Ibuprom sprint max

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IBUPROM® SPRINT MAX

Composition:

Active ingredient: ibuprofen.

One soft capsule contains 400 mg of ibuprofen;

Excipients: polyethylene glycol 600, potassium hydroxide, purified water;

Capsule shell: gelatin, sorbitol (E 420), purified water.

Pharmaceutical form. Soft capsules.

Main physicochemical characteristics: transparent, oval, soft gelatin capsules of pale yellow color.

Pharmacotherapeutic group.

Non-steroidal anti-inflammatory and antirheumatic agents. Propionic acid derivatives. Ibuprofen.

ATC code M01AE01.

Pharmacological Properties

Pharmacodynamics

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID), a derivative of propionic acid, which has demonstrated efficacy in inhibiting the synthesis of prostaglandins—mediators of pain and inflammation. Ibuprofen exerts analgesic, antipyretic, and anti-inflammatory effects. In addition, ibuprofen reversibly inhibits platelet aggregation.

Experimental data indicate that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when both agents are administered concomitantly. Some pharmacodynamic studies have shown that administration of single doses of ibuprofen 400 mg within 8 hours before or within 30 minutes after immediate-release acetylsalicylic acid (81 mg) was associated with reduced effects of acetylsalicylic acid (aspirin) on thromboxane formation or platelet aggregation. Although uncertainty remains regarding the extrapolation of these data to clinical settings, the possibility cannot be excluded that regular long-term use of ibuprofen may diminish the cardioprotective effect of low-dose acetylsalicylic acid. With occasional, non-systematic use of ibuprofen, such a clinically significant interaction is considered unlikely.

Inside the Ibuprom Sprint MAX soft capsules, ibuprofen is dissolved in a hydrophilic solvent. After oral administration, the gelatin capsule disintegrates under the action of gastric juice, thereby releasing pre-dissolved ibuprofen.

Pharmacokinetics

After oral administration, ibuprofen is rapidly absorbed, partially already in the stomach and completely in the small intestine. Following hepatic metabolism (hydroxylation, carboxylation, conjugation), pharmacologically inactive metabolites are excreted predominantly in urine (90%) and also in bile. The elimination half-life in healthy volunteers, as well as in patients with hepatic or renal disease, ranges from 1.8 to 3.5 hours. Plasma protein binding is approximately 99%. After oral administration of conventional-release dosage forms, maximum plasma concentration is reached within 1–2 hours. Peak plasma levels following oral intake with food are achieved within 1–2 hours.

In a pharmacokinetic study, the time to peak plasma concentration (Tmax) on an empty stomach was 90 minutes for the tablet formulation and 40 minutes for soft capsules. Thus, the analgesic effect of Ibuprom Sprint MAX soft capsules occurs twice as fast as that of ibuprofen tablets. Ibuprofen remains detectable in plasma for up to 8 hours after administration of Ibuprom Sprint MAX soft capsules.

Clinical characteristics.

Indications.

Symptomatic treatment of mild to moderate pain of various origins (headache, toothache, dysmenorrhea), including pain associated with colds and fever.

Contraindications.

• Hypersensitivity to ibuprofen or to any component of the medicinal product.

• Hypersensitivity reactions (e.g., bronchial asthma, rhinitis, angioedema, or urticaria) previously observed after taking ibuprofen, acetylsalicylic acid (aspirin), or other NSAIDs.

• Active peptic ulcer disease/gastrointestinal bleeding or history of recurrent episodes (two or more documented episodes of peptic ulcer or bleeding).

• History of gastrointestinal bleeding or perforation related to previous NSAID therapy.

• Severe impairment of liver function, renal function, or heart failure (NYHA class IV).

• Third trimester of pregnancy.

• Active cerebrovascular or other bleeding disorders.

• Hemorrhagic diathesis or coagulation disorders.

• Unexplained disturbances of blood formation.

• Severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

Interaction with other medicinal products and other forms of interaction.

Ibuprofen, like other NSAIDs, should not be used in combination with:

• acetylsalicylic acid (aspirin), as this may increase the risk of adverse reactions, except when aspirin (at a dose not exceeding 75 mg per day) has been prescribed by a physician.

Experimental data indicate that concomitant administration of ibuprofen may inhibit the effect of low-dose acetylsalicylic acid (aspirin) on platelet aggregation. However, limitations regarding extrapolation of these data to clinical settings do not allow definitive conclusions about whether regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. Clinically significant effects are considered unlikely with occasional use of ibuprofen.

• other NSAIDs, including selective cyclooxygenase-2 inhibitors:

Concomitant use of multiple NSAIDs may increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect. Therefore, combination therapy with ibuprofen and other NSAIDs should be avoided.

Ibuprofen should be used with caution in combination with the following medicinal products:

anticoagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin.

antihypertensive agents (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may attenuate the effects of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g., dehydrated patients or elderly patients with compromised renal function), concomitant use of ACE inhibitors or angiotensin II antagonists with cyclooxygenase-inhibiting agents may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, such combinations should be prescribed with caution, especially in elderly patients. If prolonged treatment is necessary, adequate hydration of the patient should be ensured, and monitoring of renal function should be considered at the start of combination therapy and periodically thereafter. Diuretics may increase the risk of nephrotoxic effects of NSAIDs.

Concomitant use of ibuprofen and potassium-sparing diuretics may lead to hyperkalemia (serum potassium monitoring is recommended).

corticosteroids: increased risk of gastrointestinal ulceration and bleeding.

antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.

cardiac glycosides: NSAIDs may exacerbate cardiac dysfunction, reduce glomerular filtration rate, and increase plasma levels of glycosides.

lithium: evidence suggests a potential increase in plasma lithium levels.

methotrexate: administration of ibuprofen within 24 hours before or after methotrexate administration may lead to increased methotrexate concentrations and enhanced toxicity.

cyclosporine: increased risk of nephrotoxicity.

mifepristone: NSAIDs should not be used earlier than 8–12 days after administration of mifepristone, as they may reduce its efficacy.

tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are used concomitantly with tacrolimus.

zidovudine: increased risk of hematological toxicity when zidovudine is used concomitantly with NSAIDs. Evidence suggests an increased risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia receiving concomitant treatment with zidovudine and ibuprofen.

quinolone antibiotics: concomitant use with ibuprofen may increase the risk of seizures.

sulfonylureas: blood glucose levels should be monitored as a precautionary measure during concomitant use.

probenecid and sulfinpyrazone: may delay the elimination of ibuprofen.

Special precautions for use.

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

Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforations, which can be fatal.

Respiratory effects.

Bronchospasm may occur in patients suffering from bronchial asthma or allergic diseases, or with a history of these conditions.

Other NSAIDs.

Concomitant use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided, as this increases the risk of adverse reactions.

Systemic lupus erythematosus and mixed connective tissue disease.

Ibuprofen should be used with caution in patients with systemic lupus erythematosus and mixed connective tissue disease due to an increased risk of aseptic meningitis.

Porphyrin metabolism.

Caution should be exercised in patients with inherited disorders of porphyrin metabolism (e.g., acute intermittent porphyria).

Effects on the cardiovascular and cerebrovascular systems.

Patients with a history of arterial hypertension and/or heart failure should begin treatment with caution (medical consultation is required), as fluid retention, arterial hypertension, and edema have been reported during therapy with ibuprofen, as with other NSAIDs.

Clinical trial data and epidemiological evidence suggest that the use of ibuprofen, particularly at high doses (2400 mg per day), may be associated with a slightly 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) increases the risk of arterial thrombotic complications.

Patients with uncontrolled arterial hypertension, congestive heart failure (NYHA class II–III), diagnosed ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should be treated with ibuprofen only after careful assessment of their clinical condition. High doses (2400 mg per day) should be avoided.

A careful clinical evaluation should also be performed before initiating long-term treatment in patients with risk factors for cardiovascular complications (e.g., arterial hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2400 mg per day) are required.

Cases of Kounis syndrome have been reported in patients treated with Ibuprom Sprint MAX. 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.

Effects on the kidneys.

Risk of renal impairment due to worsening kidney function.

Effects on the liver.

Liver function disturbances may occur.

Surgical procedures.

Caution should be exercised immediately after major surgical procedures.

Effects on female fertility.

Limited data suggest that medicinal products that inhibit cyclooxygenase/prostaglandin synthesis may affect ovulation. This effect is reversible upon discontinuation of treatment.

Effects on the gastrointestinal tract.

NSAIDs should be used with caution in patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn’s disease), as their condition may worsen.

Cases of gastrointestinal bleeding, perforation, and ulcers, which may be fatal, have been reported during NSAID therapy at any stage of treatment, regardless of the presence of warning symptoms or a history of severe gastrointestinal disorders.

The risk of gastrointestinal bleeding, perforation, or ulcers increases with higher NSAID doses, in patients with a history of peptic ulcer disease, especially if complicated by bleeding or perforation, and in elderly patients. These patients should start treatment with the lowest doses. For such patients, as well as for those requiring concomitant use of low-dose acetylsalicylic acid or other drugs that may increase gastrointestinal risk, the need for combination therapy with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered.

Patients with a history of gastrointestinal toxicity, particularly elderly patients, should be informed about any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly at the beginning of treatment.

Caution should be exercised when treating patients who are concurrently using drugs that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents (e.g., aspirin).

In the event of gastrointestinal bleeding or ulcers in patients receiving ibuprofen, treatment should be discontinued immediately.

Severe cutaneous adverse reactions (SCARs)

Severe cutaneous adverse reactions (SCARs), 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 of these reactions occurred within the first month of treatment.

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

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

The use of ibuprofen in cases of varicella is not recommended.

Allergy.

Caution should be exercised in patients with allergic reactions to other substances, as such patients also have an increased risk of hypersensitivity reactions when using ibuprofen.

Patients with hay fever, nasal polyps, chronic obstructive respiratory diseases, or a history of allergic conditions have an increased risk of allergic reactions, which may manifest as asthma attacks (so-called analgesic-induced asthma), angioedema (Quincke’s edema), or urticaria.

This medicinal product contains sorbitol. It is not recommended for patients with hereditary fructose intolerance.

Other.

Severe acute hypersensitivity reactions (e.g., anaphylactic shock) are very rare. If the first signs of a hypersensitivity reaction occur after taking Ibuprom Sprint MAX, treatment must be discontinued. Symptomatic and specialized therapy should be initiated in such cases.

Ibuprofen may temporarily inhibit platelet function (affect platelet aggregation). Therefore, careful monitoring of patients with coagulation disorders is recommended.

During prolonged use of Ibuprom Sprint MAX, liver and kidney function tests, as well as blood counts, should be monitored regularly.

Prolonged use of any analgesic for headache treatment may worsen the condition. If this situation is suspected or confirmed, medical advice should be sought and treatment discontinued. Medication-overuse headache should be considered in patients suffering from frequent or daily headaches despite (or due to) regular use of headache medications.

Chronic use of analgesic drugs, especially combinations of multiple analgesics, may lead to persistent kidney dysfunction with a risk of renal failure (analgesic nephropathy). This risk may be increased due to salt loss and dehydration.

The concomitant use of NSAIDs with alcohol may increase the risk of adverse effects related to the active substance, particularly gastrointestinal or central nervous system effects.

Use during pregnancy or breastfeeding.

During the first and second trimesters of pregnancy, the use of this drug should be avoided. The drug is contraindicated during the third trimester of pregnancy.

Inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonic/fetal development. Epidemiological data indicate an increased risk of miscarriage, congenital heart defects, and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformations increased from 1% to approximately 1.5%. The risk is considered to increase with higher doses and longer duration of therapy.

NSAIDs should not be used from the 20th to the 28th week of pregnancy without medical prescription. The use of NSAIDs from the 20th week of pregnancy onward may cause rare but serious kidney disorders in the unborn child, leading to low amniotic fluid levels and potential complications.

NSAIDs should not be taken during the first two trimesters of pregnancy, except when, in the physician’s opinion, the expected benefit to the patient outweighs the potential risk to the fetus. If ibuprofen is used by a woman attempting to conceive or during the first or second trimester of pregnancy, the lowest possible dose should be used for the shortest possible duration. In cases where ibuprofen treatment exceeds 48 hours, monitoring of amniotic fluid levels by ultrasound should be considered.

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

• for the fetus: cardiopulmonary toxicity (characterized by premature closure of the ductus arteriosus and pulmonary hypertension); kidney dysfunction, which may progress to renal failure associated with oligohydramnios;
• for the mother and newborn, near the end of pregnancy: possible prolongation of bleeding time, antiplatelet effect, which may occur even at very low doses; inhibition of uterine contractions, leading to delayed or prolonged labor. Therefore, ibuprofen is contraindicated during the third trimester of pregnancy.

In limited studies, ibuprofen has been detected in breast milk at very low concentrations, making it unlikely to adversely affect a breastfed infant. However, NSAIDs are not recommended during breastfeeding.

Fertility.

The use of ibuprofen may affect female fertility. This effect is reversible upon discontinuation of treatment. Therefore, the use of ibuprofen is not recommended for women experiencing difficulty conceiving.

Ability to influence reaction speed when driving or operating machinery.

Patients who experience dizziness, drowsiness, or visual disturbances while taking ibuprofen should avoid driving or operating machinery. Single-dose administration or short-term use of ibuprofen generally does not require special precautions. This primarily applies when the drug is used concomitantly with alcohol. When used according to recommended doses and treatment duration, the drug does not affect reaction speed during driving or operating machinery.

Method of Administration and Dosage.

For oral use in adults and children aged 12 years and older with body weight > 40 kg. For short-term use only. Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Capsules should preferably be taken during or after meals, swallowed whole with water, and not chewed.

Single dose for children aged 12 years and older with body weight > 40 kg and adults: 1 capsule (400 mg of ibuprofen). If necessary, 1 capsule may be administered every 6 hours. Maximum daily dose is 1200 mg (3 capsules per day). The lowest effective dose required to relieve symptoms should be used for the shortest possible duration (see section "Special Warnings and Precautions for Use"). Elderly patients do not require special dose adjustment, except in cases of severe renal or hepatic impairment.

If symptoms worsen or persist for more than 3 days, a physician should be consulted for diagnosis clarification and treatment adjustment. Treatment duration is determined individually by a physician depending on the course of the disease and the patient's condition.

Children.

Contraindicated in children under 12 years of age and those with body weight < 40 kg.

Overdose.

Administration of doses exceeding 400 mg/kg in children may cause symptoms of intoxication. The dose effect in adults is less pronounced. Elimination half-life in overdose is 1.5–3 hours.

Symptoms: in most patients, ingestion of clinically significant amounts of NSAIDs causes only nausea, vomiting, epigastric pain, or less commonly, diarrhea. Tinnitus, headache, and gastrointestinal bleeding may also occur. In severe poisoning, toxic effects on the central nervous system may develop, manifesting as drowsiness, occasionally agitation, disorientation, or coma. Seizures may occasionally occur in patients. In more severe poisoning, metabolic acidosis and prolonged prothrombin time/INR may develop (likely due to interaction with circulating blood coagulation factors). Acute renal failure and liver damage may occur. In patients with bronchial asthma, exacerbation of the disease may occur.

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

Treatment. Treatment should be symptomatic and supportive, including maintenance of airway patency and monitoring of cardiac function and vital signs until the patient's condition stabilizes. Oral activated charcoal is recommended within 1 hour after ingestion of a potentially toxic dose. In cases of frequent or prolonged muscle spasms, treatment should include intravenous administration of diazepam or lorazepam. In patients with bronchial asthma, bronchodilators should be administered.

Side effects.

The following adverse reactions have been observed with short-term use of ibuprofen at doses not exceeding 1200 mg per day. Other adverse reactions may occur during treatment of chronic diseases or with prolonged use.

Adverse reactions associated with the use of ibuprofen are classified by organ systems and frequency. Frequency is defined as follows: very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1000 to <1/100; rare: ≥1/10,000 to <1/1000; very rare: <1/10,000; frequency not known (cannot be estimated from available data). Within each frequency group, adverse reactions are listed in order of decreasing severity.

The most common adverse reactions are gastrointestinal in nature and largely dose-dependent, particularly the risk of gastrointestinal bleeding, which depends on both dose and duration of treatment. Adverse reactions occur less frequently when the maximum daily dose does not exceed 1200 mg.

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

Blood and lymphatic system disorders.

Very rare: blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include fever, sore throat, oral mucosal ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding, and bruising.

Immune system disorders.

Rare: hypersensitivity reactions including urticaria and pruritus; very rare: severe hypersensitivity reactions, symptoms of which may include facial, tongue, and laryngeal swelling, dyspnea, tachycardia, hypotension, anaphylactic reactions, angioedema, or severe shock; frequency not known: respiratory tract reactivity including bronchial asthma, asthma exacerbation, bronchospasm.

Nervous system disorders.

Uncommon: headache; very rare: aseptic meningitis, individual symptoms of which (nuchal rigidity, headache, nausea, vomiting, fever, or disorientation) may occur in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus or mixed connective tissue disease; frequency not known: dizziness, paraesthesia, somnolence.

Cardiac disorders.

Frequency not known: heart failure, edema, Couinaud's syndrome.

Vascular disorders.

Frequency not known: arterial hypertension.

Gastrointestinal disorders.

Uncommon: abdominal pain, nausea, dyspepsia; rare: diarrhea, flatulence, constipation, vomiting; very rare: peptic ulcer, gastrointestinal perforations or bleeding, melena, hematemesis, sometimes fatal (especially in elderly patients), ulcerative stomatitis, gastritis; frequency not known: exacerbation of colitis and Crohn's disease.

Hepatic disorders.

Very rare: liver function abnormalities.

Skin and subcutaneous tissue disorders.

Rare: various skin rashes; 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.

Renal and urinary disorders.

Very rare: acute renal failure, papillary necrosis, particularly with prolonged use, associated with increased serum urea levels and edema.

Laboratory investigations.

Very rare: decreased hemoglobin levels.

Shelf life. 3 years.

Storage conditions. Store at temperatures not exceeding 25 °C. Keep out of reach and sight of children.

Packaging. 6 capsules in a blister, 1 blister in a cardboard box; 10 capsules in a blister, 1 or 2 blisters in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

TOV US Farmatsiya / US Pharmacia Sp. z o.o.

Manufacturer's address.

ul. Ziebicka 40, 50-507 Wroclaw, Poland.

Marketing authorization holder.

Unilab, LP.

Address of marketing authorization holder.

966 Hungerford Drive, suite 3B, Rockville, MD 20850, USA.