IBUFEN

Patient Information Leaflet

Ibufen, 200 mg, suppositories
Ibuprofenum
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• 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 side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, you should consult your doctor.

Table of contents

1. What Ibufen is and what it is used for
2. What you need to know before using Ibufen
3. How to use Ibufen
4. Possible side effects
5. How to store Ibufen
6. Contents of the pack and other information

1. What Ibufen is and what it is used for

Ibufen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The medicine has analgesic, antipyretic and anti-inflammatory properties.
Ibufen is indicated for use in children from 6 years of age, adolescents and adults for fever of various origins (e.g. associated with influenza, common cold or other infectious diseases).
The suppository formulation is particularly recommended when oral administration of ibuprofen is not possible or when the patient is experiencing vomiting.

2. Important information before using Ibufen

When not to use Ibufen

• if the patient is allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
• if the patient has previously experienced allergic reactions after taking acetylsalicylic acid or other NSAIDs, such as rhinitis (nasal inflammation), angioedema, urticaria, bronchospasm, or asthma,
• if the patient has active or past history of peptic ulcer or duodenal ulcer, recurrent ulceration or gastrointestinal bleeding (two or more separate episodes of confirmed ulceration or bleeding),
• if the patient has experienced upper gastrointestinal bleeding or perforation following previous use of NSAIDs,
• if the patient has severe liver failure, severe kidney failure, or severe heart failure,
• if the patient is in the third trimester of pregnancy,
• if the patient has a bleeding disorder,
• in children with body weight below 20 kg.

Warnings and precautions
Before starting treatment with Ibufen, consult a doctor or pharmacist.
Allergic reactions to ibuprofen have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain.
If any of these symptoms occur, discontinue Ibufen immediately and contact a doctor or emergency medical services without delay.
Inform your pharmacist or doctor if the patient has an infection – see the section titled “Infections” below.
Consult a doctor before using Ibufen if the patient has been diagnosed with:

• systemic lupus erythematosus or mixed connective tissue disease,
• anorectal disorders,
• gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and/or heart function disorders,
• kidney function disorders,
• liver function disorders,
• blood clotting disorders,
• current or past asthma or allergic reactions, as bronchospasm may occur after taking the medicine,
• chickenpox – see the section titled “Infections” below.

Also consult a doctor if the patient is taking other medicines, especially anticoagulants, diuretics, cardiac medications, and corticosteroids (see section “Ibufen with other medicines”).
Avoid concomitant use of ibuprofen with other non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be life-threatening and may occur without warning symptoms or in patients with prior warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with a history of gastrointestinal disorders, particularly elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial treatment period.
The risk of adverse effects is higher in elderly patients compared to younger patients. The frequency and severity of adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.
Long-term, concomitant use of various analgesics may lead to kidney damage with risk of kidney failure (analgesic nephropathy). This risk may be increased by physical exertion leading to salt loss and dehydration.
Therefore, avoid long-term, concomitant use of multiple analgesics.
There is a risk of impaired kidney function in dehydrated children and adolescents.
Use of anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Ibufen, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart conditions such as heart failure, angina (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 has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• the patient has hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

Severe skin reactions
Severe skin reactions have been reported with ibuprofen use, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If any of the symptoms associated with these severe skin reactions described in section 4 occur, discontinue Ibufen immediately and seek medical help.

Infections
Ibufen may mask symptoms of infection such as fever and pain. Therefore, Ibufen may delay appropriate treatment of infection, potentially increasing 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 persist or worsen, consult a doctor immediately.
Cases of toxic amblyopia (reduced visual acuity) have been reported during ibuprofen use; therefore, any visual disturbances should be reported to a doctor.
Using the medicine for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.

Ibufen with other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use.
Ibufen may affect the action of other medicines, or other medicines may affect the action of Ibufen. For example:

• anticoagulant medicines (i.e., blood thinners or those preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan),
• analgesics,
• other non-steroidal anti-inflammatory drugs,
• diuretics,
• medicines used for depression (selective serotonin reuptake inhibitors (SSRI), lithium),
• zidovudine, ritonavir (medicines used in HIV treatment),
• methotrexate (used in cancer or rheumatoid arthritis treatment),
• corticosteroids (such as prednisolone),
• phenytoin (antiepileptic medicine),
• cyclosporine, tacrolimus (immunosuppressive medicines),
• mifepristone (used in gynecology),
• quinolone antibiotics (such as ciprofloxacin),
• cardiac glycosides (used in heart disease treatment),
• aminoglycoside antibiotics (such as streptomycin),
• probenecid, sulfinpyrazone (used in gout treatment),
• oral antidiabetic medicines (such as glimepiride),
• voriconazole, fluconazole (antifungal medicines),
• cholestyramine (used in patients with high cholesterol levels).

Some other medicines may also interact with or affect treatment with Ibufen.
Therefore, always consult a doctor or pharmacist before using Ibufen with other medicines.

Pregnancy, breastfeeding, and effects on fertility

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

Pregnancy
Do not use Ibufen during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Ibufen may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in both mother and child and may delay or prolong labor.
Do not take Ibufen during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, use the lowest effective dose for the shortest possible time. Prolonged use of Ibufen beyond a few days starting from

week 20 of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is necessary, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts, but it is very unlikely to have a negative effect on the breastfed infant.

Effect on fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may temporarily impair fertility in women. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
The medicine does not affect the ability to drive or operate machinery when used short-term and according to recommendations.

3. How to use Ibufen

This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Rectal administration.
Do not use in children weighing less than 20 kg.
Do not exceed the maximum daily dose.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
The maximum daily dose of ibuprofen in children up to 12 years of age is 20–30 mg per kg body weight, divided into 3 to 4 single doses.
Do not exceed a single dose of 10 mg per kg body weight.
This medicine is intended for short-term use only.
If it is necessary to use this medicine in children and adolescents for longer than 3 days, or if symptoms worsen, consult a doctor.
Recommended dose:

Use of Ibufen in patients with renal and/or hepatic impairment
In patients with mild to moderate renal and/or hepatic impairment, there is no need to reduce the dose.
Ibuprofen should not be used in patients with severe renal or hepatic failure.

Use of Ibufen in elderly patients
Dosage adjustment is not required in elderly patients.

Use of a higher than recommended dose of Ibufen
If a patient has taken a higher than recommended dose of Ibufen, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital to obtain advice regarding possible health risks and the necessary actions to take in such a case.

Symptoms of overdose may include nausea, epigastric pain, vomiting (possibly with blood), gastrointestinal bleeding (see also point 4 below), diarrhea, headache, tinnitus, disorientation, and nystagmus. Excitement, drowsiness, disorientation, or coma may also occur. Seizures may occur rarely. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as hematuria, hypokalemia, feeling cold, and breathing difficulties. Additionally, prothrombin time (INR) may be prolonged, likely due to impaired blood coagulation factors. Acute renal failure and liver damage may also occur. In patients with asthma, worsening of asthma symptoms may occur.
Additionally, hypotension and breathing difficulties may occur.

Cases of overdose are rare. Treatment is symptomatic and supportive. The physician will undertake appropriate management.

Missed dose of Ibufen
Do not take a double dose to make up for a missed dose.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should stop taking ibuprofen and seek immediate medical help if any of the following symptoms occur:

• Red, flat, target-like or circular spots on the trunk, often with blisters in the centre, peeling skin, and 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) – very rare.
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome) – frequency unknown.
• Red, peeling rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) – frequency unknown.

Ibufen is generally well tolerated. The adverse effects listed below have been observed during short-term use of ibuprofen at over-the-counter doses.
Adverse effects are listed according to frequency of occurrence:
Uncommon (occurring in fewer than 1 in 100 patients):

• Dyspepsia, abdominal pain, nausea, local irritation of the anus;
• Headache;
• Skin rashes of various types;
• Urticaria and itching.

Rare (occurring in fewer than 1 in 1,000 patients):

• Diarrhoea, flatulence, constipation, vomiting;
• Dizziness, insomnia, restlessness, and feeling tired.

Very rare (occurring in fewer than 1 in 10,000 patients):

• Aseptic meningitis, characterized by neck stiffness, headache, nausea, vomiting, fever, and disorientation – reported in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus and mixed connective tissue disease;
• Blood disorders (anaemia; leukopenia – reduced white blood cell count; thrombocytopenia – reduced platelet count; pancytopenia – haematological disorder with deficiency of all normal blood cells: erythrocytes, leukocytes, and thrombocytes; agranulocytosis – reduced granulocyte count). Initial symptoms include fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, nosebleeds, and skin petechiae.
• Severe hypersensitivity reactions presenting as facial, tongue, and laryngeal swelling; shortness of breath; rapid heartbeat; significant drop in blood pressure (anaphylaxis, angioedema, or shock);
• Asthma, worsening of asthma, bronchospasm, dyspnoea, and wheezing;
• Nervousness;
• Visual disturbances;
• Tinnitus, dizziness;
• Oedema, hypertension, heart failure (reported in association with use of NSAIDs);
• Gastric and duodenal ulcer disease, gastrointestinal perforation or bleeding, tarry stools, vomiting blood, sometimes with fatal outcome,

especially in elderly patients; ulcerative stomatitis, gastric mucositis, ulceration of the oral mucosa;

• Exacerbation of ulcerative colitis and Crohn's disease;
• Liver function disorders, particularly during prolonged use of ibuprofen; hepatitis and jaundice;
• Acute renal failure; renal papillary necrosis, particularly after prolonged use of ibuprofen, associated with increased serum urea levels and oedema, including peripheral oedema; presence of blood and/or protein in urine, interstitial nephritis, nephrotic syndrome;
• Decreased haematocrit and haemoglobin levels in laboratory tests.

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

• Skin becomes sensitive to light;
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Depression and psychotic reactions have been reported in isolated cases.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Ibufen

Keep this medicine out of sight and reach of children.
Do not use after the expiry date stated on the blister and the cardboard package following:
EXP. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Ibufen contains

• The active substance is ibuprofen. Each suppository contains 200 mg of ibuprofen.
• The other ingredients are: Witepsol H 15, Witepsol W 45.

What Ibufen looks like and contents of the pack
White or almost white, torpedo-shaped suppositories.
The pack contains 5 suppositories. The cardboard box contains a PVC/PE blister with
5 suppositories.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Farmina Sp. z o.o.
Plant in Myślenice
ul. Cegielskiego 2
32-400 Myślenice