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

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Read the entire 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 you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist (see section 4).

Leaflet contents:

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. How to store Amoxicillin/Clavulanic acid Kern Pharma
6. Further information

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

Amoxicillin/Clavulanic acid Kern Pharma is an antibiotic that kills bacteria causing infections. It contains two different drugs called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which sometimes may 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 to any of the other components 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 skin rash or swelling of the face or neck

• if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

• Do not take Amoxicillin/Clavulanic Acid Kern Pharma if any of the above apply to you. Before starting treatment with Amoxicillin/Clavulanic Acid Kern Pharma, if you are unsure, consult your doctor or pharmacist.

Take special care with Amoxicillin/Clavulanic Acid Kern Pharma

Inform your doctor or pharmacist before taking this medicine 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 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 medicine.

Symptoms to watch for

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

Use of other medicines

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

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

If you are taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid Kern Pharma, 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 amoxicillin excretion and is not recommended. Your doctor may adjust your dose of Amoxicillin/Clavulanic Acid Kern Pharma.

If anticoagulants (such as warfarin) are taken with Amoxicillin/Clavulanic Acid Kern Pharma, additional blood tests will be required.

Amoxicillin/Clavulanic Acid Kern Pharma may affect the action of methotrexate (a medicine 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 medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid Kern Pharma may cause adverse effects, and symptoms may make it unsafe for you to drive.

Do not drive or operate machinery unless you feel well.

3. How to take Amoxicillin/Clavulanic Acid Kern Pharma

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

Adults and children weighing 40 kg or more

• Usual dose – 1 tablet taken twice daily
• Higher dose – 1 tablet taken three times daily

Children weighing less than 40 kg

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

Seek advice from your doctor or pharmacist when administering Amoxicillin/Clavulanic Acid Kern Pharma to children weighing less than 40 kg.

Patients with kidney or liver problems

• If you have kidney problems, your dose may 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 Kern Pharma

• Swallow the tablets whole with a glass of water at the beginning of a meal or shortly before.
• Space doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not take Amoxicillin/Clavulanic Acid Kern Pharma for longer 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, 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 your doctor.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Amoxicillin/Clavulanic Acid Kern Pharma

If you forget 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 following dose.

If you stop taking Amoxicillin/Clavulanic Acid Kern Pharma

Continue taking Amoxicillin/Clavulanic Acid Kern Pharma for the full duration of 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Amoxicillin/Clavulanic Acid Kern Pharma may have adverse effects, although not everyone will experience them.

Symptoms you should be aware of

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 mouth (angioedema), causing difficulty breathing

• collapse

• chest pain during allergic reactions, which may be a sign of allergy-triggered heart attack (Kounis syndrome).

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

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.

Drug-induced enterocolitis syndrome (DIES)

DIES has mainly been 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.

Very common adverse effects

May affect more than 1 in 10 patients

• diarrhoea (in adults)

Common adverse effects

May affect up to 1 in 10 patients

• oral, vaginal, or mucosal fungal infections (candida)

• nausea, especially when taking high doses

  • if this happens, take Amoxicillin/Clavulanic Acid Kern Pharma before meals

• vomiting

• diarrhoea (in children)

Uncommon adverse effects

May affect up to 1 in 100 patients

• 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 patients

• 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 blood tests:

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

Other adverse effects

Other adverse effects that have occurred in a very small number of patients, with unknown frequency:

• Allergic reactions (see above)

• Inflammation of the large intestine (see above)

• Severe skin reactions:

  • widespread rash with blisters and peeling 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 (exfoliative bullous dermatitis)
  • red rash with bumps under the skin and blisters (exanthematous pustulosis)
  • 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))
  • blistering rash arranged in circles with central crusts or resembling a string of pearls (linear IgA 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), which may cause the skin and whites of the eyes to turn yellow

• inflammation of 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

• stained teeth (in children), which usually disappear with brushing

Adverse effects that may appear in 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

If you experience adverse effects

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of 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: 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 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 expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their packaging to the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and packaging 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 substances 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 components are: sodium starch glycolate (potato), colloidal anhydrous silica, magnesium stearate (E-470b), microcrystalline cellulose (E-460i), Opadry Oy-S-7300.

Appearance of the medicinal product and contents of the pack

Elongated, scored, white or almost white film-coated tablets.

Packs containing 20 or 30 film-coated tablets.

Amoxicillin/Clavulanic acid Kern Pharma 875/125 mg tablets are supplied 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 last approved in April 2023

Up-to-date detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.