Ibum Sprint

Leaflet attached to the packaging: patient information

IBUM SPRINT

200 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.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• 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 after 3 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

1. What is I S and what is it used for

I S contains ibuprofen, a substance from the group of non-steroidal anti-inflammatory drugs (NSAIDs) with analgesic, antipyretic, and anti-inflammatory effects. Indications for use are:

• Pains of various origins of mild to moderate severity:
• headaches (including migraines)
• toothaches
• muscle, joint, and bone pain
• post-traumatic pain
• neuralgia
• pains accompanying colds and flu.
• Painful menstruation.
• Febrile conditions of various origins (including flu, colds, or other infectious diseases).

2. Important information before taking I S

When not to take I S

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• in patients with active or past peptic ulcer disease of the stomach and/or duodenum, perforation, or bleeding, also occurring after taking NSAIDs;
• in patients who have experienced allergic symptoms in the past, such as rhinitis, urticaria, or bronchial asthma, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• in patients with severe liver failure, severe kidney failure, or severe heart failure;
• in patients taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of side effects);
• in the last three months of pregnancy;
• in patients with bleeding disorders.

Warnings and precautions

Before starting treatment with I S, the patient should discuss it with their doctor or pharmacist.

Particular caution is required when taking I S:

• if the patient has systemic lupus erythematosus and mixed connective tissue disease;
• in case of 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 hypertension and/or heart failure;
• if the patient has kidney function disorders;
• if the patient has liver function disorders;
• if the patient has blood coagulation disorders (ibuprofen may prolong bleeding time);
• if the patient has a history of bronchial asthma or allergic reactions, as taking the medicine may cause bronchospasm;
• in patients taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, or corticosteroids).

Patient with a history of hypertension and/or heart failure should be cautious and consult a doctor or pharmacist before taking the medicine, as NSAID treatment has been associated with fluid retention, hypertension, and oedema.

Taking pain-relieving/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 I S, the patient should discuss treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, or have peripheral arterial disease (poor circulation in the legs due to narrowed or blocked arteries) or have had a stroke (including mini-stroke or transient ischaemic attack - TIA);
• they have high blood pressure, diabetes, high cholesterol, or have a family history of heart disease or stroke, or if they smoke;
• they have an infection - see below, section "Infections".

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

If any of these symptoms are noticed, the patient should stop taking I S immediately and seek medical attention or call emergency services.

Infections

I S may mask the symptoms of infection, such as fever and pain. Therefore, I S may delay the use of appropriate infection treatment and lead to an 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 symptoms of the infection persist or worsen, they should consult a doctor immediately.

Long-term use of pain-relieving/anti-inflammatory medicines may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).

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. If gastrointestinal bleeding or ulceration occurs, the patient should stop taking the medicine immediately and consult a doctor. 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. Such patients should use the lowest effective dose.

Care should be taken when taking ibuprofen in patients taking other medicines that may increase the risk of stomach and intestinal disorders or bleeding, such as corticosteroids or anticoagulants, such as warfarin or acenocoumarol, or antiplatelet agents, such as acetylsalicylic acid.

Skin reactions

Severe skin reactions have been reported with I S.

If the patient experiences any of the following symptoms, they should stop taking I S and seek medical attention immediately, as they may be the first signs of a severe skin reaction: any skin rash, changes in mucous membranes, blisters, or other signs of allergy.

See section 4.

During ibuprofen treatment, severe skin reactions have occurred, 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). If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should stop taking I S and seek medical attention immediately.

The patient should consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Fertility in women

See section "Pregnancy, breastfeeding, and fertility".

Children and adolescents

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

In dehydrated patients - adolescents aged 12-18 years, there is a risk of kidney function disorders.

The elderly

In elderly patients, there is an increased risk of side effects. The frequency and severity of side effects can be reduced by using the lowest effective dose for the shortest possible duration.

I S and other medicines

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

I S may affect the action of other medicines or other medicines may affect the action of I S. For example:

• anticoagulant medicines (i.e., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Other medicines may also be affected or have an effect on I S treatment. Therefore, before taking I S with other medicines, the patient should always consult a doctor or pharmacist.

In particular, before taking I S, the patient should inform their doctor about taking any of the following medicines:

• acetylsalicylic acid in low doses (75 mg), once a day,
• other NSAIDs,
• antihypertensive or diuretic medicines,
• medicines that reduce blood clotting (anticoagulants, e.g., acenocoumarol or antiplatelet agents),
• corticosteroids (such as prednisolone or dexamethasone),
• methotrexate (an anticancer medicine),
• lithium (an antidepressant),
• zydovudine (an antiviral medicine).

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.

Pregnancy

I S should not be taken if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the mother and child and cause prolongation or delay of labour. During the first six months of pregnancy, the medicine should not be taken unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible duration. From the 20th week of pregnancy, I S may cause kidney function disorders in the unborn child if taken for more than a few days, which may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen may pass into breast milk in small amounts. Since there are no reports of harmful effects of ibuprofen on breastfed infants, breastfeeding does not need to be discontinued when taking ibuprofen in small doses for a short period.

Fertility

This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may have a negative effect on female fertility. This effect is temporary and disappears after the end of treatment.

Driving and using machines

There is no data on the effect of I S on the ability to drive and use machines, as well as on psychophysical fitness during treatment with the recommended doses and for the recommended duration.

I S contains sorbitol and sodium

The medicine contains 62.5 mg of sorbitol in each capsule. Sorbitol is a source of fructose. If the patient has been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should consult a doctor before taking the medicine or giving it to a child.

Quinoline yellow (E 104) and patent blue (E 131) in the capsule shell contain sodium. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take I S

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 a doctor or pharmacist.

The medicine is for short-term oral use. The recommended dose is:

Adults and adolescents over 12 years of age:initial dose 200 mg to 400 mg (1-2 capsules), if necessary, every 4 to 6 hours. The dose should not exceed 1200 mg (6 capsules) per day in divided doses.

The elderly: no dose adjustment is required (see section "Warnings and precautions").

The patient should use the lowest effective dose for the shortest duration necessary to relieve symptoms, which reduces the risk of side effects. 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 patient should consult a doctor if it is necessary to take the medicine for more than 3 days or if the symptoms worsen.

Use in children

The medicine should not be taken by children under 12 years of age.

Taking a higher dose of I S than recommended

If the patient has taken a higher dose of I S 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 the possible risk to their health and advice on what to do.

Symptoms may include nausea, stomach pain (abdominal pain), less frequently diarrhea, vomiting (may contain blood), headaches, ringing in the ears (tinnitus), disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, breathing problems, and gastrointestinal bleeding may occur.

Severe poisoning can cause central nervous system disorders, manifested by drowsiness, very rarely also excitement and disorientation or coma. Seizures may occur. During severe poisonings, metabolic acidosis may occur, and the prothrombin time (INR) may be increased. Acute kidney failure or liver damage may occur.

In patients with asthma, worsening of asthma symptoms may occur.

There is no specific antidote. Symptomatic and supportive treatment is used, consisting of cleansing the body. The doctor should monitor vital signs and consider oral administration of activated charcoal within 1 hour of overdose. In case of frequent or prolonged seizures, diazepam or lorazepam should be administered intravenously. In case of patients with asthma, bronchodilators should be administered.

Missing a dose of I S

The patient should not take a double dose to make up for a missed dose.

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

4. Possible side effects

Like all medicines, I S can cause side effects, although not everybody gets them.

With NSAID treatment in high doses, oedema, hypertension, and heart failure have been reported.

Taking pain-relieving/anti-inflammatory medicines like ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, especially when used in high doses.

If the patient experiences any of the following symptoms, they 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 centre, 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 fever, and enlarged lymph nodes (DRESS syndrome),
• red, scaly rash with nodules under the skin and blisters, usually located in skin folds, on the torso, and limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis).

Other possible side effects include:

Not very common(in 1 to 10 out of 1000 patients):

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

Rare(in 1 to 10 out of 10,000 patients):

• diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, excitement, irritability, and fatigue,
• oedema resulting from kidney and urinary disorders.

Very rare(less than 1 in 10,000 patients):

• tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease,
• peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding, and perforation, sometimes with a fatal outcome, especially in the elderly,
• in individual cases, the following have been reported: depression, psychotic reactions, and tinnitus, aseptic meningitis,
• reduced urine output, oedema, acute kidney failure, renal papillary necrosis, increased sodium levels in the blood (sodium retention),
• liver function disorders, especially during long-term use,
• blood count abnormalities (anaemia, leucopenia, thrombocytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial stomatitis, flu-like symptoms, fatigue, bleeding disorders (e.g., bruising, petechiae, purpura, nosebleeds),
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
• severe hypersensitivity reactions such as: facial, tongue, and laryngeal oedema, dyspnoea, tachycardia, hypotension; worsening of asthma and bronchospasm,
• in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) during ibuprofen treatment, individual cases of symptoms of aseptic meningitis have been reported, such as neck stiffness, headache, nausea, vomiting, fever, disorientation.

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

• chest pain, which may be a sign of a potentially serious allergic reaction known as Kounis syndrome,
• severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and an increased number of eosinophils (a type of white blood cell),
• red, scaly rash with nodules under the skin and blisters, usually located in skin folds, on the torso, and limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking I S and seek medical attention immediately. See also section 2,
• skin becomes sensitive to light.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products 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, more information can be collected on the safety of the medicine.

5. How to store I S

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

Store in a temperature below 25°C. Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.

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 pack and other information

What I S contains

• The active substance of the medicine is ibuprofen. One capsule contains 200 mg of ibuprofen.
• The other ingredients (excipients) are: macrogol 400, potassium hydroxide 50%, gelatine, sorbitol liquid partially dehydrated, quinoline yellow (E 104), patent blue (E 131).

What I S looks like and contents of the pack

Ibum S has the form of oval, transparent capsules of green colour, tightly filled with a solution, with a smooth, shiny surface.

One pack of the medicine contains 2, 4, 6, 7, 10, 15, 30, 45, or 60 soft capsules, in a cardboard box.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.

51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

tel.: 22 742 00 22

e-mail: [email protected]

Date of last revision of the leaflet: