Amiron 500 mg hard capsules

Package leaflet: Information for the user

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, 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. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Amitron is and what it is 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 bacterial infections 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 taking 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 apply to you. If you are unsure, consult your doctor or pharmacist before taking Amitron.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amitron 500 mg hard capsules 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 Amitron.

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

Taking Amitron with other medicines

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

• If you are taking allopurinol (used for gout) with Amitron, you may be more likely to experience 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 frequent 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 potentially increase adverse effects.

Pregnancy and breastfeeding

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

Amitron 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.

3. How to take Amitron

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in 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 weighing less than 40 kg

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

• Your doctor will tell you how much Amitron 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

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 – single circular pink or red 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, together 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 be given at the same time. Your doctor, pharmacist, or nurse can provide further 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, 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. Take the medicine with you so you can show it to them. You may also call the Toxicology Information Service at telephone number 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 you should take Amitron

• Continue taking Amitron for as long as 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 may cause the infection to return.

• After completing treatment, if you still feel unwell, you should see your doctor again.

You may develop candidiasis (a fungal infection in moist areas of the body that can cause pain, itching, and white discharge) if you take Amitron for a prolonged period. If this occurs, consult your doctor.

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

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.

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

Crystals in the urine causing acute kidney injury.

Blistering rash arranged in a ring-shaped pattern with a central crust or resembling 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 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 of which may include: skin itching or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These may be severe and, in some cases, deaths have occurred
• skin rash or flat, round red spots like pinpricks under 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 Amitron; 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, raised swollen areas on the skin, soft tissue lesions on the surface of the mouth, eyes, and genitals. You may have fever and feel very tired
• other serious skin reactions may include: changes in skin colour, lumps under the skin, blisters, pus-filled pimples, peeling, redness, pain, itching, or exfoliation. These may be accompanied by fever, headache, and body aches
• 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 Amitron for Lyme disease, causing fever, chills, headache, muscle pain, and skin rash
• inflammation of the large intestine (colon) with diarrhoea (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 older age. You should inform your doctor immediately if you have:
  • severe diarrhoea 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 itchy rash (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 have any of these, speak to your doctor, as you will need to discontinue your treatment with Amitron.

Other possible adverse effects are:

Common (may affect up to 1 in 10 people)

• skin rash
• nausea
• diarrhoea.

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 (fits), observed in patients treated with 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 you drink plenty of fluids to reduce the likelihood of these symptoms
• changes in tooth colour, which usually disappear with brushing (this has been reported in children)
• the tongue may change colour 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 white blood cell count
• low count of cells involved in blood clotting
• blood may take longer than normal to clot. This may be noticed if you have nosebleeds or cuts that bleed excessively.

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. Conservation of Amitron

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

Do not use this medicine after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month indicated.

Store in the outer packaging to protect it from moisture.

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 packaging at the SIGRE Point at your usual pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Amitron

• The active substance is amoxicillin. Each capsule contains 500 mg of amoxicillin trihydrate.
• The other components 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 package contents

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

These blisters are packed in cardboard boxes containing 20 capsules or 100 capsules (clinical pack).

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. 4th floor. Door D

28108 Alcobendas (Madrid)

Spain

Date of the most recent revision of this leaflet: November 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/

General advice regarding 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 causing 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 appropriately can reduce the likelihood of bacteria becoming resistant.

When your doctor prescribes an antibiotic, it is intended solely for the treatment of your current illness. Following the advice below will help you prevent the development of resistant bacteria that could make antibiotics ineffective:

1. It is very important to take the antibiotic at the correct dose, at the prescribed times, and for the full prescribed duration. Read the instructions in the leaflet carefully, and if you do not understand something, ask your doctor or pharmacist.

2. Do not take an antibiotic unless it has been specifically prescribed for you, and use it only for the infection for which it was prescribed.

3. Do not take antibiotics that have been prescribed for other people, even if they had an infection similar to yours.

4. Do not give antibiotics prescribed for you to other people.

5. If you have any antibiotic left after completing your treatment, return all unused medication to your pharmacy to ensure proper disposal.