AMOXICILLIN/CLAVULANIC ACID CINFA 250 mg / 62.5 mg ORAL SUSPENSION POWDER IN SACHETS

Introduction

Package Leaflet: Information for the User

amoxicillin/clavulanic acid cinfa 250 mg/62.5 mg powder for oral suspension in sachets 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 is prescribed to babies or children and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, contact your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is amoxicillin/clavulanic acid cinfa and what is it used for
2. What you need to know before taking amoxicillin/clavulanic acid cinfa
3. How to take amoxicillin/clavulanic acid cinfa
4. Possible side effects
5. Storage of amoxicillin/clavulanic acid cinfa
6. Contents of the pack and further information

1. What is amoxicillin/clavulanic acid cinfa and what is it used for

amoxicillin/clavulanic acid cinfa is an antibiotic that eliminates the bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to the group of medicines known as "penicillins" which can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

amoxicillin/clavulanic acid cinfa is used in children to treat the following infections:

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

2. What you need to know before taking amoxicillin/clavulanic acid cinfa

Do not take amoxicillin/clavulanic acid cinfa:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other components of this medicine (listed in section 6)
• if you have ever had a severe allergic reaction to any other antibiotic. This could include a 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 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 that causes your child's infection. Depending on the results, your child may receive a different presentation of amoxicillin/clavulanic acid or another medicine.

Symptoms to be aware of

Amoxicillin/clavulanic acid can worsen certain existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while your child is taking amoxicillin/clavulanic acid to reduce the risk of problems. See "Symptoms to be aware of" in section 4.

Blood and urine tests

If your child is having blood tests (such as red blood cell status or liver function tests) or urine tests (to check glucose levels), inform your doctor or nurse that they are taking amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid can alter the results of these types of tests.

Other medicines and amoxicillin/clavulanic acid cinfa

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.

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), concomitant 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 mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy and breastfeeding

If your daughter is going to take 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 sucrose

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

3. How to take amoxicillin/clavulanic acid cinfa

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

Adults and children over 40 kg

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

Children under 40 kg

All doses are expressed based on 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 per 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 medicine.
• If your child has liver problems, they will have more frequent blood tests to check how their liver is working.

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 start of meals or a while before
• Space out the doses during 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 is still unwell, they should see a doctor again.

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

If you give your child too much amoxicillin/clavulanic acid, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Consult your doctor as soon as possible. Take the package to show the doctor.

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

If you forget to take amoxicillin/clavulanic acid cinfa

If you forget to give your child a dose, 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 stop taking amoxicillin/clavulanic acid cinfa

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 can 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 can cause difficulty breathing
• collapse.

→Contact a doctor immediatelyif your child experiences any of these symptoms. Stop giving amoxicillin/clavulanic acid.

Inflammation of the large intestine

Inflammation of the large intestine, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

→Contact your doctor immediatelyif 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 in 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 itchy rash (urticarial rash)
• indigestion
• dizziness
• headache.

Uncommon 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 can form blisters that look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme)

Rare side effects that may appear in blood tests:

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

Frequency not known

Cannot be estimated from the available data.

• Allergic reactions (see above).
• Inflammation of the large intestine (see above).
• Inflammation of the membrane that surrounds the brain and spinal cord (aseptic meningitis).
• Severe skin reactions:

• widespread 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)
• widespread rash with small blisters containing pus (bullous exfoliative dermatitis)
• red, exfoliative rash with bumps under the skin and blisters (pustular exanthematous eruption)
• flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as increased white blood cell count and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

• Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced 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 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.
• Rash 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).
• Acute inflammation of the pancreas (acute pancreatitis)

If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.

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

• inflammation of the liver (hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that can make the skin and the whites of the eyes turn yellow
• inflammation of the kidney ducts
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of amoxicillin/clavulanic acid or with kidney problems)
• black, hairy tongue
• 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 red blood cell count (hemolytic anemia)
• crystals in the urine.

Reporting of side effects

If you experience any side effects, contact your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of amoxicillin/clavulanic acid cinfa

Keep this medicine out of the 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.

Do not use this medicine if you notice that the sachets are broken or damaged.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine at the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of amoxicillin/clavulanic acid cinfa

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

Appearance and packaging

Almost white powder.

Packaging of 30 and 500 (clinical packaging) sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

LABORATORIOS REIG JOFRÉ, S.A.

Jarama 111, Poligono Industrial

45007 Toledo

Date of last revision of this leaflet:April 2023.

Detailed information about this medicine 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 medicine 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/66565/P_66565.html

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