Kidofen max

Package leaflet: information for the patient

Kidofen max, 250 mg/5 mL, oral suspension
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 1 day (infants aged 3–5 months) or 3 days (infants over 6 months of age, children and adolescents), consult your doctor.

Leaflet contents

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

1. What Kidofen max is and what it is used for

Kidofen max is an analgesic, antipyretic and anti-inflammatory medicine. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The medicine contains the active substance ibuprofen.
Indications
Fever of various origins (including viral infections and post-vaccination reactions).
Pain of various origins with mild to moderate intensity:

• headaches, sore throat and muscle pain, e.g. during viral infections;
• muscle, joint and bone pain due to musculoskeletal injuries (strains, sprains);
• soft tissue injuries, postoperative pain;
• toothache, pain following dental procedures, teething pain;
• headache;
• ear pain occurring in inflammatory conditions of the middle ear.

Kidofen max is intended for short-term use. If symptoms persist or worsen, or if new symptoms occur, consult your doctor.

2. Important information before taking Kidofen max

When not to take Kidofen max

• if the patient is allergic to ibuprofen or other similar pain-relieving medicines (from the group of nonsteroidal anti-inflammatory drugs - NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
• if asthma, rhinitis, facial and (or) hand swelling, or urticaria occurred after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, because Kidofen max may cause similar adverse reactions in such patients;
• if the patient currently has or has ever had peptic ulcer disease of the stomach and (or) duodenum or gastrointestinal bleeding (two or more confirmed cases of ulceration or bleeding);
• if gastrointestinal bleeding or perforation (gastrointestinal tract perforation) has ever occurred related to the use of NSAIDs;
• if the patient has severe liver or kidney failure;
• if the patient has severe heart failure;
• if there is cerebral hemorrhage (bleeding from cerebral vessels) or any other active bleeding;
• if there are blood formation disorders of unknown origin;
• in patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake). Do not take the medicine during the last 3 months of pregnancy.

Warnings and precautions
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have occurred during treatment.
If any of these symptoms occur, Kidofen max should be discontinued immediately and medical help should be sought without delay.
Before starting Kidofen max, discuss the following with your doctor or pharmacist:

• if the patient has certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
• if the patient has hereditary blood formation disorders (e.g., acute intermittent porphyria);
• if the patient has or has ever had intestinal diseases (such as: chronic inflammatory bowel disease, ulcerative colitis, or Crohn's disease, manifesting, among others, with chronic diarrhea), because symptoms may worsen (see section 4: "Possible side effects");
• if the patient has ever had or currently has hypertension and (or) heart failure;
• if the patient has impaired kidney or liver function – during long-term treatment, liver and kidney function parameters and blood morphology should be monitored;
• if the patient has blood clotting disorders (ibuprofen may prolong bleeding time);
• if the patient has bronchial asthma or allergies (current or past), as bronchospasm may occur after taking the medicine;
• if the patient has hay fever, nasal polyps, or chronic obstructive pulmonary disease, as the risk of allergic reactions is increased. Allergic reactions may present as asthma attacks (so-called drug-induced asthma), angioedema, or urticaria;
• if the patient is taking other medicines that may increase the risk of ulceration or bleeding (such as: oral corticosteroids – e.g., prednisolone), anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet drugs (such as acetylsalicylic acid);
• if the patient is simultaneously taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), as concurrent use of these drugs should be avoided;
• if the patient has recently undergone major surgery;
• if the patient is 65 years of age or older, as the risk of adverse effects of the drug increases, especially gastrointestinal bleeding and perforation of the stomach or duodenal wall, which may be fatal. The patient should inform the doctor of any unusual gastrointestinal symptoms (especially bleeding and pain), particularly during the initial treatment period;
• if the patient has chickenpox – use of this medicine is not recommended;
• prolonged use of any pain-relieving medicines may lead to headaches that should not be treated with increased doses of this medicine.

In such cases, the medicine should be discontinued and medical advice sought. Medication-overuse headache should be suspected in patients who experience frequent or daily headaches despite (or due to) regular use of headache-relieving medicines;

• long-term use of (multiple types of) pain-relieving medicines may lead to persistent serious kidney diseases. This risk may increase during physical exertion associated with salt loss and dehydration. Therefore, this should be avoided if the patient is dehydrated, as kidney damage may occur;
• if the patient has heart diseases such as: heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to arterial narrowing or blockage), or if the patient has had any stroke (including mini-stroke or transient ischemic attack – TIA);
• if the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes;
• if the patient has an infection – see section below: "Infections". Bleeding, ulceration, or perforation of the gastrointestinal tract, which may be fatal, have been reported during treatment with all NSAIDs, with or without warning signs, or in patients with serious gastrointestinal disorders. If gastrointestinal bleeding or ulceration occurs, treatment should be stopped immediately. The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher doses of NSAIDs, especially in patients with a history of ulceration, particularly with bleeding or perforation (see section 2: "When not to take Kidofen max") and in elderly patients. In such patients, treatment should be initiated with the lowest effective dose. In these patients and in patients requiring concomitant low-dose acetylsalicylic acid or drugs increasing gastrointestinal risk, co-therapy with gastroprotective agents (e.g., misoprostol or proton pump inhibitors) should be considered.

The use of anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment.
In elderly patients, the dose may be reduced by using the lowest possible dose for the shortest possible time to minimize the risk of adverse effects.
Infections
Kidofen max may mask symptoms of infection such as fever and pain. Therefore, Kidofen max may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an ongoing infection and symptoms persist or worsen, immediate medical consultation is necessary.
Skin reactions
Severe skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have occurred with ibuprofen use. If any of the symptoms associated with these severe skin reactions described in section 4 occur, Kidofen max should be discontinued immediately and medical help sought.
Infants
This medicine should not be used in infants under 3 months of age or weighing less than 5 kg.
Kidofen max and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Do not take the following medicines simultaneously with Kidofen max. Kidofen max may affect the action of other medicines and vice versa. The patient should inform the doctor if taking any of the following medicines.
Kidofen max may affect the action of other medicines or other medicines may affect the action of Kidofen max. For example:

• anticoagulant drugs (i.e., blood thinners/preventing clot formation, such as acetylsalicylic acid, warfarin, ticlopidine);
• antihypertensive drugs (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing drugs, angiotensin II receptor antagonists such as losartan).

Medicines that may increase gastrointestinal bleeding:

• acetylsalicylic acid (used for pain relief and fever reduction);
• corticosteroids (steroid medicines used, among others, for asthma treatment);
• antiplatelet drugs (medicines reducing the risk of blood clot formation);
• selective serotonin reuptake inhibitors (medicines used for depression treatment);
• other NSAIDs, including selective cyclooxygenase-2 inhibitors (medicines used for rheumatic disease treatment).

Medicines that may cause kidney damage:

• tacrolimus (medicine used, among others, for atopic dermatitis treatment);
• cyclosporine (medicine used in organ transplant patients).

Kidofen max may enhance the effect of:

• lithium (medicine used for depression treatment);
• methotrexate (medicine used for treatment of certain cancers and rheumatoid arthritis);
• phenytoin (medicine used for epilepsy treatment).

Kidofen max may reduce the effectiveness of:

• diuretics (medicines increasing urine production).

Do not take Kidofen max simultaneously with:

• zidovudine (medicine used for HIV infection treatment), as it may prolong bleeding time;
• ritonavir (medicine used for HIV infection treatment), as it may increase NSAID plasma concentration;
• cardiac glycosides, e.g., digoxin, because NSAIDs may exacerbate heart failure symptoms and increase cardiac glycoside plasma concentration;
• quinolone antibiotics, as this may increase the risk of seizures;
• aminoglycosides, because NSAIDs may reduce their excretion;
• probenecid and sulfinpyrazone (medicines used for gout treatment), as they may delay ibuprofen excretion;
• sulfonylurea derivatives (medicines used for diabetes treatment);
• baclofen (muscle relaxant), as baclofen toxicity may develop after ibuprofen use;
• voriconazole and fluconazole (used for fungal infection treatment) – these medicines may enhance ibuprofen's effect;
• cholestyramine (medicine used to lower cholesterol levels) – these medicines should be administered with several-hour intervals.

Some other medicines may also be affected by or affect treatment with Kidofen max.
Therefore, always consult a doctor or pharmacist before using Kidofen max with other medicines.
If the patient is unsure whether they are taking any of the above-mentioned medicines, they should consult a doctor or pharmacist.
Kidofen max with food and alcohol
For patients with sensitive stomachs, it is recommended to take the medicine with food.
Do not consume alcohol while taking Kidofen max. Some adverse effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when alcohol is consumed concurrently with this medicine.
Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take Kidofen max if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and the child and may delay or prolong labor. During the first 6 months of pregnancy, Kidofen max should not be used unless the doctor considers its use absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Kidofen max may cause narrowing of a blood vessel (ductus arteriosus) in the unborn child's heart or kidney disorders, which may lead to low amniotic fluid levels (oligohydramnios). If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts.
No harmful effects on infants have been reported; therefore, discontinuation of breastfeeding is not necessary during short-term use of ibuprofen at doses used for pain and fever relief.
Fertility
Kidofen max belongs to a group of medicines (NSAIDs) that may affect fertility in women.
This effect is reversible after discontinuation of the medicine.
Driving and operating machinery
Short-term use of Kidofen max has no effect or negligible effect on the ability to drive and operate machinery.
Kidofen max contains propylene glycol (E 1520), liquid maltitol (E 965), ethanol, sodium benzoate (E 211), sodium, and benzyl alcohol
Propylene glycol (E 1520)
The medicine contains 10.64 mg of propylene glycol in each 5 mL of suspension.
Liquid maltitol (E 965)
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine.
Ethanol
The medicine contains 6.6 mg of alcohol (ethanol) in each dose (5 mL), equivalent to 0.13% (w/v). The amount of alcohol in a dose of this medicine is equivalent to less than 1 mL of beer or 1 mL of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.
Sodium benzoate (E 211)
The medicine contains 3.45 mg of sodium benzoate in each 5 mL of suspension.
Sodium
The medicine contains 9.3 mg of sodium (main component of table salt) in each 5 mL of suspension.
This corresponds to 0.5% of the maximum recommended daily sodium intake in the diet of adults.
Benzyl alcohol
The medicine contains 0.27 mg of benzyl alcohol in each 5 mL of suspension.
Benzyl alcohol may cause allergic reactions.
Do not administer to young children (under 3 years of age) for longer than one week without a doctor's or pharmacist's recommendation.
Pregnant or breastfeeding women and patients with liver or kidney diseases should consult a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

3. How to take Kidofen max

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is for oral use. Shake well before use.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, its symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Recommended dose
The daily dose of ibuprofen is 20 to 30 mg/kg body weight, given in divided doses.

Adults and adolescents over 12 years of age: the recommended dose for symptomatic treatment of pain and fever:
3 times 8 mL per day, until symptoms subside.
Elderly patients: dosage should be individually determined by a physician.
Consideration should be given to reducing the dose. In patients with renal impairment, dosage must take into account the degree of renal function.
Do not use a higher dose than recommended.
In patients with sensitive stomach, it is recommended to take the medicine during a meal.

Infants
The medicine must not be used in infants under 3 months of age or weighing less than 5 kg.

Duration of treatment
The medicine is intended for short-term use only. If symptoms persist or worsen, or if new symptoms occur, consult a physician.
In infants over 6 months of age, children under 12 years of age, and adolescents, consult a physician if treatment exceeds 3 days or if symptoms worsen.
In infants aged 3–5 months weighing 5 kg or more, consult a physician if symptoms worsen or do not improve within 24 hours.

An oral syringe with adapter supplied with the package must be used for dosing.
This ensures accurate dose measurement.
Instructions for using the syringe dosing device with adapter are provided at the end of this leaflet.

Accidental ingestion of a higher than recommended dose of Kidofen max
If a patient has taken more than the recommended dose of Kidofen max, or if a child has accidentally ingested the medicine, always contact a physician or go to the nearest hospital for assessment of potential health risks and advice on necessary actions.

Symptoms of overdose may include: nausea, stomach pain, vomiting (possibly with blood traces), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Stimulation, drowsiness, confusion, or coma may also occur. Seizures may rarely occur in patients. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as blood in urine, low blood potassium levels, feeling cold, and breathing difficulties. Additionally, prothrombin time/INR may be prolonged, likely due to interference with circulating blood coagulation factors. Acute renal failure and liver damage may also occur. In patients with asthma, worsening of asthma symptoms may occur. Additionally, low blood pressure and breathing difficulties may occur.
There is no specific antidote. The physician will provide symptomatic and supportive treatment.

Missed dose of Kidofen max
Continue taking the medicine as prescribed without increasing the next dose.
Do not take a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must immediately stop taking this medicine and contact your doctor or go to
the emergency department of the nearest hospital if any of the following occur:

• swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing, worsening of asthma, unexplained wheezing or shortness of breath, rapid heartbeat, drop in blood pressure (anaphylaxis, angioedema or severe shock). Symptoms may occur even after the first dose of the medicine;
• signs of gastrointestinal bleeding (severe abdominal pain, vomiting blood or material resembling coffee grounds, black stools or blood in stool); severe skin reactions such as: rash affecting the whole body, skin peeling, formation of blisters and shedding of skin sheets;
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome;
• severe skin reactions such as: blisters appearing on the skin and/or mucous membranes, which after rupture form painful sores, often accompanied by fever, muscle and joint pain (this is known as Stevens-Johnson syndrome), erythema multiforme (bluish-red skin lesions, sometimes with blisters) and toxic epidermal necrolysis (this is known as Lyell's syndrome);
• severe skin reactions known as DRESS syndrome. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cells);
• red scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, on the trunk and upper limbs, accompanied by fever occurring at the beginning of treatment (this is known as acute generalized exanthematous pustulosis).

Common (may affect up to 1 in 10 people):

• gastrointestinal complaints such as: abdominal pain, nausea and indigestion, diarrhoea, bloating with gas passage, constipation, heartburn, vomiting, minor blood loss from the stomach and/or intestines, which in rare cases may lead to anaemia. Uncommon (may affect up to 1 in 100 people):
• peptic ulcer disease of the stomach and/or duodenum;
• perforations or bleeding from the gastrointestinal tract;
• ulcerative stomatitis;
• worsening of symptoms of ulcerative colitis and Crohn's disease;
• gastritis;
• headache, dizziness, insomnia, restlessness, irritability or fatigue;
• visual disturbances;
• urticaria and itching;
• various skin rashes.

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

• tinnitus (ringing in the ears);
• flank pain and/or abdominal pain, blood in urine, and fever may be symptoms of kidney damage (papillary necrosis);
• increased blood urea levels;
• decreased hemoglobin concentration.

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

• psychotic reactions, depression;
• reduced urine output compared to usual, and oedema (in patients with hypertension or renal insufficiency), interstitial nephritis which may lead to acute renal failure, oedema and cloudy urine (nephrotic syndrome);
• hypertension;
• vasculitis;
• heart failure, palpitations, myocardial infarction and facial or hand swelling;
• oesophagitis, pancreatitis, formation of diaphragm-like intestinal strictures;
• liver function disorders, liver damage (first signs may include skin discoloration), especially during long-term treatment, liver failure, acute hepatitis;
• blood cell formation disorders – first symptoms include: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, severe fatigue, nosebleeds or bruising. In such cases, treatment must be immediately discontinued and medical advice sought. Self-treatment with painkillers or antipyretics (fever-reducing medicines) must not be attempted;
• severe skin infections and soft tissue complications during varicella virus infection;
• exacerbation of inflammatory conditions associated with infection (e.g. necrotizing fasciitis). If symptoms of infection appear or worsen, the patient should immediately consult a doctor who will initiate appropriate treatment;
• hair loss (alopecia);
• neck stiffness, headache, nausea, vomiting, fever, altered consciousness (symptoms of aseptic meningitis).

Frequency not known (frequency cannot be estimated from available data):

• skin becomes sensitive to light. Medicines such as Kidofen max may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If any of the above symptoms occur, the medicine should be discontinued
and medical advice sought.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed
in this leaflet, consult a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring
Adverse Drug Reactions at the Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Kidofen max

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton.
The expiry date refers to the last day of the stated month.
Store below 25ºC. Do not store in the refrigerator or freeze.
Period of use after first opening the bottle: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Kidofen max contains

• The active substance is ibuprofen.
• 5 mL of oral suspension contains 250 mg of ibuprofen.
• Other ingredients are: maltitol liquid (E 965), glycerol, sodium chloride, citric acid (E 330), sodium citrate, sucralose (E 955), polysorbate 80, xanthan gum, sodium benzoate (E 211), strawberry flavour (containing ethanol, propylene glycol (E 1520), benzyl alcohol), purified water.

What Kidofen max looks like and contents of the pack
Kidofen max is an oral suspension, white to creamy in colour, with a strawberry taste and odour.
The medicine is supplied in a 115 mL amber glass bottle of type III, with an aluminium cap with LDPE liner, together with an oral syringe made of LDPE and polystyrene and an adapter, packed in a cardboard box.
The pack contains 100 mL of oral suspension.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. + 48 42 22-53-100

Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Krzywa 2
95-030 Rzgów

Instructions for using the dosing device (oral syringe with adapter)

1. Shake the bottle well before each use.

2. Unscrew the bottle cap.

3. Insert the provided adapter into the neck of the bottle.

4. Press the syringe firmly into the depression of the adapter.

5. To fill the syringe, invert the bottle, then carefully pull the plunger down to draw the suspension up to the desired mark on the syringe scale.

6. Return the bottle to upright position and carefully remove the syringe.

7. Place the tip of the syringe into the mouth, then slowly press the plunger to gently administer the suspension, avoiding choking.

8. After administering the medicine, close the bottle, and wash and dry the syringe.