Amoxicillin Sandoz 750 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin Sandoz 750 mg film-coated tablets EFG

Amoxicillin

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor or pharmacist, even if it is not a side effect listed in this leaflet. See section 4.

Contents of the package 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

Amoxicilina Sandoz is an antibiotic. The active substance is amoxicillin. This belongs to a group of medicines known as "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 the instructions regarding dose, dosing interval, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing the 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

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

2. What you need to know before taking Amoxicilina Sandoz

Do not take Amoxicilina Sandoz:

• if you are allergic to amoxicillin, penicillin, or to 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 Amoxicilina Sandoz if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicilina Sandoz.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Amoxicilina Sandoz if:

• you have infectious mononucleosis (fever, sore throat, swollen glands, and extreme tiredness),
• 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 Amoxicilina Sandoz.

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 Amoxicilina Sandoz. This is because Amoxicilina Sandoz may alter the results of these types of tests.

Use of Amoxicilina Sandoz with other medicines

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 Amoxicilina Sandoz, you may be more likely to experience a skin allergic reaction.
• If you are taking probenecid (used to treat gout), concomitant use with probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Sandoz, additional blood tests may be required.
• If you are taking other antibiotics (such as tetracycline), Amoxicilina Sandoz may be less effective.
• If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and potentially increase 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 medicine.

Driving and use of machines

Amoxicilina Sandoz 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.

Amoxicilina Sandoz contains sodium

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

3. How to take Amoxicilina Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

• Swallow the tablets whole.
• Space the doses evenly throughout the day, with at least 4 hours between doses.

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 Amoxicilina Sandoz 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 recommended 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 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 infection: 3 g twice a day for one day.
• Lyme disease (an infection caused by parasites called ticks): isolated erythema migrans (early stage – a single circular pink or red rash): 4 g per day; systemic manifestations (late stage – 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 1 g twice a day for 7 days, in combination 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 also be administered 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 Amoxicilina Sandoz 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 Amoxicilina Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

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 forgotten doses.

How long to take Amoxicilina Sandoz

• Continue taking Amoxicilina Sandoz for the length of time prescribed by your doctor, even if you feel better. You need to take all doses to fully eliminate the infection. If some bacteria survive, the infection may return.
• If you still feel unwell after completing the treatment, 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 occur if Amoxicilina Sandoz is taken for a prolonged period. If this occurs, consult your doctor.

If you take Amoxicilina Sandoz for a prolonged period, your doctor may perform additional blood tests to monitor the normal function of your kidneys, liver, and blood.

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 experiences them.

Stop taking Amoxicilina Sandoz and go 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, round spots like the tip of a pin 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 Amoxicilina Sandoz; some signs include: rashes, fever, joint pain, and enlarged lymph nodes, especially under the arms;
• a skin reaction called 'erythema multiforme' in which you may develop: purple or reddish itchy spots 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: change in skin color, lumps under the skin, blisters, pustules, peeling, redness, pain, itching. 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 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 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 have:
  • 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 after.

If any of the above symptoms appear, 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 with your doctor, as you will need to stop treatment with Amoxicilina Sandoz.

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)

• candidiasis (fungal infection in the vagina, mouth, or skin folds); treatment can be obtained from your doctor or pharmacist for candidiasis,
• kidney problems,
• seizures (convulsions), observed in patients treated with high doses or with kidney problems,
• dizziness,
• hyperactivity,
• crystals in the urine, which may appear as cloudy urine or difficulty or discomfort when urinating. Make sure to drink plenty of fluids to reduce the likelihood of these symptoms,
• 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. You may notice this if you have nosebleeds or cuts that bleed excessively.

Frequency not known (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 mainly reported in children receiving amoxicillin. It is a type of allergic reaction with the main symptom being repeated vomiting (1 to 4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure;
• crystals in the urine causing acute kidney injury;
• blistering rash arranged in a ring with a crusted center or resembling a "string of pearls" (linear IgA disease);
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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 after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C. Keep in the original packaging.

Do not use this medicine if you notice any visible signs of deterioration.

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

6. Package contents and other information

Composition of Amoxicillin Sandoz

• The active substance is amoxicillin. Each tablet contains 750 mg of amoxicillin.
• The other components are:
  • core: magnesium stearate, povidone (K25), sodium carboxymethylstarch (type A) (derived from potato starch), and microcrystalline cellulose.
  • coating: titanium dioxide (E171), talc, and hypromellose.

Appearance of the product and contents of the pack

Amoxicillin Sandoz 750 mg tablets are white to cream-colored, film-coated, oblong, biconvex tablets, scored on both sides, approximately 10 x 21 mm.

The tablet can be divided into equal doses.

They are packed in blisters within a carton. Available pack sizes are 20, 30 and 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sandoz Farmacéutica, S.A.
Parque Norte Business Centre
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl
Austria

Date of the most recent revision of this leaflet: February 2023

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