AMOXICILLIN RATIOPHARM 500 mg FILM-COATED TABLETS

2. What you need to know before you take 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 rash or swelling of the face or throat.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Amoxicillin ratiopharm 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 Amoxicillin 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).

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

Using Amoxicillin ratiopharm 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 Amoxicillin ratiopharm, you may be more likely to suffer a skin allergic reaction.
• If you are taking anticoagulants (such as warfarin) with Amoxicillin ratiopharm, more blood tests may be needed. • 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.
• Probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

.

• If you are taking other antibiotics (such as tetracycline), 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 system.

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 ratiopharm 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 ratiopharm contains sodium

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

3. How to take Amoxicillin ratiopharm

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

• Amoxicillin ratiopharm is administered orally, the tablets can be dissolved in a little water or swallowed whole. You can take it alone or with food.
• Space the doses evenly throughout the day, at least 4 hours apart.

The usual dose is:

Children under 40 kg in weight

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

• Your doctor will tell you how much Amoxicillin ratiopharm 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 in weight

The usual dose of Amoxicillin 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 - 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 Amoxicillin ratiopharm than you should

If you have taken more Amoxicillin ratiopharm 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 difficulty urinating. Talk to your doctor as soon as possible. Bring the medicine with you.

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. Bring this leaflet with you.

If you forget to take Amoxicillin 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 forgotten doses.

How long to take Amoxicillin ratiopharm

• Continue taking Amoxicillin ratiopharm for the duration indicated by your doctor, 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 treatment, if you are still feeling unwell, you should go back to see your doctor.

Thrush (a yeast infection of the moist parts of the body that can cause pain, itching, and white discharge) may occur if you take Amoxicillin ratiopharm for a long time. If this happens, consult your doctor.

If you take Amoxicillin Ratiopharm 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 on the use of this product, 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 Amoxicillin ratiopharm and see a doctor immediately if you experience any of the following serious side effects – you may need urgent medical attention:

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

•rash or round, flat, 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 may be associated with joint pain (arthritis) and kidney problems

• a delayed allergic reaction may occur 7 to 12 days after taking Amoxicillin ratiopharm, some signs include: rash, 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 reddish patches with itching 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 feel very tired
• other serious 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 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 may be signs of a problem with your blood cells
• Jarisch-Herxheimer reaction that occurs during treatment with Amoxicillin 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
• serious liver effects may occur. 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 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 your 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 Amoxicillin ratiopharm.

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.

Rare(may affect up to 1 in 10,000 people)

• thrush (yeast 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 usual to clot. You may notice this if you have a nosebleed or cut yourself.

Not known(cannot be estimated from the available data)

• 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.

• A blistering rash 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).

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: https://www.notificaram.es. By reporting side 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 package.

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 shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Content and Additional Information

Composition ofAmoxicilina ratiopharm

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

• The other ingredients 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 Packaging Content

Film-coated tablets.

Packaging containing: 20 and 30 units.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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 Last Revision of this Leaflet:

Detailed and updated information on this medication 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 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 appearance of resistant bacteria that can make the antibiotic ineffective:

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.
5. If you still have antibiotic left after completing the treatment, return all unused medication to your pharmacy to ensure that disposal requirements are met.