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

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicilina/Ácido clavulánico ArdineClav 875mg/125mg 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) only and must 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 experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet Contents

1. What Amoxicilina/Ácido clavulánico ArdineClav is and what it is used for
2. Before taking Amoxicilina/Ácido clavulánico ArdineClav
3. How to take Amoxicilina/Ácido clavulánico ArdineClav
4. Possible side effects
5. How to store Amoxicilina/Ácido clavulánico ArdineClav
6. Further information

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

Amoxicillin/Clavulanic Acid ArdineClav 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 lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicilina/Ácido clavulánico ArdineClav 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 ArdineClav

Do not take Amoxicillin/Clavulanic Acid ArdineClav:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of Amoxicillin/Clavulanic Acid ArdineClav (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 ArdineClav if any of the above apply to you. Before starting treatment with Amoxicillin/Clavulanic Acid ArdineClav, if you are unsure, consult your doctor or pharmacist.

Take special care with Amoxicillin/Clavulanic Acid ArdineClav

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 ArdineClav.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different formulation of Amoxicillin/Clavulanic Acid or another medication.

Symptoms to watch for

Amoxicillin/Clavulanic Acid ArdineClav 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 ArdineClav 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 ArdineClav. This is because Amoxicillin/Clavulanic Acid ArdineClav 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 allopurinol (used for gout) with Amoxicillin/Clavulanic Acid ArdineClav, you may be more likely to develop a skin allergic reaction.

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

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

Amoxicillin/Clavulanic Acid ArdineClav may affect the action of methotrexate (a medicine used to treat cancer, psoriasis, or rheumatic diseases). Penicillins may reduce methotrexate excretion and potentially increase adverse effects.

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 ArdineClav may cause adverse effects, and symptoms may impair your ability to drive.

Do not drive or operate machinery unless you feel well.

3. How to take Amoxicillin/Clavulanic Acid ArdineClav

Follow exactly the instructions for use of Amoxicillin/Clavulanic Acid ArdineClav 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 the oral suspension or sachets of Amoxicillin/Clavulanic Acid ArdineClav.

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

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 ArdineClav

• Swallow the tablets whole with a glass of water at the beginning of meals or shortly before.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not take Amoxicillin/Clavulanic Acid ArdineClav for longer than 2 weeks. If you continue to feel unwell, consult your doctor.

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

If you take too much Amoxicillin/Clavulanic Acid ArdineClav, 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 the doctor.

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

If you forget to take Amoxicillin/Clavulanic Acid ArdineClav

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 following dose.

If you stop taking Amoxicillin/Clavulanic Acid ArdineClav

Continue taking Amoxicillin/Clavulanic Acid ArdineClav for the full duration of the 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, Amoxicilina/Ácido clavulánico ArdineClav may produce adverse effects, although not everyone will experience them. The adverse effects described below may occur when taking 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 mouth (angioedema), causing difficulty breathing
• collapse

?Contact a doctor immediately if you experience any of these symptoms. Stop taking Amoxicilina/Ácido clavulánico ArdineClav.

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.

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

• mouth, vaginal or mucosal fungal infections (candida)
• nausea, especially when taking high doses; if this occurs, take Amoxicilina/Ácido clavulánico ArdineClav 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 your 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 your 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, and whose exact frequency is unknown:

• Allergic reactions (see above)

• Inflammation of the large intestine (see above)

• Inflammation of the protective membrane surrounding the brain (aseptic meningitis )

• Serious 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 area – 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)).

• Chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome).

• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. It is a type of allergic reaction with the main symptom of repeated vomiting (1–4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.

• Crystals in the urine causing acute kidney injury

• 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)

• 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.

• 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 Amoxicilina/Ácido clavulánico or who have kidney problems)

• black, hairy-looking tongue

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

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

• significant reduction in white blood cell count
• low red blood cell count (haemolytic anaemia )
• crystals in the urine

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 ArdineClav

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Keep out of the reach and sight of children.

Do not use Amoxicillin/Clavulanic acid ArdineClav 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 or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Amoxicillin/Clavulanic acid ArdineClav 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 (excipients) are: anhydrous colloidal silica, magnesium stearate, sodium carboxymethyl starch (type A) (derived from potato starch) and microcrystalline cellulose 112.

Coating: Opadry Oy-S-7300, dimethicone 500 cps and purified water.

Appearance of the medicinal product and contents of the container

Film-coated, elongated white tablets, with a score line and inscription A/C.

Packaging containing 20 or 30 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio REIG JOFRE, S.A
Gran Capitan 10, 08970 Sant Joan Despí (Barcelona)

Manufacturer:

Laboratorio REIG JOFRE, S.A
C/Jarama 111. Pol Industrial
45007 Toledo

This leaflet was last revised in January 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es