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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

amoxicillin

Read all of this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only, and you should not give it to other people, even if they have the same symptoms as you, because it may be harmful to them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

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

What is Amoxicilina Sandoz

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

What Amoxicilina Sandoz is used for

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

2. What you need to know before taking Amoxicilina Sandoz

Do not take Amoxicilina Sandoz:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 conditions apply to you, inform your doctor or pharmacist before taking Amoxicilina Sandoz.

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 Amoxicilina Sandoz. This is because Amoxicilina Sandoz may alter the results of these types of tests.

Other medicines and Amoxicilina Sandoz

Tell 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 to treat gout) with Amoxicilina Sandoz, you may be more likely to experience a skin allergic reaction.
• If you are taking probenecid (used to treat gout), concomitant use with 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 needed.
• If you are taking other antibiotics (such as tetracycline), Amoxicilina 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 potentially increase adverse effects.

Pregnancy and breastfeeding

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

Driving and using machines

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

Do not drive or operate machinery unless you feel well.

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

This medicine contains sucrose and glucose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine. It may cause dental caries.

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

This medicine contains 2.40 mg of sodium benzoate in each 5 ml of suspension. 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 less than 23 mg of sodium (1 mmol) per 5 ml of oral suspension; therefore, it is essentially “sodium-free”.

3. How to take Amoxicilina Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

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

The usual 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 Amoxicilina Sandoz to give 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 weighing 40 kg or more

This suspension is generally not recommended for adults and children weighing 40 kg or more. Please seek advice from your doctor or pharmacist.

Renal problems

If you have kidney problems, your 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, symptoms may include stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which may appear as cloudy urine or difficulty urinating. Contact your doctor as soon as possible. Bring the medicine with you to show them.

If you have taken more amoxicillin than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, stating the medicine and the amount taken.

If you forget 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 forgotten doses.

How long you should take Amoxicilina Sandoz

• Continue taking Amoxicilina Sandoz for the length of time prescribed by your doctor, even if you start to feel better. You need to take all the doses to completely eliminate the infection. If some bacteria survive, the infection may return.
• If you still feel unwell after completing the treatment, you should see your doctor again.

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

If you take Amoxicilina Sandoz for a prolonged period, your doctor may perform additional blood tests to monitor the normal function of your kidneys, liver, and blood.

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 will experience them.

Stop taking Amoxicilina Sandoz 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 can be severe and, in some cases, have led to death,
• skin rash or flat, round red spots like pinpricks under the skin surface or bruising 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 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: purple or reddish itchy patches on the skin, especially on the palms of the hands or soles of the feet, swollen raised areas on the skin, soft tissue lesions in 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 occurring during treatment with Amoxicilina Sandoz for Lyme disease, causing fever, chills, headache, muscle pain, and skin rash,
• inflammation of the large intestine (colon) with diarrhea (sometimes bloody), pain, and fever,
• severe adverse effects in the liver may occur. These are mainly associated with patients undergoing prolonged treatment, males, and older age. You should inform 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 anaemia below, which may lead to jaundice.

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

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

Sometimes you may experience less severe skin reactions such as:

• a moderate rash with itching (round, pink-red spots), swollen areas resembling blisters 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, speak to your doctor, as you will need to stop your treatment with Amoxicilina Sandoz.

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 can be obtained 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 when urinating. Make sure to drink plenty of fluids to reduce the likelihood of these symptoms,
• changes in tooth coloration, which usually disappear with brushing (this has been reported in children),
• the tongue may change color to yellow, brown, or black and may appear hairy,
• excessive breakdown of red blood cells causing a type of anaemia. Signs include: tiredness, 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. You may notice this 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 a heart attack triggered by allergy (Kounis syndrome),
• drug-induced enterocolitis syndrome (DIES): DIES has mainly been reported in children receiving amoxicillin. It is a type of allergic reaction with the main symptom being 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 causing acute kidney injury,
• blistering rash arranged in circles with a central crust or resembling a "pearl necklace" (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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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

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

Do not use this medicine after the expiry date stated on the container after CAD/EXP. The expiry date refers to 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 medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicilina Sandoz

• The active substance is amoxicillin. Each 5 ml of oral suspension contains 250 mg of amoxicillin.
• The other components are: sucrose, polypyrrolidone XL, anhydrous citric acid, sodium benzoate (E-211), disodium edetate dihydrate, lemon flavor (contains glucose and maize starch), peach flavor (contains glucose and maize starch), strawberry flavor (contains glucose and maize starch), trisodium citrate.

Appearance of the product and contents of the container

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

These bottles are packed in a carton box with a measuring spoon.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Reig Jofré, S.A.

C/ Jarama s/n, Industrial Estate

45007 Toledo

Spain

Date of the most recent revision of this leaflet: February 2023.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Reconstitution Instructions

Check that the cap is intact before use.

Invert and shake the vial to dislodge powder adhering to the bottom.

Fill the vial with water up to the line on the vial label.

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

Shake well before taking each dose.