Leaflet: information for the user

amoxicillin/clavulanic acid cinfamed 500 mg/125 mg film-coated tablets EFG

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 only, and you must not give it 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.

amoxicilina/ácido clavulánico cinfamed is an antibiotic that eliminates the bacteria that cause infections. It contains two different medications called amoxicilina and acid clavulanic. Amoxicilina belongs to a group of medications known as "penicillins" that sometimes may lose its effectiveness (become inactivated). The other component (acid clavulanic) prevents this from happening.

Amoxicilina/ácido clavulánico is used in adults and children to treat the following infections:

Do not take amoxicilina/ácido clavulánico cinfamed:

• if you are allergic to amoxicilina, ácido clavulánico, penicilinas, or any of the other components of this medication (listed in section 6)
• if you have ever had a severe allergic reaction to any other antibiotic. This could include skin rash or swelling of the face or throat
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

• Do not take amoxicilina/ácido clavulánico if you fall under any of the above points.Before starting treatment with amoxicilina/ácido clavulánico if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amoxicilina/ácido clavulánico cinfamed if:

• you have infectious mononucleosis
• you are receiving treatment for liver or kidney problems
• you do not urinate regularly.

If you are unsure whether any of the above symptoms affect you, inform your doctor or pharmacist before taking amoxicilina/ácido clavulánico.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different presentation of amoxicilina/ácido clavulánico or another medication.

Symptoms to be aware of

Amoxicilina/ácido clavulánico may worsen existing conditions or cause severe side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of certain symptoms while taking amoxicilina/ácido clavulánico to reduce the risk of problems. See “Symptoms to be aware of” in section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are taking amoxicilina/ácido clavulánico. This is because amoxicilina/ácido clavulánico may alter the results of these types of tests.

Other medications and amoxicilina/ácido clavulánico cinfamed

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

If you are taking allopurinol (used for gout) with amoxicilina/ácido clavulánico, you may be more likely to suffer 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/ácido clavulánico, more blood tests will be needed.

Amoxicilina/ácido clavulánico may affect the action of methotrexate (a medication used to treat cancer and severe psoriasis), penicilinas may reduce the excretion of methotrexate and cause a potential increase in side effects.

Amoxicilina/ácido clavulánico may affect how micofenolato de mofetilo (a medication used to prevent organ rejection in transplant patients) works.

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/ácido clavulánico may cause side effects and symptoms that may make you unable to drive.

Do not drive or operate machinery unless you feel well.

amoxicilina/ácido clavulánico cinfamed contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

Adults and children 40 kg or more

The recommended dose is 1 tablet three times a day.

Children under 40 kg of weight

It is preferable to treat children 6 years or less with oral suspension of amoxicillin/clavulanic acid or the sachets.

Ask your doctor or pharmacist for advice when administering amoxicillin/clavulanic acid tablets to children weighing less than 40 kg. Tablets are not suitable for children weighing less than 25 kg.

Patients with kidney and liver problems

• If you have kidney problems, your dose may be changed. Your doctor may choose a different presentation or another medication.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How to take amoxicillin/clavulanic acid cinfamed

• Take with meals.
• Swallow the tablets whole with a glass of water.
• The groove is only for breaking the tablet if it is difficult to swallow whole. You should take the two parts of the tablet at the same time.
• Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take amoxicillin/clavulanic acid for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more amoxicillin/clavulanic acid cinfamed than you should

If you take too much amoxicillin/clavulanic acid, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible. Bring the packaging with you to show your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take amoxicillin/clavulanic acid cinfamed

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 the missed doses.

If you interrupt the treatment withamoxicillin/clavulanic acid cinfamed

Continue taking amoxicillin/clavulanic acid until you complete the treatment, even if you feel better. You need to take the complete treatment to cure the infection. If you do not, the surviving bacteria may cause you to get the infection again.

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.

Symptoms to be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) that may appear as red or purple spots on the skin, but can affect other parts of the body
• fever, joint pain, swollen lymph nodes in the neck, armpits, or groin
• swelling, sometimes of the face or throat (angioedema), which causes difficulty breathing
• collapse.

• Contact your doctor immediatelyif you experience any of these symptoms.Stop taking amoxicillin/clavulanic acid.

Colitis:

Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

• Contact your doctor immediatelyif you experience any of these symptoms.

Very common side effects

May affect more than 1 in 10 patients

• diarrhea (in adults).

Common side effects

May affect up to 1 in 10 patients

• thrush (Candida– fungal infection of the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses

• if this happens, take amoxicillin/clavulanic acid with meals

• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 patients

• skin rash, itching
• increased pruritic rash (urticarial rash)
• indigestion
• dizziness
• headache.

Side effects that may appear in blood tests:

• increase in some substances (enzymes) produced by the liver.

Rare side effects

May affect up to 1 in 1,000 patients

• skin rash, which may form blisters that look like small darts (erythema multiforme).

• If you have any of these symptoms, consult your doctor urgently.

Side effects that may appear in blood tests:

• low count of cells involved in blood clotting
• low white blood cell count.

Unknown frequency

Cannot be estimated from available data.

• allergic reactions (see above)
• colitis (see above)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• severe skin reactions:

• generalized rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread peeling of the skin (more than 30% of the body surface –toxic epidermal necrolysis)
• generalized rash with small blisters with pus (exfoliative bullous dermatitis)
• red rash, with lumps under the skin and blisters (pustular exanthema)
• flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

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

DIES has been reported mainly in children taking 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.
• Rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease).
• Acute pancreatitis

If you have intense and persistent pain in the stomach area, this could be a sign of acute pancreatitis.

• Contact a doctor immediately if you experience any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that may turn the skin and white of the eyes yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of amoxicillin/clavulanic acid or with kidney problems)
• black tongue that looks hairy.

Side effects that may appear in blood or urine tests:

• significant reduction in the number of white blood cells
• low red blood cell count (hemolytic anemia)
• crystals in the urine.

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 Vigilance of Medicinal Products 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.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light and humidity.

Medications should not be disposed of through drains or in the trash. Deposit 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. In this way, you will help protect the environment.

Composition of amoxicillin/clavulanic acid cinfamed

• The active principles are amoxicillin and clavulanic acid. Each film-coated tablet contains 500 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).
• The other components (excipients) are:

Core: anhydrous colloidal silica, magnesium stearate, sodium carboxymethylcellulose from potato (type A), and microcrystalline cellulose.

Coating: Opadry Oy-S-7300 (contains 5 cps of hypromellose (E-464), 15 cps of hypromellose (E-464), macrogol 4000 (E-1521), macrogol 6000 (E-1521), titanium dioxide (E-171)), dimethicone 500, and purified water.

Appearance of the product and contents of the packaging

Long, white, scored tablets with inscription A/C.

It is presented in Alu/Alu-poliamida-PVC blisters, and is available in packaging of 20 or 30 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A

Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible manufacturer

REIG JOFRE, S.A Laboratory

Jarama 111 Street.Industrial Park

45007 Toledo - Spain

Last review date of thisleaflet:April 2023

Detailed information about this medication 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 about this medication 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/66765/P_66765.html

QR code to:https://cima.aemps.es/cima/dochtml/p/66765/P_66765.html