Patient Information Leaflet

Amoxicilina Sandoz 250 mg/5 ml Oral Suspension Powder EFG

amoxicilina

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only, and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is Amoxicilina Sandoz

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

What is Amoxicilina Sandoz used for

Amoxicilina Sandoz is used to treat infections caused by bacteria in different parts of the body. Amoxicilina Sandoz may also be used in combination with other medications to treat stomach ulcers.

Do not take Amoxicilina Sandoz:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take amoxicillin if:

• you have infectious mononucleosis (fever, sore throat, swollen lymph nodes, 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 Amoxicilina 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 Amoxicilina Sandoz. This is because Amoxicilina Sandoz may affect the results of these types of tests.

Other medications and Amoxicilina Sandoz

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

• If you are taking allopurinol (for the treatment of gout) with Amoxicilina Sandoz, you may be more likely to suffer a skin allergic reaction.
• If you are taking probenecid (used to treat gout), the concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Sandoz, more blood tests may be necessary.
• If you are taking other antibiotics (such as tetracycline), Amoxicilina 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 adverse effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Amoxicilina Sandoz may have adverse effects and symptoms (such as allergic reactions, dizziness, and seizures) that may make it unsafe to drive.

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

Amoxicilina Sandoz contains saccharose, glucose, sodium benzoate, and sodium

This medication contains saccharose 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 saccharose and 1.33 g of glucose per 5 ml of oral suspension.

This medication contains 2.40 mg of sodium benzoate per 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 old).

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

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

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

The usual dose is:

Children under 40 kg of weight

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

• Your doctor will tell you how much Amoxicilina Sandoz to administer to your baby or child.
• The usual dose is 40 mg to 90 mg per kilogram of body weight per day, administered 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 40 kg of weight or more

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

Renal problems

If you have renal problems, the dose may be lower than the usual dose.

If you take more Amoxicilina 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 be observed as cloudy urine or difficulty urinating. Talk to your doctor as soon as possible. Bring the medication 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 forgot 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 the missed doses.

How long should you take Amoxicilina Sandoz

• Continue taking Amoxicilina 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 have finished the treatment, if you continue to feel unwell, you should go back to see your doctor.

You may develop candidiasis (a fungal infection of the moist parts of the body that may cause pain, itching, and white discharge) if you take Amoxicilina Sandoz 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 check that your kidneys, liver, and blood are functioning normally.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Amoxicilina Sandoz and see a doctor immediately if you experience any of the following severe side effects – you may need urgent medical treatment:

The following side effects are very rare(they may affect up to 1 in 10,000 people)

• allergic reactions, symptoms may include: itching or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These can be severe and, in some cases, have been fatal,
• skin rash or flat, round, red spots like the tip of a pin under the skin's surface or bruises on the skin. This is due to inflammation of the blood vessel walls 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 symptoms include: rashes, fever, joint pain, and swollen 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 on the skin, soft tissues on the surface of the mouth, eyes, and genitals. You may have a fever and feel very tired,
• other severe 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 aches,
• flu-like symptoms with skin rash, fever, inflammation of glands, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)),
• fever, chills, sore throat, or other signs of infection, or the appearance of bruises easily. These may be signs of a problem with your blood cells,
• Jarisch-Herxheimer reaction that 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 with blood), pain, and fever,
• you may experience severe side effects in the liver. These are mainly associated with prolonged treatments, men, and advanced age. Inform your doctor immediately if you have:
• • severe diarrhea with bleeding,
  • blisters, redness, or bruises on the skin,
  • dark urine or pale stools,
  • yellowing of the skin and the whites of the eyes (jaundice). See anemia below, which may cause jaundice.

These may occur during treatment or several weeks after.

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

Occasionally, you may experience milder skin reactions such as:

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

If you experience any of them, talk to your doctor as you will need to interrupt your treatment with Amoxicilina Sandoz.

Other possible side effects are:

Frequent(may affect up to 1 in 10 people)

• skin rash,
• nausea,
• diarrhea.

Rare(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), you can obtain treatment from your doctor or pharmacist for candidiasis,
• kidney problems,
• seizures (convulsions), observed in patients receiving high doses or with kidney problems,
• dizziness,
• hyperactivity,
• crystals in the urine, which may appear as cloudy urine or difficulty or discomfort urinating. Make sure to drink plenty of liquid 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 appear hairy,
• excessive breaking of red blood cells that causes a type of anemia. Symptoms include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and the whites of the eyes,
• low white blood cell count,
• low count of cells involved in blood clotting,
• blood may take longer than usual to clot. You may notice this if you bleed from the nose or cut yourself.

Unknown frequency(cannot be estimated from available data):

• chest pain in the context of allergic reactions, which may be a symptom of allergic-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.
• rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease),
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Oral powder for suspension

Store in a dry place.

Reconstituted oral suspension

Once reconstituted, the suspension must be used within the next 14 days.

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at your local SIGRE drop-off point.at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Amoxicilina Sandoz

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

Appearance of the product and contents of the package

Amoxicilina Sandoz 250 mg/5 ml oral powder for suspension is a white to slightly yellowish powder with a fruity odor, packaged in glass type III topaz 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 case with a measuring spoon.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Reig Jofré, S.A.

C/ Jarama s/n Industrial Estate

45007 Toledo

Spain

Date of the last review of this leaflet:February 2023.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

Instructions for reconstitution

Check that the cap is intact before use.

Invert and shake the bottle to release the powder adhering 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.