PROSPECTO: INFORMATION FOR THE USER

Amoxicilina/Ácido clavulánico ArdineClav875mg/125mg film-coated tablets EFG

Read this prospectus carefully before starting to take the medicine.

-Keep this prospectus, as you may need to read it again.
-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you (or your child) and should not be given to others, even if they have the same symptoms, as it may harm them.

-If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

1. What Amoxicilina/Ácido clavulánico ArdineClavis and for what it is used

2. Before taking Amoxicilina/Ácido clavulánico ArdineClav

3. How to take Amoxicilina/Ácido clavulánico ArdineClav

4. Possible adverse effects

5. Storage of Amoxicilina/Ácido clavulánico ArdineClav

6. Additional information

Amoxicilina/Ácido clavulánico ArdineClavis 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 children and adults to 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

Do not take Amoxicilina/Ácido clavulánicoArdineClav:

•If you are allergic (hypersensitive) to amoxicilina, ácido clavulánico, penicilinas, or any of the other components 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 (yellow discoloration of the skin) when taking an antibiotic.

?Do not take Amoxicilina/ácido clavulánicoArdineClavif 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 clavulánicoArdineClav

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 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 medicine.

Symptoms to be aware of

Amoxicilina/Ácido clavulánico ArdineClav may 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 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 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 medicines

Inform 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 alopurinol (used for gout) with Amoxicilina/ Ácido clavulánico 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 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 ArdineClav may affect the action of methotrexate (a medicine used to treat cancer and psoriasis or rheumatic diseases). Penicillins may reduce the excretion of methotrexate and cause a potential increase in 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 operating machinery

Amoxicilina/ Ácido clavulánico ArdineClav may 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

•Usual dose – 1 tablet administered twice a day

•Higher dose – 1 tablet administered three times a day

Children under 40 kg of weight

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

Seek advice from your doctor or pharmacist when administering Amoxicilina/Ácido clavulánico ArdineClav 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 two doses in one 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 to your 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 the infection to return.

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 skin eruption 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)

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

• red skin 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.
• kidney damage due to crystals in the urine
• skin eruption 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.

• liver inflammation (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that may 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:

• significantly reduced white blood cell count
• low red blood cell count (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 from humidity.

Keep out of the reach and sight of children.

Do not use Amoxicillin/Clavulanate ArdineClavafter 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 packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Amoxicilina/Ácido clavulánico ArdineClav 875 mg/125mg film-coated tablets

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

875 mg of amoxicilina (as amoxicilina trihydrate) and 125 mg of ácido clavulánico (as clavulanate potassium)

The other components (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 content of the packaging

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

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

REIG JOFRE, S.A Laboratory

Gran Capitan 10, 08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing:

REIG JOFRE, S.A Laboratory

C/Jarama 111. Industrial Park

45007 Toledo

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