Ibuprom ultramax sprint

Package leaflet: Information for the patient

IBUPROM ULTRAMAX SPRINT, 600 mg, soft capsules
Ibuprofenum
Please read carefully the entire leaflet 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 the
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• 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, consult your doctor.

Table of contents of the 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 adverse reactions
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

This medicine belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, anti-inflammatory and antipyretic properties.
This medicine is indicated for immediate, short-term use in adults for acute, moderate pain of various origins:

• headaches (including migraines),
• toothaches,
• muscular, joint and bone pain (including back pain),
• pain due to trauma and postoperative pain, including pain following dental procedures,
• neuralgias,
• painful menstruation.

2. Information before using the medicine

When not to use the medicine:

• if the patient is allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever experienced breathlessness, bronchial asthma, hay fever, angioedema, or urticaria after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs);
• if the patient has severe renal, hepatic, or cardiac insufficiency;
• if the patient has unexplained blood disorders;
• if the patient has cerebral haemorrhage or any other active bleeding;
• if the patient has ever experienced gastrointestinal bleeding or perforation after taking NSAIDs;
• if the patient has or has had recurrent peptic ulcers and/or duodenal ulcers or gastrointestinal bleeding (at least two confirmed cases of ulcers or bleeding);
• if the patient has severe dehydration (caused by vomiting, diarrhoea, or inadequate fluid intake);
• if the patient is in the last trimester of pregnancy;
• in patients under 18 years of age.

Warnings and precautions
The medicine should be used in adults with concomitant chronic diseases only after consultation with a doctor.
Using the medicine at the lowest effective dose for the shortest necessary duration to relieve symptoms reduces the risk of adverse effects.
The use of anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a slightly increased risk of myocardial infarction or stroke, especially when used at high doses. The recommended dose or duration of treatment must not be exceeded.
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have occurred during treatment.
If any of these symptoms occur, the medicine must be discontinued immediately and medical advice or emergency medical services must be sought without delay.
Before starting treatment, discuss with a doctor or pharmacist if:

• the patient has heart diseases, including heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (circulatory problems in legs or feet due to narrowed or blocked arteries), or has had a stroke (including mini-stroke or transient ischaemic attack "TIA");
• the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or is a smoker;
• the patient has autoimmune diseases (systemic lupus erythematosus, connective tissue diseases), due to an increased risk of aseptic meningitis;
• the patient is taking other pain-relieving NSAIDs or acetylsalicylic acid at a daily dose exceeding 75 mg;
• the patient has congenital porphyria metabolism disorders (e.g. acute intermittent porphyria);
• the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• the patient has fluid retention and oedema associated with NSAID use;
• the patient is dehydrated, due to an increased risk of renal failure;
• the patient has impaired liver or kidney function;
• the patient has active or past bronchial asthma or a history of allergic reactions (bronchospasm may occur after taking the medicine);
• the patient has undergone major surgery;
• the patient is taking other medicines (especially anticoagulants, diuretics, cardiac medicines, or corticosteroids), or has blood clotting disorders (ibuprofen may temporarily inhibit platelet aggregation and prolong bleeding time);
• when using the medicine in elderly patients (see section 3);
• the patient has an infection – see below, section titled "Infections".

Concomitant use of other non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors, should be avoided.
Patients with a history of gastrointestinal disorders, particularly elderly patients, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, especially during the initial treatment period.
Particular caution and consultation with a doctor or pharmacist are advised before using the medicine in patients with hypertension and/or heart failure with fluid retention, or a history of hypertension and oedema associated with previous NSAID use.
Ibuprofen may cause sodium, potassium, and fluid retention in patients who have not previously had kidney disease. This may lead to oedema or even heart failure or hypertension in patients predisposed to such disorders.
Long-term use of ibuprofen, especially in combination with other painkillers, may cause permanent kidney damage and risk of renal failure.
Patients at highest risk of such reactions include those with impaired kidney function, heart failure, liver dysfunction, those taking diuretics and antihypertensives (ACE inhibitors), and elderly patients. Patients who discontinue NSAID treatment generally return to their pre-treatment condition.
During long-term ibuprofen therapy, periodic monitoring of liver and kidney function and blood cell counts is necessary, especially in high-risk patients.
During long-term, high-dose painkiller treatment, headaches may occur, which should not be treated with increased doses of medication.
Severe skin reactions, 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), have been reported with ibuprofen use. If any of the symptoms associated with these severe skin reactions described in section 4 occur, the medicine must be discontinued immediately and medical help sought.

Infections
Ibuprofen 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 ongoing infection and symptoms persist or worsen, immediate medical consultation is required.
The use of the medicine should be avoided during chickenpox.
Alcohol consumption should be avoided during treatment, as it may increase adverse effects, particularly those related to the gastrointestinal tract and nervous system.

Medicine with other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
The medicine may affect other medicines, and other medicines may affect this medicine. For example:

• Anticoagulants (i.e., blood thinners or agents preventing clots, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Blood pressure-lowering medicines (ACE inhibitors, e.g., captopril, beta-blockers, e.g., atenolol, or angiotensin II receptor antagonists, e.g., losartan).

Always consult a doctor or pharmacist before using the medicine with other medicines.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib);
• diuretics and potassium-sparing agents;
• antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal adverse effects;
• methotrexate (a medicine used in cancer or rheumatic diseases), as methotrexate's effects may be enhanced;
• lithium (a medicine used in depression), as lithium's effects may be enhanced;
• cardiac glycosides (e.g., digoxin), as ibuprofen may increase the plasma concentration of this medicine;
• phenytoin (an anticonvulsant), as ibuprofen may increase the plasma concentration of this medicine;
• corticosteroids (such as prednisolone or dexamethasone), as they may increase the risk of gastrointestinal ulceration or bleeding;
• tacrolimus (an immunosuppressant), as there is an increased risk of nephrotoxicity;
• cyclosporine (an immunosuppressant), as limited data suggest an increased risk of nephrotoxicity;
• zidovudine (a medicine used in AIDS treatment), as using the medicine may increase the risk of joint bleeding or bleeding leading to swelling (in patients with haemophilia and a positive HIV antibody test);
• ritonavir (a medicine used in HIV therapy): ritonavir may increase plasma concentrations of NSAIDs;
• antibiotics (quinolones or aminoglycosides);
• sulfonylureas (antidiabetic medicines): clinical interactions between these medicines and NSAIDs may occur; blood glucose monitoring is recommended;
• probenecid and sulfinpyrazone (medicines used in gout treatment): may delay ibuprofen excretion;
• cholestyramine: may delay and reduce absorption of NSAIDs;
• voriconazole and fluconazole (antifungal medicines): may increase exposure to NSAIDs;
• baclofen (a muscle relaxant): toxic effects of baclofen may occur after starting ibuprofen;
• aminoglycosides (a class of antibiotics): NSAIDs may reduce aminoglycoside excretion;
• mifepristone: NSAIDs should not be used within 8–12 days after mifepristone administration, as they may weaken mifepristone's effect;
• calcium channel blockers: reduced antihypertensive efficacy and increased risk of gastrointestinal bleeding;
• desipramine: increased desipramine toxicity typical of tricyclic antidepressants;
• levofloxacin and ofloxacin: increased risk of serious central nervous system effects;
• thienopyridine derivatives: increased risk of bleeding due to additive antiplatelet and anticoagulant effects;
• bisphosphonates: increased risk of gastrointestinal adverse effects;
• anticoagulant medicines (i.e., blood thinners or agents preventing clots, such as aspirin – acetylsalicylic acid, warfarin, ticlopidine);
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as atenolol-containing medicines, angiotensin II receptor antagonists, such as losartan).

Concomitant use of ibuprofen with herbal products containing Ginkgo biloba or Filipendula ulmaria may increase the risk of bleeding due to antiplatelet effects. Concurrent use of ibuprofen and products containing Ephedra sinica may increase the risk of gastrointestinal mucosal damage.
Other medicines may also influence or be influenced by the medicine. Therefore, always consult a doctor or pharmacist before using the medicine with other medicines.

Medicine with food, drink, and alcohol
Food reduces the absorption of ibuprofen from the gastrointestinal tract.
During high-dose ibuprofen use combined with alcohol consumption, symptoms such as fatigue and headache may occur.

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
If the patient becomes pregnant while using the medicine, she should inform her doctor.
The medicine should not be taken during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. The medicine may cause kidney and heart dysfunction 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 its use 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 time. From week 20 of pregnancy, the medicine may cause kidney dysfunction in the unborn child if taken for longer than a few days (this may lead to low amniotic fluid levels (oligohydramnios) or narrowing of the fetal blood vessel (ductus arteriosus) in the heart). If treatment longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts. For short-term use at doses used for pain relief, harmful effects on infants seem unlikely. However, if prolonged ibuprofen use is recommended, early weaning should be considered.

Fertility
Ibuprofen may impair fertility. If the patient is planning pregnancy or has difficulty conceiving, she should inform her doctor.

Driving and operating machinery
Ibuprofen has no effect or a negligible effect on the ability to drive and operate machinery.
However, if visual disturbances, fatigue, dizziness, or other adverse nervous system effects occur, driving and operating machinery are not recommended.

The medicine contains sorbitol and potassium

Sorbitol
The medicine contains 90 mg of sorbitol per capsule.

Potassium
The medicine contains 1.2 mmol (or 47 mg) of potassium per capsule, which should be considered in patients with impaired kidney function and in patients monitoring dietary potassium intake.

3. How to use the medicine

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults:
The recommended dose is 600 mg of ibuprofen (1 capsule) as a single dose.
If necessary, the single dose of 600 mg (1 capsule) may be repeated, maintaining an interval of 6–8 hours. The maximum daily dose without prior consultation with a doctor should not exceed 1200 mg (2 capsules).
This medicine should only be used if the patient has not experienced improvement after using ibuprofen at a dose of 400 mg (maximum 1200 mg ibuprofen per day). In such a case, the 600 mg dose of ibuprofen may be taken, provided that a 6–8 hour interval is maintained from the previous 400 mg dose.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, immediate medical advice should be sought (see section 2).
Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration needed to control symptoms.
If it becomes necessary to use the medicine for longer than 3 days or if symptoms worsen, consult a doctor.

Special patient groups
Elderly patients:
Do not use without consulting a doctor. Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with caution, especially in elderly patients who are more susceptible to adverse effects and at increased risk of potentially fatal gastrointestinal bleeding, ulcers, and perforations.

Renal or hepatic impairment:
Do not use without consulting a doctor. Dose adjustment is not required in patients with mild to moderate renal or hepatic impairment. However, in these patients, the lowest effective dose should be used for the shortest possible duration needed to control symptoms.

Children and adolescents
The use of this medicinal product is contraindicated in children and adolescents under 18 years of age.

Method of administration
This medicine is intended for oral use. The capsule should be swallowed whole with a glass of water.
Patients with sensitive stomachs are advised to take the medicine with food.

Overdose
If a patient has taken more than the recommended dose or if a child accidentally ingests the medicine, seek immediate medical advice from a doctor or go to the nearest hospital to assess potential health risks and receive guidance on appropriate 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. Excitement, drowsiness, disorientation, or coma may also occur. Seizures may occur sporadically. 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, cold sensation, and breathing difficulties may occur. Additionally, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In asthmatic patients, asthma may worsen. Hypotension, breathing difficulties, or cyanosis may also occur.
In children, a single dose exceeding 400 mg/kg body weight may cause symptoms of overdose. In adults, the dose that may cause such symptoms has not been precisely established. Myoclonic seizures (repetitive muscle jerks) may occur in children.

Treatment
There is no specific antidote. Symptomatic and supportive treatment should be given. Oral activated charcoal may be considered within 1 hour of overdose.
If symptoms of overdose occur, discontinue the medicine immediately and contact a doctor or emergency department without delay.

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 medicine can cause adverse reactions, although
not everyone will experience them.
You must stop taking ibuprofen and seek immediate medical help if any
of the following symptoms occur:

• red, flat, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, sore throat, nasal ulcers, genital or eye lesions. 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 swollen 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 list below includes all adverse reactions observed during ibuprofen treatment, including those occurring after long-term, high-dose therapy used in patients with rheumatic diseases.
Regarding the adverse reactions listed below, it should be remembered that the majority are dose-dependent, and their occurrence varies individually.
Patients taking this medicine should discontinue the drug and immediately consult a doctor if symptoms or signs of ulceration, damage to mucous membranes, or gastrointestinal bleeding occur (black, tarry stools, vomiting blood), acute upper abdominal pain, blurred vision or other eye-related symptoms, skin rash or other hypersensitivity reactions, weight gain, or swelling.
The most commonly observed adverse reactions involve the gastrointestinal tract. These may include gastrointestinal ulcers, perforation, or bleeding, sometimes leading to fatal outcomes (particularly in elderly patients). These events may occur without warning symptoms or may occur in patients who previously experienced such warning signs.
The risk of gastrointestinal bleeding is particularly dependent on the dose and duration of ibuprofen use.
Taking ibuprofen, especially long-term 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).

Common (occurs in no more than 1 in 10 people):

• heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, dyspepsia, constipation, and minor gastrointestinal bleeding, which may exceptionally lead to anemia.

Uncommon (occurs in no more than 1 in 100 people):

• hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly occurring together with a drop in blood pressure); in such cases, the medicine should be discontinued and immediate medical advice sought,
• headache, drowsiness, dizziness, insomnia, restlessness, irritability, or fatigue,
• visual disturbances,
• gastrointestinal ulcers, potentially with bleeding and perforation, oral mucosal ulcers, exacerbation of ulcerative colitis, Crohn's disease, gastric mucosal inflammation, black tarry stools, vomiting blood.

Rare (occurs in no more than 1 in 1000 people):

• tinnitus,
• kidney tissue damage (papillary necrosis) and increased blood uric acid levels.

Very rare (occurs in no more than 1 in 10,000 people):

• severe, generalized hypersensitivity reactions. These may present as, for example, facial swelling, tongue swelling, laryngeal edema with impaired airway patency, respiratory insufficiency, rapid heartbeat, drop in blood pressure, up to life-threatening shock. If any of the above symptoms occur, which may happen even after the first dose, immediate medical assistance is required.

• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms may include fever, sore throat, oral ulcers, flu-like symptoms, marked weakness, nosebleeds, and subcutaneous hemorrhages. Regular blood count monitoring is recommended during prolonged treatment,

• development of edema, particularly in patients with hypertension or renal impairment, nephrotic syndrome, interstitial nephritis associated with acute renal failure. Therefore, regular monitoring of kidney function is recommended during long-term treatment,

• liver function disturbances, liver damage (especially with prolonged use), liver failure, acute hepatitis. Therefore, regular monitoring of liver function is recommended during prolonged treatment,

• palpitations, heart failure, myocardial infarction,

• hypertension,

• esophagitis, pancreatitis, formation of diaphragm-like intestinal strictures,

• psychotic reactions, depression,

• infections associated with conditions for which non-steroidal anti-inflammatory drugs are used (e.g., necrotizing fasciitis). If signs of infection develop or worsen during ibuprofen use, the patient should immediately consult a doctor. The doctor will assess whether anti-infective treatment (antibiotic therapy) is indicated. Aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or altered consciousness has been observed during ibuprofen use. Patients with autoimmune diseases (SLE, mixed connective tissue disease) appear to be particularly susceptible,

• in exceptional cases, during varicella virus infection, severe skin infections and soft tissue complications may occur.

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

• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome,
• skin becomes sensitive to light.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. 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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the representative of the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box following
"Expiry date". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What the medicine contains
The active substance is ibuprofen. Each soft capsule contains 600 mg of ibuprofen.
The other ingredients are: Macrogol 600, potassium hydroxide, purified water. Capsule shell:
gelatin, sorbitol liquid partially dehydrated, purified water;
Ink composition Opacode black NS-78-17821: black iron oxide (E 172), isopropyl alcohol, propylene glycol, hypromellose.
What the medicine looks like and contents of the pack
Oval, transparent, naturally coloured capsules with the imprint "600".
PVC/PVDC/Aluminium blister in a cardboard box.
10 pieces (1 blister containing 10 pieces)
Marketing Authorisation Holder and Importer
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
For further information, please contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warszawa
tel.: +48 (22) 543 60 00