Ibuprom max sprint

Package leaflet: Information for the user

IBUPROM MAX SPRINT
400 mg soft capsules
Ibuprofenum
Please read the entire 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
the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions 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, consult your doctor.

Table of contents

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

The medicine contains ibuprofen – an active substance belonging to the group of so-called
non-steroidal anti-inflammatory drugs (NSAIDs). It is an analgesic medicine.
It helps combat inflammation, which is one of the causes of pain. The medicine also reduces fever.
Indications for use include acute mild to moderate pain of various origins: headaches (including tension-type headache), migraine with or without aura (symptoms such as: headache, nausea, sensitivity to light and sound), toothache, neuralgia, muscle 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 the active substance or to any of the other ingredients of this medicine (listed in section 6).
• In patients who have previously experienced allergic reactions such as rhinitis, urticaria, or bronchial asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If the patient has any of the following conditions:
  • active or past peptic ulcer of the stomach and/or duodenum,
  • gastrointestinal bleeding or perforation (including cases occurring after use of non-steroidal anti-inflammatory drugs),
  • severe liver failure,
  • severe kidney failure,
  • severe heart failure,
  • bleeding tendency (haemorrhagic diathesis).
• During treatment with other non-steroidal anti-inflammatory drugs, including drugs from the group known as COX-2 inhibitors.
• During the third trimester of pregnancy.

Warnings and precautions
Before starting treatment, discuss this with your doctor or pharmacist.
When to exercise special caution when using

• If the patient has been diagnosed with systemic lupus erythematosus or mixed connective tissue disease.
• If the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease). Gastrointestinal bleeding, ulceration, or perforation may occur during treatment—complications that can be life-threatening and may not always be preceded by warning symptoms. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately and consult a doctor. Patients with a history of gastrointestinal disorders, especially elderly individuals, should inform their doctor about any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial period of treatment.

Taking anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack 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 heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has experienced any stroke (including mini-stroke or transient ischaemic attack – TIA).
• The patient has high blood pressure, diabetes, elevated 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 have included symptoms such as difficulty breathing, facial and neck swelling (angioedema), and chest pain. If any of these symptoms occur, stop taking the medicine immediately and contact a doctor or emergency medical services without delay.

Serious skin reactions have occurred during treatment with ibuprofen, including 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 related to 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. As a result, it may delay the initiation of appropriate treatment for infection and consequently 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.

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 occur, consult a doctor.

• If the patient has been diagnosed with kidney, liver, or blood clotting disorders.
• If the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids); this may increase the risk of gastrointestinal disturbances or bleeding.
• If the patient has active or past bronchial asthma or a history of allergic reactions; bronchospasm may occur after taking the medicine.
• If the patient is taking multiple painkillers simultaneously over a long period; this may lead to kidney damage with risk of kidney failure (so-called analgesic nephropathy).
• Use of the medicine in dehydrated patients (including children and adolescents) increases the risk of kidney function impairment.
• If a woman is trying to conceive, she should consult a doctor before taking ibuprofen. This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of the medicine.

Children
This medicine should not be given to children under 12 years of age.
Medicine and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

This 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 blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine),
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan),
• diuretics,
• other non-steroidal 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 medicine),
• zidovudine (an antiviral medicine),
• digoxin (a cardiac medicine),
• cyclosporine, tacrolimus (immunosuppressive medicines),
• mifepristone.

Some other medicines may also be affected by or may affect 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.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take the medicine if the patient is in the last three 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 increase the tendency to bleeding in both mother and child and may delay or prolong labour. During the first six months of pregnancy, the medicine should not be used unless a doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible time. From week 20 of pregnancy, if the medicine is taken for longer than a few days, it may lead to kidney problems in the unborn child (which may result in low levels of amniotic fluid surrounding the baby – oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
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 for the treatment of pain and fever.
Fertility
Effect of the medicine on fertility – see section Warnings and precautions.
Driving and using machines
There is no data available on the effect of the medicine on the ability to drive, operate machinery, or on psycho-physical performance when used at the 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 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 take this medicine

This medicine should always be taken exactly 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 aged 12 years and over
For short-term treatment: 1 capsule orally every 4 hours (do not exceed 3 capsules in 24 hours). 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).
The capsule should, if necessary, be taken with liquid. Do not chew the capsules.
Children under 12 years of age
This medicine must not be given to children under 12 years of age.
Elderly patients
Dosage adjustment is not required.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If treatment longer than 3 days is needed or if the patient's condition worsens, consult a doctor.
Taking more medicine than recommended
If a patient has taken more than the recommended dose, or if a child accidentally ingests the medicine, always consult a doctor or go to the nearest hospital to assess possible health risks and receive advice on appropriate actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see section 4 below), diarrhoea, headache, tinnitus, confusion and vertigo. There may also be restlessness, drowsiness, disorientation or coma. Seizures have been reported rarely. 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 of coldness and breathing difficulties may occur. In addition, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute kidney failure and liver damage may also occur. In asthmatics, asthma may be exacerbated. In addition, low blood pressure and breathing difficulties may occur.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.
If a dose is missed
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur in a patient, ibuprofen should be discontinued immediately and medical help sought:

• Red, flat, target-like or circular spots on the trunk, often with blisters in the center, peeling skin, mouth ulcers, 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 enlarged lymph nodes (DRESS syndrome).
• Red, widespread rash with scaling, subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

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

• Dyspepsia, abdominal pain, nausea;
• Headache;
• Urticaria, itching.

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

• Diarrhea, bloating, constipation, vomiting, gastritis;
• Dizziness, insomnia, restlessness, irritability and feeling tired;
• Edema.

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

• Gastric and/or duodenal ulceration, gastrointestinal bleeding (manifested, among others, by tarry stools or bloody vomiting), perforation, exacerbation of colitis and Crohn's disease, ulcerative stomatitis;
• Depression, psychotic reactions;
• Tinnitus;
• Aseptic meningitis (particularly in patients with autoimmune diseases: systemic lupus erythematosus, mixed connective tissue disease);
• Decreased urine output, renal failure (including interstitial nephritis), renal papillary necrosis;
• Liver function abnormalities, particularly during prolonged use, liver failure, acute hepatitis;
• Blood morphology disorders (anemia, leukopenia - reduced white blood cell count, thrombocytopenia - reduced platelet count, pancytopenia - hematological disorder characterized by deficiency of all normal blood cells: erythrocytes and platelets, agranulocytosis - reduced granulocyte count); initial symptoms include: fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, bleeding (e.g. bruising, petechiae, purpura (appearance of small reddish spots and nodules on the skin), nosebleeds);
• Severe hypersensitivity reactions, such as: facial, tongue and laryngeal swelling, shortness of breath, rapid heartbeat, sudden drop in blood pressure, anaphylactic shock (sudden drop in blood pressure accompanied by pallor, loss of consciousness, sweating); asthma exacerbation and bronchospasm;
• Hypertension.

Adverse reactions occurring with unknown frequency (frequency cannot be estimated from available data):

• Increased serum sodium concentration.
• Skin becomes photosensitive.
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Treatment with NSAIDs at high doses has been associated with edema and heart failure.
Use of such drugs may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a physician or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 the medicine

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use after the expiry date stated on the outer carton and immediate packaging (month/year).
Blister labelling: EXP – expiry date, Lot – batch number.
Medicines should 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 the medicine contains
The active substance is ibuprofen.
Each soft capsule contains 400 mg of ibuprofen.
The other ingredients are: macrogol 600, potassium hydroxide, gelatin, sorbitol liquid,
partially dehydrated, purified water.

What the medicine looks like and contents of the pack
Oral capsules, packed in PVC/PE/PVDC/Aluminium blisters and cardboard box.
Oral capsules, packed in PVC/PVDC/Aluminium blisters and cardboard box.

Pack sizes
10 capsules - 1 blister containing 10 capsules
20 capsules - 2 blisters containing 10 capsules each
30 capsules - 3 blisters containing 10 capsules each
40 capsules - 4 blisters containing 10 capsules each

Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50 - 507 Wrocław
For further information on this medicine, please contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02 - 822 Warszawa
tel.: +48 22 543 60 00