AMOXICILLIN SANDOZ 750 mg DISPERSIBLE TABLETS

Introduction

Prospective: patient information

Amoxicillin Sandoz 750 mg dispersible tablets EFG

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the prospectus:

1. What is Amoxicillin Sandoz and what is it used for
2. What you need to know before taking Amoxicillin Sandoz
3. How to take Amoxicillin Sandoz
4. Possible adverse effects
5. Storage of Amoxicillin Sandoz
6. Package contents and additional information

1. What is Amoxicillin Sandoz and what is it used for

What is Amoxicillin Sandoz

Amoxicillin is an antibiotic. The active ingredient is amoxicillin. It belongs to a group of medications called "penicillins".

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or common cold.

It is essential to follow the instructions regarding dosage, intake, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medications down the drain or in the trash.

What is Amoxicillin Sandoz used for

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

2. What you need to know before taking Amoxicillin Sandoz

Do not takeAmoxicillin Sandoz:

• if you are allergic to amoxicillin, penicillins, or any other component of this medication (listed in Section 6).
• if you have ever had an allergic reaction to any other antibiotic. This could include skin rash or swelling of the face or throat.

Do not take amoxicillin if any of the above points apply 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 take amoxicillin if:

• you have infectious mononucleosis (fever, sore throat, swollen glands, 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 undergoing:

• 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 amoxicillin. This is because amoxicillin can alter the results of these types of tests.

Other medications and Amoxicillin Sandoz

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

• If you are taking allopurinol (used for gout) with amoxicillin, you may be more likely to experience a skin allergic reaction.
• If you are taking probenecid (used for 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, more blood tests may be necessary.
• 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), penicillins can reduce the excretion of methotrexate and cause a potential increase in adverse effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

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

Do not drive or operate machinery unless you feel well.

Amoxicillin Sandoz 750 mg contains aspartame, benzyl alcohol, benzyl benzoate, sodium, sorbitol, and sulfur dioxide.

This medication contains 3.9 mg of aspartame in each dispersible tablet.

Aspartame contains a source of phenylalanine, which can be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it properly.

This medication contains up to 0.45 mg of benzyl alcohol in each dispersible tablet.

Benzyl alcohol can cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding and if you have liver or kidney disease. This is because large amounts of benzyl alcohol can 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 indicated by your doctor or pharmacist.

This medication contains up to 0.22 mg of benzyl benzoate in each dispersible tablet. Benzyl benzoate can increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

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

This medication contains 0.048 mg of sorbitol in each dispersible tablet.

This medication contains 36 ng of sulfur dioxide. It can rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Amoxicillin Sandoz

Follow your doctor's or pharmacist's instructions for administering this medication exactly. If in 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 evenly throughout the day, at least 4 hours apart.

The usual dose is:

Children under 40 kg in weight

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

• Your doctor will indicate how much amoxicillin 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 dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children over 40 kg in weight

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 (an infection caused by parasites called ticks):isolated erythema migrans (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.

Kidney problems

If you have kidney problems, the dose may be lower than the usual dose.

If you take more Amoxicillin Sandoz than you should

If you have taken more amoxicillin than you should, the signs may be stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which can be seen as cloudy urine or problems 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, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Amoxicillin 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 make up for forgotten doses.

How long to take Amoxicillin Sandoz

• Continue taking amoxicillin for the time your doctor has indicated, even if you feel better. You need to take all the doses to overcome the infection. If some bacteria survive, they can cause the infection to recur.
• Once you finish the treatment, if you still feel unwell, you should go back to see your doctor.

Thrush (a fungal infection of the moist areas of the body that can cause pain, itching, and white discharge) may appear if you take amoxicillin for a long time. If this happens, consult your doctor.

If you take amoxicillin for a long time, your doctor may perform additional tests to check that your kidneys, liver, and blood are functioning normally.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

Stop taking amoxicillin and see a doctor immediately if you experience any of the following serious adverse effects - you may need urgent medical treatment:

The following adverse effects are very rare (may affect up to 1 in 10,000 people)

• allergic reactions, the signs may include: itching of the skin 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 red spots under the skin surface or bruising of 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 appear 7 to 12 days after taking amoxicillin, some signs include: rashes, fever, joint pain, and swelling of the lymph nodes, especially under the arms,
• a skin reaction called 'erythema multiforme' in which you may develop: purple or reddish patches 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, or genitals. You may have a fever and feel very tired,
• other severe skin reactions can 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 white blood cells (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)),
• fever, chills, sore throat, or other signs of infection, or easy bruising. These can be signs of a problem with your blood cells,
• Jarisch-Herxheimer reaction that occurs during treatment with amoxicillin 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,
• serious adverse effects may occur in the liver. These are mainly associated with prolonged treatment, men, and advanced age. You should inform your doctor immediately if you have:
• severe diarrhea with bleeding,
• blisters, redness, or bruising of the skin,
• dark urine or pale stools,
• yellowing of the skin and the whites of the eyes (jaundice). See also anemia below, which can lead to jaundice.

These can occur during treatment or up to several weeks after.

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

• 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 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.

Sometimes you may experience less severe skin reactions such as:

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

If you experience any of these, talk to your doctor, as you will need to interrupt your treatment with amoxicillin.

Other possible adverse effects are:

Frequent(may affect up to 1 in 10 people)

• skin rash,
• nausea,
• diarrhea.

Uncommon(may affect up to 1 in 100 people)

• vomiting.

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

• thrush (fungal infection in the vagina, mouth, or skin folds), you can get treatment from your doctor or pharmacist for thrush,
• kidney problems,
• seizures (convulsions), observed in patients treated with high doses or with kidney problems,
• dizziness,
• hyperactivity,
• alteration in tooth coloration, which usually disappears with brushing (this has been reported in children),
• the tongue may change color to yellow, brown, or black and may have a hairy appearance,
• excessive breakdown of red blood cells that causes a type of anemia. The signs include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and the whites of the eyes,
• low white blood cell count,
• low number of cells involved in blood clotting,
• blood may take longer than normal to clot. You may notice this if you have a nosebleed or cut yourself.

Frequency not known(cannot be estimated from available data)

• crystals in the urine, which can cause acute kidney injury,
• blistering skin rash arranged in a circle with a central crust or like a string of pearls (linear IgA disease),

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

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Amoxicillin Sandoz

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown 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.

Keep in the original packaging to protect it from moisture.

Medications should not be thrown down the drain or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition ofAmoxicillin Sandoz 750 mg dispersible tablets

• The active ingredient is amoxicillin. Each dispersible tablet contains 750 mg of amoxicillin (as trihydrate).
• The other components are: peach-apricot flavor powder (contains benzyl benzoate, sorbitol, sulfur dioxide), orange flavor powder (contains benzyl alcohol), magnesium stearate (E 470b), aspartame (E 951), sodium croscarmellose, mannitol (E 421), talc (E 553b), anhydrous colloidal silica (E 551), microcrystalline cellulose (E 460), corn-based maltodextrin, pregelatinized pea starch, titanium dioxide (E 171).

Appearance of the Product and Container Content

Dispersible tablet

The tablets are oblong, biconvex, white to yellowish-white, approximately 9 x 20 mm in size, with a score line.

The dispersible tablets are packaged in PVC/PVDC/Alu blisters and inserted into a cardboard container.

Container sizes:

4, 10, 12, 14, 20, 24, 30, and 1000 dispersible tablets.

Only some container sizes may be marketed.

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:August 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/