AMOXICILLIN/CLAVULANIC ACID ARDINECLAV 100/12.5 mg/ml ORAL SUSPENSION POWDER

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin/Clavulanic Acid ArdineClav 100 mg/12.5 mg/ml powder for oral suspension 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 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 think any of the side effects that your child is experiencing is serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Contents of the pack:

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

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

Amoxicillin/Clavulanic Acid ArdineClav is an antibiotic that eliminates the bacteria that cause infections. It contains two different drugs called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins" that can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/Clavulanic Acid 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 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 give Amoxicillin/Clavulanic Acid ArdineClav to your child:

• if they are allergic (hypersensitive) to amoxicillin, clavulanic acid, or any of the other components of Amoxicillin/Clavulanic Acid ArdineClav (see section 6)
• if they have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This could include a skin rash or swelling of the face or neck
• if they have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

• Do not give Amoxicillin/Clavulanic Acid ArdineClav to your child if any of the above applies. Before starting treatment, if you are unsure, talk to your doctor or pharmacist.

Be careful with Amoxicillin/Clavulanic Acid ArdineClav

Tell your doctor or pharmacist before giving this medicine 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 not sure if any of the above symptoms affect your child, tell your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid ArdineClav.

In some cases, your doctor may investigate the type of bacteria that causes your child's infection. Depending on the results, your child may receive 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, convulsions, and inflammation of the large intestine. You should be aware of certain symptoms while your child is 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 your child is having blood tests (such as red blood cell status or liver function tests) or urine tests (to check glucose levels), tell your doctor or nurse that they are taking Amoxicillin/Clavulanic Acid ArdineClav. This is because Amoxicillin/Clavulanic Acid ArdineClav can alter the results of these types of tests.

Using other medicines

Tell your doctor or pharmacist if your child is using or has recently used other medicines, including those obtained without a prescription and herbal medicines.

If your child is taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid 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 Amoxicillin/Clavulanic Acid ArdineClav. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

If anticoagulants (such as warfarin) are taken 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 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 going to take this medicine and is pregnant or breastfeeding, tell your doctor or pharmacist.

Ask your doctor or pharmacist before taking any medicine.

Important information about some of the ingredients of Amoxicillin/Clavulanic Acid ArdineClav 100 mg/12.5 mg/ml powder for oral suspension

• Amoxicillin/Clavulanic Acid ArdineClav contains aspartame (E-951), which is a source of phenylalanine. This medicine may be harmful to children with phenylketonuria.

3. How to take Amoxicillin/Clavulanic Acid ArdineClav

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

Adults and children over 40 kg

• This medicine is not normally recommended for adults and children who weigh more than 40 kg. Ask your doctor or pharmacist for advice.

Children under 40 kg

All doses are expressed based on the child's body weight in kilograms.

• Your doctor will advise you on how much Amoxicillin/Clavulanic Acid 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 formulation or another medicine.
• If your child has liver problems, they will have more frequent blood tests to check how their liver is working.

How to take Amoxicillin/Clavulanic Acid ArdineClav

• Always shake the bottle well before each dose
• Give at the start of meals or a while before
• Space out the doses during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not give Amoxicillin/Clavulanic Acid ArdineClav to your child for more than two weeks. If your child is still feeling unwell, they should see a doctor again.

If you give your child too much Amoxicillin/Clavulanic Acid ArdineClav

If you give your child too much Amoxicillin/Clavulanic Acid ArdineClav, they may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible.

Take the bottle 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 give Amoxicillin/Clavulanic Acid ArdineClav

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

If your child stops taking Amoxicillin/Clavulanic Acid ArdineClav

Continue giving Amoxicillin/Clavulanic Acid ArdineClav to your child until the treatment is finished, even if they feel better. Your child needs to take the full treatment to help combat the infection. If bacteria survive, the infection will return.

If you have any other questions about 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 everyone gets them. The effects described below may occur with 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 your child experiences any of these symptoms.

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

• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 patients

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

Uncommon side effects that may appear in 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 that can form blisters, resembling small targets (erythema multiforme)

Rare side effects that may appear in blood or urine 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)
• Inflammation of the large intestine (see above)
• Inflammation of the membrane that surrounds the brain (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)
  • flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as elevated liver enzymes and eosinophilia) (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 necklace (linear IgA disease)
• Inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis)
• Acute inflammation of the pancreas (acute pancreatitis).

If your child has severe and persistent stomach pain, this could be a sign of acute pancreatitis

• Contact a doctor immediatelyif 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 cause the skin and whites of the eyes to turn yellow
• delayed blood clotting
• hyperactivity
• convulsions (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 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.

If you experience side effects

tell 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 listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: http://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Amoxicillin/Clavulanic Acid ArdineClav

Dry powder

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

Do not use this medicine 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 medicine out of the sight and reach of children.

Do not use this medicine 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 medicine if you notice signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Additional Information

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 flavor and orange flavor.

Appearance of the Product and Packaging Contents

White powder

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

Marketing Authorization Holder and Manufacturer

Holder:

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10

08970 Sant Joan Despí - Barcelona

Manufacturer:

Laboratorio Reig Jofré, S.A.

c/ Jarama 111 Industrial Estate

45007 Toledo

This prospectus was reviewed in January 2023.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

Instructions for Correct Administration of the Preparation

Administration with a dosing syringe (40 ml containers):

1. Invert the bottle to loosen the powder stuck to the bottom. Fill 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 made.
3. Pull the plunger up to the graduation corresponding to the dose 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 always shake before use.

Administration with a spoon (120 ml containers):

1. Invert the bottle to loosen the powder stuck to the bottom. Fill 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 attached spoon.
3. Proceed with administration.
4. After use, rinse the spoon and close the bottle. Store in the refrigerator and always shake before use.