Amoxicillin/clavulanic acid Ardineclav 500/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin/Clavulanic acid ArdineClav 500mg/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, consult your doctor or pharmacist.

• This medicine has been prescribed for you (or your child) only, and you should not give it 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.

Contents of the leaflet

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

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

Amoxicillin/Clavulanic Acid Ardine Clav 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 become ineffective (inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/Clavulanic acid ArdineClav is used in adults and children 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

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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 to 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 medicine.

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 your 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, additional blood tests will be required.

Amoxicillin/Clavulanic Acid ArdineClav may affect the action of methotrexate (a medicine used to treat cancer, severe 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 use of machines

Amoxicillin/Clavulanic Acid ArdineClav may cause adverse effects, and symptoms may mean you should not drive.

Do not drive or operate machinery unless you feel well.

3. How to take Amoxicillin/Clavulanic acid Ardine Clav

Follow exactly the administration instructions for Amoxicillin/Clavulanic acid ArdineClav provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults and children weighing 40 kg or more

The usual dose is:

• 1 tablet taken three times a day

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 before administering Amoxicillin/Clavulanic acid ArdineClav tablets 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 throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Amoxicillin/Clavulanic acid ArdineClav for longer than 2 weeks. If you still 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 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 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 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 – also known as thrush)
• 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 1 in 100 patients

• skin rash, itching
• increased itchy rash (urticarial habo )
• 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 appear as "target" lesions (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 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 )

• 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 body surface area – toxic epidermal necrolysis )

• widespread rash with small pustules (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 sign 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 being 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

• Rash with blisters arranged in a ring with a central crust 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 experience 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 yellowish

• 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 blood or urine tests:

• significant reduction in the number of white blood cells
• 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 Ardine Clav

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 packaging at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Additional information

Composition of Amoxicillin/Clavulanic acid ArdineClav 500 mg/125 mg film-coated tablets

The active substances are amoxicillin and clavulanic acid. Each tablet contains:

Amoxicillin (as amoxicillin trihydrate) 500 mg
Clavulanic acid (as potassium clavulanate) 125 mg

The other components (excipients) are: Anhydrous colloidal silica, magnesium stearate, sodium starch glycolate (type A) (derived from potato starch) and microcrystalline cellulose 112.

Coating: Opadry Oy-S-7300 (hypromellose (hydroxypropylmethylcellulose (E464), Macrogol (polyethylene glycol) 4000 (E1521), Macrogol (polyethylene glycol) 6000 (E1521) and Titanium dioxide (E-171)), simethicone 500 and purified water.

Appearance of the medicinal product and contents of the pack

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

Pack sizes containing 30 or 500 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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

Manufacturer:

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

This leaflet was last reviewed 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