Package leaflet: Information for the patient

IBUPROM SPRINT
200 mg, soft capsules
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be taken 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 adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse after 3 days, you should consult your doctor.

Contents of the leaflet

What the medicine is and what it is used for
Important information before use
How to take the medicine
Possible side effects
How to store the medicine
Contents of the pack and other information

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

This medicine is an analgesic. It is used in the treatment of inflammatory conditions,
which are one of the causes of pain. The medicine reduces fever.
Indications:
Mild to moderate pain of various origins, including: headache, toothache, muscle pain,
lumbosacral pain, bone and joint pain.
Painful menstruation.
Fever (e.g. associated with influenza, colds or other infectious diseases).

2. Important information before using the medicine

When not to use the medicine:

if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), or to other non-steroidal anti-inflammatory drugs (NSAIDs);
if symptoms of allergy such as rhinitis, urticaria or bronchial asthma have ever occurred in the past after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
in patients with active or previous peptic ulcer of the stomach and/or duodenum, perforation or gastrointestinal bleeding, including those occurring after use of NSAIDs;
in patients with severe liver failure, severe renal failure or severe heart failure;
in patients currently taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of adverse effects);
during the last 3 months of pregnancy;
in case of bleeding tendency. Page 1 of 7

Warnings and precautions
Before starting treatment, discuss this with your doctor or pharmacist.
Exercise particular caution when using the medicine

if the patient has systemic lupus erythematosus or mixed connective tissue disease,
if symptoms of allergic reactions occurred after taking acetylsalicylic acid,
if the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
if the patient has hypertension and/or heart function disorders,
if the patient has renal function disorders,
if the patient has hepatic function disorders,
if the patient has blood coagulation disorders,
if the patient has active or previous bronchial asthma or history of allergic reactions; bronchospasm may occur after taking the medicine,
if the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).

There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and which may occur without warning symptoms or in patients who previously experienced such warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with a history of gastrointestinal disorders, particularly elderly individuals, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial period of treatment.
Concurrent, long-term use of various painkillers may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Use of the medicine in dehydrated adolescents increases the risk of renal function impairment.
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 the medicine, the patient should discuss treatment with a doctor or pharmacist if:

the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or history of any stroke (including mini-stroke or transient ischemic attack - TIA).
the patient has hypertension, diabetes, elevated cholesterol levels, 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 have occurred, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. If any of these symptoms occur, discontinue the medicine immediately and contact a doctor or emergency medical services without delay.
Do not use higher doses or longer treatment duration than recommended. If symptoms persist, worsen, or do not resolve within 3 days, or if new symptoms appear, contact a doctor.
Skin reactions
Serious skin reactions have occurred with the use of 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 any of the symptoms associated with these serious skin reactions described in section 4 occur, discontinue the medicine immediately and seek medical help.
Infections
The medicine may mask symptoms of infection such as fever and pain. Consequently, it 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 ongoing infection and infection symptoms persist or worsen, immediate consultation with a doctor is required.
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) which may adversely affect fertility in women. This effect is reversible and disappears after discontinuation of treatment. In case of difficulty in becoming pregnant, consult a doctor before taking ibuprofen.
Consult a doctor even if the above warnings refer to conditions that occurred in the past.
Children
The medicine is not indicated for children under 12 years of age.
Medicine and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
Do not take this medicine simultaneously with other medicines from the group of non-steroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (at analgesic doses).
The medicine may affect the action of other medicines or other medicines may affect the action of this medicine. Such medicines include, for example:

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

Some other medicines may also interact with or influence treatment with this medicine.
Therefore, always consult a doctor or pharmacist before using this medicine with other medicines.
With food and drink
It is recommended to take the medicine after a meal.
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Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not take the medicine 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 function disorders in the unborn child.
It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. During the first 6 months of pregnancy, do not use the medicine unless the doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, if the medicine is taken for longer than a few days, it may result in impaired kidney function in the unborn child (which may lead to low levels of amniotic fluid surrounding the baby - oligohydramnios), or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.
Ibuprofen passes into breast milk in very small amounts and there are no known cases of adverse effects in breastfed infants.
There is no need to interrupt breastfeeding during short-term use of ibuprofen at low doses.
Driving and operating machinery
There are no data on the effect of the medicine on the ability to drive vehicles, operate machinery or psycho-physical performance when used at the recommended doses and for the recommended duration.
The medicine contains sorbitol
The medicine contains 26.24 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 patient's body cannot break down fructose, the patient should consult a doctor before taking the medicine.

3. How to use the medicine

This medicine should always be used as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents over 12 years of age:
For short-term treatment: 1 to 2 capsules orally every 4 hours after meals.
Do not exceed a dose of 6 capsules per day (maximum daily dose 1200 mg in divided doses).
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
This medicine should not be used in children under 12 years of age.
Do not exceed the recommended dose.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
This medicine is intended for short-term use. If symptoms persist or worsen, or if new symptoms occur, contact your doctor.
Do not take the medicine for longer than 3 days without consulting a doctor.
Taking more medicine than recommended
If a patient has taken more than the recommended dose, or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital to assess potential health risks and receive advice on actions to take.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see section 4 below), diarrhoea, headache, tinnitus, confusion and vertigo. Agitation, drowsiness, disorientation or coma may also occur. Seizures have been reported occasionally in patients. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold and breathing difficulties may occur. In addition, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In asthmatics, asthma exacerbation is possible. In addition, low blood pressure and breathing difficulties may occur.
There is no specific antidote. The doctor will administer symptomatic and supportive treatment.
Missed dose
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although
not everyone experiences them.
You should stop taking ibuprofen and seek immediate medical help if
any of the following symptoms occur:

red, flat, target-like or circular spots on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, in the 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 body temperature and swollen 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).

Adverse reactions occurring not very commonly (in 1 to 10 out of 1,000 patients taking the medicine):

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

Adverse reactions occurring rarely (in 1 to 10 out of 10,000 patients taking the medicine):

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

Adverse reactions occurring very rarely (less than 1 in 10,000 patients
taking the medicine):

black tarry stools, vomiting blood, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease;
gastric and (or) duodenal ulcer, gastrointestinal bleeding and perforation, sometimes fatal, particularly in elderly patients;
in isolated cases: depression, psychotic reactions and tinnitus, aseptic meningitis (manifesting as neck stiffness, headache, nausea, vomiting, fever or disturbances of consciousness). If such symptoms occur, contact a doctor immediately.
reduced urine output, oedema, acute renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention);
liver function disorders, particularly during prolonged use;
disturbances in the production of various blood cells (reduced number of red blood cells, platelets, certain types of white blood cells - leukocytes, absence of a certain type of white blood cells - granulocytes, and pancytopenia - a disorder characterized by deficiency of all blood cells): initial symptoms include fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g. bruises, petechiae, purpura, nosebleeds). In such cases, treatment must be discontinued and immediate contact with a doctor is required. These symptoms must not be treated with analgesics or antipyretics.
severe allergic reactions such as: facial, tongue and laryngeal swelling, shortness of breath, tachycardia - heart rhythm disturbances, hypotension - sudden drop in blood pressure, shock; worsening of asthma and bronchospasm;
in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms typical of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever, disorientation have been reported during ibuprofen treatment.

Adverse reactions with unknown frequency (frequency cannot be determined 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 use of NSAIDs, oedema, hypertension and heart failure have been reported. Use of such medicines may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

When the medicine is used occasionally, adverse reactions occur rarely.
Elderly patients have an increased risk of adverse reactions associated with ibuprofen use compared to younger patients. The frequency and severity of adverse reactions can be reduced by using the lowest therapeutic dose for the shortest possible duration.
Other adverse reactions may occur in some individuals during treatment.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
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 the medicine

Keep the medicine below 25°C.
Store in a place out of sight and reach of children.
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Do not use after the expiry date stated on the outer carton and immediate packaging (month/year).
The following labelling applies to the blister: EXP - expiry date, Lot - batch number.

6. Contents of the pack and other information

What the medicine contains
The active substance is ibuprofen. Each soft capsule contains 200 mg of ibuprofen.
Excipients:
Core composition: Macrogol 600, potassium hydroxide, purified water,
Capsule shell composition: gelatin, sorbitol liquid partially dehydrated, patent blue V.
What the medicine looks like and contents of the pack
Oval-shaped, blue capsule.
Available pack sizes:
2 pcs, 4 pcs, 6 pcs, 10 pcs, 12 pcs, 24 pcs, 30 pcs, 40 pcs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
US Pharmacia Sp. z o.o.
Ziębicka 40 Street
50 - 507 Wrocław
For further information about this medicine, please contact:
USP Zdrowie Sp. z o.o.
Poleczki 35 Street
02 - 822 Warsaw
Tel.: +48 22 543 60 00
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