Ibuprom Ultramax Sprint

Leaflet accompanying the packaging: patient information

IBUPROM ULTRAMAX SPRINT, 600 mg, soft capsules

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is the medicine and what is it used for
• 2. Important information before taking the medicine
• 3. How to take the medicine
• 4. Possible side effects
• 5. How to store the medicine
• 6. Contents of the packaging and other information

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

The medicine belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs) with analgesic, anti-inflammatory, and antipyretic effects.

This medicine is indicated for short-term use in adults for acute, moderate pain of various origins:

• headaches (including migraines),
• toothaches,
• muscle, joint, and bone pain (including back pain),
• traumatic and post-operative pain, including pain associated with dental procedures,
• neuralgia,
• painful menstruation.

2. Important information before taking the medicine

When not to take the medicine:

• if the patient is hypersensitive to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had dyspnea, asthma, hay fever, swelling, or hives after taking acetylsalicylic acid or other similar painkillers (NSAIDs);
• if the patient has severe kidney, liver, or heart failure;
• if the patient has unexplained blood disorders;
• if the patient has cerebral hemorrhage or other active bleeding;
• if the patient has ever had bleeding or perforation of the stomach or intestines after taking NSAIDs;
• if the patient has a history of recurrent stomach or duodenal ulcers or gastrointestinal bleeding (at least two confirmed cases of ulcers or bleeding);
• if the patient has severe dehydration (caused by vomiting, diarrhea, 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 with caution in adults with concomitant chronic diseases, after consulting a doctor.

Taking the medicine in the smallest effective dose for the shortest necessary period to relieve symptoms reduces the risk of side effects.

Taking anti-inflammatory and analgesic medicines like ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when taken in high doses.

Do not exceed the recommended dose or duration of treatment.

During ibuprofen treatment, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), and chest pain.

If any of these symptoms are observed, the medicine should be discontinued immediately and medical help sought.

Before starting treatment, the patient should discuss it with their doctor or pharmacist if:

• the patient has heart disease, including heart failure, angina pectoris (chest pain), has had a heart attack, has had a coronary artery bypass graft, has peripheral arterial disease (circulatory problems in the legs or feet due to narrowed or blocked arteries), or has had a stroke (including a mini-stroke or transient ischemic attack "TIA");
• the patient has high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if the patient smokes;
• the patient has autoimmune diseases (systemic lupus erythematosus, connective tissue diseases), due to the increased risk of developing symptoms of aseptic meningitis;
• the patient is taking other painkillers from the NSAID group or acetylsalicylic acid in a daily dose above 75 mg;
• the patient has congenital metabolic disorders (e.g., acute intermittent porphyria);
• the patient has gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• the patient has fluid retention and edema associated with the use of NSAIDs;
• the patient is dehydrated, which increases the risk of kidney failure;
• the patient has liver or kidney dysfunction;
• the patient has active or past asthma or a history of allergic reactions (which may cause bronchospasm after taking the medicine);
• the patient has undergone major surgery;
• the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, or corticosteroids), or if the patient has bleeding disorders (ibuprofen may temporarily inhibit platelet aggregation and prolong bleeding time);
• the patient is elderly (see section 3);
• the patient has an infection - see below, section entitled "Infections".

Avoid taking the medicine simultaneously with other nonsteroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors.

Patients with a history of gastrointestinal diseases, especially the elderly, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, especially during the initial treatment period.

Particular caution should be exercised and a doctor or pharmacist consulted before taking the medicine in patients with hypertension and/or heart failure with fluid retention, hypertension, and edema, which are associated with the use of NSAIDs in the past.

Ibuprofen may cause sodium, potassium, and fluid retention in patients who have not previously had kidney disease, which can lead to edema or even heart failure or hypertension in patients with a predisposition to these disorders.

Long-term use of ibuprofen, especially in combination with other painkillers, can cause permanent kidney damage and increase the risk of kidney failure.

Patients with the highest risk of such reactions are those with kidney dysfunction, heart failure, liver dysfunction, taking diuretics and antihypertensive drugs (ACE inhibitors), and the elderly.

Patients who discontinue NSAID treatment generally return to their pre-treatment state.

During long-term treatment with ibuprofen, periodic monitoring of liver and kidney function, as well as blood cell count, is necessary, especially in high-risk patients.

During long-term treatment with high doses of painkillers, headaches may occur, which should not be treated with increased doses of painkillers.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP), have been reported with ibuprofen use.

If the patient experiences any symptoms associated with these severe skin reactions, they should discontinue the medicine and seek medical attention.

Infections

may mask the signs of infection, such as fever and pain, which may delay the use of appropriate infection treatment and lead to increased risk of complications.

This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.

If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should immediately consult a doctor.

The medicine should be avoided during chickenpox.

Alcohol consumption should be avoided during treatment with the medicine, as it may increase the risk of side effects, especially those related to the gastrointestinal tract and nervous system.

Medicine interactions

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The medicine may interact with other medicines, and other medicines may interact with the effects of this medicine.

For example:

• Anticoagulants (e.g., blood thinners or anticoagulants, such as acetylsalicylic acid, warfarin, ticlopidine).
• Blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, or angiotensin II receptor antagonists, such as losartan).

Before taking the medicine with other medicines, the patient should always consult their doctor or pharmacist.

In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• Other NSAIDs (including COX-2 inhibitors, such as celecoxib or etoricoxib),
• Diuretics and potassium-sparing diuretics,
• Antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal side effects,
• Methotrexate (a medicine used to treat cancer or rheumatic diseases), as its effects may increase,
• Lithium (a medicine used to treat depression), as its effects may increase,
• Cardiac glycosides (e.g., digoxin), as ibuprofen may increase the level of this medicine in the blood,
• Phenytoin (an antiepileptic medicine), as ibuprofen may increase the level of this medicine in the blood,
• Corticosteroids (such as prednisolone or dexamethasone), as they may increase the risk of gastrointestinal ulcers or bleeding,
• Tacrolimus (an immunosuppressive medicine), as the risk of toxic effects on the kidneys may increase,
• Cyclosporin (an immunosuppressive medicine), as there is limited data on increased risk of toxic effects on the kidneys,
• Zidovudine (a medicine used to treat AIDS), as treatment with the medicine may increase the risk of bleeding into the joints or bleeding leading to swelling (in patients with hemophilia and a positive HIV test result),
• Ritonavir (a medicine used to treat HIV infection): ritonavir may increase the level of NSAIDs in the blood,
• Antibiotics (quinolones or aminoglycosides),
• Sulfonylurea derivatives (oral hypoglycemic agents): clinical interactions may occur between these medicines and NSAIDs; blood glucose monitoring is recommended,
• Probenecid and sulfinpyrazone (medicines used to treat gout): they may delay the excretion of ibuprofen,
• Cholestyramine: it may delay and reduce the absorption of NSAIDs,
• Voriconazole and fluconazole (antifungal medicines): they may increase the exposure to NSAIDs,
• Baclofen (a muscle relaxant): toxic effects of baclofen may occur after starting ibuprofen treatment,
• Aminoglycosides (a type of antibiotic): NSAIDs may decrease the excretion of aminoglycosides,
• Mifepristone: NSAIDs should not be used within 8-12 days after mifepristone administration, as they may reduce the effect of mifepristone,
• Calcium channel blockers: reduced antihypertensive effect and increased risk of gastrointestinal bleeding,
• Desipramine: increased toxicity of desipramine, typical of tricyclic antidepressants,
• Levofloxacin and ofloxacin: increased risk of serious central nervous system effects,
• Thienopyridine derivatives: increased risk of bleeding due to additive anti-aggregatory and anticoagulant effects,
• Bisphosphonates: increased risk of gastrointestinal side effects,
• Anticoagulant medicines (e.g., blood thinners or anticoagulants, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• Blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, or angiotensin II receptor antagonists, such as losartan).

Taking ibuprofen with herbal products containing Ginkgo biloba or Filipendula ulmaria may increase the risk of bleeding due to anti-aggregatory effects.

Concomitant use of ibuprofen and products containing Ephedra sinica may increase the risk of gastrointestinal mucosa damage.

Other medicines may also be affected or have an effect on the medicine.

Therefore, before taking the medicine with other medicines, the patient should always consult their doctor or pharmacist.

Medicine with food, drink, and alcohol

Food reduces the absorption of ibuprofen from the gastrointestinal tract.

When taking ibuprofen in high doses and consuming alcohol, symptoms such as fatigue and headaches may occur.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

If the patient becomes pregnant while taking the medicine, they should inform their doctor.

The medicine should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery.

The medicine may cause kidney and heart problems in the unborn child.

It may increase the risk of bleeding in the mother and child and prolong labor.

During the first 6 months of pregnancy, the medicine should not be taken unless the doctor considers it absolutely necessary.

If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time.

From the 20th week of pregnancy, the medicine may cause kidney problems in the unborn child if taken for more than a few days (which may lead to low amniotic fluid levels around the baby or narrowing of the arterial duct in the baby's heart).

If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen passes into breast milk in small amounts.

When taken for a short period in doses used to treat pain, the risk to breastfed infants appears to be low.

However, if long-term use of ibuprofen is necessary, breastfeeding should be discontinued.

Fertility

Ibuprofen may make it more difficult to become pregnant.

If the patient is planning to become pregnant or is having trouble becoming pregnant, they should inform their doctor.

Driving and using machines

Ibuprofen has no or negligible influence on the ability to drive and use machines.

If the patient experiences blurred vision, fatigue, dizziness, or other nervous system side effects, they should not drive or operate machinery.

Medicine contains sorbitol and potassium

Sorbitol

The medicine contains 90 mg of sorbitol in each capsule.

Potassium

The medicine contains 1.2 mmol (or 47 mg) of potassium per capsule, which should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake.

3. How to take the medicine

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

In case of doubt, the patient should consult their doctor or pharmacist.

The recommended dose is:

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) can be repeated, with an interval of 6-8 hours.

The maximum daily dose, without consulting a doctor, should not exceed 1200 mg (2 capsules).

The medicine should only be taken if the patient does not experience improvement after taking ibuprofen in a dose of 400 mg (maximum 1200 mg of ibuprofen per day).

In such cases, a dose of 600 mg of ibuprofen can be taken, taking into account the interval

• of 6-8 hours from the administration of the 400 mg dose.

The patient should take the smallest effective dose for the shortest possible period necessary to relieve symptoms.

If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult a doctor (see section 2).

Side effects can be minimized by taking the smallest effective doses for the shortest possible time necessary to control symptoms.

If it is necessary to take the medicine for more than 3 days or if the symptoms worsen, the patient should consult their doctor.

Special patient groups

Elderly:

The medicine should not be taken without consulting a doctor.

Nonsteroidal anti-inflammatory drugs (NSAIDs) should be used with caution, especially in elderly patients, who are more likely to experience side effects and are at risk of potentially life-threatening gastrointestinal bleeding, ulcers, and perforation.

Kidney or liver dysfunction:

The medicine should not be taken without consulting a doctor.

There is no need to modify the dose in patients with mild to moderate kidney or liver dysfunction.

However, in these patients, the smallest effective dose should be used for the shortest possible time necessary to control symptoms.

Children and adolescents

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

Method of administration

The medicine is intended for oral use.

The capsule should be swallowed whole, with a glass of water.

It is recommended that patients with sensitive stomachs take the medicine with food.

Overdose

If the patient has taken more than the recommended dose of the medicine or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to assess the risk to their health and for advice on what to do.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see section 4 below), diarrhea, headache, ringing in the ears, confusion, and eye movement disorders.

It may also cause agitation, drowsiness, disorientation, or coma.

Seizures may occur occasionally.

After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties may occur.

In addition, the prothrombin time/INR may be prolonged, probably due to the disruption of circulating clotting factors.

Acute kidney failure and liver damage may occur.

In asthmatics, asthma may worsen.

Additionally, low blood pressure and breathing difficulties or cyanosis may occur.

In children, a single dose above 400 mg/kg body weight may cause overdose symptoms.

In adults, the dose that can cause such symptoms has not been precisely determined.

In children, myoclonic seizures (repeated muscle contractions) may occur.

Treatment

There is no specific antidote.

Symptomatic and supportive treatment is used.

Activated charcoal may be considered for oral administration within 1 hour of overdose.

If symptoms of overdose occur, the patient should discontinue the medicine and seek medical attention immediately.

Missed dose

A double dose should not be taken to make up for a missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, the medicine can cause side effects, although not everybody gets them.

The patient should stop taking ibuprofen and seek medical attention immediately if they experience any of the following symptoms:

• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes.

These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• red, peeling rash with bumps under the skin and blisters, with fever.

The list of side effects below includes all side effects observed during treatment with ibuprofen, including those occurring during long-term treatment with high doses, used in patients with rheumatic diseases.

Regarding the following adverse reactions to the medicine, it should be noted that they are largely dose-dependent, and their occurrence is individually variable.

Patients taking the medicine should discontinue it and immediately consult a doctor if they experience signs or symptoms of ulcers, mucosal damage, or gastrointestinal bleeding (black stools, bloody vomiting),

severe abdominal pain, blurred vision, or other eye symptoms, skin rash, or other allergic reactions, weight gain, or edema.

The most common adverse reactions are related to the gastrointestinal tract.

Ulcers, perforation, or gastrointestinal bleeding may occur, sometimes with a fatal outcome (especially in the elderly).

These events are not always preceded by warning symptoms or may occur in patients who have experienced such warning symptoms.

The risk of gastrointestinal bleeding is particularly dependent on the dose range and duration of ibuprofen treatment.

Taking ibuprofen, especially long-term in high doses (2400 mg per day), may be associated with a small increased risk of arterial thrombosis (e.g., heart attack or stroke).

Frequent (occurring in no more than 1 in 10 people):

• heartburn, stomach pain, nausea, vomiting, bloating with gas, diarrhea, indigestion, constipation, and minor gastrointestinal bleeding, which may lead to anemia in exceptional cases.

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

• allergic reactions with skin rash and itching, as well as asthma attacks (which may be associated with a drop in blood pressure); in such cases, the medicine should be discontinued and medical attention sought immediately,
• headache, drowsiness, dizziness, insomnia, agitation, irritability, or fatigue,
• vision disturbances,
• gastrointestinal ulcers, potential gastrointestinal bleeding, mouth ulcers, exacerbation of ulcerative colitis, Crohn's disease, gastritis, gastrointestinal perforation.

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

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

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

• severe, generalized allergic reactions.

They may occur as, for example, facial swelling, tongue swelling, internal throat swelling with impaired airway patency, respiratory failure, rapid heart rate, blood pressure drop, and potentially life-threatening shock.

If any of these symptoms occur, which may happen after the first dose of the medicine, immediate medical attention is necessary.

• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis).

The first symptoms may be fever, sore throat, mouth ulcers, flu-like symptoms, significant weakness, nosebleeds, and subcutaneous bleeding.

During long-term treatment with the medicine, regular monitoring of blood morphology is recommended.

• fluid retention, particularly with hypertension and kidney failure, nephrotic syndrome, interstitial nephritis, which may be associated with acute kidney failure.

For this reason, regular monitoring of kidney function is recommended during long-term treatment with the medicine.

• liver function disorders, liver damage (especially with long-term use), liver failure, acute hepatitis.

For this reason, regular monitoring of liver function is recommended during long-term treatment with the medicine.

• palpitations, heart failure, myocardial infarction,
• hypertension,
• esophageal inflammation, pancreatitis, intestinal stricture formation.

Psychotic reactions, depression,

Infections associated with conditions that are the reason for the use of nonsteroidal anti-inflammatory drugs (e.g., the occurrence of necrotizing fasciitis).

If symptoms of infection occur or worsen during treatment with ibuprofen, the patient should immediately consult a doctor.

In rare cases, during chickenpox, severe skin and soft tissue infections may occur.

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

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Jerozolimskie Avenue 181C

02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the representative of the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store the medicine

Store in a temperature below 25°C.

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after "Expiry date".

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste.

The patient should ask their pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Contents of the packaging and other information

What the medicine contains

The active substance of the medicine 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;

Opacode black NS-78-17821 ink: iron oxide black (E 172), isopropyl alcohol, propylene glycol, hypromellose.

What the medicine looks like and contents of the pack

Oval, transparent capsules with a natural color and the imprint "600".

PVC/PVDC/Aluminum blister pack in a cardboard box.

10 capsules (1 blister pack of 10 capsules).

Marketing authorization holder and importer

US Pharmacia Sp. z o.o.

Ziębicka 40

50-507 Wrocław

For more information, please contact:

USP Zdrowie Sp. z o.o.

Poleczki 35, 02-822 Warsaw

Phone: +48 (22) 543 60 00

Date of last revision of the leaflet: