IBENAL

Patient Information Leaflet

Ibenal, 60 mg, suppositories
Ibuprofenum

Please read this 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 possible future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement within 1 day in infants aged 3 to 5 months or within 3 days in children aged 6 months and older, or if the patient's condition worsens, consult a 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 ibuprofen, a substance belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have 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, shortness of breath, 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;
• if the patient has 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 any other active bleeding;
• in patients with unexplained disorders of blood formation;
• 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 infants weighing less than 6.0 kg (under 3 months of age).

Warnings and precautions
Before starting treatment with Ibenal, consult a doctor or pharmacist if:

• the patient has certain skin diseases (systemic lupus erythematosus – SLE or mixed connective tissue disease);
• the patient has certain inherited blood formation disorders (e.g. acute intermittent porphyria);
• the patient has or has ever had intestinal diseases (ulcerative colitis or Crohn's disease);
• the patient has diseases of the rectum or anus;
• the patient has ever had high blood pressure and/or heart failure;
• the patient has impaired kidney function;
• the patient has liver disease;
• the patient currently or previously had bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, or allergies, as 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 this 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 previously experienced warning signs. If gastrointestinal bleeding or ulceration occurs, the drug should be discontinued immediately;
• caution is advised 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 with other medicines"); therefore, such combination should be avoided;
• if the patient has chickenpox (varicella), use of Ibenal should be avoided;
• there is a risk of impaired kidney function in dehydrated children and adolescents;
• medical supervision is particularly required 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 allergic symptoms appear, administration of Ibenal should be stopped immediately and medical help should be sought without delay, as these may be early 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 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 lead to an increased 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 medical consultation is required.

Ibenal with other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans 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 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, should be avoided with Ibenal.
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 the central nervous system.
Pregnancy, breastfeeding and effects on 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 Ibenal.
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 advised otherwise 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
Ibenal belongs to a group of medicines (NSAIDs) which may adversely affect fertility in women. This effect is reversible upon discontinuation of the medicine.
Driving and operating machinery
During short-term use, the medicine has no effect or has negligible effect on the ability to drive or operate machinery.

3. How to use Ibenal

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Ibenal should only be used in infants and children aged 3 months and older, and weighing no less than 6.0 kg. The maximum single dose is 10 mg per kg of body weight. The interval between doses should not be less than 6 hours. The maximum total daily dose of ibuprofen is 20 mg to 30 mg per kilogram of body weight, divided into 3 to 4 individual doses. For Ibenal, the following guidelines may be applied (the child's body weight is more important than age):
For infants and children weighing from 6.0 kg to 8.0 kg (aged 3 to 9 months): the initial dose is 1 suppository. If needed, another suppository after at least 6 to 8 hours. Do not use more than 3 suppositories (180 mg of ibuprofen) within 24 hours.
For children weighing from 8.0 kg to 12.5 kg (aged 9 months to 2 years): the initial dose is 1 suppository. If needed, another suppository after at least 6 hours. Do not use more than 4 suppositories (240 mg of ibuprofen) within 24 hours.
Suppositories are intended for rectal use.
For short-term use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
In infants aged 3 to 5 months, consult a doctor if symptoms worsen or do not improve within 24 hours.
In children aged 6 months and older, consult a doctor if the medicine needs to be administered for more than 3 days or if symptoms worsen.
If the patient feels that 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 to assess possible health risks and receive advice on necessary actions.
Symptoms may include: nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, disorientation, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties may occur.
If there are any further doubts regarding the use of this medicine, consult a 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 taking 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 of occurrence using the following categories:
Very common (affects more than 1 in 10 people)
Common (affects more than 1 in 100 people)
Uncommon (affects more than 1 in 1,000 people)
Rare (affects more than 1 in 10,000 people)
Very rare (affects less than 1 in 10,000 people)
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, dyspnea, tachycardia and hypotension (anaphylaxis, angioedema or severe shock);
• Aseptic meningitis;
• Bullous reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis;
• Acute renal failure;
• Decreased hemoglobin concentration, reduced urea clearance;
• Liver function disorders;
• Gastrointestinal ulcer, perforation or bleeding, tarry stools and bloody vomiting, oral ulceration and gastric mucositis.

Frequency not known

• Heart failure and edema;
• Hypertension;
• Respiratory tract reactivity, including asthma, bronchospasm or dyspnea;
• Exacerbation of colitis and Crohn's disease;
• Severe skin reactions known as DRESS syndrome. Symptoms of DRESS syndrome include: skin rash, fever, lymphadenopathy, and increased eosinophil count (a type of white blood cell).
• Red, scaly rash with subcutaneous nodules and blisters, predominantly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, 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, additional adverse reactions may occur during the use of Ibenal suppositories. If any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not mentioned in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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
Al. Jerozolimskie 181C
02-222 Warszawa
Tel. +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 the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the indicated 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. Such measures help protect the environment.

6. Contents of the packaging and other information

What Ibenal contains

• The active substance is ibuprofen. Each suppository contains 60 mg of ibuprofen.
• The other ingredients are hard fat (Witepsol H15 or Suppocire NA 15) and hard 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
Ostrzykowizna 14A Street
05-170 Zakroczym
Tel.: +48 22 785 27 20
Fax: +48 22 785 27 60 ext. 106