IBUFEN 200 mg Suppositories

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Ibufen, 200 mg, Suppositories
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Ibufen and what is it used for
4. Important information before using Ibufen
   1. When not to use Ibufen
   2. Warnings and precautions
   3. Ibufen and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
5. How to use Ibufen
   1. Using a higher than recommended dose of Ibufen
   2. Missing a dose of Ibufen
6. Possible side effects
   1. Reporting side effects
7. How to store Ibufen
8. Contents of the pack and other information
   1. What Ibufen contains
   2. What Ibufen looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Ibufen, 200 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 this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of Contents of the Leaflet

• 1. What is Ibufen and what is it used for
• 2. Important information 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 is Ibufen and what is it used for

Ibufen belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine has analgesic, antipyretic, and anti-inflammatory effects.
The medicine is intended for use in children from 6 years of age, adolescents, and adults in case of fever of various origins (including influenza, colds, or other infectious diseases).
The suppository form is particularly recommended in cases where oral administration of ibuprofen is impossible or the patient has vomiting.

2. Important information before using Ibufen

When not to use Ibufen

• if the patient is allergic to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever had symptoms of an allergic reaction after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, such as rhinitis (nasal congestion), angioedema, urticaria, bronchospasm, or asthma,
• in patients with active or recurrent peptic ulcer or gastrointestinal bleeding in the past (two or more separate episodes of confirmed ulceration or bleeding),
• if the patient has had gastrointestinal bleeding or perforation after using NSAIDs,
• if the patient has severe liver or 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 a body weight below 20 kg.

Warnings and precautions

Before starting treatment with Ibufen, the patient should discuss it with their doctor or pharmacist.
During treatment with ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), chest pain.
If any of these symptoms are noticed, the patient should stop using Ibufen immediately and contact their doctor or emergency medical services immediately.
The patient should inform their pharmacist or doctor if they have an infection - see below, the section entitled "Infections".
When using Ibufen, the patient should consult their doctor if they have:

• systemic lupus erythematosus and mixed connective tissue disease,
• diseases of the anus and rectum,
• diseases of the gastrointestinal tract and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and/or heart failure,
• kidney function disorders,
• liver function disorders,
• blood clotting disorders,
• active or a history of bronchial asthma or symptoms of allergic reactions in the past, as bronchospasm may occur after taking the medicine,
• chickenpox - see below, the section entitled "Infections".

The patient should also contact their doctor if they are taking other medicines, especially anticoagulants, diuretics, cardiac glycosides, and corticosteroids (see "Ibufen and other medicines").
The patient should avoid taking ibuprofen at the same time as other nonsteroidal anti-inflammatory drugs, including medicines called selective COX-2 inhibitors.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs.
If gastrointestinal bleeding or ulceration occurs, the patient should stop using the medicine immediately. Patients with a history of gastrointestinal diseases, especially the elderly, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, especially during the initial treatment period.
In elderly patients, the risk of adverse reactions due to the use of the medicine is higher than in younger patients. The frequency and severity of adverse reactions can be reduced by using the lowest effective dose for the shortest possible period.
Concomitant, long-term use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy). This risk may increase in case of physical exertion resulting in salt loss and dehydration.
Therefore, the patient should avoid concomitant, long-term use of different painkillers.
There is a risk of impaired kidney function in dehydrated children and adolescents.
Taking anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The patient should not exceed the recommended dose and duration of treatment.
Before using Ibufen, the patient should discuss treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, have peripheral arterial disease (poor circulation in the legs due to narrowed or blocked arteries), or have had any stroke (including mini-stroke or transient ischemic attack - TIA);
• they have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or smoke.

Severe skin reactions
Severe skin reactions such as 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) have been reported with the use of ibuprofen. If the patient experiences any of the symptoms associated with these severe skin reactions described in section 4, they should stop using Ibufen immediately and seek medical attention.
Infections
Ibufen may mask the symptoms of an infection, such as fever and pain. Therefore, Ibufen may delay the use of appropriate infection treatment, which can lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medicine while an infection is present, and the symptoms of the infection persist or worsen, they should consult their doctor immediately.
During treatment with ibuprofen, single cases of toxic amblyopia (visual impairment) have been reported, so any vision disturbances should be reported to the doctor.
Taking the medicine for the shortest period necessary to relieve symptoms reduces the risk of adverse reactions.

Ibufen and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
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 medicines that prevent blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),
• painkillers,
• other nonsteroidal anti-inflammatory drugs,
• diuretics,
• medicines used in depression (selective serotonin reuptake inhibitors (SSRIs), lithium),
• zydovudine, ritonavir (medicines used to treat HIV infections),
• methotrexate (a medicine used to treat cancer or rheumatoid arthritis),
• corticosteroids (such as prednisolone),
• phenytoin (an antiepileptic medicine),
• cyclosporine, tacrolimus (medicines that reduce the body's immune response),
• mifepristone (a medicine used in gynecology),
• quinolone antibiotics (such as ciprofloxacin),
• cardiac glycosides (used to treat heart conditions),
• aminoglycoside antibiotics (such as streptomycin),
• probenecid, sulfinpyrazone (medicines used to treat gout),
• oral antidiabetic medicines (such as glimepiride),
• voriconazole, fluconazole (antifungal medicines),
• cholestyramine (used in people with high cholesterol levels).

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Ibufen should not be used during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. The use of Ibufen may cause kidney and heart problems in the unborn child. It may also affect the patient's and their child's tendency to bleed and cause delayed or prolonged labor.
Ibufen should not be taken during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the patient should use the lowest effective dose for the shortest possible time. Ibufen taken for more than a few days, starting from the 20th week of pregnancy, may cause kidney problems in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the ductus arteriosus in the child's heart. If longer treatment is necessary, the doctor may recommend additional monitoring.

• The patient's doctor may recommend additional monitoring if treatment is necessary for more than a few days.

Breastfeeding
Ibuprofen passes into breast milk in small amounts, but it is unlikely to affect the breastfed baby negatively.
Fertility
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may have a negative effect on female fertility. This effect is temporary and disappears after the end of treatment.

Driving and using machines

The medicine does not affect the ability to drive or use machines if used for a short period and in accordance with the recommendations.

3. How to use Ibufen

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Rectal administration.
Do not use in children with a body weight below 20 kg.
Do not exceed the maximum daily dose.
Use the lowest 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 maximum daily dose of ibuprofen in children up to 12 years of age is 20-30 mg/kg body weight, divided into 3 to 4 single doses.
Do not exceed a single dose of 10 mg/kg body weight.
The medicine is intended for short-term use.
If there is a need to use this medicine in children and adolescents for more than 3 days or if symptoms worsen, the patient should consult their doctor.
Recommended dose:

Using Ibufen in patients with kidney and/or liver function disorders
In patients with mild and moderate kidney and/or liver function disorders, there is no need to reduce the dose.
The use of ibuprofen is not recommended in patients with severe kidney or liver failure.
Using Ibufen in elderly patients
No dose adjustment is required in elderly patients.

Using a higher than recommended dose of Ibufen

If the patient has used a higher dose of Ibufen than recommended or if 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 risk to their health and advice on what actions to take.
Symptoms of overdose may include nausea, abdominal pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, disorientation, and nystagmus. They may also include agitation, drowsiness, disorientation, or coma. Seizures have also been reported in patients. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties have been reported. Additionally, the prothrombin time (INR) may be prolonged, probably due to the disruption of blood clotting factors. Acute kidney failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur.
Furthermore, low blood pressure and breathing difficulties may occur.
Overdose cases are rare. Treatment is symptomatic and supportive. The doctor will take appropriate action.

Missing a dose of Ibufen

The patient should not take a double dose to make up for a missed dose.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibufen can cause side effects, although not everybody gets them.
The patient should stop using ibuprofen and seek medical attention immediately if they experience any of the following symptoms:

• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) - very rare.
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome) - frequency not known.
• red, peeling rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) - frequency not known.

Ibufen is generally well-tolerated. During short-term use of ibuprofen in available over-the-counter doses, the following side effects have been observed.
Side effects are listed by frequency of occurrence:
Uncommon(occurring in less than 1 in 100 patients):

• indigestion, abdominal pain, and nausea, local irritation of the anus;
• headache;
• skin rashes of various types;
• urticaria and itching.

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

• diarrhea, bloating with gas, constipation, vomiting;
• dizziness, insomnia, agitation, and fatigue.

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

• aseptic meningitis characterized by stiffness of the neck, headache, nausea, vomiting, fever, disorientation - reported in patients with existing autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue disease;
• blood disorders (anemia - anemia; leukopenia - decreased white blood cell count; thrombocytopenia - decreased platelet count; pancytopenia - a blood disorder characterized by a deficiency of all normal blood cell elements: red blood cells, white blood cells, and platelets; agranulocytosis - decreased granulocyte count). The first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, fatigue, nosebleeds, skin bruising.
• severe allergic reactions characterized by swelling of the face, tongue, and larynx; shortness of breath; rapid heartbeat; significant drop in blood pressure (anaphylaxis, angioedema, or shock);
• asthma, worsening of asthma, bronchospasm, shortness of breath, and wheezing;
• nervousness;
• vision disturbances;
• tinnitus, dizziness;
• edema, high blood pressure, heart failure (reported in association with the use of NSAIDs);
• peptic ulcer disease and duodenal ulcer, perforation, or gastrointestinal bleeding, melena, hematemesis, sometimes with a fatal outcome,

especially in the elderly; ulcerative stomatitis, gastritis, oral mucosa ulceration;

• worsening of colitis and Crohn's disease;
• liver function disorders, especially during long-term use of ibuprofen; hepatitis and jaundice;
• acute kidney failure; renal papillary necrosis, especially after long-term use of ibuprofen, associated with increased urea levels in the serum and edema, including peripheral edema; presence of blood and/or protein in the urine, interstitial nephritis, nephrotic syndrome;
• decreased hematocrit and hemoglobin levels in laboratory test results.

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

• skin becomes sensitive to light;
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

In individual cases, depression and psychotic reactions have been reported.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ibufen

The medicine should be stored out of sight and reach of children.
Do not use after the expiry date stated on the blister and carton after: EXP. The expiry date refers to the last day of that month.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
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 pack and other information

What Ibufen contains

• The active substance of the medicine 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 suppositories of torpedo shape.
The pack contains 5 suppositories. The carton contains a PVC/PE blister pack containing 5 suppositories.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Farmina Sp. z o.o.
Myślenice Plant
ul. Cegielskiego 2
32-400 Myślenice

Date of last revision of the leaflet: