Ibuprom Rapid

Package Leaflet: Information for the User

IBUPROM RAPID, 200 mg, coated tablets

Ibuprofen

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package 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 Package 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 package and other information

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

contains 200 mg of ibuprofen in the form of ibuprofen sodium dihydrate. Ibuprofen belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs) with analgesic, antipyretic, and anti-inflammatory properties.
The medicine is intended for use in the following cases:

• Pains of various origins of mild to moderate severity:
• headaches, including migraines with or without aura (along with additional symptoms such as nausea, sensitivity to light and sound); tension headaches;
• toothaches;
• muscle, joint, and bone pains;
• painful menstruation;
• neuralgia;
• pains accompanying the flu and colds.
• Fever of various origins (including flu, colds, or other infectious diseases).

2. Important information before taking the medicine

When not to take the medicine

The medicine should not be taken by patients:

• with hypersensitivity to ibuprofen or any of the other ingredients of this medicine (listed in section 6);

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• who have ever had hypersensitivity reactions (e.g., hives, runny nose, angioedema, or bronchial asthma) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
• with active or history of peptic ulcer disease of the stomach and/or duodenum (two or more distinct episodes of confirmed ulceration or bleeding);
• with perforation or bleeding of the gastrointestinal tract in the past, associated with previous NSAID treatment;
• with severe liver failure, severe kidney failure, or severe heart failure;
• in the third trimester of pregnancy;
• with hemophilia.

Warnings and precautions

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

• systemic lupus erythematosus and mixed connective tissue disease;
• allergic reaction symptoms after taking acetylsalicylic acid;
• 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;
• active or history of bronchial asthma or allergic reaction symptoms in the past; taking the medicine may cause bronchospasm;
• diseases for which the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids);
• if the patient needs to limit sodium intake in their diet.

It is recommended to avoid taking the medicine simultaneously with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning signs; these can also occur in patients who have had warning signs. In case of gastrointestinal bleeding or ulceration, the medicine should be discontinued immediately. Patients with gastrointestinal diseases, especially the elderly, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, 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).
Particular caution is advised (the patient should consult a doctor or pharmacist) before using the medicinal product in patients with hypertension and/or heart failure with fluid retention, hypertension, and edema associated with NSAID use in their history.
Taking anti-inflammatory and analgesic medicines, such as ibuprofen, may be associated with a small increased 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 longer than recommended.
During ibuprofen treatment, allergic reactions to this medicine have occurred, including difficulty breathing, swelling of the face and neck (angioedema), chest pain.
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In case of any of these symptoms, the medicine should be discontinued immediately, and medical help should be sought.
If, despite taking the medicine, symptoms persist or worsen, or new symptoms appear, the patient should consult a doctor.
Before taking the medicine, the patient should discuss their treatment with a 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 - TIA).
• the patient has hypertension, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes.
• the patient has an infection - see below, the section titled "Infections".

In connection with 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 associated with these severe skin reactions described in section 4, they should discontinue the medicine and seek medical help.

Infections

may mask the symptoms of infection, such as fever and pain. This may delay the use of appropriate infection treatment and lead to 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 infection symptoms persist or worsen, they should consult their doctor immediately.
Medicines in this group (nonsteroidal anti-inflammatory drugs) may adversely affect female fertility. This effect is temporary and reverses after treatment is stopped. In case of difficulty conceiving, the patient should consult their doctor before taking ibuprofen.

Use in the elderly

In elderly patients, there is an increased risk of adverse reactions associated with ibuprofen use compared to younger patients. The frequency and severity of adverse reactions can be reduced by using the smallest effective dose for the shortest possible duration.
The patient should consult their doctor, even if the above warnings refer to past situations.

Children and adolescents

The medicine is not indicated for children under 12 years of age.
In dehydrated patients - adolescents aged 12-18 years, there is a risk of kidney function disorders.

Interactions with other medicines

The medicine should be avoided in case of concomitant use of other nonsteroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors, such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (in analgesic doses).
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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, even those available without a prescription.
The medicine may affect the action of other medicines or other medicines may affect the action of the medicine. For example:

• Anticoagulant medicines (i.e., blood thinners or medicines that prevent blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• Medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

In particular, before taking ibuprofen, the patient should inform their doctor about taking any of the following medicines:

• Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs);
• Cardiac glycosides;
• Lithium and methotrexate;
• Cyclosporine;
• Mifepristone;
• Tacrolimus;
• Zidovudine;
• Quinolone antibiotics;
• Diuretics;
• Corticosteroids (such as prednisolone or dexamethasone).

Also, some other medicines may be affected or have an effect on the treatment with the medicine. Therefore, before taking the medicine 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
Before taking any medicine, the patient should consult their doctor.
The medicine should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery.
The medicine may cause kidney and heart disorders in the unborn child. It may also increase the risk of bleeding in the mother and child and prolong or delay labor. During 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 smallest 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 function disorders in the unborn child (which may lead to low amniotic fluid levels around the baby) 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 may pass into breast milk in small amounts. There are no known cases of adverse reactions in breastfed infants; therefore, there is no need to stop breastfeeding during short-term use of the medicine in small doses.
Before taking any medicine, the patient should consult their doctor.
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Fertility
See the section "Warnings and precautions".

Driving and using machines

There are no data on the effect of the medicine on the ability to drive vehicles, operate machinery, and mental performance during treatment with the recommended doses and duration.
Contains:
Lactose
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".
Orange yellow, lake (E 110), Allura red AC, lake (E 129)
The medicine may cause allergic reactions.

3. How to take the medicine

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is for short-term use only.
The medicine is intended for oral use only, in adults and adolescents over 12 years of age.
Usually, the following dosing is used:
Adults and adolescents over 12 years of age:initial dose - 1 to 2 tablets, then if necessary 1 to 2 tablets every 4 hours. Tablets should be taken with water. No more than 6 tablets should be taken in 24 hours. At least a 4-hour interval should be maintained between doses.
Elderly patients:in elderly patients, there is a higher risk of adverse reactions. These can be minimized by using the smallest effective dose for the shortest possible duration.
The patient should use the smallest effective dose for the shortest possible duration to relieve symptoms. If, during an infection, the symptoms (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).

Warning:

The recommended dose should not be exceeded!
In case of overdose, the patient should consult their doctor.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.
If symptoms persist or worsen, or new symptoms appear, the patient should consult their doctor.
The patient should use the smallest possible dose for the shortest possible duration. This reduces the risk of adverse reactions.
The medicine should not be taken for more than 3 days without a doctor's recommendation.
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In case of adolescents aged 12-18 years, the patient should consult their doctor if the medicine needs to be taken for more than 3 days or if symptoms worsen.

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 actions to take.
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 dizziness. There may also be agitation, drowsiness, disorientation, or coma. Rarely, patients may 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. 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 difficulty breathing 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 heart function and control vital signs if they are stable. The doctor may consider administering activated charcoal orally within 1 hour of overdose. In case of frequent or prolonged seizures, the doctor will administer diazepam or lorazepam intravenously. In case of asthma, the doctor will administer bronchodilators.

Missing a dose of the medicine

A double dose should not be taken to make up for a missed dose.
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, the medicine 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 help:

• Red, non-raised, target-like, or round 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 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, peeling rash with bumps under the skin and blisters, with 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 ibuprofen is used for other indications and long-term, other side effects may occur.
Side effects are listed according to their frequency of occurrence.
Uncommon(may occur in less than 1 in 100 people):

• Indigestion, stomach pain, nausea, headaches, hives, various skin rashes, and itching.

Rare(may occur in less than 1 in 1,000 people):

• Diarrhea, bloating, constipation, vomiting, gastritis;
• Psychotic disorders, depression, tinnitus;
• Dizziness, insomnia, agitation, irritability, and fatigue.

Very rare(may occur in less than 1 in 10,000 people):

• Black stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease;
• Reduced urine output, kidney failure, renal papillary necrosis, increased sodium levels in the blood (sodium retention);
• Liver function disorders, especially during long-term use;
• Blood count disorders (anemia, leukopenia - decreased white blood cell count, thrombocytopenia - decreased platelet count, pancytopenia - a blood disorder characterized by a deficiency of all normal blood cells: red, white, and platelets, agranulocytosis - absence of a certain type of white blood cell - granulocytes). The first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, fatigue, bleeding (e.g., bruising, petechiae, purpura, nosebleeds);
• Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis;
• Facial edema, tongue and throat edema, dyspnea;
• Tachycardia - accelerated heart rate, hypotension - sudden decrease in blood pressure, shock;
• Aseptic meningitis;
• Heart failure, hypertension, edema;
• Exacerbation of asthma and bronchospasm.

Frequency not known(frequency cannot be estimated from the available data):

• Hyperreactivity of the airways, including asthma;
• Skin becomes sensitive to light;
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

In connection with the use of NSAIDs in high doses, edema, hypertension, and heart failure have been reported. Taking such medicines as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
In some individuals, during the use of the medicine, other side effects may occur. In case of the above symptoms, as well as any other, not listed in this package leaflet, the medicine should be discontinued, and the patient should consult their doctor.

Reporting side effects

If side effects occur, including any possible side effects not listed in this package leaflet, the patient should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

There are no special precautions for storage.
The medicine should be stored out of sight and reach of children.
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 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. Contents of the package and other information

• The active substance of the medicine is ibuprofen - 1 coated tablet contains 200 mg of ibuprofen in the form of 256 mg of ibuprofen sodium dihydrate.
• Excipients are: lactose monohydrate (200 M), sodium lauryl sulfate, crospovidone, povidone (K-30), silica, colloidal anhydrous, lactose monohydrate, talc, magnesium stearate, Coating (Opadry fx 64F580006): hypromellose 2910, lactose monohydrate, macrogol (E1521), potassium aluminum silicate (E 555) / titanium dioxide (E 171), talc, titanium dioxide (E171), sodium citrate. Tusz Opacode Monogramming Ink S-1-175005 Grey: shellac, isopropyl alcohol, titanium dioxide (E 171), indigo carmine, lake (E 132), orange yellow, lake (E 110), Allura red AC, lake (E 129), propylene glycol (E 1520), n-butyl alcohol, ammonium hydroxide.

What the package contains and what it looks like

White or almost white, biconvex, coated tablets, round in shape, smooth on one side and with a gray imprint IBUPROM on the other side.
PVC/PVDC/Aluminum blisters in a carton box.
4 pieces - 1 blister of 4 coated tablets.
6 pieces - 1 blister of 6 coated tablets.
8 pieces - 1 blister of 8 coated tablets.
10 pieces - 1 blister of 10 coated tablets.
HDPE bottle with HDPE cap in a carton box.
50 coated tablets in a bottle.
96 coated tablets in a bottle.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
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To obtain more detailed information about this medicine, 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

Date of the last revision of the package leaflet:

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