Ibuprom sprint capsules

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IBUPROM® Sprint Caps

Composition:

Active ingredient: ibuprofen;

1 soft capsule contains 200 mg of ibuprofen;

Excipients: polyethylene glycol 600, potassium hydroxide, purified water, gelatin, partially dehydrated sorbitol solution, patent blue V (E 131).

Pharmaceutical form. Soft capsules.

Main physicochemical properties: oval soft capsules with transparent blue shell; capsule contents – a clear oily liquid ranging from colorless to slightly bluish.

Pharmacotherapeutic group.

Non-steroidal anti-inflammatory and antirheumatic drugs. Propionic acid derivatives.

ATC code M01AE01.

Pharmacological Properties.

Pharmacodynamics.

Ibuprofen exerts analgesic, antipyretic, and anti-inflammatory effects. Its mechanism of action is based on inhibition of prostaglandin synthesis—mediators of pain, inflammation, and temperature response.

Experimental data indicate that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when these drugs are used concomitantly. Some pharmacodynamic studies have shown that administration of single doses of 400 mg ibuprofen within 8 hours before or within 30 minutes after immediate-release acetylsalicylic acid (81 mg) resulted in reduced effect of aspirin (acetylsalicylic acid) on thromboxane formation or platelet aggregation. Although uncertainty exists regarding extrapolation of these data to clinical settings, it cannot be excluded that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. With occasional use of ibuprofen, such a clinically significant effect is considered unlikely.

Pharmacokinetics.

After oral administration, ibuprofen is rapidly absorbed from the gastrointestinal tract. Maximum plasma concentration of the active substance is reached within 1–2 hours after intake. Ibuprofen is metabolized in the liver and excreted by the kidneys (90%) unchanged and as metabolites, as well as in bile. The elimination half-life in healthy individuals is approximately 1.8 hours; in patients with hepatic or renal impairment, it ranges from 1.8 to 3.5 hours. Ibuprofen is highly bound (99%) to plasma proteins and slowly penetrates into synovial fluid, where its concentration may remain high even as plasma concentration decreases.

Clinical characteristics.

Indications.

Symptomatic treatment of headache, dental pain, and menstrual pain. Fever and muscle pain associated with common cold.

Contraindications.

• Hypersensitivity to ibuprofen or to any of the excipients of the medicinal product.
• Patients with a history of bronchospasm, asthma, rhinitis, angioedema, or skin rash associated with the use of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• Concomitant use of IBUPROM Sprint Caps with other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided.
• Active or history of peptic ulcer or gastrointestinal bleeding (two or more distinct episodes of ulceration or bleeding in the past).
• Patients with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy.
• Patients with severe renal, cardiac (NYHA class IV), or hepatic impairment.
• Children with body weight less than 20 kg.
• Patients with cerebrovascular or other active bleeding disorders.
• Patients with dehydration caused by vomiting, diarrhea, or insufficient fluid intake.
• Third trimester of pregnancy.

Interaction with other medicinal products and other forms of interaction.

Ibuprofen (like other NSAIDs) should be used with caution when administered concomitantly with the following medicinal products:

• Other NSAIDs, including salicylates: increased risk of gastrointestinal ulcers and bleeding;
• Digoxin: increased plasma levels of both drugs;
• Corticosteroids: increased risk of gastrointestinal bleeding or ulceration;
• Antithrombotic agents: increased risk of gastrointestinal bleeding;
• Anticoagulants: NSAIDs may enhance the effect of anticoagulants, such as warfarin;
• Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): may increase the risk of gastrointestinal bleeding;
• Acetylsalicylic acid or other NSAIDs and glucocorticosteroids: may increase the risk of adverse gastrointestinal effects associated with these medicinal products.

Experimental data indicate that concomitant use of ibuprofen may inhibit the effect of low-dose acetylsalicylic acid (aspirin) on platelet aggregation. However, uncertainty regarding the possibility of extrapolating these data to clinical settings does not allow definitive conclusions that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. With occasional use of ibuprofen, such clinically significant effects are considered unlikely;

• Antihypertensive and diuretic agents: NSAIDs may reduce the therapeutic effect of these drugs; in patients with impaired renal function, concomitant use of angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, angiotensin II receptor antagonists, and cyclooxygenase inhibitors may lead to further deterioration of renal function. Therefore, such combinations should be used with caution, especially in elderly patients;
• Lithium and methotrexate: evidence suggests a potential increase in plasma levels of lithium and methotrexate;
• Potassium-sparing diuretics: may lead to hyperkalemia (plasma potassium levels should be monitored);
• Cyclosporine and tacrolimus: increased risk of nephrotoxicity;
• Zidovudine: evidence suggests an increased risk of hemarthrosis and hematoma in HIV-infected patients receiving concomitant treatment with zidovudine and ibuprofen;
• Sulfonylureas: blood glucose levels should be monitored;
• Quinolone antibiotics: risk of convulsions may occur;
• Inhibitors of cytochrome CYP2C9, such as voriconazole or fluconazole, may potentiate the effect of ibuprofen.

Special precautions for use.

Adverse effects can be minimized by using the lowest effective dose required to treat symptoms for the shortest possible duration.

The drug should be used with caution in patients with:

• systemic lupus erythematosus and systemic connective tissue disorders;
• congenital porphyrin metabolism disorders (e.g., acute intermittent porphyria);
• history of arterial hypertension and/or heart failure associated with fluid retention and edema during NSAID therapy;
• impaired renal and/or hepatic function;
• recent postoperative status.

Elderly patients have an increased risk of adverse reactions when using NSAIDs, particularly gastrointestinal bleeding and perforation, which may be fatal.

Gastrointestinal bleeding, ulceration, or perforation, which may be fatal, have been reported with all NSAIDs, regardless of treatment duration, both with and without serious gastrointestinal complications in medical history.

Higher NSAID doses, advanced age, and history of peptic ulcer disease increase the risk of gastrointestinal adverse reactions. The lowest effective doses are recommended during treatment in such cases.

Concomitant use of protective agents (e.g., misoprostol or proton pump inhibitors) should be considered, especially in patients requiring long-term low-dose acetylsalicylic acid or other medications that may increase the risk of gastrointestinal adverse effects.

Patients who have experienced gastrointestinal disturbances, particularly elderly individuals, should discontinue treatment and consult a physician if any adverse symptoms occur (especially gastrointestinal bleeding).

The drug should be used with caution in patients receiving concomitant therapy with medications that may increase the risk of peptic ulceration or bleeding, including oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents such as acetylsalicylic acid.

NSAIDs should be used cautiously in patients with a history of ulcerative colitis or Crohn’s disease, as their condition may worsen.

Clinical data indicate that ibuprofen use, especially at high doses (2400 mg per day), may be associated with a small increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). Overall, epidemiological data do not suggest that low-dose ibuprofen (e.g., ≤ 1200 mg per day) is associated with an increased risk of arterial thrombotic complications.

Ibuprofen should be prescribed only after careful clinical assessment in patients with uncontrolled hypertension, congestive heart failure (NYHA class II–III), diagnosed ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. High doses (2400 mg per day) should be avoided.

A careful clinical assessment is also required before initiating long-term treatment in patients with cardiovascular risk factors (such as hypertension, hyperlipidemia, diabetes, smoking), especially if high-dose ibuprofen (2400 mg per day) is required.

Cardiovascular and cerebrovascular effects.

Cases of Kounis syndrome have been reported in patients receiving ibuprofen therapy. Kounis syndrome is defined as cardiovascular symptoms caused by an allergic or hypersensitivity reaction associated with coronary artery spasm, which may potentially lead to myocardial infarction.

Serious skin adverse reactions (SSARs)

Serious skin adverse reactions (SSARs), including exfoliative dermatitis, erythema multiforme, Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), which may be life-threatening or fatal, have been reported during ibuprofen use (see section "Adverse reactions"). Most such reactions occurred within the first month of treatment.

If signs or symptoms suggesting these reactions occur, ibuprofen should be discontinued immediately and alternative treatment options considered (if necessary).

Masking symptoms of underlying infections: Ibuprom Sprint Caps may mask symptoms of infectious diseases, potentially delaying appropriate treatment and thereby complicating disease progression. This has been observed in community-acquired bacterial pneumonia and bacterial complications of varicella. When Ibuprom Sprint Caps are used for fever or pain relief associated with infection, monitoring of the infectious condition is recommended. In outpatient settings, patients should consult a physician if symptoms persist or worsen.

Bronchospasm may occur in patients with or with a history of bronchial asthma or allergic diseases.

Prolonged use of analgesics at high doses may lead to headache that cannot be relieved by increasing the drug dose.

Long-term and uncontrolled use of analgesics, especially combinations of different analgesic active substances, may lead to chronic kidney damage with risk of renal failure (analgesic nephropathy).

There is some evidence that drugs inhibiting cyclooxygenase/prostaglandin synthesis may impair female fertility by affecting ovulation. This effect may be reversible upon discontinuation of these drugs.

Ibuprofen may temporarily inhibit platelet function/aggregation. Therefore, special monitoring is recommended in patients with coagulation disorders.

If prolonged treatment is required, regular monitoring of liver and kidney function and blood cell counts is necessary.

The use of this drug should be avoided in cases of varicella.

Alcohol consumption after NSAID use may enhance adverse effects, particularly those affecting the gastrointestinal tract or central nervous system.

There is a risk of renal failure in dehydrated children and adolescents.

Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency should not take this drug.

Use during pregnancy or breastfeeding.

Pregnancy.

Prostaglandin synthesis inhibitors may adversely affect pregnant women and/or embryonic/fetal development. Epidemiological data suggest an increased risk of miscarriage and congenital heart defects following use of prostaglandin synthesis inhibitors in early pregnancy. The risk is believed to increase with higher doses and longer duration of treatment.

NSAIDs should not be used from the 20th to the 28th week of pregnancy without medical prescription.

From the 20th week of pregnancy, ibuprofen use may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. Additionally, cases of arterial duct constriction have been reported after second-trimester treatment, most of which resolved after treatment cessation. Therefore, ibuprofen should not be prescribed during the first and second trimesters unless clearly necessary. Fetal monitoring for oligohydramnios and arterial duct constriction should be considered after several days of ibuprofen exposure starting from the 20th gestational week. If ibuprofen is used in women attempting conception or during the first and second trimesters, the dose should be as low as possible and treatment duration as short as possible. Ultrasound monitoring of amniotic fluid levels should be considered if treatment exceeds 48 hours.

During the third trimester, all prostaglandin synthesis inhibitors may pose risks:

for the fetus:

• cardiopulmonary toxicity (premature constriction/closure of the arterial duct and pulmonary hypertension);
• renal dysfunction (see above);

for the mother at the end of pregnancy and for the newborn:

• possible prolongation of bleeding time, antiaggregatory effect, which may occur even at very low doses;
• inhibition of uterine contractions, leading to delayed or prolonged labor.

Ibuprofen is contraindicated during the third trimester of pregnancy.

Lactation period.

Ibuprofen and its metabolites may pass into breast milk in low concentrations. To date, no harmful effects on infants have been reported; therefore, breastfeeding need not usually be discontinued during short-term treatment of pain and fever at recommended doses.

Ability to influence reaction speed when driving or operating machinery.

Ibuprom Sprint Caps do not affect or have minimal effect on the ability to drive or operate machinery when used short-term. However, prolonged use may cause adverse effects such as increased fatigue and dizziness.

Administration and Dosage

For oral use, intended for short-term use only.

Adults and children with body weight ≥ 40 kg: The recommended initial dose is 1–2 capsules, followed, if necessary, by 1–2 capsules (200–400 mg of ibuprofen) every 4–6 hours. Do not exceed 6 capsules (1200 mg) within 24 hours.

Children with body weight ≤ 39 kg: The drug may be administered to children with body weight above 20 kg (approximately 6 years of age). The maximum daily dose of ibuprofen is 20–30 mg per kilogram of body weight, divided into 3–4 doses, administered at intervals of 6–8 hours. Do not exceed the maximum recommended daily dose.

Children with body weight 20–29 kg: The recommended initial dose is 1 capsule (equivalent to 200 mg of ibuprofen). The maximum daily dose is 3 capsules (equivalent to 600 mg of ibuprofen).

Children with body weight 30–39 kg: The recommended initial dose is 1 capsule (equivalent to 200 mg of ibuprofen). The maximum daily dose is 4 capsules (equivalent to 800 mg of ibuprofen).

Capsules should generally be taken with food, without chewing, and swallowed with water.

Elderly patients do not require special dose adjustment.

The lowest effective dose required to relieve symptoms should be used for the shortest possible duration (see section "Special Warnings and Precautions for Use").

If symptoms persist for more than 3 days when used for treatment of illness, or more than 4 days when used for pain relief, consult a physician for diagnosis clarification and treatment adjustment.

Children

Do not administer to children with body weight less than 20 kg (approximately 6 years of age).

Overdose

In acute overdose, symptoms depend on the amount ingested and the time elapsed since ingestion. Initial symptoms commonly observed include nausea, vomiting, headache, dizziness, epigastric pain, and drowsiness. In cases of overdose, coma, arterial hypotension, hyperkalemia with cardiac rhythm disturbances, metabolic acidosis, elevated body temperature, respiratory depression, and impaired kidney function may occur. After prolonged use, hemolytic anemia, granulocytopenia, and thrombocytopenia may occasionally be observed.

Prolonged use at doses exceeding the recommended levels or overdose may lead to renal tubular acidosis and hypokalemia.

If less than 1 hour has passed after acute overdose, induction of vomiting, gastric lavage, or administration of activated charcoal is recommended.

There is no specific antidote or specific treatment for ibuprofen overdose. Symptomatic treatment should include monitoring of vital functions, measurement of blood pressure, ECG monitoring, and assessment of symptoms indicating possible gastrointestinal bleeding, metabolic acidosis, or central nervous system disturbances.

Adverse Reactions

Below is a list of adverse reactions observed in individuals using ibuprofen for short-term treatment of mild to moderate pain and fever, as well as those reported during long-term, high-dose therapy in patients with rheumatic diseases.

Clinical trial data indicate that the use of ibuprofen, particularly at high doses (2400 mg per day), may be associated with a slightly increased risk of arterial thrombotic complications (e.g., myocardial infarction or stroke).

The frequency of adverse effects is categorized as follows:

Very common: >1/10
Common: >1/100, <1/10
Uncommon: >1/1000, <1/100
Rare: >1/10,000, <1/1000
Very rare: <1/10,000, including isolated case reports

General disorders
Uncommon: hypersensitivity reactions such as urticaria and pruritus, increased sweating
Very rare: severe hypersensitivity reactions including facial, tongue, and laryngeal edema, dyspnea, tachycardia, hypotension, anaphylactoid reactions (anaphylaxis, Quincke's edema up to shock). Asthma exacerbation, bronchospasm or dyspnea, allergic rhinitis, eosinophilia

Sensory organs
Rare: disturbances of hearing (hearing loss, tinnitus or ear noise)
Uncommon: visual disturbances (toxic optic neuropathy, blurred vision or diplopia, scotoma, dryness and irritation of eyes, allergic-type conjunctival and eyelid edema)

Gastrointestinal disorders
Uncommon: abdominal pain, melena, hematemesis, dyspepsia, nausea
Rare: diarrhea, flatulence, constipation, vomiting
Very rare: heartburn, ulcerative stomatitis, gastritis, gastrointestinal perforation or hemorrhage, which in some cases may lead to fatal outcomes, especially in elderly patients. Exacerbation of ulcerative colitis and Crohn's disease, esophagitis, formation of intestinal diaphragm-like strictures. Irritation or dryness of oral mucosa, gingival mucosal ulcers, aphthous stomatitis, pancreatitis

Neurological disorders
Uncommon: headache, dizziness, insomnia, anxiety, depression, nervousness and irritability, psychomotor agitation, somnolence, confusion, hallucinations
Rare: aseptic meningitis (more frequently in patients with autoimmune disorders)

Cardiovascular system
Very rare: heart failure, tachycardia, increased blood pressure, vasculitis, myocardial infarction
Frequency not known: Kounis syndrome

Urinary system
Very rare: reduced urea excretion and edema. Acute renal failure, allergic nephritis, glomerulonephritis, oliguria, polyuria, cystitis, hematuria. Papillary necrosis, particularly with prolonged use. Increased serum urea levels

Hepatobiliary system
Very rare: liver function abnormalities, particularly with long-term use. Hepatitis, pancreatitis, duodenitis, esophagitis

Blood and lymphatic system
Very rare: blood formation disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include: high fever, sore throat, oral ulcers, flu-like symptoms, severe fatigue, unexplained bleeding and bruising

Skin and subcutaneous tissue
Very rare: severe skin adverse reactions (SSARs) (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis)
Frequency not known: drug-induced eosinophilia with systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP), photosensitivity reactions

Immune system
Uncommon: in patients with autoimmune disorders (systemic lupus erythematosus, connective tissue diseases), isolated cases of aseptic meningitis symptoms have been observed during ibuprofen therapy (nuchal rigidity, headache, nausea, vomiting, high fever, or disorientation). Allergic reactions such as skin rash, pruritus, bronchial asthma attack, hypotension

Infections and parasitic diseases
Very rare: exacerbation of infection-related inflammation

Laboratory investigations
Rare: decreased hemoglobin levels

Shelf life
3 years

Storage conditions
Store out of reach of children at a temperature not exceeding 25 °C

Packaging
6, 10, or 12 capsules in a blister, 1 blister per cardboard box; 12 capsules in a blister, 2 blisters per cardboard box; 10 capsules in a blister, 3 blisters per cardboard box

Prescription status
Over-the-counter (without prescription)

Manufacturer
TOV US Farmacja, Poland / US Pharmacia Sp. z o.o., Poland

Manufacturer's address
Ul. Ziebicka 40, 50-507 Wroclaw, Poland

Marketing Authorization Holder
Unilab, LP, USA

Address of Marketing Authorization Holder and/or its representative
966 Hungerford Drive, Suite 3B, Rockville, MD 20850, USA