AMITRON 500 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Amitron 500 mg Hard Capsules

amoxicillin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Amitron and what is it used for

Amitron is an antibiotic. The active substance is amoxicillin. This belongs to a group of medicines called “penicillins”.

What Amitron is used for

Amitron is used to treat infections caused by bacteria in different parts of the body. Amitron 500 mg hard capsules can also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before you take Amitron

Do not take 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 skin rash or swelling of the face or throat.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Amitron 500 mg hard capsules 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 not sure if any of the above situations apply to you, inform your doctor or pharmacist before taking 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 taking Amitron. This is because Amitron can affect the results of these types of tests.

Using Amitron with other medicines

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.
• Probenecid (used to treat gout), concomitant use of 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.
• Methotrexate (a medicine 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amitron may have side effects such as allergic reactions, dizziness, and convulsions that may make you unfit to drive.

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

3. How to take Amitron

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

• Swallow the capsules with water, without opening them.
• Space the doses evenly 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 Amitron to give to 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 over 40 kg of weight

The usual dose of Amitron 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 infection:3 g twice a day, for one day.
• Lyme disease (an infection caused by parasites called ticks):isolated erythema migrans (early stage - circular pink or red rash): 4 g per day; systemic manifestations (late stage - with 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 a dose of 1 g, twice a day, for 7 days with other antibiotics and medicines to treat stomach ulcers.
• To prevent heart infection during surgery:the dose will vary depending on the type of surgery. Other medicines may be given at the same time. Your doctor, pharmacist, or nurse can give you more details.
• The maximum recommended dose is 6 g per day.

Kidney problems

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

If you take more Amitron than you should

If you have taken more Amitron 500 mg hard capsules than you should, 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. Talk to your doctor as soon as possible. Bring the medicine to show them. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Amitron

• 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 to take Amitron

• Continue taking Amitron 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 can make the infection come back.

• Once you finish treatment, if you still feel unwell, you should go back to see your doctor.

You may get thrush (a fungal infection of the moist parts of the body that can cause pain, itching, and white discharge) if you take Amitron for a long time. If this happens, consult your doctor.

If you take 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 or pharmacist.

4. Possible side effects

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

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 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 string of pearls (linear IgA disease).

Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Stop taking 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 can 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 red spots under the skin or bruising of the skin. This is due to inflammation of the blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems
• a delayed allergic reaction may occur 7 to 12 days after taking Amitron, some signs include: rashes, fever, joint pain, and swelling of lymph nodes especially under the arms
• a skin reaction called ‘erythema multiforme’ in which you may develop: purple or red patches on the skin, especially on the palms of the hands or soles of the feet, swollen areas of 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 can include: changes in skin color, lumps under the skin, blisters, pimples with pus, scaling, redness, pain, itching. These can be accompanied by fever, headache, and body pain
• flu-like symptoms with skin rash, fever, gland inflammation, 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 can be signs of a blood cell problem
• 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 can occur. These are mainly associated with prolonged treatment, 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 taking 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 (may affect up to 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)

• thrush (fungal infection in the vagina, mouth, or skin folds), you can get treatment for thrush 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 urinating. Make sure to drink plenty of fluids to reduce the possibility 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 have a hairy appearance
• 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.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://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 this medicine after the expiry date which is stated on the carton after EXP.

The expiry date is the last day of the month stated.

Store in the original package to protect from moisture.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amitron

• The active substance is amoxicillin. Each capsule contains 500 mg of amoxicillin trihydrate.
• The other ingredients are magnesium stearate and gelatin capsule composed of erythrosine (E217), indigo carmine (E132), titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the product and pack contents

Amitron 500 mg hard capsules are packaged in aluminum/aluminum blister packs.

These blisters are packaged in cardboard boxes containing 20 capsules or 100 capsules (clinical packaging).

Marketing authorization holder and manufacturer

LDP LABORATORIOS TORLAN, S.A.

Ctra. de Barcelona 135-B

08290 Cerdanyola del Vallès (Barcelona)

Spain

Local Representative

LAPHYSAN, SAU

C/ Anabel Segura 11. Edificio A. Planta 4. Puerta D

28108 Alcobendas (Madrid)

Spain

Date of last revision of this leaflet: November 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

General advice on the use of antibiotics

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.

Sometimes a bacterial infection does not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria that cause the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics properly can reduce the chances of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic, it is only to treat your current illness. Paying attention to the following tips will help you prevent the emergence of resistant bacteria that can make the antibiotic not work:

1. It is very important that you take the antibiotic in the correct dose, at the indicated times, and for the correct number of days. Read the instructions in the leaflet and, if you do not understand something, ask your doctor or pharmacist.
2. You should not take an antibiotic unless it has been specifically prescribed for you, and you should only use it for the infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed for other people, even if they had a similar infection to yours.
4. You should not give antibiotics that have been prescribed for you to other people.

1. If you still have leftover antibiotic after completing treatment, return all unused medicines to your pharmacy to ensure that disposal requirements are met.