Babyfen forte

Package leaflet: information for the user

Babyfen Forte, 40 mg/mL, oral suspension
ibuprofen
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
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 any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• Consult a doctor if the child's symptoms worsen or do not improve after 3 days. In the case of administering the medicine to infants aged 3–5 months, consult a doctor immediately if symptoms worsen or persist for 24 hours.

Contents of the leaflet

1. What Babyfen Forte is and what it is used for
2. Important information before using Babyfen Forte
3. How to use Babyfen Forte
4. Possible side effects
5. How to store Babyfen Forte
6. Contents of the pack and other information

1. What Babyfen Forte is and what it is used for

Babyfen Forte contains the active substance ibuprofen. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by altering the body's response to pain and fever. Babyfen Forte is intended for short-term, symptomatic treatment of fever and mild to moderate pain.
Babyfen Forte is intended for use in children with a body weight from 5 kg (aged 3–5 months) to 40 kg (aged 12 years).

2. Important information before using Babyfen Forte

When not to use Babyfen Forte

• If the child is allergic to ibuprofen or other similar pain-relieving medicines (NSAIDs) or any of the other ingredients of this medicine (listed in section 6).
• If breathlessness, asthma, rhinitis, facial and (or) hand swelling, or urticaria occurred after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs).
• If gastrointestinal bleeding or perforation has ever occurred related to previous use of NSAIDs.
• If there is currently or has previously been gastric and (or) duodenal ulcer (peptic ulcer disease) or gastrointestinal bleeding (two or more confirmed cases of ulcers or bleeding).
• If there is cerebral bleeding (bleeding from cerebral vessels) or any other active bleeding.
• If there is severe liver or kidney failure.
• If there is severe heart failure.
• If there are blood formation disorders of unknown origin.
• In children with severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake).

Do not take this medicine during the last 3 months of pregnancy.
Warnings and precautions
Before starting treatment with Babyfen Forte, consult a doctor or pharmacist if:

• The child has certain inherited blood formation disorders (e.g. acute intermittent porphyria).
• The child has blood clotting disorders.
• The child has certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease).
• The child has or has had intestinal diseases (ulcerative colitis or Crohn's disease), as symptoms may worsen (see section 4 "Possible side effects").
• The child has had or currently has high blood pressure and (or) heart failure.
• The child has kidney function disorders.
• The child has liver diseases.
• The child has had or currently has asthma or allergic diseases that may cause breathlessness.
• The child has hay fever, nasal polyps, or chronic obstructive respiratory diseases, as there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called drug-induced asthma), angioedema, or urticaria.
• The child has recently undergone major surgery (medical supervision required).
• The child is dehydrated, due to increased risk of kidney failure in dehydrated children.
• The child is taking another NSAID (including COX-2 inhibitors such as celecoxib or etoricoxib), as simultaneous use of these medicines should be avoided (see section 2 "Babyfen Forte and other medicines").
• The child has an infection – see below, section "Infections".

Caution is advised if the patient is taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used to treat depression), or antiplatelet medicines (e.g. acetylsalicylic acid) (see section 2 "Babyfen Forte and other medicines").
This medicine should not be used routinely, as habitual use (of several types) of pain-relieving medicines may lead to permanent kidney function disorders. This risk is increased by physical exertion associated with electrolyte loss and dehydration.
Long-term use of any pain-relieving medicines for headache may increase headache severity.
If this occurs or is suspected, inform the doctor and discontinue use of this medicine. Medication-overuse headache (rebound headache) may occur in patients who frequently or daily experience headaches despite (or because of) regular use of headache medicines.
The occurrence of adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.
With prolonged use of ibuprofen, regular monitoring of liver function, kidney function, and blood morphology is necessary.
Severe skin reactions
Severe skin reactions have been reported with ibuprofen use, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
Discontinue use of Babyfen Forte and seek immediate medical help if any symptoms related to severe skin reactions described in section 4 occur.
Infections
Babyfen Forte may mask symptoms of infection such as fever and pain. Therefore, Babyfen Forte 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 is taking this medicine during an ongoing infection and infection symptoms persist or worsen, immediate medical consultation is required.
In chickenpox, the use of ibuprofen is not recommended.
NSAIDs may mask symptoms of infection and fever.
In case of gastrointestinal bleeding or gastrointestinal ulcers, discontinue use of this medicine immediately. During treatment with all NSAIDs, gastrointestinal bleeding, ulcers, or perforation (even fatal) have been reported at any stage of treatment, with or without warning symptoms or history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulcers, or perforation increases with NSAID dose, in patients with a history of ulcers, especially if complications such as bleeding or perforation occurred (see section 2 "When not to take Babyfen Forte"), and in elderly patients. These patients should start treatment with the lowest available dose. In these patients and in patients taking low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal adverse effects, consider concomitant use of protective medicines (e.g. misoprostol or proton pump inhibitors).
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slightly increased risk of myocardial infarction or stroke, especially when high doses are used. Do not exceed the recommended dose or duration of treatment.
Before starting treatment with Babyfen Forte, discuss treatment with a doctor or pharmacist if the patient:

• has heart function disorders, including heart failure, angina pectoris (chest pain), has had a myocardial infarction, peripheral artery bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including mini-stroke or transient ischemic attack - TIA).
• has high blood pressure, diabetes, high cholesterol levels, family history of heart disease or stroke, or is a smoker.

Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported during its use. If the patient notices any of these symptoms, they should immediately stop using Babyfen Forte and contact a doctor or emergency services.
Before administering Babyfen Forte, inform the doctor if any of the above conditions apply to the child.
Elderly patients
Elderly patients have a higher risk of adverse effects when taking NSAIDs, particularly gastrointestinal adverse effects.
For more information, see section 4 "Possible side effects".
Patients with a history of gastrointestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial treatment period.
Babyfen Forte and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken by the child, as well as any medicines the child may take.
Babyfen Forte may affect the action of other medicines, or other medicines may affect the action of Babyfen Forte. For example:

• anticoagulant medicines (i.e. blood thinners/preventing clot formation, such as acetylsalicylic acid, warfarin, ticlopidine),

• medicines lowering high blood pressure (ACE inhibitors such as captopril, beta-blockers such as medicines containing atenolol, angiotensin II receptor antagonists such as losartan).
  Also, some other medicines may be affected by or affect Babyfen Forte treatment. Therefore, always consult a doctor or pharmacist before using Babyfen Forte with other medicines.
  In particular, inform the doctor if the patient is taking the following medicines:

• other NSAIDs, including COX-2 inhibitors, and acetylsalicylic acid (used for fever and pain relief), as the risk of adverse effects may increase,

• digoxin (a medicine used in heart failure), as digoxin's effect may be enhanced,

• corticosteroids (medicines containing cortisone or cortisone-like substances), as the risk of gastrointestinal ulcers and bleeding may increase,

• antiplatelet medicines, as the risk of bleeding may increase,

• acetylsalicylic acid (in low doses), as blood-thinning effect may be weakened,

• anticoagulants (such as warfarin), as ibuprofen may enhance the effect of these medicines,

• phenytoin (a medicine used to treat epilepsy), as phenytoin's effect may be enhanced,

• selective serotonin reuptake inhibitors (medicines used to treat depression), as they may increase the risk of gastrointestinal bleeding,

• lithium (a medicine used to treat bipolar disorder and depression), as lithium's effect may be enhanced,

• probenecid and sulfinpyrazone (medicines used to treat gout), as ibuprofen excretion may be delayed,

• medicines for high blood pressure and diuretics, as ibuprofen may weaken their effect and kidney risk may increase,

• potassium-sparing diuretics such as amiloride, potassium canrenoate, spironolactone, triamterene, as this may lead to hyperkalemia (elevated blood potassium levels),

• methotrexate (a medicine used to treat cancer and rheumatism), as methotrexate's effect may be enhanced,

• tacrolimus and cyclosporine (immunosuppressive medicines), as kidney damage may occur,

• zidovudine (a medicine used to treat HIV/AIDS), as use of Babyfen Forte may increase the risk of intrastitial bleeding or bleeding leading to swelling in HIV(+) patients with hemophilia,

• sulfonylurea derivatives (antidiabetic medicines), as they may affect blood sugar levels,

• quinolone antibiotics, as the risk of seizures may increase,

• voriconazole and fluconazole (CYP2C9 inhibitors), used for fungal infections, as ibuprofen's effect may be enhanced. Consider reducing the ibuprofen dose, especially when high doses of ibuprofen are used with voriconazole or fluconazole,

• baclofen (used to treat muscle spasms), as baclofen toxicity may develop after ibuprofen use,

• ritonavir (used to treat HIV), as it may increase NSAID plasma concentration,

• aminoglycosides, as NSAIDs may increase aminoglycoside excretion,

• captopril, as ibuprofen may weaken captopril's effect,

• cholestyramine (used to reduce cholesterol levels), as concomitant administration delays and reduces ibuprofen absorption (by 25%). These medicines should be administered with a several-hour interval.

Babyfen Forte and alcohol
Do not consume alcohol while using Babyfen Forte. Some adverse effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when alcohol is consumed simultaneously with Babyfen Forte.
Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use this medicine during the last 3 months of pregnancy. Use may cause kidney and heart function disorders in the unborn child. It may also affect bleeding tendency in the patient and her child and delay or prolong labour. Avoid using this medicine during the first 6 months of pregnancy unless otherwise advised by a doctor. Taking ibuprofen for longer than a few days after the 20th week of pregnancy may cause kidney function disorders in the unborn child and lead to reduced amniotic fluid levels surrounding the child (oligohydramnios), or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If longer-term treatment is necessary, the doctor may recommend additional monitoring tests.
Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. Babyfen Forte may be used during breastfeeding if administered at recommended doses and for the shortest possible duration.
Fertility
Babyfen Forte belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is reversible upon discontinuation of the medicine.
Driving and operating machinery
For short-term use, this medicine does not affect or has negligible effect on the ability to drive and operate machinery.
Babyfen Forte contains sodium benzoate (E 211), benzoic acid (E 210), propylene glycol (E 1520), and sodium
This medicine contains 2 mg of sodium benzoate and less than 0.004 mg of benzoic acid in each mL.
Sodium benzoate and benzoic acid may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).
This medicine contains 1.29 mg of propylene glycol (E 1520) in each mL. Before administering the medicine to a child under 4 weeks of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
The medicine contains 24 mg of sodium (main component of table salt) in each 7.5 mL dose (maximum single dose). This corresponds to 1.2% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Babyfen Forte

Always use this medicine exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest possible duration needed to relieve symptoms.
If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
The recommended dose for pain and fever is:

Doses should be administered approximately every 6 to 8 hours.
It is not recommended for use in children under 3 months of age or weighing less than 5 kg.
Do not exceed the recommended dose.

Renal or hepatic impairment
In case of renal or hepatic impairment, there is no need to reduce the dose.

Duration of treatment
This medicine is intended for short-term use only. If symptoms worsen, consult a doctor.
Consult a doctor if symptoms in the child worsen or do not improve after 3 days.
In infants aged 3–5 months, consult a doctor immediately if symptoms worsen, or within 24 hours if symptoms persist.

Method of administration
For oral use.
Patients with sensitive stomach are advised to take the medicine during meals.
The package contains an oral syringe with a capacity of 5 mL, which should be used for administering the medicine.

Instructions for use

1. Shake the bottle vigorously in an upright position for at least one minute before each use.
2. Remove the cap from the bottle.
3. Remove the cap from the oral syringe.
4. Place the bottle on a hard, flat surface and insert the oral syringe into the bottle.
5. Slowly pull back the plunger of the oral syringe to the mark on the syringe scale corresponding to the required volume (in milliliters) according to the dosing table.
6. Remove the oral syringe from the bottle.
7. Ensure the child is held in an upright position.
8. Place the tip of the syringe into the child's mouth and slowly press the plunger to gently release the medicine.
9. Wait a moment until the child swallows the medicine.
10. Repeat steps 4 to 9 in the same way until the entire dose has been administered.
11. After using the medicine, close the bottle with the cap. Wash the oral syringe with warm water and leave it to dry.

Accidental overdose of Babyfen Forte:
If a patient has taken more than the recommended dose of Babyfen Forte or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital to assess possible health risks and receive advice on appropriate actions.
Symptoms of overdose may include nausea, abdominal pain, vomiting, gastrointestinal bleeding, headache, tinnitus, blurred vision, involuntary eye movements (nystagmus), or less commonly, diarrhea. Additionally, at high doses, dizziness, vertigo, somnolence, agitation, disorientation, coma, hypothermia (lowered body temperature), low blood potassium levels, prolonged prothrombin time/INR, acute kidney failure, liver damage, hypotension, respiratory depression, cyanosis (bluish or purplish skin or mucous membrane discoloration), and asthma exacerbation in asthmatics may occur. In severe poisoning, metabolic acidosis may develop.

Missed dose of Babyfen Forte:
Do not take a double dose to make up for a missed dose. If a patient forgets to take or administer a dose, take or administer it as soon as remembered, then continue with the next dose according to the dosing interval described above.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
The child may experience any of the known adverse effects associated with NSAIDs. If any adverse effects occur or if you have any doubts, discontinue administering the medicine to the child and consult a doctor as quickly as possible.
In elderly individuals using this medicine, there is an increased risk of adverse effects.
Medicines such as this one may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke.

DISCONTINUE USE of this medicine and seek immediate medical help if the child experiences:

• severe abdominal pain, black tarry stools, vomiting blood or vomiting material with dark specks resembling coffee grounds [symptoms of gastrointestinal bleeding].
• worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, palpitations, or a drop in blood pressure leading to shock. These symptoms may occur even after the first dose of the medicine. If any of these symptoms occur, contact a doctor immediately [symptoms of a rare but serious allergic reaction].
• red, non-elevated, flat or round spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genital organs, or eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• widespread rash, high fever, and enlarged lymph nodes [DRESS syndrome].
• red, peeling, widespread rash with subcutaneous nodules and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment [acute generalized exanthematous pustulosis]. If such symptoms occur in the patient, discontinue use of Babyfen Forte and seek immediate medical help. See also section 2.
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Inform the doctor if the child experiences any of the following adverse effects, if they worsen, or if you notice any adverse effects not listed below.

Common (may occur in up to 1 in 10 people)

• gastrointestinal disturbances such as heartburn, abdominal pain, nausea, indigestion, diarrhea, vomiting, bloating (gas), and constipation, as well as minor bleeding from the stomach and/or intestines, which in rare cases may lead to anemia.

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

• gastrointestinal ulcers which may bleed or perforate, inflammation of the oral mucosa with ulceration, exacerbation of existing bowel disease (colitis or Crohn's disease), inflammation of the gastric mucosa
• central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability, or fatigue
• visual disturbances
• various skin rashes
• allergic reactions with urticaria and itching.

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

• tinnitus (ringing in the ears)
• increased blood urea levels, flank pain and/or abdominal pain, blood in urine, and fever, which may indicate kidney damage (renal papillary necrosis)
• increased blood uric acid levels
• decreased hemoglobin concentration.

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

• esophagitis, pancreatitis, formation of diaphragm-like intestinal strictures
• heart failure, myocardial infarction, and facial or hand swelling
• reduced urine output compared to usual, and edema (especially in patients with high blood pressure or impaired kidney function), edema and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms occur or if the patient feels unwell, discontinue use of Babyfen Forte and consult a doctor immediately, as these may be early signs of kidney damage or kidney failure.
• psychotic reactions and depression
• high blood pressure, vasculitis
• palpitations
• liver function disorders, liver damage (early signs may include skin discoloration), particularly during long-term treatment, liver failure, acute hepatitis
• blood cell production disorders – early signs include: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained bruising. In such cases, discontinue treatment immediately and consult a doctor. Do not self-medicate with painkillers or antipyretics (fever-reducing medicines).
• severe skin infections and soft tissue complications during chickenpox infection
• worsening of inflammatory conditions related to infection (e.g. necrotizing fasciitis) has been reported with the use of certain painkillers (NSAIDs). If signs of infection appear or worsen, the patient should seek medical attention immediately. It should be assessed whether antimicrobial/antibiotic treatment is indicated.
• aseptic meningitis symptoms such as neck stiffness, headache, nausea, vomiting, fever, and altered consciousness have been observed during ibuprofen use. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) are at higher risk of such symptoms. If these symptoms occur, contact a doctor immediately.
• Hair loss (alopecia).

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

• Respiratory tract reactivity, including asthma, bronchospasm, or shortness of breath
• Skin becomes sensitive to light.

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

5. How to store Babyfen Forte

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
After first opening, use within 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Babyfen Forte contains

• The active substance is ibuprofen. 1 mL of oral suspension contains 40 mg of ibuprofen.
• The other ingredients are: glycerol (E 422), xanthan gum (E 415), microcrystalline cellulose, sodium carmellose (E 466), polysorbate 80 (E 433), disodium edetate, sucralose (E 955), citric acid monohydrate (E 330), sodium citrate (E 330), sodium benzoate (E 211), grape flavour (contains propylene glycol (E 1520) and flavouring substances), taste-masking flavour (contains propylene glycol (E 1520) and flavouring substances), simethicone emulsion 30% (contains benzoic acid (E 210)), sodium chloride, purified water.

What Babyfen Forte looks like and contents of the pack
Babyfen Forte is an oral suspension, almost white to creamy white in colour, with a grape odour.
The 100 mL oral suspension is packed in a 125 mL amber glass bottle (type III), closed with a child-resistant screw cap (made of PP). The cap's interior is made of HDPE, has a tamper-evident ring and a PE liner.
The cardboard box contains one bottle and one oral syringe. The oral syringe has a capacity of 5 mL and is graduated to measure doses of 1.25 mL, 2.5 mL, 3.75 mL and 5 mL.
Pack size: 100 mL

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer
ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana - Črnuče
Slovenia

This medicinal product is authorised in the countries of the European Economic Area under the following names:
Poland Babyfen Forte
Slovakia Ibuprofen Dr. Max 40 mg/mL oral suspension