IBUPROM RAPID

Package leaflet: Information for the user

IBUPROM RAPID, 200 mg, coated tablets
Ibuprofenum
Please read the entire 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
physician or pharmacist.

• Keep this leaflet, so that it can be read again if necessary.
• If advice or additional information is needed, please consult a pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, consult a physician.

Table of contents

1. What the medicine is and what it is used for
2. Important information before taking the medicine
3. How to use
4. Possible side effects
5. How to store
6. Contents of the pack 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 medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have
analgesic, antipyretic and anti-inflammatory properties.
This medicine is intended for use in the following conditions:

• Mild to moderate pain of various origins:
  • Headache, migraine with or without aura (accompanied by additional symptoms such as nausea, sensitivity to light and sound); tension-type headache;
  • Toothache;
  • Muscular, joint and bone pain;
  • Painful menstruation;
  • Neuralgia;
  • Pain associated with influenza and common cold.
• Fever of various origins (e.g. due to influenza, common cold or other infectious diseases).

2. Information before taking the medicine

When not to use the medicine
The medicine should not be used in patients:

• with hypersensitivity to ibuprofen or any of the other components of this medicine (listed in section 6);
• 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);
• with active or past history of gastric or duodenal ulcer (two or more confirmed episodes of ulceration or bleeding);
• with gastrointestinal perforation or bleeding in the past related to previous NSAID treatment;
• with severe hepatic insufficiency, severe renal insufficiency or severe heart failure;
• during the third trimester of pregnancy;
• with haemorrhagic diathesis.

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

• systemic lupus erythematosus or mixed connective tissue disease;
• allergic reactions after taking acetylsalicylic acid;
• 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;
• active or past history of bronchial asthma or previous allergic reactions; bronchospasm may occur after taking the medicine;
• diseases requiring concomitant use of other medicines (especially anticoagulants, diuretics, cardiac drugs, corticosteroids);
• if the patient needs to restrict dietary sodium intake.

Concomitant use of NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and may occur without warning symptoms. These may also occur in patients who have previously experienced warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be discontinued immediately. Patients with gastrointestinal disorders, especially elderly patients, should report any unusual gastrointestinal symptoms (particularly bleeding) to their doctor, especially during the initial treatment period.
Prolonged, concomitant use of various analgesics may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Particular caution should be exercised (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 oedema associated with previous NSAID use.
Use of anti-inflammatory and 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 breathing difficulties, facial and neck swelling (angioedema), and chest pain, have occurred during treatment. If any of these symptoms appear, discontinue the medicine immediately and contact a doctor or emergency medical services without delay.
If symptoms persist or worsen despite treatment, or new symptoms appear after 3 days, consult a doctor.
Before using the medicine, discuss treatment with a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (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 - TIA).
• the patient has hypertension, diabetes, elevated cholesterol levels, family history of heart disease or stroke, or is a smoker.
• the patient has an infection – see below, section titled "Infections".

Serious skin reactions, 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), have been reported with ibuprofen use. If any of the symptoms associated with these serious skin reactions described in section 4 occur, the medicine should be discontinued immediately and medical help sought.

Infections
The medicine may mask symptoms of infection such as fever and pain. This may delay appropriate treatment of the infection and consequently increase the 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 infection symptoms persist or worsen, consult a doctor immediately.

Use in elderly patients
In elderly patients, the risk of adverse effects associated with ibuprofen use is higher than in younger patients. The frequency and severity of adverse effects can be reduced by using the lowest therapeutic dose for the shortest possible duration.
Consult a doctor even if the above warnings refer to conditions that occurred in the past.

Children and adolescents
The medicine should not be given to children under 12 years of age without medical advice.
In dehydrated adolescents aged 12–18 years, there is a risk of impaired renal function.

Medicine and other medicines
Avoid using this medicine concomitantly with other NSAIDs (including cyclooxygenase-2 inhibitors such as celecoxib or etoricoxib), other analgesics, or acetylsalicylic acid (at analgesic doses).
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use, including those available without a prescription.
This medicine may affect the action of other medicines or other medicines may affect the action of this medicine. For example:

• Anticoagulant medicines (i.e. blood thinners or those preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• Medicines lowering blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan).

In particular, before taking ibuprofen, inform the doctor if any of the following medicines are being taken:

• 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).

Some other medicines may also be affected by or may affect treatment with this medicine. Therefore, always consult a doctor or pharmacist before using this medicine 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
Consult a doctor before taking any medicine.
Do not take the medicine if you are 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 problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. The medicine should not be used during the first 6 months of pregnancy 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, prolonged use of the medicine for more than a few days may lead to impaired renal function in the unborn child (which may result in low levels of amniotic fluid surrounding the baby – oligohydramnios), or narrowing of the 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 of the medicine at low doses.
Consult a doctor before using any medicine.

Effect on fertility
Medicines in this group (non-steroidal anti-inflammatory drugs) may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment. In case of difficulty conceiving, consult a doctor before taking ibuprofen.

Driving and operating machinery
There is no data available on the effect of the medicine on the ability to drive, operate machinery or psychomotor performance when used at recommended doses and for the recommended duration.

Contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine.

IBUPROM RAPID contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 1 tablet, meaning the medicine is considered "sodium-free".

IBUPROM RAPID contains sunset yellow, lake (E 110) and 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 patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for short-term use only.
The medicine is intended for oral use only, in adults and adolescents aged above 12 years.
The usual dosage is as follows:
Adults and adolescents over 12 years of age: Initial dose – 1 to 2 tablets, then if needed, 1 to 2 tablets every four hours. Swallow tablets with water. Do not take more than 6 tablets in 24 hours. There should be at least a four-hour interval between doses.
Elderly patients: In elderly patients, there is an increased risk of adverse effects. This risk can be minimized by using the lowest effective dose for the shortest possible duration.
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 your doctor immediately (see section 2).

Warning:
Do not exceed the recommended dose!
In case of overdose, consult your doctor.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
If symptoms persist or worsen, or if new symptoms occur, consult your doctor.
Use the lowest possible dose for the shortest possible time. This reduces the risk of adverse effects.
Do not take the medicine for longer than 3 days without medical advice.
For adolescents aged 12–18 years, consult a doctor if treatment is required for more than 3 days or if symptoms worsen.

Taking more than the recommended dose of the medicine
If a patient takes more than the recommended dose or if a child accidentally ingests the medicine, always consult a doctor or go to the nearest hospital to assess potential 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 nystagmus. Stimulation, drowsiness, disorientation, or coma may also occur. Seizures have been reported occasionally. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, 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 interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In asthmatic patients, asthma may be exacerbated. Hypotension and breathing difficulties may also occur.
There is no specific antidote. Treatment is symptomatic and supportive, aimed at maintaining vital functions until the drug is eliminated from the body. The doctor will monitor cardiac function and vital signs as long as they remain stable. The doctor may consider administering activated charcoal orally within 1 hour of overdose. In case of frequent or prolonged seizures, the doctor may administer diazepam or lorazepam intravenously. In patients with asthma, the doctor will administer bronchodilators.

Missed dose
Do not take a double dose to make up for a missed dose.
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 one may 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 sought:

• Red, flat, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, 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 fever, 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).

The 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 over a prolonged period, additional adverse reactions may occur.
Adverse reactions are listed according to frequency of occurrence.
Not common (may occur in up to 1 in 100 people):

• Dyspepsia, abdominal pain, nausea, headache, urticaria, various types of skin rashes, and itching.

Rare (may occur in up to 1 in 1,000 people):

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

Very rare (may occur in up to 1 in 10,000 people):

• Tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease;
• Decreased urine output, renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention);
• Liver function disorders, particularly during prolonged use;
• Blood count abnormalities (anemia, leukopenia – reduced number of white blood cells, thrombocytopenia – reduced number of platelets, pancytopenia – hematological disorder with deficiency of all normal blood cells: red cells, white cells, and platelets, agranulocytosis – absence of granulocytes, a type of white blood cell). Initial symptoms include fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, bleeding (e.g. bruising, petechiae, purpura, nosebleeds);
• Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis;
• Facial, tongue, and laryngeal swelling, shortness of breath;
• Tachycardia – increased heart rate, hypotension – sudden drop in blood pressure, shock;
• Aseptic meningitis;
• Heart failure, hypertension, edema;
• Asthma exacerbation and bronchospasm.

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

• Airway hyperreactivity, including asthma;
• Skin becomes light-sensitive;
• Chest pain, which may indicate a potentially serious allergic reaction called Kounis syndrome.

Treatment with NSAIDs at high doses has been associated with the occurrence of edema, hypertension, and heart failure. Use of such drugs may be linked with a small increased risk of myocardial infarction (heart attack) or stroke.
Other adverse reactions may occur in some individuals during treatment. If any of the symptoms listed above, or other symptoms not mentioned in this leaflet, are observed, the medicine should be discontinued and a doctor consulted.

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

5. How to store

No special storage conditions are required.
Keep the medicine out of the sight and reach of children.
Do not use the 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 what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information what it contains

• The active substance is ibuprofen – 1 coated tablet contains 200 mg of ibuprofen in the form of 256 mg of ibuprofen sodium dihydrate.
• Excipients: monohydrate lactose (200 M), sodium lauryl sulfate, crospovidone, povidone (K-30), colloidal hydrated silica, monohydrate lactose, talc, magnesium stearate, Coating (Opadry fx 64F580006): hypromellose 2910, monohydrate lactose, macrogol (E 1521), potassium-aluminum silicate (E 555) / titanium dioxide (E 171), talc, titanium dioxide (E 171), disodium citrate dihydrate. Ink 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 it looks like and what the packaging contains
White or almost white, round, biconvex coated tablets, smooth on one side and printed in grey with "IBUPROM" on the other side.
PVC/PVDC/Aluminum blisters in a cardboard box.
4 pcs – 1 blister containing 4 coated tablets.
6 pcs – 1 blister containing 6 coated tablets.
8 pcs – 1 blister containing 8 coated tablets.
10 pcs – 1 blister containing 10 coated tablets.
HDPE bottle with HDPE cap in a cardboard box.
50 coated tablets in a bottle.
96 coated tablets in a bottle.
Not all pack sizes may be marketed.

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