Ibuprom

Package leaflet: Information for the patient

IBUPROM
200 mg coated tablets
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 so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3 days, you should consult your doctor.

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 an analgesic. It is used in the treatment of inflammation, which is one of the causes of pain. The medicine reduces fever.
The medicine is indicated for mild to moderate pain of various origins, including: headaches, toothaches, muscle pain, lumbosacral pain, bone and joint pain. Painful menstruation. Fever (e.g. in influenza, colds, or other infectious diseases).

2. Information before using the medicine

When not to use the medicine:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), or to other non-steroidal anti-inflammatory drugs (NSAIDs),
• if symptoms of allergy such as rhinitis, urticaria or bronchial asthma ever occurred in the past after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• in patients with active or past history of peptic ulcer or duodenal ulcer, gastrointestinal perforation or bleeding, including cases occurring after use of NSAIDs,
• in patients with severe liver failure, severe kidney failure or severe heart failure,
• in patients taking other non-steroidal anti-inflammatory drugs simultaneously, including COX-2 inhibitors (increased risk of adverse effects),
• during the third trimester of pregnancy,
• in case of bleeding tendency.

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Warnings and precautions
Before starting treatment with medicine I, discuss it with your doctor or pharmacist.
Exercise special caution when using the medicine:

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

There is a risk of gastrointestinal bleeding, ulceration or perforation, which
may be fatal and which may occur without warning symptoms or in patients
who previously experienced such warning signs. In case of gastrointestinal
bleeding or ulceration, the medicine should be discontinued immediately.
Patients with a history of gastrointestinal disorders, particularly elderly individuals,
should inform their doctor about any unusual gastrointestinal symptoms
(particularly bleeding), especially during the initial period of treatment.
Concomitant, long-term use of various painkillers may lead to
kidney damage with risk of kidney failure (analgesic nephropathy).
Use of the medicine in dehydrated patients (children and adolescents) increases the risk of
kidney function disorders.
Use of anti-inflammatory/pain-relieving 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.
Allergic reactions to ibuprofen have been reported, including difficulty
breathing, facial and neck swelling (angioedema), chest pain.
If any of these symptoms occur, discontinue the medicine immediately
and contact a doctor or emergency medical services without delay.
Before using medicine I, 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 legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischemic attack - TIA),
• the patient has hypertension, diabetes, elevated cholesterol levels, family history of heart disease or stroke, or if the patient smokes.
• the patient has an infection - see below, section titled "Infections".

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Do not use higher doses or longer treatment duration than recommended. If symptoms
persist, worsen or do not resolve within 3 days, or if new symptoms appear, contact
your doctor.
Serious skin reactions have been reported with ibuprofen use, 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 develops any of the
symptoms related to these serious skin reactions described in section 4, the medicine should be discontinued immediately and medical help sought.
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) which may
adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.
Infections
The medicine may mask signs of infection such as fever and pain. Therefore, it may
delay initiation of appropriate infection treatment 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 ongoing infection and infection symptoms persist or worsen, immediate
consultation with a doctor is required.
Children
The medicine is not indicated for children under 6 years of age.
Medicine and other medicines
Inform your doctor or pharmacist about all medicines currently taken or
recently used, as well as any medicines the patient plans to use.
Do not take medicine I simultaneously with other medicines from the group of non-steroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (at analgesic doses).
Concomitant use of medicine I with these medicines increases the risk of
adverse effects.
Medicine I may affect the action of other medicines or other medicines may affect the action
of medicine I, for example:

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

Some other medicines may also be affected by or influence treatment with medicine I.
Therefore, always consult your doctor or pharmacist before using medicine I
with other medicines.
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, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using 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 child or cause delivery complications. The medicine may cause kidney and heart function disorders in the unborn child. It may increase the tendency to bleeding in both mother and child and may cause delayed or prolonged labour. During the first 6 months of pregnancy, the medicine should not be used unless the doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible duration should be used. From
week 20 of pregnancy, the medicine, if taken for longer than a few days, may result in kidney function disorders in the unborn child (which may lead 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 for longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in very small amounts and there are no known cases of adverse effects in breastfed infants. There is no need to interrupt breastfeeding during short-term use of ibuprofen at low doses.
Fertility
If experiencing difficulty in becoming pregnant, consult your doctor before taking ibuprofen.
Driving and operating machinery
There are no data on the effect of the medicine on the ability to drive, operate machinery,
or psycho-motor performance when used at recommended doses and for the recommended duration.
The medicine contains sucrose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking the medicine.

3. How to use the medicine

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Children aged 6 to 9 years (body weight 20 - 29 kg)
For short-term treatment: 1 tablet orally every 6 - 8 hours after meals. Do not exceed a dose of 3 tablets per day (maximum daily dose 600 mg in divided doses).
Children aged 10 to 12 years (body weight 30 - 39 kg)
For short-term treatment: 1 tablet orally every 6 hours after meals. Do not exceed a dose of 4 tablets per day (maximum daily dose 800 mg in divided doses).
Adults and adolescents over 12 years of age
For short-term treatment: 1 to 2 tablets orally every 4 hours after meals. Do not exceed a dose of 6 tablets per day (maximum daily dose 1200 mg in divided doses).
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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).
This medicine should not be used in children under 6 years of age.
Do not exceed the recommended dose.
If the effect of the medicine seems too strong or too weak, consult a doctor.
This medicine is intended for short-term use. If symptoms persist or worsen, or if new symptoms occur, contact a doctor.
Do not take this medicine for longer than 3 days without consulting a doctor.
Overdose
If a patient has taken more than the recommended dose, or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital to assess possible health risks and receive advice on necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see section 4 below), diarrhoea, headache, tinnitus, confusion and vertigo. Excitement, drowsiness, disorientation or coma may also occur. Seizures may occur occasionally in patients. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold and breathing difficulties may occur. In addition, prothrombin time/INR may be prolonged, probably due to impaired function of circulating coagulation factors. Acute kidney failure and liver damage may also occur. In asthmatics, asthma may be exacerbated. In addition, low blood pressure and breathing difficulties may occur.
There is no specific antidote. The doctor will administer symptomatic and supportive treatment.
Missed dose
Do not take 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 experiences them.
If any of the following symptoms occur in a patient, ibuprofen use must be stopped immediately and medical help should be sought:

• Red, flat, target-like or circular skin rashes, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genital organs 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).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome).
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Adverse reactions occurring not very often (in 1 to 10 out of 1,000 patients using the medicine):

• Headache, dyspepsia, abdominal pain, nausea, urticaria, itching.

Adverse reactions occurring rarely (in 1 to 10 out of 10,000 patients using the medicine):

• Diarrhea, bloating, constipation, vomiting, gastric mucosal inflammation, dizziness, insomnia, restlessness, irritability and fatigue,
• Edema due to kidney and urinary tract disorders. page 5/8

Adverse reactions occurring very rarely (less than 1 in 10,000 patients using the medicine):

• Tarry stools, vomiting blood, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease,
• Gastric and/or duodenal ulceration, gastrointestinal bleeding and perforation, sometimes fatal, particularly in elderly patients,
• In isolated cases: depression, psychotic reactions and tinnitus, aseptic meningitis,
• Decreased urine output, edema, acute renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention),
• Liver function disturbances, particularly during prolonged use,
• Blood morphology abnormalities (anemia, leukopenia - reduced white blood cell count, thrombocytopenia - reduced platelet count, pancytopenia - hematological disorder characterized by deficiency of all normal blood cells: erythrocytes and platelets, agranulocytosis - reduced granulocyte count). Initial symptoms include: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, hemorrhagic diathesis (e.g. bruising, petechiae, purpura, nosebleeds),
• Severe hypersensitivity reactions such as: facial, tongue and laryngeal swelling, shortness of breath, tachycardia - heart rhythm disturbances, hypotension - sudden drop in blood pressure, shock; worsening of asthma and bronchospasm,
• In patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms typical of aseptic meningitis have been reported during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever and disorientation.

Adverse reactions 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 serious allergic reaction called Kounis syndrome.

Edema, hypertension and heart failure have been reported during treatment with NSAIDs.
Use of such medicines may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
When the medicine is used occasionally, adverse reactions occur rarely.
In elderly patients, the risk of adverse reactions associated with ibuprofen use is increased compared to younger patients. The frequency and severity of adverse reactions can be reduced by using the lowest therapeutic dose for the shortest possible duration.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 492 13 01
Fax: +48 (22) 492 13 09
Website: https://smz.ezdrowie.gov.pl
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Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine

Medicine packed in a blister in a cardboard box or in a bottle in a cardboard box:
do not store above 30°C.
Medicine packed in a sachet: do not store above 25°C.
Keep the medicine out of the sight and reach of children.
Do not use after the expiry date stated on the carton and primary packaging (month/year).
Blister labelling used: EXP – expiry date, Lot – batch number.
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 packaging and other information

What the medicine contains

• The active substance is ibuprofen. One coated tablet contains: 200 mg of ibuprofen.
• The other ingredients are Core of the tablet: microcrystalline cellulose, corn starch, pregelatinized starch, guar gum, talc, crospovidone (type A), colloidal anhydrous silica, hardened vegetable oil; Coating composition: 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 contents of the pack
Available pack sizes:
2 tablets – 1 sachet containing 2 tablets;
2 tablets – 1 blister containing 2 tablets;
4 tablets – 1 blister containing 4 tablets;
6 tablets – 1 blister containing 6 tablets;
10 tablets – 1 blister containing 10 tablets;
12 tablets – 1 blister containing 12 tablets;
20 tablets – 2 blisters containing 10 tablets each;
24 tablets – 2 blisters containing 12 tablets each;
30 tablets – 1 bottle containing 30 tablets;
50 tablets – 1 high-density polyethylene (HDPE) bottle with a high-density polyethylene (HDPE) violet-colored cap and a multilayer seal, packed in a cardboard box containing 50 tablets;
96 tablets – 1 high-density polyethylene (HDPE) bottle with a high-density polyethylene (HDPE) violet-colored cap and a multilayer seal, packed in a cardboard box containing 96 tablets.
Not all pack sizes may be marketed.
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Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
Ziębicka Street 40
50-507 Wrocław, Poland
For further information about this medicine, please contact:
USP Zdrowie Sp. z o.o.
Poleczki Street 35
02-822 Warsaw, Poland
Tel.: +48 (22) 543 60 00
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