Ibenal

Leaflet attached to the packaging: patient information

Ibenal, 125 mg, suppositories
Ibuprofen

Read the leaflet carefully before taking 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.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• 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 there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Ibenal and what is it used for

Ibenal contains ibuprofen, a substance from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), with analgesic, antipyretic, and anti-inflammatory effects.
The medicine is intended for short-term use in the following cases:

• fever of various origins,
• pain of mild to moderate severity.

Ibenal suppositories are used when oral administration is not recommended, e.g., when vomiting occurs.

2. Important information before taking Ibenal

When not to take Ibenal:

• if the patient 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 patient has ever experienced shortness of breath, asthma, hay fever, facial swelling, and/or hand swelling or hives after taking ibuprofen, acetylsalicylic acid, or other similar painkillers (from the NSAID group);
• if the patient has ever had bleeding or perforation of the gastrointestinal tract associated with previous NSAID treatment;
• if the patient has active stomach or duodenal ulcer or a history of recurrent peptic ulcer or bleeding (two or more separate episodes of confirmed ulceration or bleeding);
• in patients with bleeding from the blood vessels of the brain or other active bleeding;
• in patients with unexplained blood clotting disorders;
• in patients with hemophilia;
• in patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake);
• if there is severe liver, kidney, or heart failure;
• if the patient is in the last trimester of pregnancy;
• in children weighing less than 12.5 kg (up to 2 years of age).

Warnings and precautions

Before starting Ibenal, the patient should discuss it with their doctor or pharmacist:

• If the patient has certain skin diseases (systemic lupus erythematosus - SLE or mixed connective tissue disease).
• If the patient has certain congenital blood disorders (e.g., acute intermittent porphyria).
• If the patient has or has had intestinal diseases (ulcerative colitis or Crohn's disease).
• If the patient has rectal or anal diseases.
• If the patient has ever had high blood pressure and/or heart failure.
• If the patient has impaired kidney function.
• If the patient has liver disease.
• If the patient has asthma, chronic rhinitis, sinusitis, nasal polyps, or allergies, now or in the past, bronchospasm may occur.
• During long-term use of Ibenal, regular monitoring of liver and kidney function parameters, as well as blood morphology, is required.
• Side effects can be minimized by using the smallest effective dose for the shortest necessary time to control symptoms.
• In elderly patients, there is an increased risk of side effects.
• Habitual use of (some) painkillers may lead to severe kidney disorders. This risk may increase during physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.
• Long-term use of painkillers for headaches may exacerbate these conditions. If suspected or confirmed, medical advice should be sought and treatment discontinued. Medication-overuse headache should be expected in patients who frequently or daily experience headaches, despite (or due to) regular use of painkillers.
• There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning signs; they can also occur in patients who have had warning signs. In case of gastrointestinal bleeding or ulceration, the medicine should be discontinued immediately.
• Caution should be exercised in patients taking medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g., prednisolone), anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (antidepressants), or antiplatelet agents (e.g., acetylsalicylic acid).
• Concomitant use with NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, such as celecoxib or etoricoxib, increases the risk of side effects (see "Ibenal and other medicines"), so it should be avoided.
• If the patient has chickenpox (varicella), they should avoid taking Ibenal.
• There is a risk of kidney function impairment in dehydrated children and adolescents.
• Medical supervision is particularly required immediately after major surgery.
• NSAIDs may mask infection and fever symptoms.
• If the patient has an infection - see the section titled "Infections" below.

Skin reactions
Severe skin reactions have been reported with Ibenal. If any skin rash, mucosal lesions, blisters, or other signs of hypersensitivity occur, the patient should stop taking Ibenal and seek medical help immediately, as these may be the first signs of a severe skin reaction. See section 4.
Taking anti-inflammatory or painkillers, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. The recommended dose should not be exceeded, and the duration of treatment should be as short as possible.
Before taking Ibenal, the patient should discuss treatment with their doctor or pharmacist if:

• the patient has heart diseases, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, or 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, or a family history of heart disease or stroke, or smokes.

Infections
Ibenal may mask infection symptoms, such as fever and pain. As a result, Ibenal may delay the use of appropriate infection treatment, potentially leading to 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 infection symptoms persist or worsen, they should consult their doctor immediately.

Ibenal and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Ibenal may affect the action of other medicines or other medicines may affect the action of Ibenal. For example:

• anticoagulant medicines (i.e., blood thinners or medicines that prevent blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

The patient should avoid taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors, with Ibenal.
In particular, the patient should inform their doctor about taking the following medicines:

Also, some other medicines may be affected by or have an effect on Ibenal treatment.
Therefore, before taking Ibenal with other medicines, the patient should always consult their doctor or pharmacist.

Taking Ibenal with alcohol

The patient should not drink alcohol while taking Ibenal. Alcohol may enhance some side effects, such as those affecting the gastrointestinal tract or the central nervous system.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a baby, they should consult their doctor or pharmacist before taking Ibenal.
Pregnancy
The patient should inform their doctor if they are pregnant while taking Ibenal.
Ibenal should not be taken during the last 3 months of pregnancy.
The medicine should not be taken during the first 6 months of pregnancy, unless the doctor recommends otherwise.
Breastfeeding
The medicine passes into breast milk, but it can be used during breastfeeding if taken in the recommended dose and for the shortest possible period.
Fertility
The medicine belongs to a group of medicines (NSAIDs) that may have a negative effect on female fertility.
This effect is reversible after discontinuation of the medicine.

Driving and using machines

During short-term use, the medicine has no or negligible influence on the ability to drive and use machines.

3. How to take Ibenal

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Ibenal should only be used in children aged 2 years and older and weighing at least 12.5 kg.
The maximum total daily dose of the medicine is 20 mg to 30 mg per kilogram of body weight, divided into 3 to 4 single doses. For Ibenal, the following guidelines can be applied (body weight is more important than age):
For children weighing 12.5 kg to 17 kg (aged 2 to 4 years):the initial dose is 1 suppository.
If necessary, the next suppository can be taken after at least 6 to 8 hours. No more than 3 suppositories (375 mg of ibuprofen) should be taken in 24 hours.
For children weighing 17 kg to 20.5 kg (aged 4 to 6 years):the initial dose is 1 suppository.
If necessary, the next suppository can be taken after at least 6 hours. No more than 4 suppositories (500 mg of ibuprofen) should be taken in 24 hours.
The medicine should not be used in children weighing less than 12.5 kg, as products containing a lower amount of ibuprofen are recommended for these children.
Suppositories are intended for rectal use.
For short-term use only.
The patient should use the smallest effective dose for the shortest period necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
The patient should consult their doctor if the medicine needs to be taken for more than 3 days or if the symptoms worsen.
If the patient feels that the effect of the medicine is too strong or too weak, they should talk to their doctor or pharmacist.

Taking a higher dose of Ibenal than recommended

If the patient has taken a higher dose of Ibenal than recommended or a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on the possible health risk and advice on what to do.
Symptoms may include: nausea, stomach pain, vomiting (which may contain blood), headaches, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and breathing difficulties have been reported.
In case of any further doubts about the use of the medicine, the patient should consult their doctor or pharmacist.

Missing a dose of Ibenal

The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Ibenal can cause side effects, although not everybody gets them.
The following side effects have been observed in patients taking ibuprofen for short-term treatment of pain or fever of mild to moderate severity. When ibuprofen is used for other indications or for a long time, other side effects may also occur.
Side effects are ranked according to frequency using the following terms:
Very common (occurring in more than 1 in 10 patients)
Common (occurring in more than 1 in 100 patients)
Uncommon (occurring in more than 1 in 1,000 patients)
Rare (occurring in more than 1 in 10,000 patients)
Very rare (occurring in less than 1 in 10,000 patients)
Frequency not known (cannot be estimated from the available data)

Uncommon

• Hypersensitivity with urticaria and itching;
• Headaches;
• Abdominal pain, nausea, and indigestion;
• Skin rash.

Rare

• Diarrhea, bloating, constipation, vomiting.

Very rare

• Skin infection;
• Blood disorders;
• Severe hypersensitivity reactions, including facial swelling, tongue and throat swelling, shortness of breath, tachycardia, and hypotension (anaphylaxis, angioedema, or severe shock);
• Aseptic meningitis;
• Blistering reactions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis;
• Acute kidney failure;
• Decreased hemoglobin, decreased urea clearance;
• Liver function disorders;
• Peptic ulcer, perforation, or gastrointestinal bleeding, melena, and hematemesis, oral ulceration, and gastritis.

Frequency not known

• Heart failure and edema;
• Hypertension;
• Respiratory tract reactivity, including asthma, bronchospasm, or shortness of breath;
• Exacerbation of ulcerative colitis and Crohn's disease;
• Severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and an increased number of eosinophils (a type of white blood cell).
• A red scaly rash with thickening of the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking Ibenal and seek medical help immediately. See also section 2.
• The skin becomes sensitive to light.

In some people, during the use of Ibenal suppositories, other side effects may occur. If other side effects not listed in this leaflet occur, the patient should inform their doctor or pharmacist.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
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, more information can be collected on the safety of the medicine.

5. How to store Ibenal

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
The medicine should not be stored at temperatures above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Ibenal contains

• The active substance of the medicine is ibuprofen. Each suppository contains 125 mg of ibuprofen.
• The other ingredients are solid fat (Witepsol H15 or Suppocire NA 15) and solid fat (Witepsol W45 or Suppocire NAS 40).

What Ibenal looks like and contents of the packaging

Suppositories are white or yellowish-white and have a cylindrical shape.
Aluminum/PE blisters with a leaflet in a cardboard box.
The packaging contains 5, 10, 15, or 20 suppositories.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Phone: +48 22 785 27 20
Fax: +48 22 785 27 60 ext. 106

Date of last revision of the leaflet: