Leaflet: information for the user

amoxicillin/clavulanic acid cinfa 875 mg/125 mg powder for oral suspension in EFG sachets

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

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

• Middle ear and nasal sinus infections.
• Respiratory tract infections.
• Urinary tract infections.
• Skin and soft tissue infections, including dental infections.
• Bone and joint infections.

Do not take amoxicillin/clavulanic acid cinfa:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (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 amoxicillin/clavulanic acid if you are included in any of the above points. Before starting treatment with amoxicillin/clavulanic acid, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amoxicillin/clavulanic acid cinfa 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 amoxicillin/clavulanic acid.

Your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different presentation of amoxicillin/clavulanic acid or another medicine.

Be aware of the following symptoms

Amoxicillin/clavulanic acid may worsen existing conditions or cause severe side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of the following symptoms while taking amoxicillin/clavulanic acid to reduce the risk of problems. See “Be aware of the following symptoms” in section 4.

Blood and urine tests

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

Other medicines and amoxicillin/clavulanic acid cinfa

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

If you are taking allopurinol (used for gout) with amoxicillin/clavulanic acid, you may be more likely to suffer a skin allergic reaction.

If you are taking probenecid (used to treat gout), the concurrent use of probenecid may reduce the excretion of amoxicillin and is not recommended

If you are taking anticoagulants (such as warfarin) with amoxicillin/clavulanic acid, more blood tests will be needed.

Amoxicillin/clavulanic acid may affect the action of 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.

Amoxicillin/clavulanic acid may affect how micophenolate mofetil (a medicine 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 medicine.

Driving and operating machinery

Amoxicillin/clavulanic acid may cause side effects and symptoms that may make you unable to drive. Do not drive or operate machinery unless you feel well.

amoxicillin/ ácido clavulánico cinfa contains aspartame (E-951).

This medicine contains 12.50 mg of aspartame in each sachet.

Aspartame contains a source of phenylalanine that may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

amoxicillin/ ácido clavulánico cinfa contains glucose.

This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

amoxicillin/ ácido clavulánico cinfa contains saccharose.

This medicine contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

• Recommended dose - 1 tablet administered twice a day.
• Higher dose - 1 tablet administered three times a day.

Children under 40 kg of weight

Amoxicillin/clavulanate 875 mg/125 mg oral powder for suspension in sachets is not recommended.

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/clavulanate cinfa

• Just before taking amoxicillin/clavulanate, open the sachet and mix the contents in half a glass of water.
• Take it at the beginning of meals or a little earlier.
• Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take amoxicillin/clavulanate for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more amoxicillin/clavulanate cinfa than you should

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

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 forget to take amoxicillin/clavulanate 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 the missed doses.

If you interrupt the treatment with amoxicillin/clavulanate cinfa

Continue taking amoxicillin/clavulanate until you complete the treatment, even if you feel better. You need to take the full 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 questions 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. The side effects described below may occur when taking this medicine.

Symptoms to be aware of

Allergic reactions:

•Skin rash.

•Swelling 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 glands in the neck, armpits, or groin.

•Swelling, sometimes of the face or throat (angioedema), which causes difficulty breathing.

•Collapsing.

• Contact your doctor immediatelyif you experience any of these symptoms.Stop takingamoxicillin/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, takeamoxicillin/clavulanic acidbefore meals.

•Vomiting.

•Diarrhea (in children).

Uncommon side effects(may affect up to 1 in 100 patients):

•Skin rash, itching.

•Increased pruritic rash (urticarial hives).

•Indigestion.

•Dizziness.

•Headache.

Side effects that may appear in blood tests:

•Increased levels of certain 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 resemble small darts (erythema multiforme).

• If you experience 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 count of white blood cells.

Unknown frequency(cannot be estimated from available data):

•Allergic reactions (see above).

•Colitis (see above).

•Meningitis (inflammation of the protective membrane surrounding the brain).

•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 bumps under the skin and blisters (pustular exanthema).

-Symptoms similar to the flu, with skin rash, fever, swollen glands, and abnormal blood test results (such as increased eosinophils (eosinophilia) 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 as a string of pearls (IgA linear disease).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
• Acute pancreatitis.

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

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

•Liver inflammation (hepatitis).

•Icterus, caused by increased bilirubin in the blood (a substance produced by the liver) that may turn the skin and white of the eyes yellow.

•Renal duct inflammation.

•Coagulation disorder.

•Hypervigilance.

•Seizures (in patients taking high doses of amoxicillin/clavulanic acid or with renal problems).

•Black tongue that appears hairy.

•Stained teeth (in children), which usually disappears with brushing.

Side effects that may appear in blood or urine tests:

•Significant reduction in the number of white blood cells.

•Low count of red blood cells (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 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. Store in the original packaging to protect it from moisture.

Do not use this medication if you observe that the packets are torn or damaged.

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 pointat 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/clavulanic acid cinfa

• The active principles are amoxicillin and clavulanic acid. Each sachet contains 875 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).
• The other components (excipients) are: aspartame (E-951) and orange aroma (contains corn-derived glucose, sucrose, and cornstarch).

Appearance of the product and contents of the packaging

White to off-white powder.

It is presented in single-dose sachets of Paper/Alu/Thermofused resin laminate, in packaging of 20, 30, or 500 (clinical packaging) sachets with powder for oral suspension.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Cinfa Laboratories, S.A.

Olaz-Chipi Highway, 10. Areta Industrial Estate

31620 Huarte (Navarra)–Spain

Responsible manufacturer:

LABORATORIOS REIG JOFRÉ, S.A.

Jarama Street, 111.Industrial Park

45007 Toledo

Spain

Last review date of this leaflet: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/66567/P_66567.html

QR code to:https://cima.aemps.es/cima/dochtml/p/66567/P_66567.html