AMOXICILLIN/CLAVULANIC ACID KERN PHARMA 875 mg/125 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

Contents of the pack:

1. What Amoxicillin/Clavulanic Acid Kern Pharma is and what it is used for
2. Before taking Amoxicillin/Clavulanic Acid Kern Pharma
3. How to take Amoxicillin/Clavulanic Acid Kern Pharma
4. Possible side effects
5. Storage of Amoxicillin/Clavulanic Acid Kern Pharma
6. Additional information

1. What Amoxicillin/Clavulanic Acid Kern Pharma is and what it is used for

Amoxicillin/Clavulanic Acid Kern Pharma is an antibiotic that eliminates the bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medications known as "penicillins," which can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/Clavulanic Acid Kern Pharma 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. Before taking Amoxicillin/Clavulanic Acid Kern Pharma

Do not take Amoxicillin/Clavulanic Acid Kern Pharma

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of Amoxicillin/Clavulanic Acid Kern Pharma (see section 6)
• if you have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This could include a 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 Amoxicillin/Clavulanic Acid Kern Pharma if you are included in any of the above points.Before starting treatment with Amoxicillin/Clavulanic Acid Kern Pharma, if you are unsure, consult your doctor or pharmacist.

Be cautious with Amoxicillin/Clavulanic Acid Kern Pharma

Tell 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 Amoxicillin/Clavulanic Acid Kern Pharma.

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 or another medication.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid Kern Pharma can worsen certain existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking Amoxicillin/Clavulanic Acid 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 tests) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Kern Pharma. This is because Amoxicillin/Clavulanic Acid Kern Pharma can alter the results of these types of tests.

Use of other medications

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

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

If you are taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid Kern Pharma, you may be more likely to experience a skin allergic reaction.

If you are taking probenecid (used to treat gout), concomitant use of probenecid can reduce the excretion of amoxicillin and is not recommended. Your doctor may adjust the dose of Amoxicillin/Clavulanic Acid Kern Pharma.

If you are taking anticoagulants (such as warfarin) with Amoxicillin/Clavulanic Acid Kern Pharma, more blood tests will be needed.

Amoxicillin/Clavulanic Acid 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, consult your doctor or pharmacist.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

Amoxicillin/Clavulanic Acid Kern Pharma can have side effects, and the symptoms may make you unfit to drive.

Do not drive or operate machinery unless you feel well.

3. How to take Amoxicillin/Clavulanic Acid Kern Pharma

Follow the instructions for administration of Amoxicillin/Clavulanic Acid Kern Pharma exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults and children over 40 kg

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

Children under 40 kg

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

Ask your doctor or pharmacist for advice when administering Amoxicillin/Clavulanic Acid Kern Pharma to children who weigh 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 formulation 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 Kern Pharma

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

If you take more Amoxicillin/Clavulanic Acid Kern Pharma than you should

If you take too much Amoxicillin/Clavulanic Acid Kern Pharma, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible.

Bring the package with you to show the doctor.

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

If you forget to take Amoxicillin/Clavulanic Acid 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 Amoxicillin/Clavulanic Acid Kern Pharma

Continue taking Amoxicillin/Clavulanic Acid Kern Pharma until you finish the treatment, even if you feel better. You need to complete the treatment to cure the infection. If you do not, the surviving bacteria may cause the infection to return.

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

4. Possible side effects

Like all medications, Amoxicillin/Clavulanic Acid Kern Pharma can have side effects, although not everyone experiences them.

Symptoms to be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) that can appear as red or purple spots on the skin but can affect other parts of the body
• fever, joint pain, swollen glands in the neck, armpits, or groin
• swelling, sometimes of the face or mouth (angioedema), which can cause difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which can be a symptom of an allergy-induced heart attack (Kounis syndrome)

• Contact your doctor immediatelyif you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic Acid Kern Pharma.

Inflammation of the large intestine

Inflammation of the large intestine, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

• Contact your doctor as soon as possiblefor advice if you have these symptoms.

Acute pancreatitis

If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)

DIES has been reported mainly in children receiving 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.

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

• vomiting
• diarrhea (in children)

Uncommon side effects

May affect up to 1 in 100 patients

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

Uncommon side effects that may appear in your 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 can form blisters that look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

Rare side effects that may appear in your blood tests:

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

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)
• Inflammation of the large intestine (see above)
• 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 the body surface – toxic epidermal necrolysis)
  • widespread rash with small blisters containing pus (bullous exfoliative dermatitis)
  • red rash with bumps under the skin and blisters (pustular exanthematous eruption)
  • flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results (such as elevated liver enzymes and eosinophilia) (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 (linear IgA disease)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

• Contact a doctor immediatelyif you experience any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that can make the skin and whites of the eyes turn yellow
• inflammation of the kidney ducts
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Amoxicillin/Clavulanic Acid or with kidney problems)
• black hairy tongue
• stained teeth (in children), which usually disappears with brushing

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

• significant decrease in the number of white blood cells
• low count of red blood cells (hemolytic anemia)
• crystals in the urine that cause acute kidney injury

If you experience side effects

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Amoxicillin/Clavulanic Acid Kern Pharma

Do not store above 25 ºC.

Keep in the original packaging to protect from light and moisture.

Keep out of the reach and sight of children.

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

Medications should not be disposed of down the drain or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional Information

Composition of Amoxicillin/Clavulanic Acid Kern Pharma 875 mg/125 mg film-coated tablets

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

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

Appearance and packaging of the product

White or off-white, elongated, scored tablets.

Packaging containing 20 or 30 film-coated tablets.

Amoxicillin/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

Manufacturer:

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

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.