PATIENT INFORMATION LEAFLET

Amoxicillin/Clavulanic Acid Kern Pharma 875 mg/125 mg Film-Coated Tablets EFG

Read this leaflet carefully before you start taking this medicine.

• 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 (or your child) and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you are experiencing to be serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist (see section 4).

Amoxicilina/Ácido clavulánico Kern Pharma is an antibiotic that eliminates bacteria causing infections. It contains two different medications called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medications known as “penicilins” which can sometimes lose its effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico Kern Pharma 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 Kern Pharma

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or any of the other components of Amoxicilina/Ácido clavulánico Kern Pharma (see 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 neck
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

• Do not take Amoxicilina/Ácido clavulánico Kern Pharma if you fall under any of the above points. Before starting treatment with Amoxicilina/Ácido clavulánico Kern Pharma, if you are unsure, consult your doctor or pharmacist.

Be especially careful with Amoxicilina/Ácido clavulánico Kern Pharma

Inform your doctor or pharmacist before taking this medication 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 Kern Pharma.

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 or another medication.

Symptoms to be aware of

Amoxicilina/Ácido clavulánico Kern Pharma may worsen existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine. Be aware of certain symptoms while taking Amoxicilina/Ácido clavulánico Kern Pharma 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 Kern Pharma. This is because Amoxicilina/Ácido clavulánico Kern Pharma may alter the results of these types of tests.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription and herbal medications.

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

If you are taking allopurinol (used to treat gout) with Amoxicilina/Ácido clavulánico Kern Pharma, you may be more likely to experience a skin allergic reaction.

If you are taking probenecid (used to treat gout), concurrent use of probenecid may reduce amoxicillin excretion and is not recommended. Your doctor may adjust the dose of Amoxicilina/Ácido clavulánico Kern Pharma.

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

Amoxicilina/Ácido clavulánico Kern Pharma may affect the action of methotrexate (a medication used to treat cancer or rheumatic diseases).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are breastfeeding, speak with your doctor or pharmacist.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Amoxicilina/Ácido clavulánico Kern Pharma may cause side effects, and symptoms may make it unsafe to drive.

Do not drive or operate machinery unless you feel well.

Follow exactly the administration instructions for Amoxicilina/Ácido clavulánico Kern Pharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 the oral suspension of Amoxicilina/Ácido clavulánico or the sachets.

Ask your doctor or pharmacist for advice when administering Amoxicilina/Ácido clavulánico Kern Pharma to children weighing less than 40 kg.

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 functioning.

How to take Amoxicilina/Ácido clavulánico Kern Pharma

• Swallow the tablets whole with a glass of water at the beginning of meals or a little before.
• Space the doses throughout the day, at least 4 hours apart. Do not take two doses in one hour.
• Do not take Amoxicilina/Ácido clavulánico Kern Pharma for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more Amoxicilina/Ácido clavulánico Kern Pharma than you should

If you take too much Amoxicilina/Ácido clavulánico Kern Pharma, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible.

Take the packaging with you to show to your doctor.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Amoxicilina/Ácido clavulánico Kern Pharma

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.

If you stop taking Amoxicilina/Ácido clavulánico Kern Pharma

Continue taking Amoxicilina/Ácido clavulánico Kern Pharma until you complete the treatment, even if you feel better. You need to take the complete 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 doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, Amoxicilina/Clavulánico Kern Pharma may cause side effects, although not everyone will experience them.

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 mouth (angioedema), which causes difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of an allergic-induced heart attack (Kounis syndrome).

• Contact your doctor immediatelyif you experience any of these symptoms.Stop taking Amoxicilina/Ácido clavulánico Kern Pharma.

Colitis

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

• Contact your doctor as soon as possibleso 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.

Drug-induced enterocolitis syndrome (DIES)

DIES has mainly been reported in children taking amoxicilina. 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.

Very common side effects

May affect more than 1 in 10 patients

• diarrhea (in adults).

Common side 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 happens, take Amoxicilina/Ácido clavulánico Kern Pharma before meals

• vomiting
• diarrhea (in children).

Rare side effects

May affect 1 in 100 patients

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

Side effects that may appear in blood tests:

Increased levels of certain substances (enzymes) produced by the liver.

Rare side effects

May affect up to 1 in 1,000 patients

• skin rash, which may form blisters that resemble small darts (eritema multiforme)

• if you experience any of these symptoms, consult a doctor urgently

Side effects that may appear in blood tests:

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

Other side effects

Other side effects that have occurred in a very small number of patients and whose exact frequency is unknown:

• Allergic reactions (see above)
• Colitis (see above)
• 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 (more than 30% of the body surface –toxic epidermal necrolysis)
  • generalized rash with small blisters containing pus (dermatitis exfoliativa bullosa)
  • red rash, with bumps under the skin and blisters (pustulosis exanthemática).
  • 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)).
  • rash with blisters arranged in a circle with a central crust or like a string of pearls (IgA linear disease).
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

• Contact a doctor immediately if you experience any of these symptoms.

• liver inflammation (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that may turn the skin and the white of the eyes yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Amoxicilina/ácido clavulánico or with kidney problems)
• black tongue that appears hairy
• stained teeth (in children), which usually disappears with brushing.

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.

If you experience side effects

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting 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 the Vigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above 25 °C.

Store in the original packaging to protect it from light and humidity.

Keep out of the reach and sight of children.

Do not use Amoxicilina/Clavulanic Acid Kern Pharma after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Amoxicilina/Clavulanic Acid Kern Pharma 875 mg/125 mg Film-Coated Tablets

• The active ingredients are amoxicilina and clavulanic acid. Each tablet contains 875 mg of amoxicilina (as amoxicilina trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).

• The other components are: sodium starch glycolate (potato), anhydrous colloidal silica, magnesium stearate (E-470b), microcrystalline cellulose (E-460i), Opadry Oy-S-7300.

Appearance of the product and contents of the package

Long, scored, white or off-white tablets.

Packages containing 20 or 30 film-coated tablets.

Amoxicilina/Clavulanic Acid Kern Pharma 875/125 mg tablets are presented in aluminum/aluminum blisters.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing:

Reig Jofré, S.A.

Gran Capità, 10

08970 Sant Joan Despí (Barcelona)

or

Laboratorio Reig Jofré, S.A.

Jarama, 111

45007 – Toledo

This leaflet was approved in April 2023

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