Amoxicillin Sandoz 1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin Sandoz 1,000 mg film-coated tablets EFG

Amoxicillin

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the 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 your doctor's instructions regarding dosage, dosing intervals, and duration of treatment.

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

What Amoxicilina Sandoz is used for

Amoxicilina Sandoz is used to treat bacterial infections in different 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 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 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 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.

Using Amoxicilina Sandoz with other medicines

Tell 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 amoxicillin excretion and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Sandoz, more blood tests may be needed.
• 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 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

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; therefore, it is essentially "sodium-free".

3. How to take Amoxicilina Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. 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 – single pink or red circular rash): 4 g per day; systemic manifestations (late stage – more severe symptoms or when the disease spreads through the body): up to 6 g per day.
• Stomach ulcers: a dose of 750 mg or 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.

Kidney 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. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

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 a missed dose.

How long to take Amoxicilina Sandoz

• Continue taking Amoxicilina Sandoz for the length of time prescribed by your doctor, even if you start to feel better. You need to take all the doses to completely eliminate the infection. If some bacteria survive, the infection may return.
• Once you have completed 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 occur if Amoxicilina Sandoz is taken 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 monitor 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 Amoxicilina Sandoz 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 can be severe and, in some cases, have resulted in death,
• skin rash or flat, round red spots under 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 swollen lymph nodes, especially under the arms,
• a skin reaction called 'erythema multiforme', in which you may develop: itchy purple or reddish spots on the skin, especially on the palms of the hands or soles of the feet, raised swollen 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 aches,
• 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 occurring during treatment with Amoxicilina Sandoz for Lyme disease, causing fever, chills, headache, muscle pain, and skin rash,
• inflammation of the large intestine (colon) with diarrhea (sometimes bloody), pain, and fever,
• serious adverse effects in the liver may occur. These are mainly associated with patients undergoing prolonged treatment, males, and advanced age. You should contact 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.

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 rash with itching (round, pink-red wheals), 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:

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 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 leading to 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 allergy-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 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,
• rash with blisters arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease),
• inflammation of the membranes covering the brain and spinal cord (aseptic meningitis).

Reporting of adverse effects

If you experience any type of 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 through the Spanish Pharmacovigilance System for Human Medicinal Products: 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 which is 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 Point in your usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin Sandoz

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

Appearance of the product and contents of the pack

Amoxicillin Sandoz 1,000 mg tablets are film-coated, white to cream-colored, oblong, biconvex tablets, scored on both sides, approximately 11 x 22.5 mm.

The tablet can be divided into equal doses.

They are packaged in blisters within a carton. Available pack sizes are 20 and 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl
Austria

Date of the most recent review 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 Medical Devices (AEMPS) http://www.aemps.gob.es/