Patient Information Leaflet

IBUM SPRINT
200 mg, soft capsules
Ibuprofen
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, you should consult your doctor.

Contents of the leaflet

What I S is and what it is used for
What you need to know before taking I S
How to take I S
Possible side effects
How to store I S
Contents of the pack and other information

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

I S contains ibuprofen – a substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic and anti-inflammatory properties. The indications for use of I S are:

Mild to moderate pain of various origins:
- Headaches (including migraines)
- Toothaches
- Muscular, joint and bone pain
- Pain following injuries
- Neuralgic pain
- Pain associated with cold and flu
Painful menstruation
Fever of various causes (e.g. during flu, cold or other infectious diseases)

2. Important information before using Ibum Sprint

When not to use Ibum Sprint

if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
in patients with active or past peptic ulceration or gastrointestinal bleeding, perforation, or history of gastrointestinal bleeding or perforation associated with previous nonsteroidal anti-inflammatory drugs (NSAIDs);
in patients who have previously experienced allergic reactions such as rhinitis, urticaria or bronchial asthma during treatment with acetylsalicylic acid or other NSAIDs;
in patients with severe hepatic insufficiency, severe renal insufficiency or severe heart failure;
in patients concurrently taking other nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of adverse effects);
during the last three months of pregnancy;
in patients with bleeding disorders.

Warnings and precautions
Before using Ibum Sprint, consult your doctor or pharmacist.
Exercise particular caution when using Ibum Sprint:

if the patient has systemic lupus erythematosus or mixed connective tissue disease;
if the patient has experienced allergic reactions after taking acetylsalicylic acid;
if the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (such as ulcerative colitis or Crohn's disease);
if the patient has hypertension and/or cardiac dysfunction;
if the patient has renal dysfunction;
if the patient has hepatic dysfunction;
if the patient has coagulation disorders (ibuprofen may prolong bleeding time);
if the patient has active or past bronchial asthma or allergic reactions, as the drug may cause bronchospasm;
in patients taking other medications (especially anticoagulants, diuretics, cardiac medications or corticosteroids).

Patients who have previously experienced hypertension and/or heart failure
should exercise particular caution and consult their doctor or pharmacist before
using the medicine, as fluid retention, hypertension and oedema have been reported during NSAID treatment.
The use of anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with
a small increased risk of myocardial infarction or stroke, particularly when used at high
doses. Do not exceed the recommended dose or duration of treatment.
Before using Ibum Sprint, the patient should discuss treatment with a doctor or
pharmacist if:

the patient has heart disease, such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischaemic attack - TIA);
the patient has hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes;
the patient has an infection – see below, section titled "Infections".

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported.
If any of these symptoms occur, discontinue Ibum Sprint immediately and
contact a doctor or emergency medical services without delay.
Infections
Ibum Sprint may mask symptoms of infection such as fever and pain. Consequently, Ibum Sprint
may delay appropriate treatment of infection and thereby increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an existing infection and symptoms persist or worsen, medical advice should be sought immediately.
Prolonged, concomitant use of painkillers may lead to kidney damage with risk of renal failure (analgesic nephropathy).
There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and which may occur without warning symptoms or in patients with prior warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be discontinued immediately and medical advice sought. Patients with a history of gastrointestinal disorders, particularly elderly patients, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, particularly during the initial phase of treatment. Such patients should use the lowest effective dose.
Exercise caution when using ibuprofen in patients concurrently taking other medicines that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulants such as warfarin or acenocoumarol, or antiplatelet agents such as acetylsalicylic acid.
Skin reactions
Serious skin reactions have been reported with the use of Ibum Sprint.
If any skin rash, mucosal lesions, blisters or other allergic symptoms appear, stop taking Ibum Sprint immediately and seek medical help promptly, as these may be early signs of a very serious skin reaction. See section 4.
Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported with ibuprofen. If the patient experiences any of the symptoms associated with these serious skin reactions described in section 4, Ibum Sprint should be discontinued immediately and medical help sought.
Consult your doctor, even if the above warnings relate to conditions that occurred in the past.
Effect on fertility in women
See section "Pregnancy, breastfeeding and effect on fertility".
Children and adolescents
This medicine is not recommended for use in children under 12 years of age.
In dehydrated adolescents aged 12–18 years, there is a risk of impaired renal function.
Elderly patients
Elderly patients have an increased risk of adverse effects.
The frequency and severity of adverse effects can be reduced by using the lowest effective dose for the shortest possible duration.
Ibum Sprint and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used or planned to be used.
Ibum Sprint may affect the action of other medicines or other medicines may affect
the action of Ibum Sprint. 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-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan).

Also, some other medicines may be affected by or may affect treatment with Ibum Sprint. Therefore, always consult your doctor or pharmacist before taking Ibum Sprint with other medicines.
In particular, before taking Ibum Sprint, inform your doctor if you are taking any of the following medicines:

low-dose acetylsalicylic acid (75 mg) once daily;
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 medicine);
zidovudine (an antiviral medicine).

Pregnancy, breastfeeding and effect on fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take Ibum Sprint if you are 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 both mother and child and may delay or prolong labour.
Do not use this medicine during the first six months of pregnancy unless strictly necessary and prescribed by your doctor. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibum Sprint may cause renal dysfunction in the unborn child if taken for more than a few days, which may lead to reduced amniotic fluid volume (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts. As there are no reports of harmful effects of ibuprofen on infants, interruption of breastfeeding is not necessary during short-term use of low-dose ibuprofen.
Fertility
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) which may temporarily impair fertility in women. This effect is reversible and resolves after stopping treatment.
Driving and using machines
There are no data on the effect of Ibum Sprint on the ability to drive and operate machinery or on psycho-physical performance when used at the recommended doses and for the recommended duration.
Ibum Sprint contains sorbitol and sodium
The medicine contains 62.5 mg of sorbitol per capsule. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, the patient should consult a doctor before taking the medicine or giving it to a child.
Quinoline yellow (E 104) and patent blue (E 131) present in the capsule shell contain sodium. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Ibum Sprint

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is for short-term oral use. The recommended dose is:
Adults and adolescents over 12 years of age: initial dose of 200 mg to 400 mg (1-2 capsules), if necessary, every 4 to 6 hours. Do not exceed a dose of 1200 mg (6 capsules) per day in divided doses.
Elderly patients: no dose adjustment is required (see section "Warnings and precautions").
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. This reduces the risk of adverse effects. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Consult a doctor if treatment with this medicine is required for more than 3 days or if symptoms worsen.
Use in children
This medicine should not be used in children under 12 years of age.
Taking more than the recommended dose of Ibum Sprint
If a patient takes more than the recommended dose of Ibum Sprint or if a child accidentally ingests the medicine, always contact a doctor or go to the nearest hospital for assessment of potential health risks and advice on appropriate actions.
Symptoms may include nausea, stomach pain (epigastric pain), less commonly diarrhea, vomiting (possibly with blood), headache, ringing in the ears (tinnitus), disorientation, and nystagmus. After a large overdose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, feeling cold, breathing difficulties, and gastrointestinal bleeding may occur.
Severe poisoning may cause central nervous system disturbances, such as drowsiness, very rarely excitement, disorientation, or coma. Seizures may very rarely occur. In severe cases, metabolic acidosis may develop and prothrombin time (INR) may be prolonged. Acute kidney failure or liver damage may occur.
In patients with asthma, worsening of asthma symptoms may occur.
There is no specific antidote. Treatment is symptomatic and supportive, including decontamination of the body. The doctor should monitor vital signs and consider administering activated charcoal orally within 1 hour of overdose. In cases of frequent or prolonged convulsions, intravenous diazepam or lorazepam should be administered. In patients with asthma, bronchodilators should be given.
Missed dose of Ibum Sprint
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 experiences them.
Treatment with high-dose NSAIDs has been associated with occurrence of
edema, hypertension, and heart failure.
Use of medicines such as ibuprofen may be associated with a small increased risk of
heart attack (myocardial infarction) or stroke.
If any of the following symptoms occur in the patient, ibuprofen must be discontinued immediately and medical help should be sought:

red, flat, target-like or circular skin lesions, often with blisters in the center, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs, 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 subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Other possible adverse reactions include:
Not common (in 1 to 10 out of 1,000 patients):

headache, dyspepsia, abdominal pain, nausea, urticaria, itching.

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

diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, restlessness, irritability, and feeling of fatigue,
edema due to kidney and urinary tract disorders.

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

black, tarry stools, vomiting blood, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease,
gastric and (or) duodenal ulcer disease, gastrointestinal bleeding and perforation, sometimes fatal, particularly in elderly patients,
in isolated cases: depression, psychotic reactions, tinnitus, aseptic meningitis,
decreased urine output, edema, acute renal failure, papillary necrosis, increased serum sodium concentration (sodium retention),
liver function disorders, particularly during long-term use,
blood morphology abnormalities (anemia, leukopenia - reduced white blood cell count, thrombocytopenia - reduced platelet count, agranulocytosis - reduced granulocyte count). Initial symptoms include: fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, hemorrhagic diathesis (e.g. bruising, petechiae, purpura, nosebleeds),
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
severe hypersensitivity reactions such as: facial, tongue and laryngeal swelling, dyspnea, tachycardia - cardiac arrhythmia, hypotension - sudden drop in blood pressure, shock; exacerbation of asthma and bronchospasm,
in patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms occurring in aseptic meningitis have been reported,

such as neck stiffness, headache, nausea, vomiting, fever, disorientation.
Frequency unknown (frequency cannot be estimated from available data):

chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome,
severe skin reactions known as DRESS syndrome. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell),
red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the medication must be discontinued immediately and medical help should be sought without delay. See also section 2,
skin becomes sensitive to light.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ibum Sprint

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep 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 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 I S contains

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

What I S looks like and contents of the pack
Ibum S is in the form of oval, transparent green capsules, hermetically filled with a solution, having a smooth, glossy surface.
One package contains 2, 4, 6, 7, 10, 15, 30, 45 or 60 soft capsules in a cardboard box.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information on the medicinal product
tel.: 22 742 00 22
e-mail: [email protected]