Ibuprofen Tzf

Leaflet accompanying the packaging: patient information

Ibuprofen TZF, 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 advised by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or you feel worse, consult your doctor.

Table of contents of the 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 NSAIDs (non-steroidal anti-inflammatory drugs) with analgesic, anti-inflammatory, and antipyretic effects.

Indications:

Pain of various origins of mild to moderate severity:

• headache (including migraine),
• toothache,
• muscle, joint, and bone pain (including back pain),
• post-traumatic, post-operative pain, including pain after dental surgery,
• menstrual cramps. Febrile conditions of various origins (including flu, cold).

If after 3 days there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Ibuprofen TZF

When not to take Ibuprofen TZF

if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);

if you have ever had any symptoms of allergy in the form of rhinitis, urticaria, or bronchial asthma after taking ibuprofen, aspirin (acetylsalicylic acid), or other non-steroidal anti-inflammatory drugs (NSAIDs);

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

if you have been diagnosed with active or recurrent peptic ulcer (gastric and/or duodenal ulcer) or gastrointestinal bleeding (two or more separate episodes of confirmed peptic ulcer or gastrointestinal bleeding);

in patients with a tendency to bleed;

if you have severe liver or kidney failure;

if you have severe heart failure;

in the last three months of pregnancy.

Warnings and precautions

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

If you notice any of these symptoms, stop taking Ibuprofen TZF immediately and consult your doctor or emergency medical services.

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

Please inform your pharmacist or doctor if you have an infection - see below, section entitled "Infections".

Infections

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

This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.

If you are taking this medicine during an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

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

Particular caution should be exercised if:

you have heart disease, such as heart failure, coronary heart disease, angina pectoris (chest pain), you have had a heart attack, coronary artery bypass grafting, you have peripheral arterial 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);

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;

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

you are dehydrated (especially in children and adolescents and the elderly) - there is an increased risk of kidney function disorder;

you have asthma, allergic rhinitis, or symptoms of allergic reactions

• after taking the medicine, bronchospasm, urticaria, or angioedema may occur; in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) - exacerbation of symptoms may occur.

Severe skin reactions, 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) have occurred with ibuprofen.

If you experience any symptoms associated with these severe skin reactions described in section 4, stop taking Ibuprofen TZF and seek medical attention.

Avoid concomitant use of ibuprofen with other NSAIDs, including COX-2 inhibitors (selective cyclooxygenase-2 inhibitors), due to the increased risk of gastrointestinal bleeding.

Patients 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 prone 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.

Cases of bleeding, ulceration, or perforation of the gastrointestinal tract, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning signs or previous serious gastrointestinal adverse reactions.

The risk of gastrointestinal bleeding, ulcers, or perforation increases with the dose of NSAIDs and is higher in patients with a history of ulcers, especially if they were complicated by bleeding or perforation (see section 2, subsection "When not to take Ibuprofen TZF"), and also in the elderly.

Such patients should start treatment with the lowest available dose.

For these patients, as well as for patients who require concomitant use of low-dose aspirin or other drugs that increase the risk of gastrointestinal disorders, consideration should be given to concomitant use of protective agents (e.g., misoprostol or proton pump inhibitors).

If gastrointestinal bleeding or ulceration occurs during treatment with Ibuprofen TZF, the medicine should be discontinued and a doctor consulted.

Caution is recommended in patients taking concomitantly medications that may increase the risk of gastrointestinal ulcers or bleeding, such as oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (used to treat various disorders, including depression), and antiplatelet agents (e.g., acetylsalicylic acid) (see section 2, "Ibuprofen TZF and other medicines").

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 painkillers and anti-inflammatory drugs, 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.

Long-term use of ibuprofen, especially in combination with other painkillers, may cause permanent kidney damage and increase the risk of kidney failure.

Patients with the highest risk of such reactions are those with kidney function disorders, heart failure, liver function disorders, taking diuretics and antihypertensive drugs (ACE inhibitors), and the elderly.

Patients who discontinue treatment with NSAIDs usually return to their pre-treatment state.

In patients with kidney, liver, or heart function disorders, the smallest effective dose should be used for the shortest possible duration of treatment, and kidney function should be monitored, especially in patients with long-term treatment.

Ibuprofen, like other NSAIDs, may affect platelet aggregation and prolong bleeding time in healthy individuals.

Severe skin reactions have been reported with Ibuprofen TZF.

If you experience: any skin rash, changes in the mucous membranes, blisters, or other symptoms of allergy, stop taking Ibuprofen TZF and seek medical attention immediately, as these may be the first symptoms of a very severe skin reaction. See section 4.

During long-term use of painkillers, a headache may occur, which should not be treated by increasing the dose of the medicine.

Stop taking the medicine and consult your doctor.

Avoid taking Ibuprofen TZF during chickenpox.

Avoid consuming alcohol while taking the medicine, as it may exacerbate side effects, especially those related to the gastrointestinal tract and nervous system.

In case of new or worsening symptoms, consult your doctor or pharmacist.

Ibuprofen TZF and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

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

This applies to medicines used in the treatment or prevention of:

• cancer and immune system disorders (methotrexate);
• manic-depressive illness (lithium);
• irregular heartbeat (digoxin);
• pharmacological termination of pregnancy (mifepristone);
• pain relief (acetylsalicylic acid);
• thromboembolic diseases (anticoagulant medicines, i.e., blood thinners/anti-clotting agents, such as aspirin/acetylsalicylic acid, dicoumarol, warfarin, ticlopidine);
• depression (medicines called selective serotonin reuptake inhibitors - SSRIs);
• high blood pressure (medicines that lower blood pressure, i.e., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan, diuretics);
• organ rejection after transplantation (immunosuppressive agents, such as cyclosporine or tacrolimus);
• inflammation (corticosteroids);
• bacterial infections (some antibiotics, including aminoglycosides);
• fungal infections (e.g., voriconazole or fluconazole);
• diabetes (sulfonylurea derivatives);
• high cholesterol (cholestyramine);
• HIV infection (zidovudine).

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

Therefore, before taking Ibuprofen TZF with other medicines, always consult your doctor or pharmacist.

Ibuprofen TZF with food, drink, and alcohol

The medicine can be taken with food or drink.

The medicine can also be taken on an empty stomach.

To avoid gastrointestinal disorders, it is recommended to take the medicinal product during a meal or after a meal.

Avoid concomitant use of 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 child, consult your doctor or pharmacist before taking this medicine.

Pregnancy

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

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

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

During the first six months of pregnancy, do not take Ibuprofen TZF 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 and the shortest possible treatment period should be used.

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 can lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart.

If you take Ibuprofen TZF for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen passes into breast milk in small amounts.

With short-term use of ibuprofen in therapeutic doses, harmful effects on breastfed infants seem unlikely.

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

Fertility

Taking Ibuprofen TZF may impair female fertility and is not recommended in women planning pregnancy.

Driving and using machines

Patients who experience side effects such as dizziness, drowsiness, fatigue, visual disturbances, should not drive or operate machinery.

Ibuprofen TZF contains lactose monohydrate and sodium

Lactose monohydrate

If you have been diagnosed with intolerance to some sugars, consult your 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

Always take this medicine exactly as described in this patient leaflet or as advised by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist.

Short-term oral use.

Method of administration

Oral administration.

This medicine should be taken during meals or on an empty stomach.

To avoid gastrointestinal disorders, it is recommended to take the medicinal product during a meal or after a meal.

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

Swallow the tablets whole, do not chew, break, crush, or suck them to avoid discomfort in the mouth and throat irritation.

Dosage

Use 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, consult your doctor immediately (see section 2).

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

The maximum daily dose should not exceed 1200 mg.

Children from 6 to 9 years old (with a body weight of 20 to 29 kg)

Usually, 200 mg (1 tablet) is taken, if necessary, every 6 to 8 hours.

Do not take more than 600 mg (3 tablets) per day in divided doses.

Children from 10 to 12 years old (with a body weight of 30 to 39 kg)

Usually, 200 mg (1 tablet) is taken, if necessary, every 6 hours.

Do not take more than 800 mg (4 tablets) per day in divided doses.

Adults and adolescents over 12 years old (with a body weight over 40 kg):

Initial dose - 2 tablets, then if necessary, 1 to 2 tablets every 4 to 6 hours.

Do not take more than 6 tablets (1200 mg of ibuprofen) in 24 hours.

Maintain at least a 4-hour interval between doses.

Do not take Ibuprofen TZF in children under 6 years old.

Elderly patients

In elderly patients, there is an increased risk of side effects.

To minimize the risk of side effects, the medicine should be taken in the smallest effective dose for the shortest necessary period to relieve symptoms.

Patients should be regularly monitored for gastrointestinal bleeding during ibuprofen treatment.

Patients with liver or kidney function disorders

Your doctor will determine the appropriate dose for patients with liver or kidney function disorders.

Taking a higher dose of Ibuprofen TZF than recommended

If you have taken a higher dose of Ibuprofen TZF than recommended or if a child has accidentally taken the medicine, always consult your doctor or go to the nearest hospital to get an opinion on possible health risks and 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.

Excitement, drowsiness, or coma may also occur.

Seizures have been reported in some patients.

After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported.

Blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties have also 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, and bradycardia may occur.

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

Missing a dose of Ibuprofen TZF

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

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

Stop taking ibuprofen and seek medical attention immediatelyif you experience any of the following symptoms:

• angioedema (rare side effect):
• swelling of the face, tongue, or throat,
• difficulty swallowing,
• urticaria and difficulty breathing.
• red, non-raised, target-like or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes.
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.
• gastrointestinal bleeding (frequent side effect):
• bloody stools,
• bloody vomiting.

Ibuprofen TZF may cause blood system disorders (agranulocytosis, leukopenia, thrombocytopenia) with decreased resistance to infection (rare side effect).

Consult your doctor immediately if you have an infection with symptoms such as fever, significant weakness, or fever with infection symptoms such as sore throat, oral ulcers, urinary tract disorders.

Inform your doctor that you are taking this medicine.

Severe skin reactions known as DRESS syndrome may occur.

The symptoms of DRESS syndrome include: widespread skin rash, high fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell); (frequency of occurrence - unknown, cannot be determined based on available data).

A red, peeling rash with nodules under the skin and blisters, accompanied by fever, may occur.

Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis); (frequency of occurrence - unknown, cannot be determined based on available data).

Other side effects

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

• headache, dizziness;
• nausea, diarrhea, nausea, vomiting, abdominal pain, bloating, constipation, bloody stools, bloody vomiting, gastrointestinal bleeding;
• rash;
• fatigue.

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

• rhinitis (cold);
• allergic reactions, urticaria, itching, rash, angioedema;
• insomnia, restlessness;
• paresthesia (tingling);
• drowsiness;
• visual disturbances, hearing disturbances;
• photosensitivity;
• asthma, bronchospasm, dyspnea;
• blood disorders (decreased red blood cell count or hemoglobin, which may cause pallor and lead to weakness);
• hepatitis, jaundice, liver function disorders, kidney function disorders;
• gastritis, duodenal ulcer, gastric ulcer, oral ulcers, gastrointestinal perforation.

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

• severe allergic reactions (anaphylactic shock, angioedema);
• aseptic meningitis;
• depression, confusion;
• tinnitus (ringing in the ears), vertigo of labyrinthine origin;
• visual disturbances;
• liver damage.

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

• pancreatitis;
• liver failure.

Frequency not known (frequency cannot be determined based on available data):

• worsening of ulcerative colitis and Crohn's disease;
• heart failure, myocardial infarction;
• hypertension;
• skin becomes sensitive to light.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine.

5. How to store Ibuprofen TZF

Store below 30°C.

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

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

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 TZF contains

• The active substance of the medicine is ibuprofen (Ibuprofenum). Each coated tablet contains 200 mg of ibuprofen.
• The other ingredients (excipients) are: corn starch, sodium lauryl sulfate, anhydrous colloidal 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, smooth tablets on both sides.

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

The blisters are placed in a carton.

Marketing authorization holder and manufacturer/importer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna

ul. A. Fleminga 2

03-176 Warsaw

Phone number: (22) 811-18-14

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

Date of last revision of the leaflet: