40 kg of weight

All doses are based on the child's body weight in kilograms.

• Your doctor will tell you how much Amoxicilina Sandoz to administer to your baby or child.
• The usual dose is 40 mg to 90 mg per kilogram of body weight per day, administered in two or three divided doses.
• The maximum recommended dose is 100 mg per kilogram of body weight per day.

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.

• Severe infections:750 mg to 1 g three times a day.
• Urinary tract infections:3 g twice a day, for one day.
• Lyme disease (a disease caused by some parasites called ticks):erythema migrans isolated (early stage – circular pink or red rash): 4 g per day; systemic manifestations (late stage – with more severe symptoms or when the disease spreads throughout the body): up to 6 g per day.
• Stomach ulcers:one dose of 750 mg or one dose of 1 g, twice a day, for 7 days with other antibiotics and medications to treat stomach ulcers.
• To prevent heart infection during surgery:The dose will vary depending on the type of surgery. Other medications may be administered at the same time. Your doctor, pharmacist, or nurse can provide more details.
• The maximum recommended dose is 6 g per day.

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

• If you forget to take a dose, take it as soon as you remember.
• Do not take the next dose too soon, wait at least 4 hours before taking the next dose.
• Do not take a double dose to compensate for the missed doses.

How long should you take Amoxicilina Sandoz

• Continue taking Amoxicilina Sandoz for the time your doctor has told you, even if you feel better. You need to take all the doses to overcome the infection. If some bacteria survive, they may cause the infection to recur.
• Once you have finished the treatment, if you continue to feel unwell, you should go back to see your doctor.

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)

• allergic reactions, symptoms may include: itching or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These can be severe and, in some cases, have been fatal,
• skin rash or flat, round, red spots like the tip of a pin under the skin's surface or bruises on the skin. This is due to inflammation of the blood vessel walls due to an allergic reaction. It may be associated with joint pain (arthritis) and kidney problems,
• you may experience a delayed allergic reaction up to 7 to 12 days after taking Amoxicilina Sandoz, some symptoms include: rashes, fever, joint pain, and lymph node enlargement, especially under the arms,
• a skin reaction called 'erythema multiforme' in which you may develop: purple or reddish rashes with itching on the skin, especially on the palms of the hands or soles of the feet, swollen areas on the skin, soft tissues on the surface of the mouth, eyes, and genitals. You may have a fever and feel very tired,
• other severe skin reactions may be:skin color change, lumps under the skin, blisters,pus, peeling, redness, pain,. They may be accompanied by fever, headache, and body aches,
• flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)),
• fever, chills, sore throat, or other signs of infection, or the appearance of bruises easily. These may be signs of a problem with your blood cells,
• Jarisch-Herxheimer reaction that occurs during treatment with Amoxicilina Sandoz for Lyme disease and causes fever, chills, headache, muscle pain, and skin rash,
• inflammation of the large intestine (colon) with diarrhea (sometimes with blood), pain, and fever,
• you may experience severe side effects in the liver. These are mainly associated with prolonged treatments, men, and advanced age. Inform your doctor immediately if you have:
• • severe diarrhea with bleeding,
  • blistering, redness, or bruising on the skin,
  • dark urine or pale stools,
  • yellowing of the skin and white of the eyes (jaundice). See anemia below, which may cause jaundice.

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:

• a moderate rash with itching (round, pink-red spots), swollen areas with blister-like appearance on the forearms, legs, palms, hands, or feet. This is rare (can affect up to 1 in 100 people).

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)

• skin rash,
• nausea,
• diarrhea.

Rare(can affect up to 1 in 100 people)

• vomiting.

Very rare(can affect up to 1 in 10,000 people)

• candidiasis (vaginal, oral, or skin fungal infection), you can obtain treatment from your doctor or pharmacist for candidiasis,
• kidney problems,
• seizures (convulsions), observed in patients treated with high doses or kidney problems,
• dizziness,
• hyperactivity,
• crystals in the urine, which may appear as cloudy urine or difficulty or discomfort urinating. Make sure to drink plenty of liquid to reduce the likelihood of these symptoms,
• your tongue may change color to yellow, brown, or black and may appear hairy,
• excessive red blood cell rupture causing a type of anemia. Symptoms include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and white of the eyes,
• low white blood cell count,
• low count of cells involved in blood clotting,
• blood may take longer than usual to clot. You may notice this if you bleed from the nose or cut yourself.

Unknown frequency(cannot be estimated from available data)

• chest pain in the context of allergic reactions, which may be a symptom of allergic-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 taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure,
• crystals in the urine that cause acute kidney injury.
• skin rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease),
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

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

• The active ingredient is amoxicillin. Each tablet contains 1,000 mg of amoxicillin.
• The other components are:
• core:magnesium stearate, povidone (K25), sodium carboxymethylcellulose (type A) (derived from potato starch), microcrystalline cellulose,
• coating:titanium dioxide (E171), talc, hypromellose.

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/