AMITRON 1 g POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User.

Amitron 1 g Powder for Solution for Injection

Amoxicillin Sodium

Read all of this leaflet carefully before you start using this medicine.

-Keep this leaflet, you may need to read it again.

-If you have any further questions, ask your doctor, pharmacist, or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet (see section 4).

Contents of the pack:

1. What is Amitron and what it is used for
2. What you need to know before you use Amitron
3. How to use Amitron
4. Possible side effects
5. Storage of Amitron
6. Contents of the pack and other information

1. What is Amitron and what it is used for

What is Amitron

Amitron is an antibiotic. The active substance is amoxicillin. This belongs to a group of medicines called "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 the instructions regarding dose, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medicine if, once the treatment is finished, you have leftover antibiotic. Return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

What Amitron is used for

Amitron is used to treat infections caused by bacteria in different parts of the body.

Amitron powder for solution for injection is normally used for the urgent treatment of severe infections if patients cannot take Amitron orally.

2. What you need to know before you use Amitron

Do not use Amitron:

• 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 a skin rash or swelling of the face or throat.

Do not use Amitron if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before using Amitron.

Warnings and precautions

Consult your doctor or pharmacist before using Amitron 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 not sure if any of the above situations apply to you, inform your doctor or pharmacist before using Amitron.

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)

Tell your doctor or pharmacist that you are using Amitron. This is because Amitron can alter the results of these types of tests.

Other medicines and Amitron

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

• If you are taking allopurinol (used for gout) with Amitron, you may be more likely to suffer 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 Amitron, more blood tests may be needed.
• If you are taking other antibiotics (such as tetracycline), Amitron 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 cause a potential increase in side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines:

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

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

Amitron 1 g powder for solution for injection contains sodium.

This medicine contains 63 mg of sodium (a major component of cooking/table salt) in each vial. This is equivalent to 3.2% of the maximum recommended daily sodium intake for an adult.

3. How to use Amitron

You will never administer this medicine to yourself. A qualified person, such as a doctor or nurse, will administer the medicine to you.

Amitron should be administered as an injection into a vein (intravenously).

Your doctor will decide how much you need each day and how often you should receive it.

Make sure to drink plenty of fluids while receiving Amitron.

To treat infections

The usual doses are as follows.

Children under 40 kg in weight

• Most infections: 20 mg to 200 mg per kilogram of body weight, in divided doses throughout the day.
• Lyme disease (an infection caused by parasites called ticks): isolated erythema migrans (early stage - pink or red circular rash): 25 mg to 50 mg per kilogram of body weight in divided doses throughout the day; systemic manifestations (late stage - with more serious symptoms or when the disease spreads throughout the body): 100 mg per kilogram of body weight, in divided doses, throughout the day
• Maximum single dose: 50 mg per kilogram of body weight.

Adults, elderly patients, and children over 40 kg in weight

• Usual daily dose: 750 mg to 6 g administered in divided doses.
• Maximum daily intravenous dose: 12 g per day.
• Maximum single intravenous dose: 2 g by perfusion or 1 g by bolus injection.
• Maximum intramuscular daily dose: 4 g per day;
• Maximum single dose: 1 g.
• Lyme disease (an infection caused by parasites called ticks): isolated erythema migrans (early stage - pink or red circular rash): 4 g per day; systemic manifestations (late stage - with more serious symptoms or when the disease spreads throughout the body): 6 g per day.

Kidney problems

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

If you receive more Amitron than you should

It is unlikely that you will be given too much, but if you think you have been given too much Amitron, tell your doctor, pharmacist, or nurse immediately. The signs may be stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which can be seen as cloudy urine or problems urinating.

If you have received more Amitron than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you miss a dose of Amitron

Talk to your doctor, pharmacist, or nurse.

How long will you need to use Amitron

Do not stop receiving Amitron unless your doctor tells you to.

Normally, you will not be given Amitron for more than 2 weeks without your doctor reviewing your treatment.

Candidiasis (a fungal infection of the moist parts of the body that can cause pain, itching, and white discharge) may occur if you use Amitron for a long time. If this happens, consult your doctor, pharmacist, or nurse.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop receiving Amitron 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 round, flat, red spots 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 using Amitron, 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 on the skin, soft tissues on the surface of the mouth, eyes, or genitals. You may have a fever and be very tired
• other serious skin reactions may include: change in skin color, lumps under the skin, blisters, pimples with pus, peeling, redness, pain, itching. These may be associated with fever, headache, and body pain
• 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 Amitron 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 treatments, 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 using the medicine and see a doctor immediately.

Sometimes you may experience less serious skin reactions such as:

• a moderate rash with itching (round, pink-red patches), swollen areas with a blister-like appearance on the forearms, legs, palms, hands, or feet. This is uncommon (affects less than 1 in 100 people).

If you experience any of these, talk to your doctor as you will need to interrupt your treatment with Amitron.

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)

• candidiasis (fungal infection in the vagina, mouth, or skin folds), you can get treatment for candidiasis from your doctor or pharmacist
• kidney problems
• seizures (convulsions), observed in patients treated with high doses or with kidney problems
• dizziness
• hyperactivity
• crystals in the urine, which can appear as cloudy urine or difficulty or discomfort when urinating. Make sure to drink plenty of fluids to reduce the possibility of these symptoms
• 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 normal 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 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 (1-4 hours after using the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

• Crystals in the urine that cause acute kidney injury.
• A skin rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).
• Inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amitron

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

Do not use Amitron after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month shown.

Store in the original packaging to protect from light.No special storage conditions are required.

Amitron should be administered by a healthcare professional. The expiry date and storage conditions that appear on the labeling are for the information of the doctor, pharmacist, or nurse. The doctor, pharmacist, or nurse will reconstitute the medicine. When administered directly into a vein, it should be used immediately after reconstitution (this process usually takes about 5 minutes).

From a microbiological point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not exceed the times indicated for chemical and physical stability during use, whichever is shorter.

Medicines should not be disposed of via wastewater or household waste.If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amitron 1 g

The active ingredient is sodium amoxicillin.

Each vial contains 1 g of amoxicillin.

Product Appearance and Container Content

Powder for injectable solution. Each container contains a vial with a sterile white to off-white powder.

Marketing Authorization Holder and Manufacturer

LDP Laboratorios TORLAN, S.A.

Ctra. de Barcelona, 135-B

08290-CERDANYOLA DEL VALLES (Barcelona - SPAIN)

Other Presentations

Amitron 500 mg powder for injectable solution

This leaflet was approved in March 2025

This information is intended only for doctors or healthcare professionals

Intravenous Administration

The usual solvent is water for injectable preparations.

A transient pink coloration may or may not appear during reconstitution. The reconstituted solutions are normally colorless or pale straw-colored. All solutions should be shaken vigorously before injection. Any unused antibiotic solution should be discarded.

For single use.