Amoxicillin/clavulanic acid Ardineclav 875/125 mg powder for oral suspension in sachets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin/Clavulanic acid ArdineClav 875 mg/125 mg powder for oral suspension in sachets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet. 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 you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is 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 you take Amoxicillin/Clavulanic acid ArdineClav
3. How to take Amoxicillin/Clavulanic acid ArdineClav
4. Possible side effects
5. How to store 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 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, penicillins, or any of the other components 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 skin rash or swelling of the face or neck

• if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

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

Take special care with Amoxicillin/Clavulanic Acid 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 conditions apply to you, inform your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid ArdineClav.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe 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 be aware of certain symptoms while taking Amoxicillin/Clavulanic Acid ArdineClav to reduce the risk of complications. See "Symptoms to watch for" in section 4.

Blood and urine tests

If you are having blood tests (such as studies of red blood cells or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are 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 you are currently using, or have recently used, any other medicines, including those obtained without a prescription and herbal medicines.

If you are taking allopurinol (used for gout) together 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 your 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, severe psoriasis, or rheumatic diseases). Penicillins may reduce the excretion of methotrexate and potentially increase its adverse effects.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are breastfeeding, speak with your doctor or pharmacist.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid ArdineClav may cause adverse effects, and symptoms may impair your ability to drive.

Do not drive or operate machinery unless you feel well.

Important information about some of the components of Amoxicillin/Clavulanic Acid ArdineClav 875 mg/125 mg powder for oral suspension in sachets

This medicine contains glucose. Patients with glucose or galactose malabsorption problems should not take this medicine.

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

It may cause dental caries.

This medicine contains 12.50 mg of aspartame per sachet.

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Amoxicillin/Clavulanic Acid ArdineClav

Follow exactly the instructions for use of Amoxicillin/Clavulanic Acid ArdineClav as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults and children weighing 40 kg or more

• Usual dose – 1 sachet taken twice daily
• Higher dose – 1 sachet taken three times daily

Children weighing less than 40 kg

Amoxicillin/Clavulanic Acid ArdineClav 875 mg/125 mg sachets are not recommended.

Patients with kidney or liver problems

• If you have kidney problems, your dose may be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor liver function.

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. Stir with a spoon to ensure complete homogenization.
• Take at the beginning of meals or shortly before.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Amoxicillin/Clavulanic Acid ArdineClav for longer than 2 weeks. If you continue to feel unwell, consult your doctor.

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

If you take 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 packaging with you to show the doctor.

You may also call the Toxicology Information Service at telephone number 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 for the full duration of the treatment, even if you feel better. You need to complete the full course to cure the infection. If you do not, surviving bacteria may cause the infection to return.

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

4. Possible adverse effects

Like all medicines, Amoxicillin/Clavulanic Acid ArdineClav may produce adverse effects, although not everyone experiences them. The adverse effects described below may occur when taking this medicine.

Symptoms you should 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 your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic Acid 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 for advice if you experience 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

• thrush (candida – fungal infection in the vagina, mouth, or mucous membranes)

• nausea, especially when taking high doses

  • if this occurs, take Amoxicillin/Clavulanic Acid 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 your 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, which may blister and resemble target-like lesions (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 your doctor urgently

Rare adverse effects that may appear in your 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 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 (exfoliative bullous dermatitis)
  • red rash with bumps under the skin and hives (pustular exanthema)
  • 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 during allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome)
• Drug-induced enterocolitis syndrome (DIES): DIES has been reported primarily 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 central crusts or resembling a "pearl necklace" (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 you experience 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 tubules

• delayed blood clotting

• hyperactivity

• seizures (in patients taking high doses of Amoxicillin/Clavulanic Acid or who have 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

Keep in the original packaging to protect from moisture. No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Amoxicillin/Clavulanic Acid ArdineClav after the expiry date stated on the package. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Information for the user

Composition of Amoxicillin/Clavulanic acid ArdineClav 875 mg/125 mg powder for oral suspension in sachets

The active substances are Amoxicillin and Clavulanic acid. Each sachet contains:

Amoxicillin (as amoxicillin trihydrate) 875 mg

Clavulanic acid (as potassium clavulanate) 125 mg

The other components (excipients) are: Aspartame (E-951) and orange flavouring (containing glucose derived from maize, sucrose and maize starch).

Appearance of the medicine and contents of the container

White to off-white powder.

Pack sizes of 20, 30 and 500 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio Reig Jofré, S.A.

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

Manufacturer:

Laboratorio Reig Jofré, S.A.

C/Jarama 111. Pol Industrial

45007 Toledo

This leaflet was last reviewed in January 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (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.