Ibuprofen Tzf

Leaflet attached to the packaging: patient information

Ibuprofen TZF, 400 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 directed by a doctor or pharmacist.

• The 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 leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their 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 packaging 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 for use:

Pain of various origins of mild to moderate severity:

• headaches (including migraines),
• toothaches,
• muscle, joint, and bone pain (including back pain),
• post-traumatic, post-operative pain, including pain after dental surgery,
• painful menstruation. Febrile conditions of various origins (including flu, colds).

If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

2. Important information before taking Ibuprofen TZF

When not to take Ibuprofen TZF

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 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 non-steroidal 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 been diagnosed with active or recurrent gastric and/or duodenal ulcers (peptic ulcers) or gastrointestinal bleeding (two or more separate episodes of confirmed peptic ulcers or gastrointestinal bleeding);

in patients with a tendency to bleed;

if there is severe liver or kidney failure;

if there is severe heart failure;

in the last three months of pregnancy.

Warnings and precautions

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

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

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

The patient should inform their pharmacist or doctor if they have an infection - see below, the 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 the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should immediately consult their doctor.

Before starting treatment with Ibuprofen TZF, the patient should discuss it with their doctor or pharmacist.

Particular caution should be exercised 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 has had any stroke (including mini-stroke or transient ischemic attack - TIA);

the patient has high blood pressure, diabetes, has high cholesterol levels, has a history of heart disease or stroke in their family, or 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 dehydrated (especially in adolescents and the elderly) - there is an increased risk of kidney function disorder;

if the patient has asthma, hay fever, 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) - symptoms may worsen.

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 occurred with the use of ibuprofen. If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should immediately stop taking Ibuprofen TZF and seek medical attention.

The patient should avoid taking ibuprofen with other NSAIDs, including so-called 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 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.

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

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 those who require concomitant use of low-dose aspirin or other drugs that increase the risk of gastrointestinal disorders, the use of protective agents (e.g., misoprostol or proton pump inhibitors) should be considered.

If gastrointestinal bleeding or ulcers occur during treatment with Ibuprofen TZF, the medicine should be discontinued and the patient should consult their doctor.

Caution should be exercised in patients taking medicines 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 the patient should consult their doctor or pharmacist before taking the medicine if they have high blood pressure or heart failure with fluid retention, high blood pressure, and edema, which are associated with the use of NSAIDs in the past.

Taking anti-inflammatory and analgesic medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. The recommended dose should not be exceeded, and the duration of treatment should be as short as possible.

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

Patient groups at the highest risk of such reactions include those with kidney function disorders, heart failure, liver function disorders, taking diuretics and antihypertensive medicines (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, 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 the use of Ibuprofen TZF. If the following occur: any skin rash, changes in the mucous membranes, blisters, or other symptoms of allergy, the patient should 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 analgesic medicines, headache may occur, which should not be treated by increasing the dose of the medicine. The patient should stop taking the medicine and consult their doctor.

The patient should avoid taking Ibuprofen TZF during chickenpox.

The patient should avoid consuming alcohol while taking the medicine, as it may increase the risk of side effects, especially those related to the gastrointestinal tract and nervous system.

If new or worsening symptoms occur, the patient should contact their 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. This applies to medicines used to treat or prevent:

• cancer and immune system disorders (methotrexate);
• manic-depressive illness (lithium);
• irregular heart rhythm (digoxin);
• pharmacological termination of pregnancy (mifepristone);
• pain (acetylsalicylic acid);
• thromboembolic disorders (anticoagulant medicines, e.g., aspirin/acetylsalicylic acid, dicoumarol, warfarin, ticlopidine);
• depression (selective serotonin reuptake inhibitors - SSRIs);
• high blood pressure (blood pressure-lowering medicines, e.g., ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan, diuretics);
• organ rejection after transplantation (immunosuppressive medicines, such as cyclosporine or tacrolimus);
• inflammation (corticosteroids);
• bacterial infections (certain 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, the patient should always consult their 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.

The patient should avoid taking ibuprofen with alcohol due to the possibility of increasing gastrointestinal 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 their 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. This 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. During 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 during the first and/or second trimester of pregnancy, the smallest effective dose should be used for the shortest possible duration.

Taking Ibuprofen TZF for more than a few days from the 20th week of pregnancy may cause kidney disorders in the unborn child, which can lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If the patient takes Ibuprofen TZF for more than a few days, their 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, the patient should consider stopping breastfeeding.

Fertility

The use of Ibuprofen TZF may impair female fertility and is not recommended in women planning a pregnancy.

Driving and operating machinery

Patients who experience side effects such as dizziness, drowsiness, fatigue, vision disturbances, or other central nervous system disturbances 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 their 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 patient leaflet or as directed by a doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

The medicine is for short-term oral use.

Method of administration

Oral administration.

The medicine should be taken with food 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. The tablets should be swallowed whole and not chewed, broken, crushed, or sucked to avoid discomfort in the mouth and throat irritation.

Dosage

The smallest effective dose should be used for the shortest necessary period to alleviate symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult their doctor (see section 2).

If the medicine needs to be taken for more than 3 days or if the symptoms worsen, the patient should consult their doctor.

The maximum daily dose should not exceed 1200 mg.

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

Usually, 400 mg (1 tablet) is taken, and the dose can be repeated 3 times a day, with a 4-hour interval. The maximum daily dose should not exceed 1200 mg (3 tablets per day).

Children

Ibuprofen TZF should not be taken by children under 12 years old.

Elderly patients

Elderly patients are at a higher risk of side effects. To minimize the risk of side effects, the smallest effective dose should be used for the shortest necessary period to alleviate symptoms.

Patient monitoring for gastrointestinal bleeding is recommended during ibuprofen treatment.

Patient with liver or kidney function disorders

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

Taking a higher dose of Ibuprofen TZF than recommended

If the patient has taken a higher dose of Ibuprofen TZF than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to assess the risk to their health and receive 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 may occur in some patients. 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. Additionally, 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 slow heart rate may occur. In patients with asthma, worsening of asthma symptoms may occur.

Missing a dose of Ibuprofen TZF

The patient should not take a double dose to make up for a missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

Severe side effects

The patient should stop taking ibuprofen and seek medical attention immediatelyif they 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. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• 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). The patient should immediately contact their doctor if they experience any infection with symptoms such as fever, significant weakness, or fever with symptoms of infection, such as sore throat, oral ulcers, urinary tract disorders. The patient should inform their doctor that they are taking this medicine.

Severe skin reactions known as DRESS syndrome may occur. 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 bumps 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

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

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

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

• rhinitis (cold);
• allergic reactions, urticaria, itching, purpura, angioedema;
• insomnia, restlessness;
• paresthesia (tingling);
• drowsiness;
• vision disturbances, hearing disturbances;
• photosensitivity;
• asthma, bronchospasm, dyspnea;
• blood disorders (decreased red blood cell count or hemoglobin, which can 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 out of 10,000 treated patients):

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

Very rare (occurring in less than 1 out of 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they 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 packaging and other information

What Ibuprofen TZF contains

• The active substance of the medicine is ibuprofen (Ibuprofenum).Each coated tablet contains 400 mg of ibuprofen.
• The other ingredients (excipients) are: cornstarch, 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 what the pack contains

White, biconvex, smooth tablets.

A PVC/PVDC/Aluminum blister pack containing 10 coated tablets. The blister packs are placed in a carton.

Marketing authorization holder and importer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.

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 the last revision of the leaflet: