Leaflet: information for the user

amoxicilina cinfa 1000 mg EFG tablets

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only, and should not be given to others even if they have the same symptoms as you, 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.

What is amoxicilina cinfa

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

What is amoxicilina cinfa used for

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

Do not take amoxicilina cinfa:

• if you are allergic to amoxicilina, penicilins, 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 if any of the above points affect you. If you are unsure, consult your doctor or pharmacist before taking amoxicilina.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amoxicilina cinfa 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 affect you, inform your doctor or pharmacist before taking amoxicilina.

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

Other medications and amoxicilina cinfa

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

• If you are taking alopurinol (used for gout) with amoxicilina, you may be more likely to have a skin allergic reaction.
• If you are taking probenecid (used to treat gout), the concomitant use of probenecid may reduce the excretion of amoxicilina and is not recommended.
• If you are taking anticoagulants (such as warfarin) with amoxicilina, more blood tests may be necessary.
• If you are taking other antibiotics (such as tetracycline), amoxicilina 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 adverse effects.

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 may have adverse effects and symptoms (such as allergic reactions, dizziness, and seizures) that may make you unfit to drive.

Do not drive or operate machinery unless you are feeling 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”

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

• Swallow the tablet with water.
• Space the doses uniformly throughout the day, at least separated by 4 hours.
• The groove is only for breaking the tablet if it is difficult to swallow it whole.

The recommended 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 to administer 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 40 kg of weight or more

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 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 kidney problems, the dose may be lower than the usual dose.

If you take more amoxicillin cinfa than you should

If you have taken more amoxicillin 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 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 forgot to take amoxicillin 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 compensate for the missed doses.

How long should you take amoxicillin cinfa

• Continue taking amoxicillin for the time your doctor 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 finish the treatment, if you continue to feel unwell, you should go back to see your doctor.

Candidiasis (a fungal infection of the moist parts of the body that may cause pain, itching, and white discharge) may appear if you take amoxicillin for a prolonged period. If this happens, consult your doctor.

If you take amoxicillin 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 amoxicillin 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 (they may affect up to 1 in 10,000 people).

• Allergic reactions, symptoms may include: skin itching or rash, facial swelling, lip, tongue, body, or difficulty breathing. These can be severe and, in some cases, have been fatal.
• 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 the 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 symptoms include: rashes, fever, joint pain, and lymph node enlargement, 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 areas on the skin, soft tissues on the surface of the mouth, eyes, and genitals. You may have a fever and feel very tired.
• Other severe skin reactions may include: skin color change, lumps under the skin, blisters, pustules 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 eosinophils and elevated liver enzymes) (drug reaction with 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 amoxicillin treatment 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.
• You may experience severe liver problems. These are mainly associated with prolonged treatment, 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
• Yellowing of the skin and the white of the eyes (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 the forearms, legs, palms, hands, or feet. This is rare (it may affect up to 1 in 100 people).

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

Other possible side effects are:

Frequent(they may affect up to 1 in 10 people)

• Skin rash
• Nausea
• Diarrhea.

Rare(they may affect up to 1 in 100 people)

• Vomiting.

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

• Candidiasis (vaginal, oral, or skin fungal infection), 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
• Hypersensitivity
• 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 appear hairy
• Excessive red blood cell rupture causing a type of anemia. Symptoms include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and the 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 frequency(it 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.

• Crystals in the urine that cause acute kidney injury, which may appear as cloudy urine or difficulty or discomfort urinating. Make sure to drink plenty of fluids to reduce the risk of these symptoms.
• 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 the 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 use this medication after the expiration date that appears on the packaging after CAD. 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 observe visible signs of deterioration.

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

Composition of amoxicillin 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 aroma (contains glucose and cornstarch), sodium saccharin, magnesium stearate (E-470b), sodium lauryl sulfate, microcrystalline cellulose (E-460).

Appearance of the product and contents of the package

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

amoxicillin cinfais presented in packaging containing 20, 30 or 500 tablets in a PVC-aluminum blister.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Laboratorio Reig Jofré, S.A.

C/Jarama 111, Industrial Estate

45007 Toledo.

Date of the last review of this leaflet:May 2023

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/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your 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 to:https://cima.aemps.es/cima/dochtml/p/62880/P_62880.html