AMOXICILLIN/CLAVULANIC ACID ARDINECLAV 875/125 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Amoxicillin/Clavulanic Acid ArdineClav875mg/125mg 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

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

Amoxicillin/Clavulanic Acid ArdineClav 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 medicines known as "penicillins" which can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/Clavulanic Acid 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, 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) when taking an antibiotic.

Do not take Amoxicillin/Clavulanic Acid ArdineClav if you are included in any of the above points. Before starting treatment with Amoxicillin/Clavulanic Acid ArdineClav, if you are unsure, consult your doctor or pharmacist.

Be especially careful with Amoxicillin/Clavulanic Acid ArdineClav

Tell 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 symptoms affect 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, you may be prescribed a different formulation of Amoxicillin/Clavulanic Acid or another medicine.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid ArdineClav 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 ArdineClav 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 status or liver function tests) or urine tests (to check 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

Tell your doctor or pharmacist if you are using or have recently used 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 suffer 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 you are taking anticoagulants (such as warfarin) with Amoxicillin/Clavulanic Acid ArdineClav, more blood tests will be needed.

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

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 medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid ArdineClav may have side effects and symptoms that may make you unfit to drive.

Do not drive or operate machinery unless you feel well.

3. How to take Amoxicillin/Clavulanic Acid ArdineClav

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

Adults and children over 40kg

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

Children under 40kg in weight

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

Ask your doctor or pharmacist for advice when administering Amoxicillin/Clavulanic Acid ArdineClav to children who weigh less than 40 kg.

Patient with kidney and liver problems

• If you have kidney problems, your dose may be changed. Your doctor may choose a different formulation or another medicine.
• 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 ArdineClav

• 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 ArdineClav for more than 2 weeks. If you are still feeling unwell, consult your doctor.

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

If you take too much Amoxicillin/Clavulanic Acid ArdineClav, 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, telephone 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 next dose.

If you stop taking Amoxicillin/Clavulanic Acid ArdineClav

Continue taking Amoxicillin/Clavulanic Acid ArdineClav until you finish the treatment, even if you feel better. You need to take the complete treatment to cure the infection. If you do not, the bacteria that survive may cause you to have the infection again.

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

4. Possible side effects

Like all medicines, Amoxicillin/Clavulanic Acid ArdineClav can cause side effects, although not everybody gets them. The side effects described below may occur when taking this medicine.

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

Contact a doctor immediatelyif you experience any of these symptoms and stop taking Amoxicillin/Clavulanic Acid ArdineClav.

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.

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 Amoxicillin/Clavulanic Acid ArdineClav before meals
• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 patients

• skin rash, itching
• increased itchy rash (urticaria)
• indigestion
• dizziness
• headache.

Uncommon side effects that may appear in your blood or urine tests:

• increase in some 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 blood 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)
• Inflammation of the membrane that surrounds the brain and spinal cord (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 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 white blood cell count and liver enzymes) (drug reaction with eosinophilia and systemic symptoms - DRESS).

• Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced myocardial infarction (Kounis syndrome).
• 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 medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
• Crystals in the urine that cause acute kidney injury
• 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)
• Acute inflammation of the pancreas (acute pancreatitis).

If you have severe and persistent stomach pain, 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) that can make the skin and the 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 reduction in the number of white blood cells
• low red blood cell count (hemolytic anemia)
• crystals in the urine.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: http://www.notificaRAM.es. By reporting side 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 expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Amoxicillin/Clavulanic Acid ArdineClav 875 mg/125mg 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 ingredients (excipients) are: anhydrous colloidal silica, magnesium stearate, sodium carboxymethylcellulose (type A) (derived from potato starch), and microcrystalline cellulose 112.

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

Appearance of the product and pack contents

White, film-coated, elongated tablets with a score line and inscription A/C.

Packaging containing 20, 30, or 500 film-coated tablets.

Not all 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 updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es