Ibuprom Sprint

Package Leaflet: Information for the Patient

IBUPROM SPRINT

200 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 a doctor or pharmacist.

• This package 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 package leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact a 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 pack and other information

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

It is a pain-relieving medicine. It is used to treat inflammation, which is one of the causes of pain. The medicine lowers fever.

Indications for use of the medicine:

Pain of various origins of mild to moderate severity, including: headaches, toothaches, muscle pain, lower back pain, bone and joint pain. 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 the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) and to other nonsteroidal anti-inflammatory drugs (NSAIDs);
• if after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, there have been any allergic symptoms in the past, such as runny nose, hives, or asthma;
• in patients with stomach or duodenal ulcer, active or past, perforation or bleeding, also those that occurred after taking NSAIDs;
• in patients with severe liver, kidney, or heart failure;
• in patients taking other nonsteroidal anti-inflammatory drugs at the same time, including COX-2 inhibitors (increased risk of side effects);
• in the last 3 months of pregnancy;
• in case of bleeding disorder. Page 1 7

Warnings and precautions

Before starting to take the medicine, the patient should discuss it with a doctor or pharmacist.

Special caution should be exercised when taking the medicine

• if the patient has systemic lupus erythematosus and mixed connective tissue disease,
• if there are symptoms of allergic reactions after taking acetylsalicylic acid,
• if the patient has gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• if the patient has high blood pressure and/or heart failure,
• if the patient has kidney function disorders,
• if the patient has liver function disorders,
• if the patient has blood clotting disorders,
• if the patient has a history of asthma or allergic reactions; after taking the medicine, bronchospasm may occur,
• if the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs. In case of gastrointestinal bleeding or ulceration, the medicine should be discontinued immediately. 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 other painkillers at the same time may lead to kidney damage with a risk of kidney failure (analgesic nephropathy). Taking the medicine by dehydrated adolescents increases the risk of kidney function disorders. Taking anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. The recommended dose should not be exceeded, and the treatment duration should be as short as possible. Before taking the medicine, the patient should discuss the treatment with a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has peripheral artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes.
• the patient has an infection - see below, the section entitled "Infections".

During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), chest pain. If any of these symptoms are noticed, the medicine should be discontinued immediately, and medical help should be sought. The recommended dose and treatment duration should not be exceeded. If symptoms persist, worsen, or new symptoms occur, a doctor should be consulted. Skin reactions Severe skin reactions have occurred with ibuprofen, 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). If the patient experiences any symptoms related to these severe skin reactions described in section 4, the medicine should be discontinued immediately, and medical help should be sought. Infections The medicine may mask the symptoms of infection, such as fever and pain. This 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 the patient is taking this medicine during an infection and the infection symptoms persist or worsen, they should consult a doctor immediately. This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and reverses after the treatment is stopped. If the patient is having trouble getting pregnant, they should consult a doctor before taking ibuprofen. The patient should consult a doctor, even if the above warnings refer to past situations.

Children

The medicine is not indicated for children under 12 years of age.

Medicine and other medicines

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 patient should not take the medicine at the same time as other nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors, such as celecoxib or etoricoxib), other pain-relieving medicines, or acetylsalicylic acid (in pain-relieving doses). The medicine may affect the action of other medicines or other medicines may affect the action of this medicine. Such medicines include:

• anticoagulant medicines (e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),
• diuretics,
• corticosteroids (e.g., prednisolone or dexamethasone),
• methotrexate (an anticancer medicine),
• lithium (an antidepressant),
• zydovudine (an antiviral medicine).

Also, some other medicines may be affected or may affect the treatment with this medicine. Therefore, before taking the medicine with other medicines, the patient should always consult a doctor or pharmacist. With food and drinkIt is recommended to take the medicine after a meal. Page 3 7

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine. The patient should not take the medicine if they are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. The medicine may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the patient and the baby and cause prolongation or prolongation of 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, if taken for more than a few days, may cause kidney problems in the unborn baby (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, the doctor may recommend additional monitoring. 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 when taking ibuprofen for a short period and in small doses.

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 period.

The medicine contains sorbitol

The medicine contains 26.24 mg of sorbitol in each capsule. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, they should consult a 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 a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist.

Adults and adolescents over 12 years of age:

For temporary treatment: 1 to 2 capsules orally every 4 hours after meals. The dose should not exceed 6 capsules per day (maximum daily dose 1200 mg in divided doses). The smallest effective dose should be used for the shortest possible time. If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should consult a doctor immediately (see section 2). The medicine should not be taken by children under 12 years of age. The recommended dose should not be exceeded. If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor. The medicine is intended for short-term use. If symptoms persist, worsen, or new symptoms occur, the patient should consult a doctor. The medicine should not be taken for more than 3 days without consulting a doctor.

Taking a higher dose of the medicine than recommended

If the patient has taken a higher dose of the medicine than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do. Page 4 7Symptoms 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 nystagmus. 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 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 provide symptomatic and supportive treatment.

Missing a dose of the medicine

A double dose should not be taken 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. The patient should stop taking ibuprofen and seek medical help 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 of the 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 fever, and swollen lymph nodes (DRESS syndrome).
• red, peeling rash with nodules under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Uncommon side effects(affecting 1 to 10 in 1,000 patients taking the medicine):

• headache, indigestion, abdominal pain, nausea, hives, itching.

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

• diarrhea, bloating, constipation, vomiting, gastritis;
• insomnia, agitation, irritability, and fatigue;
• edema resulting from kidney and urinary disorders.

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

• tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease;
• peptic ulcer disease and/or duodenal ulcer, gastrointestinal bleeding, and perforation, sometimes with fatal outcome, especially in the elderly;
• in single cases, depression, psychotic reactions, and tinnitus, aseptic meningitis (symptoms include stiff neck, headache, nausea, vomiting, fever, or changes in consciousness). If such symptoms occur, the patient should immediately consult a doctor.
• decreased urine output, edema, acute kidney failure, renal papillary necrosis, increased sodium levels in the serum (sodium retention);
• liver function disorders, especially during long-term treatment;
• disorders of blood cell production (decreased red blood cell count, platelet count, certain white blood cell count - leukocytes, and granulocytopenia, as well as pancytopenia - a disorder characterized by a deficiency of all blood cells): the first symptoms are fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g., bruising, petechiae, purpura, nosebleeds). In such a case, the treatment should be discontinued, and the patient should immediately consult a doctor. These symptoms should not be treated with pain-relieving or antipyretic medicines.

Side effects with unknown frequency(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. With the treatment of NSAIDs, reports of edema, high blood pressure, and heart failure have been made. Taking such medicines as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

In the case of temporary use of the medicine, side effects are rare. In elderly patients, there is an increased risk of side effects associated with the use of ibuprofen compared to younger patients. The frequency and severity of side effects can be reduced by using the smallest therapeutic dose for the shortest possible period. In some people, during the use of the medicine, other side effects may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in this package leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 492 13 01, fax: +48 22 492 13 09, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to 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

The medicine should be stored at a temperature below 25°C. It should be kept out of sight and reach of children. Page 6 7The medicine should not be used after the expiry date stated on the carton and blister packaging (month/year). The labeling used for the blister is: EXP - expiry date, Lot - batch number.

6. Contents of the pack and other information

What the medicine contains

The active substance of the medicine is ibuprofen. Each soft capsule contains 200 mg of ibuprofen. The excipients are: Core of the capsule:Macrogol 600, potassium hydroxide, purified water, Capsule shell:gelatin, sorbitol liquid, partially dehydrated, patent blue V.

What the medicine looks like and contents of the pack

The capsule is oval in shape and blue in color.

Available packs:

2 pieces, 4 pieces, 6 pieces, 10 pieces, 12 pieces, 24 pieces, 30 pieces, 40 pieces. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

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

To obtain more detailed information about this medicine, the patient should contact: 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: Page 7 7