IBUPROFEN 200 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. IBUPROFEN POLFARMEX, 200 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Ibuprofen Polfarmex and what is it used for
4. Important information before taking Ibuprofen Polfarmex
   1. When not to take Ibuprofen Polfarmex:
   2. Warnings and precautions
   3. Children and adolescents
   4. Ibuprofen Polfarmex and other medicines
   5. Ibuprofen Polfarmex with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Ibuprofen Polfarmex contains lactose
5. How to take Ibuprofen Polfarmex
   1. Oral administration
   2. Adults and children over 12 years of age
   3. Children over 12 years of age
   4. Elderly patients
   5. Using a higher than recommended dose of Ibuprofen Polfarmex
   6. Missing a dose of Ibuprofen Polfarmex
   7. Stopping treatment with Ibuprofen Polfarmex
6. Possible side effects
7. How to store Ibuprofen Polfarmex
8. Contents of the pack and other information
   1. What Ibuprofen Polfarmex contains
   2. What Ibuprofen Polfarmex looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet

Package Leaflet: Information for the User

IBUPROFEN POLFARMEX, 200 mg, coated tablets

Ibuprofen

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Ibuprofen Polfarmex and what is it used for
• 2. Important information before taking Ibuprofen Polfarmex
• 3. How to take Ibuprofen Polfarmex
• 4. Possible side effects
• 5. How to store Ibuprofen Polfarmex
• 6. Contents of the pack and other information

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

Ibuprofen is a propionic acid derivative. It belongs to the group of NSAIDs, has analgesic, antipyretic, and anti-inflammatory effects. The mechanism of action of ibuprofen is based on the inhibition of prostaglandin synthesis. It temporarily inhibits platelet aggregation.

Ibuprofen Polfarmex is indicated for use in:

• symptomatic treatment of rheumatoid arthritis and osteoarthritis;
• symptomatic treatment of juvenile rheumatoid arthritis;
• pain of various origins of mild to moderate intensity, e.g. painful menstruation, headaches, toothaches, muscle pain, post-traumatic pain;
• fever of various origins;
• relief of symptoms of colds and flu.

2. Important information before taking Ibuprofen Polfarmex

When not to take Ibuprofen Polfarmex:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you have hypersensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs, manifested by asthma, nasal mucosa inflammation, urticaria;
• if you have active or recurrent peptic ulcer disease of the stomach and/or duodenum with perforation or bleeding;
• if you are in the third trimester of pregnancy;
• if you have severe heart, liver, or kidney failure;
• if you have a bleeding disorder;
• if you are taking other NSAIDs, including COX-2 inhibitors.

Warnings and precautions

Before starting treatment with Ibuprofen Polfarmex, discuss it with your doctor or pharmacist.

Be particularly careful when taking Ibuprofen Polfarmex:

• like other NSAIDs, ibuprofen may mask the symptoms of infection and fever;
• if you have a history of hypertension and/or heart disease (described as fluid retention and edema associated with NSAID use);
• if you have liver dysfunction;
• if you have systemic lupus erythematosus and mixed connective tissue disease, there is a greater risk of developing aseptic meningitis;
• if you have impaired kidney function, as there is a risk of further deterioration of their function;
• if you have a history of gastrointestinal diseases, such as ulcerative colitis, Crohn's disease, the disease may worsen;
• if you have coagulation disorders (e.g. hemophilia), ibuprofen may prolong bleeding time;
• if you have active or a history of bronchial asthma, as well as allergic diseases, ibuprofen increases the risk of bronchospasm;
• if you are elderly, the risk of side effects increases;
• if you have vision disturbances (blurred vision, color vision disturbances), you should discontinue the medicine and consult an ophthalmologist.

Before taking Ibuprofen Polfarmex, be particularly careful because 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.

The use of ibuprofen should be discontinued in case of bleeding or gastrointestinal ulceration.

Patients who have had gastrointestinal diseases, especially the elderly, should be informed about the need to report any unusual gastrointestinal symptoms, especially bleeding, to their doctor.

This is especially important in the initial treatment period.

For such patients, the use of the lowest possible dose of the medicine is recommended.

Concomitant use of ibuprofen and anticoagulant medications (e.g. warfarin, acenocoumarol), antiplatelet agents (e.g. salicylic acid), or corticosteroids increases the risk of bleeding or gastrointestinal disorders.

Caution should be exercised when using concomitantly with cyclosporine, methotrexate, digoxin, lithium, probenecid, valproic acid.

Concomitant consumption of alcohol increases the risk of gastrointestinal bleeding.

Ibuprofen may cause a sudden decrease in blood glucose levels.

Ibuprofen Polfarmex may hinder fertility.

If a woman plans to become pregnant or is having trouble becoming pregnant, she should inform her doctor.

Taking anti-inflammatory/pain-relieving medications, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses.

Do not exceed the recommended dose and duration of treatment.

Before taking Ibuprofen Polfarmex, the patient should discuss the treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, have peripheral artery disease (poor circulation in the legs due to narrowing or blockage of arteries) or have had any stroke (including mini-stroke or transient ischemic attack - TIA).
• they have high blood pressure, diabetes, high cholesterol levels, or have a family history of heart disease or stroke, or if they smoke.

Long-term, concomitant use of ibuprofen and other pain-relieving medications increases the risk of kidney damage, kidney failure (analgesic nephropathy).

In people taking NSAIDs, very rare, severe skin reactions (some fatal) have been observed, such as: exfoliative dermatitis; Stevens-Johnson syndrome; toxic epidermal necrolysis.

The greatest risk of these reactions occurs at the beginning of treatment with ibuprofen, most often in the first month of taking the medicine.

After the first symptoms of a rash, oral mucosa damage, or other signs of hypersensitivity appear, the medicine should be discontinued.

Children and adolescents

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

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 taken concomitantly with the following medicines:

• with acetylsalicylic acid or other NSAIDs: the risk of side effects increases;
• with blood pressure-lowering medications (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan): NSAIDs may reduce the effectiveness of blood pressure-lowering medications;
• with diuretics: there is limited evidence of reduced effectiveness of diuretics;
• with anticoagulant medications (e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine): NSAIDs may increase the effect of anticoagulant medications;
• with zidovudine: there is evidence of prolonged bleeding time in patients treated concomitantly with ibuprofen and zidovudine;
• with methotrexate and lithium: it has been proven that NSAIDs can increase the serum concentration of both lithium and methotrexate; monitoring of lithium and methotrexate serum concentrations is recommended;
• with corticosteroids: concomitant use of NSAIDs and corticosteroids may increase the risk of side effects, especially those related to the gastrointestinal tract;
• with cardiac glycosides: NSAIDs may exacerbate heart failure symptoms and increase cardiac glycoside serum concentrations;
• with mifepristone: NSAIDs taken between 8 and 12 days after mifepristone administration may reduce its effectiveness;
• with cyclosporine: concomitant use of NSAIDs and cyclosporine increases the risk of nephrotoxicity;
• with quinolone antibiotics: concomitant use of NSAIDs with quinolone antibiotics increases the risk of seizures.

Ibuprofen Polfarmex with food and drink

The medicine should be taken immediately after meals, with a large amount of fluid; in cases of gastrointestinal disorders, it is recommended to administer the medicine during meals or with milk.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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.

The use of ibuprofen is contraindicated during the third trimester of pregnancy.

The use of the medicine is not recommended during breastfeeding.

Driving and using machines

There is no data on the harmful effects of the medicine on the ability to drive and use machines.

In rare cases, especially when taking high doses, vision disturbances (blurred or double vision) may occur.

Consult your doctor about the possibility of driving vehicles.

Ibuprofen Polfarmex contains lactose

The medicine contains lactose.

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Ibuprofen Polfarmex

This medicine should always be taken exactly as directed by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist.

Oral administration

The medicine should be taken immediately after meals, with a large amount of fluid; in cases of gastrointestinal disorders, it is recommended to administer the medicine during meals or with milk.

The medicine is not indicated for children under 12 years of age, except for juvenile rheumatoid arthritis.

Adults and children over 12 years of age

The recommended daily dose is from 1200 mg to 1800 mg in divided doses.

In some patients, ibuprofen may be administered in 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 brought under control, without exceeding 2400 mg of ibuprofen per day.

Rheumatoid arthritis, osteoarthritis: 400 mg three to four times a day.

The dose should be adjusted according to the patient's response to the medicine.

Usually, in patients with rheumatoid arthritis, higher doses are required than in patients 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.

Do not recommend for children with a body weight below 7 kg.

Mild to moderate pain, painful menstruation, fever, relief of cold and flu symptoms: 200 mg to 400 mg as a single dose or three to four times a day as needed.

A single dose greater than 400 mg does not produce a stronger analgesic effect.

Without a doctor's recommendation, do not take a dose greater than 1200 mg of ibuprofen per day.

Children over 12 years of age

The daily dose is 20 mg/kg body weight in divided doses.

In the treatment of fever or pain, the medicine should not be used for more than three days without consulting a doctor.

Elderly patients

No dose adjustment is necessary unless liver or kidney function is impaired.

In case of kidney and liver function disorders, the dose should be determined individually.

Taking the medicine in the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of side effects.

Using a higher than recommended dose of Ibuprofen Polfarmex

In adult patients, the single dose of ibuprofen that may cause overdose symptoms is not precisely determined.

In children, overdose symptoms may occur after taking a dose above 400 mg (two tablets).

The half-life is then between 1.5 and 3 hours.

Overdose symptoms: vomiting; nausea; abdominal pain; gastrointestinal bleeding; tinnitus; headache; dizziness; rarely diarrhea.

In case of severe poisoning, metabolic acidosis, drowsiness, very rarely: agitation and disorientation or coma may occur.

During severe poisoning, an increase in prothrombin time may occur.

Very rarely, seizures may occur.

Overdose symptoms also include: acute kidney failure; liver damage; worsening of asthma symptoms in patients with asthma.

In case of the above symptoms, seek medical attention immediately.

It is recommended to provide symptomatic and supportive treatment.

The doctor will monitor vital signs.

Treatment includes gastric lavage, administration of activated charcoal (if the medicine has been taken no more than 1 hour before), and, in case of frequent or prolonged seizures, the doctor may recommend intravenous administration of diazepam or lorazepam.

In patients with asthma, the doctor will administer bronchodilators.

Missing a dose of Ibuprofen Polfarmex

Do not take a double dose to make up for a missed dose.

Stopping treatment with Ibuprofen Polfarmex

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibuprofen Polfarmex can cause side effects, although not everybody gets them.

Side effects are listed by frequency, starting from the most common, according to the following convention: very common (affects more than 1 in 10 people); common (affects 1 to 10 people in 100); uncommon (affects 1 to 10 people in 1,000); rare (affects 1 to 10 people in 10,000); very rare (affects less than 1 in 10,000 people); frequency not known (cannot be estimated from the available data).

Uncommon: indigestion; abdominal pain and discomfort; heartburn; nausea; dizziness; rash; urticaria; itching.

Rare: diarrhea; bloating; constipation; vomiting; gastritis; headache; edema; itching.

Very rare: oral mucosa ulceration; worsening of ulcerative colitis; Crohn's disease; melena; hematemesis; duodenitis; esophagitis; depression; insomnia; disorientation; mood changes; agitation; drowsiness; irritability and fatigue; seizures; aseptic meningitis with fever or coma; tinnitus; decreased urine output; kidney failure; renal papillary necrosis; increased sodium levels in the blood (sodium retention); liver function disorders, especially during long-term use: hepatitis, pancreatitis, jaundice, increased liver enzyme activity; anemia (hemolytic and aplastic); agranulocytosis (lack of granulocytes in the blood); leukopenia (decreased white blood cell count); thrombocytopenia (decreased platelet count); pancytopenia (decreased blood cell count); erythema multiforme; Stevens-Johnson syndrome; toxic epidermal necrolysis (Lyell's syndrome); urticaria; erythema multiforme; alopecia; exfoliative dermatitis; photosensitivity; facial, laryngeal, or lingual edema; dyspnea; tachycardia - arrhythmias; hypotension - sudden decrease in blood pressure; shock; acute shock; worsening of asthma; bronchospasm; hypotension; hypertension; heart failure associated with the use of NSAIDs in high doses.

Peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding (which can be fatal), and perforation may occur, especially in the elderly.

The first symptoms of blood and lymphatic system disorders: fever; sore throat; superficial oral mucosa ulcers; flu-like symptoms; fatigue; bleeding (e.g. bruising, petechiae, purpura, nosebleeds).

Cases of hypersensitivity reactions to ibuprofen have been observed: allergic reactions; neutropenia; eosinophilia; decreased hematocrit; hearing loss; vision disturbances.

In patients with autoimmune diseases, such as systemic lupus erythematosus, mixed connective tissue disease, taking ibuprofen, single cases of aseptic meningitis symptoms have been observed: neck stiffness; headache; nausea; vomiting; fever; disorientation.

In single cases, acute hypersensitivity reactions manifested by hypotension have occurred.

In connection with NSAID treatment, reports of edema, hypertension, and heart failure have been made.

Taking such medications as Ibuprofen Polfarmex 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 any not listed in this leaflet, please 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:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected].

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuprofen Polfarmex

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister or container after the words "EXP".

The expiry date refers to the last day of the month.

Store in a temperature below 25°C.

Medicines should not be disposed of via wastewater or household waste.

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 Ibuprofen Polfarmex contains

• The active substance of the medicine is ibuprofen.
• One coated tablet contains 200 mg of ibuprofen.
• The other ingredients are: corn starch, sodium carmellose, povidone, hypromellose, talc.
• Coating: hypromellose, lactose monohydrate, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172).

What Ibuprofen Polfarmex looks like and contents of the pack

Coated tablets are yellow-brown, round, and biconvex.

The pack contains 60 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.

ul. Józefów 9

99-300 Kutno

Poland

Tel.: 24 357 44 44

Fax: 24 357 45 45

Date of last revision of the leaflet