Amoxicillin/clavulanic acid Cinfa 875 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 875 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, as 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 adverse 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 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 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) 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 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.

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 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 to reduce the risk of complications. See “Symptoms to watch for” in section 4.

Blood and urine tests

If you are undergoing blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you 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 you are taking, have recently taken, or might need to take any other medicines.

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

If you are taking probenecid (used to treat gout), concomitant use with 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 methotrexate excretion and potentially increase 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Amoxicillin/clavulanic acid may cause adverse effects, and symptoms may make it unsafe for you to drive. Do not drive or operate machinery unless you feel well.

amoxicillin/clavulanic acid cinfa contains aspartame (E-951).

This medicine contains 12.50 mg of aspartame per sachet.

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

amoxicillin/clavulanic acid 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/clavulanic acid cinfa contains sucrose.

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

• Recommended dose – 1 sachet taken twice daily.
• Higher dose – 1 sachet taken three times daily.

Children weighing less than 40 kg

Amoxicillin/clavulanic acid 875 mg/125 mg powder for oral suspension in sachets is 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 working.

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 the 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, stating 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 treatment with amoxicillin/clavulanic acid cinfa

Continue taking amoxicillin/clavulanic acid until the end of the prescribed 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 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 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 people):

• Diarrhoea (in adults).

Common adverse effects (may affect up to 1 in 10 people):

• Thrush (Candida – fungal infection of 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 people):

• Skin rash, itching.
• Increased itchy rash (urticarial wheals).
• 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 people):

• Skin rash, which may blister and resemble small targets (central dark 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 available data):

• Allergic reactions (see above).
• Inflammation of the large intestine (see above).
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis).
• Serious 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).
  • red rash with lumps 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 allergy-triggered heart attack (Kounis syndrome).
  • Drug-induced enterocolitis syndrome (DIES):

DIES has been mainly reported 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 crusted circular blisters or resembling a string of beads (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 discoloration (in children), which usually disappears with brushing.

Adverse effects that may appear in blood or urine tests:

• Significant reduction in white blood cell count.
• Low red blood cell count (haemolytic anaemia).
• Crystals in the urine.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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. Store in the original packaging to protect it from moisture.

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 empty containers and unused medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers 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 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 flavour (containing glucose derived from maize, sucrose and maize starch).

Appearance of the product and contents of the pack

White to off-white powder.

It is presented in single-dose sachets made of Paper/Alu/Thermoformed resin film, in packs of 20, 30 or 500 (hospital pack) sachets containing powder for oral suspension.

Only certain pack sizes may be marketed.

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, 111. Pol Industrial

45007 Toledo

Spain

Date of the most recent review of this leaflet: April 2023.

Detailed information on this medicinal product 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 leaflet and packaging. 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