Amoxicillin Ratiopharm 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicilina ratiopharm 500mg film-coated tablets EFG

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, 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 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.

Contents of the leaflet:

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

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

What Amoxicilina ratiopharm is

Amoxicilina ratiopharm is an antibiotic. The active substance is amoxicillin. It 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 your doctor's instructions regarding dose, dosing interval, and duration of treatment.

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

What Amoxicilina ratiopharm is used for

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

2. What you need to know before starting Amoxicillin ratiopharm

Do not take Amoxicillin ratiopharm

• if you are allergic to amoxicillin, penicillins, 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 take Amoxicillin ratiopharm if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicillin ratiopharm.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicillin ratiopharm 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 situations apply to you, inform your doctor or pharmacist before taking Amoxicillin ratiopharm.

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

Using Amoxicillin ratiopharm with other medicines

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 for gout) together with Amoxicillin ratiopharm, you may be more likely to experience a skin allergic reaction.

• If you are taking anticoagulants (such as warfarin) with Amoxicillin ratiopharm, additional blood tests may be required.

• Methotrexate (a medicine used to treat cancer and severe psoriasis): penicillins may reduce methotrexate excretion and potentially increase adverse effects.

• Probenecid (used to treat gout): concomitant use with probenecid may reduce amoxicillin excretion and is not recommended.

• If you are taking other antibiotics (such as tetracyclines), Amoxicillin ratiopharm may be less effective.

Taking Amoxicillin ratiopharm with food and drinks

Amoxicillin ratiopharm can be taken with or without food, as its absorption is hardly affected by the presence of food in the digestive tract.

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

Amoxicillin ratiopharm may cause adverse effects and symptoms (such as allergic reactions, dizziness, and seizures) that could impair your ability to drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take Amoxicilina ratiopharm

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

• Amoxicilina ratiopharm is administered orally; the tablets may be dissolved in a small amount of water or swallowed whole. You may take it with or without food.
• Space your doses evenly throughout the day, with at least 4 hours between doses.

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 ratiopharm 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 Amoxicilina ratiopharm 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 – 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.

• For prevention of 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, your dose may be lower than the usual dose.

If you take more Amoxicilina ratiopharm than you should

If you have taken more Amoxicilina ratiopharm 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 for identification.

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

If you forget to take Amoxicilina ratiopharm

• 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 ratiopharm

• Continue taking Amoxicilina ratiopharm for the length of time prescribed by your doctor, even if you feel better. You need to take all the doses to completely 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.

Candidiasis (a fungal infection affecting moist areas of the body that may cause pain, itching, and white discharge) may occur if Amoxicilina ratiopharm is taken for a prolonged period. If this happens, consult your doctor.

If you take Amoxicilina ratiopharm for a prolonged period, your doctor may perform additional 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 experiences them.

Stop taking Amoxicilina ratiopharm and go 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 red pinpoint spots 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 ratiopharm; some signs include: rashes, fever, joint pain, and enlarged 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, or 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 associated with 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 ratiopharm 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

• serious liver effects may occur. These are mainly associated with patients undergoing prolonged treatment, males, and elderly individuals. 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 anemia 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 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 Amoxicilina ratiopharm.

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 treated with high doses or who have 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 discoloration, which usually disappear 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 causing 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

Not known (cannot be estimated from available data)

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

• Drug-Induced Enterocolitis Syndrome (DIES):

DIES has been reported mainly in children receiving amoxicillin. It is a 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, diarrhea, and low blood pressure.

• blistering rash arranged in circles 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)

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 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 ratiopharm

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

Do not store above 25°C. Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging, following "EXP*". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return any 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 will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicilina ratiopharm

• The active substance is Amoxicillin. Each film-coated tablet contains 574 mg of amoxicillin trihydrate, equivalent to 500 mg of amoxicillin.

• The other components are: magnesium stearate, povidone (K 25), sodium starch glycolate from potato (potato starch), microcrystalline cellulose, talc, titanium dioxide (E-171), and hypromellose.

Appearance of the product and contents of the pack

Film-coated tablets.

Pack sizes: 20 and 30 units.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Manufacturer:

Merckle GmbH

Ludwig Merckle Strasse, 3

89143 Blaubeuren (Germany)

or

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Date of the most recent revision of this leaflet:

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for 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 presence of 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, which could render antibiotics ineffective:

1. It is very important to take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the instructions in the leaflet carefully, and if anything is unclear, 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 medicines to your pharmacy to ensure proper disposal.