Kruxade

PACKAGE LEAFLET: INFORMATION FOR THE USER

Kruxade 875 mg/125 mg powder for oral suspension in sachets, 875 mg/125 mg film-coated tablets

Generic medicine
Amoxicillin/clavulanic acid
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Kruxade is and what it is used for
2. What you need to know before taking Kruxade
3. How to take Kruxade
4. Possible side effects
5. How to store Kruxade
6. Contents of the pack and other information

1. WHAT KRUXADE IS AND WHAT IT IS USED FOR

Kruxade is an antibiotic that works by killing bacteria that cause infections.
It contains two different medicines called amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of medicines known as "penicillins," whose
activity can sometimes be blocked (rendered inactive).
The other active component (clavulanic acid) prevents this from happening.
Kruxade 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. WHAT YOU SHOULD KNOW BEFORE TAKING KRUXADE

Do not take Kruxade:

• if you are allergic to amoxicillin, clavulanic acid, penicillin, or any of the other components of this medicine (listed in section 6)
• if you have had a severe allergic reaction to any other antibiotic. This may include a skin rash or swelling of the face or throat
• if you have had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

Do not take Kruxade if any of the above apply to you. If you have any doubts, speak with your
doctor or pharmacist before taking Kruxade.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine if you:

• have infectious mononucleosis
• have been treated for liver or kidney problems
• do not urinate regularly.

If you are unsure whether any of the conditions listed above apply to you, discuss them with your doctor or
pharmacist before taking Kruxade.
In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection. Based on the results,
they may prescribe a different dose of Kruxade or a different medicine.
Conditions to which you should pay attention
Kruxade may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and
inflammation of the intestine. You should be aware of certain symptoms while taking Kruxade in order to reduce any risk. See "Conditions to which you should pay attention" in Section 4.
Blood and urine tests
If you are about to have blood tests (for example, tests related to red blood cells or liver function) or urine tests (for glucose),
inform your doctor or nurse that you are taking Kruxade. This is because Kruxade may affect the results of these tests.
Other medicines and Kruxade
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
If you are taking allopurinol (used for gout) together with Kruxade, you are more likely to develop a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Kruxade.
If you are taking medicines (such as warfarin) that help prevent blood clots together with Kruxade, additional blood tests may be needed.
Kruxade may affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Kruxade may affect how mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs) works.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Kruxade may cause side effects that could affect your ability to drive. Do not drive or operate machinery unless you feel well enough to do so.
Important information about some excipients
Kruxade 875 mg/125 mg film-coated tablets contain less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".
Kruxade 875 mg/125 mg oral suspension powder contains sucrose. Therefore, if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE KRUXADE

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and children weighing 40 kg or more
875 mg/125 mg powder for oral suspension in sachets

• Recommended dose – 1 sachet twice daily
• Higher dose – 1 sachet three times daily

875 mg/125 mg film-coated tablets

• Usual dose – 1 tablet twice daily
• Higher dose – 1 tablet three times daily

Children weighing less than 40 kg
875 mg/125 mg film-coated tablets
Children up to 6 years of age should preferably be treated with amoxicillin/clavulanic acid powder for oral suspension or sachets.
Ask your doctor or pharmacist for advice on administering Kruxade tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.

875 mg/125 mg powder for oral suspension
Kruxade 875 mg/125 mg powder for oral suspension in sachets is not recommended.

Patients with kidney or liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
• If you have liver problems, you may require more frequent blood tests to monitor liver function.

How to take Kruxade
Powder for oral suspension

• Just before taking Kruxade, open the sachet and mix the contents in half a glass of water.
• Take with food.
• Space doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Kruxade for longer than 2 weeks. If you continue to feel unwell, you must return to your doctor.

Film-coated tablets

• Take with food.
• Swallow the tablet whole with a glass of water.
• Space doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Kruxade for longer than 2 weeks. If you continue to feel unwell, you must return to your doctor.

If you take more Kruxade than you should
If you take too much Kruxade, symptoms may include stomach disturbances (nausea, vomiting, or diarrhoea) or seizures. Inform your doctor as soon as possible. Bring the medicine pack or container to show your doctor.

If you forget to take Kruxade
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early; wait approximately 4 hours. Do not take a double dose to make up for a missed dose.

If you stop taking Kruxade
Continue taking Kruxade for the full duration of treatment, even if you feel better. You need every dose to fight the infection. If some bacteria survive, they may cause the infection to return.

If you have any questions about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Kruxade can cause adverse reactions, although not everyone experiences them. The adverse reactions that may occur with this medicine are listed below.

Conditions you should pay attention to

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis), which may appear as raised red or purple spots on the skin, but can affect other parts of the body
• fever, joint pain, swelling of the lymph nodes in the neck, armpit, or groin
• swelling, sometimes of the face or throat (angioedema), causing breathing difficulties
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome)

Contact your doctor immediately if any of these symptoms occur. Stop taking Kruxade.

Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually accompanied by blood and mucus, stomach pain and/or fever.

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.

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

Contact your doctor as soon as possible for advice if you experience these symptoms.

Very common adverse reactions
May affect more than 1 in 10 people

• diarrhoea (in adults)

Common adverse reactions
May affect up to 1 in 10 people

• thrush (candida – a fungal infection of the vagina, mouth, or skin folds)
• nausea, especially when taking high doses: if affected, take Kruxade with meals
• vomiting
• diarrhoea (in children)

Uncommon adverse reactions
May affect up to 1 in 100 people

• skin rashes, itching
• raised itchy rash (urticaria)
• indigestion
• dizziness
• headache

Uncommon adverse reactions may be detected through blood tests:

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

Rare adverse reactions
May affect up to 1 in 1,000 people

• skin rashes, which may appear as blisters and look like small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme). If you notice any of these symptoms, contact your doctor urgently.

Rare adverse reactions may be detected through blood tests:

• low number of cells involved in blood clotting
• low number of white blood cells

Frequency not known
Frequency cannot be estimated from the available data

• Allergic reactions (see above)
• Intestinal inflammation (see above)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Severe skin reactions:
  • widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin detachment (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis)
  • red rash with crusts, swellings under the skin, and blisters (pustular exanthema)
  • flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms – DRESS)

If you experience any of these symptoms, contact your doctor immediately.

• rash with blisters arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease)
• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin levels in the blood (a substance produced in the liver), which may make the skin and whites of the eyes appear yellow
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Kruxade or who have kidney problems)
• black hairy tongue
• tooth staining (in children), usually removable by brushing

Adverse reactions that may be detected through blood or urine tests:

• severe reduction in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in the urine leading to acute kidney damage

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE KRUXADE

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the
environment.
Store Kruxade in the original packaging to protect the product from light and
moisture.
Store at a temperature not exceeding 25°C.

6. PACK CONTENTS AND OTHER INFORMATION

What Kruxade contains
Kruxade 875 mg/125 mg film-coated tablets
Each tablet contains:

• Active substance: 875 mg Amoxicillin + 125 mg Clavulanic Acid
• Excipients: colloidal anhydrous silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hypromellose, titanium dioxide, macrogol 4000, macrogol 6000, dimethicone.

Kruxade 875 mg/125 mg powder for oral suspension
Each sachet contains:

• Active substance: 875 mg Amoxicillin + 125 mg Clavulanic Acid
• Excipients: colloidal anhydrous silica, lemon flavour, strawberry flavour, xanthan gum, sucrose.
  • See section 2 for further information on one of the excipients in Kruxade 875 mg/125 mg film-coated tablets and Kruxade 875 mg/125 mg powder for oral suspension.

Description of the appearance of Kruxade and pack contents
Film-coated tablets: carton containing 12 tablets.
Powder for oral suspension: carton containing 12 sachets.
Marketing Authorization Holder
Eberlife farmaceutici S.p.A. - Via G. Porzio snc, 80143 CDN Isola E1, Napoli
Manufacturer
Laboratorio Reig Jofré, S.A.
C/Jarama s/n, Poligono Industrial
45007 Toledo - Spain
2024
Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes a bacterial infection does not respond to antibiotic treatment. The most common reason for this is that the bacteria causing the infection are resistant to the antibiotic being used. This means that bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons. By using antibiotics appropriately, you can help reduce the emergence of bacterial resistance.
When your doctor prescribes you an antibiotic, it is intended only for the illness you currently have. Please pay attention to the following advice to help prevent the emergence of bacterial resistance, which can lead to loss of antibiotic effectiveness.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the full prescribed duration. Read the instructions in this leaflet carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection they were prescribed for.
3. Do not use antibiotics prescribed for other people, even if you have a similar infection.
4. Do not give your antibiotics, prescribed specifically for you, to other people.
5. If you have leftover antibiotic after completing your treatment, return it to the pharmacist for proper disposal.

Reconstitution instructions
The contents of the sachets must be dissolved in half a glass of water before administration.