Ibuprofen Banner

Leaflet attached to the packaging: information for the user

Ibuprofen Banner, 100 mg, chewable capsules, soft

Ibuprofen

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

This medicine should always be taken 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 you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• In the case of children and adolescents aged 7 to 17 years, if there is no improvement or the patient feels worse after 3 days, you should consult a doctor. In the case of adults, if there is no improvement or the patient feels worse after 3 days in the case of fever or 4 days in the case of pain, you should consult a doctor.

Table of contents of the leaflet:

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

1. What is Ibuprofen Banner and what is it used for

The active substance is ibuprofen, which belongs to non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen Banner is used for the short-term symptomatic treatment of mild to moderate pain, such as headache, menstrual pain, toothache, and fever and pain in the course of a cold.

2. Important information before taking Ibuprofen Banner

Do not take this medicine or give it to a child:

• if the patient is allergic to ibuprofen, peanuts, or soy, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had a hypersensitivity reaction (e.g., shortness of breath, asthma, hay fever, hives, swelling of the face, tongue, lips, or throat) after taking ibuprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has severe kidney, heart, or liver failure;
• if the patient has a current brain hemorrhage (cerebrovascular hemorrhage) or other bleeding;
• if the patient has blood disorders of unknown cause;
• if the patient has severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake);
• if the patient has active or recurrent stomach or duodenal ulcers (peptic ulcers) or gastrointestinal bleeding (two or more episodes of confirmed peptic ulcers or gastrointestinal bleeding);
• if the patient has ever had gastrointestinal bleeding or perforation associated with previous use of NSAIDs.

Do not take this medicine if you are in the last 3 months of pregnancy.

Warnings and precautions

During the use of ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), and chest pain. If any of these symptoms are noticed, you should stop taking Ibuprofen Banner and immediately consult a doctor or emergency medical services.
Before starting treatment with Ibuprofen Banner, you should discuss it with your doctor or pharmacist if you have:

• asthma or other allergic diseases, as shortness of breath may occur;
• hay fever, nasal polyps, or chronic obstructive respiratory disease, as there is an increased risk of allergic reactions. These reactions may manifest as asthma attacks (so-called analgesic-induced asthma), angioedema, or urticaria;
• constipation;
• kidney function disorders;
• liver function disorders. In the case of long-term administration of Ibuprofen Banner, regular monitoring of liver function parameters, kidney function, and blood morphology is required;
• you should be cautious if you are taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids (such as prednisolone), anticoagulants (such as warfarin), selective serotonin reuptake inhibitors (a medicine used to treat depression), or antiplatelet agents (such as acetylsalicylic acid);
• if you are taking another NSAID medicine (including COX-2 inhibitors, such as etoricoxib or celecoxib), you should avoid taking them at the same time (see "Ibuprofen Banner and other medicines");
• if you have systemic lupus erythematosus (SLE, an autoimmune disease affecting connective tissue, causing joint pain, skin changes, and disorders of other organs) or mixed connective tissue disease;
• if you have certain inherited blood disorders (e.g., acute intermittent porphyria);
• if you have bleeding disorders;
• severe skin reactions have occurred with ibuprofen, including 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 the patient experiences any symptoms associated with these severe skin reactions, you should stop taking Ibuprofen Banner and seek medical attention.
• if you have chronic inflammatory bowel disease, such as Crohn's disease or ulcerative colitis;
• if the child is dehydrated, as there is a risk of kidney function disorders in dehydrated children;
• if the patient has recently undergone surgery;
• if the patient has chickenpox, it is recommended to avoid taking Ibuprofen Banner during the infection.
• if the patient has an infection - see below, the section entitled "Infections".

The occurrence of side effects can be minimized by using the smallest effective dose for the shortest necessary period to control symptoms.
Cases of gastrointestinal bleeding, gastrointestinal ulcers, or gastrointestinal perforation, which can be fatal, have been reported with the use of all NSAIDs at any time during treatment, with or without warning symptoms, or in patients who have previously experienced severe gastrointestinal events. If gastrointestinal bleeding or ulcers occur, treatment should be stopped immediately. The risk of gastrointestinal bleeding, ulcers, or perforation increases with the dose of NSAIDs, in patients with a history of gastrointestinal ulcers, especially if complicated by bleeding or perforation (see section 2). Do not use Ibuprofen Banner in elderly patients. Such patients should start treatment with the lowest available dose. In these patients, as well as in patients requiring low doses of acetylsalicylic acid or other medicines that increase the risk of gastrointestinal disorders, it is recommended to consider concurrent use of protective agents (e.g., misoprostol or proton pump inhibitors).
Generally, habitual use of painkillers for headaches can worsen them. If this occurs or is suspected, you should stop taking Ibuprofen Banner and consult a doctor. Medication-induced headaches should be suspected in patients who frequently or daily experience headaches despite (or due to) regular use of painkillers.

Regarding adults taking this medicine

The warnings and information provided in this section apply, and the following additional information:

• ibuprofen belongs to a group of medicines that may impair fertility in women. This effect is reversible after stopping the medicine. It is unlikely that this medicine, when used sporadically, will affect fertility, but you should inform your doctor before taking it if you have difficulty conceiving;
• in the first 6 months of pregnancy, this medicine should only be taken on the advice of a doctor;
• taking anti-inflammatory and pain-relieving medicines, such as Ibuprofen Banner, 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 taking Ibuprofen Banner, you should discuss treatment with your doctor or pharmacist if you have heart disease, such as heart failure, or if you have had a stroke.

Elderly patients

In elderly patients, there is an increased risk of side effects, especially those related to the stomach and intestines, when taking NSAIDs. For more information, see section 4, "Possible side effects".
If there is a history of side effects in the gastrointestinal tract, especially in the elderly, any worrying symptoms in the abdominal cavity (especially gastrointestinal bleeding) should be reported, especially in the initial phase of treatment.

Ibuprofen Banner and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Ibuprofen Banner may affect the action of other medicines or other medicines may affect the action of Ibuprofen Banner. For example:

• anticoagulant medicines (i.e., blood thinners/preventing blood clots, such as aspirin/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).

Some other medicines may also be affected or have an effect on treatment with Ibuprofen Banner.
Therefore, before taking Ibuprofen Banner with other medicines, you should always consult a doctor or pharmacist.
This is especially true for the following medicines:

Taking Ibuprofen Banner with alcohol

You should not drink alcohol while taking Ibuprofen Banner. The occurrence of certain side effects, such as those related to the gastrointestinal or central nervous system, may be more likely if alcohol is consumed at the same time as Ibuprofen Banner.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, you should consult a doctor or pharmacist before taking this medicine.
Pregnancy
You should inform your doctor if you become pregnant while taking Ibuprofen Banner. Do not take this medicine if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause problems with the kidneys and heart of the unborn child. It may affect the tendency to bleed in the mother and her child and may cause delayed or prolonged delivery beyond the expected time. Do not use this medicine in the first 6 months of pregnancy unless it is absolutely necessary and advised by a doctor. Ibuprofen taken for more than a few days from the 20th week of pregnancy may cause kidney problems in the unborn child, which can lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If the patient requires treatment for more than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Only small amounts of ibuprofen and its breakdown products pass into breast milk. Ibuprofen Banner can be used during breastfeeding if it is used in the recommended dose and for the shortest possible time.
Fertility
Ibuprofen Banner belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is reversible after stopping the medicine.

Driving and using machines

When used for a short period, this medicine does not affect or has a negligible effect on the ability to drive and use machines.
Ibuprofen Banner contains soy lecithin.Do not use if you are allergic to peanuts or soy.
Ibuprofen Banner contains glucose syrup.If your doctor has told you that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
Ibuprofen Banner containsless than 1 mmol (23 mg) of sodium per chewable capsule, which means the medicine is considered "sodium-free".

3. How to take Ibuprofen Banner

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
Ibuprofen Banner is taken orally.
The capsules should be chewed and then swallowed. It is not necessary to drink water.
This medicine is intended for short-term use.
You should use the smallest effective dose for the shortest possible time necessary to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, you should consult a doctor immediately (see section 2).

Do not recommend taking this medicine to children under 7 years of age or children weighing less than 20 kg.

Children weighing 20 to 39 kg (aged 7 to 11 years):

The recommended dose of the medicine is as follows:
In children, the dosage of ibuprofen is based on body weight, with a single dose usually ranging from 5 to 10 mg/kg, and the maximum total daily dose ranging from 20 to 30 mg/kg.

Maximum daily dose

600 mg of ibuprofen
(6 capsules)
900 mg of ibuprofen
(9 capsules)
If necessary, doses should be given approximately every 6 to 8 hours, (with a minimum of 6 hours between each dose).
WARNING: Do not exceed the recommended dose.
Adults and adolescents weighing ≥ 40 kg (aged 12 and over):
Initial dose, 200 mg or 400 mg of ibuprofen. If necessary, additional doses of 200 mg or 400 mg of ibuprofen (2 or 4 capsules) can be taken. The interval between consecutive doses should be determined based on the observed symptoms and taking into account the maximum daily dose. It should not be less than 6 hours. Do not exceed the total daily dose of 1200 mg of ibuprofen.

Child's body weight Age Single dose

≥40 kg
200 mg or 400 mg of ibuprofen (2
or 4 capsules)
1200 mg (12 capsules)
(Adults and adolescents from 12 years old)
When using the medicine in children and adolescents aged 7 to 17 years, you should consult a doctor if it is necessary to use the medicine for more than 3 days or if the symptoms worsen. If adults need to take the medicine for more than 3 days in the case of fever or more than 4 days in the case of pain, or if the symptoms worsen, you should consult a doctor.

Taking a higher dose of Ibuprofen Banner than recommended

If you have taken a higher dose of Ibuprofen Banner than recommended or if a child has accidentally taken the medicine, you should always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to your health and advice on what to do in such a case.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), ringing in the ears, headache, dizziness, disorientation, nystagmus, gastrointestinal bleeding (see also section 4 below), or rarely diarrhea. After taking a large dose, dizziness, blurred vision, low blood pressure, excitement, disorientation, coma, hyperkalemia

(elevated potassium levels in the blood), kidney damage (renal failure), liver damage, depression, severe skin reactions, and blood disorders. If any of these symptoms occur, you should stop taking Ibuprofen Banner and seek medical attention immediately.

Missing a dose of Ibuprofen Banner

Do not take a double doseto make up for a missed dose of the medicine.
If you have any further questions about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The occurrence of side effects can be minimized by using the smallest effective dose for the shortest necessary period to control symptoms. Although side effects are not very common, a child may experience one of the known side effects of NSAIDs. If this happens or if there are concerns, you should stop giving the medicine to the child and consult a doctor as soon as possible. In elderly patients taking this medicine, there is an increased risk of side effects related to the stomach and intestines.

STOP TAKING THIS MEDICINE AND IMMEDIATELY CONSULT A DOCTOR IF YOU EXPERIENCE:

• symptoms of gastrointestinal bleedingsuch as severe abdominal pain, black, tarry stools, vomiting blood or dark particles that look like coffee grounds.
• symptoms of a rare but severe allergic reaction, such as worsening of asthma, wheezing, or shortness of breath for unknown reasons, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, decreased blood pressure leading to shock. These side effects may occur even after the first use of this medicine. If any of these symptoms occur, you should immediately call a doctor.
• severe skin reactions, such as rashes covering the whole body, peeling of the skin, blistering, or peeling of the skin, including a severe skin reaction known as DRESS syndrome (frequency not known). Symptoms of DRESS syndrome include: skin rash, fever, swelling of the lymph nodes, and an increased number of eosinophils (a type of white blood cell).
• red, scaly rash with bumps under the skin and blisters, usually on the folds of the skin, on the torso and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis).
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).
• red, scaly rash with bumps under the skin and blisters, with fever at the beginning of treatment (acute generalized exanthematous pustulosis).
• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Tell your doctor if you experience any of the following side effects or if they worsen any side effects not listed in the leaflet.

Common(occurring in less than 1 in 10 treated patients)

• stomach and intestinal disorders, such as heartburn, stomach pain, and nausea, indigestion, diarrhea, vomiting, bloating (gas) and constipation, as well as minor bleeding in the stomach and/or intestines, which can rarely cause anemia.

Uncommon(occurring in less than 1 in 100 treated patients)

• stomach and intestinal ulcers, perforation, or bleeding, inflammation of the mucous membrane of the mouth with ulcers, worsening of existing intestinal disease (ulcerative colitis or Crohn's disease), inflammation of the stomach lining;
• headache, dizziness, insomnia, restlessness, irritability, or fatigue;
• vision disorders;
• various skin rashes;
• allergic reactions with hives and itching.

Rareside effects (occurring in less than 1 in 1,000 treated patients)

• ringing in the ears;
• increased blood urea levels, pain in the sides of the torso and/or abdomen, blood in the urine, and fever may be signs of kidney damage (renal papillary necrosis);
• increased blood uric acid levels;
• decreased hemoglobin levels.

Very rareside effects (occurring in less than 1 in 10,000 treated patients)

• esophageal inflammation, pancreatitis, formation of diaphragm-like constrictions of the intestinal lumen;
• heart failure, myocardial infarction, and swelling of the face or hands;
• kidney failure, decreased urine output, and swelling (especially in patients with high blood pressure or kidney function disorders), swelling and cloudy urine (nephrotic syndrome); interstitial kidney disease, which can lead to acute kidney failure. If any of the above symptoms occur or if the patient feels unwell in general, you should stop taking Ibuprofen Banner and consult a doctor immediately, as these may be the first signs of kidney damage or failure;
• psychotic reactions, depression;
• high blood pressure, vasculitis;
• palpitations;
• liver function disorders, liver damage (the first symptoms may include skin discoloration), especially during long-term treatment, liver failure, acute hepatitis;
• blood cell production problems - the first symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained bruising. In such cases, you should stop the therapy and consult a doctor. Do not attempt to treat yourself with painkillers or antipyretics;
• severe skin and soft tissue infections during chickenpox;
• worsening of inflammatory conditions associated with infection (e.g., necrotizing fasciitis) after taking some painkillers (NSAIDs). If symptoms of infection occur or worsen, you should immediately consult a doctor. In this case, it should be determined whether there are indications for the use of anti-infective agents or antibiotics;
• aseptic meningitis with stiffness of the neck, headache, nausea, vomiting, fever, or changes in consciousness. This is more likely to occur in patients with autoimmune disorders (SLE, mixed connective tissue disease). If such symptoms occur, you should immediately consult a doctor;
• severe skin reactions involving a rash, redness, and blistering [e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)], hair loss (alopecia).

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

• respiratory symptoms including asthma, bronchospasm, or shortness of breath;
• a severe skin reaction known as DRESS syndrome. Symptoms of DRESS syndrome include: skin rash, fever, swelling of the lymph nodes, and an increased number of eosinophils (a type of white blood cell). Red, scaly rash with bumps under the skin and blisters, usually on the folds of the skin, on the torso and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop taking Ibuprofen Banner and seek medical attention immediately. See also section 2;
• the skin becomes sensitive to light.

Taking 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 possible 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 Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309
e-mail: ndl@urpl.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 Ibuprofen Banner

Do not store above 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
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 Ibuprofen Banner contains

The active substance of the medicine is ibuprofen. One soft chewable capsule contains 100 mg of ibuprofen
The other ingredients are: gelatin, purified water, glucose syrup, sucrose, fumaric acid (E297), sucralose, citric acid (E330), acesulfame potassium (E950), disodium edetate, orange flavor* and Opacode White NS-7818011** *The flavor contains: d-limonene, ethyl acetate, and alpha-pinene **The ink composition includes: purified water, titanium dioxide (E171), propylene glycol, isopropyl alcohol, hypromellose 3cP The following substances are used in the manufacturing process: medium-chain triglycerides, isopropyl alcohol, and soy lecithin

• The following substances are used in the manufacturing process: medium-chain triglycerides, isopropyl alcohol, and soy lecithin

What Ibuprofen Banner looks like and what the pack contains

Ibuprofen Banner is a light yellow to dark yellow, square, soft gelatin chewable capsule with a white imprint of a hashtag (#).
Ibuprofen Banner is available in PVC/PE/PVdC/Aluminum blisters
The packaging contains 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 48 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Patheon Softgels B.V. (operating under the name Banner Pharmacaps Europe)
De Posthoornstraat 7
5048 AS Tilburg
Noord-Brabant
Netherlands

Manufacturer:

Patheon Softgels B.V.
De Posthoornstraat 7
5048 AS Tilburg
Noord-Brabant
Netherlands

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

Netherlands
Ibuprofen Banner 100 mg, soft chewable capsules
Austria
Ibuprofen Banner 100 mg, soft capsules for chewing
Czech Republic
Ibuprofen Banner 100 mg, soft chewable capsules
France
Ibuprofen Banner 100 mg, soft capsules to chew
Croatia
Ibuprofen Banner 100 mg, soft chewable capsules
Ireland
Ibuprofen Banner 100 mg, soft chewable capsules
Latvia
Ibuprofen Banner 100 mg, soft chewable capsules
Malta
Ibuprofen Banner 100 mg, soft chewable capsules
Poland
Ibuprofen Banner 100 mg, soft chewable capsules
Romania
Ibuprofen Banner 100 mg, soft chewable capsules

Date of last revision of the leaflet: 12/2024