Ibuprom Regular

Leaflet attached to the packaging: patient information

IBUPROM REGULAR, 200 mg, coated tablets

(Ibuprofen)

You should carefully read the contents of the leaflet 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should 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 is IR and what is it used for
• 2. Important information before taking IR
• 3. How to take IR
• 4. Possible side effects
• 5. How to store IR
• 6. Package contents and other information

1. What is IR and what is it used for

One coated tablet of IR contains 200mg of ibuprofen, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine relieves such ailments as fever, pain, and swelling by acting at the site of their occurrence.

The medicine is intended for use in the following cases:

• pains of various origins of mild to moderate severity: headaches, e.g. migraines, back pain, toothaches, e.g. after tooth extraction, neuralgia, joint and muscle pains, painful menstruation.
• fever in the course of flu and colds.

IR is intended for adults and adolescents over 12 years of age with a body weight of over 40 kg.

This medicine is indicated for short-term, occasional use. The doctor may prescribe the use of the medicine for other purposes than those listed above (also in some chronic diseases). In this case, the doctor's instructions regarding dosage and treatment duration should be followed.

If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking IR

When not to take IR

IR should not be taken:

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• in patients who have had hypersensitivity reactions (e.g. hives, rhinitis, angioedema or bronchial asthma) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) in the past,
• in patients with active or past peptic ulcer or gastrointestinal bleeding (two or more confirmed episodes of ulceration or bleeding),
• in patients with a history of gastrointestinal perforation or bleeding associated with previous NSAID treatment (see "Warnings and precautions"),
• in patients with severe liver failure, severe kidney failure, or severe heart failure (see "Warnings and precautions"),
• in the last trimester of pregnancy (see "Pregnancy, breastfeeding, and fertility"),
• in patients with hemorrhagic diathesis.

Warnings and precautions

Before starting treatment with IR, the patient should discuss it with their doctor if they have:

• systemic lupus erythematosus and mixed connective tissue disease,
• gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and/or heart failure,
• kidney function disorders,
• liver function disorders,
• blood coagulation disorders (ibuprofen may prolong bleeding time),
• active or past bronchial asthma or a history of allergic reactions; after taking the medicine, bronchospasm may occur,
• the patient has an infection - see below, the section entitled "Infections".
• diseases for which the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).

IR should be avoided in combination with other NSAIDs, including selective cyclooxygenase-2 inhibitors.

In dehydrated patients - children and adolescents, there is a risk of kidney function disorders.

Infections

IR may mask the symptoms of infection, such as fever and pain. Therefore, IR 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 associated with chickenpox. If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should consult their doctor immediately.

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. In case of gastrointestinal bleeding or ulceration, the medicine should be discontinued immediately. Patients 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 (analgesic nephropathy).

Taking anti-inflammatory/analgesic medicines, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded, and the treatment duration should not be prolonged.

During ibuprofen treatment, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling of the face and neck (angioedema), chest pain. If any of these symptoms are noticed, IR should be discontinued immediately and medical help should be sought.

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

Before taking IR, 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), has had a heart attack, coronary artery bypass grafting, has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack).
• the patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes.

Skin reactions

Severe skin reactions have occurred with ibuprofen, 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 of the symptoms associated with these severe skin reactions described in section 4, they should discontinue IR immediately and seek medical attention.

This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is transient and disappears after the end of treatment.

IR 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, including those available without a prescription.

Ibuprofen should be avoided in combination with the following medicines:

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

IR may affect the action of other medicines or other medicines may affect the action of IR. For example:

• anticoagulant medicines (i.e. blood thinners/anti-clotting agents, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-adrenergic 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 other things, in the treatment of manic states and recurrent depression) and methotrexate (a medicine used, among other things, in the treatment of certain cancers and rheumatoid arthritis),
• cyclosporin,
• mifepristone,
• tacrolimus,
• zydovudine (an antiviral medicine),
• quinolone antibiotics,
• corticosteroids.

Other medicines may also be affected or have an effect on IR treatment. Therefore, before taking IR 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 taking this medicine.

Pregnancy

IR should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. IR may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the mother and child and cause delayed or prolonged labor.

During the first 6 months of pregnancy, IR should not be used 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, IR may cause kidney function disorders in the unborn child if taken for more than a few days. This may lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is required for a longer period, 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, so there is no need to stop breastfeeding during short-term use of the medicine in recommended doses. Before taking any medicine, the patient should consult their doctor.

Fertility

See "Warnings and precautions".

Driving and using machines

No effect of IR on the ability to drive and use machines is expected after taking the recommended dose and duration of treatment.

3. How to take IR

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

The medicine should be taken orally, for a short period. In case of doubt, the patient should consult their doctor.

Adults and adolescents over 12 years of age and with a body weight of over 40 kg:1 or 2 tablets every 4-6 hours.

Tablets should be taken with water. No more than 6 tablets (1200 mg of ibuprofen) should be taken in 24 hours. A 4-hour interval should be maintained between doses.

In case of liver or kidney function disorders, the doctor will determine the individual dosage.

The medicine is not indicated for children under 12 years of age.

Elderly patients:dose modification is not necessary.

A higher dose of the medicine than recommended should not be taken.

The patient should consult their doctor if the medicine needs to be taken for more than 3 days or if symptoms worsen.

The lowest effective dose should be used 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).

Taking a higher dose of IR than recommended

If the patient has taken a higher dose of IR 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 to do in such a case.

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 may experience seizures. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness may occur, as well as black stools, bloody vomiting (sometimes fatal, especially in the elderly), and problems with breathing. Additionally, 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 breathing difficulties may occur.

There is no specific antidote. Treatment is symptomatic and supportive, consisting of maintaining vital functions until the medicine is eliminated from the body. The doctor will monitor the patient's heart function and control their vital signs, as long as they are stable. The doctor may consider administering activated charcoal orally within 1 hour of overdose. In case of frequent or prolonged seizures, diazepam or lorazepam should be administered intravenously. Patients with asthma should be given bronchodilators.

Missing a dose of IR

A double dose should not be taken to make up for a missed dose.

Stopping IR treatment

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

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

• 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 rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).
• 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).

During short-term use of ibuprofen in doses available without a prescription, the following side effects have been observed. When using ibuprofen for other indications and long-term, other side effects may occur.

Side effects are ranked according to frequency of occurrence, using the following terms:

Very common: occurs in more than 1 in 10 treated patients.

Common: occurs in less than 1 in 10 but more than 1 in 100 patients.

Uncommon: occurs in less than 1 in 100 but more than 1 in 1,000 patients.

Rare: occurs in less than 1 in 1,000 but more than 1 in 10,000 patients.

Very rare: occurs in less than 1 in 10,000 patients and in individual cases.

Frequency not known: cannot be estimated from the available data.

Uncommon:

• stomach pain, nausea, and indigestion,
• headache,
• various skin rashes,
• hives and itching.

Rare:

• diarrhea, bloating, constipation, vomiting, gastritis,
• dizziness,
• psychotic disorders, depression, insomnia, agitation,
• ringing in the ears,
• irritability, fatigue.

Very rare:

• peptic ulcers, perforation, or gastrointestinal bleeding, black stools, bloody vomiting (sometimes fatal, especially in the elderly), oral ulceration, exacerbation of ulcerative colitis and Crohn's disease,
• aseptic meningitis,
• acute kidney failure, renal papillary necrosis, especially with prolonged use, associated with an increased level of urea in the blood and edema, hypernatremia (sodium retention), decreased urine output,
• liver function disorders,
• blood count disorders (anemia, leukopenia - decreased white blood cell count, thrombocytopenia - decreased platelet count, pancytopenia - a hematological disorder characterized by a deficiency of all normal morphological elements of the blood: red blood cells, white blood cells, and platelets, agranulocytosis - decreased count of a certain type of white blood cells - granulocytes). The first symptoms include: fever, sore throat, superficial oral ulceration, flu-like symptoms, severe fatigue, unexplained bleeding and bruising (e.g. petechiae, purpura, and nosebleeds),
• severe hypersensitivity reactions. Symptoms may include: facial swelling, tongue or laryngeal edema, shortness of breath, tachycardia, decreased blood pressure (anaphylaxis, angioedema, or severe shock),
• heart failure and edema,
• hypertension,
• decreased hemoglobin level.

Frequency not known:

• respiratory tract hyperreactivity, e.g. asthma, asthma exacerbation, bronchospasm, shortness of breath,
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome,
• skin becomes sensitive to light.

In some people, other side effects may occur during treatment with the medicine. If the patient notices any of the above symptoms, as well as any other symptoms not listed in this leaflet, they should discontinue the medicine and consult their doctor.

Reporting side effects

If any side effects occur, including any 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 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the representative of the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store IR

The medicine should be stored out of sight and reach of children.

There are no special recommendations for storing the medicine.

The medicine should not be used after the expiry date stated on the carton and blister after:

EXP. The expiry date refers to the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Package contents and other information

What IR contains

The active substance of the medicine is ibuprofen.

The excipients are: microcrystalline cellulose, corn starch, pregelatinized corn starch, hydrogenated vegetable oil, crospovidone (type A), talc, anhydrous colloidal silica.

Coating: Opadry White 65F280000 (polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, potassium silicate and titanium dioxide (E 171), carnauba wax.

What IR looks like and what the package contains

Coated tablets (15 mm x 6 mm) of white or almost white color with a slight gloss, oblong in shape, convex on both sides with an engraving "RR" on one side.

PVC/PVDC/Aluminum blister in a cardboard box.

Package sizes:

10 pieces - 1 blister of 10 coated tablets;

HDPE polyethylene bottle in a cardboard box.

Package size:

50 pieces - 1 bottle of 50 coated tablets;

96 pieces - 1 bottle of 96 coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.

ul. Ziębicka 40

50-507 Wrocław

To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:

USP Zdrowie Sp. z o.o.

ul. Poleczki 35

02-822 Warsaw

tel. +48 (22) 543 60 00

This medicinal product is authorized for marketing in the Member States of the European Economic Area under the following 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

Date of last revision of the leaflet: October 2024