Ibenal

Package Leaflet: Information for the Patient

Ibenal, 60 mg, suppositories
Ibuprofen

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

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• This 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, the doctor or pharmacist should be informed. See section 4.
• If after 1 day in infants aged 3 to 5 months or after 3 days in children aged 6 months, there is no improvement or the patient feels worse, a doctor should be consulted.

Table of Contents of the Leaflet:

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

When not to use Ibenal:

• if the patient is hypersensitive 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 dyspnea, asthma, rhinitis, facial and/or hand edema, or urticaria after using 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 peptic ulcer or a history of peptic ulcer (two or more separate episodes of confirmed ulceration or bleeding);
• in patients with cerebral hemorrhage 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 third trimester of pregnancy;
• in infants weighing less than 6.0 kg (up to 3 months of age).

Warnings and precautions

Before starting treatment with Ibenal, the patient should discuss it with a 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 gastrointestinal 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, currently 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 headache 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), Ibenal should be avoided.
• 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 below under "Infections".

Skin reactions
Severe skin reactions have been reported with Ibenal. If any skin rash, mucosal lesions, blisters, or other signs of hypersensitivity occur, Ibenal should be discontinued and medical help sought 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 and treatment duration should not be exceeded.
Before using Ibenal, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart disease, 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 narrowed or blocked 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. Therefore, 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, medical advice should be sought immediately (see section 2).

Ibenal and other medicines

The patient should tell the doctor or pharmacist about all medicines being taken currently or recently and about medicines planned to be taken.
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, or angiotensin II receptor antagonists, such as losartan).

Concomitant use of Ibenal with other nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors, should be avoided.
In particular, the doctor should be informed about the use of the following medicines:

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

Using Ibenal with alcohol

Alcohol should not be consumed during Ibenal treatment. Alcohol may enhance some side effects, such as those affecting the gastrointestinal tract or 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 a doctor or pharmacist before taking Ibenal.
Pregnancy
The doctor should be informed if the patient is pregnant during Ibenal treatment.
Ibenal should not be used during the last 3 months of pregnancy.
The medicine should not be used 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 adversely affect 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 use Ibenal

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
Ibenal should only be used in infants and children aged 3 months and older and weighing at least 6.0 kg. The maximum single dose is 10 mg per kilogram of body weight. The interval between doses should not be less than 6 hours. The maximum total daily dose of ibuprofen is 20 to 30 mg per kilogram of body weight, divided into 3 to 4 single doses. For Ibenal, the following guidelines can be applied (the child's weight is more important than age):
For infants and children weighing 6.0 to 8.0 kg (aged 3 to 9 months):the initial dose is 1 suppository. If necessary, the next suppository after at least 6 to 8 hours. Do not use more than 3 suppositories (180 mg of ibuprofen) in 24 hours.
For children weighing 8.0 to 12.5 kg (aged 9 months to 2 years):the initial dose is 1 suppository. If necessary, the next suppository after at least 6 hours. Do not use more than 4 suppositories (240 mg of ibuprofen) in 24 hours.
Suppositories are intended for rectal use.
For short-term use only.
The smallest effective dose should be used for the shortest period necessary to relieve symptoms. If the symptoms of infection (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
In infants aged 3 to 5 months, medical advice should be sought if symptoms worsen or do not improve after 24 hours.
In children aged 6 months, medical advice should be sought if the medicine needs to be given for more than 3 days or if symptoms worsen.
If the patient feels that the effect of the medicine is too strong or too weak, they should talk to a doctor or pharmacist.

Using a higher dose of Ibenal than recommended

If the patient has used a higher dose of Ibenal than recommended or a 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.
Symptoms may include: nausea, stomach pain, vomiting (which may contain blood), headache, 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 urine, feeling cold, and breathing difficulties have been reported.
In case of any further doubts about using this medicine, the patient should consult a doctor or pharmacist.

Missing a dose of Ibenal

A double dose should not be used 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. During use of ibuprofen for other indications or long-term, other side effects may also occur.
Side effects are ranked according to frequency of occurrence 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;
• Headache;
• Abdominal pain, nausea, and indigestion;
• Skin rash.

Rare

• Diarrhea, bloating, constipation, vomiting.

Very rare

• Skin infection;
• Blood disorders;
• Severe hypersensitivity reactions, including facial, tongue, and throat edema, dyspnea, 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 mucosal ulceration, and gastritis.

Frequency not known

• Heart failure and edema;
• Hypertension;
• Respiratory tract reactivity, including asthma, bronchospasm, or dyspnea;
• Exacerbation of ulcerative colitis and Crohn's disease;
• Severe skin reactions known as DRESS syndrome. Symptoms of DRESS syndrome include skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell).
• Red scaly rash with thickening of the skin and blisters, usually located in skin folds, on the trunk, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, Ibenal should be discontinued and medical help sought immediately. See also section 2.
• The skin becomes sensitive to light.

In some individuals, during use of Ibenal suppositories, other side effects may occur. If other side effects not listed in this leaflet occur, the doctor or pharmacist should be informed.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. 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
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.
Reporting side effects will help to gather more information 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 expiration date stated on the packaging after EXP.
The expiration date refers to the last day of the month stated.
The medicine should not be stored above 25°C.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 Ibenal contains

• The active substance of the medicine is ibuprofen. Each suppository contains 60 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 pack

Suppositories are white or yellowish-white and cylindrical in shape.
Aluminum/PE blisters with a leaflet in a cardboard box.
The pack 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: