KENDO 200 mg /Ml Oral Drops, Solution

Зміст інструкції

1. KENDO 200 mg/ml oral drops, solution
   1. What is Kendo and what is it used for
   2. What you need to know before taking Kendo
   3. How to use Kendo
   4. Possible side effects
   5. How to store Kendo
   6. Contents of the pack and other information

KENDO 200 mg/ml oral drops, solution

Ibuprofen

Read this leaflet carefully before taking this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen 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 you take 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 is Kendo and what is it used for

This medicine contains the active ingredient ibuprofen, belonging to a group of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs) which work by relieving pain (analgesic action) and lowering
body temperature in febrile states (antipyretic action).
Kendo is indicated

• for the treatment of pain of various origins and nature, such as headache, toothache, neuralgia (pain in one or more nerves), bone, joint and muscle pain (osteo-articular and muscular), 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 for the treatment of pain (analgesics), medicines used to lower fever (antipyretics), other anti-inflammatory medicines similar to NSAIDs, or to any of the other components of this medicine (listed in paragraph 6);
• if you are in the last 3 months of pregnancy or if you are breastfeeding (See paragraph “Pregnancy, breastfeeding and fertility”);
• if you suffer from problems with the stomach and intestines associated with the presence of lesions (active or severe gastroduodenal ulcers) or if you suffer from other stomach disorders (gastropathies);
• if you have suffered in the past from disorders of the stomach and intestines associated with bleeding (gastrointestinal hemorrhage, perforation related to previous active treatments or a history of hemorrhage, recurrent peptic ulcer, with two or more distinct episodes of demonstrated ulceration or bleeding);
• if you suffer from severe problems with the liver or kidneys (severe hepatic or renal insufficiency);
• if you suffer from severe heart disorders (severe heart failure);
• if you have lost a lot of fluids (severe dehydration) due to vomiting, diarrhea or insufficient fluid intake.

Do not use Kendo in children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking Kendo.
Consult your pharmacist or nurse if you have an infection (see the paragraph “infections” below).
Avoid taking this medicine if you are already taking other anti-inflammatory medicines (See the paragraph
“Other medicines and Kendo”).
Taking this medicine at high doses and for prolonged treatments 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 determine changes in your diagnostic tests (see also the paragraph “Possible
side effects”).
Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen. Stop Kendo immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.
Take special care with Kendo:
In association with treatment with ibuprofen, severe skin reactions have been reported including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP).
Stop using Kendo and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph 4.
Take this medicine with caution if:

• you are taking other medicines (See the paragraph “Other medicines and Kendo”);
• you have suffered in the past from disorders of the intestine (ulcerative colitis, Crohn's disease);
• if you suffer from heart disorders (congestive heart failure, ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease) or if you think you are at risk of these conditions (for example if you suffer from hypertension, diabetes or high cholesterol or are a smoker);
• if you have high blood pressure;
• if you suffer from respiratory disorders such as asthma, runny nose (chronic rhinitis), presence of polyps in the nose (nasal polyposis), inflammation of the nasal mucosa (sinusitis), or suffer/have suffered from allergies, because you may experience difficulty breathing (bronchospasm), redness of the skin with itching (urticaria) or swelling of the skin and throat (angioedema), especially if you have already had allergic reactions after the use of other medicines used for the treatment of joint or muscle pain, fever or for the treatment of inflammation (NSAIDs). In this case, consult your doctor before taking this medicine.
• if you suffer from a disease that can affect different organs and tissues of the body (systemic lupus erythematosus or systemic lupus) or a disease of the connective tissue, present in many parts of the body, such as bones and cartilage, because in rare cases, symptoms of “aseptic meningitis” have been observed in patients treated with ibuprofen. Although this is more likely to occur in patients with systemic lupus erythematosus and connective tissue diseases, it has also been observed in patients who did not manifest concomitant chronic diseases.
• if you are elderly;
• if you suffer from kidney or liver disorders;
• if you have blood clotting problems;
• if you notice eye problems, especially in case of prolonged treatments, undergo periodic eye examinations. If you experience vision problems, stop treatment with Kendo.

Infections
Kendo may mask the symptoms of infections such as fever and pain. It is therefore possible that Kendo may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox.
If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

Problems with the stomach and/or intestines (gastrointestinal bleeding, ulceration and perforation).
During treatment with anti-inflammatory medicines (NSAIDs), bleeding in the stomach and/or intestines (gastrointestinal bleeding, ulceration and perforation) has occurred. These effects can be fatal and can occur at any time during treatment, with or without symptoms and even if you have not previously suffered from severe stomach and intestinal disorders, especially if you are an elderly person. In this case and in patients with a history of lesions (ulcer) the initial dose should be the lowest possible.
In addition, your doctor may indicate medicines that perform a protective action on the stomach (misoprostol or proton pump inhibitors), especially if you are taking other medicines (for example, aspirin or medicines that increase the risk of gastrointestinal problems.
During treatment with this medicine, especially at the beginning and if you are an elderly person, pay close attention to the symptoms you may have, especially in the stomach and intestines, and if you have suffered from the problems described in the past.
If you experience bleeding or ulceration in the stomach and/or intestines, stop treatment with this medicine.

Skin reactions
Severe skin reactions have been reported in association with treatment with Kendo. Stop taking Kendo and consult your doctor immediately if you experience rash, mucous membrane lesions, blisters or other signs of allergy, as they may be the first signs of a very serious skin reaction.
See paragraph 4.
In adolescents with dehydration, the use of Kendo may lead to alterations in kidney function.
The use of medicines such as Kendo may:

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

Other medicines and Kendo
Tell 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 for the treatment of allergies (corticosteroids);
• medicines used for the treatment of some blood clotting problems (antiplatelet agents, such as low-dose acetylsalicylic acid and coumarin anticoagulants, such as warfarin or heparin);
• medicines used for the treatment of some mental disorders (selective serotonin reuptake inhibitors);
• medicines used for the treatment of 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 and have kidney problems; in these cases you need to take a sufficient amount of fluids, in addition the doctor may periodically check the correct functioning of your kidneys after the start of treatment and in subsequent periods;
• lithium (a medicine used to treat mental illness) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may ask you to undergo 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 some heart diseases). Medicines such as Kendo can worsen heart disease;
• cholestyramine (a medicine used to lower lipids in the blood);
• cyclosporine (medicines used if you have had an organ transplant), because medicines such as Kendo can increase the risk of kidney damage;
• herbal extracts such as Ginkgo Biloba, because if taken together with medicines such as Kendo, they can increase the risk of gastrointestinal bleeding;
• mifepristone (a medicine used in women to induce abortion);
• quinolone antibiotics (medicines used to treat infections), because if taken together with medicines such as Kendo, there is a possible increased risk of developing seizures;
• sulfonylureas, medicines used to treat diabetes; if treatment with these drugs is necessary, your doctor may have you undergo blood tests;
• tacrolimus, a medicine used to prevent and treat rejection in case of organ transplantation, 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 have you undergo 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), oxipentifylline (a medicine for treating leg ulcers) because they can increase the side effects on the stomach and intestines;
• baclofen, a medicine for relaxing muscles.

During treatment in association with other medicines, you must take a sufficient amount of fluids; after the start of treatment, it is recommended to perform checks on kidney function.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Kendo in the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. Kendo can cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor longer than expected.
You should not take Kendo in the first 6 months of pregnancy, unless absolutely necessary and under the advice of your doctor.
If treatment is necessary during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, Kendo can cause kidney problems in the fetus, if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing the narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is necessary 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.
Stop treatment with this medicine if you intend to become pregnant, if you have fertility problems or if you are to undergo investigations on fertility, because this medicine may temporarily impair your fertility.

Driving and using machines
This medicine can cause drowsiness, dizziness or depression, which can alter the ability to drive vehicles and use machinery. If this should occur, avoid driving vehicles and using machinery.

Kendo contains:
Sucrose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine;

Sodium sulfite
Rarely it can cause severe hypersensitivity reactions and bronchospasm;

Ethanol (contained in the aroma)
This medicine contains 66 mg of alcohol (ethanol) per dose of 50 drops (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 parahydroxybenzoate
This medicine contains methyl parahydroxybenzoate which can cause allergic reactions (even delayed);

Potassium
This medicine contains 259 mg (6.6 mmol) of potassium per maximum daily dose. This should be taken into
consideration in people with reduced kidney function or who are following 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 following the instructions provided in this leaflet, or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
You must use the lowest effective dose for the shortest period necessary to relieve symptoms.
If you have an infection, consult your doctor immediately if symptoms (such as fever and pain)
persist or worsen (see section 2).

Use in adults and adolescents over 12 years
The recommended dose is 25-50 drops 2-3 times a day (25 drops = 200 mg of ibuprofen).
The maximum recommended dose is 50 drops 3 times a day.
Do not exceed the recommended doses, especially if you are an elderly person, if you have kidney or liver problems,
take the lowest indicated dose.
You can take Kendo on an empty stomach.
However, if you have stomach problems, it is preferable to take the medicine on a full stomach.
If, after 3 days of treatment, you do not notice an improvement in your health condition, consult your doctor.
If adolescents (aged 12 years or older) need to take the medicine 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 the cap and simultaneously turn it
counterclockwise until it opens (Fig. 1).
Place the bottle upright, with the opening facing down (Fig. 2).
Wait a few seconds until the liquid starts to descend.
If the liquid does not descend, tap the bottom of the bottle 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 you should, or if your child has mistakenly taken this medicine, always contact
a doctor or the nearest hospital to obtain advice on the risk and recommendations regarding
actions to be taken.
Symptoms of an overdose may appear within 4 – 6 hours of taking ibuprofen.
Symptoms of an overdose may include nausea, stomach pain, abdominal pain, vomiting (possibly
with traces of blood), a 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, it has been
reported drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children),
weakness and dizziness, blood in the urine, low potassium levels in the blood, feeling cold to the body and
breathing problems.
Rarely, it may present: uncontrolled eye movements (nystagmus), lowering of body temperature (hypothermia), effects on the kidney, bleeding of the stomach and intestines, profound loss
of consciousness (coma), temporary cessation of breathing (apnea), diarrhea, reduction of the activity of the nervous system (depression of the Central Nervous System) and respiratory activity (depression of the respiratory system).
Furthermore, it may also manifest: disorientation, a state of excitement, fainting, lowering of
blood pressure (hypotension), decrease or increase in heart rate (bradycardia or tachycardia).
If you take significantly high doses of ibuprofen, you may experience serious damage to the kidneys and
liver.
In cases of severe poisoning, metabolic acidosis (increased acids in the blood) may occur.
If you have any doubts about the use of Kendo, consult your doctor or pharmacist

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

4. Possible side effects

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

• reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genitals 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 and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The following side effects may occur, which generally resolve with discontinuation of
treatment:

Common (may affect up to 1 in 10 people)

• dizziness
• discomfort
• fatigue

Uncommon (may affect up to 1 in 100 people)

• increased stomach acidity (gastritis);
• allergic reactions such as skin rash, hives, itching, rash, formation of red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), asthma, difficulty breathing (bronchospasm or dyspnea), asthma attacks with low blood pressure;
• insomnia, anxiety;
• numbness of the limbs or other parts of the body, drowsiness;
• nasal congestion (rhinitis);
• difficulty breathing (bronchospasm, dyspnea);
• temporary interruption of breathing (apnea);
• visual disturbances;
• impaired hearing;
• ringing in the ears (tinnitus);
• vertigo;
• liver disorders (altered liver function);
• liver inflammation (hepatitis);
• yellowing of skin and eyes (jaundice);
• skin reactions to light (photosensitivity reaction);
• kidney diseases (damage to renal function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure).

Rare (may affect up to 1 in 1000 people)

• disease that can affect different organs and tissues of the body (lupus erythematosus);
• reduction in the number of blood cells: reduction of white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (hemolytic anemia and aplastic anemia), platelets (thrombocytopenia);
• inhibition of platelet aggregation which can lead to bleeding;
• depression, confusion, hallucinations;
• inflammation of the optic nerve (optic neuritis);
• inflammation of the meninges, the membranes that cover the brain (aseptic meningitis), especially in patients with pre-existing autoimmune disorders (See section “Warnings and Precautions”), with symptoms of stiff neck, 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 a part of the body (edema);
• alteration of the results of some diagnostic tests: increase in liver enzyme levels (increased transaminases), and alkaline phosphatase concentrations, reduction of hemoglobin (protein that carries oxygen to tissues), reduction of the percentage of blood occupied by red blood cells (hematocrit), prolongation of bleeding time, decrease in blood calcium levels and increase in 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 it difficult to breathe, rapid heartbeat, severe allergic reaction with rapid onset and that can cause death (anaphylaxis), severe skin disorders (blistering reactions including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis and erythema multiforme);
• feeling of perceiving your heartbeat (palpitations)
• heart disease (heart failure);
• heart attack (myocardial infarction);
• fluid buildup around the lungs (acute pulmonary edema);
• increased blood pressure (hypertension);
• liver disease (hepatic failure).

Not known (frequency cannot be estimated based on available data)

• feeling of heaviness in the stomach;
• nausea;
• vomiting;
• diarrhea;
• flatulence;
• constipation;
• digestive disorders (dyspepsia);
• abdominal and epigastric pain;
• heartburn;
• blood in the stool (melena) and in the vomit (hematemesis);
• inflammation of the mouth with formation of lesions (ulcerative stomatitis);
• worsening of some 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, perforation or gastrointestinal bleeding, sometimes fatal), especially in elderly people.
• It is possible that a serious 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 cells).
• A widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Kendo if you develop these symptoms and contact your doctor immediately. See also paragraph 2.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the website:
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 Kendo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
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 protect the environment.

6. Contents of the pack and other information

What Kendo contains
Kendo 200 mg/ml oral drops, solution
The active ingredient is ibuprofen. Each ml of solution contains 200 mg of ibuprofen.
The other ingredients are: sucrose, glycerol, potassium hydroxide, anhydrous sodium sulfite, polysorbate 20,
methyl parahydroxybenzoate, disodium citrate dihydrate, sodium saccharin, sodium edetate, flavour of
orange/lemon/caramel, erythrosine (E127), purified water.

Description of the appearance of Kendo and contents of the pack
Kendo is presented as drops for oral solution.
Each pack contains 1 bottle of 12.5 ml or 20 ml of solution equipped with a dropper.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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)