AMOXICILLIN CINFA 500 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

amoxicilina cinfa 500 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is amoxicilina cinfa and what is it used for
2. What you need to know before you take amoxicilina cinfa
3. How to take amoxicilina cinfa
4. Possible side effects
5. Storage of amoxicilina cinfa
6. Contents of the pack and other information

1. What is amoxicilina cinfa and what is it used for

What is amoxicilina cinfa

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

What amoxicilina cinfa is used for

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

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 skin 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 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 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 suffer a skin allergic reaction.
• If you are taking probenecid (used to treat gout), 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 needed.
• 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 adverse 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.

3. How to take amoxicilina cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

• Swallow the capsules with water, without opening them.
• Space the doses evenly throughout the day, at least 4 hours apart.

The recommended 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 recommended 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 recommended 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 - circular pink or red rash): 4 g per day; systemic manifestations (late stage - with more severe symptoms or when the disease spreads throughout your 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 difficulty urinating. Talk to your doctor as soon as possible. Take 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 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 amoxicilina 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 can cause the infection to come back.
• Once you have finished treatment, if you are still feeling 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 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 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 amoxicilina and see a doctor immediately if you get 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 serious and, in some cases, have been fatal
• rash on the skin or small, flat, round, red spots under the skin surface or bruising on 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 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 spots with itching on the skin, especially on the palms of the hands or soles of the feet, swollen areas with a blister-like appearance on the skin, soft tissues on the surface of the mouth, eyes, or genitals. You may have fever and be 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 treatment, males, and the elderly. You should tell your doctor immediately if you:
• • have severe diarrhea with bleeding
  • have blisters, redness, or bruising on the skin
  • have dark urine or pale stools
  • have 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 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 have 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 (fungal infection of 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
• your tongue may change color to yellow, brown, or black and may have a hairy appearance
• a severe breakdown of red blood cells that causes 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
• your blood may take longer than normal to clot. You may notice this if you have nosebleeds or if you 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 myocardial infarction (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES):

DIES has been reported mainly in children receiving 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 when urinating. Make sure to drink plenty of fluids to reduce the possibility 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 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 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 refers to the last day of the month stated.

Store below 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicilina Cinfa

• The active ingredient is amoxicillin. Each capsule contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin.
• The other components are: magnesium stearate (E-470b) and anhydrous colloidal silica.
• The gelatin capsule is composed of: gelatin, red iron oxide (E-172), yellow iron oxide (E-172), titanium dioxide (E-171), and erythrosine (E-127).

Appearance of the Product and Container Content

Containers containing 20 or 30 hard capsules with a red cap and yellow body of amoxicillin (trihydrate) in a PVC-PVDC/aluminum blister pack.

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 Leaflet: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 leaflet 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/62586/P_62586.html

QR code at: https://cima.aemps.es/cima/dochtml/p/62586/P_62586.html