Package leaflet: information for the user

IBUPROFEN POLFARMEX, 200 mg, film-coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Leaflet contents

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

1. What Ibuprofen Polfarmex is and what it is used for

Ibuprofen is a propionic acid derivative. It belongs to the group of NSAIDs and has analgesic, antipyretic, and anti-inflammatory properties. The mechanism of action of ibuprofen involves inhibition of prostaglandin synthesis. It reversibly inhibits platelet aggregation.
Ibuprofen Polfarmex is indicated for:

symptomatic treatment of rheumatoid arthritis and osteoarthritis;
symptomatic treatment of juvenile rheumatoid arthritis;
relief of mild to moderate pain of various origins, e.g. dysmenorrhea, headache, toothache, muscle pain, post-traumatic pain;
reduction of fever of various causes;
alleviation of symptoms associated with colds and influenza.

2. Important information before using Ibuprofen Polfarmex

When not to use Ibuprofen Polfarmex:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if the patient has hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), manifested by bronchial asthma, rhinitis, or urticaria;
if the patient has active or a history of peptic ulcer of the stomach and/or duodenum with perforation or bleeding;
if the patient is in the third trimester of pregnancy;
if the patient has severe heart, liver, or kidney failure;
if the patient has a bleeding tendency;
if the patient is concurrently using other NSAIDs, including COX-2 inhibitors.

Warnings and precautions
Before starting treatment with Ibuprofen Polfarmex, consult your doctor or pharmacist.
Exercise special caution when using Ibuprofen Polfarmex:

as with other NSAIDs, ibuprofen may mask symptoms of infection and fever;
if the patient has a history of hypertension and/or heart disorders (fluid retention and oedema associated with NSAID use have been reported);
if the patient has impaired liver function;
if the patient has systemic lupus erythematosus or mixed connective tissue disease, there is an increased risk of developing aseptic meningitis;
if the patient has impaired kidney function, as there is a risk of further deterioration;
if the patient has a history of gastrointestinal disorders such as ulcerative colitis or Crohn’s disease, an exacerbation may occur;
if the patient has bleeding disorders (e.g. haemophilia), ibuprofen may prolong bleeding time;
if the patient has active or a history of bronchial asthma or allergic conditions, ibuprofen increases the risk of bronchospasm;
when used in elderly patients, the risk of adverse effects increases;
if the patient experiences visual disturbances (e.g. scotoma, colour vision disturbances), discontinue the drug and consult an ophthalmologist.

Special caution is required before using Ibuprofen Polfarmex due to the risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms or in patients with previous warning signs. Treatment with ibuprofen should be discontinued if gastrointestinal bleeding or ulceration occurs. Patients with a history of gastrointestinal disorders, particularly elderly patients, should be informed of the need to report any unusual gastrointestinal symptoms, especially bleeding, to their doctor. This is particularly important during the initial treatment period. In such patients, the lowest effective dose should be used.

Concurrent use of ibuprofen with anticoagulant drugs (e.g. warfarin, acenocoumarol), antiplatelet agents (e.g. salicylic acid), or corticosteroids increases the risk of gastrointestinal bleeding or disturbances.
Exercise caution when co-administering with cyclosporine, methotrexate, digoxin, lithium, probenecid, or valproic acid.
Alcohol consumption increases the risk of gastrointestinal bleeding. Ibuprofen may cause a sudden drop in blood glucose levels.

Ibuprofen Polfarmex may impair fertility. If a patient is planning pregnancy or has difficulty conceiving, she should inform her doctor.
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 Ibuprofen Polfarmex, the patient should discuss treatment with a doctor or pharmacist if:

the patient has heart disease, such as heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack - TIA).
the patient has hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or is a smoker.

Long-term, concurrent use of ibuprofen and other analgesic drugs increases the risk of kidney damage and renal failure (post-analgesic nephropathy).
Very rarely, severe skin reactions (some fatal), such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been observed in patients taking NSAIDs. The highest risk of these reactions occurs at the beginning of treatment, most commonly within the first month of taking the drug. If the first signs of rash, oral mucosal lesions, or other signs of hypersensitivity occur, discontinue the drug immediately.

Children and adolescents
In dehydrated children and adolescents, there is a risk of impaired kidney function.

Ibuprofen Polfarmex and other medicines
Ibuprofen Polfarmex may affect the action of other medicines, or other medicines may affect the action of Ibuprofen Polfarmex. Ibuprofen, like other NSAIDs, should not be used concurrently with the following medicines:

acetylsalicylic acid or other NSAIDs: increased risk of adverse effects;
antihypertensive drugs (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan): NSAIDs may reduce the effectiveness of antihypertensive drugs;
diuretics: there is limited evidence of reduced diuretic efficacy;
anticoagulant drugs (i.e. blood thinners/preventing clot formation, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine): NSAIDs may enhance the effect of anticoagulants;
zidovudine: evidence shows prolonged bleeding time in patients treated with both ibuprofen and zidovudine;
methotrexate and lithium: NSAIDs have been shown to increase serum concentrations of both lithium and methotrexate; monitoring of serum lithium and methotrexate levels is recommended;
corticosteroids: concurrent use of NSAIDs and corticosteroids may increase the risk of adverse effects, especially gastrointestinal;
cardiac glycosides: NSAIDs may exacerbate symptoms of heart failure and increase serum concentrations of cardiac glycosides;
mifepristone: NSAIDs used 8 to 12 days after mifepristone administration may reduce its effectiveness;
cyclosporine: concurrent use of NSAIDs and cyclosporine increases the risk of nephrotoxic effects;
quinolone antibiotics: concurrent use of NSAIDs with quinolone antibiotics increases the risk of seizures.

Other medicines may also interact with or be affected by treatment with Ibuprofen Polfarmex. Therefore, always consult a doctor or pharmacist before using Ibuprofen Polfarmex with other medicines.

Ibuprofen Polfarmex with food and drink
The medicine should be taken immediately after meals, with a large amount of liquid. In patients with gastrointestinal disturbances, it is recommended to take the medicine during meals or with milk.

Pregnancy and breastfeeding
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.
There is limited data on the safety of ibuprofen use in pregnant women. Ibuprofen is not recommended during the first and second trimesters of pregnancy.
Ibuprofen is contraindicated during the third trimester of pregnancy.
Use of the medicine is not recommended during breastfeeding.

Driving and operating machinery
There are no data on harmful effects of the medicine on the ability to drive or operate machinery.
In rare cases, mainly when high doses are used, visual disturbances (blurred or double vision) may occur. Consult a doctor regarding the ability to drive.

Ibuprofen Polfarmex contains lactose
The medicine contains lactose. If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Ibuprofen Polfarmex

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Oral administration
The medicine should be taken immediately after meals, with a large amount of fluid. In cases of
gastrointestinal disturbances, it is recommended to take the medicine during meals or
with milk.
The medicine is not indicated for children under 12 years of age, except in juvenile rheumatoid
arthritis.
Adults and children over 12 years of age
The recommended daily dose is 1200 mg to 1800 mg, given in divided doses. In some
patients, ibuprofen may be administered at a maintenance dose of 600 mg to 1200 mg per day.
In severe or acute conditions, it may be beneficial to increase the dose until the acute phase is controlled,
without exceeding 2400 mg of ibuprofen per day.
Rheumatoid arthritis, osteoarthritis
400 mg three to four times daily. The dose should be adjusted according to the patient's response to
the medicine.
Typically, higher doses are required in patients with rheumatoid arthritis than in those with osteoarthritis.
The maximum dose is 2400 mg of ibuprofen per day.
Juvenile rheumatoid arthritis
Up to 40 mg/kg body weight per day in divided doses.
Use is not recommended in children with body weight below 7 kg.
Mild to moderate pain, painful menstruation, fever, relief of cold and flu symptoms
200 to 400 mg as a single dose or three to four times daily, as needed. A single dose exceeding 400 mg does not result in stronger analgesic effect.
Without medical advice, a daily dose exceeding 1200 mg of ibuprofen should not be used.
Children over 12 years of age
The daily dose is 20 mg/kg body weight in divided doses. When treating fever or pain, the medicine should not be used for longer than three days without consulting a physician.
Elderly patients
Dosage adjustment is not necessary, provided liver and/or kidney function is not impaired.
In cases of impaired renal or hepatic function, the dose should be individually determined.
Taking the medicine at the lowest effective dose for the shortest duration necessary to relieve
symptoms reduces the risk of adverse effects.
Use of a higher than recommended dose of Ibuprofen Polfarmex
In adult patients, the single dose of ibuprofen that may cause symptoms of overdose is not precisely defined. In children, overdose symptoms may occur after ingesting a dose
exceeding 400 mg (two tablets). The half-life is then between 1.5 and 3 hours.
Symptoms of overdose: vomiting; nausea; epigastric pain; gastrointestinal bleeding; tinnitus;
headache; dizziness; less frequently, diarrhea. In severe poisoning, metabolic acidosis, drowsiness, and very rarely excitement, disorientation, or coma may occur. During
severe poisoning, prolonged prothrombin time may occur. Seizures may very rarely occur.
Other symptoms of overdose include: acute renal failure; liver damage; worsening of asthma symptoms in patients with asthma. If any of the above symptoms occur, contact a physician immediately.
Symptomatic and supportive treatment is recommended. The physician will monitor vital signs.
Therapeutic measures include gastric lavage and administration of activated charcoal (if no more than 1 hour has passed since ingestion of the medicine). In cases of frequent or
prolonged seizures, the physician may recommend intravenous diazepam or
lorazepam. In patients with asthma, the physician will administer bronchodilators.
Missed dose of Ibuprofen Polfarmex
Do not take a double dose to make up for a missed dose.
Discontinuation of Ibuprofen Polfarmex
If you have any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions have been listed according to their frequency, starting with the most common, using the following convention: very common (occur in more than 1 in 10 people); common (occur in 1 to 10 in 100 people); uncommon (occur in 1 to 10 in 1,000 people); rare (occur in 1 to 10 in 10,000 people); very rare (occur in less than 1 in 10,000 people); frequency not known (frequency cannot be estimated from the available data).

Uncommon: dyspepsia; abdominal pain and discomfort; heartburn; nausea; dizziness; rash; urticaria; pruritus.
Rare: diarrhoea; flatulence; constipation; vomiting; gastric mucosal inflammation; headache; oedema; pruritus.
Very rare: ulcerative stomatitis; exacerbation of colitis; Crohn's disease; melaena; haematemesis; duodenitis; oesophagitis; depression; insomnia; disorientation; mood changes; restlessness; somnolence; irritability and fatigue; convulsions; aseptic meningitis with fever or coma; tinnitus; reduced urine output; renal failure; renal papillary necrosis; increased serum sodium concentration (sodium retention); hepatic function disorders, particularly during long-term use: hepatitis, pancreatitis, jaundice, increased liver enzyme activity; anaemia (haemolytic and aplastic); agranulocytosis (absence in blood of white blood cells called granulocytes); leukopenia (reduced number of white blood cells); thrombocytopenia with or without purpura (reduced number of platelets); pancytopenia (reduced number of blood cells); erythema multiforme; Stevens-Johnson syndrome; toxic epidermal necrolysis (Lyell's syndrome); urticaria; erythema multiforme; alopecia; exfoliative dermatitis; photosensitivity; facial, laryngeal or lingual oedema; dyspnoea; tachycardia – cardiac arrhythmia; hypotension – sudden drop in blood pressure; shock; anaphylactic shock; exacerbation of asthma; bronchospasm; hypotension; hypertension; heart failure associated with the use of NSAIDs at high doses.

Peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding (which may be fatal) and perforation may occur, particularly in elderly patients.
Initial symptoms of blood and lymphatic system disorders: fever; sore throat; superficial oral mucosal ulcers; influenza-like symptoms; fatigue; bleeding (e.g. bruising, petechiae, purpura, epistaxis).
Cases of hypersensitivity reactions to ibuprofen have been observed: allergic reactions; neutropenia; eosinophilia; decreased haematocrit; hearing loss; visual disturbances.
In patients with autoimmune diseases such as systemic lupus erythematosus or mixed connective tissue disease receiving ibuprofen, isolated cases of aseptic meningitis symptoms have been observed: neck stiffness; headache; nausea; vomiting; fever; disorientation.
In isolated cases, acute hypersensitivity reactions manifested as hypotension have occurred.
Treatment with NSAIDs has been associated with reports of oedema, hypertension and heart failure.
The use of medicines such as Ibuprofen Polfarmex 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 not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 49-21-301, fax: +48 22 49-21-309, e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ibuprofen Polfarmex

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, or container
following the label "EXP". The expiry date refers to the last day of the specified month.
Store below 25°C.
Medicines must 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 Ibuprofen Polfarmex contains

The active substance is ibuprofen. One coated tablet contains 200 mg of ibuprofen.
Other components: corn starch, sodium croscarmellose, povidone, hypromellose, talc. Coating: hypromellose, monohydrate lactose, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172).

What Ibuprofen Polfarmex looks like and contents of the pack
Yellow-brown, round, biconvex coated tablets.
The pack contains 60 tablets.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: 24 357 44 44
Fax: 24 357 45 45