Kidofen duo

Package leaflet: Information for the patient

Kidofen duo, (100 mg + 125 mg)/5 mL, oral suspension
Ibuprofenum + Paracetamolum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Kidofen duo is an analgesic, antipyretic and anti-inflammatory medicine.
The medicine contains ibuprofen and paracetamol.
Indications for use of Kidofen duo:

• treatment of fever and various types of pain of mild to moderate intensity, including postoperative pain.

2. Important information before taking Kidofen Duo

When not to take Kidofen Duo

• if the patient is allergic to ibuprofen or paracetamol (the active substances), other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced breathlessness, asthma, rhinitis, facial and/or hand swelling, or urticaria after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), because Kidofen Duo may cause similar symptoms in these patients;
• if the patient currently has gastrointestinal bleeding;
• if the patient has ever experienced perforation (a hole) in the stomach or intestinal wall related to the use of non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has severe liver or kidney failure;
• if the patient has severe heart failure;
• if the patient has a bleeding disorder (coagulation disorders);
• if the patient has or has had inflammatory bowel diseases, peptic ulcer disease of the stomach and/or duodenum;
• if the patient has had ulceration and/or gastrointestinal bleeding;
• if the patient is concurrently using other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors – increased risk of adverse effects;
• if the patient is concurrently using other medicines containing paracetamol – increased risk of severe adverse effects;
• if the patient is in the last trimester of pregnancy.

Warnings and precautions
Taking anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before starting to take Kidofen Duo, discuss this with your doctor or pharmacist:

• if the patient has heart diseases such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• if the patient has high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes;
• if the patient has stomach and/or intestinal disorders (e.g., chronic inflammatory bowel disease, ulcerative colitis, Crohn's disease – characterized by, among others, chronic diarrhea, or diseases of the anus and rectum), as this increases the risk of gastrointestinal bleeding;
• if the patient has systemic lupus erythematosus (a chronic autoimmune disease affecting multiple organs) or mixed connective tissue disorders, as there is a risk of aseptic meningitis (see section 4);
• taking medicines such as Kidofen Duo may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended.
• if the patient has impaired heart, kidney, or liver function, is taking diuretics, or has lost significant fluids due to, for example, major surgery – the doctor will recommend regular monitoring of kidney function;
• if the patient has bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, or allergies (current or past), as bronchospasm may occur after taking the medicine;
• if the patient is 65 years of age or older, as the risk of adverse effects of the medicine increases, especially gastrointestinal bleeding and perforation of the stomach or intestinal wall, which can be fatal. The patient should inform the doctor about any unusual gastrointestinal symptoms (especially bleeding, pain), particularly during the initial treatment period;
• if the patient has chickenpox – use of the medicine is not recommended;
• if the patient has an infection – see below, section titled "Infections".

Infections
Kidofen Duo may mask symptoms of infection such as fever and pain. Therefore, Kidofen Duo may delay appropriate treatment of infection and consequently lead to an increased 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 of infection persist or worsen, medical advice should be sought immediately.
Skin reactions
Severe skin reactions associated with the use of Kidofen Duo have been reported.
If any skin rash, mucosal lesions, blisters, or other allergic symptoms appear, the patient should stop taking Kidofen Duo and seek immediate medical help, as these may be the first signs of a very serious skin reaction. See section 4.
The following warnings should be observed during treatment with Kidofen Duo:

• if headaches occur during long-term use of high doses of painkillers, they should not be relieved by increasing the dose of the painkiller;
• if Kidofen Duo is used long-term, the doctor will recommend regular monitoring of kidney and liver function and blood tests;
• if visual disturbances occur, the patient should contact an ophthalmologist.

During treatment with Kidofen Duo, the patient should immediately inform the doctor if they have serious conditions, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a serious condition called metabolic acidosis (abnormalities in blood and body fluids) when taking paracetamol regularly over a long period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Children
This medicine should not be used in children under 2 years of age.
Kidofen Duo and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not use the following medicines concurrently with Kidofen Duo. Kidofen Duo may affect the action of other medicines or other medicines may affect the action of Kidofen Duo.
Do not use Kidofen Duo:

• with other medicines containing paracetamol;
• with other NSAIDs such as ibuprofen, diclofenac, naproxen, nimesulide;
• with acetylsalicylic acid used for pain relief and fever reduction;
• with selective cyclooxygenase-2 inhibitors (medicines used to treat rheumatic disease, e.g., celecoxib).

The patient should inform the doctor or pharmacist if they are taking any of the following medicines:

• chloramphenicol (an antibiotic used topically to treat skin and eye infections);
• cholestyramine (a medicine used to lower cholesterol levels);
• metoclopramide and domperidone (medicines that inhibit vomiting);
• anticoagulant medicines (i.e., blood thinners/preventing blood clots, such as acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as medicines containing atenolol, angiotensin II receptor antagonists such as losartan);
• selective serotonin reuptake inhibitors (medicines used to treat depression);
• antiplatelet medicines (medicines that reduce the risk of blood clot formation);
• cardiac glycosides (medicines used to treat heart failure and heart rhythm disorders);
• cyclosporine (a medicine used in organ transplant patients);
• corticosteroids (medicines used, among others, in the treatment of rheumatic disease);
• diuretics (medicines that increase urine production), as there is an increased risk of kidney function disorders, such as increased potassium levels in the blood (hyperkalemia). If such a disorder occurs, the patient should drink large amounts of fluids;
• lithium (a medicine used to treat certain psychiatric disorders);
• methotrexate (a cytostatic medicine used to treat certain cancers);
• mifepristone (a medicine used for medical abortion);
• tacrolimus (a medicine used, among others, in the treatment of atopic dermatitis);
• quinolone antibiotics (medicines used to treat infections);
• zidovudine (a medicine used to treat HIV infection);
• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be urgently treated (see section 2).

Some other medicines may also be affected by or affect treatment with Kidofen Duo.
Therefore, always consult a doctor or pharmacist before using Kidofen Duo with other medicines.
Taking Kidofen Duo with food and drink
Kidofen Duo should be taken after meals.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take Kidofen Duo 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. Kidofen Duo should not be used during the first 6 months of pregnancy 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 Duo may cause narrowing of a blood vessel (ductus arteriosus) in the child's heart or kidney disorders, which may lead to low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment is necessary for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen and paracetamol pass into breast milk in small amounts. There are no reports of harmful effects of the medicine on infants; therefore, discontinuation of breastfeeding is not necessary during short-term use of ibuprofen and paracetamol at doses not exceeding those recommended for pain and fever relief.
Fertility
Kidofen Duo may make it more difficult to become pregnant. If the patient is planning to become pregnant or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
Kidofen Duo has no effect or negligible effect on the ability to drive and operate machinery. However, in some cases, dizziness, drowsiness, or visual disturbances may occur; in such cases, driving and operating machinery should not be undertaken.
Kidofen Duo contains sucrose, macrogolglycerol ricinoleate, sodium benzoate, sodium, propylene glycol, and benzyl alcohol
Sucrose
The medicine contains 2006 mg of sucrose in each 5 mL of suspension. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.
Macrogolglycerol ricinoleate
The medicine may cause gastrointestinal discomfort and diarrhea.
Sodium benzoate
The medicine contains 11.8 mg of sodium benzoate in each 5 mL of suspension.
Sodium
The medicine contains 10.25 mg of sodium in each 5 mL of suspension.
The medicine contains 123 mg of sodium (main component of table salt) in 60 mL of suspension. This corresponds to 6.15% of the maximum recommended daily sodium intake in the diet for adults.
Propylene glycol
The medicine contains 29.33 mg of propylene glycol in each 5 mL of suspension.
Benzyl alcohol
The medicine contains 0.51 µg 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 contact their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

3. How to take Kidofen Duo

This medicine should always be taken according to the instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use. Shake well before use.
Recommended dose
The maximum daily dose of ibuprofen is 20 to 30 mg/kg body weight, administered according to the following schedule.

Children:
Child's age Dose Frequency
2 - 3 years (10 - 16 kg) 5 mL of suspension 3 times daily
4 - 6 years (17 - 20 kg) 7 mL of suspension 3 times daily
7 - 9 years (21 - 30 kg) 10 mL of suspension 3 times daily
10 - 12 years (31 – 40 kg) 14 mL of suspension 3 times daily

Adults and adolescents over 12 years of age:
20 mL of suspension 3 times daily.

This medicine is intended for use when paracetamol or ibuprofen used separately are ineffective.

Children
Do not use this medicine in children under 2 years of age.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

An oral dosing syringe or measuring device with an adapter is provided with the package to facilitate accurate dose measurement.

Instructions for using the oral dosing syringe with adapter:

1. Unscrew the bottle cap.
2. Insert the provided adapter into the neck of the bottle.
3. Firmly press the syringe into the adapter's opening.
4. Invert the bottle upside down and slowly pull down the syringe plunger to draw the suspension up to the desired mark on the syringe scale.
5. Return the bottle to upright position and carefully remove the syringe.
6. Place the tip of the syringe into the mouth and slowly depress the plunger to administer the suspension carefully, avoiding choking.
7. After administering the medicine, close the bottle tightly, wash the syringe and dry it thoroughly.

Taking more than the recommended dose of Kidofen Duo
If a patient has taken more than the recommended dose of Kidofen Duo, or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital immediately for advice on potential health risks and necessary actions. Symptoms may include nausea, stomach pain, vomiting (possibly with blood), diarrhea, headache, ringing in the ears, pallor, excessive sweating. After a large overdose, drowsiness, occasional agitation, disorientation or coma, palpitations, seizures (especially in children), weakness and dizziness, blood in urine, feeling cold and breathing difficulties may occur. Signs of liver damage may appear 12 to 48 hours after overdose and may include upper abdominal discomfort, recurrence of nausea, and jaundice.

Missed dose of Kidofen Duo
Do not take a double dose to make up for a missed dose.
If a patient forgets to take a dose, it should be taken as soon as remembered, and the next dose should be taken no sooner than 6 hours after.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately contact a doctor or go to the nearest hospital if any of the following occur:

• rash, severe swelling of the face, lips or throat causing difficulty breathing, speaking or swallowing, low blood pressure, slow or rapid heartbeat, pallor, restlessness, excessive sweating, dizziness, loss of consciousness, respiratory arrest and cardiac arrest, worsening of asthma and bronchospasm;
• gastrointestinal bleeding (vomiting blood or coffee-ground-like material, black stools or blood in stool).

The following adverse reactions may occur:
Common (may occur in up to 1 in 10 people):

• dyspepsia, abdominal pain and nausea.

Uncommon (may occur in up to 1 in 100 people):

• urticaria, itching;
• headache;
• diarrhoea, flatulence, constipation, vomiting;
• peptic ulcer;
• perforation or gastrointestinal bleeding, manifesting as tarry stools or bloody vomit, sometimes fatal, especially in elderly patients;
• ulcerative stomatitis;
• exacerbation of colitis and Crohn's disease;
• gastritis.

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

• dizziness;
• insomnia, agitation, irritability;
• feeling of fatigue;
• depression, psychotic reactions;
• tinnitus;
• oedema;
• urticaria, erythema, dermatitis.

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

• oedema;
• hypertension;
• cardiac dysfunction;
• renal dysfunction (interstitial nephritis, nephrotic syndrome, acute or chronic renal failure, necrosis of renal papillae);
• increased serum urea concentration;
• liver enlargement, liver function abnormalities, liver damage, acute hepatitis;
• marked decrease in all blood cells (manifesting as fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, severe exhaustion, nosebleeds or subcutaneous haemorrhages);
• severe skin and soft tissue infections as a complication of varicella;
• appearance of blisters on the skin and/or mucous membranes, which upon rupture form painful sores, often accompanied by fever, muscle and joint pain (this is known as Stevens-Johnson syndrome);
• neck stiffness, headache, nausea, vomiting, fever, disorientation (symptoms of aseptic meningitis, which may occur in patients with systemic lupus erythematosus or mixed connective tissue disease).

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

• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymphadenopathy, and increased eosinophil count (a type of white blood cell).
• Red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, Kidofen duo must be discontinued immediately and medical help should be sought without delay. See also section 2.
• Skin becomes photosensitive.
• Serious condition which may lead to blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

If any of the above symptoms occur, the medicine should be discontinued
and a doctor should be consulted.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Kidofen Duo

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not store in the refrigerator. Do not freeze.
Shelf life after first opening: 6 months.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Kidofen Duo contains

• The active substances in this medicine are: ibuprofen and paracetamol.
• 5 mL of oral suspension contains 100 mg of ibuprofen and 125 mg of paracetamol.
• Other ingredients are: macrogol glycerol ricinoleate, sodium chloride, citric acid, sodium benzoate, xanthan gum, sucrose, sodium saccharin, glycerol, hypromellose, sucralose, sodium citrate, raspberry flavour AR 0320 (Himbeere fl. (a mixture of flavouring substances and solvent, including propylene glycol (E 1520), benzyl alcohol), cis-3-hexenol, vanillin, propylene glycol (E 1520), purified water.

What Kidofen Duo looks like and contents of the pack
Kidofen Duo is an oral suspension with a raspberry flavour and is almost white to beige in colour.
The medicine pack contains:

• An amber glass bottle containing 100 mL of suspension, closed with a white aluminium screw cap, supplied with a measuring spoon, in a cardboard box with a leaflet, or:
• An amber glass bottle containing 100 mL of suspension, closed with a white aluminium screw cap, supplied with an oral dosing syringe and an adapter, in a cardboard box with a leaflet.

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