Ibuprofen Tzf

Package Leaflet: Information for the Patient

Ibuprofen TZF, 600 mg, Film-Coated Tablets

Ibuprofen

Read the package 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 package leaflet for the patient or as advised by a doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

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

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

Ibuprofen TZF belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs) with analgesic, anti-inflammatory, and antipyretic effects.

Indications for use:

For short-term use in adults for acute, moderate pain of various origins, such as:

• headaches (including migraines),
• toothaches,
• muscle, joint, and bone pain (including back pain),
• neuralgia,
• post-traumatic, post-operative pain, including pain after dental surgery,
• menstrual cramps.

2. Important information before taking Ibuprofen TZF

When not to take Ibuprofen TZF

if the patient is hypersensitive to the active substance, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6);

if the patient has ever had any symptoms of allergy in the form of rhinitis, urticaria, or bronchial asthma in connection with the administration of ibuprofen, aspirin (acetylsalicylic acid), or other nonsteroidal anti-inflammatory drugs (NSAIDs);

if the patient has ever had gastrointestinal bleeding or perforation of the gastrointestinal tract in connection with previously taken NSAIDs;

if the patient has active or recurrent peptic ulcer disease or gastrointestinal bleeding (past severe bleeding, two or more independent episodes of confirmed ulceration or bleeding);

in patients with bleeding disorders (tendency to bleed);

if there is severe liver or kidney failure;

if there is severe heart failure;

if there is coronary artery disease;

in the last three months of pregnancy;

• if there is cerebral or other active bleeding;
• if the patient is significantly dehydrated (due to vomiting, diarrhea, or insufficient fluid intake); under the age of 18.

Warnings and precautions

Ibuprofen TZF should be used in adults with concomitant chronic diseases only after consulting a doctor.

During the use of ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), and chest pain.

If any of these symptoms are observed, the patient should immediately discontinue Ibuprofen TZF and contact a doctor or medical emergency services.

The occurrence of side effects can be minimized by using the smallest effective dose for the shortest necessary period to control symptoms.

The patient should inform the pharmacist or doctor if they have an infection - see below, section "Infections".

Infections

Ibuprofen TZF may mask the symptoms of an infection, such as fever and pain. Therefore, Ibuprofen TZF may delay the application of appropriate infection treatment and consequently lead to increased risk of complications.

This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox.

If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should immediately consult a doctor.

Before starting treatment with Ibuprofen TZF, the patient should discuss the treatment with a doctor or pharmacist if:

the patient has heart disease, such as heart failure, coronary artery disease, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, or has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or if the patient has had any stroke (including mini-stroke or transient ischemic attack - TIA);

the patient has high blood pressure, diabetes, high cholesterol levels, or if there is a history of heart disease or stroke in the patient's family, or if the patient smokes;

the patient has autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease) - there is an increased risk of developing aseptic meningitis;

the patient is taking other painkillers from the NSAID group or acetylsalicylic acid in a daily dose above 75 mg;

the patient has been diagnosed with congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria);

the patient has been diagnosed with fluid retention and edema associated with the use of NSAIDs;

the patient has kidney or liver function disorders;

the patient is taking anticoagulant, diuretic, cardiac glycoside, or corticosteroid medications;

the patient has been diagnosed with bleeding disorders (ibuprofen may temporarily inhibit platelet aggregation and prolong bleeding time);

the patient is dehydrated (especially in the elderly) and is at increased risk of kidney function disorders;

the patient has recently undergone major surgery;

the patient has a history of asthma, hay fever, or allergic reactions - after taking the medicine, bronchospasm, urticaria, or angioedema may occur;

the patient has a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) - symptoms may worsen;

the patient is elderly (see section 3).

Avoid concomitant use of ibuprofen with other NSAIDs, including COX-2 inhibitors (e.g., celecoxib or etoricoxib), due to increased risk of gastrointestinal bleeding.

Patient with a history of gastrointestinal disease, especially the elderly, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, especially at the start of treatment.

Elderly patients are more susceptible to side effects, especially gastrointestinal bleeding and ulcers.

Elderly patients should report any unusual abdominal symptoms (especially gastrointestinal bleeding) to their doctor, especially at the start of treatment.

Particular caution should be exercised and a doctor or pharmacist consulted before taking the medicine in patients with hypertension or heart failure with fluid retention, hypertension, and edema, which are associated with the use of NSAIDs in the past.

Taking anti-inflammatory and analgesic medications, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, especially when used in high doses.

Do not exceed the recommended dose and duration of treatment.

Long-term use of ibuprofen, especially in combination with other analgesics, may 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 the elderly.

Patient who discontinue treatment with NSAIDs generally return to their pre-treatment state.

During long-term treatment with ibuprofen, periodic monitoring of liver and kidney function, as well as blood morphology with a smear, is necessary, especially in patients at high risk.

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 predispositions to these disorders.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of ibuprofen.

If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should immediately discontinue Ibuprofen TZF and seek medical attention.

During long-term use of analgesics, headache may occur, which should not be treated with increased doses of the medicine.

The patient should discontinue the medicine and consult a doctor.

Ibuprofen TZF should be avoided during chickenpox.

Alcohol consumption should be avoided during treatment with the medicine, as it may exacerbate side effects, especially those related to the gastrointestinal tract and nervous system.

If new or worsening symptoms occur, the patient should consult a doctor or pharmacist.

Ibuprofen TZF and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Ibuprofen TZF may affect the action of other medicines or other medicines may affect the action of Ibuprofen TZF.

• other NSAIDs (including COX-2 inhibitors, such as celecoxib or etoricoxib);
• diuretics and potassium-sparing diuretics;
• antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal side effects;
• methotrexate (a medicine used to treat cancer or rheumatic diseases), as it may increase the effect of methotrexate;
• lithium (a medicine used to treat depression), as it may increase the effect of lithium;
• cardiac glycosides (e.g., digoxin), as ibuprofen may increase the level of this medicine in the blood;
• phenytoin (an antiepileptic medicine), as ibuprofen may increase the level of this medicine in the blood;
• corticosteroids (such as prednisolone or dexamethasone), as they may increase the risk of gastrointestinal ulcers or bleeding;
• tacrolimus (a medicine that suppresses immune reactions), as it may increase the risk of toxic effects on the kidneys;
• cyclosporin (a medicine that suppresses immune reactions), as there is limited data on increased risk of toxic effects on the kidneys;
• zydovudine (a medicine used to treat AIDS), as taking Ibuprofen TZF may increase the risk of bleeding into the joints or bleeding that leads to swelling (in patients with hemophilia and a positive HIV antibody test);
• ritonavir (a medicine used to treat HIV infection): ritonavir may increase the level of NSAIDs in the blood;
• antibiotics (quinolones or aminoglycosides);
• sulfonylurea derivatives (oral hypoglycemic agents): clinical interactions may occur between these medicines and NSAIDs; blood glucose monitoring is recommended;
• probenecid and sulfinpyrazone (medicines used to treat gout): they may delay the excretion of ibuprofen;
• cholestyramine: it may delay and reduce the absorption of NSAIDs;
• voriconazole and fluconazole (antifungal agents): they may increase the exposure to NSAIDs;
• baclofen (a muscle relaxant): toxic effects of baclofen may occur after starting ibuprofen treatment;
• aminoglycosides (a type of antibiotic): NSAIDs may decrease the excretion of aminoglycosides;
• mifepristone: NSAIDs should not be used within 8-12 days after mifepristone administration, as they may reduce the effect of mifepristone;
• calcium channel blockers: reduced antihypertensive efficacy and increased risk of gastrointestinal bleeding;
• desipramine: increased toxicity of desipramine, typical of tricyclic antidepressants;
• levofloxacin and ofloxacin: increased risk of serious central nervous system side effects;
• thienopyridine derivatives: increased risk of bleeding due to additive anti-aggregatory and anticoagulant effects;
• bisphosphonates: increased risk of gastrointestinal side effects;
• medicines with anticoagulant effect (e.g., blood thinners or medicines that prevent blood clots, 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);
• Concomitant use of ibuprofen with herbal products containing Ginkgo biloba or Filipendula ulmaria may increase the risk of bleeding due to anti-aggregatory effects. Concomitant use of ibuprofen and products containing Ephedra sinica may cause increased risk of gastrointestinal mucosa damage.

Other medicines may also be affected or have an effect on treatment with Ibuprofen TZF.

Therefore, before taking Ibuprofen TZF with other medicines, the patient should always consult a doctor or pharmacist.

Ibuprofen TZF with food, drink, and alcohol

The medicine can be taken with food or drink.

In patients with sensitive stomachs, it is recommended to take the medicine during meals to avoid gastrointestinal discomfort.

Alcohol consumption should be avoided during treatment with the medicine due to the possibility of exacerbating side effects.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Pregnancy

Ibuprofen TZF should not be taken during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery.

The medicine may cause kidney and heart disorders in the unborn child.

Ibuprofen TZF may increase the risk of bleeding in pregnant women and their children and may contribute to delayed or prolonged labor.

In the first six months of pregnancy, Ibuprofen TZF should not be taken unless absolutely necessary and only on the advice of a doctor.

If Ibuprofen TZF is to be taken during an attempt to conceive or in the first and (or) second trimester of pregnancy, the smallest possible effective dose should be used and the shortest possible treatment period.

Taking Ibuprofen TZF for more than a few days from the 20th week of pregnancy may cause kidney function disorders in the unborn child, which may lead to reduced amniotic fluid (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart.

If the patient takes Ibuprofen TZF for more than a few days, the doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen passes into breast milk in small amounts.

During short-term use of ibuprofen in therapeutic doses, harmful effects on infants are unlikely.

However, if long-term use of ibuprofen is recommended, breastfeeding should be discontinued.

Fertility

Ibuprofen may make it more difficult to conceive.

If the patient plans to conceive or is having difficulty conceiving, they should inform their doctor.

Driving and using machines

Ibuprofen TZF has no or negligible influence on the ability to drive and use machines if taken for a short period and in accordance with the recommended dosage.

However, patients who experience side effects such as dizziness, fatigue, visual disturbances, or other side effects should not drive or operate machinery.

Ibuprofen TZF contains lactose monohydrate and sodium

Lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

Sodium

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

3. How to take Ibuprofen TZF

This medicine should always be taken exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist.

In case of doubt, the patient should consult a doctor or pharmacist.

Method of administration

Ibuprofen TZF is taken orally.

To avoid gastrointestinal discomfort, it is recommended to take the medicine during or after meals.

Ibuprofen TZF tablets should be taken with a glass of water.

The tablets should be swallowed whole, without chewing, breaking, crushing, or sucking, to avoid discomfort in the mouth and throat irritation.

Dosage

The smallest effective dose should be used for the shortest period necessary to relieve symptoms.

If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult a doctor (see section 2).

If it is necessary to take the medicine for more than 3 days or if the symptoms worsen, the patient should consult a doctor.

The maximum daily dose should not exceed 1200 mg.

Adults

The recommended dose is 600 mg of ibuprofen (1 tablet) as a single dose.

If necessary, the single dose of 600 mg (1 tablet) can be repeated, with an interval of 6-8 hours.

The maximum daily dose without consulting a doctor should not exceed 1200 mg (2 tablets).

Ibuprofen TZF should only be used if the patient does not feel improvement after taking ibuprofen in a dose of 400 mg (maximum 1200 mg of ibuprofen per day).

In such cases, a dose of 600 mg of ibuprofen can be used, taking into account the 6-8 hour interval from the administration of the 400 mg dose.

Elderly patients

Not recommended without consulting a doctor.

Nonsteroidal anti-inflammatory drugs (NSAIDs) should be used with caution, especially in elderly patients, who are more prone to side effects and at risk of potentially fatal gastrointestinal bleeding, ulcers, and perforation.

Patient with kidney or liver function disorders

Not recommended without consulting a doctor.

There is no need to modify the dose in patients with mild to moderate kidney or liver function disorders.

However, in these patients, the smallest effective dose should be used for the shortest possible time necessary to control symptoms.

Overdose of Ibuprofen TZF

If the patient has taken more than the recommended dose of Ibuprofen TZF or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to assess the potential risk to their health and for advice on what to do.

Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, disorientation, and nystagmus.

They may also include agitation, drowsiness, or coma.

Seizures may occur in some cases.

After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties have been reported.

In addition, the prothrombin time/INR may be prolonged, probably due to interference with the action of circulating clotting factors.

In severe poisoning, metabolic acidosis may occur.

During severe poisonings, acute kidney failure and liver damage, hypotension, respiratory failure, bradycardia, or cyanosis may occur.

In patients with asthma, worsening of asthma symptoms may occur.

Treatment

There is no specific antidote.

Supportive and symptomatic treatment is used.

Oral administration of activated charcoal within 1 hour of overdose may be considered.

If symptoms of overdose occur, the patient should immediately discontinue the medicine and consult a doctor or hospital emergency department.

Missed dose of Ibuprofen TZF

A double dose should not be taken to make up for a missed dose.

In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

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

The most common serious side effects are related to the gastrointestinal tract, i.e., ulcers, perforation, or gastrointestinal bleeding, sometimes with a fatal outcome (especially in the elderly).

These side effects are not always preceded by warning symptoms or may occur in patients who have had such warning symptoms.

The risk of gastrointestinal bleeding is particularly dependent on the dose range and duration of ibuprofen use.

If the patient experiences any of the following symptoms, they should immediately stop taking ibuprofen and seek medical attention:

A red, blistering rash with bumps under the skin and blisters, accompanied by fever.

Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Severe side effects include skin reactions, such as reddened, flat, plate-like, or round patches 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).

Severe skin reactions known as DRESS syndrome may occur.

Symptoms of DRESS syndrome include widespread skin rash, high fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell).

Severe side effects also include chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome (frequency not known).

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 side effects

Frequent (occurring in 1 to 10 in 100 treated patients):

• heartburn, indigestion, diarrhea, nausea, vomiting, abdominal pain, bloating, constipation, gastrointestinal bleeding.

Uncommon (occurring in 1 to 10 in 1000 treated patients):

• allergic reactions, urticaria, itching, asthma attacks (possibly with a drop in blood pressure); in such cases, the medicine should be discontinued and a doctor consulted immediately;
• insomnia, drowsiness;
• headache, dizziness;
• agitation, irritability, or fatigue;
• visual disturbances;
• gastrointestinal ulcers, potentially with bleeding and perforation, oral ulcers, exacerbation of ulcerative colitis, Crohn's disease, gastritis, black stools, bloody vomiting.

Rare (occurring in 1 to 10 in 10,000 treated patients):

• tinnitus (ringing in the ears);
• kidney tissue damage (renal papillary necrosis) and increased uric acid levels in the blood.

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

• severe, generalized allergic reactions. They may occur as, for example, facial swelling, tongue swelling, internal throat swelling with impaired airway patency, respiratory failure, rapid heart rate, blood pressure drop, potentially life-threatening shock. If any of these symptoms occur, immediate medical attention is necessary;
• blistering reactions, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and exfoliative dermatitis. The greatest risk of these severe reactions occurs at the beginning of treatment, usually within the first month of taking the medicine;

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

• skin becomes sensitive to light.

Reporting side effects

If side effects occur, including any side effects not listed in this package leaflet, the patient should tell their doctor, 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

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.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ibuprofen TZF

Store at a temperature below 30°C.

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date (EXP) stated on the blister pack and carton.

The expiry date (EXP) refers to the last day of the month stated.

Do not use this medicine if the blister is damaged.

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

The patient should ask their 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 TZF contains

• The active substance of the medicine is ibuprofen (Ibuprofenum). Each film-coated tablet contains 600 mg of ibuprofen.
• The other ingredients (excipients) are: cornstarch, sodium lauryl sulfate, colloidal anhydrous silica, sodium croscarmellose, povidone K-30, microcrystalline cellulose, talc, stearic acid, Opadry White 32K580000 coating: hypromellose, lactose monohydrate, titanium dioxide (E 171), triacetin.

What Ibuprofen TZF looks like and contents of the pack

White, biconvex, film-coated tablets, smooth on both sides.

PVC/PVDC/Aluminum blister pack containing 10 film-coated tablets.

The blister pack is placed in a carton.

Marketing authorization holder and importer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna

ul. A. Fleminga 2

03-176 Warsaw

Phone: (22) 811-18-14

To obtain more detailed information about this medicine, the patient should contact the marketing authorization holder.

Date of last revision of the package leaflet: