Kendo

Italy
Brand name Kendo
Form drops, oral solution
Active substance / Dosage
IBUPROFENE
Prescription type Over-the-counter
ATC code
M01AE01
Registration number 038061
Manufacturer ABC FARMACEUTICI S.P.A.
Kendo drops, oral solution

Table of Contents

Package leaflet: Information for the patient

KENDO 200 mg/ml oral drops, solution

Ibuprofen
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

  • Keep this leaflet. You may need to read it again.
  • If you need more information or advice, consult your pharmacist.
  • If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
  • Talk to your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What Kendo is and what it is used for

This medicinal product contains the active substance ibuprofen, belonging to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which work by relieving pain (analgesic effect) and reducing body temperature in feverish conditions (antipyretic effect).
Kendo is indicated:

  • for the treatment of pain of various origin and nature, such as headache, toothache, neuralgia (nerve pain), bone, joint and muscle pain (osteo-articular and muscular pain), and menstrual pain;
  • as an adjunct in the treatment of symptoms of fever and influenza.

Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before taking Kendo

Do not take Kendo

  • if you are allergic to ibuprofen, acetylsalicylic acid, other medicines used to treat pain (analgesics), medicines used to reduce fever (antipyretics), or other similar anti-inflammatory medicines (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
  • if you are in the last 3 months of pregnancy or if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
  • if you have stomach or intestinal problems associated with lesions (active or severe gastroduodenal ulcer) or other stomach disorders (gastropathies);
  • if you have previously experienced stomach or intestinal disorders associated with bleeding (gastrointestinal haemorrhage, perforation related to previous active treatment, or history of bleeding, recurrent peptic ulcer with two or more distinct episodes of proven ulceration or bleeding);
  • if you have severe liver or kidney problems (severe hepatic or renal insufficiency);
  • if you have severe heart problems (severe heart failure);
  • if you have lost a significant amount of fluids (severe dehydration) due to vomiting, diarrhoea, or insufficient fluid intake.

Do not use Kendo in children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Kendo.
Talk to your pharmacist or nurse if you have an infection (see section “Infections” below).
Avoid taking this medicine if you are already taking other anti-inflammatory medicines (see section
“Other medicines and Kendo”).
Taking this medicine at high doses and for prolonged periods may increase the risk of heart problems (stroke and heart attack).
The risk of side effects can be reduced by using the lowest effective dose for the shortest possible time.
The use of Kendo may cause changes in your diagnostic test results (see also section “Possible
side effects”).
Signs of an allergic reaction to ibuprofen have been reported, including breathing difficulties, swelling of the face and neck (angioedema), and chest pain. Stop taking Kendo immediately and contact your doctor or emergency medical services right away if you notice any of these signs.
Exercise particular caution with Kendo:
Serious skin reactions have been reported in association with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
Stop using Kendo and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Take this medicine with caution if:

  • you are taking other medicines (see section “Other medicines and Kendo”);
  • you have previously suffered from intestinal disorders (ulcerative colitis, Crohn’s disease);
  • you have heart problems (congestive heart failure, ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease) or think you may be at risk of these conditions (for example, if you have hypertension, diabetes, high cholesterol, or are a smoker);
  • you have high blood pressure;
  • you have respiratory disorders such as asthma, runny nose (chronic rhinitis), nasal polyps (nasal polyposis), inflammation of the nasal mucosa (sinusitis), or suffer/have suffered from allergies, as you may experience breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema), especially if you have previously had allergic reactions after using other medicines used to treat joint or muscle pain, fever, or inflammation (NSAIDs). In this case, consult your doctor before taking this medicine.
  • you suffer from a disease that can affect multiple organs and tissues in the body (systemic or disseminated lupus erythematosus) or a connective tissue disorder present in many parts of the body, such as bones and cartilage, as symptoms of “aseptic meningitis” have been observed in rare cases in patients treated with ibuprofen. Although this is more likely to occur in patients with systemic lupus erythematosus and related connective tissue disorders, it has also been observed in patients without concomitant chronic diseases.
  • you are elderly;
  • you have kidney or liver problems;
  • you have blood clotting disorders;
  • you experience eye problems, especially during prolonged treatment, regular ophthalmological checks are recommended. If you experience vision disturbances, stop treatment with Kendo.

Infections
Kendo may mask symptoms of infections such as fever and pain. Therefore, Kendo could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
Stomach and/or intestinal problems (gastrointestinal bleeding, ulceration and perforation).
During treatment with anti-inflammatory medicines (NSAIDs), bleeding in the stomach and/or intestine (gastrointestinal haemorrhage, ulceration and perforation) has occurred. These effects can be fatal and may occur at any time during treatment, with or without warning symptoms, and even if you have not previously suffered from serious stomach or intestinal disorders, especially if you are elderly. In such cases and in patients with a history of lesions (ulcers), the initial dose should be as low as possible.
Additionally, your doctor may prescribe medicines that protect the stomach (misoprostol or proton pump inhibitors), especially if you are taking other medicines (e.g., aspirin or medicines that increase the risk of gastrointestinal problems).
During treatment with this medicine, especially at the beginning and if you are elderly, pay close attention to any symptoms, particularly those affecting the stomach and intestine, and if you have previously experienced the problems described.
If gastrointestinal bleeding or ulceration occurs, discontinue treatment with this medicine.
Skin reactions
Serious skin reactions have been reported in association with Kendo treatment. Stop taking Kendo and consult your doctor immediately if you develop a skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction.
See section 4.
In adolescents with dehydration, the use of Kendo may lead to impaired kidney function.
The use of medicines like Kendo may:

  • be associated with the development of kidney diseases, even severe ones (such as renal papillary necrosis, analgesic nephropathy, and renal failure); therefore, your doctor will monitor your kidney function;
  • mask signs and symptoms of ongoing infections (fever, pain, swelling)

Other medicines and Kendo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and consult your doctor if you are taking the following medicines:

  • medicines used to reduce inflammation and treat allergies (corticosteroids);
  • medicines used to treat certain blood clotting disorders (antiplatelet agents, such as low-dose acetylsalicylic acid, and anticoagulants such as warfarin or heparin);
  • medicines used to treat certain mental disorders (selective serotonin reuptake inhibitor antidepressants);
  • medicines used to treat high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II antagonists such as losartan), especially if you are elderly or have kidney problems; in these cases, it is important to maintain adequate fluid intake, and your doctor may periodically check your kidney function after starting treatment and during follow-up periods;
  • lithium (a medicine used to treat mental illnesses) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may ask you to have blood tests;
  • methotrexate, a medicine used to treat cancer or rheumatoid arthritis;
  • moclobemide, a medicine used to treat depression;
  • aminoglycosides (antibiotic medicines);
  • cardiac glycosides (medicines used to treat certain heart conditions). Medicines like Kendo may worsen heart disease;
  • cholestyramine (a medicine used to lower blood lipids);
  • cyclosporine (medicines used if you have had an organ transplant), as medicines like Kendo may increase the risk of kidney damage;
  • herbal extracts such as Ginkgo biloba, as when taken together with medicines like Kendo, they may increase the risk of gastrointestinal bleeding;
  • mifepristone (a medicine used in women to induce abortion);
  • quinolone antibiotics (medicines used to treat infections), as when taken together with medicines like Kendo, there may be an increased risk of seizures;
  • sulfonylureas, medicines used to treat diabetes; if concomitant treatment is necessary, your doctor may perform blood tests;
  • tacrolimus, a medicine used to prevent and treat organ transplant rejection; concomitant administration with Kendo may increase the risk of kidney damage;
  • zidovudine and ritonavir, medicines used to treat AIDS; if concomitant treatment is necessary, your doctor may perform blood tests;
  • probenecid, a medicine used to treat gout;
  • CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat fungal infections);
  • alcohol, bisphosphonates (medicines for treating bone diseases), oxpentifylline (a medicine for treating leg ulcers), as they may increase gastrointestinal side effects;
  • baclofen, a medicine used to relax muscles.

During combination treatment with other medicines, you must maintain adequate fluid intake; after starting treatment, kidney function monitoring is recommended.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Kendo during the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. Kendo may cause kidney and heart problems in the fetus. It may affect your and your baby’s tendency to bleed and delay or prolong labour beyond the expected duration.
You should not take Kendo during the first 6 months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From the 20th week of pregnancy, Kendo may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Do not take this medicine if you are breastfeeding, as ibuprofen passes into breast milk.
Discontinue treatment with this medicine if you plan to become pregnant, have fertility problems, or are undergoing fertility investigations, as this medicine may temporarily impair fertility.
Driving and using machines
This medicine may cause drowsiness, dizziness, or depression, which may affect your ability to drive or operate machinery. If this occurs, avoid driving and using machinery.
Kendo contains:
Sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine;
Sodium sulfite
Rarely may cause severe hypersensitivity reactions and bronchospasm;
Ethanol (contained in the flavouring)
This medicine contains 66 mg of alcohol (ethanol) per 50-drop dose (2 mL equivalent to 400 mg of ibuprofen). The amount in 2 mL of this medicine is equivalent to less than 2 mL of beer or 1 mL of wine.
The small amount of alcohol in this medicine will not produce significant effects.
Methyl 4-hydroxybenzoate
This medicine contains methyl 4-hydroxybenzoate, which may cause allergic reactions (including delayed reactions);
Potassium
This medicine contains 259 mg (6.6 mmol) of potassium per maximum daily dose. This should be considered in individuals with reduced kidney function or those on a low-potassium diet;
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to use Kendo

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).

Use in adults and adolescents over 12 years of age
The recommended dose is 25–50 drops 2–3 times daily (25 drops = 200 mg of ibuprofen).
The maximum recommended dose is 50 drops three times daily.
Do not exceed the recommended doses, especially if you are elderly or have kidney or liver problems; in such cases, use the lowest indicated dose.
Kendo may be taken on an empty stomach.
However, if you have gastric problems, it is preferable to take the medicine with food.
If you do not notice any improvement in your condition after 3 days of treatment, consult your doctor.
If adolescents (aged 12 years or older) require treatment for more than 3 days, or if symptoms worsen, consult a doctor.

Instructions for use
The bottle has a child-resistant closure: to open, press down on the cap and simultaneously turn it counterclockwise until it opens (Fig. 1).
Place the bottle upright with the opening facing downwards (Fig. 2).

Two blue drawings show hands opening a vial and a hand holding it upside down to release a drop of liquid

Wait a few seconds until the liquid starts to flow.
If the liquid does not flow, tap the bottom of the bottle gently with a finger 3–4 times.
Before taking, briefly mix the contents of the glass.

If you take more Kendo than you should
If you have taken more Kendo than recommended, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risk and actions to take.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Symptoms of overdose may include nausea, stomach ache, abdominal pain, vomiting (possibly with traces of blood), deep sleep with reduced response to normal stimuli (lethargy), drowsiness, headache, ringing in the ears (tinnitus), dizziness, confusion, uncontrolled eye movements, uncontrolled body movements (convulsions), and loss of consciousness. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness, dizziness, blood in urine, low potassium levels in blood, feeling cold, and breathing difficulties may occur.
Rarely, the following may occur: uncontrolled eye movements (nystagmus), lowering of body temperature (hypothermia), kidney problems, gastrointestinal bleeding, deep loss of consciousness (coma), temporary cessation of breathing (apnea), diarrhoea, reduced activity of the central nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, disorientation, excited state, fainting, low blood pressure (hypotension), and decreased or increased heart rate (bradycardia or tachycardia) may occur.
If significantly high doses of ibuprofen are taken, severe kidney and liver damage may occur.
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may develop.

If you have any doubts about how to use Kendo, consult your doctor or pharmacist.

If you forget to take Kendo
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking ibuprofen and contact your doctor immediately if you notice any of the following symptoms:

  • Flat red spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
  • Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
  • Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized pustular eruption).

The following side effects may occur, which generally resolve upon discontinuation of treatment:
Common (may affect up to 1 in 10 people)

  • Dizziness
  • Malaise
  • Fatigue

Uncommon (may affect up to 1 in 100 people)

  • Increased stomach acidity (gastritis);
  • Allergic reactions such as skin rash, urticaria, itching, exanthema, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), asthma, breathing difficulties (bronchospasm or dyspnea), asthma attacks with low blood pressure;
  • Insomnia, anxiety;
  • Numbness of limbs or other body parts, drowsiness;
  • Nasal congestion (rhinitis);
  • Breathing difficulties (bronchospasm, dyspnea);
  • Temporary interruption of breathing (apnea);
  • Visual disturbances;
  • Hearing impairment;
  • Ringing in the ears (tinnitus);
  • Vertigo;
  • Liver problems (altered liver function);
  • Inflammation of the liver (hepatitis);
  • Yellowing of the skin and eyes (jaundice);
  • Skin reactions to light (photosensitivity reaction);
  • Kidney disorders (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and renal failure).

Rare (may affect up to 1 in 1,000 people)

  • Disease that may affect various organs and tissues of the body (lupus erythematosus);
  • Reduction in blood cell counts: reduction in white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (hemolytic anemia, aplastic anemia), platelets (thrombocytopenia);
  • Inhibition of platelet aggregation which may lead to bleeding;
  • Depression, confusion, hallucinations;
  • Inflammation of the optic nerve (optic neuritis);
  • Inflammation of the meninges, the membranes covering the brain (aseptic meningitis), especially in patients with pre-existing autoimmune disorders (see section “Warnings and Precautions”), with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation;
  • Worsening of inflammation caused by an existing infection (e.g., development of necrotizing fasciitis);
  • Eye disorders with visual disturbances and inflammation of the optic nerve (toxic optic neuritis);
  • Swelling due to fluid accumulation in part of the body (edema);
  • Changes in results of certain diagnostic tests: increased levels of liver enzymes (elevated transaminases), increased alkaline phosphatase concentrations, reduced hemoglobin (the protein that carries oxygen to tissues), reduced percentage of blood volume occupied by red blood cells (hematocrit), prolonged bleeding time, decreased blood calcium levels, and increased blood uric acid levels;
  • Increased concentration of non-protein nitrogen in the blood (hyperazotemia).

Very rare (may affect up to 1 in 10,000 people)

  • Inflammation of the pancreas, a gland involved in digestive processes (pancreatitis);
  • Severe allergic reactions, which may include symptoms such as swelling of the face, tongue, and throat making breathing difficult, rapid heartbeat, severe and rapidly developing allergic reaction that may be fatal (anaphylaxis), severe skin disorders (bullous reactions including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, and erythema multiforme);
  • Awareness of your own heartbeat (palpitations);
  • Heart disease (heart failure);
  • Heart attack (myocardial infarction);
  • Accumulation of fluid around the lungs (acute pulmonary edema);
  • Increased blood pressure (hypertension);
  • Liver disease (hepatic failure).

Not known (frequency cannot be estimated from the available data)

  • Feeling of heaviness in the stomach;
  • Nausea;
  • Vomiting;
  • Diarrhea;
  • Flatulence;
  • Constipation;
  • Digestive problems (dyspepsia);
  • Abdominal and epigastric pain;
  • Heartburn;
  • Blood in stools (melena) and in vomit (hematemesis);
  • Mouth inflammation with lesion formation (ulcerative stomatitis);
  • Worsening of certain intestinal disorders (colitis and Crohn's disease);
  • Increased risk of heart problems (stroke and heart attack), especially if you take this medicine at high doses;
  • Formation of lesions in the stomach or intestine (peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal), particularly in elderly people.
  • A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell).
  • A widespread, red, scaly rash with pustules under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop taking Kendo if you develop these symptoms and contact your doctor immediately. See also section 2.
  • Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Kendo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
The expiry date applies to the product when kept in its original, undamaged packaging and stored correctly.
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.

6. Pack contents and other information

What Kendo contains
Kendo 200 mg/ml oral drops, solution
The active substance is ibuprofen. Each ml of solution contains 200 mg of ibuprofen.
The other components are: sucrose, glycerol, potassium hydroxide, anhydrous sodium sulfite, polysorbate 20,
methyl parahydroxybenzoate, sodium dihydrate citrate, sodium saccharin, sodium edetate, orange/lemon/caramel
flavour, erythrosine (E127), purified water.
Description of the appearance of Kendo and pack contents
Kendo is presented as oral drops solution.
Each pack contains one bottle of 12.5 ml or 20 ml of solution with a dropper.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10015 S. Bernardo d’Ivrea (TO)