Ibuprofen Forte Doz

Leaflet attached to the packaging: patient information

IBUPROFEN FORTE DOZ, 400 mg, coated tablets

Ibuprofen

You should carefully read the contents of the leaflet 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.

• 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 the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If symptoms worsen or do not improve after 3 days, you should contact a doctor.

Table of contents of the leaflet

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

1. What is Ibuprofen Forte DOZ and what is it used for

The active substance of Ibuprofen Forte DOZ is ibuprofen.
Ibuprofen belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs) that have anti-inflammatory, analgesic, and antipyretic effects.
Ibuprofen Forte DOZ is used to treat:

• pain of various origins with mild to moderate severity: headache (including tension headache and migraine), toothache, muscle, joint, and bone pain, pain associated with flu and colds, neuralgia;
• fever of various origins (including flu, colds, or other infectious diseases);
• painful menstruation.

The medicine is intended for short-term use.

2. Important information before taking Ibuprofen Forte DOZ

When not to take Ibuprofen Forte DOZ

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had symptoms of hypersensitivity after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, such as rhinitis, urticaria, edema, or asthma;
• if the patient has or has had stomach or duodenal ulcer, perforation (hole) or bleeding from the gastrointestinal tract (two or more episodes), also related to previous NSAID treatment;
• in patients with severe liver or kidney failure;
• in patients with severe heart failure;
• if the patient has had cerebral bleeding or other active bleeding;
• in patients taking other nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors) at the same time, as there is an increased risk of side effects;
• in women in the last three months of pregnancy;
• in patients with a bleeding disorder (tendency to bleed).

Warnings and precautions

• if the patient has connective tissue diseases, such as systemic lupus erythematosus and mixed connective tissue disease;
• if the patient has or has had intestinal disease (ulcerative colitis, Crohn's disease);
• if the patient has high blood pressure and/or heart disease;
• if the patient has kidney problems;
• if the patient has liver problems;
• immediately after major surgical procedures;
• if the patient has bleeding disorders;
• if the patient has asthma or has had an allergic reaction, as taking the medicine may cause bronchospasm;
• drinking alcohol while taking ibuprofen increases the risk of side effects;
• when the patient is taking other medicines [corticosteroids, diuretics, cardiac glycosides, and especially anticoagulants], they should consult a doctor before taking ibuprofen with these medicines;
• there is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal. These reactions do not have to be preceded by warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be stopped immediately;
• patients with current or past gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period;
• concomitant, long-term use of different painkillers may lead to kidney damage and even kidney failure (so-called analgesic nephropathy);
• this medicine belongs to a group of drugs that may adversely affect female fertility. This effect is temporary and disappears after treatment is stopped;
• in case of chickenpox, it is recommended to avoid taking the medicine.

Skin reactions
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP), have been reported with ibuprofen use. If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should stop taking Ibuprofen Forte DOZ and seek medical attention immediately.
Taking anti-inflammatory/pain-relieving drugs like 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. If symptoms persist, worsen, or do not improve after 3 days in the case of fever and after 4 days in the case of pain, or if new symptoms occur, you should consult a doctor.
During ibuprofen treatment, allergic reactions to the drug have occurred, including difficulty breathing, facial and neck edema (angioedema), and chest pain. If any of these symptoms are noticed, the patient should stop taking Ibuprofen Forte DOZ immediately and consult a doctor or emergency medical services immediately.
Before taking Ibuprofen Forte DOZ, the patient should discuss treatment with their doctor or pharmacist:

• if the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, has had coronary artery bypass grafting, has peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has had a stroke (including a mini-stroke or transient ischemic attack - TIA);
• if the patient has high blood pressure, diabetes, high cholesterol, has a family history of heart disease or stroke, or smokes;
• if the patient has an infection - see below, the section entitled "Infections". Ibuprofen Forte DOZ may mask the signs of infection, such as fever and pain. Therefore, Ibuprofen Forte DOZ may delay the start of appropriate infection treatment, which may lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medicine while having an infection and the infection symptoms persist or worsen, they should consult a doctor immediately.

Ibuprofen Forte DOZ and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those obtained without a prescription. Ibuprofen Forte DOZ may affect the action of other medicines, and other medicines may affect the action of Ibuprofen Forte DOZ.
For example:

• blood-thinning medicines (e.g., aspirin, warfarin, ticlopidine);
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan). Other medicines may also be affected or have an effect on ibuprofen treatment. Therefore, before taking Ibuprofen Forte DOZ with other medicines, the patient should always consult their doctor or pharmacist. Ibuprofen Forte DOZ should not be taken with the following medicines:
• acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs,
• digoxin, used in heart failure,
• medicines used to treat high blood pressure,
• diuretics,
• antiplatelet agents,
• anticoagulants,
• phenytoin, used to treat epilepsy,
• selective serotonin reuptake inhibitors, used to treat depression,
• lithium, used to treat mental disorders,
• probenecid and sulfinpyrazone, used to treat gout,
• potassium-sparing diuretics,
• methotrexate, used to treat cancer,
• zidovudine, used to treat HIV infection (human immunodeficiency virus),
• corticosteroids, used in inflammatory conditions,
• tacrolimus and cyclosporin, used to treat atopic dermatitis,
• sulfonylurea derivatives, used to treat diabetes,
• quinolone antibiotics.

Taking Ibuprofen Forte DOZ with food and drink

Ibuprofen Forte DOZ should be taken with a large amount of water.
In patients with gastrointestinal problems, it is recommended to take the medicine with food.

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.
Pregnancy
Taking Ibuprofen Forte DOZ during the last three months of pregnancy is contraindicated, as it may increase the risk of complications for the mother and child before and after delivery and cause complications during delivery. The medicine may cause kidney and heart problems in the unborn child. It may affect the mother's and child's tendency to bleed and cause prolonged or delayed delivery.
In the first six months of pregnancy, Ibuprofen Forte DOZ should not be taken unless it is necessary and advised by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest dose should be used for the shortest possible time.
Ibuprofen Forte DOZ taken for more than a few days, starting from the 20th week of pregnancy, may cause kidney problems in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the fetal ductus arteriosus. If the patient needs to take the medicine for more than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts.
So far, no cases of side effects have been reported in breastfed infants.
It is not necessary to stop breastfeeding during short-term treatment with ibuprofen at recommended doses.
Fertility
The medicine belongs to a group of NSAIDs that may adversely affect female fertility. This effect is temporary and disappears after treatment is stopped.

Driving and using machines

There is no data on the effect of Ibuprofen Forte DOZ on the ability to drive and use machines.

Ibuprofen Forte DOZ contains sodium

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

3. How to take Ibuprofen Forte DOZ

This medicine should always be taken exactly as described in this patient leaflet or as advised by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The patient should take the smallest effective dose for the shortest necessary period to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult a doctor immediately (see section 2).
Usual doses:
Adults and adolescents over 12 years: the initial dose is one tablet, then another tablet can be taken if necessary after 4 hours. Do not take more than three tablets (1200 mg of ibuprofen) in 24 hours. A 4-hour interval should be maintained between doses.
No dose change is necessary in the elderly.
Tablets should be taken after a meal and washed down with water. In patients with gastrointestinal problems, it is recommended to take the medicine with food.
The medicine should not be taken by children under 12 years of age.
The medicine is intended for oral use only and short-term use. The patient should take the smallest effective dose for the shortest period to relieve symptoms. The medicine should not be taken for more than 3 days without a doctor's recommendation.
If symptoms persist, worsen, or new symptoms occur, the patient should consult a doctor.

Taking a higher dose of Ibuprofen Forte DOZ than recommended

Overdose cases are rare. If the patient has taken a higher dose of Ibuprofen Forte DOZ than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what actions to take. The doctor may order gastric lavage. Activated charcoal can be given orally within 1 hour of overdose.
In most patients, overdose symptoms may occur: nausea, vomiting, abdominal pain, diarrhea, tinnitus, headache, gastrointestinal bleeding.
Severe poisoning affects the nervous system and is characterized by drowsiness, and very rarely, excitement, disorientation, or coma may also occur. Seizures may occur very rarely.
During severe poisonings, the following may also occur: metabolic acidosis, bleeding disorders, acute kidney failure, or liver damage. Symptoms of metabolic acidosis may include nausea, stomach pain, vomiting (which may contain blood), headache, tinnitus, disorientation, and nystagmus. 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 occurred. In patients with asthma, asthma symptoms may worsen. Additionally, low blood pressure and shallow breathing may occur.

Missing a dose of Ibuprofen Forte DOZ

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Ibuprofen Forte DOZ

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 Forte DOZ can cause side effects, although not everybody gets them.
Taking medicines like Ibuprofen Forte DOZ may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Ibuprofen Forte DOZ is generally well-tolerated. In some patients taking ibuprofen for a short period and in doses available without a prescription, the following side effects have occurred:
Uncommon (affecting more than 1 in 1,000 patients but less than 1 in 100 patients): indigestion, abdominal pain, nausea, headaches, urticaria, itching.
Rare (affecting more than 1 in 10,000 patients but less than 1 in 1,000 patients): diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, excitement, irritability, or fatigue.
Very rare (affecting less than 1 in 10,000 patients): worsening of ulcerative colitis and Crohn's disease (chronic inflammatory bowel diseases), stomach and duodenal ulcers, perforations (holes) and bleeding from the gastrointestinal tract (symptoms include black stools, bloody vomiting), sometimes fatal, especially in the elderly, acute kidney failure, kidney necrosis with edema, especially during long-term use, liver function disorders, especially during long-term use, anemia, decreased white blood cell count (leukopenia), decreased platelet count (thrombocytopenia), a disorder characterized by a lack of red blood cells, white blood cells, and platelets (pancytopenia), decreased granulocyte count (agranulocytosis) - the first symptoms of blood disorders are fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, unexplained bleeding (e.g., bruising, petechiae, purpura, nosebleeds), facial edema, tongue and laryngeal edema, shortness of breath, rapid heartbeat (tachycardia), low blood pressure (hypotension), worsening of asthma symptoms and bronchospasm, palpitations, heart failure, and heart attack.
Additionally, severe skin reactions may occur, such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If severe skin reactions occur, the patient should stop taking ibuprofen immediately and seek medical attention.
Frequency not known:

• skin becomes sensitive to light,
• red, scaly rash with bumps under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking Ibuprofen Forte DOZ immediately and seek medical attention immediately. See also section 2.
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

In patients with autoimmune diseases (in which the immune system destroys its own tissues, such as systemic lupus erythematosus), single cases of symptoms have been reported during ibuprofen treatment, which occur in aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever, and disorientation.
Severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: widespread skin rash, high body temperature, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell). If such symptoms occur, the patient should stop taking Ibuprofen Forte DOZ immediately and seek medical attention immediately.
When taking ibuprofen for other indications and long-term, other side effects may occur.

If any of the side effects worsen or any side effects not listed in the leaflet occur, the patient should tell their doctor or pharmacist.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient 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
Jerozolimskie Avenue 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Ibuprofen Forte DOZ

Keep out of the sight and reach of children.
There are no special storage instructions.
Do not take Ibuprofen Forte DOZ after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 Forte DOZ contains

• The active substance of Ibuprofen Forte DOZ is ibuprofen (Ibuprofenum). Each coated tablet contains 400 mg of ibuprofen.
• The medicine also contains povidone, corn starch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate. The coating contains Aqua Polish P white 010.28: hypromellose, macrogol, talc, titanium dioxide (E 171).

What Ibuprofen Forte DOZ looks like and contents of the pack

Ibuprofen Forte DOZ is a coated tablet.
A carton box contains:

• 5 tablets, 10 tablets, or 20 tablets in PVC/Aluminum blisters;
• 60 tablets in an HDPE container with an LDPE cap;
• 60 tablets in an HDPE container with a PE screw cap and a seal.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
DOZ S.A.
Jerozolimskie Avenue 134
02-305 Warsaw
Phone number: 800 110 110
Manufacturer:
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza Street 25A
11-001 Dywity

Date of last revision of the leaflet: