Kidofen Duo

Leaflet attached to the packaging: patient information

Kidofen duo, (100 mg + 125 mg)/5 mL, oral suspension

Ibuprofen+ Paracetamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 a pain-relieving, antipyretic, and anti-inflammatory medicine.
The medicine contains ibuprofen and paracetamol.

Indications for use of Kidofen duo:

• treatment of fever and pain of various origins of mild to moderate severity, post-operative pain.

2. Important information before taking Kidofen duo

When not to take Kidofen duo

• if the patient is allergic to ibuprofen or paracetamol (active substances) and 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 shortness of breath, asthma, runny nose, facial swelling, and/or hand swelling or hives after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), as Kidofen duo may cause similar symptoms in these patients;
• if the patient currently has gastrointestinal bleeding;
• if the patient has ever had a perforation (hole) in the wall of the stomach or intestine, associated with 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 (blood clotting disorders);
• if the patient has had inflammatory bowel disease (e.g., chronic enteritis, ulcerative colitis, Crohn's disease - characterized by, among other things, chronic diarrhea, anal and rectal diseases), as the risk of gastrointestinal bleeding increases;
• if the patient has had ulcers and/or gastrointestinal bleeding;
• if the patient is taking other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors - increased risk of side effects;
• if the patient is taking other medicines containing paracetamol - increased risk of severe side 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, especially when used in high doses. Do not exceed the recommended dose and duration of treatment.
Before starting to take Kidofen duo, discuss it with your doctor or pharmacist:

• if the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• if the patient has high blood pressure, diabetes, has high cholesterol levels, has a family history of heart disease or stroke, or smokes;
• if the patient has stomach and/or intestinal diseases (such as chronic enteritis, ulcerative colitis, Crohn's disease - characterized by, among other things, chronic diarrhea, diseases of the anus and rectum), as the risk of gastrointestinal bleeding increases;
• if the patient has systemic lupus erythematosus (a chronic disease caused by immune system disorders affecting many organs) or mixed connective tissue disease, as there is a risk of aseptic meningitis (see section 4);
• the use of such medicines 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 of the medicine. Do not use higher doses and longer treatment than recommended.
• if the patient has heart, kidney, or liver function disorders, is taking diuretics, or has lost a lot of fluid due to, for example, major surgery - the doctor will order regular kidney function monitoring;
• if the patient has asthma, chronic rhinitis, sinusitis, nasal polyps, or allergies (current or past), as bronchospasm may occur after taking the medicine;
• if the patient is over 65 years old, as the risk of adverse reactions to 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), especially in the initial treatment period;
• if the patient has chickenpox - the use of the medicine is not recommended;
• if the patient has an infection - see below, the section entitled "Infections".

Infections

Kidofen duo may mask the symptoms of infection, such as fever and pain. Therefore, Kidofen duo may delay the use of appropriate infection treatment 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 is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should consult a doctor immediately.

Skin reactions

Severe skin reactions have been reported with the use of Kidofen duo.
If the following occur: any skin rash, changes in the mucous membranes, blisters, or other symptoms of an allergic reaction, the patient should stop taking Kidofen duo and seek medical attention immediately, as these may be the first symptoms of a very severe skin reaction. See section 4.
When using Kidofen duo, the following warnings should be observed:

• if headaches occur during long-term use of high doses of pain-relieving medicines, they should not be alleviated by increasing the dose of the pain-relieving medicine;
• if Kidofen duo is taken for a long time - the doctor will order regular monitoring of kidney and liver function, as well as blood tests;
• if vision disturbances occur - the patient should contact an ophthalmologist.

During the use of Kidofen duo, the patient should immediately inform their doctor if they have severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if they are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to have a severe disease called metabolic acidosis (a blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or took paracetamol with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea (nausea) and vomiting.

Children

The medicine should not be used in children under 2 years of age.

Kidofen duo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Do not take the following medicines with Kidofen duo. Kidofen duo may affect the action of other medicines or other medicines may affect the action of Kidofen duo.
Do not take Kidofen duo:

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

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

• chloramphenicol (an antibiotic used for local treatment of skin and eye infections);
• cholestyramine (a medicine used to lower cholesterol levels);
• metoclopramide and domperidone (medicines that prevent 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-adrenergic blockers, such as 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 clots);
• digitalis glycosides (medicines used to treat heart failure and heart rhythm disorders);
• cyclosporin (a medicine used in patients after organ transplantation);
• corticosteroids (medicines used, among other things, to treat rheumatic disease);
• diuretics (medicines that increase urine production), as there is an increased risk of kidney function disorders, such as high potassium levels in the blood (hyperkalemia). If such a disorder occurs, the patient should drink plenty of fluids;
• lithium (a medicine used to treat certain mental illnesses);
• methotrexate (a cytostatic medicine used to treat certain cancers);
• mifepristone (a medicine used for medical abortion);
• tacrolimus (a medicine used to treat, among other things, 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 treated urgently (see section 2).

Also, some other medicines may be affected or have an effect on the treatment with Kidofen duo.
Therefore, before using Kidofen duo with other medicines, the patient should always consult their doctor or pharmacist.

Taking Kidofen duo with food and drink

Kidofen duo should be taken after a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking 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 risk of bleeding in the patient and their child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Kidofen duo should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Kidofen duo may cause the unborn child's heart to narrow (constriction of the ductus arteriosus) or kidney problems, which can lead to low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment is necessary for a longer period 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 on babies, so breastfeeding does not need to be stopped during short-term use of ibuprofen and paracetamol in doses not exceeding the recommended doses for pain and fever relief.
Fertility
Kidofen duo may make it harder to conceive. If the patient plans to conceive or is having trouble conceiving, they should inform their doctor.

Driving and using machines

Kidofen duo has no or negligible influence on the ability to drive and use machines. However, in some cases, dizziness, drowsiness, vision disturbances, or other symptoms may occur, and the patient should not drive or operate machines in such cases.
Kidofen duo contains sucrose, macrogol glycerol 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 some sugars, they should consult their doctor before taking the medicine.

Macrogol glycerol ricinoleate

The medicine may cause indigestion 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 (the main component of table salt) in 60 mL of suspension. This corresponds to 6.15% of the maximum recommended daily intake of sodium 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 give to small children (under 3 years old) for more than a week without consulting a doctor or pharmacist.
Pregnant or breastfeeding women, as well as patients with liver or kidney disease, should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

3. How to take Kidofen duo

This medicine should always be taken exactly as advised by the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.
The medicine is for oral use. Shake before use.
Recommended dose
The maximum daily dose of ibuprofen is 20 to 30 mg/kg body weight, given according to the following scheme.

Children:

Age of the child Dose Take

2 - 3 years (10 - 16 kg)

5 mL of suspension
3 times a day

4 - 6 years (17 - 20 kg)

7 mL of suspension
3 times a day

7 - 9 years (21 - 30 kg)

10 mL of suspension
3 times a day

10 - 12 years (31 – 40 kg)

14 mL of suspension
3 times a day

Adults and adolescents over 12 years:

20 mL of suspension 3 times a day.
The medicine is intended for use in situations where paracetamol or ibuprofen alone are ineffective.

Children

Do not give to children under 2 years of age.
Use the smallest effective dose for the shortest necessary period. If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
A measuring cup or oral syringe with an adapter is attached to the packaging to facilitate accurate dosing.

Instructions for using the dosing device in the form of an oral syringe with an adapter:

• 1. Unscrew the bottle cap.
• 2. Place the attached adapter into the bottle neck opening.
• 3. The oral syringe should be firmly pushed into the adapter recess.
• 4. To fill the syringe, turn the bottle upside down and then carefully move the syringe plunger down, drawing the suspension to the desired mark on the scale.
• 5. Turn the bottle back to its original position and carefully remove the syringe from the bottle.
• 6. Place the syringe tip in the mouth and, pressing the plunger slowly, carefully administer the suspension to avoid choking.
• 7. After use, close the bottle and wash and dry the syringe.

Taking a higher dose of Kidofen duo than recommended

If the patient has taken a higher dose of Kidofen duo than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what to do in such a case. Symptoms may include nausea, stomach pain, vomiting (which may contain blood), diarrhea, headache, ringing in the ears, pallor, excessive sweating. After taking a large dose, drowsiness, occasional excitement, disorientation, or coma, palpitations, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and breathing difficulties may occur. Symptoms of liver damage may occur 12 to 48 hours after overdose and may be manifested by abdominal distension, return of nausea, and jaundice.

Missing a dose of Kidofen duo

Do not take a double dose to make up for a missed dose.
If the patient forgets to take a dose, they should take it as soon as they remember, and then take the next dose not earlier than 6 hours later.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor or go to the nearest hospital if they experience:

• rash, severe swelling of the face, lips, or throat, making it difficult to breathe, speak, or swallow, low blood pressure, slow or fast heart rate, pallor, anxiety, excessive sweating, dizziness, loss of consciousness, respiratory or cardiac arrest, worsening of asthma, and bronchospasm;
• gastrointestinal bleeding (vomiting blood or coffee grounds-like material, black stools, or blood in the stool).

The following side effects may occur:

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

• indigestion, stomach pain, nausea.

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

• hives, itching;
• headache;
• diarrhea, bloating, constipation, vomiting;
• stomach ulcers;
• perforation or bleeding of the gastrointestinal tract, manifested by black stools or bloody vomiting, sometimes fatal, especially in the elderly;
• ulcerative stomatitis;
• worsening of ulcerative colitis and Crohn's disease;
• gastritis.

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

• dizziness;
• insomnia, excitement, irritability;
• fatigue;
• depression, psychotic reactions;
• ringing in the ears;
• edema;
• hives, rash, skin inflammation.

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

• edema;
• high blood pressure;
• heart function disorders;
• kidney function disorders (interstitial nephritis, nephrotic syndrome, and acute or chronic kidney failure, renal papillary necrosis);
• increased urea levels in the blood;
• liver enlargement, liver function disorders, liver damage, acute hepatitis;
• significant decrease in the number of all blood cells (manifested by fever, sore throat, superficial oral mucosal ulceration, flu-like symptoms, severe fatigue, nosebleeds, or bruising);
• severe skin and soft tissue infections, which are a complication of chickenpox;
• blisters on the skin and/or mucous membranes, which form painful sores when they burst, often accompanied by fever, muscle and joint pain (this is called Stevens-Johnson syndrome);
• stiffness of the neck, headaches, nausea, vomiting, fever, disorientation (these are symptoms of aseptic meningitis, which may occur in patients with systemic lupus erythematosus and mixed connective tissue disease).

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

• Severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include skin rash, fever, lymph node swelling, and an increased number of eosinophils (a type of white blood cell).
• A red scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized pustular psoriasis). If such symptoms occur, the patient should stop taking Kidofen duo and seek medical attention immediately. See also section 2.
• The skin becomes sensitive to light.
• A serious condition that can cause acidification of the blood (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

If any of the above symptoms occur, the patient should stop taking the medicine and consult their doctor.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Kidofen duo

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 carton.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Kidofen duo contains

• The active substances of the medicine are ibuprofen and paracetamol.
• 5 mL of oral suspension contains 100 mg of ibuprofen and 125 mg of paracetamol.
• The other ingredients are macrogol glycerol ricinoleate, sodium chloride, citric acid, sodium benzoate, xanthan gum, sucrose, sodium saccharin, glycerol, hypromellose, sucralose, sodium citrate, raspberry flavor AR 0320 (a mixture of flavoring substances and solvents, 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 a raspberry-flavored oral suspension with a nearly white to beige color.
The packaging of the medicine is:

• a brown glass bottle containing 100 mL of suspension, closed with a white aluminum cap with a measuring cup, in a cardboard box with a leaflet or:
• a brown glass bottle containing 100 mL of suspension, closed with a white aluminum cap with an oral syringe and adapter, in a cardboard box with a leaflet.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: +48 42 22-53-100

Date of the last revision of the leaflet: