Ibuprom regular

Package leaflet: Information for the user

IBUPROM REGULAR, 200 mg, coated tablets
( Ibuprofenum )
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be taken 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 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 after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What I R is and what it is used for

One coated tablet of I R contains 200 mg of ibuprofen, which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs). The medicine relieves symptoms such as fever, pain,
and swelling by acting at the site where these symptoms originate.
I R is indicated for use in the following conditions:

• Mild to moderate pain of various origins: headache, e.g. migraine, lower back pain, toothache, e.g. after tooth extraction, neuralgia, joint and muscle pain, painful menstruation.
• Fever associated with influenza and common cold.

I R is intended for use in adults and adolescents aged over 12 years with body weight above 40 kg.
I R is indicated for short-term, immediate use only. Your doctor may prescribe this medicine for other conditions not listed above (including certain chronic diseases). In such cases, follow your doctor's instructions regarding dosage and duration of treatment.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before taking Ibuprom Regular

When not to use Ibuprom Regular
Ibuprom Regular must not be used:

• if the patient is allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6),
• in patients who have previously experienced hypersensitivity reactions (e.g. urticaria, rhinitis, angioedema, or bronchial asthma) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients with active or a history of peptic ulceration or bleeding of the stomach and/or duodenum (two or more distinct episodes of confirmed ulceration or bleeding),
• in patients with a history of gastrointestinal perforation or bleeding associated with previous NSAID therapy (see section "Warnings and precautions"),
• in patients with severe hepatic insufficiency, severe renal insufficiency, or severe heart failure (see section "Warnings and precautions"),
• during the third trimester of pregnancy (see section "Pregnancy, breastfeeding and fertility"),
• in patients with haemorrhagic diathesis.

Warnings and precautions
Before starting treatment with Ibuprom Regular, consult a doctor if the patient has previously been diagnosed with:

• systemic lupus erythematosus or mixed connective tissue disease,
• gastrointestinal disorders and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and/or cardiac dysfunction,
• renal function disorders,
• hepatic function disorders,
• blood coagulation disorders (ibuprofen may prolong bleeding time),
• active or past history of bronchial asthma or allergic reactions; bronchospasm may occur after taking the medicine,
• an existing infection – see below, section titled "Infections",
• diseases requiring concomitant use of other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).

Concomitant use of Ibuprom Regular with NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
In dehydrated children and adolescents, there is a risk of renal dysfunction.

Infections
Ibuprom Regular may mask symptoms of infection such as fever and pain. Consequently, Ibuprom Regular may delay appropriate treatment of the infection, thereby increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with varicella. If the patient takes this medicine during an existing infection and symptoms persist or worsen, immediate medical advice must be sought.

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be life-threatening and which may occur without warning symptoms or in patients with previous warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine must be discontinued 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 stages of therapy.

Prolonged, concomitant use of various analgesics may lead to kidney damage with risk of renal failure (analgesic nephropathy).

The 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. The recommended dose and duration of treatment should not be exceeded.

Allergic reactions to ibuprofen have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. If any of these symptoms occur, Ibuprom Regular must be discontinued immediately and medical help must be sought without delay.

If symptoms persist, worsen, or do not improve within 3 days, or if new symptoms occur, medical advice should be sought.

Before using Ibuprom Regular, 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 history of stroke (including mini-stroke or transient ischaemic attack).
• the patient has hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

Skin reactions
Serious skin reactions have been reported with the use of ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP). If any of the symptoms associated with these serious skin reactions described in section 4 occur, Ibuprom Regular must be discontinued immediately and medical help must be sought.

This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and ceases upon discontinuation of therapy.

Ibuprom Regular and other medicines
Inform the doctor about all medicines currently used, recently used, or planned for use, including those available without prescription.

Concomitant use of ibuprofen with the following medicines should be avoided:

• acetylsalicylic acid,
• other NSAIDs, including selective cyclooxygenase-2 inhibitors.

Ibuprom Regular may affect the action of other medicines, or other medicines may affect the action of Ibuprom Regular. For example:

• anticoagulant medicines (i.e. blood thinners/preventing clot formation), such as aspirin (acetylsalicylic acid), warfarin, ticlopidine,
• antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Ibuprofen should be used with caution with the following medicines:

• diuretics,
• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs),
• cardiac glycosides,
• lithium (a medicine used, among others, in the treatment of manic states and recurrent depression) and methotrexate (a medicine used, among others, in certain cancers and rheumatoid arthritis),
• cyclosporine,
• mifepristone,
• tacrolimus,
• zidovudine (an antiviral medicine),
• quinolone antibiotics,
• corticosteroids.

Other medicines may also interact with or influence treatment with Ibuprom Regular.
Therefore, always consult a doctor or pharmacist before using Ibuprom Regular with other medicines.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or 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
Ibuprom Regular should not be taken during the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. Ibuprom Regular may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labour.

During the first 6 months of pregnancy, Ibuprom Regular should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. From the 20th week of pregnancy, Ibuprom Regular may cause renal dysfunction in the unborn child if taken for longer than a few days. This 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 may pass into breast milk in small amounts. There are no known cases of adverse effects in breastfed infants; therefore, there is no need to interrupt breastfeeding during short-term use at recommended doses. However, consult a doctor before using any medicine.

Fertility
See section "Warnings and precautions".

Driving and operating machinery
No effects of Ibuprom Regular on the ability to drive or operate machinery are expected when used at recommended doses and for the specified duration of treatment.

3. How to use I R

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine should be taken orally, for short-term use only. If in doubt, consult your doctor.
Adults and adolescents over 12 years of age and weighing more than 40 kg: 1 or 2 tablets every 4–6 hours.
Swallow the tablets with water. Do not exceed 6 tablets (1200 mg of ibuprofen) in 24 hours. Maintain an interval of at least 4 hours between doses.
In patients with impaired liver or kidney function, the doctor will determine an individual dosage.
This medicine is not recommended for children under 12 years of age.
Elderly patients: dose adjustment is not necessary.
Do not take more than the recommended dose.
Consult your doctor if treatment with this medicine is required for more than 3 days or if symptoms worsen.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If signs of infection (such as fever and pain) persist or worsen during treatment, consult your doctor immediately (see section 2).

Overdose of I R
If a patient takes more than the recommended dose of I R or if a child accidentally ingests the medicine, seek medical advice immediately from a doctor or go to the nearest hospital to assess potential health risks and receive guidance 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 nystagmus. Excitement, drowsiness, disorientation, or coma may also occur.
Seizures may occur rarely in patients. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur.
Prolongation of prothrombin time/INR may also occur, likely due to interference with circulating coagulation factors. Acute kidney failure and liver damage may develop. In asthmatic patients, asthma may worsen. Additionally, low blood pressure and breathing difficulties may occur.
There is no specific antidote. Treatment is symptomatic and supportive, aimed at maintaining vital functions until the drug is eliminated from the body. Cardiac function should be monitored and vital signs controlled, provided they are stable. The doctor may consider administering activated charcoal orally within 1 hour of overdose. In case of frequent or prolonged seizures, intravenous diazepam or lorazepam should be administered. Patients with asthma should receive bronchodilators.

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

Stopping treatment with I R
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur in a patient, ibuprofen should be stopped immediately and medical help should be sought:

• Red, flat, target-like or circular spots on the trunk, often with blisters in the center, peeling skin, and mucosal 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).
• Widespread rash, high body temperature, and enlarged 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 listed below have been observed during short-term use of ibuprofen at over-the-counter doses. When ibuprofen is used for other indications or for prolonged periods, additional adverse reactions may occur.
Adverse reactions are listed according to frequency using the following categories:
Very common: affects more than 1 in 10 treated patients.
Common: affects less than 1 in 10 but more than 1 in 100 patients.
Uncommon: affects less than 1 in 100 but more than 1 in 1,000 patients.
Rare: affects less than 1 in 1,000 but more than 1 in 10,000 patients.
Very rare: affects less than 1 in 10,000 patients and in isolated cases.
Frequency not known: cannot be estimated from available data.

Uncommon:

• Abdominal pain, nausea, and dyspepsia,
• Headache,
• Various types of skin rashes,
• Urticaria and itching.

Rare:

• Diarrhea, flatulence, constipation, vomiting, gastritis,
• Dizziness,
• Psychotic disorders, depression, insomnia, restlessness,
• Tinnitus,
• Irritability, fatigue.

Very rare:

• Gastrointestinal ulcers, perforation or bleeding of the gastrointestinal tract, tarry stools, vomiting blood (sometimes fatal, especially in elderly patients), ulcerative stomatitis, exacerbation of colitis and Crohn's disease,
• Aseptic meningitis,
• Acute renal failure, renal papillary necrosis, particularly with long-term use, associated with increased blood urea nitrogen and edema, hypernatremia (sodium retention), decreased urine output,
• Liver function disorders,
• Blood count abnormalities (anemia, leukopenia - reduced number of white blood cells, thrombocytopenia - reduced number of platelets, pancytopenia - hematological disorder characterized by deficiency of all normal blood cells: red blood cells, white blood cells, and platelets, agranulocytosis - reduced number of granulocytes, a type of white blood cell). Initial symptoms include: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, unexplained bleeding and bruising (e.g., petechiae, purpura, epistaxis),
• Severe hypersensitivity reactions. Symptoms may include: swelling of the face, tongue or larynx, difficulty breathing, tachycardia, drop in blood pressure (anaphylaxis, angioedema or severe shock),
• Heart failure and edema,
• Hypertension,
• Decreased hemoglobin concentration.

Frequency not known:

• Hyperreactivity of the respiratory tract, e.g., asthma, worsening of asthma, bronchospasm, shortness of breath,
• Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome,
• Skin becomes sensitive to light.

Other adverse reactions may occur in some individuals during treatment. If any of the above symptoms, or any other symptoms not listed in this leaflet, are observed, the medicine should be discontinued and a doctor should be consulted.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 Warsaw
Phone: +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 representative of the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store I R

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
Do not use the medicine after the expiry date stated on the cardboard box and on the blister after:
EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What I R contains
The active substance is ibuprofen.
The excipients are: microcrystalline cellulose, corn starch, pregelatinized corn starch,
hydrogenated vegetable oil, crospovidone (type A), talc, colloidal anhydrous silica.
Coating: Opadry White 65F280000 (polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc,
potassium aluminium silicate and titanium dioxide (E 171), carnauba wax).

What I R looks like and contents of the pack
Film-coated tablets (15 mm x 6 mm), white or almost white in colour with a slight sheen, oblong-shaped,
biconvex, marked with the engraving "RR" on one side.
Blister pack made of PVC/PVDC/Aluminium in a cardboard box.
Pack sizes:
10 tablets – 1 blister containing 10 film-coated tablets;
Bottle made of HDPE polyethylene in a cardboard box.
Pack sizes:
50 tablets – 1 bottle containing 50 film-coated tablets;
96 tablets – 1 bottle containing 96 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
For further information, please contact the representative of the marketing authorisation holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel. +48 (22) 543 60 00

This medicinal product is authorised for marketing in the European Economic Area countries under the following trade names:
Poland IBUPROM REGULAR
Bulgaria IBUPROM REGULAR
Estonia Ibuprofenum US Pharmacia
Latvia Ibuprofenum US Pharmacia, 200 mg, apvalkotās tabletes
Romania Ibuprofen US Pharmacia, 200 mg, comprimate filmate