AMOXICILLIN SANDOZ 250 mg/5 ml ORAL SUSPENSION POWDER

Introduction

Patient Information Leaflet

Amoxicillin Sandoz 250 mg/5 ml Powder for Oral Suspension EFG

amoxicillin

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you (or your child) only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are 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. Storage of Amoxicillin Sandoz
6. Package contents and additional information

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

What Amoxicillin Sandoz is

Amoxicillin Sandoz is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called "penicillins".

What Amoxicillin Sandoz is 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 medications to treat stomach ulcers.

2. What you need to know before taking Amoxicillin Sandoz

Do not take Amoxicillin Sandoz:

• if you are allergic to amoxicillin, penicillin, or any of the other ingredients of this medication (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 unsure, consult your doctor or pharmacist before taking Amoxicillin Sandoz.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 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).

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

Other medications and Amoxicillin Sandoz

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

• If you are taking allopurinol (for the treatment of gout) with Amoxicillin Sandoz, you may be more likely to experience 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 necessary.
• If you are taking other antibiotics (such as tetracycline), Amoxicillin Sandoz may be less effective.
• If you are taking methotrexate (a medication 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

Amoxicillin Sandoz may have side effects, and symptoms (such as allergic reactions, dizziness, and convulsions) may make you unfit to drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin Sandoz contains sucrose, glucose, sodium benzoate, and sodium

This medication contains sucrose and glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

Patients with diabetes mellitus should note that this medication contains 1.75 g of sucrose and 1.33 g of glucose per 5 ml of oral suspension.

This medication contains 2.40 mg of sodium benzoate in each 5 ml of oral suspension. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medication contains less than 23 mg of sodium (1 mmol) per 5 ml of oral suspension; this is essentially "sodium-free".

3. How to take Amoxicillin Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• Shake the bottle well before each dose.
• Space out the doses evenly throughout the day, at least 4 hours apart.

The usual dose is:

Children under 40 kg in 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 in weight

This suspension is not normally recommended for adults and children who weigh more than 40 kg. Ask your doctor or pharmacist for advice.

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 than you should, the signs may be stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which may appear as cloudy urine or difficulty urinating. Talk to your doctor as soon as possible. Take the medication with you to show them.

If you have taken more amoxicillin than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication 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

• 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 may cause the infection to recur.
• 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 areas of the body that can cause pain, itching, and white discharge) may occur 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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medication can cause side effects, although not everyone 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 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 red, flat, round 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 occur 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 feel very tired,
• other serious skin reactions may be: changes in skin color, lumps under the skin, blisters, pustules, peeling, redness, pain, itching, exfoliation. 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 may 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 may occur. These are mainly associated with prolonged treatment, males, 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 occur, stop taking the medication and see a doctor immediately.

Sometimes you may experience less severe 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 experience 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 on 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,
• discoloration of the teeth, which usually disappears with brushing (this has been reported in children),
• the tongue may change color to yellow, brown, or black and may have a hairy appearance,
• a excessive 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 usual 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 myocardial infarction (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 medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure,
• crystals in the urine that cause acute kidney injury.
• blistering skin rash arranged in a circle with 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 side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Amoxicillin Sandoz

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

Do not use this medication after the expiration date stated on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Powder for oral suspension

Store in a dry place.

Reconstituted oral suspension

Once reconstituted, the suspension should be used within 14 days.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicilina Sandoz

• The active ingredient is amoxicillin. In each 5 ml of oral suspension, the amoxicillin content is 250 mg.
• The other components are: sucrose, poliplasdone XL, anhydrous citric acid, sodium benzoate (E-211), disodium edetate dihydrate, lemon flavor (contains glucose and corn starch), peach flavor (contains glucose and corn starch), strawberry flavor (contains glucose and corn starch), trisodium citrate.

Appearance of the Product and Container Content

Amoxicilina Sandoz 250 mg/5 ml powder for oral suspension is a white to slightly yellowish powder with a fruity odor, packaged in type III amber glass bottles of 120 ml, with an aluminum screw cap coated internally with a protective lacquer and a PVC stopper inside.

These bottles are packaged in a box with a measuring spoon.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Reig Jofré, S.A.

C/ Jarama s/n Polígono Industrial

45007 Toledo

Spain

Date of the Last Revision of this Prospectus: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/

Reconstitution Instructions

Check that the cap is intact before use.

Invert and shake the bottle to loosen the powder stuck to the bottom.

Fill the bottle with water just up to the line on the bottle label.

Invert and shake well, refill with water up to the line. Invert and shake again.

Shake well before taking each dose.