Ibuprofen tzf

Package leaflet: Information for the patient

Ibuprofen TZF, 400 mg, coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult a doctor.

Contents of the leaflet

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

Ibuprofen TZF belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs)
which have analgesic, anti-inflammatory and antipyretic properties.
Indications:
Pain of various origins, mild to moderate in intensity:

• headaches (including migraines),
• toothaches,
• muscle, joint and bone pain (including back pain),
• pain due to injury or following surgery, including dental procedures,
• painful menstruation.
  Feverish conditions of various causes (e.g. during influenza, colds).

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

2. Important information before using Ibuprofen TZF

When not to use Ibuprofen TZF
if the patient is allergic to ibuprofen or to any of the other ingredients of this medicine
(listed in section 6);
if the patient has ever previously experienced any allergic symptoms such as
nasal congestion, urticaria or bronchial asthma following the intake of ibuprofen, aspirin
(acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs (NSAIDs);
if the patient has ever previously experienced gastrointestinal bleeding or
gastrointestinal perforation related to previous use of NSAIDs;
if the patient has active or recurrent gastric or duodenal ulcer (peptic ulcer) or bleeding from a peptic ulcer (two or more separate episodes of confirmed peptic ulcer or bleeding from a peptic ulcer);
in patients with a tendency to bleeding;
if there is severe hepatic insufficiency or severe renal insufficiency;
if there is severe heart failure;
during the last three months of pregnancy.

Warnings and precautions
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported during treatment.
If any of these symptoms occur, Ibuprofen TZF should be discontinued immediately and medical advice should be sought urgently.

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Inform your pharmacist or doctor if the patient has an infection – see below, section titled “Infections”.

Infections
Ibuprofen TZF may mask signs of infection such as fever and pain. Therefore, Ibuprofen TZF may delay appropriate treatment of infection and consequently increase the 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 existing infection and symptoms of infection persist or worsen, medical advice should be sought immediately.

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

Exercise particular caution if:

• the patient has heart diseases such as heart failure, ischemic heart disease, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has experienced any stroke (including mini-stroke or transient ischemic attack – TIA);
• the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or is a smoker;
• the patient has autoimmune diseases (systemic lupus erythematosus or mixed connective tissue disease) – increased risk of developing aseptic meningitis;
• the patient is dehydrated (especially in adolescents and elderly patients) – increased risk of renal impairment;
• the patient has asthma, hay fever or allergic reactions;
  • bronchospasm, urticaria or angioedema may occur after taking the medicine;
• the patient has a history of gastrointestinal disorders (ulcerative colitis, Crohn’s disease) – symptoms may worsen.

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 been reported with ibuprofen use. If any of the symptoms associated with these severe skin reactions described in section 4 occur, Ibuprofen TZF should be discontinued immediately and medical help should be sought.

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

Patients with a history of gastrointestinal disorders, especially elderly patients, should report any unusual gastrointestinal symptoms (particularly bleeding), especially at the beginning of treatment.

Elderly patients are at higher risk of adverse effects, particularly gastrointestinal bleeding and ulceration. Elderly patients should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the beginning of treatment.

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

The risk of gastrointestinal bleeding, peptic ulcers or gastrointestinal perforation increases with higher NSAID doses and is greater in patients with a history of peptic ulcers, especially if complicated by bleeding or perforation (see section 2, subsection “When not to use Ibuprofen TZF”), and in elderly patients. Such patients should start treatment with the lowest available dose.

In these patients, and in patients requiring additional use of low-dose acetylsalicylic acid or other drugs increasing the risk of gastrointestinal disorders, concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.

If gastrointestinal bleeding occurs or gastrointestinal ulceration is diagnosed during treatment with Ibuprofen TZF, the drug should be discontinued and medical advice sought.

Exercise caution in patients concurrently taking medications that may increase the risk of peptic ulcers or gastrointestinal bleeding, e.g. oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (used in treatment of various disorders including depression), and antiplatelet agents such as acetylsalicylic acid (see section 2, “Ibuprofen TZF and other medicines”).

Particular caution and consultation with a doctor or pharmacist is advised before using Ibuprofen TZF in patients with hypertension or heart failure with fluid retention, or with hypertension and edema previously associated with NSAID use.

Use of anti-inflammatory and analgesic 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.

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

Patients at greatest risk of such reactions include those with impaired renal function, heart failure, hepatic dysfunction, those taking diuretics and antihypertensive agents (ACE inhibitors), and elderly patients. Patients who discontinue treatment with NSAIDs usually return to their pre-treatment state.

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

Severe skin reactions associated with the use of Ibuprofen TZF have been reported. If any skin rash, mucosal lesions, blisters or other allergic symptoms appear, discontinue Ibuprofen TZF immediately and seek medical help promptly, as these may be early signs of a very serious skin reaction. See section 4.

During long-term use of analgesics, headache may occur, which should not be treated by increasing the dose of the medicine. Discontinue use and consult a doctor.

Avoid using Ibuprofen TZF during chickenpox.

Avoid alcohol consumption during treatment, as it may increase adverse effects, particularly those affecting the gastrointestinal and nervous systems.

If new symptoms occur or existing symptoms worsen, contact your doctor or pharmacist.

Ibuprofen TZF and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, and any medicines planned for use.

Ibuprofen TZF may affect the action of other medicines or other medicines may affect the action of Ibuprofen TZF. This includes medicines used to treat or prevent:

• cancer and immune system disorders (methotrexate);
• bipolar disorder (lithium);
• irregular heartbeat (digoxin);
• medical termination of pregnancy (mifepristone);
• pain (acetylsalicylic acid);
• thromboembolic disorders (anticoagulant medicines, i.e. blood thinners/preventing clot formation, such as aspirin/acetylsalicylic acid, dicoumarol, warfarin, ticlopidine);
• depression (medicines called selective serotonin reuptake inhibitors – SSRI);
• high blood pressure (antihypertensive medicines, i.e. blood pressure-lowering agents such as ACE inhibitors like captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan, diuretics);
• organ rejection after transplantation (immunosuppressants 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);
• human immunodeficiency virus (HIV) infection (zidovudine).

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

Ibuprofen TZF with food, drink and alcohol
The medicine can be taken with or without food or drink. It may also be taken on an empty stomach.
To avoid gastrointestinal discomfort, it is recommended to take the medicine during or after a meal.

Avoid concomitant use of ibuprofen with alcohol due to the potential for increased gastrointestinal adverse effects.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Ibuprofen TZF must not be used 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 problems in the unborn child. Ibuprofen TZF may increase the tendency to bleeding in both the pregnant woman and the child, and may delay or prolong labor. During the first six months of pregnancy, Ibuprofen TZF should not be used unless absolutely necessary and only on the advice of a doctor.

If Ibuprofen TZF is to be used when trying to conceive or during the first and/or second trimester of pregnancy, the lowest possible effective dose for the shortest possible duration should be used. Taking Ibuprofen TZF for longer than a few days beyond 20 weeks of pregnancy may cause kidney dysfunction in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If Ibuprofen TZF is used for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts. Short-term use of ibuprofen at therapeutic doses is unlikely to have harmful effects on infants. However, if long-term use of ibuprofen is recommended, earlier weaning from breastfeeding should be considered.

Fertility
Use of Ibuprofen TZF may impair female fertility and is not recommended in women attempting to conceive.

Driving and operating machinery
Patients who experience adverse effects such as dizziness, drowsiness, fatigue, or visual 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 certain sugars, the patient should consult a doctor before taking this medicine.

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

3. How to use Ibuprofen TZF

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for short-term oral use only.
Method of administration
For oral use.
This medicine may be taken during or without food.
To avoid gastrointestinal discomfort, it is recommended to take the medicine during or immediately 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 oral discomfort and throat irritation.
Dosage
The lowest effective dose for the shortest necessary duration should be used to relieve symptoms. If symptoms of an infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
If it is necessary to use the medicine for longer than 3 days or if symptoms worsen, consult your doctor.
The maximum daily dose must not exceed 1,200 mg.
Adults and adolescents over 12 years of age (weighing over 40 kg):
The usual dose is 400 mg (1 tablet). If needed, this dose may be repeated up to 3 times daily, with at least 4 hours between doses. The maximum daily dose must not exceed 1,200 mg (3 tablets per day).
Children
Ibuprofen TZF must not be used in children under 12 years of age.
Elderly patients
Elderly patients have an increased risk of adverse effects. To minimize this risk, the lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
Patients should be monitored regularly for gastrointestinal bleeding during ibuprofen treatment.
Patients with impaired liver or kidney function
Your doctor will determine the appropriate dose for patients with impaired liver or kidney function.
Use of a higher than recommended dose of Ibuprofen TZF
If a patient takes more than the recommended dose of Ibuprofen TZF, or if a child accidentally ingests the medicine, always contact a doctor or go to the nearest hospital for assessment of potential health risks and advice on necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Agitation, drowsiness, or coma may also occur. Seizures may occur in some patients. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. In addition, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. In severe poisoning, metabolic acidosis may occur. During severe intoxication, acute kidney failure and liver damage, hypotension, respiratory depression, and bradycardia may occur. In patients with asthma, worsening of asthma symptoms may occur.
Missed dose of Ibuprofen TZF
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
Stop taking ibuprofen immediately and seek medical help if any of the following symptoms occur:

• Angioedema (a rare adverse effect):
  • swelling of the face, tongue or throat,
  • difficulty swallowing,
  • urticaria and breathing difficulties.
• Red, flat, target-like or circular skin lesions on the trunk, often with blisters in the centre, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs 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 indicate a potentially serious allergic reaction known as Kounis syndrome.
• Gastrointestinal bleeding (a common adverse effect):
  • bloody stools,
  • vomiting blood.

Ibuprofen TZF may cause blood disorders (agranulocytosis, leucopenia, thrombocytopenia) associated with reduced resistance to infection (a rare adverse effect). You should contact your doctor immediately if you develop an infection with symptoms such as fever, marked weakness, or fever with signs of infection such as sore throat, oral ulcers, or urinary tract disturbances. Inform your doctor that you are taking this medicine.
Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: widespread skin rash, high fever, enlarged lymph nodes, and increased eosinophil count (a type of white blood cell); (frequency unknown – cannot be estimated from available data).
A red, scaly rash with subcutaneous nodules and blisters, accompanied by fever, may occur. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis); (frequency unknown – cannot be estimated from available data).
Other adverse effects
Common (occur in 1 to 10 out of 100 treated patients):

• Headache, dizziness;
• Dyspepsia, diarrhoea, nausea, vomiting, abdominal pain, bloating, constipation, bloody stools, vomiting blood, gastrointestinal bleeding;
• Rash;
• Feeling of fatigue.

Uncommon (occur in 1 to 10 out of 1,000 treated patients):

• Rhinitis (nasal catarrh);
• Hypersensitivity reactions, urticaria, pruritus, purpura, angioedema;
• Insomnia, restlessness;
• Paraesthesia (tingling);
• Somnolence;
• Visual disturbances, hearing disturbances;
• Photophobia;
• Asthma, bronchospasm, dyspnoea;
• Blood count abnormalities (reduction in red blood cells or haemoglobin, which may cause pallor and lead to weakness);
• Hepatitis, jaundice, liver function abnormalities, kidney function abnormalities;
• Gastritis, duodenal ulcer, gastric ulcer, oral ulceration, gastrointestinal perforation.

Rare (occur in 1 to 10 out of 10,000 treated patients):

• Severe hypersensitivity reactions (anaphylactic shock, oedema);
• Aseptic meningitis;
• Depression, confusion;
• Tinnitus (ringing in the ears), vestibular dizziness;
• Visual disturbances;
• Liver damage.

Very rare (occur in less than 1 out of 10,000 treated patients):

• Pancreatitis;
• Liver failure.

Frequency unknown (frequency cannot be estimated from available data):

• Exacerbation of colitis and Crohn's disease;
• Heart failure, myocardial infarction;
• Hypertension;
• Skin becomes sensitive to light.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ibuprofen TZF

Store below 30°C.
Keep the medicine out of 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 stated month.
Do not use this medicine if the blister is damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Ibuprofen TZF contains

• The active substance is ibuprofen (Ibuprofenum). Each coated tablet contains 400 mg of ibuprofen.
• The other ingredients (excipients) are: maize starch, sodium lauryl sulfate, colloidal anhydrous silica, sodium croscarmellose, povidone K-30, microcrystalline cellulose, talc, stearic acid, coating Opadry White 32K580000: hypromellose, monohydrate lactose, 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/Aluminium blister pack containing 10 film-coated tablets. Blisters are placed in a cardboard box.
Marketing Authorisation Holder and Importer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Phone number: (22) 811-18-14
For further information about this medicine, please contact the Marketing Authorisation Holder.