Package Leaflet: Information for the User

Amoxicilina ratiopharm 500 mg tabletscoated with EFG film

Read 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 others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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 side effects

5. Storage of Amoxicilina ratiopharm

6. Contents of the pack and additional information

What is Amoxicilina ratiopharm

Amoxicilina ratiopharm is an antibiotic. The active ingredient is amoxicilina. This belongs to a group of medicines called “penicillins”.

What is Amoxicilina ratiopharm used for

Amoxicilina ratiopharm is used to treat infections caused by bacteria in different parts of the body. Amoxicilina ratiopharm may also be used in combination with other medications to treat stomach ulcers.

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Do not take Amoxicilina ratiopharm

• if you are allergic to amoxicillin, penicillins, or any of the other components of this medication (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 Amoxicilina ratiopharm if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicilina ratiopharm.

Warnings and precautions

Consult your doctor or pharmacist before taking Amoxicilina ratiopharm if:

• You have infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue)
• 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 Amoxicilina ratiopharm.

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).

Inform your doctor or pharmacist that you are taking Amoxicilina ratiopharm. This is because Amoxicilina ratiopharm may affect the results of these types of tests.

Use of Amoxicilina ratiopharm with other medications

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

• If you are taking allopurinol (used for gout) with Amoxicilina ratiopharm, you may be more likely to experience a skin rash.

• If you are taking anticoagulants (such as warfarin) with Amoxicilina ratiopharm, more blood tests may be necessary.

• Methotrexate (a medication used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in adverse effects.

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

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

Administration of Amoxicilina ratiopharm with food and beverages

Amoxicilina ratiopharm can be taken with or without food, as its absorption is barely affected by the presence of food in the digestive system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Amoxicilina ratiopharm may have adverse effects, and symptoms (such as allergic reactions, dizziness, and seizures) may make it unsafe to drive.

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

Amoxicilina ratiopharm contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

• Amoxicilina ratiopharm is administered orally, the tablets can be dissolved in a little water or taken whole. You can take it alone or with food.
• Space the doses uniformly throughout the day, at least separated by 4 hours.

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 Amoxicilina ratiopharm to administer to your baby or child.

• The usual dose is 40 mg to 90 mg per kilogram of body weight per day, administered 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 40 kg of weight 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 infections:3 g twice a day, for one day.

•Lyme disease (a disease caused by some parasites called ticks):erythema migrans isolated (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:one dose of 750 mg or one dose of 1 g, twice a day, for 7 days with other antibiotics and medications to treat stomach ulcers.

•To prevent heart infection during surgery:The dose will vary depending on the type of surgery. Other medications may be administered at the same time. Your doctor, pharmacist or nurse can provide more details.

• The maximum recommended dose is 6 g per day.

Renal problems

If you have renal problems, the 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, the signs may be stomach discomfort (nausea, vomiting or diarrhea) or crystals in the urine, which may be observed as cloudy urine or difficulty urinating. Talk to your doctor as soon as possible. Bring the medication to show it to them.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring this leaflet with you.

If you forgot 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 compensate for the missed doses.

How long should you take Amoxicilina ratiopharm

• Continue taking Amoxicilina ratiopharm 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 may cause the infection to recur.

• Once you have finished the treatment, if you continue to feel unwell, you should go back to see your doctor.

You may experience candidiasis (a fungal infection of the moist parts of the body that can cause pain, itching and white discharge) if you take Amoxicilina ratiopharm 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 other doubts about the use of this medication, ask your doctor or pharmacist

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Amoxicilina ratiopharm and see a doctor immediately if you experience any of the following severe side effects – you may need urgent medical treatment:

The following side effects are very rare (can affect up to 1 in 10,000 people)

• Allergic reactions, symptoms may include: itchy skin or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These can be severe and, in some cases, have been fatal

• Skin rash or flat, round, red spots like the tip of a pin under the skin's surface or bruises 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 symptoms include: rashes, fever, joint pain, and swollen lymph nodes, especially under the arms

• A skin reaction called 'erythema multiforme' in which you may develop: purple or reddish rashes with itchy skin, especially on the palms of your hands or soles of your feet, swollen, raised areas on the skin, soft tissues on the surface of your mouth, eyes, and genitals. You may have a fever and feel very tired

• Other severe skin reactions may be: changes in skin color, lumps under the skin, blisters, pustules, peeling, redness, pain, itching, exfoliation. These may be associated with fever, headache, and body aches

• Flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as increased eosinophils (eosinophilia) and elevated liver enzymes (drug-induced eosinophilia and systemic symptoms (DRESS)).

• Fever, chills, sore throat, or other signs of infection, or the appearance of bruises easily. These may be signs of a problem with your blood cells

• Jarisch-Herxheimer reaction that occurs during treatment with Amoxicilina ratiopharm 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

• Severe liver damage effects may occur. These are mainly associated with prolonged treatments, men, and advanced age. Inform your doctor immediately if you have:

• Severe diarrhea with bleeding
• Blisters, redness, or bruises on the skin
• Dark urine or pale stools
• Skin and white of the eyes yellowish (jaundice). See anemia below, which may cause jaundice.

These may occur during treatment or several weeks after.

If any of the above symptoms appear, stop taking the medicine and see your doctor immediately.

Occasionally, you may experience milder skin reactions such as:

• A moderate rash with itching (round, pink-red spots), swollen areas with blister-like appearance on forearms, legs, palms, hands, or feet. This is rare (can affect up to 1 in 100 people).

If you have any of them, talk to your doctor as you will need to interrupt your treatment with Amoxicilina ratiopharm.

Other possible side effects are:

Frequent(can affect up to 1 in 10 people)

• Skin rash

• Nausea

• Diarrhea.

Rare(can affect up to 1 in 100 people)

• Vomiting.

Very rare(can affect up to 1 in 10,000 people)

• Candidiasis (fungal infection in the vagina, mouth, or skin folds), you can get treatment from your doctor or pharmacist for candidiasis

• Kidney problems

• Seizures (convulsions), observed in patients treated with high doses or kidney problems

• Dizziness

• Hyperactivity

• Crystals in the urine, which may appear as cloudy urine or difficulty or discomfort urinating. Make sure to drink plenty of liquid to reduce the likelihood of these symptoms

• Alteration in tooth color, which usually disappears with brushing (this has been reported in children)

• The tongue may change color to yellow, brown, or black and may appear hairy

• Excessive breaking of red blood cells that causes a type of anemia. Symptoms include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowish color of the skin and white of the eyes

• Low white blood cell count

• Low count of cells involved in blood clotting

• Blood may take longer than usual to clot. You may notice this if you bleed from the nose or cut yourself.

Unknown(Cannot be estimated from available data)

• Chest pain in the context of allergic reactions, which may be a symptom of an allergic-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.

• Rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not use this medicationafter the expiration date that appears on the packaging, after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAmoxicilina ratiopharm

- The active ingredient is Amoxicilina. Each film-coated tablet contains 574 mg of amoxicilina trihydrate equivalent to 500 mg of amoxicilina.

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

Appearance of the product and contents of the package

Film-coated tablets.

Packages containing: 20 and 30 units.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing:

Merckle GmbH

Ludwig Merckle Strasse, 3

89143 Blaubeuren (Germany)

or

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Last review date of this leaflet:

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/