AMOXICILLIN CINFA 1000 mg TABLETS

2. What you need to know before taking amoxicilina cinfa

Do not take amoxicilina cinfa:

• 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 amoxicillin if any of the above points apply to you. If you are unsure, consult your doctor or pharmacist before taking amoxicillin.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take amoxicilina cinfa 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 unsure whether any of the above situations apply to you, inform your doctor or pharmacist before taking amoxicillin.

Blood and Urine Tests

If you are undergoing:

• 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 amoxicillin. This is because amoxicillin can alter the results of these types of tests.

Other Medications and amoxicilina cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

• If you are taking allopurinol (used for gout) with amoxicillin, you may be more likely to experience 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 necessary.
• If you are taking other antibiotics (such as tetracycline), amoxicillin may be less effective.
• If you are taking methotrexate (a medication 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, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Using Machines

Amoxicillin may have side effects, and symptoms (such as allergic reactions, dizziness, and convulsions) may make it unwise for you to drive.

Do not drive or operate machinery unless you feel well.

amoxicilina cinfa contains glucose

This medication contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

amoxicilina cinfa contains sodium

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

3. How to take amoxicilina cinfa

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• Swallow the tablet with water.
• Space the doses evenly throughout the day, at least 4 hours apart.
• The score line is only for breaking the tablet if you find it difficult to swallow whole.

The recommended dose is:

Children under 40 kg of body weight

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

• Your doctor will tell you how much amoxicillin to give to your baby or child.
• The recommended 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 over 40 kg of Body Weight

The recommended dose of amoxicillin 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 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.

Kidney Problems

If you have kidney problems, the dose may be lower than the usual dose.

If you take more amoxicilina cinfa than you should

If you have taken more amoxicillin than you should, the signs may include 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 medication 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 medication and the amount ingested.

If you forget to take amoxicilina cinfa

• 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 amoxicilina cinfa

• Continue taking amoxicillin for the time your doctor has indicated, even if you feel better. You need to take all the doses to overcome the infection. If some bacteria survive, they can cause the infection to recur.
• Once you finish treatment, if you continue to feel 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 occur if you take amoxicillin for a long time. If this happens, consult your doctor.

If you take amoxicillin for a long time, your doctor may perform additional tests to check that your kidneys, liver, and blood are functioning normally.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop taking amoxicilina and see a doctor immediately if you experience 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 severe and, in some cases, have been fatal
• skin rash or red, flat, round spots 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, 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 reddish rashes with itching on the skin, especially on the palms of the hands or soles of the feet, swollen, raised areas on the skin, soft tissues on the surface of the mouth, eyes, or genitals. You may have a fever and feel very tired
• other severe skin reactions may include: change in skin color, lumps under the skin, blisters, pimples with pus, peeling, redness, pain, itching. 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, 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
• serious liver effects may occur. These are mainly associated with prolonged treatments, men, and the elderly. You should inform 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 medication and see your doctor immediately.

Sometimes you may experience less severe 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.

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
• 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, which can cause a type of anemia. The signs include: fatigue, 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.

Frequency Not Known(cannot be estimated from available data)

• Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced myocardial infarction (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES):

DIES has been reported mainly in children who receive amoxicillin. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

• crystals in the urine that cause acute kidney injury, which can appear as cloudy urine or difficulty or discomfort when urinating. Make sure to drink plenty of fluids to reduce the likelihood of these symptoms.
• A skin rash with blisters 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 Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of amoxicilina cinfa

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

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Do not use this medication if you notice visible signs of deterioration.

Medications should not be thrown away in drains or trash. Deposit the packaging and any unused medications in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Amoxicilina Cinfa

• The active ingredient is amoxicillin. Each tablet contains amoxicillin trihydrate equivalent to 1000 mg (1 g) of amoxicillin.
• The other components are: crospovidone (E-1202), raspberry flavor (contains glucose and corn starch), sodium saccharin, magnesium stearate (E-470b), sodium lauryl sulfate, microcrystalline cellulose (E-460).

Appearance of the Product and Package Contents

Amoxicilina Cinfa 1000 mg are elongated, scored, white or almost white tablets with the inscription A/1.

Amoxicilina Cinfa is presented in packages containing 20, 30 or 500 tablets in a PVC-aluminum blister pack.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorio Reig Jofré, S.A.

C/Jarama 111, Polígono Industrial

45007 Toledo.

Date of the Last Revision of this Prospectus:May 2023

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/

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62880/P_62880.html

QR code at: https://cima.aemps.es/cima/dochtml/p/62880/P_62880.html