AMOXICILLIN REIWA HEALTHCARE 250 mg ORAL SUSPENSION POWDER in sachet

Introduction

Package Leaflet: Information for the User

Amoxicillin Reiwa Healthcare 250 mg Powder for Oral Suspension in Sachet EFG

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 Package Leaflet

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

1. What is Amoxicillin Reiwa Healthcare and what is it used for

What is Amoxicillin Reiwa Healthcare

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

What is Amoxicillin Reiwa Healthcare used for

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

This medicine can also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before you take Amoxicillin Reiwa Healthcare

Do not take Amoxicillin Reiwa Healthcare:

• 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 if any of the above applies to you, inform your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking amoxicillin 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 applies to you, inform your doctor or pharmacist before taking amoxicillin.

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 amoxicillin. This is because amoxicillin may affect the results of these types of tests.

Other medicines and Amoxicillin Reiwa Healthcare

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 amoxicillin, you may be more likely to suffer a skin allergic reaction.
• If you are taking 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 amoxicillin, more blood tests may be needed.
• If you are taking other antibiotics (such as tetracycline) amoxicillin 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 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

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

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

Amoxicillin Reiwa Healthcare contains aspartame, sucrose and sulfite

• This medicine contains 1.5 mg of aspartame in each sachet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.
• This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
• This medicine contains sulfites. It can rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Amoxicillin Reiwa Healthcare

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

• Empty the contents of the sachet into 10 to 20 ml of water. Shake until a suspension is formed. Take immediately.
• 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 Amoxicillin Reiwa Healthcare to give to your baby or child.
• 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 Amoxicillin Reiwa Healthcare 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 will be able to 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 Amoxicillin Reiwa Healthcare than you should

If you have taken more Amoxicillin Reiwa Healthcare 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 with you to show them.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Amoxicillin Reiwa Healthcare

• 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 Amoxicillin Reiwa Healthcare

• Keep taking amoxicillin for as long as your doctor has told you to, even if you feel better. You need to take all the doses to get rid of the infection. If some bacteria survive, they may cause the infection to come back.
• Once you have finished the treatment, if you are still feeling unwell, you should go back to see your doctor.

Thrush (a fungal infection of the moist parts of the body that can cause pain, itching and white discharge) may appear if you take amoxicillin for a long time. If this happens, talk to your doctor.

If you take amoxicillin for a long time, your doctor may do 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.

Stop taking this medicine and see a doctor immediately if you get 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 red patches 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 can be associated with joint pain (arthritis) and kidney problems
• blistering rash, arranged in a circle with a central crust or like a string of pearls (IgA disease)
• a delayed allergic reaction may appear 7 to 12 days after taking amoxicillin, 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 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: change in skin color, lumps under the skin, blisters, pimples with pus, peeling, redness, pain, itching. These can be associated with fever, headache and body pain
• symptoms similar to flu with rash, fever, swelling of the lymph nodes and abnormal blood test results (including increased white blood cells (eosinophilia) and 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 problem with your blood cells
• Jarisch-Herxheimer reaction, which occurs during treatment with amoxicillin 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
• 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 administering the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea and low blood pressure.
• Crystals in the urine that cause acute kidney injury.
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
• serious side effects can occur in the liver. These are mainly associated with prolonged treatments, men 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 cause 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 have any of these, talk to your doctor as you will need to stop your treatment with Amoxicillin Reiwa Healthcare.

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 when 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
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin Reiwa Healthcare

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.

Do not store above 25°C.

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 any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Amoxicillin Reiwa Healthcare

• The active substance in each sachet is 250 mg of amoxicillin.
• The other ingredients are: colloidal silicon dioxide (Aerosil 200), strawberry flavoring (contains sulfites) and tutti frutti, talc, aspartame (E951), sucrose.

Appearance of the product and pack contents

Amoxicillin Reiwa Healthcare 250 mg powder for oral suspension in sachets EFG contains a yellowish-ivory powder in paper/aluminum sachets. These sachets are packaged in a cardboard box. It is available in packs of 16 and 30 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

Reiwa Healthcare, S.L.

Carretera de Fuencarral 22,

28108 Alcobendas (Madrid), Spain

Manufacturer

Netpharmalab Consulting Services, S.L.

Carretera de Fuencarral 22,

28108 Alcobendas (Madrid), Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Amoxicillin Reiwa Healthcare 250 mg Pulver zur Herstellung einer Suspension zum Einnehmen

Portugal: Amoxicilina Reiwa Healthcare 250 mg pó para suspensão oral em saqueta

Date of last revision of this leaflet:December 2024

Other sources of information

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