AMOXICILLIN/CLAVULANIC ACID ARDINECLAV 500/125 mg ORAL SUSPENSION POWDER IN SACHETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin/Clavulanic Acid ArdineClav 500 mg/125 mg powder for oral suspension in sachets 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 has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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. 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 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 is used in adults 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 take Amoxicillin/Clavulanic Acid ArdineClav:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, to penicillins or to any of the other ingredients of Amoxicillin/Clavulanic Acid ArdineClav (see section 6)
• if you 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 you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

• Do not take Amoxicillin/Clavulanic Acid ArdineClav if you are included in any of the above points. Before starting treatment with Amoxicillin/Clavulanic Acid ArdineClav, if you are not sure, consult your doctor or pharmacist.

Be especially careful with Amoxicillin/Clavulanic Acid ArdineClav

Tell 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 not sure if any of the above symptoms affect you, inform your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid ArdineClav.

In some cases, your doctor may investigate the type of bacteria that is causing your infection. Depending on the results, you may be prescribed 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 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 you are having blood tests (such as red blood cell tests or liver function tests) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid ArdineClav. This is because Amoxicillin/Clavulanic Acid ArdineClav can alter the results of these types of tests.

Use of other medicines

Tell 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 Amoxicillin/Clavulanic Acid ArdineClav, you may be more likely to experience a skin allergic reaction.

If you are 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 you are taking anticoagulants (such as warfarin) 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, 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, consult your doctor or pharmacist.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid ArdineClav may have side effects and the symptoms can make you unfit to drive.

Do not drive or operate machinery unless you are feeling well.

Important information about some of the ingredients of Amoxicillin/Clavulanic Acid ArdineClav 500 mg/125 mg powder for oral suspension in sachets

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

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

3. How to take Amoxicillin/Clavulanic Acid ArdineClav

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

Adults and children over 40 kg

The usual dose is:

• 1 sachet three times a day

Children under 40 kg

Amoxicillin/Clavulanic Acid ArdineClav 500 mg/125 mg sachets are not recommended.

Patients with kidney and liver problems

• If you have kidney problems, your dose may be changed. Your doctor may choose a different formulation 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 Amoxicillin/Clavulanic Acid ArdineClav

• Just before taking Amoxicillin/Clavulanic Acid ArdineClav, open the sachet and mix the contents in half a glass of water or juice and stir with a spoon to achieve perfect homogenization
• Take it 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 take Amoxicillin/Clavulanic Acid ArdineClav for more than 2 weeks. If you are still feeling unwell, consult your doctor.

If you take more Amoxicillin/Clavulanic Acid ArdineClav than you should

If you take too much Amoxicillin/Clavulanic Acid ArdineClav, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible. Take the package with you to show the doctor.

You can also call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Amoxicillin/Clavulanic Acid 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 Amoxicillin/Clavulanic Acid ArdineClav

Continue taking Amoxicillin/Clavulanic Acid ArdineClav until you finish the treatment, even if you feel better. You need to take the full treatment to cure the infection. If you do not, the bacteria that survive may cause you to have the infection again.

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 everybody gets 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 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 your doctor immediatelyif you experience any of these symptoms. Stop taking 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 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 in the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses

• if this happens, take Amoxicillin/Clavulanic Acid ArdineClav before meals

• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 patients

• skin rash, itching
• increased itchy rash (urticaria)
• indigestion
• dizziness
• headache.

Uncommon side effects that may appear in your blood tests:

• Increased levels of some substances (enzymes) produced by the liver.

Rare side effects

May affect up to 1 in 1,000 patients

• skin rash, which can form blisters that look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme)

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

Rare side effects that may appear in your 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 not known:

• 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 with pus (bullous exfoliative dermatitis)
  • red rash with bumps under the skin and blisters (pustular exanthematous)
  • flu-like symptoms with skin rash, fever, gland inflammation, 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 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 pancreatitis (inflammation of the pancreas).

If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.

• Contact your doctor immediatelyif you have any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that can make the skin and whites of the eyes turn yellow
• inflammation of the kidney ducts
• 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 red blood cell count (hemolytic anemia)
• crystals in the urine.

If you experience side effects

• If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to 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 Pharmacovigilance System for Human Use Medicines: http://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid ArdineClav

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

Keep out of the reach and sight of children.

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

Do not use Amoxicillin/Clavulanic Acid ArdineClav if the sachets are broken or damaged.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Additional Information

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

The active ingredients are Amoxicillin and Clavulanic Acid. 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 packaging content

Yellowish-white powder with a pleasant taste.

Packaging of 30 and 500 sachets

Marketing authorization holder and manufacturer

Holder:

LABORATORIO REIG JOFRÉ, S.A.

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

Manufacturer:

Laboratorio REIG JOFRE, S.A

C/Jarama 111. Pol Industrial

45007 Toledo

This leaflet was revised 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

Reconstitution instructions

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