Amoxicillin/clavulanic acid Ardineclav 100/12.5 mg/ml powder for oral suspension EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin/Clavulanic acid ArdineClav 100 mg/12.5 mg/ml powder for oral suspension EFG

Read the entire leaflet carefully before starting to take this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine is usually prescribed for babies or children and should not be given to other people, even if they have the same symptoms as your child, as it could harm them.
• If you consider any of the side effects your child experiences to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Amoxicillin/Clavulanic acid ArdineClav is and what it is used for
2. Before administering Amoxicillin/Clavulanic acid ArdineClav
3. How to administer Amoxicillin/Clavulanic acid ArdineClav
4. Possible side effects
5. Storage of 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 kills bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins" which can sometimes become ineffective (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 infants 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 administering Amoxicillin/Clavulanic Acid ArdineClav

Do not administer Amoxicillin/Clavulanic Acid ArdineClav to your child:

• if he or she is allergic (hypersensitive) to amoxicillin, clavulanic acid, or any of the other components of Amoxicillin/Clavulanic Acid ArdineClav (see section 6)

• if he or she has ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This could include skin rash or swelling of the face or neck

• if he or she has ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

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

Take special care with Amoxicillin/Clavulanic Acid ArdineClav

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

• he or she has infectious mononucleosis
• he or she is receiving treatment for liver or kidney problems
• he or she does not urinate regularly.

If you are unsure whether any of the above conditions affect your child, inform your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid 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 formulation of Amoxicillin/Clavulanic Acid or another medicine.

Symptoms to watch for

Amoxicillin/Clavulanic Acid ArdineClav may worsen certain existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should watch for certain symptoms while your child is taking Amoxicillin/Clavulanic Acid ArdineClav, to reduce the risk of complications. See "Symptoms to watch for" in section 4.

Blood and urine tests

If your child is undergoing blood tests (such as studies of red blood cell status or tests to check liver function) or urine tests (to monitor glucose levels), inform your doctor or nurse that he or she is taking Amoxicillin/Clavulanic Acid ArdineClav. This is because Amoxicillin/Clavulanic Acid ArdineClav may alter the results of these types of tests.

Use of other medicines

Inform your doctor or pharmacist if your child is using or has recently used any 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, he or she may be more likely to develop 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, additional blood tests will be required.

Amoxicillin/Clavulanic Acid ArdineClav may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases). Penicillins may reduce methotrexate excretion and potentially increase its adverse effects.

Pregnancy and breastfeeding

If your daughter is pregnant or breastfeeding and is to take this medicine, inform your doctor or pharmacist.

Ask your doctor or pharmacist before taking any medicine.

Important information about some of the components 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 exactly the instructions given by your doctor for taking Amoxicillin/Clavulanic acid ArdineClav. If you have any doubts, consult your doctor or pharmacist.

Adults and children weighing 40 kg or more

• Amoxicillin/Clavulanic acid ArdineClav is not usually recommended for adults and children weighing more than 40 kg. Seek advice from your doctor or pharmacist.

Children weighing less than 40 kg

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

• Your doctor will advise you on how much Amoxicillin/Clavulanic acid ArdineClav to give your baby or child.
• A plastic dosing syringe will be provided. You must use it to administer the correct dose to your baby or child.
• Usual dose – 40 mg/5 mg up to 80 mg/10 mg per kilogram of body weight per day, given in three divided doses.

Patients with kidney or 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, blood tests will be performed more frequently to monitor liver function.

How to take Amoxicillin/Clavulanic acid ArdineClav

• Always shake the bottle well before each dose.
• Take at the beginning of a meal or shortly before eating.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not give Amoxicillin/Clavulanic acid ArdineClav to your child for longer than two weeks. If your child still feels unwell, you must see the doctor again.

If you give more Amoxicillin/Clavulanic acid ArdineClav than you should

If you give your child too much Amoxicillin/Clavulanic acid ArdineClav, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible.

Take the bottle with you to show the doctor.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication 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 administering the next dose.

If your child stops taking Amoxicillin/Clavulanic acid ArdineClav

Continue giving your child Amoxicillin/Clavulanic acid ArdineClav for the full duration of the treatment, even if they start to feel better. Your child must complete the full course to effectively fight the infection. If bacteria survive, the infection may return.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Amoxicilina/Ácido clavulánico ArdineClav may produce adverse effects, although not everyone experiences them. The effects described below may occur with this medicine.

Symptoms to watch for

Allergic reactions:

• skin rash

• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may 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 a doctor immediately if your child experiences any of these symptoms.

Stop administering Amoxicilina/Ácido clavulánico ArdineClav.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

• Contact your doctor as soon as possible to receive advice if your child has these symptoms.

Very common adverse effects

May affect more than 1 in 10 patients

• diarrhoea (in adults)

Common adverse effects

May affect up to 1 in 10 patients

• mouth, vaginal or mucosal fungal infection (candidiasis)

• nausea, especially when taking high doses

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

• vomiting

• diarrhoea (in children)

Uncommon adverse effects

May affect up to 1 in 100 patients

• skin rash, itching
• increased itchy rash (urticarial wheals)
• indigestion
• dizziness
• headache

Uncommon adverse effects that may appear in blood tests:

• increase in certain substances (enzymes) produced by the liver

Rare adverse effects

May affect up to 1 in 1,000 patients

• skin rash that may form blisters resembling small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

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

Rare adverse effects that may appear in blood tests:

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

Other adverse effects

Other adverse effects that have occurred in a very small number of patients, with unknown frequency.

• Allergic reactions (see above)

• Inflammation of the large intestine (see above)

• Inflammation of the protective membrane surrounding 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 skin peeling (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread rash with small pus-filled blisters (bullous exfoliative dermatitis)
  • red rash with bumps under the skin and blisters (exanthematous pustulosis)
  • flu-like symptoms with skin rash, fever, swollen glands and abnormal blood test results (such as increased white blood cells (eosinophilia) 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 an allergic-triggered heart attack (Kounis syndrome)

• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. It is a type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure

• Crystals in the urine causing acute kidney injury

• Blistering rash arranged in circles with a central crust or resembling a string of pearls (linear IgA disease)

• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

• Acute inflammation of the pancreas (acute pancreatitis)

If you have severe and persistent pain in the stomach 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 increased bilirubin in the blood (a substance produced by the liver), which may cause the skin and whites of the eyes to turn yellow

• inflammation of the kidney ducts

• delayed blood clotting

• hyperactivity

• seizures (in patients taking high doses of Amoxicilina/Ácido clavulánico or with kidney problems)

• black, hairy-looking tongue

• stained teeth (in children), which usually disappear with brushing

Adverse effects that may appear in blood or urine tests:

• significant reduction in white blood cell count
• low red blood cell count (haemolytic anaemia)
• crystals in the urine

If you experience adverse effects

• If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid ArdineClav

Dry powder

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Liquid suspension

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

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

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if signs of deterioration are observed.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers 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 flavoring, and orange flavoring.

Appearance of the product and contents of the container

Whiteish powder

Available in 40 ml 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, Polígono Industrial

45007 Toledo

This leaflet was last reviewed in January 2023.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

Instructions for the correct administration of the preparation

Administration using the dosing syringe (40 ml containers):

1. Invert the bottle to dislodge any powder adhering to the bottom. Add water up to the mark indicated on the label and shake well before use.
2. Unscrew the bottle cap and insert the syringe into the bottle after the suspension has been prepared.
3. Pull the plunger to the graduation corresponding to the dose prescribed by the physician.
4. Remove the syringe through the neck of the bottle.
5. Proceed with administration.
6. After use, rinse the syringe and close the bottle. Store in the refrigerator and always shake well before use.

Administration using the spoon (120 ml containers):

1. Invert the bottle to dislodge any powder adhering to the bottom. Add water up to the mark indicated on the label and shake well before use.
2. Administer the amount of suspension prescribed by the physician using the provided spoon.
3. Proceed with administration.
4. After use, rinse the spoon and close the bottle. Store in the refrigerator and always shake well before use.