Amoxicillin/clavulanic acid Combix 875 mg/125 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Amoxicillin/Clavulanic Acid Combix 875 mg/125 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 has been prescribed for you (or your child) only; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Amoxicillin/Clavulanic Acid Combix is and what it is used for
2. What you need to know before taking Amoxicillin/Clavulanic Acid Combix
3. How to take Amoxicillin/Clavulanic Acid Combix
4. Possible side effects
5. How to store Amoxicillin/Clavulanic Acid Combix
6. Contents of the pack and other information

1. What Amoxicilina/Ácido Clavulánico Combix is and what it is used for

Amoxicilina/Ácido Clavulánico Combix 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 become ineffective (inactivated). The other component (clavulanic acid) prevents this from happening.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Amoxicilina/Ácido Clavulánico Combix is used in children and adults 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 Combix

Do not take Amoxicillin/Clavulanic Acid Combix

• 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 (hypersensitivity) 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 Combix if any of the above apply to you. Before starting treatment with Amoxicillin/Clavulanic Acid Combix, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Combix 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 Combix.

In some cases, your doctor may investigate the type of bacteria causing your infection.

Depending on the results, you may be prescribed a different formulation of Amoxicillin/Clavulanic Acid Combix or another medicine.

Symptoms to watch for

Amoxicillin/Clavulanic Acid Combix 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 Combix 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 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 Combix. This is because Amoxicillin/Clavulanic Acid Combix may alter the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic Acid Combix

Tell 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 Combix, you may be more likely to experience a skin allergic reaction.

If you are taking probenecid (used to treat gout), your doctor may adjust your dose of Amoxicillin/Clavulanic Acid Combix. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and potentially increase its adverse effects.

If anticoagulants (such as warfarin) are taken with Amoxicillin/Clavulanic Acid Combix, more blood tests will be needed.

Amoxicillin/Clavulanic Acid Combix may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy, breastfeeding, and fertility

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.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid Combix may cause adverse effects, and the symptoms may mean you should not drive. Do not drive or operate machinery unless you feel well.

3. How to take Amoxicillin/Clavulanic Acid Combix

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

• Usual dose – 1 tablet taken twice a day.
• Higher dose – 1 tablet taken three times a day.

Children weighing less than 40 kg

It is preferable to treat children aged 6 years or younger with oral amoxicillin/clavulanic acid suspension or sachets.

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 liver function.

How to take Amoxicillin/Clavulanic Acid Combix

• Take with food.
• Swallow the tablets whole with a glass of water. The tablets may be broken along the score line to make swallowing easier. Both halves of the tablet should be taken at the same time.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within one hour.
• Do not take Amoxicillin/Clavulanic Acid Combix for longer than 2 weeks. If you still feel unwell, consult your doctor.

If you take more Amoxicillin/Clavulanic Acid Combix than you should

If you take too much Amoxicillin/Clavulanic Acid Combix, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible. Take the packaging with you to show your doctor.

You may also 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 Combix

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 a missed dose.

If you stop taking Amoxicillin/Clavulanic Acid Combix

Continue taking Amoxicillin/Clavulanic Acid Combix until the end of the prescribed course, 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 with 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 Combix.

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 as soon as possible for advice if you have these symptoms.

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.

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 in the vagina, mouth or mucous membranes), nausea, especially when taking high doses

→ if this happens, take Amoxicillin/Clavulanic Acid Combix with food

• 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 your 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 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 a doctor urgently.

Rare adverse effects that may appear in your blood tests:

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

Frequency not known

The frequency cannot be estimated from the available data.

• allergic reactions (see above)
• inflammation of the large intestine (see above)
• inflammation of the membranes surrounding 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 body surface – toxic epidermal necrolysis)
  • widespread blistering rash with pus-filled blisters (exfoliative bullous dermatitis)
  • red rash with bumps under the skin and blisters (exanthematous pustulosis)
  • blistering rash arranged in circles with central crusts or resembling a string of pearls (linear IgA disease)
  • 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.

→Contact a doctor immediately if you have 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 yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Amoxicillin/Clavulanic Acid Combix or with kidney problems)
• black, hairy-looking tongue

Adverse effects that may appear in your blood or urine tests:

• marked decrease in white blood cell count
• low red blood cell count (haemolytic anaemia)
• crystals in the urine causing acute kidney injury.

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://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 Combix

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Do not use if the tablets are broken or damaged.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin/Clavulanic Acid Combix

• The active substances are amoxicillin and clavulanic acid. Each tablet contains 1004.40 mg of amoxicillin trihydrate, equivalent to 875 mg of amoxicillin, and 297.81 mg of potassium clavulanate, equivalent to 125 mg of clavulanic acid.
• Other components are: core: microcrystalline cellulose (E460), crospovidone (E1201), sodium croscarmellose (E468), anhydrous colloidal silica (E551), magnesium stearate (E470b); coating: butylated methacrylate copolymer, titanium dioxide (E171), talc (E553b), macrogol 6000.

Appearance of the product and contents of the pack

Amoxicillin/Clavulanic Acid Combix is a white or almost white, film-coated, oblong, scored tablet.

The score line is intended only for ease of swallowing and tablet splitting, but not for dividing into equal doses.

The tablets are available in blisters packed in boxes containing 20 or 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

PenCef Pharma GmbH

Breitenbachstrasse 13

13509 Berlin

Germany

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

Medical advice/education

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.

Sometimes a bacterial infection does not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Proper use of antibiotics can reduce the likelihood of bacteria becoming resistant.

When your doctor prescribes an antibiotic, it is intended solely for the treatment of your current illness. Following the advice below will help you prevent the development of resistant bacteria, which could render antibiotics ineffective.

1. It is very important to take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the labeling instructions carefully and, if you do not understand something, ask your doctor or pharmacist.
2. Do not take an antibiotic unless it has been specifically prescribed for you, and use it only for the infection it was prescribed for.
3. Do not take antibiotics prescribed for other people, even if they have the same or a similar infection to yours.
4. Do not give antibiotics prescribed for you to other people.
5. If you have any antibiotic left after completing your treatment, return all unused medicines to your pharmacy to ensure proper disposal.

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/