Ibuprom Max Sprint

Package Leaflet: Information for the Patient

IBUPROM MAX SPRINT

400 mg Soft Capsules

Ibuprofen

Read the package 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 package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should consult your doctor.

Table of Contents of the Package 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 side effects
• 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

The medicine contains ibuprofen, an active substance belonging to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). It is a pain-relieving medicine. It helps to combat inflammation, which is one of the causes of pain. The medicine also lowers fever. The indications for use of the medicine are acute pains of various origins of mild to moderate severity: headaches (including tension headaches), migraines with or without aura (symptoms such as headache, nausea, sensitivity to light and sound), toothaches, neuralgia, muscle pains, bone and joint pains. Painful menstruation. Fever (including in the course of flu, colds, or other infectious diseases).

2. Important information before taking the medicine

When not to take the medicine

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• In people who have had allergic symptoms (such as hay fever, urticaria, or asthma) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
• If you have: active stomach or duodenal ulcer, or a history of stomach or duodenal ulcer, bleeding or perforation (including those caused by nonsteroidal anti-inflammatory drugs), severe liver failure, severe kidney failure, or severe heart failure,

bleeding disorders.

• During treatment with other nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors.
• In the third trimester of pregnancy.

Warnings and precautions

Before taking the medicine, discuss it with your doctor or pharmacist.

When to be particularly careful when taking

• If you have been diagnosed with systemic lupus erythematosus or mixed connective tissue disease.
• If you have been diagnosed with gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease). During treatment with the medicine, gastrointestinal bleeding, ulceration, or perforation may occur - a complication that can be fatal and is not always preceded by warning signs. If gastrointestinal bleeding or ulceration occurs, you should stop taking the medicine immediately and consult your doctor. Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.

Taking pain-relieving and anti-inflammatory medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose and duration of treatment. Before taking the medicine, you should discuss your treatment with your doctor or pharmacist if: you have heart disease, such as heart failure, angina pectoris (chest pain), you have had a heart attack, coronary artery bypass grafting, or you have peripheral artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or if you have had any stroke (including mini-stroke or transient ischemic attack - TIA). you have high blood pressure, diabetes, high cholesterol levels, or if there is a history of heart disease or stroke in your family, or if you smoke. you have an infection - see below, the section entitled "Infections". During treatment with ibuprofen, allergic reactions to this medicine have occurred, including difficulty breathing, swelling of the face and neck (angioedema), and chest pain. If you notice any of these symptoms, you should stop taking the medicine immediately and contact your doctor or emergency medical services immediately. 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 occurred during treatment with ibuprofen. If you experience any symptoms related to these severe skin reactions described in section 4, you should stop taking the medicine immediately and seek medical attention.

Infections may mask the symptoms 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 related to chickenpox. If you are taking this medicine during an infection and the symptoms of the infection persist or worsen, you should consult your doctor immediately. Do not take higher doses or longer treatment than recommended. If symptoms persist, worsen, or do not improve after 3 days, or if new symptoms occur, you should consult your doctor.

• If you have kidney, liver, or blood clotting disorders.
• If you are taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids); this may increase the risk of stomach and intestinal disorders or bleeding.
• If you have been diagnosed with asthma or a history of allergic reactions; after taking the medicine, bronchospasm may occur.
• If you are taking pain-relieving medicines for a long time; this may lead to kidney damage with a risk of kidney failure (so-called analgesic nephropathy).
• Taking the medicine by dehydrated patients (youth) increases the risk of kidney damage.
• If you are trying to become pregnant, you should consult your doctor before taking ibuprofen. This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may have a negative effect on female fertility. This effect is temporary and disappears after stopping the medicine.

Children

The medicine should not be given to children under 12 years of age.

Medicine and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. The medicine may affect the action of other medicines or other medicines may affect the action of the medicine. These medicines include, for example:

• anticoagulant medicines (i.e., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),
• diuretics,
• other nonsteroidal anti-inflammatory drugs,
• certain antidepressants (selective serotonin reuptake inhibitors),
• corticosteroids (e.g., prednisolone, dexamethasone),
• quinolone antibiotics (e.g., nalidixic acid, ofloxacin, ciprofloxacin),
• methotrexate (an anticancer medicine),
• lithium (an antidepressant),
• zydovudine (an antiviral medicine),
• digoxin (a cardiac glycoside),
• cyclosporine, tacrolimus (immunosuppressive medicines),
• mifepristone.

Also, some other medicines may be affected or have an effect on the treatment with the medicine. Therefore, before taking the medicine with other medicines, you should always consult your doctor or pharmacist. With food and drinkIt is recommended to take the medicine after a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

Do not take the medicine if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medicine may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in you and your child and cause prolongation or prolongation of labor. During the first 6 months of pregnancy, you should not take the medicine unless your doctor considers it absolutely necessary. If treatment is necessary during this period or during attempts to become pregnant, you should use the smallest possible dose for the shortest possible time. From the 20th week of pregnancy, the medicine, if taken for more than a few days, may cause kidney problems in the unborn child (which can lead to low amniotic fluid levels around the baby, oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen passes into breast milk in very small amounts, and no adverse effects have been reported in breastfed infants. There is no need to stop breastfeeding during short-term use of ibuprofen in small doses used to treat pain and fever.

Fertility

Effect of the medicine on fertility - see section Warnings and precautions.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive vehicles, operate machinery, and psychophysical fitness during treatment with the medicine in recommended doses and for the recommended duration.

The medicine contains sorbitol

The medicine contains 95.94 mg of sorbitol in each capsule. Sorbitol is a source of fructose. If you have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should consult your doctor before taking the medicine.

3. How to take the medicine

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Adults and adolescents over 12 years of ageFor temporary treatment: 1 capsule orally every 4 hours (do not take more than 3 capsules in 24 hours). You should use the smallest effective dose for the shortest possible time to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, you should consult your doctor immediately (see section 2). If necessary, the capsule should be taken with a liquid. The capsules should not be chewed. Children under 12 years of ageThe medicine should not be given to children under 12 years of age. Elderly patientsNo dose adjustment is necessary. You should use the smallest effective dose for the shortest possible time to relieve symptoms. If it is necessary to take the medicine for more than 3 days or if your condition worsens, you should consult your doctor.

Taking a higher dose of the medicine than recommended

If you have taken a higher dose of the medicine than recommended or if a child has accidentally taken the medicine, you should always consult your doctor or go to the nearest hospital to get an opinion on the possible risk to your health and advice on what to do in this situation. 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, and confusion. It may also cause agitation, drowsiness, disorientation, or coma. Rarely, patients may experience seizures. 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 difficulty breathing have occurred. Additionally, 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 difficulty breathing may occur. There is no specific antidote.The doctor will use symptomatic and supportive treatment.

Missing a dose of the medicine

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following symptoms, you should stop taking ibuprofen and seek medical attention immediately:

• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• red, peeling, widespread rash with nodules under the skin and blisters, with fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Uncommon side effects(in 1 to 10 out of 1000 patients taking the medicine):

• indigestion, stomach pain, nausea;
• headache;
• urticaria, itching.

Rare side effects(in 1 to 10 out of 10,000 patients taking the medicine):

• diarrhea, bloating, constipation, vomiting, gastritis;
• dizziness, insomnia, agitation, irritability, and fatigue;
• edema.

Very rare side effects(less than 1 in 10,000 patients taking the medicine):

• gastric and (or) duodenal ulcer, gastrointestinal bleeding (manifested by, among other things, black stools, bloody vomiting), perforation, exacerbation of colitis and Crohn's disease, ulcerative stomatitis;
• depression, psychotic reactions;
• tinnitus;
• aseptic meningitis (especially in people with autoimmune diseases: systemic lupus erythematosus, mixed connective tissue disease);
• reduced urine output, kidney failure (including interstitial nephritis), renal papillary necrosis;
• liver function disorders, especially during long-term use, liver failure, acute hepatitis;
• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia); the first symptoms are: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g., bruising, petechiae, purpura);
• severe hypersensitivity reactions, such as: facial edema, tongue and laryngeal edema, dyspnea, tachycardia, sudden decrease in blood pressure, anaphylactic shock (sudden drop in blood pressure with accompanying pallor, loss of consciousness, sweating); exacerbation of asthma and bronchospasm;
• hypertension.

Side effects with unknown frequency(which cannot be estimated from the available data)

• increased sodium levels in the blood.
• skin becomes sensitive to light.
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Taking nonsteroidal anti-inflammatory drugs in high doses has been reported to be associated with edema and heart failure. Taking such medicines as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, you should consult your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the 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 Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information 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 after the expiry date stated on the carton and blister pack (month/year). The applied labeling for the blister is: EXP - expiry date, Lot - batch number. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What the medicine contains

The active substance is ibuprofen. One soft capsule contains 400 mg of ibuprofen. The other excipients are: macrogol 600, potassium hydroxide, gelatin, liquid sorbitol, partially dehydrated, purified water.

What the medicine looks like and contents of the package

Oral capsules, packaged in PVC/PE/PVDC/Aluminum blisters and a cardboard box. Oral capsules, packaged in PVC/PVDC/Aluminum blisters and a cardboard box.

Packaging

10 capsules - 1 blister of 10. 20 capsules - 2 blisters of 10. 30 capsules - 3 blisters of 10. 40 capsules - 4 blisters of 10.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o. ul. Ziębicka 40, 50-507 Wrocław

• For more detailed information about this medicine, you should consult: USP Zdrowie Sp. z o.o. ul. Poleczki 35, 02-822 Warszawa, tel.: +48 22 543 60 00 Date of last revision of the package leaflet: