AMOXICILINA 1000 mg Dispersible Tablet

Package Insert: Information for the Patient

Amoxicilina Sandoz 1000 mg Dispersible Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

What is Amoxicilina Sandoz

Amoxicilina is an antibiotic. The active ingredient is amoxicilina. It belongs to a group of medicines called “penicillins”.

What is Amoxicilina Sandoz used for

Amoxicilina is used to treat infections caused by bacteria in different parts of the body. Amoxicilina can also be used in combination with other medications to treat stomach ulcers.

Do not takeAmoxicilina Sandoz:

Do not take amoxicillin if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking amoxicillin.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeamoxicillin 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 amoxicillin.

Blood and urine tests

If you are having:

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

Inform your doctor or pharmacist that you are taking amoxicillin. This is because amoxicillin may affect the results of these types of tests.

Other medications and Amoxicilina Sandoz

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, you may be more likely to have a skin allergic reaction.
• If you are taking probenecid (used for gout), the concurrent use of probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with amoxicillin, you may need more blood tests.
• If you are taking other antibiotics (such as tetracycline), amoxicillin may be less effective.
• If you are taking methotrexate (used for cancer and severe psoriasis treatment), 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

Amoxicillin may have adverse effects and symptoms (such as allergic reactions, dizziness, and convulsions) that may make it unsafe to drive.

Do not drive or operate machinery unless you are feeling well.

Amoxicilina Sandoz 1000 mg contains aspartame, benzyl alcohol, benzoate, sodium, sorbitol, and sulfur dioxide.

This medication contains 5.2 mg of aspartame in each dispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains up to 0.60 mg of benzyl alcohol in each dispersible tablet.

Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding and have liver or kidney diseases. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis). This medication should not be used for more than one week in children under 3 years of age unless instructed by your doctor or pharmacist.

This medication contains up to 0.29 mg of benzoate in each dispersible tablet. Benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

This medication contains less than 1 mmol of sodium (23 mg) per dispersible tablet; it is essentially “sodium-free”.

This medication contains 0.064 mg of sorbitol in each dispersible tablet.

This medication contains 48 ng of sulfur dioxide. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

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 tablets can be used in two ways. They can be suspended in water to drink, or they can be taken directly with a sufficient amount of water. The tablets can be broken to facilitate swallowing.
• 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 amoxicillin you should 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 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 amoxicillin 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 infection: 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: a dose of 750 mg or a 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 amoxicillin 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.

If you have taken more amoxicillin than you should, consult your doctor immediately, your pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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

• Continue taking amoxicillin for the time your doctor 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 finish 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 can cause pain, itching, and white discharge) if you take amoxicillin for a prolonged period. If this happens, consult your doctor.

If you take amoxicillin 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 amoxicillin 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: skin itching or rash, facial swelling, lip, tongue, body, or difficulty breathing. These can be severe and, in some cases, have been fatal,
• Rash on the skin 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,
• A delayed allergic reaction may occur 7 to 12 days after taking amoxicillin, 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: changes in skin color, lumps under the skin, blisters, pustules, peeling, redness, pain, itching, exfoliation. They may be accompanied by fever, headache, and body pain,
• 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 amoxicillin treatment 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 liver side effects. These are mainly associated with prolonged treatment, men, and advanced age. Inform your doctor immediately if you have:
• Severe diarrhea with bleeding,
• Blisters, redness, or bruises on the skin,
• Dark urine or pale stools,
• Yellowing of the skin and the white of the eyes (jaundice). See anemia below, which can cause jaundice.

These may occur during treatment or several weeks after.

The frequency of the following side effects is not known (cannot be estimated from available data):

• Chest pain in the context of allergic reactions, which may be a symptom of an 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 administering the medication). Other symptoms may include abdominal pain, lethargy,

Diarrhea, and low blood pressure.

If any of the above symptoms appear, stop taking the medication and see your doctor immediately.

At times, you may experience milder skin reactions such as:

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

Discuss this with your doctor as you will need to interrupt your amoxicillin treatment.

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 (fungal infection in the vagina, mouth, or skin folds), 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,
• Hypervigilance,
• Alteration in tooth color, which usually disappears with brushing (this has been reported in children),
• The 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 the 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.

Frequency unknown(cannot be estimated from available data)

• Crystals in the urine, which cause acute kidney injury,
• Rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease),

• Inflammation of the protective membrane surrounding the brain (aseptic meningitis).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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 and blister after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at the 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 ofAmoxicilina Sandoz 1000 mg dispersible tablets

Appearance of the product and contents of the package

Dispersible tablet

The tablets are oblong, biconvex, white to light yellow, approximately 10 x 22 mm in size, with a notch.

Thedispersible tablets are packaged in PVC/PVDC/Alu blisters and inserted into a cardboard package.

Package sizes:

2, 6, 8, 10, 12, 14, 16, 20, 24, 30, 100 and 1000 dispersible tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:August 2023

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/