KRUXADE 875 mg/125 mg Proszek Do Sporządzania Zawiesiny Doustnej

Treść ulotki

1. Kruxade 875 mg/125 mg powder for oral suspension in sachets, 875 mg/125 mg film-coated tablets
   1. WHAT IS KRUXADE AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KRUXADE
2. Kruxade 875 mg/125 mg powder for oral suspension, contains sucrose therefore
   1. HOW TO TAKE KRUXADE
   2. POSSIBLE SIDE EFFECTS
   3. HOW TO STORE KRUXADE
   4. PACKAGE CONTENTS AND OTHER INFORMATION

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

Generic medicine
Amoxicillin/clavulanic acid

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 IS KRUXADE AND WHAT IT IS USED FOR

Kruxade is an antibiotic that works by killing the bacteria that cause infections.
It contains two different medicines called amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of medicines called “penicillins” whose
activity can sometimes be blocked (they are inactivated).
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 NEED TO KNOW BEFORE YOU TAKE KRUXADE

Do not take Kruxade:

• if you are allergic to amoxicillin, clavulanic acid, penicillin or to any of the other ingredients 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 problems with your liver or jaundice (yellowing of the skin) when you have taken an antibiotic.

Do not take Kruxade if any of these apply to you.If you are unsure, talk to 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 problems with your liver or kidneys
• do not urinate regularly.

If you are not sure whether any of the above applies to you, talk to your doctor or pharmacist before taking Kruxade.
In some cases, your doctor may perform a test to assess the type of bacteria that caused your infection. Based on the results, they may prescribe a different dose of Kruxade or a different medicine.

Conditions you need to be aware of
Kruxade can worsen some existing conditions or cause serious side effects. These may include allergic reactions, convulsions and inflammation of the intestines. You should be aware of certain symptoms while taking Kruxade in order to reduce any risk. See “ Conditions you need to be aware of

of” in Section 4.
Blood and urine tests
If you are about to have blood tests (such as tests related to red blood cells or liver function tests) or urine tests (for glucose), tell your doctor or nurse that you are taking Kruxade. This is because Kruxade can affect the results of these types of tests.

Other medicines and Kruxade
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking allopurinol (used for gout) with Kruxade, you are very likely to have an allergic skin 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, you may need to have additional blood tests.
Kruxade can affect the mechanism of action of methotrexate (a medicine used to treat tumors or rheumatic diseases).
Kruxade can affect the functioning of mycophenolate mofetil (a drug used to prevent rejection of transplanted organs).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Kruxade can have side effects and the symptoms may make you unfit to drive vehicles. Do not drive vehicles or use machines unless you feel well.

Important information about some excipients
Kruxade 875 mg/125 mg film-coated tablets contains less than 1 mmol (23
mg) of sodium per dose, i.e. essentially ‘sodium-free’.

Kruxade 875 mg/125 mg powder for oral suspension, contains sucrose therefore

if your doctor has diagnosed you with an intolerance to some sugars, contact them before
taking this medicine.

3. HOW TO TAKE KRUXADE

Take this medicine exactly as your doctor or
pharmacist has instructed. If you have any doubts, ask 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 a day
• Higher dose - 1 sachet three times a day

875 mg/125 mg film-coated tablets

• Usual dose - 1 tablet twice a day
• Higher dose - 1 tablet three times a day

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 are not
recommended.

Patients with kidney and liver problems

• If you have kidney problems, the dose may be adjusted. Your doctor may choose a different dosage or a different medicine.
• If you have liver problems, you may be required to have more frequent blood tests to check how your liver is working.

How to take Kruxade

Powder for oral suspension

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

Film-coated tablets

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

If you take more Kruxade than you should
If you take too much Kruxade, symptoms may include stomach upset
(nausea, vomiting or diarrhoea) or convulsions. Tell your doctor as soon as possible.
Bring the medicine packaging or the bottle to show to the doctor.

If you forget to take Kruxade
If you forget to take a dose, take it as soon as you remember. You should not
take the next dose too soon, but wait about 4 hours. Do not take
a double dose to make up for a missed dose.

If you stop taking Kruxade
Continue to take Kruxade until the treatment is finished, even if you feel
better. You need every dose to fight the infection. If some bacteria
survive, they can cause the infection to return.
If you have any further questions about the use of this medicine, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Kruxade can cause side effects, although not everybody gets them. The side effects that may occur with this medicine are listed below.

Conditions you should pay attention to
Allergic reactions:

• skin rash
• inflammation of the blood vessels ( vasculitis) which may be visible 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), which causes difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome)

Contact your doctor immediatelyif any of these symptoms occur. Stop taking Kruxade.
Intestinal inflammation
Intestinal inflammation, which causes 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 enterocolitic syndrome (DIES):
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a certain type of allergic reaction with the main symptom of repetitive vomiting (1-4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.

Contact your doctoras soon as possible for advice if these symptoms occur

Very common side effects
May affect more than 1 in 10 people

• diarrhoea (in adults).

Common side effects
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 you suffer from this, take Kruxade with meals
• vomiting
• diarrhoea (in children).

Uncommon side effects
May affect up to 1 in 100 people

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

Uncommon side effects can be seen from blood tests:

• increase in some proteins ( enzymes) produced by the liver.

Rare side effects
May affect up to 1 in 1000 people

• skin rashes, which may appear as blisters and look like small targets (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 side effects can be seen from blood tests:

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

Frequency not known
The 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 detachment, particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome), and a more severe form, causing extensive skin detachment (more than 30% of the body surface - toxic epidermal necrolysis)
• widespread red rash with small blisters containing pus ( bullous exfoliative dermatitis)
• rash, red, with scabs and swellings under the skin and blisters (pustulous exanthem)
• flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased number of white blood cells (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms).

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

• rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease)
• inflammation of the liver ( hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) which can cause the skin and whites of the eyes to appear yellow
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• convulsions (in people taking high doses of Kruxade or who have kidney problems)
• black tongue that appears covered in hair
• stains on teeth (in children), usually removed by brushing.

Side effects that can be seen from blood or urine tests:

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects 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 pack after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.
Store Kruxade in the original package to protect the product from light and
humidity.
Store at a temperature not exceeding 25°C.

6. PACKAGE CONTENTS AND OTHER INFORMATION

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

• active ingredient: 875 mg of Amoxicillin + 125 mg of Clavulanic Acid
• excipients: colloidal silicon dioxide, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hypromellose, titanium dioxide, macrogol 4000, macrogol 6000, dimethicone.

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

• active ingredient: 875 mg of Amoxicillin + 125 mg of Clavulanic Acid
• excipients: colloidal silicon dioxide, lemon aroma, strawberry aroma, xanthan gum, sucrose.
• See section 2 for further information regarding one of the excipients of Kruxade 875 mg/125 mg film-coated tablets and Kruxade 875 mg/125 mg oral suspension powder.

Description of the appearance of Kruxade and contents of the pack
Film-coated tablets: blister pack of 12 tablets.
Oral suspension powder: pack of 12 sachets.

Marketing Authorisation 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
Behavioral hygiene
Antibiotics are used to treat bacterial infections. They are not effective
for viral infections.
Sometimes an infection caused by bacteria does not respond to antibiotic therapy. The
most common reason for this is that the bacteria causing the infection are
resistant to the antibiotic being used. This means that the bacteria survive
and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for several reasons. By using antibiotics in
a proper manner, the emergence of bacterial resistance can be reduced.
When your doctor prescribes antibiotic therapy, it is indicated only for the
disease you currently have. Pay attention to the following advice, in order to avoid
the emergence of bacterial resistance which causes the blocking of antibiotic activity.

• 1. It is very important that you take the antibiotic at the correct dose, at the scheduled times

if it is not clear to you, ask your doctor or pharmacist for clarification.

• 2. Do not take antibiotics if they have not been expressly prescribed for you and use them only for the infection for which they have been prescribed.
• 3. Do not use antibiotics that have been prescribed to other people, even if you have a similar infection to theirs.
• 4. Do not give antibiotics prescribed expressly for you to others.
• 5. If you have any antibiotic left over at the end of the treatment, return it to the pharmacist so that it can be disposed of properly.

Instructions for reconstitution
The contents of the sachets must be dissolved in half a glass of water before
administration.