Ibuprom forte

Package leaflet: information for the patient

IBUPROM FORTE, 400 mg, coated tablets
(Ibuprofenum)
Please read all of this leaflet carefully before taking this medicine, because 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 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 after 3 days, or if you feel worse, contact your doctor.

Contents of the leaflet

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

1. What it is and what it is used for
One coated tablet of I F contains 400 mg of ibuprofen, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine relieves symptoms such as fever, pain, and swelling by acting at the site where they occur.
I F 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 F is intended for adults and adolescents over 12 years of age with body weight above 40 kg.
This medicine is indicated for short-term, temporary use. A doctor may prescribe the medicine for other conditions than those listed above (including certain chronic diseases). In such cases, follow the 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 I F

When not to take I F
Do not take I F:

• if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6),
• in patients who have previously experienced allergic reactions (e.g. urticaria, rhinitis, angioedema, or bronchial asthma) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
• in patients with active or past history of peptic ulcer or bleeding in the stomach and/or duodenum (two or more confirmed episodes of 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 liver impairment, severe renal impairment, or severe heart failure (see section "Warnings and precautions"),
• during the third trimester of pregnancy (see section "Pregnancy, breastfeeding and fertility"),
• in patients with bleeding disorders.

Warnings and precautions
Before starting treatment with I F, consult your doctor if you have previously been diagnosed with:

• systemic lupus erythematosus or mixed connective tissue disease,
• gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and/or heart function disorders,
• kidney function disorders,
• liver function disorders,
• blood clotting disorders (ibuprofen may prolong bleeding time),
• active or past history of bronchial asthma or allergic reactions; bronchospasm may occur after taking the medicine,
• if you have an infection – see below, section titled "Infections",
• conditions where you are taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).

Concomitant use of I F with NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
In dehydrated children and adolescents, there is a risk of impaired kidney function.
Infections
I F may mask symptoms of infection such as fever and pain. Therefore, I F may delay appropriate treatment of infection, potentially leading to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and symptoms persist or worsen, consult your doctor immediately.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms or in patients with previous warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with a history of gastrointestinal disorders, especially elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial phase of therapy.
Long-term, concomitant use of various painkillers may lead to kidney damage with risk of renal failure (analgesic nephropathy).
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. Do not exceed the recommended dose or duration of treatment.
Allergic reactions to ibuprofen, including difficulty in breathing, facial and neck swelling (angioedema), and chest pain, have been reported. If any of these symptoms occur, discontinue I F immediately and contact your doctor or emergency medical services without delay.
If symptoms persist, worsen, or do not improve after 3 days, or if new symptoms appear, contact your doctor.
Before taking I F, discuss treatment with your doctor or pharmacist if:

• you have heart conditions such as heart failure, angina (chest pain), history of heart attack, coronary 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).

• you have hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if you smoke.

Skin reactions
Severe skin reactions have been reported with ibuprofen use, including 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 you experience any symptoms related to these severe skin reactions described in section 4, discontinue I F immediately and seek medical help.
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of therapy.

I F and other medicines
Inform your doctor about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription.
Avoid concomitant use of ibuprofen with the following medicines:

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

I F may affect the action of other medicines or other medicines may affect the action of I F. 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-blockers, such as medicines containing 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 influence or be influenced by treatment with I F.
Therefore, always consult your doctor or pharmacist before taking I F with other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take I F if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. I F 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.
Do not use I F during the first 6 months of pregnancy unless your doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest effective dose for the shortest possible duration should be used. From week 20 of pregnancy, I F may cause kidney function disturbances 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 longer than a few days is required, your doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen may pass into breast milk in small amounts. No adverse effects have been reported in breastfed infants; therefore, there is no need to interrupt breastfeeding during short-term use at recommended doses. However, consult your doctor before taking any medicine.

Fertility
See section "Warnings and precautions".

Driving and operating machinery
I F is not expected to affect the ability to drive or operate machinery when used at recommended doses and for the recommended duration of treatment.

3. How to use I F

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

Taking more medicine I F than recommended
If a patient has taken more than the recommended dose of I F, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital for advice on possible health risks and what actions should be taken.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Agitation, drowsiness, disorientation, or coma may also occur.
Seizures have occurred occasionally 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, probably due to interference with circulating coagulation factors. Acute kidney failure and liver damage may occur. 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 parameters checked, 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 be given bronchodilators.

If you forget to take I F
Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following symptoms occur in a patient, ibuprofen should be discontinued 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 effects 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 effects may occur.
Adverse effects are listed according to frequency of occurrence, using the following categories:
Very common: affects more than 1 in 10 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 based on available data.

Uncommon:

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

Rare:

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

Very rare:

• Gastrointestinal ulcers, perforation or gastrointestinal bleeding, 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 prolonged use, associated with increased serum urea levels and edema, hypernatremia (sodium retention), reduced urine output,
• Liver function disorders,
• Blood count abnormalities (anemia, leukopenia - reduced number of white blood cells, thrombocytopenia - reduced platelet count, 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 may include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding and bruising (e.g., petechiae, purpura, epistaxis),
• Severe hypersensitivity reactions. Symptoms may include: facial, tongue or laryngeal swelling, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe shock),
• Heart failure and edema,
• Hypertension,
• Decreased hemoglobin concentration.

Frequency not known:

• Respiratory hyperreactivity, e.g., asthma, worsening of asthma, bronchospasm, dyspnea,
• Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome,
• Skin becomes sensitive to light.

Other adverse effects 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 effects
If any adverse effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse effects can also be reported to the representative of the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store I F

Keep this medicine out of sight and reach of children.
There are no special requirements for storage of this medicine.
Do not use this medicine after the expiry date stated on the outer carton and on the blister after:
EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What I F contains
The active substance is ibuprofen.
The other ingredients are: microcrystalline cellulose, maize starch, pregelatinized maize starch,
hydrogenated vegetable oil, crospovidone (type A), talc, colloidal anhydrous silica.
Coating: Opadry White 65F2280000 (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E 171),
talc, potassium-aluminium silicate and titanium dioxide (E 171), Carnauba wax).

What I F looks like and contents of the pack
Film-coated tablets (18 mm x 8 mm) white or almost white with a slight sheen, elongated in shape,
biconvex on both sides.

Blister pack made of PVC/PVDC/Aluminium in a cardboard box.
Pack sizes:
12 tablets – 1 blister containing 12 film-coated tablets;
24 tablets – 2 blisters each containing 12 film-coated tablets;
48 tablets – 4 blisters each containing 12 film-coated tablets.

HDPE polyethylene bottle in a cardboard box.
Pack size:
48 tablets – 1 bottle containing 48 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, Poland

For further information, please contact the representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa, Poland
Tel. +48 (22) 543 60 00

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland – IBUPROM FORTE
Bulgaria – IBUPROM MAX
Estonia – Ibuprofenum US Pharmacia
Latvia – Ibuprofenum US Pharmacia, 400 mg, apvalkotās tabletes
Romania – Ibuprofen US Pharmacia, 400 mg, comprimate filmate