Ibuteva

Leaflet accompanying the packaging: patient information

IbuTeva, 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 the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days in children and adolescents or after 7 days in adults there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

1. What is IbuTeva and what is it used for

IbuTeva belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs), which work by reducing pain, inflammation, and high temperature.
IbuTeva is used to relieve mild to moderate pain such as: headache, including migraine headache, toothache, painful menstruation, and fever.

2. Important information before taking IbuTeva

When not to take IbuTeva:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• if the patient has had a hypersensitivity reaction, such as: asthma, hay fever, itchy skin rash, or swelling of the face, lips, tongue, or throat after taking medicines containing acetylsalicylic acid or other painkillers and anti-inflammatory drugs (NSAIDs)
• if the patient has had stomach or duodenal ulcers or bleeding in the stomach or duodenum associated with the use of painkillers and anti-inflammatory drugs (NSAIDs)
• if the patient has stomach or duodenal ulcers or bleeding, or if the patient has had two or more such episodes in the past
• if the patient has severe liver, kidney, or heart problems (including coronary artery disease)
• if the patient is in the last three months of pregnancy
• if the patient is significantly dehydrated (due to vomiting, diarrhea, or insufficient hydration)
• if the patient has active bleeding (including cerebral hemorrhage)
• if the patient has been diagnosed with unknown origin disorders causing abnormal blood cell production.

Warnings and precautions

Before starting to take IbuTeva, the patient should discuss it with their doctor:

• if the patient has systemic lupus erythematosus or other autoimmune diseases
• if the patient has a congenital red blood cell disorder - porphyria
• if the patient has chronic inflammatory bowel diseases, such as: ulcerative colitis, Crohn's disease, or other stomach or intestinal diseases
• if the patient has blood cell production disorders
• if the patient has blood clotting problems
• if the patient has allergies, hay fever, asthma, chronic nasal congestion, nasal polyps, or chronic obstructive pulmonary disease, as ibuprofen may cause bronchospasm and breathing difficulties
• if the patient has severe liver, kidney, or heart problems,
• if the patient has heart problems, including heart failure, angina pectoris, or high blood pressure, or if the patient has had a heart attack, bypass surgery, or any stroke or transient ischemic attack (TIA), or if the patient has problems with blood circulation in the arms and legs (peripheral arterial disease). See "Effect on the heart and brain".
• if the patient has recently undergone major surgery
• if the patient is in the first six months of pregnancy
• if the patient is breastfeeding
• if the patient has an infection - see below, "Infections".

The patient should use the smallest possible dose for the shortest duration necessary to reduce the risk of side effects.

Effect on the gastrointestinal tract

The patient should avoid taking IbuTeva with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
Elderly patients
If the patient is elderly, they may be more prone to side effects, especially gastrointestinal bleeding and perforation, which can be fatal.
Ulcers, perforations, and gastrointestinal bleeding
If the patient has had a stomach or duodenal ulcer, especially if it was complicated by perforation or bleeding, the patient should be carefully monitored for any unusual abdominal symptoms and immediately inform their doctor, especially if they occur at the beginning of treatment. The risk of gastrointestinal bleeding is higher in elderly patients. If gastrointestinal bleeding or ulcers occur, treatment must be discontinued.
Gastrointestinal bleeding, ulcers, or perforation can occur without warning signs even in patients who have never had such problems before. It can be fatal.
The risk of ulcers, perforations, or gastrointestinal bleeding usually increases with high doses of ibuprofen. The risk also increases if certain other medicines are taken at the same time (see "IbuTeva and other medicines").
NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as their condition may worsen.
Effect on the heart and brain
Taking anti-inflammatory/pain-relieving medicines like ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, especially if taken in high doses. The patient should not exceed the recommended dose or duration of treatment.
Before starting to take IbuTeva, the patient should discuss it with their doctor or pharmacist if:

• the patient has heart problems, including heart failure, angina pectoris, or if they have had a heart attack, bypass surgery, peripheral arterial disease, or any stroke or transient ischemic attack (TIA).
• the patient has high blood pressure, diabetes, high cholesterol, or if any family members have heart disease or stroke, or if the patient is a smoker.

Effect on the kidneys
Ibuprofen may cause kidney problems in dehydrated children and adolescents.
Ibuprofen may cause kidney problems even in patients who have not had kidney problems before. As a result, swelling of the feet and ankles, as well as heart failure or increased blood pressure, may occur in patients with these tendencies.
Ibuprofen may cause kidney damage, especially in patients who already have kidney, heart, or liver problems, or who are taking diuretics or ACE inhibitors, as well as in the elderly. Discontinuation of ibuprofen usually leads to recovery.
Ibuprofen may cause kidney damage, especially in patients who have recently had kidney, heart, or liver problems, or who are taking diuretics or angiotensin-converting enzyme (ACE) inhibitors, as well as in the elderly. Stopping ibuprofen usually leads to improvement.
Skin reactions
Severe skin reactions have been reported with ibuprofen. If the patient experiences: any skin rash, changes in the mucous membranes, blisters, or other signs of allergy, they should stop taking ibuprofen and seek medical help immediately, as these may be the first signs of a severe skin reaction. See section 4.
Infections
Ibuprofen may mask the signs of infection, such as fever and pain. As a result, ibuprofen may delay the use of appropriate infection treatment and lead to 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 while an infection is present, and the infection symptoms persist or worsen, they should consult their doctor immediately.
Chickenpox
During chickenpox (varicella), it is recommended to avoid taking ibuprofen.
Aseptic meningitis (meningitis without bacterial infection)
There have been reports of meningitis (symptoms include stiff neck, headache, nausea, vomiting, fever, or disorientation) during treatment with ibuprofen. Although the likelihood of illness is higher in patients with autoimmune diseases, such as systemic lupus erythematosus or mixed connective tissue disease, it has also been reported in patients who do not have a chronic disease.
Other warnings
During long-term use of high doses of painkillers, headaches may occur, which should not be treated with increased doses of this medicine. Habitual use of painkillers may cause permanent kidney damage and increase the risk of kidney failure.
Ibuprofen may temporarily prolong bleeding time.
During long-term administration of ibuprofen, regular monitoring of liver parameters, kidney function, and blood morphology is required.
IbuTeva may make it difficult to become pregnant. The patient should inform their doctor if they plan to become pregnant or if they have problems becoming pregnant. See "Pregnancy, breastfeeding, and fertility".
Children and adolescents
IbuTeva should not be used in children under 6 years of age.

IbuTeva and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The side effects of IbuTeva may be increased by certain medicines taken at the same time. Additionally, IbuTeva may increase or decrease the effectiveness of other medicines taken at the same time or increase their side effects.

• In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines: other non-steroidal anti-inflammatory drugs (NSAIDs)
• anticoagulant medicines (blood thinners or medicines that prevent blood clotting, e.g., acetylsalicylic acid, warfarin, heparin)
• platelet aggregation inhibitors (to prevent blood clotting), such as clopidogrel, ticlopidine
• selective serotonin reuptake inhibitors (used in depression), such as paroxetine, sertraline, citalopram
• corticosteroids (used to treat inflammatory conditions)
• methotrexate (used to treat cancer and autoimmune diseases)
• digoxin (used to treat various heart conditions)
• phenytoin (used to prevent epileptic seizures)
• lithium (used to treat depression and mania)
• diuretics (including potassium-sparing diuretics)
• medicines used to treat high blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II antagonists, such as losartan)
• cholestyramine (used to treat high cholesterol levels)
• aminoglycosides (used against certain types of bacteria)
• cyclosporine, tacrolimus (used as immunosuppressants after organ transplantation)
• zidovudine (used to treat HIV patients)
• mifepristone
• probenecid or sulfinpyrazone (used to treat gout)
• quinolone antibiotics
• sulfonylurea (used to treat type 2 diabetes)
• fluconazole or voriconazole (used to treat fungal infections)
• bisphosphonates (used in osteoporosis, Paget's disease, and to reduce calcium levels in the blood)
• pentoxifylline (used to treat circulation disorders in the arms and legs)
• baclofen (a muscle relaxant)
• ginkgo biloba (Japanese ginkgo)

IbuTeva with food and drink

IbuTeva should be swallowed with a glass of water during or after a meal.
The patient should avoid drinking alcohol, as it may increase the side effects of IbuTeva, especially those related to the stomach, intestines, or brain.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
IbuTeva should not be taken during the last 3 months of pregnancy, as it may cause serious heart, lung, and kidney problems in the unborn child. If the medicine is taken at the end of pregnancy, it may cause bleeding in the mother and child and weaken uterine contractions, which may prolong labor.
During the first 6 months of pregnancy, IbuTeva should only be used on the advice of a doctor and only if absolutely necessary.
While taking the medicine, ibuprofen is present in small amounts in breast milk, and during short-term treatment with this medicine, there is usually no need to stop breastfeeding. However, if long-term use of the medicine is recommended, the patient should consider stopping breastfeeding.
This medicine belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is temporary and reverses after the end of treatment.

Driving and using machines

Ibuprofen may impair the patient's reaction time in some individuals due to side effects such as dizziness, drowsiness, or vision disturbances. In individual cases, the ability to drive or operate machinery may be impaired. This effect may be increased if the patient consumes alcohol.

IbuTeva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take IbuTeva

IbuTeva should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.
The patient should use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the patient has an infection and the symptoms (such as fever and pain) persist or worsen, they should consult their doctor immediately (see section 2).
In adults, IbuTeva should not be used without consulting a doctor for more than 7 days.
In children and adolescents, IbuTeva should not be used without consulting a doctor for more than 3 days.

Recommended dose:

Adults and children over 12 years old (with a body weight of 40 kg or more):Mild to moderate pain and fever

1 to 2 tablets taken in a single dose or 3 to 4 times a day every 4 to 6 hours.
The maximum daily dose should not exceed 6 tablets (1200 mg).
Migraine
Adults and children over 12 years old (≥40kg):
2 tablets taken in a single dose, if necessary 2 tablets every 4 to 6 hours.
The maximum daily dose should not exceed 6 tablets (1200mg).
Painful menstruation
Adults and children over 12 years old:
1 to 2 tablets, 1 to 3 times a day if necessary, every 4 to 6 hours. The maximum dose should not exceed 6 tablets (1200 mg) per day.
Children aged 6-12 years
Mild to moderate pain and fever
Children aged 6-9 years (with a body weight of 20-29 kg): 1 tablet, 1 to 3 times a day every 4 to 6 hours.
The maximum dose should not exceed 3 tablets per day.
Children aged 10-12 years (with a body weight of 30-40 kg): 1 tablet, 1 to 4 times a day every 4 to 6 hours.
The maximum dose should not exceed 4 tablets per day.
IbuTeva should not be used in children under 6 years of age.

Method of administration:

Tablets should be swallowed with a glass of water during or after a meal. To facilitate swallowing or to adjust the dose, the tablets can be divided into equal halves.
Elderly patients
If the patient is elderly, they should always consult their doctor before starting to take IbuTeva, as they may be more prone to side effects, especially gastrointestinal bleeding and perforation, which can be fatal. The doctor will recommend the appropriate use of the medicine.
Liver and kidney function disorders
If the patient has reduced liver or kidney function, they should always consult their doctor before taking IbuTeva. The doctor will recommend the appropriate use of the medicine.

Overdose of IbuTeva

If the patient has taken more than the recommended dose of IbuTeva or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what to do.
Symptoms of overdose may include: nausea, stomach pain, diarrhea, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. Gastrointestinal bleeding may also occur.
In severe cases of overdose, the following symptoms have been reported: drowsiness, chest pain, palpitations, loss of consciousness, agitation, disorientation, coma, convulsions (especially in children), weakness, dizziness, convulsions (especially in children), vision disturbances, eye problems, kidney failure, blood in the urine, liver damage, decreased blood pressure, feeling cold, breathing difficulties, cyanosis of the lips, tongue, and fingers, and increased bleeding tendency. In patients with asthma, asthma attacks may worsen.

Missed dose of IbuTeva

If the patient misses a dose, they should take it as soon as possible, unless there are less than four hours left before the next dose.
The patient should not take a double dose to make up for a missed dose.
If the patient is unsure about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, IbuTeva can cause side effects, although not everybody gets them.
The risk of side effects is higher with high doses and longer treatment duration.
The following side effects are important and require immediate action if they occur.The patient should stop taking IbuTeva and contact their doctor immediately if they experience:

• Black, tarry stools or vomiting blood (gastrointestinal bleeding), frequent side effect
• Swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing, and hives (angioedema, uncommon side effect),
• rapid heartbeat, significantly lowered blood pressure, or life-threatening shock (anaphylactic reaction, rare side effect)
• If the patient develops an infection with symptoms such as fever and serious deterioration of general health or fever with local signs of infection, such as sore throat, mouth ulcers, or urinary problems, they should consult their doctor immediately. Ibuprofen may reduce the number of white blood cells, which can lead to decreased immunity to infection (agranulocytosis, very rare side effect). The patient should inform their doctor that they are taking this medicine.
• Severe skin and mucous membrane changes with rash, peeling of the skin, especially on the legs, hands, feet, and face, which may also include the mouth and eyes (erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, very rare side effects).
• Severe skin infection with tissue destruction (necrotizing fasciitis, very rare side effect).
• The patient may experience severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, swelling of the lymph nodes, and an increased number of eosinophils (a type of white blood cell, frequency not known).
• A red, scaly rash with thickening of the skin and blisters, usually on the folds of the skin, on the torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis, AGEP, frequency not known). If such symptoms occur, the patient should stop taking IbuTeva and seek medical help immediately. See also section 2.

Other possible side effects:

• Frequent (may occur in up to 1 in 10 patients):
  headache, dizziness
• gastrointestinal disorders (indigestion, diarrhea, nausea, vomiting, stomach pain, bloating, constipation, black stools, gastrointestinal bleeding, vomiting blood)
• complications of diverticulitis (perforation or fistula)
• rash
• fatigue

Uncommon (may occur in up to 1 in 100 patients)

• hay fever (rhinitis)
• photosensitivity reaction
• insomnia, restlessness
• vision disturbances
• hearing impairment
• asthma, bronchospasm, breathing difficulties
• mouth ulcers
• stomach ulcers, duodenal ulcers, perforated stomach ulcers, gastritis
• liver inflammation, jaundice, abnormal liver function
• itching, small bruises on the skin and mucous membranes
• photosensitivity
• impaired kidney function
• drowsiness
• tingling
• hearing loss

Rare (may occur in up to 1 in 1,000 patients)

• anaphylactic reaction
• depression, disorientation
• vision disturbances
• ringing in the ears (tinnitus), dizziness of labyrinthine origin
• liver damage
• fluid retention (edema)
• increased levels of urea and liver enzymes, decreased hemoglobin and hematocrit values, inhibited platelet aggregation, prolonged bleeding time, decreased serum calcium levels, increased serum uric acid levels.

Very rare (may occur in up to 1 in 10,000 patients)

• blood cell production disorders (anemia, leukopenia, thrombocytopenia, neutropenia, pancytopenia, agranulocytosis)
• heart failure, heart attack, or increased blood pressure
• pancreatitis
• esophagitis
• intestinal stricture
• liver failure
• hair loss (alopecia)

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

• worsening of ulcerative colitis and Crohn's disease (intestinal disease)

Medicines like IbuTeva may cause a small increased risk of heart attack (myocardial infarction) or stroke.
Fluid retention (edema), increased blood pressure, and heart failure have been observed with the use of NSAIDs.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store IbuTeva

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the packaging after "Expiry date", "Expiration date", or "EXP". The expiry date refers to the last day of the month stated.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What IbuTeva contains

• The active substance of IbuTeva is ibuprofen. Each tablet contains 200 mg of ibuprofen.
• The other ingredients of the medicine are: Tablet core:microcrystalline cellulose, anhydrous colloidal silica, hydroxypropylcellulose, sodium lauryl sulfate, sodium croscarmellose, talc. Tablet coating(Opadry White 06B28499):hypromellose 5cP, hypromellose 15cP, hypromellose 50cP, macrogol 400, titanium dioxide (E 171).

What IbuTeva looks like and contents of the pack

Coated tablet.
200 mg: white, oval, biconvex coated tablets with a score line on one side.
Pack sizes:
Blisters:6, 10, 12, or 24 coated tablets.
Bottle:30 or 50 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel. (22) 345 93 00

Manufacturer:

Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
Medis International a.s.
výrobní závod Bolatice
Průmyslová 961/16, 747 23 Bolatice
Czech Republic
Balkanpharma-Razgrad AD
68 Aprilsko vastanie Bled
Razgrad 7200
Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Ireland
Buplex 400 mg film-coated tablets
Malta
Irfen 400 mg
Norway
Ifenin
Poland
IbuTeva
Romania
Adagin Forte 400 mg film-coated tablets
Date of last revision of the leaflet:January 2022