Ibuprex

Package leaflet: Information for the user

IBUPREX, 200 mg, coated tablets
Ibuprofen
Please read this leaflet carefully before using the medicine, because it contains
important information for the patient.
This medicine should always be used 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment for fever or 4 days of treatment for pain, or if you feel worse, you should contact your doctor.

Table of contents of the leaflet

1. What the medicine is and what it is used for
2. What you need to know before taking this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

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

The active substance is ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen reduces fever and has analgesic (pain-relieving) properties.
The medicine is indicated for symptomatic treatment of mild to moderate pain, including headache, migraine, menstrual pain, bone, muscle and joint pain (including pain due to injuries), toothache, lower back pain, as well as for the treatment of fever, for example in upper respiratory tract infections, colds, influenza or other infectious diseases.
If there is no improvement after 3 days of treatment for fever or 4 days of treatment for pain, or if you feel worse, you should consult your doctor.

2. 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)
• if the patient has ever experienced asthma, difficulty breathing, runny nose, swelling or hives after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs)
• if the patient currently has or has had recurrent peptic ulcer disease of the stomach and/or duodenum
• if the patient has ever experienced gastric and/or duodenal ulceration, gastrointestinal bleeding or perforation related to treatment with NSAIDs
• if the patient has severe liver failure, severe kidney failure, coronary artery disease or severe heart failure
• in children under 6 years of age or with body weight below 20 kg
• if the patient is experiencing bleeding
• if the patient has unexplained disorders of the blood system
• in patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
• in women during the last three months of pregnancy.

Warnings and precautions
Before starting treatment, discuss the following with your doctor or pharmacist:

• if the patient has certain skin diseases (systemic lupus erythematosus or mixed connective tissue disease). Treatment should be stopped immediately at the first sign of skin rash, mucosal lesions or any other symptoms of allergic reaction.
• if the patient experiences skin reactions. Serious skin reactions associated with medicines containing ibuprofen have been reported, 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 the patient develops any of the symptoms related to these serious skin reactions described in section 4, the medicine should be stopped immediately and medical help should be sought.
• if the patient has hereditary blood disorders (acute intermittent porphyria).
• if the patient currently has or has ever had a disease of the large intestine (ulcerative colitis or Crohn's disease).
• if the patient has impaired kidney function.
• if the patient has impaired liver function.
• immediately after major surgical procedures, and in patients with reduced blood clotting or those receiving anticoagulant therapy; ibuprofen may temporarily inhibit platelet aggregation.
• if the patient currently has or has ever had asthma or allergic conditions, hay fever, nasal polyps, or chronic obstructive respiratory disorders, as there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (e.g. so-called analgesic-induced asthma), throat swelling causing difficulty in swallowing and breathing, or hives.
• 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 legs due to narrowed or blocked arteries), or if the patient has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• if the patient has high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.
• if the patient has an infection – see below, section titled "Infections".

Allergic reactions to ibuprofen have occurred, including difficulty breathing, facial and neck swelling (angioedema), and chest pain.
If any of these symptoms occur, the medicine should be stopped immediately and the patient should contact a doctor or emergency medical services without delay.
Using the medicine at the lowest effective dose for the shortest necessary duration to relieve symptoms reduces the risk of adverse effects.
Elderly patients are more susceptible to adverse effects, particularly gastrointestinal bleeding and perforation.
The risk of gastrointestinal bleeding, ulceration or perforation increases with higher doses of NSAIDs. In patients with increased risk of gastrointestinal ulceration and bleeding, as well as in patients requiring concomitant treatment with low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal adverse events, concomitant protective treatment (e.g. misoprostol or proton pump inhibitors) should be considered.
Caution is advised in patients receiving medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents such as acetylsalicylic acid (see section "Interaction with other medicines" below).
Concomitant use with other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided due to increased risk of adverse effects (see section "Interaction with other medicines" below).
Very rarely, severe skin reactions associated with NSAID use have been observed. The medicine should be discontinued and a doctor contacted immediately if skin reactions or mucosal changes occur.
Taking anti-inflammatory or 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.
Chronic use of (various) pain-relieving medicines may lead to kidney damage with risk of kidney failure (analgesic nephropathy).
Prolonged use of pain-relieving medicines may lead to headaches, which should not be treated with increased doses of the medicine.
If alcohol is consumed concurrently, adverse effects, particularly those affecting the gastrointestinal tract, may be intensified.
There is some evidence that cyclooxygenase-inhibiting medicines such as ibuprofen may cause reversible difficulties in becoming pregnant. This effect resolves after discontinuation of the medicine.
Use of ibuprofen is not recommended in cases of chickenpox.
Infections
The medicine may mask symptoms of infection, such as fever and pain. As a result, it may delay appropriate treatment of 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 ongoing infection and symptoms persist or worsen, immediate consultation with a doctor is required.
Children and adolescents
There is a risk of impaired kidney function in dehydrated children and adolescents.
Medicines and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The medicine may affect the action of other medicines, and other medicines may affect the action of this medicine. For example:

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

Also, some other medicines may be affected by or may affect treatment with this medicine.
Therefore, always consult a doctor or pharmacist before using this medicine together with other medicines.
Concomitant use of this medicine and the following medicines:

With food, drink and alcohol
The tablet should be swallowed with an adequate amount of water.
Concomitant use of ibuprofen with alcohol should be avoided due to the possibility of increased gastrointestinal adverse effects.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be taken if the patient is 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 also increase the tendency to bleeding in both the mother and her child and may delay or prolong labour.
During the first six months of pregnancy, this medicine should not be used unless absolutely necessary and only on the advice of a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible duration should be used.
From week 20 of pregnancy, use of this medicine for longer than a few days may result in impaired kidney function in the unborn child. It may also lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a 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.
The medicine passes into breast milk, but may be used during breastfeeding if administered at recommended doses and for the shortest possible duration.
This medicine belongs to the group of NSAIDs (non-steroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery when used short-term and according to recommendations.

Medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning 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 a
doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If symptoms of infection (such as fever and pain) persist or worsen, medical advice should be sought
immediately (see section 2).
Do not use this medicine for more than 3 days to treat fever or for more than 4 days to treat pain
without consulting a doctor. If treatment in children and adolescents requires administration for
longer than 3 days, or if symptoms worsen, consult a 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) up to 3–4 times daily, at intervals of 4–6 hours. Do not exceed 1200 mg
(6 tablets) in a 24-hour period.
Children aged 6–12 years (with body weight above 20 kg):
200 mg (1 tablet) up to three times daily, with at least 6–8 hours between doses. In older children
(aged 10 years and above, with body weight above 30 kg), the daily dose may be increased to
800 mg (1 tablet four times daily). Do not exceed the daily dose of 600 mg (3 tablets) or 800 mg
(4 tablets), respectively.
Painful menstruation:
200–400 mg (1 or 2 tablets) as needed, 1–3 times daily, with intervals of 4–6 hours between doses.
Do not exceed 1200 mg (6 tablets) in a 24-hour period.
Tablets should be taken with a glass of water.
Taking more medicine than you should
If a patient takes more than the recommended dose, or if a child accidentally ingests the medicine,
seek medical advice from a doctor or go to the nearest hospital immediately to assess possible health
risks and receive guidance on necessary 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. Excitement, drowsiness, disorientation or coma may also occur. 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 cold and breathing difficulties may occur. In addition, prothrombin time/INR may be
prolonged, probably due to impaired function of circulating coagulation factors. Acute kidney
failure and liver damage may occur. In asthmatics, asthma may worsen. Hypotension, breathing
difficulties and cyanosis may also occur.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.
If you forget to take a dose
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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Taking the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.
The likelihood of adverse effects increases in elderly patients.
Contact a doctor immediately if any of the following occur:

• rash, severe swelling of the face, lips or throat causing difficulty breathing, speaking or swallowing, low blood pressure, slow or rapid heartbeat, pale skin, restlessness, excessive sweating, dizziness, bronchospasm
• gastrointestinal bleeding (vomiting blood or black stools or blood in the stool)
• red, flat, target-like or circular skin lesions, often with blisters in the centre, skin peeling, 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 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 effects are listed according to frequency of occurrence.
Uncommon (may affect less than 1 in 100 treated patients):

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

Rare (may affect less than 1 in 1,000 treated patients):

• diarrhoea, flatulence, constipation and vomiting, gastritis
• dizziness, insomnia, fatigue, tinnitus
• restlessness, irritability, depression, psychotic reactions
• oedema.

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

• gastric and/or duodenal ulcer disease
• gastrointestinal bleeding (caused by perforation of the stomach or intestinal wall), sometimes fatal, especially in elderly patients
• erosive stomatitis
• worsening of symptoms of colitis and Crohn's disease
• hypertension, heart failure
• renal failure, renal papillary necrosis
• reduced urine output
• increased blood sodium concentration (causing oedema)
• liver function disorders, particularly during long-term use of the medicine
• marked decrease in all blood cells (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include: fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, marked exhaustion, nosebleeds or subcutaneous haemorrhages
• erythema multiforme (bluish-red skin lesions, sometimes with blisters)
• toxic epidermal necrolysis, occurrence of blisters on the skin and/or mucous membranes which, when ruptured, form painful wounds; fever, muscle and joint pain often occur simultaneously (this is known as Stevens-Johnson syndrome)
• extensive peeling and necrosis of the epidermis
• systemic lupus erythematosus (a chronic disease caused by immune system disorders affecting multiple organs)
• mixed connective tissue disease
• neck stiffness, headache, nausea, vomiting, fever, disorientation (symptoms of aseptic meningitis)
• severe hypersensitivity reactions: facial, tongue and laryngeal oedema causing difficulty breathing, speaking or swallowing, dyspnoea, tachycardia, hypotension or shock, worsening of asthma symptoms.

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

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

Taking medicines such as this may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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; tel: +48 22 492 13 01; fax: +48 22 492 13 09; website: https://smz.ezdrowie.gov.pl .
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store the medicine

Keep the medicine out of the sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after the
symbol EXP. 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What the medicine contains

• The active substance 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), Opadry 200 White coating (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 film-coated tablets, round, biconvex, white or almost white.
In a cardboard box: 2 PVC/Aluminium blisters, 5 tablets per blister.
Marketing Authorisation 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}