PATIENT INFORMATION LEAFLET

ArdineClav 500 mg/125 mg Powder for Oral Suspension in EFG Blister Packs

Read this 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) and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you think you are having a serious side effect or if any of the side effects get serious, or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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 ArdineClav is used in adults and children 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 clavulánico ArdineClav:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, 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 (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 your doctor or pharmacist.

Be especially careful with Amoxicilina/Ácido clavulánico 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 symptoms affect you, inform your doctor or pharmacist before taking Amoxicilina/ Ácido clavulánico ArdineClav.

In some cases, 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 allopurinol (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 amoxicillin and is not recommended.

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

Amoxicilina/Ácido clavulánico ArdineClav may affect the action of methotrexate (a medicine 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 to your doctor or pharmacist.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery:

Amoxicilina/Ácido clavulánico ArdineClav may have side effects and symptoms may make you unable to drive.

Do not drive or operate machinery unless you feel well.

Important information about one of the components of Amoxicilina/Ácido clavulánico ArdineClav 500 mg/125 mg powder for oral suspension in sachets:

This medicine contains saccharose and glucose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

Patients with diabetes mellitus should note that this medicine contains 3.5 g of saccharose per sachet.

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 three times a day

Children under 40 kg of weight

Amoxicilina/Ácido clavulánico ArdineClav 500 mg/125 mg sachets, is not recommended.

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

How to take Amoxicilina/Ácido clavulánico ArdineClav

• Just before taking Amoxicilina/ Ácido clavulánico ArdineClav, open the sachet and mix the contents in half a glass of water or juice and shake with a spoon to achieve perfect homogenization
• Take it 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 upset (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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 ArdineClav can cause side effects, although not everyone will experience them. The side effects described below may occur when taking this medication.

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 glands in the neck, armpits, or groin
• swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing
• collapse.

• Contact your 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 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 of the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses

• if this happens, take Amoxicilina/Ácido clavulánico ArdineClav before meals

• vomiting
• diarrhea (in children).

Uncommon side effects

May affect 1 in 100 patients

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

Side effects that may appear in blood 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 may form blisters that look like small darts (erythema multiforme)

• if you have any of these symptoms, consult your doctor urgently

Side effects that may appear in blood tests:

• low count of cells involved in blood clotting
• low white blood cell count

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)
• inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• severe skin reactions:
• generalized 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 (toxic epidermal necrolysis)
• generalized rash with small blisters with pus (exfoliative bullous dermatitis)
• red rash, with lumps under the skin and blisters (pustular exanthem)
• flu-like symptoms with skin rash, fever, swollen glands, 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 myocardial infarction (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES): DIES has mainly been reported 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.

• Contacta doctor immediately if you experience any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that may turn the skin and the white of the eyes yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• convulsions (in patients taking high doses of Amoxicilina/Ácido clavulánico or with kidney problems)
• black tongue that looks 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 red blood cell count (hemolytic anemia)
• crystals in the urine.

If you have side effects

• If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet,inform your doctor or pharmacist.

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 not mentioned in this leaflet. You can also report them directly through the Spanish System for the 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 above 25°C.

Store in the original packaging to protect it from light and humidity.

Keep out of reach and sight of children.

Do not use Amoxicillin/Clavulanate ArdineClav after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not use Amoxicillin/Clavulanate ArdineClav if the packets are torn or damaged.

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 Amoxicillin/Clavulanic Acid ArdineClav 500 mg/125 mg powder for oral suspension in sachets

The active principles are Amoxicillin and Acid clavulanic. Each sachet contains Amoxicillin (as amoxicillin trihydrate) 500 mg

Clavulanic acid (as potassium clavulanate) 125 mg

The other components (excipients) are: Silicon dioxide, anhydrous trisodium citrate, sucrose, raspberry flavoring (contains glucose in maltodextrin from corn and glucose) and fruit flavoring (contains glucose).

Appearance of the product and contents of the packaging

White-yellowish powder and pleasant taste.

Packaging of 30 and 500 sachets

Holder of the marketing authorization and responsible for manufacturing

Holder:

Laboratorio REIG JOFRÉ, S.A.

Gran Capitán, 10, 08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing:

Laboratorio REIG JOFRE, S.A

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

Instructions for reconstitution

Empty the contents of the sachet into 10-20 ml of water, shake until a suspension is obtained, and take immediately.