Ibuteva Max

Leaflet accompanying the packaging: patient information

IbuTeva Max, 400 mg, coated tablets
Ibuprofen

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your 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, you should contact a doctor.

Table of contents of the leaflet

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

1. What is IbuTeva Max and what is it used for

IbuTeva Max belongs to a group of medicines called NSAIDs (nonsteroidal anti-inflammatory drugs), which work by reducing pain, inflammation, and high temperature.
IbuTeva Max 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 Max

When not to take IbuTeva Max:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• if you have 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 you have had stomach or duodenal ulcers or bleeding in the stomach or duodenum associated with the use of painkillers and anti-inflammatory drugs (NSAIDs)
• if you have stomach or duodenal ulcers or bleeding, or if you have had two or more such episodes in the past
• if you have severe liver, kidney, or heart problems (including coronary artery disease)
• if you are in the last three months of pregnancy
• if you are significantly dehydrated (due to vomiting, diarrhea, or insufficient hydration)
• if you have active bleeding (including cerebral hemorrhage)
• if you have been diagnosed with unknown origin disorders causing abnormal blood cell production.

Warnings and precautions

You should discuss with your doctor before starting to take IbuTeva Max:

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

You should use the lowest possible dose for the shortest possible time to reduce the risk of side effects.
Effect on the digestive system
You should avoid taking IbuTeva Max with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
Elderly patients
If you are elderly, you may be more prone to side effects, especially gastrointestinal bleeding and perforation, which can be fatal.
Ulcers, perforations, and bleeding in the stomach or duodenum
If you have had stomach or duodenal ulcers in the past, especially if they were complicated by perforation or bleeding, you should be carefully monitored for any unusual abdominal symptoms and immediately inform your doctor, especially if they occur at the beginning of treatment. The risk of gastrointestinal bleeding and ulcers is higher in elderly patients. If gastrointestinal bleeding or ulcers occur, treatment must be discontinued.
Bleeding, ulcers, or perforation of the stomach or intestines may occur without warning signs, even in patients who have never had such problems before. It can be fatal.
The risk of ulcers, perforations, or bleeding in the digestive system usually increases with high doses of ibuprofen. The risk also increases if certain other medicines are taken at the same time (see "IbuTeva Max 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. You should not exceed the recommended dose or duration of treatment.
Before starting to take IbuTeva Max, you should discuss it with your doctor or pharmacist if:

• you have heart problems, including heart failure, angina pectoris, or if you have had a heart attack, bypass surgery, or any stroke or transient ischemic attack (TIA).
• you have high blood pressure, diabetes, high cholesterol, or if any of your family members have heart problems or stroke, or if you are 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 may occur, as well as heart failure or increased blood pressure in patients with a tendency to these conditions.
Ibuprofen may cause kidney damage, especially in patients who have recently had kidney, heart, or liver problems, patients taking diuretics or angiotensin-converting enzyme (ACE) inhibitors, as well as elderly patients.
Stopping ibuprofen usually leads to improvement.
Skin reactions
Severe skin reactions have been reported with ibuprofen. If you experience: any skin rash, changes in mucous membranes, blisters, or other signs of allergy, you should stop taking ibuprofen and seek medical attention 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 related to chickenpox. If you are taking this medicine while an infection is present, and the symptoms of the infection persist or worsen, you should immediately consult a doctor.
Chickenpox
During chickenpox (varicella), it is recommended to avoid taking ibuprofen.
Aseptic meningitis (meningitis without bacterial infection)
During ibuprofen treatment, cases of meningitis (symptoms include stiff neck, headache, nausea, vomiting, fever, or disorientation) have been reported. 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 Max may make it difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you have problems becoming pregnant. See "Pregnancy, breastfeeding, and fertility".
Children and adolescents
You should not use it in children under 12 years of age.

IbuTeva Max and other medicines

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

• In particular, you should inform your doctor or pharmacist if you are taking any of the following medicines: other nonsteroidal anti-inflammatory drugs (NSAIDs)
• anticoagulant medicines (blood thinners or anticoagulants, e.g., acetylsalicylic acid, warfarin, heparin)
• platelet aggregation inhibitors (anti-clotting agents, such as clopidogrel, ticlopidine)
• selective serotonin reuptake inhibitors (antidepressants, 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 or ritonavir (used to treat HIV-infected 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 for osteoporosis, Paget's disease, and to reduce calcium levels in the blood)
• pentoxifylline (oxpentifylline) (used to treat circulation disorders in the arms and legs)
• baclofen (a muscle relaxant)
• ginkgo biloba (ginkgo biloba).

IbuTeva Max with food and drink

IbuTeva Max should be swallowed with a glass of water during or after meals.
You should avoid consuming alcohol, as it may increase the side effects of IbuTeva Max, especially those related to the stomach, intestines, or brain.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult a doctor or pharmacist before taking this medicine.
IbuTeva Max 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 delay labor.
During the first 6 months of pregnancy, IbuTeva Max should only be used on the advice of a doctor and only if it is absolutely necessary.
During breastfeeding, 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, you 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 therapy.

Driving and using machines

Ibuprofen may impair reaction time in some patients due to side effects such as dizziness, drowsiness, or vision disturbances. In individual cases, the ability to drive or operate machines may be impaired. This effect may be increased if alcohol is consumed at the same time.
IbuTeva Max 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 Max

IbuTeva Max should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
You should use the lowest effective dose for the shortest possible time to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, you should immediately consult a doctor (see section 2).
In adults, IbuTeva Max should not be used without consulting a doctor for more than 7 days.
In children and adolescents, IbuTeva Max 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

½ to 1 tablet given as a single dose or 3 to 4 times a day every 4 to 6 hours.
The maximum daily dose should not exceed 3 tablets (1200 mg).
Migraine
1 tablet given 1-3 times a day, every 4 to 6 hours.
The maximum daily dose should not exceed 3 tablets (1200mg).
Painful menstruation
½ to 1 tablet given 1 to 3 times a day if necessary, every 4 to 6 hours. The maximum dose should not exceed 3 tablets (1200 mg) per day.

Method of administration:

Tablets should be swallowed with a glass of water during or after meals. To facilitate swallowing or adjust the dose, tablets may be divided in half.
If in adults after 7 days there is no improvement or the symptoms worsen, you should contact a doctor. If it is necessary to use the medicine in children and adolescents for more than 3 days or if the symptoms worsen, you should consult a doctor.
Elderly patients
If you are elderly, you should always consult a doctor before starting to take IbuTeva Max, as you 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 you have reduced liver or kidney function, you should always consult a doctor before taking IbuTeva Max. The doctor will recommend the appropriate use of the medicine.

Taking a higher dose of IbuTeva Max than recommended:

If you have taken a higher dose of IbuTeva Max than recommended or if a child has accidentally taken the medicine, you should always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to your health and advice on what to do in such a case.
Overdose symptoms may include: nausea, stomach pain, diarrhea, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. Bleeding in the stomach or intestines may also occur.
After taking a large dose, in severe cases of overdose, the following have been reported: drowsiness, chest pain, palpitations, loss of consciousness, agitation, disorientation, coma, seizures (mainly 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, worsening of the disease may occur.

Missing a dose of IbuTeva Max:

If you miss a dose, you should take it as soon as possible, unless there are less than four hours left before the next dose.
You should not take a double dose to make up for a missed dose of the medicine.
In case of doubts about taking the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, IbuTeva Max can cause side effects, although not everybody gets them.
The occurrence of side effects is more likely after taking high doses and long-term treatment.
The following side effects are important and require immediate action. You should stop taking IbuTeva Max and immediately consult a doctor if you 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, significant drop in blood pressure, or life-threatening shock (anaphylactic reaction, rare side effect)
• If you experience an infection with symptoms such as fever and severe deterioration of general health or fever with local signs of infection, such as sore throat, mouth, or urinary problems, you should immediately consult a doctor. Ibuprofen may cause a decrease in the number of white blood cells, which may lead to reduced immunity to infections. You should inform your doctor about taking this medicine.
• Severe skin and mucous membrane reactions with rash, skin peeling, especially on the hands and feet, which may also affect the face and mouth (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, very rare side effects).
• It can also occur in a more severe form, with blisters merging and skin necrosis (Lyell's syndrome). It can also occur with severe infection and tissue necrosis (necrotizing fasciitis, very rare side effect)
• Severe skin reactions known as DRESS syndrome may occur. 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 unknown)
• A red, scaly rash with thickening of the skin and blisters, usually in skin folds, on the trunk, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis, AGEP, frequency unknown). If such symptoms occur, you should stop taking IbuTeva Max and seek medical attention immediately. See also section 2.

Other possible side effects
Common (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)
• 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
• Hepatitis, jaundice, abnormal liver function
• Itching, small bruises on the skin and mucous membranes
• Photosensitivity
• Impaired kidney function
• Drowsiness
• Numbness
• Hearing loss

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

• Anaphylactic reaction
• Depression, disorientation
• Vision disturbances
• Tinnitus (ringing in the ears), vertigo of labyrinthine origin
• Liver damage
• Fluid retention (edema), increased blood urea nitrogen and liver enzyme activity, 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 disorders (anemia, leukopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis)
• Heart failure, myocardial infarction, 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 ulcers in the colon (ulcerative colitis) and Crohn's disease (inflammatory bowel disease)

Medicines like IbuTeva Max 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.
Taking IbuTeva Max may cause a decrease in the number of white blood cells and the patient's immunity to infections. If you experience an infection with symptoms such as fever and severe deterioration of general health or fever with local signs of infection, such as sore throat, mouth, or urinary problems, you should immediately consult a doctor. Blood tests will be performed to check for possible decreased white blood cell count (agranulocytosis). It is important to inform your doctor about taking this medicine.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your 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 the medicine.

5. How to store IbuTeva Max

The medicine should be stored out of sight and reach of children.
You should not use 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. You should ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What IbuTeva Max contains

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

What IbuTeva Max looks like and contents of the pack

Coated tablet.
400 mg: white, oval, biconvex coated tablets with a dividing line on one side.
Pack sizes:
Blister packs:6, 12, or 24 coated tablets.
Bottle: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 Max
Romania
Adagin Forte 400 mg film-coated tablets
Date of last revision of the leaflet:January 2022