PATIENT INFORMATION LEAFLET

Amoxicillin/Clavulanic Acid ArdineClav 100 mg/12.5 mg/ml Powder for Oral Suspension EFG

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 is usually prescribed for babies or children and should not be given to others, even if they have the same symptoms as your child, as it may harm them.
• If you consider any of the side effects you are experiencing to be serious or if you notice any side effects not mentioned in this leaflet, inform 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” which sometimes may lose its effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico ArdineClav 100 mg/12.5 mg/ml powder for oral suspension is used in babies 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 administer Amoxicilina/Ácido clavulánico ArdineClav to your child:

• if they are allergic (hypersensitive) to amoxicilina, ácido clavulánico or to any of the other components of Amoxicilina/Ácido clavulánico ArdineClav (see section 6)
• if they 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 they have ever had liver problems or jaundice (yellow discoloration of the skin) when taking an antibiotic.

• Do not give Amoxicilina/Ácido clavulánico ArdineClav to your child if any of the above points apply. Before starting treatment if you are unsure, speak with your doctor or pharmacist.

Be particularly careful with Amoxicilina/Ácido clavulánico ArdineClav

Inform your doctor or pharmacist before administering this medication to your child if:

• they have infectious mononucleosis
• they are receiving treatment for liver or kidney problems
• they do not urinate regularly.

If you are unsure whether any of the above symptoms affect your child, inform your doctor or pharmacist before taking Amoxicilina/Ácido clavulánico ArdineClav.

In some cases, your doctor may investigate the type of bacteria causing your child's infection. Depending on the results, your child may receive a different presentation of Amoxicilina/Ácido clavulánico or another medication.

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 your child is 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 your child is undergoing blood tests (such as studies of red blood cell status or studies to check liver function) or urine tests (to monitor glucose levels), inform your doctor or nurse that they 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 your child is using or has recently used other medications, including those obtained without a prescription and herbal medications.

If your child is taking allopurinol (used for gout) with Amoxicilina/Ácido clavulánico ArdineClav, they may be more likely to have a skin allergic reaction.

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

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

Amoxicilina/Ácido clavulánico ArdineClav may affect the mode of action of methotrexate (a medication for cancer or rheumatic diseases).Penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

Pregnancy and breastfeeding

If your daughter is taking this medication and is pregnant or breastfeeding, inform your doctor or pharmacist.

Ask your doctor or pharmacist before taking any medication.

Important information about one of the components of Amoxicilina/Ácido clavulánico ArdineClav 100 mg/12.5 mg/ml powder for oral suspension

• Amoxicilina/Ácido clavulánico ArdineClav contains aspartame (E-951) which is a source of phenylalanine. This medication may be harmful to children with phenylketonuria.

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

Adults and children weighing 40 kg or more

• It is not usually recommended for adults and children weighing more than 40 kg. Ask your doctor or pharmacist for advice.

Children weighing less than 40 kg

All doses are expressed in relation to the child's body weight in kilograms.

• Your doctor will advise you how much Amoxicilina/Ácido clavulánico ArdineClav to give to your baby or child.
• You will be provided with a plastic dosing syringe. You must use it to give the correct dose to your baby or child.
• The usual dose is – 40 mg/5 mg to 80 mg/10 mg per kilogram of body weight per day, administered in three divided doses.

Patients with kidney and liver problems

• If your child has kidney problems, the dose may be reduced. Your doctor may choose a different presentation or another medication.
• If your child has liver problems, blood tests will be performed more frequently to check how their liver is functioning.

How to administer Amoxicilina/Ácido clavulánico ArdineClav

• Always shake the bottle well before each dose
• Administer at the beginning of meals or a little before
• Space doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not administer Amoxicilina/Ácido clavulánico ArdineClav to your child for more than two weeks. If your child continues to feel unwell, they should return to see the doctor.

If you administer more Amoxicilina/Ácido clavulánico ArdinneClav than you should

If you administer too much Amoxicilina/Ácido clavulánico ArdineClav to your child, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or convulsions may appear. Consult your doctor as soon as possible.

Take the bottle 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 administer Amoxicilina/Ácido clavulánico ArdineClav

If you forget to administer a dose to your child, give it to them as soon as you remember. Do not give them the next dose too soon, wait at least 4 hours before giving them the next dose.

If your child stops taking Amoxicilina/Ácido clavulánico ArdineClav

Continue administering Amoxicilina/Ácido clavulánico ArdineClav to your child until they have completed the treatment, even if they are feeling better. Your child needs to take the complete treatment to help them fight the infection. If bacteria survive, they will get the infection again.

If you have any other doubts about the use of this product, consult 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 appear with this medicine.

Be aware of these symptoms

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 of the face or mouth (angioedema), which can cause difficulty breathing
• collapse.

• Contact a doctor immediatelyif your child experiences any of these symptoms.

Stop administering 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 possibleso they can advise you if your child has 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 Amoxicilina/Ácido clavulánico ArdineClav before meals

• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 patients

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

Uncommon 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 resemble small darts (erythema multiforme)

• If you have any of these symptoms, consult a doctor urgently

Uncommon 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 exanthema)
  • flu-like symptoms with skin rash, 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 can be a symptom of allergic-induced myocardial infarction (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 abdominal area, this could be a sign of acute pancreatitis

• Contact a doctor immediately if your child has 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 can 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 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 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 are experiencing are severe or if you notice any side effect not mentioned in this leafletinform 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.

Dry Powder

Do not store at a temperature above 25 °C. Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Liquid Suspension

Store in the refrigerator (2 °C – 8 °C). Do not freeze.

Once reconstituted, the suspension must be used within the first 7 days.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe signs of deterioration.

Medicines should not be disposed of through the drains or in the trash. Dispose of the containers and medicines that you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition of Amoxicillin/Clavulanic Acid ArdineClav 100 mg/12.5 mg/ml powder for oral suspension

Each ml of suspension contains:

Amoxicillin (as amoxicillin trihydrate) 100 mg

Clavulanic acid (as potassium clavulanate) 12.5 mg

The other components (excipients) are: anhydrous colloidal silica, hydrated colloidal silica, succinic acid, xanthan gum, hydroxypropylmethylcellulose, sodium benzoate (E-211), aspartame (E-951), raspberry flavoring and orange flavoring.

Appearance of the product and contents of the package

White powder

It is presented in containers of 40 and 120 ml. The 40 ml container includes a dosing syringe and the 120 ml container includes a spoon, to facilitate the administration of the product.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Reig Jofré, S.A Laboratory

Gran Capitán, 10

08970 Sant Joan Despí- Barcelona

Responsible for manufacturing:

Reig Jofré, S.A Laboratory

c/ Jarama 111 Industrial Estate

45007 Toledo

This leaflet has been reviewed in January 2023.

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

Instructions for the correct administration of the preparation

Administration with dosing syringe (40 ml containers):

1. Invert the bottle to release the powder adhering to the bottom. Complete with water up to the line indicated on the label and shake before use.
2. Remove the cap from the bottle and insert the syringe into the bottle once the suspension has been prepared.
3. Pull the plunger to the graduation corresponding to the dosage indicated by the doctor.
4. Remove the syringe through the mouth of the bottle.
5. Proceed with administration
6. After use, rinse the syringe and close the bottle. Store in the refrigerator and shake always before use.

Administration with spoon (120 ml containers):

1. Invert the bottle to release the powder adhering to the bottom. Complete with water up to the line indicated on the label and shake before use.

2. Administer the amount of suspension indicated by the doctor using the spoon provided.

3. Proceed with administration.

4. After use, rinse the spoon and close the bottle. Store in the refrigerator and shake always before use.