Ibuprex

Leaflet accompanying the packaging: information for the user

IBUPREX, 200 mg, coated tablets

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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days of fever treatment or 4 days of pain treatment there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

The active substance of the medicine is ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen reduces fever and has an analgesic effect.
The medicine is indicated for the symptomatic treatment of mild to moderate pain, including headache, migraine, painful menstruation, bone, muscle, and joint pain (also due to injuries), toothache, lower back pain, and fever, including in the course of upper respiratory tract infections, common cold, and flu or other infectious diseases.
If after 3 days of fever treatment or 4 days of pain treatment there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking the medicine

When not to take the medicine:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• if you have ever had difficulty breathing, asthma, nasal congestion, swelling, or hives after taking acetylsalicylic acid or other similar painkillers (NSAIDs)
• if you have or have had recurrent stomach ulcers and/or duodenal ulcers
• if you have ever had stomach and/or duodenal ulcers, bleeding, or perforation of the gastrointestinal tract associated with NSAID treatment
• if you have severe liver failure, severe kidney failure, coronary heart disease, or severe heart failure
• in children under 6 years of age or with a body weight below 20 kg
• if you have bleeding
• if you have unexplained blood disorders
• in patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake)
• in women during the last three months of pregnancy.

Warnings and precautions

Before starting to take the medicine, you should discuss it with your doctor or pharmacist:

• if you have certain skin diseases (systemic lupus erythematosus or mixed connective tissue disease). You should stop taking the medicine immediately after the first appearance of a skin rash, mucosal lesions, or any other signs of an allergic reaction.
• if you have skin reactions. Serious skin reactions have been reported with the use of ibuprofen-containing medicines, 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 you experience any of the symptoms associated with these serious skin reactions, you should stop taking the medicine immediately and seek medical attention.
• if you have a history of hereditary blood disorders (acute intermittent porphyria).
• if you have or have had inflammatory bowel disease (ulcerative colitis or Crohn's disease).
• if you have kidney function disorders.
• if you have liver function disorders.
• after major surgical procedures and in people with reduced blood clotting or taking anticoagulant medications; ibuprofen may temporarily inhibit platelet aggregation.
• if you have or have had asthma or allergic disease, hay fever, nasal polyps, or chronic obstructive pulmonary disease, as there is an increased risk of allergic reactions. Allergic reactions can occur in the form of asthma attacks (so-called analgesic asthma), throat swelling making it difficult to swallow and breathe, or hives.
• if you have heart diseases, such as heart failure, angina pectoris (chest pain), you have had a heart attack, coronary artery bypass grafting, you have peripheral artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries), or if you have had any stroke (including mini-stroke or transient ischemic attack - TIA).
• if you have high blood pressure, diabetes, you have high cholesterol levels, there is a history of heart disease or stroke in your family, or if you smoke.
• if you have an infection - see below, the section entitled "Infections".

While taking ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling in the face and neck (angioedema), chest pain.
If you notice any of these symptoms, you should stop taking the medicine immediately and contact your doctor or emergency medical services.
Taking the medicine in the smallest effective dose for the shortest necessary period to relieve symptoms reduces the risk of side effects.
Elderly people are more likely to experience side effects, especially gastrointestinal bleeding and perforation.
The risk of bleeding, ulcers, and perforation of the gastrointestinal tract increases with the increase in the dose of NSAIDs. In patients who are at increased risk of ulcers and gastrointestinal bleeding, as well as in patients who require concomitant treatment with low doses of acetylsalicylic acid or other medicines that may increase the risk of adverse events in the gastrointestinal tract, concomitant treatment with protective agents (e.g., misoprostol or proton pump inhibitors) may be considered.
You should be cautious in patients receiving medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulant medications, such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents, such as acetylsalicylic acid (see "Concomitant use with other medicines" below).
You should avoid concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the increased risk of side effects (see "Concomitant use with other medicines" below).
Very rarely, serious skin reactions have been observed with the use of NSAIDs. You should stop taking the medicine and contact your doctor if you experience skin reactions or changes in the mucous membranes.
Taking anti-inflammatory or analgesic medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. You should not exceed the recommended dose and duration of treatment.
Chronic use of (various) analgesic medicines may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).
After long-term use of analgesic medicines, headaches may occur, which should not be treated with increased doses of the medicine.
When consuming alcohol, side effects, especially those related to the gastrointestinal tract, may be exacerbated.
There is evidence that cyclooxygenase-inhibiting medicines, such as ibuprofen, may cause temporary difficulties in getting pregnant. The effect disappears after stopping the medicine.
Ibuprofen should be avoided in case of chickenpox.
Infections
may mask the objective signs of infection, such as fever and pain. As a result, it may delay the application of appropriate infection treatment, which may lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection, and the symptoms of the infection persist or worsen, you should contact your doctor immediately.

Children and adolescents

There is a risk of kidney function disorders in dehydrated children and adolescents.

Medicine and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
The medicine may affect the action of other medicines, and other medicines may affect the action of the medicine.
For example:

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

Also, some other medicines may be affected or have an effect on the treatment with the medicine.
Therefore, before taking the medicine with other medicines, you should always consult your doctor or pharmacist.

Concomitant use of the medicine and the following medicines:

With food, drink, and alcohol
The tablet should be swallowed and washed down with a sufficient amount of water.
You should avoid taking ibuprofen with alcohol due to the possibility of exacerbating gastrointestinal side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
You should not take the medicine if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart disorders in the unborn baby. It may also increase the risk of bleeding in you and your baby and cause delayed or prolonged labor.
During the first 6 months of pregnancy, you should not take the medicine unless it is absolutely necessary and only on the advice of your doctor. If treatment is necessary during this period or when trying to conceive, you should use the smallest dose for the shortest possible time.
From the 20th week of pregnancy, taking the medicine may cause kidney function disorders in the unborn baby if taken for more than a few days. This may also lead to a low level of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If treatment is required for a longer period than a few days, your doctor may recommend additional monitoring.
The medicine passes into breast milk, but it can be used during breastfeeding if taken in the recommended doses and for the shortest possible time.
The medicine belongs to a group of NSAIDs that may have a negative effect on female fertility. This effect is temporary and disappears after stopping the treatment.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines if taken for a short period and in accordance with the recommendations.

Medicine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take the medicine

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
In case of doubt, you should consult your doctor or pharmacist.
You should take the smallest effective dose for the shortest necessary period to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, you should contact your doctor immediately (see section 2).

The medicine should not be taken for more than 3 days in the treatment of fever and 4 days in the treatment of pain without consulting a doctor. If it is necessary to give the medicine to children and adolescents for more than 3 days or if the symptoms worsen, you should contact your doctor.

Treatment of fever and pain, including headache, migraine, toothache, bone, muscle, and joint pain, back pain

Adults, elderly, adolescents (over 12 years of age):

• 200 - 400 mg (1 or 2 tablets) 3 - 4 times a day at 4 - 6 hour intervals. The maximum dose is 1200 mg (6 tablets) per day.

Children aged 6-12 years (with a body weight over 20 kg):
200 mg (1 tablet) 3 times a day, with an interval of 6 - 8 hours between doses. In the case of older children (from 10 years of age, with a body weight over 30 kg), the daily dose may be increased to 800 mg (1 tablet 4 times a day). The maximum dose is 600 mg (3 tablets) and 800 mg (4 tablets) per day, respectively.
Painful menstruation:

• 200 - 400 mg (1 or 2 tablets) as needed, 1-3 times a day, with an interval of 4 - 6 hours between doses. The maximum dose is 1200 mg (6 tablets) per day.

The tablets should be washed down with a glass of water.

Overdose

If you have taken more than the recommended dose of the medicine or if a child has accidentally taken the medicine, you should always consult your doctor or go to the nearest hospital to get an opinion on the possible risk to your health and advice on what to do.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see section 4 below), diarrhea, headache, ringing in the ears, confusion, and dizziness. It may also cause agitation, drowsiness, disorientation, or coma. Seizures have been reported occasionally in patients. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, there may be an increased prothrombin time/INR, probably due to the disruption of circulating clotting factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. Additionally, there may be low blood pressure and difficulty breathing, as well as cyanosis.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.

Missed dose

You should not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Taking the medicine in the smallest effective dose for the shortest necessary period to relieve symptoms reduces the risk of side effects.
The likelihood of side effects increases in elderly patients.

You should contact your doctor immediately if you experience:

• rash, severe swelling of the face, lips, or throat making it difficult to breathe, speak, or swallow, low blood pressure, slow or fast heart rate, pale skin, anxiety, increased sweating, dizziness, bronchospasm
• gastrointestinal bleeding (vomiting blood or black stools or blood in stools)
• red, non-raised, target-like, or circular patches on the skin, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions 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 thickening under the skin and blisters, usually on the skin folds, trunk, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop taking the medicine and seek medical attention immediately. See also section 2.

Side effects are ranked according to frequency of occurrence.

Uncommon (may affect up to 1 in 100 people):

• stomach pain, nausea, indigestion
• headache
• hives, itching.

Rare (may affect up to 1 in 1,000 people):

• diarrhea, bloating, constipation, and vomiting, stomach inflammation
• dizziness, insomnia, fatigue, ringing in the ears
• irritability, agitation, depression, psychotic reactions
• swelling.

Very rare (may affect up to 1 in 10,000 people):

• stomach and/or duodenal ulcers
• gastrointestinal bleeding (caused by perforation of the stomach or intestinal wall) sometimes with a fatal outcome, especially in elderly patients
• ulcerative stomatitis
• worsening of symptoms of ulcerative colitis and Crohn's disease
• high blood pressure, heart failure
• kidney failure, renal papillary necrosis
• decreased urine output
• increased sodium levels in the blood (causing swelling)
• liver function disorders, especially during long-term use of the medicine
• significant decrease in the number of all blood cells (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial oral mucosal ulceration, flu-like symptoms, severe fatigue, nosebleeds, or subcutaneous bleeding
• erythema multiforme (blue-red spots on the skin, sometimes with blisters)
• toxic epidermal necrolysis, occurrence of blisters on the skin and/or mucous membranes, which after rupture form painful ulcers, often accompanied by fever, muscle and joint pain (this is called Stevens-Johnson syndrome)
• exfoliation of large skin areas and necrosis
• systemic lupus erythematosus (a chronic disease caused by immune system disorders, affecting many organs)
• mixed connective tissue disease
• stiffness of the neck, headaches, nausea, vomiting, fever, disturbances of orientation (these are symptoms of aseptic meningitis)
• severe allergic reactions: swelling of the face, lips, and throat making it difficult to breathe, speak, or swallow, shortness of breath, rapid heart rate, low blood pressure, or shock, worsening of asthma symptoms.

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

• severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell).
• red, scaly rash with thickening under the skin and blisters, usually on the skin folds, trunk, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop taking the medicine and seek medical attention immediately. See also section 2.
• the skin becomes sensitive to light.
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Taking such medicines as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. 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, Al. Jerozolimskie 181C, 02-222 Warsaw; phone: +48 22 492 13 01; fax: +48 22 492 13 09; 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.

5. How to store the medicine

The medicine should be stored out of the sight and reach of children.
There are no special precautions for the storage of the medicine.
You should not take this medicine after the expiry date stated on the carton and blister after the EXP symbol. 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.

6. Contents of the pack and other information

What the medicine contains

• The active substance of the medicine is ibuprofen. Each tablet contains 200 mg of ibuprofen.
• The other ingredients (excipients) are: tablet core (microcrystalline cellulose, hypromellose 5 cP, sodium croscarmellose, colloidal anhydrous silica, purified water, macrogol 6000, sodium stearyl fumarate), coating Opadry 200 White (polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, methacrylic acid, and ethyl acrylate copolymer (1:1), sodium carbonate).

What the medicine looks like and contents of the pack

10 coated tablets, round, biconvex, white or almost white in color.
In a cardboard box, 2 blisters of PVC/Aluminum, 5 tablets in each blister.

Marketing authorization holder

OLIMP LABORATORIES Sp. z o.o.
Pustynia 84F
39-200 Dębica
+48 14 680 32 00

Manufacturer

OLIMP LABORATORIES Sp. z o.o.
Pustynia 84F
39-200 Dębica
OLIMP LABORATORIES Sp. z o.o.
Nagawczyna 109 c
39-200 Dębica
{Logo Olimp Laboratories}

Date of last revision of the leaflet: