Amoxicillin/clavulanic acid CINFA 500 mg/125 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 500 mg/125 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; you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because 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.

Leaflet contents

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 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.

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 cinfa if any of the above apply to you. Before starting treatment with amoxicillin/clavulanic acid cinfa, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 conditions apply to you, inform your doctor or pharmacist before taking amoxicillin/clavulanic acid cinfa.

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

Symptoms to watch for

Amoxicillin/clavulanic acid cinfa 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 taking amoxicillin/clavulanic acid cinfa to reduce the risk of complications. See "Symptoms to watch for" in section 4.

Blood and urine tests

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

Other medicines and amoxicillin/clavulanic acid cinfa

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

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

If you are taking probenecid (used to treat gout), concomitant use with amoxicillin/clavulanic acid cinfa may reduce the excretion of amoxicillin and is not recommended.

If anticoagulants (such as warfarin) are taken with amoxicillin/clavulanic acid cinfa, additional blood tests will be required.

Amoxicillin/clavulanic acid cinfa may affect the action of methotrexate (a medicine used to treat cancer and severe psoriasis); penicillins may reduce methotrexate excretion and potentially increase adverse effects.

Amoxicillin/clavulanic acid cinfa may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Amoxicillin/clavulanic acid cinfa may cause adverse effects, and symptoms may affect your ability to drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin/clavulanic acid cinfa contains sucrose

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

3. How to take amoxicillin/clavulanic acid cinfa

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

The recommended dose is:

• 1 sachet taken three times a day

Children weighing less than 40 kg

Amoxicillin/clavulanic acid 500 mg/125 mg sachets are not recommended.

Patients with kidney or liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor how your liver is functioning.

How to take amoxicillin/clavulanic acid cinfa

• Just before taking amoxicillin/clavulanic acid, open the sachet and mix the contents in half a glass of water.
• Take it at the beginning of meals or shortly before eating.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take amoxicillin/clavulanic acid for longer than 2 weeks. If you still feel unwell, consult your doctor.

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

If you take too much amoxicillin/clavulanic acid, symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible. Take the packaging with you to show your doctor.

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

If you forget to take amoxicillin/clavulanic acid 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 forgotten doses.

If you stop taking amoxicillin/clavulanic acid cinfa

Continue taking amoxicillin/clavulanic acid until the end of the treatment, even if you feel better. You need to complete the full course to cure the infection. If you do not, surviving bacteria may cause the infection to 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 listed 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 your doctor immediately if you experience any of these symptoms. Stop taking 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 you experience 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

• oral, vaginal or mucosal fungal infection (Candida)
• 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 experience 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 (bullous exfoliative dermatitis)

• exfoliative red rash with lumps under the skin and blisters (exanthematous pustulosis)

• 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 allergy-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 blisters arranged in a ring 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 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), which may cause the skin and whites of the eyes to turn yellowish
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of amoxicillin/clavulanic acid or who have kidney problems)
• black, hairy-looking tongue
• tooth staining (in children), which usually disappears with brushing

Adverse effects that may appear in blood or urine tests:

• marked decrease in the number of white blood cells
• low red blood cell count (haemolytic anaemia)
• crystals in the urine

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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.

This medicine does not require any special storage conditions.

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

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 in doubt, ask your pharmacist how to dispose of unused containers and medicines. 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 500 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).
• The other components (excipients) are: silicon dioxide, sucrose, lemon flavouring (contains glucose in maltodextrin derived from corn) and strawberry flavouring (contains glucose in maltodextrin derived from corn).

Appearance of the medicine and contents of the pack

Whiteish 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.

C/Jarama s/n, Polígono 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 Medical Devices (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/66566/P_66566.html

QR code to: https://cima.aemps.es/cima/dochtml/p/66566/P_66566.html