AMOXICILLIN SANDOZ 1000 mg FILM-COATED TABLETS

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 fatigue),
• you have kidney problems,
• you do not urinate regularly.

If you are not sure if any of the above situations apply 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 suffer a skin allergic reaction.
• If you are taking probenecid (used to treat 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 Sandoz, more blood tests may be needed.
• 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 adverse 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.

Amoxicillin Sandoz contains sodium

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

3. How to take Amoxicillin Sandoz

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• Swallow the tablets.
• Space the doses evenly during the day, at least 4 hours apart.

The usual dose is:

Children under 40 kg of 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 of 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 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 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 difficulty urinating. Talk to your doctor as soon as possible. Take the medicine with you to show them. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

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 Sandoz for the time your doctor has told you, even if you feel better. You need to take all the doses to overcome the infection. If some bacteria survive, they can make the infection come back.
• 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 parts of the body that can cause pain, itching, and white discharge) may appear if you take Amoxicillin Sandoz for a long time. If this happens, consult your doctor.

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

If you have any other questions about the use of this medicine, 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 experience 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 can 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 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 can 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 reddish 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 be very tired,
• other serious skin reactions can be: change in skin color, lumps under the skin, blisters, pustules, peeling, redness, pain, itching. They can 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 can occur. These are mainly associated with prolonged treatments, men, and the elderly. You should tell 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.

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

Sometimes you may experience 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 have any of these, talk to your doctor as you will need to interrupt 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.

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 for thrush from your doctor or pharmacist,
• kidney problems,
• seizures (convulsions), observed 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 when urinating. Make sure to drink plenty of fluids to reduce the possibility 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 a type of 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 number of cells involved in blood clotting,
• the 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 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 skin rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease),
• inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis).

Reporting of side effects

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

5. Conservation 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 is the last day of the month stated.

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 in doubt, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicillin Sandoz

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

Appearance of the Product and Container Content

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

The tablet can be divided into equal doses.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sandoz Pharmaceutical, S.A. Business Center 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 medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/