Ibuprofen banner

Package leaflet: Information for the user

Ibuprofen Banner, 100 mg, chewable soft capsules
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains information important for you.
This medicine should always be taken exactly as described in this patient leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist. If you experience any adverse reactions, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• In children and adolescents aged 7 to 17 years, if there is no improvement after 3 days or if the patient feels worse, consult a doctor. In adults, if there is no improvement after 3 days in case of fever or 4 days in case of pain, or if the patient feels worse, consult a doctor.

Contents of the leaflet:

1. What Ibuprofen Banner is and what it is 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 pack and other information

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

The active substance is ibuprofen, which belongs to the group of 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 for fever and pain associated with colds.

2. Information before taking Ibuprofen Banner

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

• the patient is allergic to ibuprofen, peanuts, soya, or any of the other ingredients of this medicine (listed in section 6);
• the patient has ever experienced a hypersensitivity reaction (e.g. difficulty breathing, asthma, rhinitis, rash, swelling of the face, tongue, lips or throat) after taking ibuprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs);
• the patient has severe kidney, heart, or liver failure;
• the patient currently has bleeding in the brain (cerebrovascular haemorrhage) or any other bleeding;
• the patient has unexplained blood disorders;
• the patient has severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake);
• the patient has active or recurrent peptic ulcer or duodenal ulcer (peptic ulcer disease) or gastrointestinal bleeding (two or more episodes of confirmed peptic ulcer or bleeding from peptic ulcer);
• the patient has ever experienced gastrointestinal bleeding or perforation associated with previous use of NSAIDs.

Do not take this medicine if the patient is in the last three months of pregnancy.
Warnings and precautions
Allergic reactions to this medicine, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have occurred during use of ibuprofen. If any of these symptoms occur, Ibuprofen Banner should be stopped immediately and the patient should contact a doctor or emergency medical services without delay.

Before starting treatment with Ibuprofen Banner, consult a doctor or pharmacist if the patient has:

• asthma or other allergic conditions, as breathing difficulties may occur;
• hay fever, nasal polyps, or chronic obstructive respiratory disorders, as there is an increased risk of allergic reactions. These may manifest as bronchial asthma attacks (so-called drug-induced asthma), Quincke's oedema, or urticaria;
• problems with bowel movements;
• impaired kidney function;
• impaired liver function. Regular monitoring of liver function, kidney function, and blood counts is required during prolonged treatment with Ibuprofen Banner;
• caution is advised if the patient is taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used to treat depression), or antiplatelet agents (e.g. acetylsalicylic acid);
• if the patient is taking another NSAID (including COX-2 inhibitors such as etoricoxib or celecoxib), concurrent use should be avoided (see section "Ibuprofen Banner with other medicines");
• if the patient has SLE (systemic lupus erythematosus, an autoimmune disease affecting connective tissue causing joint pain, skin changes, and organ dysfunction) or mixed connective tissue disease;
• if the patient has certain inherited blood disorders (e.g. acute intermittent porphyria);
• if the patient has blood clotting disorders;
• serious skin reactions, such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP), have been reported with ibuprofen use. If the patient develops any symptoms related to these serious skin reactions described in section 4, Ibuprofen Banner should be stopped immediately and medical help should be sought;
• if the patient has chronic inflammatory bowel disease, such as Crohn's disease or ulcerative colitis;
• if the child is dehydrated, as there is a risk of impaired kidney function in dehydrated children;
• if the patient has recently undergone surgery;
• if the patient has chickenpox, use of Ibuprofen Banner during infection is not recommended;
• the patient has an infection – see below, section titled "Infections".

The risk of adverse effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Cases of gastrointestinal bleeding, gastrointestinal ulcers, or gastrointestinal perforation, which may be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms, and in patients with or without a history of serious gastrointestinal events. If gastrointestinal bleeding or ulceration occurs, treatment should be stopped immediately. The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher NSAID doses, in patients with a history of peptic ulcer disease, especially if complicated by bleeding or perforation (see section 2). Do not use Ibuprofen Banner in elderly patients. These patients should start treatment with the lowest available dose. In these patients, as well as in patients requiring low-dose acetylsalicylic acid or other drugs increasing the risk of gastrointestinal disorders, concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
Regular long-term use (of several types) of painkillers may lead to chronic serious kidney disease with risk of kidney failure (analgesic nephropathy).

Infections
Ibuprofen Banner may mask the clinical signs of infection, such as fever and pain. Therefore, Ibuprofen Banner 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 takes this medicine during an infection and infection symptoms persist or worsen, immediate medical advice should be sought.

Taking anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

Before taking Ibuprofen Banner, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina (chest pain), has had a heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs or feet due to narrowed or blocked arteries), or has had any type of stroke (including "mini-stroke" or transient ischaemic attack "TIA");
• the patient has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

Long-term use of painkillers for headache may worsen it. If this occurs or is suspected, use of Ibuprofen Banner should be stopped and the patient should contact a doctor. Medication-overuse headache should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of painkillers.

For adults taking this medicine
The warnings and information given in this section apply, and additionally the following:

• ibuprofen belongs to a group of medicines that may impair fertility in women. This effect is reversible upon discontinuation of the medicine. It is unlikely that this medicine, when used occasionally, will affect the ability to become pregnant, but the doctor should be informed about fertility problems before taking the medicine;
• during the first 6 months of pregnancy, this medicine should be taken only on medical advice;
• taking anti-inflammatory and pain-relieving medicines such as Ibuprofen Banner may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment;
• before taking Ibuprofen Banner, the patient should discuss treatment with a doctor or pharmacist if the patient has heart diseases such as heart failure, or has had any type of stroke; or if the patient has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes;
• patients with blood clotting disorders or other bleeding disorders should discuss treatment with a doctor or pharmacist.

Elderly patients
Elderly patients have a higher risk of adverse effects, particularly affecting the stomach and intestines, when taking NSAIDs. For additional information, see section 4, "Possible side effects".
If the patient has previously experienced gastrointestinal adverse effects, especially elderly patients, any concerning gastrointestinal symptoms (particularly gastrointestinal bleeding) should be reported, especially during the initial phase of treatment.

Ibuprofen Banner with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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;
• blood pressure-lowering medicines (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 may affect treatment with Ibuprofen Banner.
Therefore, always consult a doctor or pharmacist before using Ibuprofen Banner with other medicines.
This particularly applies to the following medicines:

Use of Ibuprofen Banner with alcohol
Alcohol should not be consumed while taking Ibuprofen Banner. The occurrence of certain adverse effects, such as gastrointestinal or central nervous system adverse effects, may be more likely if alcohol is consumed simultaneously with Ibuprofen Banner.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Inform your doctor if you become pregnant while taking Ibuprofen Banner. This medicine should not be used if you are in the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may affect the tendency to bleed in both you and your child and may delay or prolong labour beyond the expected time. This medicine should not be used during the first six months of pregnancy unless absolutely necessary and recommended by a doctor. Ibuprofen taken for longer than a few days from week 20 of pregnancy may cause kidney problems in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you require treatment for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. Ibuprofen Banner may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration.

Fertility
Ibuprofen Banner belongs to a group of medicines (NSAIDs) which may impair female fertility. This effect is reversible upon discontinuation of the medicine.

Driving and operating machinery
When used short-term, this medicine has no effect or negligible effect on the ability to drive and operate machinery.

Ibuprofen Banner contains soya lecithin. Do not use if you are allergic to peanuts or soya.

Ibuprofen Banner contains glucose and sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, you should consult your doctor before taking this medicine.

Ibuprofen Banner contains less than 1 mmol (23 mg) of sodium per chewable soft capsule, meaning the medicine is considered "sodium-free".

3. How to use Ibuprofen Banner

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Ibuprofen Banner is administered orally.
The capsules should be chewed and then swallowed. It is not necessary to drink water afterwards.
This medicine is intended for short-term use only.
The lowest effective dose for the shortest possible duration necessary to relieve symptoms should be used.
If symptoms of infection (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
This medicine is not recommended for children under 7 years of age or for children weighing
less than 20 kg.
Children weighing 20 to 39 kg (aged 7 to 11 years):
The recommended dosage is as follows:
Ibuprofen dosing in children is based on body weight. The usual single dose is 5 to 10 mg/kg body weight, and the maximum total daily dose is 20 to 30 mg/kg body weight.

Maximum dose
daily
600 mg of ibuprofen
(6 capsules)
900 mg of ibuprofen
(9 capsules)
If necessary, doses should be administered approximately every 6 to 8 hours, (maintaining a minimum interval of 6 hours between each dose).
WARNING: Do not exceed the recommended dose.
Adults and adolescents with body weight ≥ 40 kg (aged 12 years and above):
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) may be taken. The interval between doses should be determined according to observed symptoms and taking into account the maximum daily dose. It should not be less than 6 hours. The total daily dose of 1200 mg of ibuprofen should not be exceeded.
Body weight Single dose Maximum daily dose
(age)
≥40 kg 200 mg or 400 mg of ibuprofen (2 1200 mg (12 capsules)
(Adults and adolescents from 12 years) or 4 capsules)
When using the medicine in children and adolescents aged 7 to 17 years, consult a doctor if treatment lasts more than 3 days or if symptoms worsen. In adults, if there is a need to use the medicine for longer than 3 days for fever or longer than 4 days for pain, or if symptoms worsen, consult a doctor.
Taking more than the recommended dose of Ibuprofen Banner
If a patient has taken more than the recommended dose of Ibuprofen Banner or if a child has accidentally taken the medicine, always contact a doctor or go to the nearest hospital to obtain advice on possible health risks and what actions should be taken in such a case.
Symptoms of overdose may include nausea, stomach pain, vomiting (blood traces may occur), tinnitus, headache, disorientation, nystagmus, gastrointestinal bleeding (see also section 4 below) or rarely diarrhea. After taking a large dose, dizziness, blurred vision, low blood pressure, restlessness, confusion, coma, hyperkalemia (elevated potassium levels in blood), prolonged prothrombin time/INR probably due to interference with circulating coagulation factors, acute kidney failure, liver damage, respiratory depression, cyanosis, worsening of asthma in asthmatics, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low potassium levels in blood, feeling cold and breathing difficulties may occur.
Missed dose of Ibuprofen Banner
Do not take a double dose to make up for a missed dose.
If you have further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The occurrence of side effects can be minimized by using the lowest effective dose for the shortest
duration necessary to control symptoms. Although side effects do not occur very often, a child may
experience one of the known side effects of NSAIDs. If any occur, or if there are concerns, administration
of this medicine to the child should be stopped and medical advice should be sought as soon as possible.
In elderly patients taking this medicine, there is an increased risk of developing conditions associated
with adverse effects.
STOP TAKING THIS MEDICINE AND SEEK IMMEDIATE MEDICAL ATTENTION IF THE PATIENT
EXPERIENCES:

• Symptoms of gastrointestinal bleeding such as: severe abdominal pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds.
• Symptoms of a rare but serious allergic reaction, such as worsening asthma, wheezing or unexplained shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, low blood pressure leading to shock. These adverse effects may occur even after the first dose of this medicine. If any of these symptoms occur, seek immediate medical attention.
• Severe skin reactions, such as rashes covering the entire body, peeling of the outer skin layer, blistering or shedding of the skin, including a serious skin reaction known as DRESS syndrome (frequency unknown). Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell).
• Red, flat, non-elevated, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genital organs and 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 swollen lymph nodes (DRESS syndrome).
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Tell your doctor if the patient experiences any of the following side effects or if any side effects
worsen, including any possible side effects not listed in this leaflet.
Common (may affect up to 1 in 10 people)

• Gastrointestinal disorders such as heartburn, abdominal pain and nausea, indigestion, diarrhoea, vomiting, bloating (gas) and constipation, and minor gastrointestinal bleeding which may exceptionally lead to anaemia.

Uncommon (may affect up to 1 in 100 people)

• Gastric and intestinal ulcers, perforation or bleeding, inflammation of the oral mucosa with ulceration, exacerbation of existing bowel disease (colitis or Crohn's disease), inflammation of the gastric mucosa;
• Headache, dizziness, insomnia, restlessness, irritability or fatigue;
• Visual disturbances;
• Various skin rashes;
• Hypersensitivity reactions with urticaria and itching.

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

• Tinnitus (ringing in the ears);
• Increased blood urea levels, flank and/or abdominal pain, blood in the urine and fever may indicate kidney damage (papillary necrosis);
• Increased blood uric acid levels;
• Decreased haemoglobin levels.

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

• Oesophagitis, pancreatitis, development of diaphragm-like intestinal strictures;
• Heart failure, myocardial infarction and facial or hand swelling;
• Reduced urine output compared to usual, and oedema (especially in patients with high blood pressure or impaired kidney function), oedema 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 generally feels unwell, treatment with Ibuprofen Banner should be stopped immediately and medical advice should be sought without delay, as these may be early signs of kidney damage or kidney failure;
• Psychotic reactions, depression;
• High blood pressure, vasculitis;
• Palpitations;
• Liver function disorders, liver damage (initial symptoms may include skin discolouration), particularly during long-term treatment, liver failure, acute hepatitis;
• Problems with blood cell formation – initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nosebleeds and skin bleeding, and unexplained bruising. In such cases, treatment should be stopped immediately and medical advice should be sought. Do not self-medicate with painkillers or antipyretics (fever-reducing medicines);
• Severe skin infections and soft tissue complications during chickenpox infection;
• Exacerbation of infection-related inflammatory conditions (e.g. necrotizing fasciitis) has been reported following use of certain painkillers (NSAIDs). If signs of infection occur or worsen, seek medical advice immediately. In such cases, it should be determined whether antimicrobial or antibiotic treatment is indicated;
• Symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever or altered consciousness have been observed during ibuprofen use. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more susceptible. If such symptoms occur, contact a doctor immediately;
• Severe skin reactions with rash, redness and blistering [e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome)], hair loss (alopecia).

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

• Respiratory symptoms including asthma, bronchospasm or shortness of breath;
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell). A red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, stop taking Ibuprofen Banner and seek immediate medical help. See also section 2;
• Skin becomes sensitive to light.

Use of medicines such as this one may be associated with a small increased risk of heart attack
(myocardial infarction) or stroke.
Reporting of side effects
If any side effects occur, including any possible side effects not mentioned in this leaflet, inform your
doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse
Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal
Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Ibuprofen Banner

Do not store above 30°C.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ibuprofen Banner contains
The active substance is ibuprofen. Each soft capsule contains 100 mg of ibuprofen.
The other ingredients are: gelatine, purified water, liquid glucose, sucrose, fumaric acid (E 297), sucralose, citric acid (E 330), potassium acesulfame (E 950), disodium edetate, orange flavour*, and Opacode White NS-7818011**.
*The flavour contains: d-limonene, ethyl acetate, and alpha-pinene.
**The ink contains: purified water, titanium dioxide (E 171), propylene glycol, isopropyl alcohol, hypromellose 3 cP.
Substances used in the manufacturing process: medium-chain triglycerides, isopropyl alcohol, and soybean lecithin.

What Ibuprofen Banner looks like and contents of the pack
Ibuprofen Banner is a light yellow to dark yellow, square-shaped, soft gelatin chewable capsule with a white ink imprint of a hashtag (#).
Ibuprofen Banner is available in PVC/PE/PVdC/Aluminium blisters.
Pack sizes contain 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Patheon Softgels B.V. (trading as Banner Pharmacaps Europe)
De Posthoornstraat 7
5048 AS Tilburg
Noord-Brabant
The Netherlands

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands Ibuprofen Banner 100 mg, zachte kauwcapsules
Austria Ibuprofen Banner 100 mg Weichkapsel zum Zerbeißen
Czech Republic Ibuprofen Banner 100 mg měkká žvýkací tobolka
France Ibuprofen Banner 100 mg, capsules molles à mâcher
Croatia Ibuprofen Banner 100 mg meke kapsule za žvakanje
Ireland Ibuprofen Banner 100 mg soft chewable capsules
Latvia Ibuprofen Banner 100 mg mīkstās, košļājamās kapsulas
Malta Ibuprofen Banner 100 mg soft chewable capsules
Poland Ibuprofen Banner 100 mg kapsułki do żucia elastyczne
Romania Ibuprofen Banner 100 mg capsule moi masticabile