Amoxicillin/clavulanic acid Cinfa 250 mg/62.5 mg powder for oral suspension in sachets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

amoxicillin/clavulanic acid cinfa 250 mg/62.5 mg powder for oral suspension in sachets EFG

Read the entire 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 infants or children and should not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What amoxicillin/clavulanic acid cinfa is and what it is 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. How to store amoxicillin/clavulanic acid cinfa
6. Contents of the pack and other information

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

amoxicillin/clavulanic acid cinfa is an antibiotic that kills bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a 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 ingredients of this medicine (listed in section 6)
• if you have ever had a serious 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) while taking an antibiotic.

Do not take amoxicillin/clavulanic acid if any of the above apply to you. Before starting treatment with amoxicillin/clavulanic acid, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before starting your child on amoxicillin/clavulanic acid cinfa if:

• your child has infectious mononucleosis
• your child is receiving treatment for liver or kidney problems
• your child does not urinate regularly.

If you are unsure whether any of the above conditions apply, 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 be given a different formulation of amoxicillin/clavulanic acid or another medicine.

Symptoms to watch for

Amoxicillin/clavulanic acid may worsen certain existing conditions or cause serious adverse 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 complications. See “Symptoms to watch for” in section 4.

Blood and urine tests

If your child is undergoing blood tests (such as tests to assess red blood cells or liver function) or urine tests (to monitor glucose levels), inform your doctor or nurse that your child is taking amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid may alter the results of these tests.

Other medicines and amoxicillin/clavulanic acid cinfa

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

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

If your child is taking probenecid (used to treat gout), concomitant use with amoxicillin/clavulanic acid 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 methotrexate excretion and increase the potential for adverse 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 her 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 diagnosed your child with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take amoxicillin/clavulanic acid cinfa

Follow exactly the instructions given by your doctor or pharmacist for administering this medicine. If in 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. Please seek advice from your doctor or pharmacist.

Children weighing less than 40 kg

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

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

Patients with kidney or liver problems

• If your child has kidney problems, the dose may be reduced. Your doctor may choose a different formulation or another medicine.
• If your child has liver problems, blood tests will be performed more frequently to monitor liver function.

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 shortly before meals.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not administer amoxicillin/clavulanic acid to your child for longer than 2 weeks. If your child still feels unwell, you must see the 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. Contact your doctor as soon as possible. Take the packaging along to show the doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the name of 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 the next dose too soon; wait at least 4 hours before administering the next dose.

If you interrupt treatment with amoxicillin/clavulanic acid cinfa

Continue giving your child amoxicillin/clavulanic acid until the full course is completed, even if they feel better. Your child needs to complete the full course to help fight the infection. If bacteria survive, the infection may return.

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

Symptoms to watch for

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may 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), causing difficulty breathing
• collapse

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

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

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

Very common adverse effects

May affect more than 1 in 10 patients

• diarrhoea (in adults)

Common adverse 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 occurs, take amoxicillin/clavulanic acid before meals

• vomiting
• diarrhoea (in children)

Uncommon adverse effects

May affect up to 1 in 100 patients

• skin rash, itching
• increased itchy rash (urticarial wheal )
• indigestion
• dizziness
• headache

Uncommon adverse effects that may appear in blood tests:

• Increase in certain substances (enzymes) produced by the liver

Rare adverse effects

May affect up to 1 in 1,000 patients

• skin rash that may blister and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme )
• if you have any of these symptoms, consult your doctor urgently

Rare adverse effects that may appear in blood tests:

• low count of 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 protective membrane surrounding the brain (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 skin peeling (more than 30% of body surface – toxic epidermal necrolysis )

• widespread rash with small pus-filled blisters (exfoliative bullous dermatitis )

• exfoliative red 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 cells (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 an allergic-triggered heart attack (Kounis syndrome).

• Drug-induced enterocolitis syndrome (DIES):

DIES has been reported mainly in children receiving amoxicillin. It is a 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, diarrhoea, and low blood pressure.

• Crystals in the urine causing acute kidney injury.
• Rash with blistering arranged in a ring-shaped pattern with a central crust or resembling a string of pearls (linear IgA disease).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
• Acute inflammation of the pancreas (acute pancreatitis)

If you have severe and persistent pain in the stomach area, 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 increased bilirubin in the blood (a substance produced by the liver), which may cause the skin and whites of the eyes to turn yellowish

• inflammation of the kidney ducts

• delayed blood clotting

• hyperactivity

• seizures (in patients taking high doses of amoxicillin/clavulanic acid or who have kidney problems)

• black, hairy-looking tongue

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

Adverse effects that may appear in blood or urine tests:

• significant decrease in white blood cell count
• low red blood cell count (haemolytic anaemia )
• crystals in the urine

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 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 refers to the last day of the month indicated.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of 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/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 components (excipients) are: silicon dioxide, sucrose, lemon flavour (contains glucose in maltodextrin derived from maize) and strawberry flavour (contains glucose in maltodextrin derived from maize).

Appearance of the product and contents of the pack

Almost white powder.

Packs of 30 and 500 (clinical pack) 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 the most recent revision of this leaflet: April 2023.

Detailed 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/66565/P_66565.html

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