PATIENT INFORMATION LEAFLET

Amoxicilina/Ácido clavulánico ArdineClav 500mg/125mg film-coated tablets

Read this leaflet carefully before you start taking the 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. Do not pass it on to others even if their symptoms are the same. It may harm them.

-If you think any of the side effects get serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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. Storage of Amoxicilina/Ácido clavulánico ArdineClav

6. Further information

Amoxicilina/Ácido clavulánico ArdineClav is an antibiotic that eliminates the bacteria that cause infections. It contains two different medications called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medications known as “penicilinas” that sometimes may lose its effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico ArdineClavis used in adults and childrento treat the following infections:

• Middle ear and nasal sinus infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections, including dental infections
• Bone and joint infections

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Do not take Amoxicilina/Ácido clavulánico ArdineClav:

•if you are allergic (hypersensitive) to amoxicilina, ácido clavulánico, penicilinas, or any other component of Amoxicilina/Ácido clavulánico 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 Amoxicilina/Ácido clavulánico ArdineClav if you are included in any of the above points.Before starting treatment with Amoxicilina/Ácido clavulánico ArdineClav if you are unsure, consult with your doctor or pharmacist.

Be especially careful with Amoxicilina/Ácido clavulánico ArdineClav

Inform 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 Amoxicilina/Ácido clavulánico ArdineClav.

Your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different presentation of Amoxicilina/Ácido clavulánico or another medication.

Symptoms to be aware of

Amoxicilina/Ácido clavulánico ArdineClavmay worsen existing conditions or cause serious side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of certain symptoms while taking Amoxicilina/Ácido clavulánico ArdineClavto reduce the risk of problems. See “Symptoms to be aware of” in thesection 4.

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are taking Amoxicilina/Ácido clavulánico ArdineClav. This is because Amoxicilina/Ácido clavulánico ArdineClav may alter the results of these types of tests.

Use of other medications

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

If you are taking allopurinol (used for gout) with Amoxicilina/Ácido clavulánico ArdineClav, you may be more likely to experience a skin allergic reaction.

If you are taking probenecid (used to treat gout), your doctor may adjust the dose of Amoxicilina/Ácido clavulánico ArdineClav.The concomitant use of probenecid may reduce the excretion of amoxicilina and is not recommended.

If you are taking anticoagulants (such as warfarin) with Amoxicilina/Ácido clavulánico ArdineClav, more blood tests will be required.

Amoxicilina/Ácido clavulánico ArdineClavmay affect the action of methotrexate (a medication used to treat cancer and severe 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, speak with your doctor or pharmacist.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Amoxicilina/Ácido clavulánico ArdineClavmay cause side effects and symptoms that may make you unable to drive.

Do not drive or operate machinery unless you feel well.

Follow exactly the administration instructions for Amoxicilina/Ácido clavulánico ArdineClav as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults and children 40 kg or more

The usual dose is:

•1 tablet administered three times a day

Children under 40 kg

It is preferable to treat children 6 years or less with the oral suspension of Amoxicilina/Ácido clavulánico ArdineClav or the sachets.

Ask your doctor or pharmacist for advice when administering Amoxicilina/Ácido clavulánico ArdineClav tablets to children weighing 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 presentation or another medication.

•If you have liver problems, you will have more frequent blood tests to check how your liver is functioning.

How to take Amoxicilina/Ácido clavulánico ArdineClav

•Swallow the tablets whole with a glass of water at the beginning of meals or a little before.

•Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.

•Do not take Amoxicilina/Ácido clavulánico ArdineClav for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more Amoxicilina/Ácido clavulánico ArdineClav than you should

If you take too much Amoxicilina/Ácido clavulánico ArdineClav, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible. Bring the packaging with you to show the doctor.

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

If you forget to take Amoxicilina/Ácido clavulánico 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 Amoxicilina/Ácido clavulánico ArdineClav

Continue taking Amoxicilina/Ácido clavulánico ArdineClav until you complete the treatment, even if you feel better. You need to take the full treatment to cure the infection. If you do not, the surviving bacteria may cause you to get the infection again.

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

Like all medicines, Amoxicilina/Ácido clavulánico ArdineClavcan cause side effects, although not everyone will experience 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 may appear as red or purple spots on the skin, but can affect other parts of the body
• fever, joint pain, swollen lymph nodes in the neck, armpits, or groin
• swelling, sometimes of the face or mouth (angioedema), which causes difficulty breathing
• collapse

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

Colitis

Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

?Contact your doctor as soon as possibleto advise you, 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 to1 in 10 patients

• thrush (candida– fungal infection of the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses, if this occurs, takeAmoxicilina/Ácido clavulánico ArdineClavbefore meals
• vomiting
• diarrhea (in children).

Uncommon side effects

May affect1 in 100 patients

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

Side effects that may appear in blood tests:

Rare side effects

May affect up to1 in 1,000 patients

• if you experience any of these symptoms, consult a doctor urgently

Side effects that may appear in 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)
• Colitis (see above)
• Meningitis aséptica (inflammation of the protective membrane surrounding the brain)
• Severe skin reactions:

• generalized eruption with blisters and skin peeling, 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 the body surface –toxic epidermal necrolysis)

• generalized eruption with small blisters with pus (exfoliative bullous dermatitis)

• red eruption, with lumps under the skin and blisters (pustular exanthema)
• flu-like symptoms with skin eruption, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils 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 allergic-induced heart attack (Kounis syndrome)
• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children taking 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.
• Crystals in the urine that cause acute kidney injury
• Rash with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Acute pancreatitis.

If you have intense 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.

• hepatitis (inflammation of the liver)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that can turn the skin and white of the eyes yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses ofAmoxicilina/Ácido clavulánicoor who have kidney problems)
• black tongue that appears hairy
• stained teeth (in children), which usually disappears with brushing.

Side effects that may appear in blood or urine tests:

• significant reduction in the number of white blood cells
• low count of red blood cells (hemolytic anemia)
• crystals in the urine.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store at a temperature above25ºC.

Store in the original packaging to protect it fromhumidity.

Keep out of the reach and sight of children.

Do not use Amoxicillin/clavulanate Ardine Clavafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Amoxicilina/Ácido clavulánico ArdineClav500 mg/125 mg film-coated tablets

The active principles are amoxicilina and ácido clavulánico. Each tablet contains:

AAmoxicilina (as amoxicilina trihydrate) 500 mg

Ácido clavulánico (as clavulanate potassium) 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 (hydroxypropylmethylcellulose (E464),Macrogol (polyethylene glycol) 4000 (E1521), Macrogol (polyethylene glycol) 6000 (E1521) and DTitanium dioxide (E-171)), dimethicone 500 and purified water.

Appearance of the product and contents of the package

Long, white, coated tablets with a notch and inscription A/C.

Containers holding 30 or 500 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

REIG JOFRE, S.A Laboratory

Gran Capitan 10, 08970 Sant Joan Despí (Barcelona). Spain

Responsible for manufacturing:

REIG JOFRE, S.A Laboratory

C/Jarama 111. Industrial Park

45007 Toledo. Spain

This leaflet has been reviewed in January 2023.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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