Amoxicillin Sandoz Farmacéutica 250 mg/5 ml powder for oral suspension EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Amoxicilina Sandoz Farmacéutica 250 mg/5 ml powder for oral suspension EFG

amoxicillin

Read the entire leaflet carefully before you start taking this medicine, because 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Amoxicilina Sandoz Farmacéutica is and what it is used for
2. What you need to know before taking Amoxicilina Sandoz Farmacéutica
3. How to take Amoxicilina Sandoz Farmacéutica
4. Possible adverse effects
5. How to store Amoxicilina Sandoz Farmacéutica
6. Contents of the pack and other information

1. What Amoxicilina Sandoz Farmacéutica is and what it is used for

What Amoxicilina Sandoz Farmacéutica is

Amoxicilina Sandoz Farmacéutica is an antibiotic. The active substance is amoxicillin. This medicine belongs to a group of medicines known as "penicillins".

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, timing, and duration of treatment.

Do not keep or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

What Amoxicilina Sandoz Farmacéutica is used for

Amoxicillin is used to treat bacterial infections in different parts of the body. Amoxicillin may also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before taking Amoxicilina Sandoz Farmacéutica

Do not take Amoxicilina Sandoz Farmacéutica

• 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 skin rash or swelling of the face or throat.

Do not take amoxicillin if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking amoxicillin.

Warnings and precautions

Talk to your doctor before starting amoxicillin 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 unsure whether any of the above conditions apply to you, inform your doctor or pharmacist before taking amoxicillin.

Blood and urine tests

If you are undergoing:

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

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

Other medicines and Amoxicilina Sandoz Farmacéutica

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

• if you are taking allopurinol (used for gout) with amoxicillin, you may be more likely to experience a skin allergic reaction,
• if you are taking probenecid (used for 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, more blood tests may be needed,
• if you are taking other antibiotics (such as tetracycline), amoxicillin may be less effective,
• if you are taking methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce methotrexate excretion and potentially increase adverse effects.

Pregnancy, breastfeeding and fertility

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

Driving and using machines

Amoxicillin may cause adverse effects, and symptoms (such as allergic reactions, dizziness, and seizures) may mean you should not drive.

Do not drive or operate machinery unless you feel well.

Amoxicilina Sandoz Farmacéutica contains aspartame, sodium benzoate, benzyl alcohol, benzyl benzoate, sorbitol, glucose, and sulfur dioxide.

• This medicine contains 8.5 mg of aspartame (E951) per dose. Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
• This medicine contains 7.1 mg of sodium benzoate (E211), which is a mild irritant to the eyes, skin, and mucous membranes. This medicine 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 of age).
• This medicine contains up to 3 mg of benzyl alcohol per dose. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome"), in children. Do not administer this medicine to your newborn (up to 4 weeks of age) unless specifically recommended by your doctor.

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 one week in children under 3 years of age unless directed by your doctor or pharmacist.

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

3. How to take Amoxicilina Sandoz Farmacéutica

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Shake the bottle well before each dose.
• Space your doses evenly throughout the day, with at least 4 hours between doses.

The recommended dose is:

Children weighing less than 40 kg

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

• Your doctor will tell you how much amoxicillin to give your baby or child.
• The recommended 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 weighing 40 kg 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 (an infection transmitted by parasites called ticks): Isolated erythema migrans (early stage - single red or pink circular rash): 4 g per day; Systemic manifestations (late stage - 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 1 g twice a day for 7 days, in combination with other antibiotics and medications for treating stomach ulcers.
• To prevent heart 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 can provide further details.
• The maximum recommended dose is 6 g per day.

Renal problems

If you have kidney 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, symptoms may include gastrointestinal discomfort (feeling unwell, nausea, or diarrhea), crystals in the urine (which may appear as cloudy urine), or difficulty urinating. Contact your doctor as soon as possible. Take the medicine with you so you can show it.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget 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 make up for a missed dose.

How long should you take Amoxicilina Sandoz Farmacéutica

• Continue taking amoxicillin for as long as your doctor has instructed, even if you feel better. You need to take all doses to fully eliminate the infection. If some bacteria survive, the infection may return.
• After completing the treatment, if you still feel unwell, you should see your doctor again.

Prolonged use of amoxicillin may lead to candidiasis (a fungal infection in moist areas of the body that may cause pain, itching, and white discharge). If this occurs, consult your doctor.

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

Reconstitution of the suspension is carried out by the doctor or pharmacist.

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

Once the foam has settled, slowly add tap water exactly up 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, which is white to slightly yellowish in color and has a fruity odor, is ready for use.

Shake the bottle well before taking each dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking amoxicillin and see a doctor immediately if you experience any of the following serious adverse effects – you may need urgent medical treatment:

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

• allergic reactions, signs may include: skin itching or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These may be severe and, in some cases, have led to death,

• skin rash or flat red spots resembling the tip of a pin beneath the skin surface, or skin bruising. This is due to inflammation of the walls of blood vessels 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 amoxicillin; some signs include: rashes, fever, joint pain, and swollen lymph nodes, especially under the arms,

• a skin reaction called “erythema multiforme,” in which you may develop: itchy purple or reddish spots on the skin, especially on the palms of the hands or soles of the feet, swollen raised areas on the skin, soft tissue lesions on the surface of the mouth, eyes, and genitals. You may also have fever and feel very tired,

• other serious skin reactions may include: changes in skin color, lumps under the skin, blisters, pustules, peeling, redness, pain, itching, exfoliation. These may be accompanied by fever, headache, and body pain,

• flu-like symptoms with skin rash, fever, swollen glands, 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, which occurs during treatment with amoxicillin for Lyme disease and causes fever, chills, headache, muscle pain, and skin rash,

• inflammation of the large intestine (colon) with diarrhea (sometimes with blood), abdominal pain, and fever,

• serious adverse effects in the liver may occur. These are mainly associated with patients undergoing prolonged treatment, males, and elderly individuals. You should contact your doctor immediately if you experience:

• severe diarrhea with bleeding,

• blisters, redness, or bruising on the skin,

• dark urine or pale stools,

• yellowing of the skin and whites of the eyes (jaundice). See also anemia below, which may lead to jaundice.

These may occur during treatment or up to several weeks afterward.

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

Sometimes you may experience less severe skin reactions such as:

• a moderate itchy rash (round, pink-red spots), swollen areas resembling blisters on forearms, legs, palms, hands, or feet. This is uncommon (may affect up to 1 in 100 people).

If you have any of these, speak with your doctor, as you will need to stop your treatment with amoxicillin.

Other possible adverse 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)

• candidiasis (fungal infection in the vagina, mouth, or skin folds); treatment is available from your doctor or pharmacist for candidiasis,
• kidney problems,
• seizures (convulsions), observed in patients treated with high doses or with kidney problems,
• dizziness,
• hyperactivity,
• discoloration of teeth, which usually resolves with brushing (this has been reported in children),
• the tongue may turn yellow, brown, or black and may appear hairy,
• excessive breakdown of red blood cells leading to a type of anemia. Signs include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and whites of the eyes,
• low number of white blood cells,
• low number of cells involved in blood clotting,
• blood may take longer than normal to clot. This may be noticeable if you have nosebleeds or cuts that bleed excessively.

Frequency not known (cannot be estimated from available data)

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

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

• crystals in the urine causing acute kidney injury,
• blistering rash arranged in circles with central crusts or resembling a string of pearls (linear IgA disease),
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting of adverse effects

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

5. Storage of Amoxicillin Sandoz Farmacéutica

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

Do not use this medicine after the expiry date stated on the container and blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep the container tightly closed to protect 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 medicine if clumps of powder are visible in the vial before reconstitution.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Amoxicilina Sandoz Farmacéutica

The active substance is amoxicillin (as amoxicillin trihydrate).

5 ml of reconstituted suspension contain:

Amoxicillin trihydrate equivalent to 250 mg of amoxicillin.

The other excipients are anhydrous citric acid (E330), sodium benzoate (E211), aspartame (E951), talc (E553b), anhydrous trisodium citrate (E331), guar gum (E412), precipitated silicon dioxide (E551), powdered lemon flavour (containing, among others, sorbitol, sulphur dioxide, glucose), powdered peach and apricot flavour (containing, among others, sorbitol, sulphur dioxide, benzyl benzoate), powdered orange flavour (containing, among others, benzyl alcohol).

Nature of the product and pack contents

White to slightly yellowish powder with a characteristic fruity odour.

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 polypropylene screw cap (press and turn) and sealing membrane.

The dosing spoon supplied, marked with fill lines at 1.25 ml, 2.5 ml and 5.0 ml, is made of polypropylene.

Individual packs of 60 ml and 100 ml in cardboard box.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Sandoz GmbH

Biochemiestrasse, 10

6250 - Kundl

Austria

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Ospamox 250 mg/5 ml - Powder for oral suspension

Belgium: Amoxicilline Sandoz 250mg/5ml powder for oral suspension

Netherlands: Amoxicilline Sandoz Forte 250 mg/5 ml, powder for oral suspension

Portugal: AMOXICILINA SANDOZ 250 MG/5 ML POWDER FOR ORAL SUSPENSION

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

Date of the most recent review of this leaflet: 01/2024.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es.

Reconstitution Instructions

Reconstitution of the suspension should be performed by a physician or pharmacist.

After opening the screw cap, ensure that the seal on the bottle cap is intact and properly adhered to the rim of the bottle. Do not use if the seal is not intact. Shake the bottle to loosen the powder. To reconstitute the suspension, fill the bottle with fresh tap water to approximately 1 cm below the fill line, close the bottle, and shake immediately and thoroughly.

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

Shake the bottle vigorously again.

The reconstituted suspension, which is white to slightly yellowish in color and has a fruity odor, is now ready for use.

Do not use the reconstituted suspension if its color is not white to slightly yellowish.

Shake the bottle well before taking each dose.