Babifen

Package Leaflet: Information for the Patient

Babyfen, 20 mg/mL, Oral Suspension

Ibuprofen

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

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any questions or need further information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days the child's or adolescent's symptoms worsen or do not improve, you should consult a doctor.
• If the medicine is given to infants aged 3-5 months, you should consult a doctor immediately if the symptoms worsen or if they do not improve within 24 hours.

Table of Contents of the Package Leaflet

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

1. What is Babyfen and what is it used for

This medicine contains ibuprofen. Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which reduce pain, swelling, and lower fever.

Babyfen is used in children from 3 months of age (with a body weight over 5 kg) and older for short-term symptomatic treatment of:

• mild or moderate pain, such as headache and toothache,
• fever,
• subfebrile state and pain associated with colds and flu.

2. Important information before taking Babyfen

When not to give Babyfen:

• if the child is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if the child has had asthma, bronchospasm, or allergic reactions after taking ibuprofen, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• if the child has stomach or duodenal ulcers, or bleeding in the stomach (or has had at least two such episodes);
• if the child has had bleeding or perforation of the digestive tract after taking NSAIDs;
• if the child has severe liver, kidney, or heart failure;
• if the child has a disease that increases the risk of bleeding;
• if the child has significant dehydration (due to vomiting, diarrhea, or insufficient fluid intake);
• if the child has bleeding in the brain (cerebral hemorrhage) or other active bleeding.

Women should not take this medicine during the last 3 months of pregnancy.

Warnings and precautions

Before starting treatment with Babyfen, you should discuss it with your doctor or pharmacist if your child has any of the following conditions.

Babyfen should only be used after consulting a doctor in the following cases:

• in patients who have had stomach or duodenal ulcers, due to the increased risk of gastrointestinal bleeding;
• in patients with asthma, as this medicine may increase the risk of bronchospasm (narrowing of the airways);
• in patients with kidney disease, as this medicine may impair kidney function;
• in patients with liver function disorders;
• in patients who have or have had high blood pressure or heart failure (see "Effect on the cardiovascular system" below);
• in patients with chronic inflammatory bowel diseases (such as ulcerative colitis or Crohn's disease), as this medicine may exacerbate these conditions;
• in patients with systemic lupus erythematosus (SLE) or mixed connective tissue disease, as there is an increased risk of developing aseptic meningitis;
• in children who have hay fever, nasal polyps, or chronic obstructive pulmonary disease, as this medicine may increase the risk of an allergic reaction.

In adults, before starting treatment with Babyfen, you should discuss it with your doctor or pharmacist:

• if you are planning to become pregnant (for more information, see "Pregnancy, breastfeeding, and fertility" below),
• if you are in the first six months of pregnancy,
• if you are breastfeeding.

Elderly

If it is necessary to use this medicine in elderly patients, you should use the smallest effective dose for the shortest possible time, as elderly patients are at increased risk of adverse reactions, which can be more severe.

Effect on the gastrointestinal tract

The risk of adverse reactions, particularly gastrointestinal bleeding, ulcers, and perforation, increases with dose.

If gastrointestinal bleeding or stomach ulcers occur during treatment with Babyfen, you should discontinue treatment.

If your child has any unusual digestive problems, you should report them to your doctor immediately.

Effect on the cardiovascular system

Anti-inflammatory and pain-relieving medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses.

You should not exceed the recommended dose or duration of treatment.

Before taking Babyfen, you should discuss treatment with your doctor or pharmacist if you have:

• heart disease, including heart failure, angina (chest pain), or if you have had a heart attack, coronary artery bypass grafting, peripheral artery disease (poor circulation in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including mini-stroke or transient ischemic attack, TIA);
• high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you smoke.

During treatment with ibuprofen, there have been reports of allergic reactions to this medicine, including difficulty breathing, swelling of the face and throat (angioedema), and chest pain.

If you notice any of these symptoms, you should stop taking Babyfen and seek medical help immediately.

Other warnings

• dehydrated children and adolescents, as well as the elderly, are at risk of kidney problems. This can occur, for example, due to vomiting or diarrhea, or insufficient fluid intake.
• frequent use of painkillers can lead to permanent kidney damage, and the risk increases with physical exertion - therefore, you should avoid physical exertion during treatment.
• you should talk to your doctor or pharmacist if your child has an infection - see "Infections" below.
• with long-term use of any painkillers, there may be a headache that cannot be cured with higher doses of the medicine. In such cases, you should consult your doctor about further treatment.

Skin reactions

There have been reports of severe skin reactions associated with ibuprofen, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP).

If your child experiences any symptoms associated with these severe skin reactions, you should stop taking Babyfen and seek medical help immediately.

Infections

Babyfen may mask the symptoms of an infection, such as fever and pain. Therefore, Babyfen may delay the use of appropriate infection treatment and lead to an increased risk of complications.

This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox.

If your child is taking this medicine and has an infection, and the symptoms of the infection persist or worsen, you should consult a doctor immediately.

This medicine should not be used during chickenpox.

Adverse reactions can be minimized by using the smallest effective dose for the shortest necessary period.

Babyfen with other medicines

Taking Babyfen with other medicines may cause interactions.

You should tell your doctor or pharmacist about all medicines your child is taking or has recently taken, including those without a prescription, especially:

• acetylsalicylic acid, other NSAIDs, including COX-2 inhibitors (e.g., celecoxib), medicines that affect blood clotting (e.g., warfarin), antiplatelet agents (e.g., ticlopidine), corticosteroids, and medicines used to treat depression, known as SSRIs (selective serotonin reuptake inhibitors), which increase the risk of adverse reactions from the gastrointestinal tract, including bleeding and stomach ulcers;
• digoxin (used to treat heart conditions), lithium (used to treat mental illnesses), and phenytoin (used to treat epilepsy), as ibuprofen may increase their levels in the blood and enhance their effects;
• acetylsalicylic acid, as it may cause a disturbance in the blood-thinning effect;
• medicines that lower high blood pressure (e.g., ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan) and diuretics, as ibuprofen may reduce their effect, and diuretics may increase the risk of kidney damage;
• methotrexate (a medicine used to treat cancer or rheumatoid arthritis), as its excretion may be reduced; oral hypoglycemic agents (sulfonylurea derivatives), as their effect may be enhanced; cases of hypoglycemia (low blood sugar) have been rarely reported when taking these medicines together;
• tacrolimus and cyclosporin (medicines used to treat skin diseases or after transplants), as they may cause kidney damage;
• mifepristone (a medicine used to terminate pregnancy), as it may reduce the effect of mifepristone;
• zydovudine (a medicine used to treat HIV or AIDS), as taking ibuprofen may increase the risk of bleeding into the joints or bleeding that leads to swelling in patients with hemophilia who are HIV-positive;
• quinolone antibiotics, as they may increase the risk of seizures;
• aminoglycoside antibiotics, as their excretion may be prolonged;
• CYP2C9 inhibitors (voriconazole or fluconazole used in fungal infections), as they may enhance the effect of ibuprofen;
• cholestyramine (used to reduce cholesterol), as it may reduce the absorption of ibuprofen;
• products containing Japanese ginkgo (a herbal medicine), as it may increase the risk of bleeding.

Babyfen may also change the effect of other medicines, and vice versa.

Therefore, you should always consult your doctor or pharmacist before taking Babyfen with other medicines.

Babyfen with alcohol

You should avoid drinking alcohol, as it increases the risk of adverse reactions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take Babyfen if you are 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 affect the child's and mother's tendency to bleed and may cause the delivery to be later or longer than expected.

You should not take Babyfen during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by your doctor.

If treatment is necessary during this period or when trying to conceive, you should use the smallest dose for the shortest possible time.

If Babyfen is used for more than a few days from the 20th week of pregnancy, it may cause the unborn child to have narrowing of the arterial duct (a blood vessel in the heart) or kidney problems, which can lead to low levels of amniotic fluid surrounding the child (oligohydramnios).

If you require treatment for a longer period, your doctor may recommend additional monitoring.

Breastfeeding

Only small amounts of ibuprofen and its breakdown products pass into breast milk.

This medicine can be taken during breastfeeding, if it is used in the recommended dose and for the shortest possible time.

Longer treatment is not recommended for breastfeeding mothers.

Fertility

Babyfen belongs to a group of medicines that may affect fertility in women.

This effect is reversible when the medicine is stopped.

Therefore, it is not recommended to use ibuprofen in women who are trying to conceive or have difficulty conceiving.

Driving and using machines

Ibuprofen usually does not affect the ability to drive or use machines.

However, some patients taking ibuprofen may experience dizziness, vision disturbances, and other central nervous system disorders.

As these adverse reactions may occur, you should not perform tasks such as driving or using machines unless you are sure that treatment with ibuprofen does not affect your ability to perform these tasks.

This recommendation is even more relevant when combined with alcohol.

Babyfen contains sorbitol (E 420), aspartame (E 951), sodium, sodium benzoate (E 211), and propylene glycol (E 1520)

Babyfen contains 210 g of sorbitol per mL of suspension.

Sorbitol is a source of fructose.

If your child has been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the body cannot break down fructose, you should consult your doctor before taking this medicine or giving it to your child.

Sorbitol may cause gastrointestinal upset and have a mild laxative effect.

Babyfen contains 0.038 mg of aspartame (E 951) per mL of suspension.

Aspartame is a source of phenylalanine.

It may be harmful to patients with phenylketonuria.

This is a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired excretion.

Babyfen contains less than 1 mmol (23 mg) of sodium per 10 mL (maximum single dose), which means the medicine is essentially "sodium-free".

Babyfen contains 0.1 mg of sodium benzoate (E 211) per mL of suspension.

Sodium benzoate (E 211) may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

• Babyfen contains 2.4 mg of propylene glycol (E 1520) per mL of suspension.

If your child is under 4 weeks of age, you should talk to your doctor or pharmacist before giving this medicine, especially if your child is taking other medicines that contain propylene glycol or alcohol.

3. How to take Babyfen

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

In case of doubt, you should consult your doctor or pharmacist.

This medicine is intended for short-term oral use only.

You should use the smallest effective dose for the shortest possible time necessary to relieve symptoms.

If your child's symptoms (such as fever and pain) persist or worsen during an infection, you should consult a doctor immediately (see section 2).

It is recommended that patients with stomach upset take Babyfen with food.

Doses should be given every 6-8 hours as needed.

The intervals between doses should be determined by the symptoms.

You should not exceed the maximum daily dose.

The dose is:

A 5 mL oral syringe is included with the packaging to measure the correct dose and administer the medicine.

Instructions for using the oral syringe:

• 1. Shake the bottle well before each use.
• 2. Remove the cap from the bottle.
• 3. Remove the syringe cap.
• 4. Place the bottle on a hard, flat surface and insert the syringe into the bottle.
• 5. Slowly pull the syringe plunger to the mark corresponding to the volume in milliliters (mL) according to the dosage table.
• 6. Remove the syringe from the bottle.
• 7. Make sure the child is held upright.
• 8. Place the end of the syringe in the child's mouth and slowly press the syringe plunger to gently release the medicine.

• 9. Wait until the child swallows the medicine.
• 10. Repeat steps 4-9 in the same way until the entire single dose is administered.
• 11. After administering the medicine, close the bottle and wash the syringe with warm water and let it dry.

Duration of treatment

In infants aged 3-5 months, you should consult a doctor immediately if the symptoms worsen or do not improve within 24 hours.

If the use of this medicine is necessary for more than 3 days in children or adolescents (aged 12-18 years), or if the symptoms worsen, you should consult a doctor.

This medicine is not intended for children under 3 months of age or with a body weight less than 5 kg.

Elderly

In these patients, there is an increased risk of adverse reactions, so you should use the smallest effective dose for the shortest time necessary to relieve symptoms.

In patients with kidney or liver function disorders, the dosage should be determined individually.

Kidney or liver function disorders

There is no need to adjust the dose in patients with mild to moderate kidney or liver function disorders.

This medicine should not be used if the patient has severe kidney or liver failure.

Overdose of Babyfen

If your child has taken more of this medicine than they should, or if they have taken more than the recommended dose, you should always consult a doctor or go to the nearest hospital to assess the risk to their health and for advice on what to do.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus.

After taking large doses, there have been reports of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing problems.

Other symptoms of overdose include drowsiness or dry mouth.

In cases of severe overdose, there may be kidney failure and liver damage.

Missed dose of Babyfen

You should not give a double dose to make up for a missed dose.

Continue with the recommended dosage schedule as described above.

If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

Side effects can be minimized by taking the smallest effective dose for the shortest possible time.

In elderly patients, there is an increased risk of side effects.

In case of severe reactions, such as swelling of the face or difficulty breathing, blisters on the skin, vision disturbances, black stools, or bloody vomiting, you should stop taking the medicine and seek medical help immediately.

If your child experiences any of the following symptoms, you should stop taking ibuprofen and seek medical help (see also section 2):

• red, flat, target-like, or circular patches on the trunk, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare: may occur in 1 in 10,000 patients),
• there may be a severe skin reaction called DRESS (drug reaction with eosinophilia and systemic symptoms). The symptoms of DRESS include: skin rash, fever, swelling of the lymph nodes, and an increase in the number of eosinophils (a type of white blood cell), frequency not known (frequency cannot be estimated from the available data),
• there may be a severe skin reaction called acute generalized exanthematous pustulosis (AGEP). The symptoms of AGEP include: a red, scaly, widespread rash with bumps under the skin and blisters, mainly on the skin folds, trunk, and upper limbs, which is accompanied by fever at the beginning of treatment, frequency not known (frequency cannot be estimated from the available data).

The following side effects may occur when taking ibuprofen, listed by frequency:

Common(may occur in 1 in 10 patients):

• nausea (feeling sick),
• vomiting,
• diarrhea,
• constipation,
• bloating,
• indigestion,
• stomach pain,
• gastrointestinal bleeding (black stools or bloody vomiting),
• dizziness,
• fatigue,
• headache,
• irritability,
• restlessness,
• rash.

Uncommon(may occur in 1 in 100 patients):

• allergic reactions,
• various kidney function disorders, such as kidney inflammation, nephrotic syndrome (a set of symptoms related to kidney disease), and kidney failure, acute kidney failure,
• nasal passage inflammation,
• stomach lining inflammation,
• duodenal ulcer,
• stomach ulcer,
• mouth ulcers,
• perforation of the gastrointestinal tract,
• liver inflammation,
• jaundice,
• liver function disorders,
• asthma,
• bronchospasm,
• shortness of breath,
• insomnia,
• tingling sensation,
• drowsiness,
• restlessness,
• hives,
• itching,
• purpura (purple spots on the skin),
• angioedema (swelling of the face, lips, tongue, or throat),
• increased sensitivity of the skin to sunlight,
• vision disturbances,
• hearing disturbances,
• balance disorders,
• ringing in the ears.

Rare(may occur in 1 in 1,000 patients):

• aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord without bacterial infection),
• systemic lupus erythematosus (an autoimmune disease),
• depression,
• disorientation,
• hallucinations,
• optic neuritis (inflammation of the optic nerve),
• toxic optic neuropathy (damage to the optic nerve),
• edema (swelling),
• reduced number of certain blood cells (e.g., red or white blood cells, or platelets).

Very rare(may occur in 1 in 10,000 patients):

• pancreatitis (inflammation of the pancreas),
• esophagitis (inflammation of the esophagus),
• intestinal stricture (narrowing of the intestine),
• liver failure,
• palpitations,
• heart failure,
• heart attack,
• acute respiratory distress syndrome,
• high blood pressure,
• severe skin reactions,
• gangrene (death of tissue due to lack of blood supply), especially after long-term use,
• severe allergic reactions, which may include symptoms such as swelling of the face, tongue, and throat, difficulty breathing, rapid heartbeat, low blood pressure (anaphylaxis, angioedema, or severe shock).

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

• worsening of ulcerative colitis and Crohn's disease,
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Medicines like Babyfen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

During treatment, there have been reports of discomfort when swallowing and burning sensation in the throat or mouth.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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, you can help provide more information on the safety of this medicine.

5. How to store Babyfen

Keep this medicine out of the sight and reach of children.

After opening the packaging, the suspension can be stored for 3 months.

Do not use this medicine after the expiration date stated on the carton and label after EXP.

The expiration date refers to the last day of the month stated.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste.

Ask your 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 Babyfen contains

The active substance is ibuprofen.

Each mL of oral suspension contains 20 mg of ibuprofen.

• The other ingredients are: glycerol, sorbitol, liquid (non-crystallizing) (E 420), xanthan gum, microcrystalline cellulose, and sodium croscarmellose, polysorbate 80, disodium edetate, sodium saccharin, citric acid monohydrate, sodium citrate, sodium benzoate (E 211), simethicone emulsion 30%, sodium chloride, purified water.

What Babyfen looks like and contents of the pack

Babyfen is a white or brownish homogeneous suspension with a peach flavor.

100 mL of oral suspension is directly packaged in a 125 mL brown glass bottle with a PP cap or a PP cap with a child-resistant closure, together with a 5 mL oral syringe, in a cardboard box.

The cardboard box contains one (1) bottle and one plastic oral syringe with a 5 mL graduation for oral dosing.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Dr. Max Pharma s.r.o.

Na Florenci 2116/15

Nové Město

110 00 Prague 1

Czech Republic

Phone: (+420) 516 770 199

Manufacturer/Importer:

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana – Črnuče

Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria

BlokMAX for kids 100 mg/5 ml oral suspension

Czech Republic

Ibuprofen Dr.Max 100 mg/5 ml peroral suspension

Spain

BYNER 20 mg/ml oral suspension

Hungary

Dolowill Baby 100 mg/ 5 ml oral suspension

Croatia

BlokMAX za djecu 100 mg/5 ml oral suspension

Romania

PADUDEN, cu aromă de caise 20 mg/ml oral suspension

Slovenia

IBUPROFEN Alkaloid-INT 20 mg/ml peroral suspension

Poland

Babyfen

Date of last revision of the package leaflet: 10/2024