Amoxicillin Sandoz 750 mg dispersible tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Amoxicillin Sandoz 750 mg dispersible tablets EFG

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Contents of this leaflet:

1. What Amoxicillin Sandoz is and what it is used for
2. What you need to know before taking Amoxicillin Sandoz
3. How to take Amoxicillin Sandoz
4. Possible side effects
5. How to store Amoxicillin Sandoz
6. Contents of the pack and other information

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

What Amoxicilina Sandoz is

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

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

It is important that you follow your doctor's instructions regarding dosage, timing, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

What Amoxicilina Sandoz is used for

Amoxicillin is used to treat bacterial infections in various parts of the body. Amoxicillin may also be used in combination with other medicines for the treatment of stomach ulcers.

2. What you need to know before starting to take Amoxicillin Sandoz

Do not take Amoxicillin Sandoz:

• if you are allergic to amoxicillin, penicillins, or any of the other ingredients of this medicine (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 apply to you. If you are unsure, consult your doctor or pharmacist before taking amoxicillin.

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 conditions apply to you, inform your doctor or pharmacist before taking amoxicillin.

Blood and urine tests

If you are undergoing:

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

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

Other medicines and Amoxicillin Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• 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 with probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with amoxicillin, additional blood tests may be required.
• If you are taking other antibiotics (such as tetracyclines), amoxicillin may be less effective.
• If you are taking methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce methotrexate excretion and potentially increase adverse effects.

Pregnancy and breastfeeding

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

Driving and using machines

Amoxicillin may cause adverse effects, and symptoms (such as allergic reactions, dizziness, and seizures) may mean you should not 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 medicine contains 3.9 mg of aspartame per dispersible tablet.

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains up to 0.45 mg of benzyl alcohol per dispersible tablet.

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

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

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

This medicine contains 0.048 mg of sorbitol per dispersible tablet.

This medicine contains 36 ng of sulfur dioxide. Rarely, this may cause severe hypersensitivity reactions and bronchospasm.

3. How to take Amoxicilina Sandoz

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. 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 may be split to facilitate swallowing.
• Space the doses evenly throughout the day, at least 4 hours apart.

The usual dose is:

Children weighing less than 40 kg

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

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

Adults, elderly patients, and children weighing 40 kg 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 (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 – more severe symptoms or when the disease spreads through your 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, together with other antibiotics and medications for treating stomach ulcers.
• To prevent heart infection during surgery: the dose will vary depending on the type of surgery. Other medications may be given at the same time. Your doctor, pharmacist, or nurse can provide further details.
• The maximum recommended dose is 6 g per day.

Renal problems

If you have kidney 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, symptoms may include stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which may appear as cloudy urine or difficulty urinating. Contact your doctor as soon as possible. Take the medicine with you to show it.

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

If you forget 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 make up for missed doses.

How long to take Amoxicilina

• Continue taking amoxicillin for as long as your doctor has told you, even if you feel better. You need to take all doses to completely eliminate the infection. If some bacteria survive, the infection may return.
• After completing the treatment, if you still feel unwell, you should see your doctor again.

Candidiasis (a fungal infection affecting moist areas of the body that may cause pain, itching, and white discharge) may develop if amoxicillin is taken for a prolonged period. If this occurs, consult your doctor.

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

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

4. Possible adverse effects

Like all medicines, this medicine 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; signs may include: skin itching or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These may be severe and, in some cases, have led to death;
• skin rash or flat red spots like pinpricks beneath the skin surface, or bruising on the skin. This is due to inflammation of the walls of blood vessels caused by 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 signs include: rashes, fever, joint pain, and swollen lymph nodes, especially under the arms;
• a skin reaction called 'erythema multiforme', in which you may develop: itchy purple or reddish rashes on the skin, especially on the palms of the hands or soles of the feet, swollen raised areas on the skin, soft tissue lesions on the surface of the mouth, eyes, and genitals. You may also have fever and feel very tired;
• other serious skin reactions may include: changes in skin color, lumps under the skin, blisters, pustules, peeling, redness, pain, itching, exfoliation. These may be accompanied by fever, headache, and body pain;
• 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));
• fever, chills, sore throat, or other signs of infection, or easy bruising. These may be signs of a problem with your blood cells;
• Jarisch-Herxheimer reaction, which 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 bloody), abdominal pain, and fever;
• serious adverse effects in the liver may occur. These are mainly associated with prolonged treatment, male sex, and advanced age. You should inform your doctor immediately if you experience:
• severe diarrhea with bleeding;
• blisters, redness, or bruising on the skin;
• dark urine or pale stools;
• yellowing of the skin and whites of the eyes (jaundice). See also anemia below, which may lead to jaundice.

These may occur during treatment or up to several weeks afterwards.

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

• Chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES):

DIES has been reported mainly in children receiving amoxicillin. It is a type of allergic reaction with the main symptom being repeated vomiting (1–4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

If any of the above symptoms occur, stop taking the medicine and see your doctor immediately.

Sometimes you may experience less severe skin reactions such as:

• a moderate itchy rash (round, pink-red spots), swollen areas resembling blisters on forearms, legs, palms, hands, or feet. This is uncommon (may affect up to 1 in 100 people).

If you have any of these, speak to your doctor, as you will need to discontinue your treatment with amoxicillin.

Other possible adverse effects are:

Common (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)

• candidiasis (fungal infection in the vagina, mouth, or skin folds); treatment can be obtained from your doctor or pharmacist for candidiasis;
• kidney problems;
• epileptic seizures (convulsions), observed in patients treated with high doses or who have kidney problems;
• dizziness;
• hyperactivity;
• change 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 appear hairy;
• excessive breakdown of red blood cells causing a type of anemia. Signs include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and whites of the eyes;
• low number of white blood cells;
• low number of cells involved in blood clotting;
• blood may take longer than normal to clot. This may be noticeable if you have nosebleeds or cuts.

Frequency not known (cannot be estimated from available data)

• crystals in the urine, which may cause acute kidney injury;
• blistering rash arranged in circles with a central crust or resembling a "pearl necklace" (linear IgA disease);
• inflammation of the protective membrane surrounding the brain (aseptic meningitis).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Amoxicillin Sandoz 750 mg dispersible tablets

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

Appearance of the product and contents of the container

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 placed in cardboard cartons.

Pack sizes:

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

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

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 most recent review of this leaflet: August 2023

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