Ibuprofen
Ibuprofen Hasco contains ibuprofen, a substance from the group of non-steroidal anti-inflammatory drugs (NSAIDs), with analgesic, antipyretic, and anti-inflammatory effects.
The indications for use of the medicine are:
Before starting treatment with Ibuprofen Hasco, you should discuss it with your doctor or pharmacist.
You should be particularly careful when taking Ibuprofen Hasco:
You should avoid taking Ibuprofen Hasco at the same time as other non-steroidal anti-inflammatory drugs (including selective cyclooxygenase-2 inhibitors, such as celecoxib or etoricoxib), as this increases the risk of side effects.
Patient with a history of gastrointestinal diseases, especially elderly patients, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, especially during the initial treatment period.
You should be particularly careful and consult a doctor or pharmacist before taking the medicine if you have:
During treatment with ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling in the face and neck area (angioedema), chest pain.
If you notice any of these symptoms, you should stop taking Ibuprofen Hasco immediately and contact a doctor or medical emergency services immediately.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and do 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, ibuprofen treatment should be discontinued. Patients with a history of gastrointestinal diseases, especially elderly patients, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, especially during the initial treatment period. These patients should use the smallest effective dose of the medicine.
You should be careful when taking ibuprofen with other medications that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulant medications (such as acenocoumarol or heparin), selective serotonin reuptake inhibitors, or antiplatelet agents such as acetylsalicylic acid.
Ibuprofen may cause sodium, potassium, and fluid retention in patients who have not previously had kidney disease. This can lead to edema or even heart failure or hypertension in patients with a predisposition to these disorders.
Long-term use of ibuprofen, especially in combination with other painkillers, can cause permanent kidney damage and increase the risk of kidney failure.
Patient with the highest risk of such reactions are those with kidney function disorders, heart failure, liver function disorders, taking diuretic and antihypertensive medications (ACE inhibitors), and elderly patients. Patients who discontinue treatment with NSAIDs generally return to their pre-treatment state.
Skin reactions
Severe skin reactions have been reported with the use of Ibuprofen Hasco. If you experience:
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP) have been reported with the use of ibuprofen. If a patient experiences any of the symptoms associated with these severe skin reactions described in section 4, they should stop taking Ibuprofen Hasco immediately and seek medical attention.
In the case of long-term treatment with ibuprofen, periodic monitoring of liver and kidney function, as well as blood cell count, is necessary, especially in patients at high risk.
Infections
Ibuprofen Hasco may mask the symptoms of infection, such as fever and pain. Therefore, Ibuprofen Hasco may delay the use of appropriate infection treatment and consequently lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If a patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should consult a doctor immediately.
During long-term treatment with high doses of painkillers, headaches may occur, which should not be treated with increased doses of painkillers.
Ibuprofen may temporarily inhibit platelet aggregation and prolong bleeding time. Therefore, patients with bleeding disorders or those taking anticoagulant medications should be closely monitored.
You should avoid consuming alcohol while taking the medicine, as it may increase the risk of side effects, especially those related to the gastrointestinal tract and nervous system.
Fertility in women
See section "Pregnancy, breastfeeding, and fertility".
Children and adolescents
In dehydrated patients - children and adolescents, there is a risk of kidney function disorders.
Elderly patients
In elderly patients, there is an increased risk of side effects caused by the use of NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 3).
Taking the medicine in the smallest effective dose for the shortest period necessary to alleviate symptoms reduces the risk of side effects.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should avoid taking Ibuprofen Hasco if you are taking other non-steroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors, such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (in analgesic doses).
Ibuprofen Hasco may affect the action of other medicines or other medicines may affect the action of Ibuprofen Hasco. For example:
Some other medicines may also be affected or have an effect on Ibuprofen Hasco treatment. Therefore, before taking Ibuprofen Hasco with other medicines, you should always consult a doctor or pharmacist.
In particular, before taking ibuprofen, you should inform your doctor about taking any of the following medicines:
Some anticoagulant medications (e.g., acetylsalicylic acid, acenocoumarol, warfarin, ticlopidine), some antihypertensive medications (e.g., ACE inhibitors, such as captopril, beta-blockers, or angiotensin II receptor antagonists), and some other medications may be affected or have an effect on ibuprofen. Therefore, before taking ibuprofen with other medications, you should always consult a doctor.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking this medicine.
Pregnancy
You should not take Ibuprofen Hasco 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 disorders in the unborn child. It may increase the risk of bleeding in the mother and child and cause delayed or prolonged labor. During the first six months of pregnancy, you should not take the medicine unless it is absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, you should take the smallest effective dose for the shortest possible time. From the 20th week of pregnancy, Ibuprofen Hasco may cause kidney function disorders in the unborn child, and if taken for more than a few days, it 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, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts. With short-term use of ibuprofen in doses used to treat pain and fever, harmful effects on infants are unlikely. However, if long-term use of ibuprofen is necessary, you should consider stopping breastfeeding.
Fertility
Ibuprofen may make it more difficult to become pregnant. If you are planning to become pregnant or are having trouble becoming pregnant, you should inform your doctor.
Ibuprofen Hasco generally does not affect the ability to drive or use machines. However, side effects caused by high doses of the medicine, such as fatigue, drowsiness, dizziness (reported frequently), and vision disturbances (reported infrequently), may impair the ability to drive or use machines in individual cases. This effect may be enhanced by concurrent alcohol consumption.
The medicine contains 62.5 mg of sorbitol in each capsule. Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you 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 the medicine is considered "sodium-free".
This medicine should always be taken according to the doctor's or pharmacist's recommendations. If you have any doubts, you should consult a doctor or pharmacist.
The medicine is taken orally.
Ibuprofen Hasco should always be taken according to the doctor's recommendations. The dose of ibuprofen depends on the patient's age and body weight.
You should take the smallest effective dose for the shortest period necessary to alleviate symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen during treatment, you should consult a doctor immediately (see section 2).
The medicine is intended for patients with a body weight over 20 kilograms (approximately 6 years of age).
Mild to moderate pain and fever
Adults and adolescents over 12 years of age (with a body weight ≥ 40 kg):
The initial dose is 1 to 2 capsules (200 mg - 400 mg of ibuprofen).
Then, if necessary, 1 (200 mg) to 2 (400 mg) capsules every 4 (for a dose of 200 mg) to 6 hours (for a dose of 400 mg). The maximum daily dose should not exceed 1200 mg (6 capsules).
Dosing for migraines: 400 mg (2 capsules) given as a single dose, if necessary 400 mg given every 4 to 6 hours. The maximum daily dose should not exceed 1200 mg (6 capsules).
Children aged 6-12 years (with a body weight > 20 kg):
Children aged 6-9 years (20-29 kg): the daily dose is usually 20 mg/kg of body weight in divided doses, the initial dose is 200 mg (1 capsule). Then, if necessary, 1 capsule every 8 hours. The maximum daily dose is 3 capsules (600 mg of ibuprofen).
Children aged 10-12 years (with a body weight of 30-39 kg): the initial dose is 200 mg (1 capsule). Then, if necessary, 1 capsule every 6 hours. The maximum daily dose is 4 capsules (800 mg of ibuprofen).
Painful menstruation
Adults and adolescents over 12 years of age:
200-400 mg (1-2 capsules), 1-3 times a day as needed, every 4 to 6 hours. The maximum daily dose should not exceed 1200 mg (6 capsules).
Symptomatic treatment of degenerative joint disease and rheumatoid arthritis (including juvenile rheumatoid arthritis):
Adults and adolescents over 12 years of age:
The usual dose is 400-600 mg (2-3 capsules) 3 times a day. A maintenance dose of 600-1200 mg (3-6 capsules) may be effective in some patients. In acute and severe conditions, the dose may be increased to a maximum of 2400 mg (12 capsules) in 3 or 4 divided doses. After clinical improvement, the dose should be reduced to the smallest effective dose.
Children aged 6-12 years with juvenile rheumatoid arthritis:
The recommended dose is 20 mg/kg of body weight to 40 mg/kg of body weight per day in 3 or 4 divided doses. After improvement, the dose should be reduced to the smallest effective dose.
Elderly patients:
Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with caution, especially in elderly patients, who are more prone to side effects and potentially fatal gastrointestinal bleeding, ulcers, and perforation.
If treatment is necessary, Ibuprofen Hasco should be used in the smallest doses for the shortest period necessary to control symptoms. Treatment should be regularly reassessed and discontinued if no benefit is observed or if signs of intolerance appear.
Kidney function disorders:
In patients with mild to moderate kidney function disorders, the dose should be as small as possible and used for the shortest period necessary to control symptoms and monitor kidney function.
Liver function disorders:
In patients with mild to moderate liver function disorders, the dose should be as small as possible and used for the shortest period necessary to control symptoms and monitor liver function.
If symptoms worsen despite treatment, you should consult a doctor.
If you have taken more than the recommended dose of Ibuprofen Hasco or if a child has accidentally taken the medicine, you 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.
Symptoms may include nausea, stomach pain (abdominal pain), diarrhea, vomiting (which may contain blood), headache, ringing in the ears (tinnitus), dizziness, and disorientation. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness may occur. In addition, blood in the urine, feeling cold, breathing difficulties, and gastrointestinal bleeding may occur.
Overdose cases are rare.
In children, taking a single dose of more than 400 mg (2 capsules) may cause overdose symptoms. In adults, the dose that may cause such symptoms has not been precisely determined.
Severe poisoning can cause central nervous system disorders, manifested as drowsiness, very rarely also agitation and disorientation or coma. Very rarely, seizures may occur. In children, myoclonic seizures (repeated muscle contractions) may occur.
During severe poisonings, metabolic acidosis (a disorder of acid-base balance) may occur, and the prothrombin time (a parameter related to blood clotting) may be increased. Acute kidney failure, liver damage, hypotension, respiratory failure, or cyanosis may occur.
In patients with asthma, worsening of asthma symptoms may occur.
There is no specific antidote (antidote). Treatment is symptomatic and supportive, involving cleansing of the body. The doctor should monitor vital signs and consider oral administration of activated charcoal within 1 hour of overdose.
If overdose symptoms occur, you should stop taking the medicine immediately and consult a doctor.
You should not take a double dose to make up for a missed dose.
If you have any further doubts about taking the medicine, you should consult a doctor.
Like all medicines, Ibuprofen Hasco can cause side effects, although not everybody gets them.
The list of side effects below includes all side effects observed during treatment with ibuprofen, including those occurring during long-term therapy with high doses, used in patients with rheumatic diseases.
Regarding the side effects of the medicine, it should be remembered that they are largely dose-dependent, and their occurrence is individually variable.
If a patient experiences any of the following symptoms, they should stop taking ibuprofen and seek medical attention immediately:
red, non-raised, target-like, or circular spots 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 rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
The most common side effects observed are related to the gastrointestinal tract. Ulcers, perforation, or gastrointestinal bleeding may occur, which can be fatal, especially in elderly patients. These side effects do not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs.
The risk of gastrointestinal bleeding is particularly dependent on the dose range and duration of ibuprofen use.
Taking ibuprofen, especially long-term and in high doses (2400 mg per day), may be associated with a slight increase in the risk of arterial thrombosis (e.g., heart attack or stroke).
Other possible side effects include:
Infrequent(occurring in 1 to 10 out of 1000 patients):
Rare(occurring in 1 to 10 out of 10,000 patients):
Very rare(occurring in less than 1 out of 10,000 patients):
Frequency not known(frequency cannot be estimated from the available data):
If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.
Store at a temperature below 25°C. Store in the original packaging to protect from moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Ibuprofen Hasco is a soft capsule, oval, green, transparent, with a smooth and shiny surface, containing liquid ibuprofen.
The packaging of the medicine contains 60 soft capsules.
Hasco-Lek S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
phone: 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl
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