Package Insert: Information for the User

Amoxicilina/Ácido Clavulánico Combix 875 mg/125 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you (or your child), and should not be given 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 not listed in this package insert. See section 4.

Amoxicilina/Ácido Clavulánico Combix is an antibiotic that eliminates the bacteria that cause infections. It contains two different medications called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medications known as “penicilinas” that sometimes may lose its effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido Clavulánico Combix is used in children and adults 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

Do not take Amoxicilina/Ácido Clavulánico Combix

• if you are allergic to amoxicilina, ácido clavulánico, penicilinas, or any of the other components of this medication (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) when taking an antibiotic.

Do not take Amoxicilina/Ácido Clavulánico Combix if you are included in any of the above points. Before starting treatment with Amoxicilina/Ácido Clavulánico Combix, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amoxicilina/Ácido Clavulánico 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 symptoms affect you, inform your doctor or pharmacist before taking Amoxicilina/Ácido Clavulánico Combix.

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

Depending on the results, your doctor may prescribe a different presentation of Amoxicilina/Ácido Clavulánico Combix or another medication.

Symptoms to be aware of

Amoxicilina/Ácido Clavulánico Combix may worsen existing conditions or cause serious side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of certain symptoms while taking Amoxicilina/Ácido Clavulánico Combix to reduce the risk of problems. See “Symptoms to be aware of” in section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are taking Amoxicilina/Ácido Clavulánico Combix. This is because Amoxicilina/Ácido Clavulánico Combix may alter the results of these types of tests.

Other medications and Amoxicilina/Ácido Clavulánico Combix

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

If you are taking allopurinol (used for gout) with Amoxicilina/Ácido Clavulánico Combix, you may be more likely to suffer a skin allergy reaction.

If you are taking probenecid (used to treat gout), your doctor may adjust the dose of Amoxicilina/Ácido Clavulánico Combix. Concomitant use of probenecid may reduce the excretion of amoxicilina and is not recommended.

If you are taking methotrexate (a medication used to treat cancer and severe psoriasis), penicilins may reduce the excretion of methotrexate and cause a potential increase in side effects.

If you are taking anticoagulants (such as warfarin) with Amoxicilina/Ácido Clavulánico Combix, more blood tests will be required.

Amoxicilina/Ácido Clavulánico Combix may affect how micofenolato de mofetilo (a medication 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Amoxicilina/Ácido Clavulánico Combix may cause side effects, and symptoms may make you unable to drive. Do not drive or operate machinery unless you feel well.

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

Adults and children 40 kg or more

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

Children under 40 kg of weight

It is preferable to treat children 6 years or less with oral suspension of Amoxicillin/Clavulanic Acid or the sachets.

Patients with kidney and liver problems

• If you have kidney problems, your dose may be changed. Your doctor may choose a different presentation or another medication.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How to take Amoxicillin/Clavulanic Acid Combix

• Take with meals
• Swallow the tablets whole with a glass of water. The tablets can be broken along the notch to make them easier to swallow. You should take both halves of the tablet at the same time.
• Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in one hour.
• Do not take Amoxicillin/Clavulanic Acid Combix for more than 2 weeks. If you continue to 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, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible. Bring the packaging with you to show the doctor.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 the missed doses.

If you interrupt the treatment with Amoxicillin/Clavulanic Acid Combix

Continue taking Amoxicillin/Clavulanic Acid Combix until you complete the treatment, even if you feel better. You need to take the full treatment to cure the infection. If you do not, the surviving bacteria may cause you to get the infection again.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects listed below may occur with this medicine.

Symptoms to be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) that may appear as red or purple spots on the skin, but can affect other parts of the body
• fever, joint pain, swollen lymph nodes in the neck, armpits, or groin
• swelling, sometimes of the face or throat (angioedema), which causes difficulty breathing
• collapse.

→Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicilina/Ácido Clavulánico Combix.

Colitis

Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

→ Contact your doctor as soon as possibleso that they can advise you, if you have these symptoms.

Acute pancreatitis

If you have intense and persistent pain in the abdominal area, this could be a sign of acute pancreatitis.

Very common side effects

May affect more than 1 in 10 people

• diarrhea (in adults).

Common side effects

May affect up to 1 in 10 people

• thrush (Candida infection in the vagina, mouth, or mucous membranes) nausea, especially when taking high doses

→ If this happens, take Amoxicilina/Ácido Clavulánico Combix with meals

• vomiting
• diarrhea (in children).

Uncommon side effects

May affect 1 in 100 people

• skin rash, itching
• increased pruritic rash (urticarial)
• indigestion
• dizziness
• headache.

Side effects that may appear in blood tests:

• increase in some substances (enzymes) produced by the liver.

Rare side effects

May affect up to 1 in 1,000 people

• skin rash, which may form blisters that look like small darts (erythema multiforme)

→ If you have any of these symptoms, see a doctor urgently.

Side effects that may appear in 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)
• colitis (see above)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• severe skin reactions:
• • generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (toxic epidermal necrolysis)
  • generalized rash with small blisters with pus (exfoliative dermatitis)
  • red rash, with bumps under the skin and blisters (pustular exanthem)
  • rash with blisters arranged in a circle with a central crust or as a string of pearls (IgA linear disease)
  • flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils 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 allergic-induced myocardial infarction (Kounis syndrome)
• drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children taking amoxicillin. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

→ Contact a doctor immediately if you have any of these symptoms.

• hepatitis (inflammation of the liver)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that may turn the skin and white of the eyes yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Amoxicilina/Ácido Clavulánico Combix or with kidney problems)
• black tongue that looks hairy

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 that cause acute kidney damage.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from moisture.

Do not use if the tablets are broken or damaged.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amoxicilina/Ácido Clavulánico Combix

-The active principles are amoxicilina and ácido Clavulánico. Each tablet contains 1004.40 mg of amoxicilina trihydrate corresponding to 875 mg of amoxicilina and 297.81 mg of clavulanato potásico corresponding to 125 mg of ácido clavulánico.

-The other components are:nucleus:microcrystalline cellulose (E460), crospovidona (E1201), croscarmelosa sódica (E468), anhydrous colloidal silica (E551), magnesium stearate (E470b);coating:basic butylated methacrylate copolymer, titanium dioxide (E171), talc (E553b), macrogol 6000.

Appearance of the product and contents of the package

Amoxicilina/Ácido Clavulánico Combix is a film-coated, white or almost white, oblong, scored tablet.

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses

The tablets are available in blisters packaged in boxes of 20 or 30 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

PenCef Pharma GmbH

Breitenbachstrasse 13

13509 Berlin

Germany

Last review date of this leaflet: April 2023

The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/