Package Insert: Information for the Patient

Amoxicilina Sandoz Pharmaceutical 250 mg/5 ml Powder for Oral Suspension EFG

amoxicilina

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

What is Amoxicilina Sandoz Farmacéutica

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

What is Amoxicilina Sandoz Farmacéutica used for

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

Do not takeAmoxicilina Sandoz Farmacéutica

• 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 amoxicillin if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking amoxicillin.

Warnings and precautions

Consult your doctor 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 amoxicillin.

Blood and urine tests

If you are having:

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

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

Other medications andAmoxicilina Sandoz Farmacéutica

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• if you are taking allopurinol (used for gout) with amoxicillin, you may be more likely to have an allergic reaction on the skin,
• if you are taking probenecid (used for 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 amoxicillin, you may need more blood tests,
• if you are taking other antibiotics (such as tetracycline), amoxicillin may be less effective,
• if you are taking methotrexate (used for cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in adverse effects.

Pregnancy,breastfeeding, and fertility

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

Driving and operating machinery

Amoxicillin may cause 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 Farmacéutica contains aspartame, sodium benzoate, benzyl alcohol, benzyl benzoate, sorbitol, glucose, and sulfur dioxide.

• This medication contains 8.5 mg of aspartame (E951) per dose. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.
• This medication contains 7.1 mg of sodium benzoate (E211) that is a mild irritant to the eyes, skin, and mucous membranes. This medication contains up to 0.44 mg of benzyl benzoate per dose. Benzyl benzoate and sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).
• This medication contains up to 3 mg of benzyl alcohol per dose. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked to the risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children. Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor has recommended it.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

This product should not be used for more than a week in children under 3 years of age unless your doctor or pharmacist has advised you to do so.

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

• This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".
• This medication contains 0.14 mg of sorbitol per dose.
• This medication contains 0.1 micrograms of sulfur dioxide. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.
• This medication contains 0.68 mg of glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as 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 evenly throughout the day, at least 4 hours apart.

The recommended 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 amoxicillin to administer to your baby or child.
• The recommended 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, and children 40 kg of weight or more

The recommended dose of amoxicillin 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 infections: 3 g twice a day for one day.
• Lyme disease (infection transmitted by ticks): Erythema migrans (initial phase - circular red or pink rash): 4 g per day, Systemic manifestations (late phase - for more severe symptoms or when the disease spreads throughout the body): up to 6 g per day.
• Stomach ulcers:one dose of 750 mg or 1 g twice a day for 7 days with other antibiotics and medications to treat stomach ulcers.
• To prevent cardiac infection during surgery:the dose will vary depending on the type of surgery. Other medications may also be administered at the same time. Your doctor, pharmacist, or nurse may provide more details.
• The maximum recommended dose is 6 g per day.

Renal problems

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

If you take more Amoxicilina Sandoz Farmacéutica than you should

If you have taken more amoxicillin than you should, the signs may be stomach upset (feeling unwell, nausea, or diarrhea) or crystals in the urine, which may appear as cloudy urine, or problems urinating. Talk to your doctor as soon as possible. Bring the medication to show them.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Amoxicilina Sandoz Farmacéutica

• 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 compensate for the missed doses.

How long should you take Amoxicilina Sandoz Farmacéutica

• Continue taking amoxicillin for the time your doctor 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 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 amoxicillin for a prolonged period. If this happens, consult your doctor.

If you take amoxicillin for a prolonged period, your doctor may perform additional tests to check that your kidneys, liver, and blood are functioning normally.

The reconstitution of the suspension is done by the doctor or pharmacist.

To reconstitute the suspension, fill the bottle with fresh tap water approximately 1 cm below the fill line, close, and shake well immediately.

Once the foam has settled, add tap water slowly exactly to the fill line (55 ml of water for 60 ml, 92 ml of water for 100 ml of suspension).

Shake vigorously again. The suspension, white to slightly yellowish in color and with a fruity odor, is ready for use.

Shake the bottle well before taking each dose.

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 amoxicillin 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 can 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,
• Rash or flat, round, red spots like the tip of a needle under the skin's surface or bruises on the skin. This is due to the inflammation of the blood vessel walls due to an allergic reaction. It may be associated with joint pain (arthritis) and kidney problems,
• You may experience a delayed allergic reaction up to 7 to 12 days after taking amoxicillin, some symptoms include: rashes, fever, joint pain, and lymph node enlargement, especially under the arms,
• A skin reaction called "erythema multiforme" in which you may develop: purple or reddish rashes 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 havefever and be 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 pain,

• Symptoms similar to the flu with skin rash, fever, gland inflammation, 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 amoxicillin treatment for Lyme disease and causes fever, chills, headache, and muscle pain, and skin rash,
• Inflammation of the large intestine (colon) with diarrhea (sometimes with blood), pain, and fever,
• You may experience severe liver side effects. These are mainly associated with prolonged treatments, men, and the elderly. Inform your doctor immediately if you have:

• Severe diarrhea with bleeding,
• Blisters, redness, or bruises on the skin,
• Dark urine or pale stools,
• The skin and white of the eyes turn yellow (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 spots), swollen areas with blister-like appearance on forearms, legs, palms, hands, or feet. This is rare (it can affect 1 in 100 people).

If you experience any of them, talk to your doctor as you will need to interrupt your amoxicillin treatment

Other possible side effects are:

Frequent(they can affect up to 1 in 10 people)

• Skin rash,
• Nausea,
• Diarrhea.

Rare(they can affect up to 1 in 100 people)

• Vomiting.

Very rare(they can affect up to 1 in 10,000 people)

• Candidiasis (fungal infection in the vagina, mouth, or skin folds), you can get treatment from your doctor or pharmacist for candidiasis,
• Kidney problems,
• Seizures (convulsions), observed in patients treated with high doses or kidney problems,
• Dizziness,
• Hypersensitivity,
• Discoloration of the teeth, which usually disappears with brushing (this has been reported in children),
• Your tongue may turn yellow, brown, or black and may appear hairy,
• Excessive breakdown of red blood cells, which causes a type of anemia. Symptoms include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowish discoloration of the skin and white 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(it cannot be estimated from available data)

• Chest pain in the context of allergic reactions, which may be a symptom of an allergic-induced heart attack (Kounis syndrome),
• Drug-induced enterocolitis syndrome (DIES):

DIES has mainly been reported in children receiving amoxicillin. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1 to 4 hours after medication administration). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure,

• Crystals in the urine that cause acute kidney damage,
• 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 or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: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 and the blister after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Keep the packaging perfectly closed to protect it from moisture.

Storage conditions after reconstitution:

Store in the refrigerator (between 2°C and 8°C)

Validity period after reconstitution:

14 days

Do not use this medication if you see lumps of powder in the bottle before reconstitution.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofAmoxicilina Sandoz Pharmaceutical

The active ingredient is amoxicillin (as amoxicillin trihydrate).

5 ml of reconstituted suspension contains:

Amoxicillin trihydrate corresponding to 250 mg of amoxicillin.

The other excipients are anhydrous citric acid (E330), sodium benzoate (E211), aspartame (E951),

talco (E553b), trisodium citrate anhydrous (E331), guar gum (E412), precipitated silicon dioxide (E551), lemon powder flavor (which contains, among others, sorbitol, sulfur dioxide, glucose), peach and apricot powder flavor (which contains, among others, sorbitol, sulfur dioxide, benzyl benzoate), orange powder flavor (which contains, among others, benzyl alcohol).

Appearance of the product and contents of the package

White to slightly yellowish powder with a characteristic fruity odor.

Amber glass bottles containing 6.6 g of powder for 60 ml of oral suspension and 11 g of powder for 100 ml of oral suspension, with a polypropylene screw cap (pressure + turn) and a sealing membrane.

The dosing spoon packaged with filling marks at 1.25 ml, 2.5 ml, and 5.0 ml is made of polypropylene.

Individual 60 ml and 100 ml containers in a cardboard box

Clinical containers of 10x60 ml, 20x60 ml, 40x60 ml, 10x100 ml, and 40x100 ml in a cardboard box.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Sandoz GmbH

Biochemiestrasse, 10

6250 -Kundl

Austria

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Austria:Ospamox 250 mg/5 ml - Pulver für orale Suspension

Belgium:Amoxicilline Sandoz 250mg/5ml poeder voor orale suspensie

Netherlands:Amoxicilline Sandoz Forte 250 mg/5 ml,poeder voor orale suspensie

Portugal:AMOXICILINA SANDOZ 250 MG/5 ML PÓ PARA SUSPENSÃO ORAL

United Kingdom

(Northern Ireland) :Amoxicillin 250 mg/5 ml Suspension

Date of the last review of this leaflet:01/2024.

The detailed information of 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

The reconstitution of the suspension is performed by the doctor or pharmacist.

Once the screw cap is opened, make sure the seal of the screw cap is intact and well adhered to the rim of the bottle. Do not use if it is not intact. Shake the bottle to release the powder. To reconstitute the suspension, fill the bottle with fresh tap water approximately 1 cm below the filling mark, close and shake well immediately.

Once the foam has settled, add tap water slowly exactly to the filling mark (55 ml of water for 60 ml, 92 ml of water for 100 ml of suspension).

Shake vigorously again.

The suspension, white to slightly yellowish in color and fruity odor, is ready for use.

Do not use the reconstituted suspension if the color is not between white and slightly yellowish.

Shake the bottle well before taking each dose.