Amoxicillin CINFA 500 mg hard capsules EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What amoxicilina cinfa is

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

What amoxicillin cinfa is used for

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

2. What you need to know before taking amoxicillin cinfa

Do not take amoxicillin 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 amoxicillin if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking amoxicillin cinfa.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take amoxicillin 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 unsure whether any of the above conditions apply to you, inform your doctor or pharmacist before taking amoxicillin.

Blood and urine tests

If you are undergoing:

• urine tests (urine glucose) or blood tests for liver function
• estriol tests (used during pregnancy to check whether the baby is developing normally),

inform your doctor or pharmacist that you are taking amoxicillin. This is because amoxicillin may alter the results of these types of tests.

Other medicines and amoxicillin cinfa

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

• 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 with 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 needed.
• If you are taking other antibiotics (such as tetracycline), amoxicillin 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 potentially increase adverse effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Amoxicillin may cause adverse effects, and symptoms (such as allergic reactions, dizziness, and seizures) may mean you should not drive.

Do not drive or operate machinery unless you feel well.

3. How to take amoxicilina cinfa

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

• 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 weighing less than 40 kg

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

• Your doctor will tell you how much amoxicillin to give 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 weighing 40 kg 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 infection: 3 g twice a day for one day.
• Lyme disease (an infection caused by parasites called ticks): isolated erythema migrans (early stage – single pink or red circular rash): 4 g per day; systemic manifestations (late stage – 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 1 g twice a day for 7 days, in combination with other antibiotics and medications for treating 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 further 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, symptoms may include stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which may appear as cloudy urine or difficulty urinating. Contact your doctor as soon as possible. Take the medicine with you to show it.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 a missed dose.

How long should you take amoxicilina cinfa

• Continue taking amoxicillin for as long as your doctor has instructed, even if you feel better. You need to take all the doses to fully eliminate the infection. If some bacteria survive, the infection may return.
• If you still feel unwell after completing the treatment, you should see your doctor again.

Candidiasis (a fungal infection affecting moist areas of the body that may cause pain, itching, and white discharge) may occur if amoxicillin is taken 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking amoxicillin and see a doctor immediately if you experience any of the following serious adverse effects – you may need urgent medical treatment:

The following adverse effects are very rare (may affect up to 1 in 10,000 people):

• allergic reactions, signs may include: skin itching or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These can be severe and, in some cases, have resulted in death
• skin rash or flat, round red spots like pinpricks under the skin surface, or bruising on the skin. This is due to inflammation of the walls of blood vessels caused by 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 swollen lymph nodes, especially under the arms
• a skin reaction called ‘erythema multiforme’ in which you may develop: purple or reddish itchy skin lesions, especially on the palms of the hands or soles of the feet, raised swollen areas on the skin, soft tissue lesions on the mouth, eyes, and genitals. You may also have fever and feel very tired
• other serious skin reactions may include: change in skin color, lumps under the skin, blisters, pus-filled pimples, peeling, redness, pain, itching. These may be associated with fever, headache, and body aches
• flu-like symptoms with skin rash, fever, swollen glands, 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 occurring during amoxicillin treatment for Lyme disease, causing fever, chills, headache, muscle pain, and skin rash
• inflammation of the large intestine (colon) with diarrhea (sometimes with blood), abdominal pain, and fever
• serious adverse effects in the liver may occur. These are mainly associated with patients on prolonged treatment, males, and advanced age. You should inform your doctor immediately if you experience:
  • severe diarrhea with bleeding
  • blisters, redness, or bruising on the skin
  • dark urine or pale stools
  • yellowing of the skin and whites of the eyes (jaundice). See also anemia below, which may lead to jaundice.

These may occur during treatment or up to several weeks afterwards.

If any of the above symptoms occur, stop taking the medicine and see your doctor immediately.

Sometimes you may experience less severe skin reactions such as:

• a moderate itchy rash (round pink-red spots), swollen areas resembling blisters on forearms, legs, palms, hands, or feet. This is uncommon (may affect up to 1 in 100 people).

If you have any of these, speak with your doctor as you will need to discontinue your amoxicillin treatment.

Other possible adverse 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)

• candidiasis (fungal infection in the vagina, mouth, or skin folds); treatment can be obtained from your doctor or pharmacist for candidiasis
• kidney problems
• epileptic seizures (convulsions), observed in patients treated with high doses or with kidney problems
• dizziness
• hyperactivity
• the tongue may change color to yellow, brown, or black and may appear hairy
• excessive breakdown of red blood cells causing a type of anemia. Signs include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and whites of the eyes
• low number of white blood cells
• low number of cells involved in blood clotting
• blood may take longer than normal to clot. You may notice this if you have nosebleeds or bleeding from cuts

Frequency not known (cannot be estimated from available data)

• Chest pain in the context of allergic reactions, which may be a symptom of allergy-triggered 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 being 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 causing acute kidney injury, which may appear as cloudy urine or difficulty or discomfort when urinating. Make sure to drink plenty of fluids to reduce the likelihood of these symptoms.
• Blistering rash arranged in circles with central crusts or resembling a string of pearls (linear IgA disease).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of amoxicilina cinfa

Keep this medicine out of sight and reach of children.

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

Store below 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of amoxicillin cinfa

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

Appearance of the medicine and contents of the pack

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

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 most recent revision of this leaflet: May 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62586/P_62586.html

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