AMOXICILLIN SANDOZ 500 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Amoxicillin Sandoz 500 mg Hard Capsules 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.

• 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Antibiotics are used to treat bacterial infections. They do not work for viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing your treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

What is Amoxicillin Sandoz used for

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

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

Do not take Amoxicillin 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 a skin rash or swelling of the face or throat.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amoxicillin 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 not sure if any of the above applies to you, inform your doctor or pharmacist before taking Amoxicillin Sandoz.

Blood and urine tests

If you are having:

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

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

Using Amoxicillin Sandoz with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

• If you are taking allopurinol (used for gout) with Amoxicillin Sandoz, you may be more likely to get a skin rash.
• If you are taking probenecid (used to treat gout), taking probenecid with Amoxicillin Sandoz may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicillin Sandoz, you may need to have more blood tests.
• If you are taking other antibiotics (such as tetracycline), Amoxicillin 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 cause a potential increase in side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amoxicillin Sandoz may cause side effects such as allergic reactions, dizziness, and convulsions, which may make you unfit to drive.

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

3. How to take Amoxicillin Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

• Swallow the capsules whole with water, without opening them.
• Space the doses evenly throughout the day, at least 4 hours apart.

The usual dose is:

Children under 40 kg body weight

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

• Your doctor will tell you how much Amoxicillin Sandoz to give to 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 over 40 kg body weight

The usual dose of Amoxicillin 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 - circular pink or red rash): 4 g per day; systemic manifestations (late stage - with more severe symptoms or when the disease spreads throughout 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 with other antibiotics and medicines to treat stomach ulcers.
• To prevent heart infection during surgery:the dose will vary depending on the type of surgery. Other medicines may be given at the same time. Your doctor, pharmacist, or nurse can give you 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 Sandoz 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. Take the medicine with you to show the doctor. If you have taken more Amoxicillin Sandoz than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine 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

• Keep taking Amoxicillin Sandoz for as long as your doctor has told you. Even if you feel better, you need to take all the doses to get rid of the infection. If some bacteria survive, they can cause the infection to come back.
• Once you have finished your treatment, if you are still feeling unwell, you should go back to see your doctor.

You may get thrush (a fungal infection of the moist parts of the body that can cause pain, itching, and white discharge) if you take Amoxicillin Sandoz for a long time. If this happens, talk to your doctor. If you take Amoxicillin Sandoz for a long time, your doctor may do extra tests to check that your kidneys, liver, and blood are working normally.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Amoxicillin Sandoz and see a doctor immediately if you get any of the following serious side effects – you may need urgent medical treatment:

The following side 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 serious and, in some cases, have been fatal,
• skin rash or round red patches 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 Sandoz, 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 red patches with itching on the skin, especially on the palms of the hands or soles of the feet, swollen areas with a blister-like appearance on the skin, soft tissues on the surface of the mouth, eyes, or genitals. You may have a fever and feel very tired,
• other serious skin reactions can be: change in skin color, lumps under the skin, blisters, pustules, peeling, redness, pain, itching. 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 Sandoz 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 liver effects. These are mainly associated with prolonged treatments, men, and the elderly. You should tell your doctor immediately if you:
• • have severe diarrhea with bleeding,
  • have blisters, redness, or bruising of the skin,
  • have dark urine or pale stools,
  • have 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.

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

Sometimes you may get less serious skin reactions such as:

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

If you get any of these, talk to your doctor as you will need to stop your treatment with Amoxicillin Sandoz.

Other possible side 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.

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

• thrush (fungal infection in the vagina, mouth, or skin folds), you can get treatment for thrush from your doctor or pharmacist,
• kidney problems,
• seizures (convulsions), seen in patients treated with high doses or with kidney problems,
• dizziness,
• hyperactivity,
• crystals in the urine, which can appear as cloudy urine or difficulty or discomfort urinating. Make sure to drink plenty of fluids to reduce the chance of these symptoms,
• the tongue may change color to yellow, brown, or black and may have a hairy appearance,
• a severe breakdown of red blood cells that causes anemia. The signs include: tiredness, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and the whites of the eyes,
• low white blood cell count,
• low platelet count,
• the blood may take longer than normal to clot. You may notice this if you have nosebleeds or if you cut yourself.

Frequency not known(cannot be estimated from the available data)

• chest pain in the context of allergic reactions, which can be a symptom of allergy-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 to 4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure,
• crystals in the urine that cause acute kidney injury.
• a blistering skin rash with a circular pattern and a central crust or like a string of pearls (linear IgA disease),
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side 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 carton after EXP. The expiry date refers to the last day of the month shown.

Store below 25°C. Store in the original package.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the SIGRE collection point at your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicillin Sandoz

• The active ingredient is amoxicillin. Each capsule contains 500 mg of amoxicillin.
• The other components are:
• core:magnesium stearate and microcrystalline cellulose.
• coating:yellow iron oxide (E172), titanium dioxide (E171), and gelatin.

Appearance of the Product and Container Content

Amoxicillin Sandoz 500 mg capsules are hard gelatin capsules, yellow, opaque, with the imprint “AMOX 500” on the body.

They are packaged in blisters in a box. It is available in packs of 20 and 30 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Date of the Last Revision of this Leaflet:February 2023

Detailed and updated 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/