Ibuprom

Leaflet attached to the packaging: patient information

IBUPROM

200 mg coated tablets

Ibuprofen

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects 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 their doctor.

Table of contents of the leaflet

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

1. What the medicine is and what it is used for

The medicine is a pain-relieving drug. It is used to treat inflammation, which is one of the causes of pain. The medicine lowers fever.

The indications for use of the medicine are pain of various origins of mild to moderate severity, including: headaches, toothaches, muscle pain, lower back pain, bone and joint pain. Painful menstruation. Fever (including in the course of flu, colds or other infectious diseases).

2. Important information before taking the medicine

When not to take the medicine:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) and to other non-steroidal anti-inflammatory drugs (NSAIDs),
• if after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, the patient has ever had symptoms of allergy such as runny nose, hives or bronchial asthma,
• in patients with active or recurrent stomach and/or duodenal ulcers, bleeding or perforation, also those that occurred after taking NSAIDs,
• in patients with severe liver, kidney or heart failure,
• in patients taking other non-steroidal anti-inflammatory drugs at the same time, including COX-2 inhibitors (increased risk of side effects),
• in the third trimester of pregnancy,
• in case of bleeding disorders.

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Warnings and precautions

Before starting to take the medicine, the patient should discuss it with their doctor or pharmacist.

Special caution should be exercised when taking the medicine:

• if the patient has been diagnosed with lupus or mixed connective tissue disease,
• if symptoms of allergic reactions occur after taking acetylsalicylic acid,
• if the patient has been diagnosed with gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• if the patient has been diagnosed with hypertension and/or heart failure,
• if the patient has been diagnosed with kidney function disorders,
• if the patient has been diagnosed with liver function disorders,
• if the patient has been diagnosed with blood clotting disorders,
• if the patient has a history of active or recurrent bronchial asthma or symptoms of allergic reactions in the past; after taking the medicine, bronchospasm may occur,
• if the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).

There is a risk of gastrointestinal bleeding, ulceration or perforation, which can be fatal and does not have to be preceded by warning signs or may occur in patients who have had such warning signs.

In case of gastrointestinal bleeding or ulceration, the medicine should be stopped immediately.

Patient with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.

Concomitant, long-term use of different painkillers may lead to kidney damage with a risk of kidney failure (analgetic nephropathy).

Taking the medicine by dehydrated patients (children and adolescents) increases the risk of kidney function disorders.

Taking anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, especially when taken in high doses.

Do not exceed the recommended dose and duration of treatment.

During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling of the face and neck (angioedema), chest pain.

If any of these symptoms are noticed, the medicine should be stopped immediately and medical help should be sought.

Before taking the medicine, the patient should discuss the treatment with their doctor or pharmacist if:

• the patient has heart diseases, such as heart failure, angina pectoris (chest pain), the patient has had a heart attack, coronary artery bypass grafting, the patient has peripheral artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or if the patient has had any stroke (including mini-stroke or transient ischemic attack - TIA),
• the patient has high blood pressure, diabetes, high cholesterol levels, there is a history of heart disease or stroke in the patient's family, or if the patient smokes.
• the patient has an infection - see below, section "Infections".

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Do not take higher doses or longer treatment than recommended.

If symptoms persist, worsen or do not improve after 3 days, or if new symptoms occur, the patient should consult their doctor.

Due to the use of ibuprofen, severe skin reactions have occurred, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).

If the patient experiences any symptoms related to these severe skin reactions described in section 4, they should stop taking the medicine immediately and seek medical help.

This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect female fertility.

This effect is temporary and reverses after the end of treatment.

Infections

may mask the symptoms of infection, such as fever and pain.

This may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications.

This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox.

If the patient takes this medicine during an infection and the symptoms of the infection persist or worsen, they should consult their doctor immediately.

Children

The medicine is not indicated for children under 6 years of age.

Medicine and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Do not take the medicine at the same time as other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors, such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (in pain-relieving doses).

Concomitant use of the medicine with these medicines increases the risk of side effects.

The medicine may affect the action of other medicines or other medicines may affect the action of the medicine, for example:

• anticoagulant medicines (e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),
• diuretics,
• corticosteroids (e.g., prednisolone or dexamethasone),
• methotrexate (anticancer medicine),
• lithium (antidepressant),
• zydovudine (antiviral medicine).

Also, some other medicines may be affected or may affect the treatment with the medicine.

Therefore, before taking the medicine with other medicines, the patient should always consult their doctor or pharmacist.

With food and drink

It is recommended to take the medicine after a meal.

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Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Do not take the medicine if the patient is in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery.

The medicine may cause kidney and heart problems in the unborn baby.

It may increase the risk of bleeding in the patient and the baby and cause delayed or prolonged labor.

In the first 6 months of pregnancy, the medicine should not be taken unless the doctor considers it absolutely necessary.

If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.

From the 20th week of pregnancy, the medicine, if taken for more than a few days, may cause kidney problems in the unborn baby (which can lead to low levels of amniotic fluid around the baby, oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart.

If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen passes into breast milk in very small amounts and no cases of side effects in breastfed infants have been reported.

There is no need to stop breastfeeding when taking ibuprofen for a short period and in small doses.

Fertility

In case of difficulty conceiving, the patient should consult their doctor before taking ibuprofen.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive vehicles, operate machinery, and mental fitness during treatment with the recommended doses and for the recommended period.

The medicine contains sugar

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take the medicine

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

In case of doubt, the patient should consult their doctor or pharmacist.

Children aged 6 to 9 years (body weight 20-29 kg)

For temporary treatment, 1 tablet orally every 6-8 hours after meals.

Do not take more than 3 tablets per day (maximum daily dose 600 mg in divided doses);

Children aged 10 to 12 years (body weight 30-39 kg)

For temporary treatment, 1 tablet orally every 6 hours after meals.

Do not take more than 4 tablets per day (maximum daily dose 800 mg in divided doses);

Adults and adolescents over 12 years of age

For temporary treatment, 1 to 2 tablets orally every 4 hours after meals.

Do not take more than 6 tablets per day (maximum daily dose 1200 mg in divided doses).

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Take the smallest effective dose for the shortest necessary period to relieve symptoms.

If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).

The medicine should not be taken by children under 6 years of age.

Do not exceed the recommended dose.

If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

The medicine is intended for short-term use.

If symptoms persist, worsen, or new symptoms occur, the patient should consult their doctor.

Do not take the medicine for more than 3 days without consulting a doctor.

Taking a higher dose of the medicine than recommended

If the patient has taken a higher dose of the medicine 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 possible health risks and advice on what to do.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see section 4 below), diarrhea, headache, ringing in the ears, confusion, and nystagmus.

It may also cause agitation, drowsiness, disorientation, or coma.

Occasionally, patients experience seizures.

After taking high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred.

Blood in the urine, low potassium levels in the blood, feeling cold, and difficulty breathing may also occur.

In addition, the prothrombin time/INR may be prolonged, probably due to the disruption of circulating clotting factors.

Acute kidney failure and liver damage may occur.

In asthmatics, asthma may worsen.

Additionally, low blood pressure and difficulty breathing may occur.

There is no specific antidote.

The doctor will administer symptomatic and supportive treatment.

Missing a dose of the medicine

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient experiences any of the following symptoms, they should stop taking ibuprofen immediately and seek medical help:

• red, non-raised, plate-like or round spots on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes.
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• red, peeling rash with nodules under the skin and blisters, with fever.

Uncommon side effects(in 1 to 10 out of 1000 patients taking the medicine):

• headache, indigestion, stomach pain, nausea, hives, itching.

Rare side effects(in 1 to 10 out of 10,000 patients taking the medicine):

• diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, agitation, irritability, and fatigue,
• edema resulting from kidney and urinary disorders.

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Very rare side effects(less than 1 in 10,000 patients taking the medicine):

• tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease,
• gastric and/or duodenal ulcer, gastrointestinal bleeding, and perforation, sometimes fatal, especially in the elderly,
• in single cases, the following have been reported: depression, psychotic reactions, and tinnitus, aseptic meningitis,
• reduced urine output, edema, acute kidney failure, renal papillary necrosis, increased sodium levels in the serum (sodium retention),
• liver function disorders, especially during long-term use,
• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia).
• severe allergic reactions such as: facial edema, tongue and laryngeal edema, dyspnea, tachycardia, hypotension, shock; exacerbation of asthma and bronchospasm,
• in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis have been reported, such as neck stiffness, headache, nausea, vomiting, fever, disorientation.

Side effects with unknown frequency(frequency cannot be estimated from available data):

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

With the use of NSAIDs, reports of edema, hypertension, and heart failure have been made.

Taking such medicines as ibuprofen may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.

In the case of temporary use of the medicine, side effects are rare.

In elderly patients, there is an increased risk of side effects associated with the use of ibuprofen compared to younger patients.

The frequency and severity of side effects can be reduced by using the smallest therapeutic dose for the shortest possible period.

Reporting side effects

If side effects occur, including any possible side effects not listed in this leaflet, the patient should tell their doctor or pharmacist.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

• Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 (22) 492 13 01, fax: +48 (22) 492 13 09, website: https://smz.ezdrowie.gov.pl

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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 the medicine

Medicine packaged in a blister in a cardboard box or in a bottle in a cardboard box:

do not store above 30°C.

Medicine packaged in a sachet: do not store above 25°C.

Store the medicine out of sight and reach of children.

Do not use after the expiry date stated on the carton and blister pack (month/year).

The labeling used for the blister is: EXP - expiry date, Lot - batch number.

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 the medicine contains

• The active substance of the medicine is ibuprofen.
• One coated tablet contains: 200 mg of ibuprofen.
• Other ingredients are: Tablet core: cellulose powder, corn starch, pregelatinized starch, guar gum, talc, crospovidone (type A), colloidal silicon dioxide, hardened vegetable oil; Coating: hydroxypropylcellulose, macrogol 400, talc, gelatin, sucrose, kaolin, confectioner's sugar (a mixture of sucrose and corn starch), calcium carbonate, dried arabic gum dispersion, titanium dioxide (E 171), white pigment - Opalux White AS 7000, carnauba wax, black ink - Opacode Black S-1-17823.

What the medicine looks like and what the pack contains

Available packs:

2 pieces - 1 sachet of 2 pieces;

2 pieces - 1 blister of 2 pieces;

4 pieces - 1 blister of 4 pieces;

6 pieces - 1 blister of 6 pieces;

10 pieces - 1 blister of 10 pieces;

12 pieces - 1 blister of 12 pieces;

20 pieces - 2 blisters of 10 pieces;

24 pieces - 2 blisters of 12 pieces;

30 pieces - 1 bottle of 30 pieces;

50 pieces - 1 HDPE bottle with an HDPE cap, purple in color, with a multi-layered seal in a cardboard box of 50 pieces;

96 pieces - 1 HDPE bottle with an HDPE cap, purple in color, with a multi-layered seal in a cardboard box of 96 pieces.

Not all pack sizes may be marketed.

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Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.

ul. Ziębicka 40

50-507 Wrocław

To obtain more detailed information about this medicine, the patient should contact:

USP Zdrowie Sp. z o.o.

ul. Poleczki 35

• 02-822 Warsaw, tel.: +48 (22) 543 60 00

Date of last revision of the leaflet:

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