Leaflet: information for the user

amoxicillin/clavulanic acid cinfa 250 mg/62.5 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 is usually prescribed for babies or children and should not be given to other people, even if they have the same symptoms, 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” which can sometimes lose its effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from happening.

amoxicilina/ácido clavulánico cinfa is used in 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:

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 administer amoxicillin/clavulanic acid cinfa to your child if:

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

If you are unsure whether any of the above symptoms affect your child, inform your doctor or pharmacist before taking amoxicillin/clavulanic acid.

In some cases, your doctor may investigate the type of bacteria causing your child's infection. Depending on the results, your child may receive 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 certain symptoms while your child is 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 your child is having blood tests (such as studies of red blood cell status or studies to check liver function) or urine tests (to control glucose levels), inform your doctor or nurse that they are taking amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid may alter the results of these types of tests.

Other medicines and amoxicillin/clavulanic acid cinfa

Inform your doctor or pharmacist if your child is taking, has taken recently, or may need to take any other medicine.

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

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

If anticoagulants (such as warfarin) are taken 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 your daughter is taking this medicine and is pregnant or breastfeeding, inform your doctor or pharmacist.

Consult your doctor or pharmacist before using any medicine.

amoxicillin/clavulanic acid cinfa contains saccharose

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

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

Adults and children weighing 40 kg or more

• These sachets are not normally recommended for adults and children weighing 40 kg or more. Ask your doctor or pharmacist for advice.

Children weighing less than 40 kg

All doses are expressed in relation to the child's body weight in kilograms.

• Your doctor will advise you how much amoxicillin/clavulanic acid to give to your baby or child.
• The usual dose is 20 mg/5 mg to 60 mg/15 mg per kilogram of body weight and day, administered in three divided doses.

Patients with kidney and liver problems

• If your child has kidney problems, the dose may be reduced. Your doctor may choose a different presentation or another medication.
• If your child has liver problems, blood tests will be performed more frequently to check how the liver is functioning.

How to administer amoxicillin/clavulanic acid cinfa

• Just before administering amoxicillin/clavulanic acid, open the sachet and mix the contents in half a glass of water
• Administer 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 administer amoxicillin/clavulanic acid to your child for more than 2 weeks. If your child continues to feel unwell, they should return to see the doctor.

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

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

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

If you forget to take amoxicillin/clavulanic acid cinfa

If you forget to administer a dose to your child, give it as soon as you remember. Do not give your child the next dose too soon, wait at least 4 hours before giving the next dose.

If you interrupt the treatment with amoxicillin/clavulanic acid cinfa

Continue administering amoxicillin/clavulanic acid to your child until the treatment is completed, even if they feel better. Your child needs to take the complete treatment to help fight the infection. If the bacteria survive, the infection will return.

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. The side effects described below may occur when taking this medicine.

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 glands in the neck, axilla, or groin
• swelling, sometimes of the face or throat (angioedema), which causes difficulty breathing
• collapse.

→Contact a doctor immediately if your child experiences any of these symptoms.Stop administering amoxicillin/clavulanic acid.

Colitis:

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

→Contact your doctor immediately if your child experiences 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 before 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:

• 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 appear as 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 white blood cell count

Unknown frequency

Cannot be estimated from available data.

• Allergic reactions (see above).
• Colitis (see above).
• Menigitis aséptica (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 exfoliative rash, with lumps 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 leukocytes (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 (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 pearl necklace (IgA linear disease).
• Menigitis aséptica (inflammation of the protective membrane surrounding the brain and spinal cord).
• Acute pancreatitis (inflammation of the pancreas)

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

• Contact a doctor immediately if your child experiences any of these symptoms.

• hepatitis (inflammation of the liver)
• 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 appears hairy
• stained teeth (in children), which usually disappears with brushing.

Side effects that may appear in blood or urine tests:

• significantly reduced white blood cell count
• 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 prospectus. You can also report them directly through the Spanish System for the Vigilance 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.

Do not use this medication if you observe that the blisters are broken or damaged.

This medication does not require special storage conditions. Store in the original packaging to protect it from moisture.

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. In case of 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 ofamoxicillin/clavulanic acid cinfa

• The active principles are amoxicillin and clavulanic acid. Each sachet contains 250 mg of amoxicillin (as amoxicillin trihydrate) and 62.5 mg of clavulanic acid (as potassium clavulanate).

• The other components (excipients) are: silicon dioxide, sucrose, lemon flavoring (contains glucose in maltodextrin from corn)and strawberry flavoring (contains glucose in maltodextrin from corn).

Appearance of the product and contents of the packaging

Almost white powder.

Pouches of 30 and 500 (clinical packaging) sachets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

LABORATORIOS REIG JOFRÉ, S.A.

Jarama 111, Industrial Estate

45007 Toledo

Date of the last review of this leaflet:April 2023.

The detailed information on this medicine 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 on this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66565/P_66565.html

QR code to:https://cima.aemps.es/cima/dochtml/p/66565/P_66565.html