Ibenal

Package leaflet: Information for the patient

Ibenal, 125 mg, suppositories
Ibuprofenum

Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3 days, consult your doctor.

Table of contents:

1. What Ibenal is and what it is 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 Ibenal is and what it is used for

Ibenal contains the active substance ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), having analgesic, antipyretic, and anti-inflammatory properties.
Ibenal is intended for short-term use in the following conditions:

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

Ibenal suppositories are used when oral administration of the medicine is not advisable, for example, in the presence of vomiting.

2. Important information before using Ibenal

When not to use Ibenal:

• if the patient is allergic to ibuprofen or other similar painkillers (non-steroidal anti-inflammatory drugs, NSAIDs) or to any of the other ingredients of this medicine (listed in section 6);
• if asthma, difficulty breathing, nasal congestion, swelling of the face and/or hands, or hives occurred after taking ibuprofen, acetylsalicylic acid, or other similar painkillers (NSAIDs);
• if gastrointestinal bleeding or perforation has ever occurred related to previous treatment with NSAIDs;
• in patients with active or past peptic ulcer disease of the stomach and/or duodenum (two or more separate episodes of confirmed ulceration or bleeding);
• in patients with cerebral haemorrhage or other active bleeding;
• in patients with unexplained blood formation disorders;
• in patients with bleeding disorders;
• in patients with severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake);
• in cases of severe liver, kidney, or heart failure;
• if the patient is in the last trimester of pregnancy;
• in children weighing less than 12.5 kg (under 2 years of age).

Warnings and precautions
Before starting treatment with Ibenal, discuss the following 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 inherited blood formation disorders (e.g. acute intermittent porphyria).
• If the patient currently has or has ever had intestinal diseases (ulcerative colitis or Crohn's disease).
• If the patient has diseases of the rectum or anus.
• 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 currently or in the past has bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, or allergies, bronchospasm may occur.
• During prolonged use of Ibenal, regular monitoring of liver and kidney function and blood morphology is required.
• Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
• Elderly patients have an increased risk of adverse effects.
• Habitual use of (some) painkillers may lead to serious kidney disorders. This risk may increase during physical exertion associated with loss of salts and dehydration. Such use should therefore be avoided.
• Long-term use of painkillers for headache may worsen these symptoms. If such a situation is suspected or confirmed, medical advice should be sought and treatment discontinued. Medication-overuse headache should be expected in patients who experience frequent or daily headaches despite (or because of) regular use of painkillers.
• There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms; they may also occur in patients who have experienced warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine must be discontinued immediately.
• Exercise caution 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 drugs (e.g. acetylsalicylic acid).
• Concomitant use with NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors such as celecoxib or etoricoxib, increases the risk of adverse effects (see section "Ibenal and other medicines"); therefore, such combination should be avoided.
• If the patient has chickenpox (varicella), avoid using Ibenal.
• There is a risk of impaired kidney function in dehydrated children and adolescents.
• Medical supervision is particularly necessary immediately after major surgery.
• NSAIDs may mask symptoms of infection and fever.
• If the patient has an infection – see the section below titled "Infections".

Skin reactions
Severe skin reactions associated with the use of Ibenal have been reported. If any skin rash, mucosal lesions, blisters, or other allergy symptoms appear, the patient must stop taking Ibenal immediately and seek medical help without delay, as these may be the first signs of a very serious skin reaction. See section 4.
Taking anti-inflammatory or 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 using Ibenal, the patient should discuss treatment with a doctor or pharmacist if:

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

Infections
Ibenal may mask symptoms of infection such as fever and pain. Therefore, Ibenal 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 existing infection and symptoms of infection persist or worsen, immediate consultation with a doctor is required.

Ibenal and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Ibenal may affect the action of other medicines, and other medicines may affect the action of Ibenal. For example:

• anticoagulant medicines (i.e. blood thinners or those preventing clot formation, such as aspirin – acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan).

Concomitant use of other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors, with Ibenal should be avoided.
In particular, inform the doctor if the patient is taking the following medicines:

Some other medicines may also be affected by or have an effect on treatment with Ibenal.
Therefore, always consult a doctor or pharmacist before using Ibenal together with other medicines.
Use of Ibenal with alcohol
Alcohol should not be consumed during treatment with Ibenal. Alcohol may intensify certain adverse effects, such as those affecting the gastrointestinal tract or central nervous system.
Pregnancy, breastfeeding and fertility
If a woman is pregnant, breastfeeding, thinks she may be pregnant or is planning to have a child, she should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you become pregnant while using Ibenal.
Ibenal must not be used during the last 3 months of pregnancy.
This medicine should not be used during the first 6 months of pregnancy unless otherwise directed by a doctor.
Breastfeeding
The medicine passes into breast milk, but may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration.
Fertility
This medicine belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible upon discontinuation of the medicine.
Driving and operating machinery
During short-term use, this medicine has no influence or has a negligible influence on the ability to drive or operate machinery.

3. How to use Ibenal

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your 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 of ibuprofen per kilogram of body weight, divided into 3 to 4 individual doses. The following dosage guidelines apply for Ibenal (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 needed, a second suppository after at least 6 to 8 hours. Do not use more than 3 suppositories (375 mg of ibuprofen) within 24 hours.
For children weighing 17 kg to 20.5 kg (aged 4 to 6 years): The initial dose is 1 suppository.
If needed, a second suppository after at least 6 hours. Do not use more than 4 suppositories (500 mg of ibuprofen) within 24 hours.
This medicine should not be used in children weighing less than 12.5 kg, as other products containing a lower dose of ibuprofen are recommended for these children.
The suppositories are for rectal use only.
For short-term use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Consult a doctor if treatment with this medicine is needed for more than 3 days or if symptoms worsen.
If the patient feels the medicine’s effect is stronger or weaker than expected, speak to a doctor or pharmacist.
Use of a higher than recommended dose of Ibenal
If a patient has used more than the recommended dose of Ibenal or if a child has accidentally taken the medicine, always contact a doctor or go to the nearest hospital for advice on possible health risks and what actions should be taken.
Symptoms may include: nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion, and nystagmus. After a large overdose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, feeling cold, and breathing difficulties may occur.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.
Missed dose of Ibenal
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below have been observed in patients who have taken ibuprofen for short-term treatment of mild to moderate pain or fever. When ibuprofen is used for other indications or over a prolonged period, additional adverse reactions may also occur.
Adverse reactions are listed according to frequency using the following categories:
Very common (affecting more than 1 in 10 patients)
Common (affecting more than 1 in 100 patients)
Uncommon (affecting more than 1 in 1,000 patients)
Rare (affecting more than 1 in 10,000 patients)
Very rare (affecting 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 dyspepsia;
• Skin rash.

Rare

• Diarrhea, flatulence, constipation, vomiting.

Very rare

• Skin infection;
• Blood disorders;
• Severe hypersensitivity reactions, including facial, tongue and throat swelling, difficulty breathing, tachycardia and hypotension (anaphylaxis, angioedema or severe shock);
• Aseptic meningitis;
• Vesicular skin reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis;
• Acute kidney failure;
• Decreased hemoglobin concentration, reduced urea clearance;
• Liver function disorders;
• Gastrointestinal ulceration, perforation or bleeding, tarry stools and vomiting blood, oral ulceration and gastric mucosal inflammation.

Frequency not known

• Heart failure and edema;
• Hypertension;
• Respiratory tract reactivity, including asthma, bronchospasm or shortness of breath;
• Exacerbation of 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 subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, administration of Ibenal must be discontinued immediately and medical help should be sought without delay. See also section 2.
• Skin becomes sensitive to light.

In some individuals, when using Ibenal in suppository form, other adverse reactions may occur. If any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ibenal

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ibenal contains

• The active substance 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 pack
The suppositories are white or yellowish-white and cylindrical in shape.
Aluminium/PE blisters placed together with the leaflet in a cardboard box.
The pack contains 5, 10, 15 or 20 suppositories.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
LEK-AM Sp. z o.o. Pharmaceutical Company
ul. Ostrzykowizna 14A
05-170 Zakroczym
Tel.: +48 22 785 27 20
Fax: +48 22 785 27 60 ext. 106