AMOXICILLIN CINFA 1000 mg ORAL SUSPENSION POWDER IN SACHETS

2. What you need to know before you take amoxicilina cinfa

Do not take amoxicilina cinfa

• 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 amoxicilina if any of the above applies to you. If you are not sure, 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 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 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).

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

Other medicines and amoxicilina cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• If you are taking allopurinol (used for gout) with amoxicilina, you may be more likely to get a skin rash.
• If you are taking probenecid (used to treat gout), taking probenecid with amoxicilina may reduce the excretion of amoxicilina and is not recommended.
• If you are taking anticoagulants (such as warfarin) with amoxicilina, you may need to have more blood tests.
• If you are taking other antibiotics (such as tetracycline), amoxicilina 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

Amoxicilina may cause 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.

amoxicilina cinfa contains sucrose and glucose

This medicine contains sucrose and glucose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine. It may cause tooth decay.

amoxicilina cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per sachet, which is essentially “sodium-free”.

3. How to take amoxicilina cinfa

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. If you are unsure, 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 out the doses evenly during the day, at least 4 hours apart.

The usual dose is:

Children under 40 kg body weight

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

• Your doctor will tell you how much amoxicilina 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 body weight

The usual dose of amoxicilina 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 - pink or red circular 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 amoxicilina cinfa than you should

If you have taken more amoxicilina 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 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

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

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

If you take amoxicilina 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 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 amoxicilina and see a doctor immediately if you get 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 red 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 appear 7 to 12 days after taking amoxicilina, 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-purple spots with itching on the skin, especially on the palms of the hands or soles of the feet, swollen areas with a raised edge on the 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 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 that occurs during treatment with amoxicilina 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 get less serious skin reactions such as:

• a moderate rash with itching (round pink-red spots), swollen areas with a blister-like appearance on the skin of the forearms, legs, palms, hands, or feet. This is uncommon (may affect up to 1 in 100 people).

If you get any of these, talk to your doctor as you will need to stop your treatment with amoxicilina.

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 (a yeast infection of the vagina, mouth, or skin folds), you can get treatment for thrush from your doctor or pharmacist
• kidney problems
• seizures (convulsions), seen in patients treated with high doses or with kidney problems
• dizziness
• hyperactivity
• discoloration of the teeth, which usually goes away with brushing (this has been reported in children)
• the tongue may change color to yellow, brown, or black and may have a hairy appearance
• a severe 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 platelet count
• the blood may take longer than normal to clot. You may notice this if you have a nosebleed or cut yourself.

Frequency 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 who receive amoxicilina. 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 can appear as cloudy urine or difficulty or discomfort urinating. Make sure to drink plenty of fluids to reduce the chance of these symptoms.
• A skin eruption with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).
• Inflammation of the membranes that surround 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 to the Spanish Medicines Agency: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing amoxicilina cinfa

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.

Store at room temperature.

Do not use this medicine if you notice visible signs of deterioration.

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 to protect the environment.

6. Container Content and Additional Information

Composition of Amoxicilina Cinfa

• The active ingredient is amoxicillin. Each sachet contains amoxicillin trihydrate, equivalent to 1000 mg (1 g) of amoxicillin.
• The other components are: anhydrous trisodium citrate, sodium lauryl sulfate, titanium dioxide (E-171), raspberry flavor (contains glucose and corn starch), anhydrous colloidal silica, talc, and sucrose.

Appearance of the Product and Container Content

Amoxicilina Cinfa 1000 mg powder for oral suspension in sachets contains a homogeneous white oral suspension powder.

Each container contains 20, 30, or 500 (clinical container) sachets.

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 about 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/64117/P_64117.html

QR code at: https://cima.aemps.es/cima/dochtml/p/64117/P_64117.html