Nurofen dla dzieci Forte truskavkovi

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Nurofen for Children Forte Strawberry(Nurofen Junior Fieber- und Schmerzsaft Erdbeer)

40 mg/ml, oral suspension

Ibuprofen
Nurofen for Children Forte Strawberry and Nurofen Junior Fieber- und Schmerzsaft Erdbeer are different trade names for the same medicine.
For children weighing from 5 kg (from 3 months of age) to 40 kg (12 years)

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
• You should keep this leaflet, so that you can read it again if you need to. If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 24 hours (infants aged 3-5 months, weighing over 5 kg) or 3 days (children over 6 months) there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet:

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

1. What is Nurofen for Children Forte Strawberry and what is it used for

Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
The action of these medicines is to change the body's response to pain and elevated body temperature.
Nurofen for Children Forte Strawberry is intended for short-term, symptomatic treatment of:

• fever,
• pain of mild to moderate severity.

If after 24 hours (infants aged 3-5 months, weighing over 5 kg) or 3 days (children over 6 months) there is no improvement or the patient feels worse, they should contact a doctor.

2. Important information before using Nurofen for Children Forte Strawberry

When not to use Nurofen for Children Forte Strawberry

• If the child is allergic to ibuprofen or other similar painkillers (from the NSAID group) or any of the other ingredients of this medicine (listed in section 6).
• If the child has ever had breathing difficulties, asthma, hay fever, swelling of the face and/or hands or hives after taking acetylsalicylic acid or other similar painkillers (from the NSAID group).
• If the child has ever had bleeding or perforation of the gastrointestinal tract associated with previous use of NSAIDs.
• If the child currently has or has had stomach and/or duodenal ulcers (ulcer disease) or bleeding (two or more confirmed cases of ulcers or bleeding).
• If the child has severe liver and kidney failure.
• If the child has severe heart failure.
• If the child has had bleeding in the brain (cerebral hemorrhage) or other active bleeding.
• If the child has blood clotting disorders, as ibuprofen may prolong bleeding time.
• If the child has blood production disorders of unknown origin.
• In children with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

Do not take the medicine in the last 3 months of pregnancy.

Warnings and precautions

Before starting treatment with Nurofen for Children Forte Strawberry, you should discuss it with your doctor or pharmacist

• If the child has an infection - see below, "Infections".
• If the child has certain inherited blood production disorders (e.g. acute intermittent porphyria).
• If the child has blood clotting disorders.
• If the child has certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease).
• If the child has intestinal diseases (ulcerative colitis or Crohn's disease), as their symptoms may worsen.
• If the child has or has had high blood pressure and/or heart failure.
• If the child has kidney function disorders.
• If the child has liver diseases. With long-term use of Nurofen for Children Forte Strawberry, regular monitoring of liver function, kidney function, and blood morphology parameters is required.
• Caution is recommended when using other medicines that may increase the risk of gastrointestinal ulcers or bleeding, such as oral corticosteroids (such as prednisolone), blood thinners (such as warfarin), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet agents (such as acetylsalicylic acid). If the child is also taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), they should be avoided.
• The risk of side effects can be reduced by using the smallest effective dose for the shortest possible time.
• Generally, continuous use of (various) painkillers can lead to persistent serious kidney disease. This risk may increase during physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.
• As a result of long-term use of any type of painkillers, headaches may occur, which should not be treated with increased doses of this medicine. In such a case, the medicine should be discontinued and a doctor consulted. The diagnosis of headache caused by drug abuse should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of pain-relieving medications.
• If the child has or has had asthma, or allergic diseases that can cause shortness of breath.
• If the child has hay fever, nasal polyps, chronic obstructive pulmonary disease, there is an increased risk of allergic reactions. Allergic reactions can occur as asthma attacks (so-called aspirin-induced asthma), Quincke's edema, or hives.
• Caution is advised when using Nurofen for Children Forte Strawberry in the event of chickenpox (chickenpox).
• If the child has recently undergone major surgery (medical supervision is required).
• If the child is dehydrated, due to the increased risk of kidney failure in dehydrated children.

Infections
Nurofen for Children Forte Strawberry may mask the symptoms of infection, such as fever and pain. In this regard, Nurofen for Children Forte Strawberry 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 immediately consult a doctor.
Skin reactions
Severe skin reactions have been reported with the use of Nurofen for Children Forte Strawberry. If any skin rash, mucosal lesions, blisters, or other signs of allergy occur, the use of Nurofen for Children Forte Strawberry should be discontinued and medical help sought immediately, as these may be the first signs of a severe skin reaction. See section 4.
Gastrointestinal bleeding, ulcers, or perforation, which can be fatal, have been reported during treatment with all NSAIDs, with or without warning symptoms, or in patients with a history of serious gastrointestinal disorders. If gastrointestinal bleeding or ulcers occur, treatment should be discontinued immediately. The risk of gastrointestinal bleeding, ulcers, or perforation increases with the dose of NSAIDs in patients who have had ulcers, especially with bleeding or perforation (see section 2 "When not to use Nurofen for Children Forte Strawberry") and in the elderly. These patients should start treatment with the lowest effective dose. In these patients, as well as in patients requiring concomitant use of low-dose acetylsalicylic acid or medications that increase the risk of gastrointestinal reactions, consideration should be given to combination therapy with protective agents (such as misoprostol or proton pump inhibitors).
Taking anti-inflammatory and pain-relieving medications, 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 using Nurofen for Children Forte Strawberry, the patient should discuss treatment with their doctor or pharmacist if:

• The patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, has had a bypass operation, 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).
• The patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes.

If any of the above applies to the child, they should consult a doctor before using Nurofen for Children Forte Strawberry.
Elderly patients
Elderly patients using this medicine are at increased risk of side effects, especially those affecting the stomach and intestines.
Patients with a history of gastrointestinal disorders, especially in the elderly, should report any unusual abdominal symptoms (mainly gastrointestinal bleeding) to their doctor, especially during the initial treatment phase.

Nurofen for Children Forte Strawberry and other medicines

Tell your doctor or pharmacist about all medicines your child is currently taking or has recently taken, as well as any medicines your child may be taking.
Nurofen for Children Forte Strawberry may affect the action of other medicines or other medicines may affect the action of Nurofen for Children Forte Strawberry. For example:

• Medicines with anticoagulant action (i.e. blood thinners/anti-clotting agents, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• Medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Some other medicines may also be affected or have an effect on treatment with Nurofen for Children Forte Strawberry. Therefore, before using Nurofen for Children Forte Strawberry with other medicines, you should always consult a doctor or pharmacist.
In particular, you should inform your doctor if your child is taking any of the following medicines:

Nurofen for Children Forte Strawberry with alcohol

Do not drink alcohol while using Nurofen for Children Forte Strawberry.
Certain side effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when alcohol and Nurofen for Children Forte Strawberry are taken together.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use the medicine during the last 3 months of pregnancy. Avoid using this medicine during the first 6 months of pregnancy, unless your doctor advises otherwise.
Breastfeeding
Only small amounts of ibuprofen and its breakdown products pass into breast milk. Nurofen for Children Forte Strawberry can be used during breastfeeding, if administered in the recommended doses and for the shortest possible time.
Fertility
Nurofen for Children Forte Strawberry belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is temporary after stopping the medicine.

Driving and using machines

During short-term use, the medicine does not affect or has a negligible effect on the ability to drive and use machines.

Important information about some of the ingredients of Nurofen for Children Forte Strawberry

• Nurofen for Children Forte Strawberry contains liquid maltitol. If you have been told that you have an intolerance to some sugars, you should consult your doctor before taking the medicine.
• The medicine may have a mild laxative effect.
• The energy value for maltitol is: 2.3 kcal/g
• This medicine contains less than 1 mmol of sodium (23 mg) per dose, so it is considered "sodium-free".
• Nurofen for Children Forte Strawberry contains 16.45 mg of propylene glycol in each 5 ml of suspension.

3. How to use Nurofen for Children Forte Strawberry

Nurofen for Children Forte Strawberry should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.

Use the smallest effective dose for the shortest possible time. If the symptoms of infection (such as fever and pain) persist or worsen, you should immediately consult a doctor (see section 2).

Recommended dose for pain and fever:

*Doses should be given every 6 to 8 hours.

Do not recommend for children under 3 months or weighing less than 5 kg.

In patients with sensitive stomachs, it is recommended to take Nurofen for Children Forte Strawberry with food.
WARNING: do not exceed the recommended dose.

For oral use

Method of administration using an oral syringe

• 1. Shake the bottle well.
• 2. Remove the cap from the bottle by pressing it down and turning it to the left.
• 3. The syringe should be firmly inserted into the opening in the neck of the bottle.
• 4. To fill the syringe, turn the bottle upside down. Holding the syringe in place, gently pull the plunger down, drawing the suspension to the correct mark on the syringe.
• 5. Turn the bottle back over and remove the syringe by gently turning it.
• 6. Place the end of the syringe in the child's mouth. Press the plunger slowly and gently administer the suspension. Rinse the syringe with warm water and let it dry. Store it out of reach and sight of children.

Duration of treatment

This medicine is intended for short-term use only. If the symptoms in children over 6 months persist for more than 3 days or the patient feels worse, they should consult a doctor.

In the case of infants aged 3-5 months (weighing over 5 kg), a doctor should be consulted if the symptoms do not improve within 24 hours.

If the symptoms worsen, you should consult a doctor.

Taking a higher dose of Nurofen for Children Forte Strawberry than recommended

If the patient has used a higher dose of Nurofen for Children Forte Strawberry than recommended or if the child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do in such a case.
Symptoms may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding, headache, ringing in the ears, disorientation, or nystagmus, or less frequently, diarrhea.
After taking a large dose, there have been reports of balance disorders, vision disorders, low blood pressure, excitement, disorientation, coma, hyperkalemia, metabolic acidosis, increased prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, and worsening of asthma in asthmatic patients, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and breathing difficulties.

Missing a dose of Nurofen for Children Forte Strawberry

Do not take a double dose to make up for a missed dose. If the patient forgets to take or give a dose, they should take or give it as soon as they remember, and then take or give the next dose of the medicine according to the dosing interval described above.

If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Nurofen for Children Forte Strawberry can cause side effects, although not everybody gets them. The risk of side effects can be reduced by using the smallest effective dose for the shortest possible time. In children, one of the known side effects of NSAIDs may occur. If side effects occur or if you are unsure, you should stop giving the medicine and talk to a doctor as soon as possible. Elderly patients using this medicine are at increased risk of side effects.

STOP USING the medicine and seek medical help immediately if your child experiences:

• symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, vomiting blood or coffee grounds-like vomit.
• symptoms of rare but serious allergic reactions, such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, and a drop in blood pressure leading to shock. Symptoms may occur even after the first use of the medicine. If any of these symptoms occur, you should immediately contact a doctor.
• severe skin reactionssuch as a rash covering the whole body, peeling, blistering, and shedding of the skin.

If any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor.

Common(may affect up to 1 in 10 people)

• Gastrointestinal disorders such as heartburn, stomach pain, nausea, indigestion, diarrhea, vomiting, bloating (gas), constipation, and minor gastrointestinal bleeding, which in rare cases may cause anemia.

Uncommon(may affect up to 1 in 100 people)

• Ulcers in the gastrointestinal tract, which may bleed or perforate, oral mucosal inflammation with ulcers, worsening of existing intestinal diseases (ulcerative colitis or Crohn's disease), gastritis
• Central nervous system disorders, such as headaches, dizziness, insomnia, agitation, irritability, or fatigue
• Vision disorders
• Various skin rashes
• Allergic reactions with hives and itching.

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

• Tinnitus (ringing in the ears)
• Increased blood urea levels, side and/or abdominal pain, blood in the urine, and fever, which may be signs of kidney damage (renal papillary necrosis)
• Increased blood uric acid levels
• Decreased hemoglobin levels.

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

• Esophagitis, pancreatitis, formation of intestinal strictures
• Heart failure, heart attack, and facial or hand swelling
• Kidney failure, and swelling (especially in patients with high blood pressure or impaired kidney function), and clouding of the 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, they should stop using Nurofen for Children Forte Strawberry and consult a doctor immediately, as these may be the first signs of kidney damage or failure
• Psychotic reactions and depression
• High blood pressure, vasculitis
• Rapid heartbeat
• Liver function disorders, liver damage (the first symptoms may be skin discoloration), especially during long-term treatment, liver failure, acute hepatitis
• Blood production disorders - the first symptoms are: fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained bruising. In such cases, treatment should be discontinued immediately and a doctor consulted. Do not self-medicate with painkillers or antipyretics
• Severe skin and soft tissue infections during chickenpox
• Aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, and impaired consciousness. In patients with autoimmune disorders (lupus, mixed connective tissue disease), there is a higher risk of such symptoms. If such symptoms occur, you should immediately consult a doctor
• Severe skin reactions, such as a rash covering the whole body, peeling, blistering, and shedding of the skin (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia).

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

• Respiratory tract reactions, including asthma, bronchospasm, shortness of breath
• Severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell)
• A red scaly rash with thickening of the skin and blisters, mainly in the skin folds, on the trunk, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop using Nurofen for Children Forte Strawberry and seek medical help immediately. See also section 2
• The skin becomes sensitive to light.

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

Reporting side effects

If you experience any side effects, including any side effects not listed in the 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 181 C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nurofen for Children Forte Strawberry

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Do not store above 25°C.
Shelf life after first opening: 6 months.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Nurofen for Children Forte Strawberry contains

The active substance of the medicine is ibuprofen. Each 1 ml of oral suspension contains 40 mg of ibuprofen.
The other ingredients are: citric acid monohydrate, sodium citrate, sodium chloride, sodium saccharin, polysorbate 80, domiphen bromide, liquid maltitol, glycerol, xanthan gum, strawberry flavor (contains propylene glycol), and purified water.

What Nurofen for Children Forte Strawberry looks like and what the pack contains

Nurofen for Children Forte Strawberry is a white oral suspension with a characteristic strawberry flavor.
Each bottle contains 100 ml.
The packaging includes an oral syringe with a capacity of 5 ml, graduated at 1.25 ml, 2.5 ml, 3.75 ml, and 5 ml.
Outer packaging: cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Reckitt Benckiser Deutschland GmbH
Darwinstrasse 2-4, 69115 Heidelberg, Germany

Manufacturer:

Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
HU8 7DS Hull
United Kingdom
RB NL Brands B.V.
Schiphol Boulevard 207, 1118 BH Schiphol, Netherlands

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warszawa

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warszawa
Marketing authorization number in Germany, the country of export:76554.00.00

Parallel import authorization number: 113/22

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

Date of approval of the leaflet: 28.02.2022

[Information about the trademark]